| 1 |
NCT02915302 |
Completed
Has Results |
Safety and Immunogenicity of Fluzone® Quadrivalent Vaccine Administered to Healthy Children |
|
- Biological: Fluzone Quadrivalent vaccine, No Preservative
|
Interventional
|
Phase 4 |
- Sanofi Pasteur, a Sanofi Company
- Sanofi
|
Industry |
- Allocation: Randomized
- Intervention Model: Parallel Assignment
- Masking: Single (Outcomes Assessor)
- Primary Purpose: Prevention
|
- Percentage of Participants With Fever (Fever Rate) Following Vaccination With Fluzone Quadrivalent Vaccine
- Geometric Mean Titers (GMTs) of Influenza Vaccine Antibodies
- Percentage of Participants With Seroconversion (Seroconversion Rate [SCR]) to Influenza Vaccine Antigens
|
1950 |
All |
6 Months to 35 Months (Child) |
NCT02915302 |
GRC88
U1111-1143-9273 |
|
September 23, 2016 |
March 6, 2017 |
March 6, 2017 |
September 27, 2016 |
April 3, 2018 |
April 3, 2018 |
- Birmingham, Alabama, United States
- Harrisburg, Arkansas, United States
- Downey, California, United States
- (and 33 more...)
|
|
| 2 |
NCT03546192 |
Completed
Has Results |
Immunogenicity and Safety of Fluzone® Quadrivalent, Southern Hemisphere 2015 Formulation (Intramuscular Route) |
|
- Biological: Fluzone Quadrivalent Influenza Vaccine
|
Interventional
|
Phase 4 |
- Sanofi Pasteur, a Sanofi Company
- Sanofi
|
Industry |
- Allocation: Non-Randomized
- Intervention Model: Parallel Assignment
- Masking: None (Open Label)
- Primary Purpose: Prevention
|
- Number of Participants With Seroprotection to Influenza Vaccine Antigens at Day 0 (Pre-vaccination) and Day 21 (Post-vaccination)
- Geometric Mean Titers (GMTs) of Influenza Vaccine Antibodies at Day 0 (Pre-vaccination) and Day 21 (Post-vaccination)
- Geometric Mean Titer Ratio (GMTR) of Influenza Vaccine Antibodies
- (and 3 more...)
|
120 |
All |
18 Years and older (Adult, Older Adult) |
NCT03546192 |
GRC85
U1111-1143-9256 |
|
June 17, 2015 |
July 17, 2015 |
July 17, 2015 |
June 5, 2018 |
August 1, 2018 |
August 1, 2018 |
- Sanofi Pasteur Investigational Site 002
Manila, Philippines - Sanofi Pasteur Investigational Site 003
Manila, Philippines - Sanofi Pasteur Investigational Site 001
Quezon City, Philippines
|
|
| 3 |
NCT02222870 |
Completed
Has Results |
Safety and Immunogenicity Among Healthy Children Receiving Fluzone® Quadrivalent, Influenza Vaccine |
|
- Biological: Fluzone® Quadrivalent Influenza Vaccine, No Preservative
|
Interventional
|
Phase 4 |
- Sanofi Pasteur, a Sanofi Company
- Sanofi
|
Industry |
- Allocation: Randomized
- Intervention Model: Parallel Assignment
- Masking: None (Open Label)
- Primary Purpose: Prevention
|
- Percentage of Participants Reporting Solicited Injection-site or Systemic Reactions Following Vaccination With the 2014-2015 Formulation of Fluzone® Quadrivalent Influenza Vaccine
- Geometric Mean Titers (GMTs) of Influenza Antibodies Before and Post Vaccination With the 2014-2015 Formulation of Fluzone® Quadrivalent Influenza Vaccine
- Number of Participants With Seroprotection Before and Following Vaccination With the 2014-2015 Formulation of Fluzone® Quadrivalent Vaccine
- (and 2 more...)
|
60 |
All |
6 Months to 8 Years (Child) |
NCT02222870 |
GRC56
U1111-1143-8966 |
|
August 2014 |
December 2014 |
June 2015 |
August 21, 2014 |
October 19, 2015 |
October 19, 2015 |
- Bardstown, Kentucky, United States
- Salt Lake City, Utah, United States
|
|
| 4 |
NCT02539108 |
Completed
Has Results |
Safety and Immunogenicity of the 2015-2016 Formulation of Fluzone® Quadrivalent (Influenza Vaccine) Among Healthy Children |
|
- Biological: Fluzone® Quadrivalent Influenza Vaccine, No Preservative
|
Interventional
|
Phase 4 |
- Sanofi Pasteur, a Sanofi Company
- Sanofi
|
Industry |
- Allocation: Non-Randomized
- Intervention Model: Parallel Assignment
- Masking: None (Open Label)
- Primary Purpose: Prevention
|
- Number of Participants Reporting Solicited Injection-Site and Solicited Systemic Reactions Following Vaccination With the 2015-2016 Formulation of Fluzone® Quadrivalent Influenza Vaccine.
- Geometric Mean Titers of Influenza Virus Antibodies Following Vaccination With the 2015-2016 Formulation of Fluzone® Quadrivalent Influenza Vaccine
- Number of Participants Who Achieved Seroprotection to Influenza Virus Antigens Pre- and Post-Vaccination With the 2015-2016 Formulation of Fluzone® Quadrivalent Influenza Vaccine
- (and 2 more...)
|
60 |
All |
6 Months to 8 Years (Child) |
NCT02539108 |
GRC58
U1111-1161-2526 |
|
August 2015 |
December 2015 |
July 2016 |
September 2, 2015 |
November 29, 2016 |
October 20, 2016 |
- Bardstown, Kentucky, United States
- Salt Lake City, Utah, United States
|
|
| 5 |
NCT02908269 |
Completed
Has Results |
Safety and Immunogenicity of Fluzone® Quadrivalent and Fluzone® High-Dose, Influenza Vaccines, 2016-2017 Formulations |
|
- Biological: Fluzone Quadrivalent vaccine, 2016-2017 formulation, No Preservative
- Biological: Fluzone High-Dose, vaccine, 2016-2017 formulation
|
Interventional
|
Phase 4 |
- Sanofi Pasteur, a Sanofi Company
- Sanofi
|
Industry |
- Allocation: Non-Randomized
- Intervention Model: Parallel Assignment
- Masking: None (Open Label)
- Primary Purpose: Prevention
|
- Number of Participants Reporting Solicited Injection Site Reactions (Pain, Erythema, and Swelling) and Systemic Reactions (Fever, Headache, Malaise, Myalgia): Group 1 (3 to < 9 Years of Age)
- Number of Participants Reporting Solicited Injection Site Reactions (Pain, Erythema, and Swelling) and Systemic Reactions (Fever, Headache, Malaise, Myalgia): Group 2 (18 to < 65 Years) and Group 3 (≥ 65 Years)
- Geometric Mean Titers (GMTs) of Influenza Vaccine Antibodies (Group 1: 3 to < 9 Years)
- (and 5 more...)
|
180 |
All |
3 Years and older (Child, Adult, Older Adult) |
NCT02908269 |
GRC71
U1111-1174-4738 |
|
September 15, 2016 |
December 9, 2016 |
December 9, 2016 |
September 20, 2016 |
February 2, 2018 |
January 8, 2018 |
- Bardstown, Kentucky, United States
- Metairie, Louisiana, United States
|
|
| 6 |
NCT01430819 |
Completed
Has Results |
Study of Fluzone® Influenza Virus Vaccine 2011-2012 Formulation (Intramuscular Route) Among Adults |
|
- Biological: Influenza Virus Vaccine: Fluzone® 2011-2012 Formulation
- Biological: Influenza Virus Vaccine: Fluzone® High-Dose 2011-2012 Formulation
|
Interventional
|
Phase 4 |
- Sanofi Pasteur, a Sanofi Company
- Sanofi
|
Industry |
- Allocation: Randomized
- Intervention Model: Parallel Assignment
- Masking: Triple (Participant, Investigator, Outcomes Assessor)
- Primary Purpose: Prevention
|
- Number of Participants Reporting at Least One Solicited Injection Site or Systemic Reaction Following Vaccination With One Dose of Either Fluzone® or Fluzone® High-Dose Vaccine
|
300 |
All |
65 Years and older (Older Adult) |
NCT01430819 |
GRC48
U 1111-1120-1287 |
|
September 2011 |
February 2012 |
February 2012 |
September 8, 2011 |
May 27, 2013 |
May 16, 2013 |
- Colorado Springs, Colorado, United States
- Council Buffs, Iowa, United States
- Metairie, Louisiana, United States
- (and 3 more...)
|
|
| 7 |
NCT02563093 |
Completed
Has Results |
Study of Fluzone® Quadrivalent, Fluzone® Intradermal Quadrivalent, and Fluzone® High-Dose, Influenza Vaccines in Adults |
|
- Biological: Fluzone Quadrivalent vaccine, 2015-2016 formulation, No Preservative
- Biological: Fluzone Intradermal Quadrivalent vaccine, 2015-2016 formulation
- Biological: Fluzone High-Dose vaccine, 2015-2016 formulation
|
Interventional
|
Phase 4 |
- Sanofi Pasteur, a Sanofi Company
- Sanofi
|
Industry |
- Allocation: Randomized
- Intervention Model: Parallel Assignment
- Masking: None (Open Label)
- Primary Purpose: Prevention
|
- Number of Participants With Solicited Injection-Site or Systemic Reactions After Receipt of the 2015-2016 Formulation of Fluzone Quadrivalent, Fluzone Intradermal Quadrivalent, or Fluzone High-Dose Vaccine
- Geometric Mean Titers of Influenza Antibodies Pre- and Post-Vaccination With the 2015-2016 Formulation of Fluzone Quadrivalent, Fluzone Intradermal Quadrivalent, or Fluzone High-Dose Vaccine
- Number of Participants Achieving Seroprotection Pre and Post-Vaccination With the 2015-2016 Formulation of Fluzone Quadrivalent, Fluzone Intradermal Quadrivalent, or Fluzone High-Dose Vaccine
- (and 2 more...)
|
208 |
All |
18 Years and older (Adult, Older Adult) |
NCT02563093 |
GRC57
U1111-1161-2491 |
|
September 2015 |
December 2015 |
July 2016 |
September 29, 2015 |
December 12, 2016 |
December 12, 2016 |
- Santa Rosa, California, United States
- Council Bluffs, Iowa, United States
- Metairie, Louisiana, United States
- Cincinnati, Ohio, United States
|
|
| 8 |
NCT02258334 |
Completed
Has Results |
Study of Fluzone® Quadrivalent, Fluzone® Intradermal, and Fluzone® High-Dose, Influenza Vaccines in Adults |
|
- Biological: Fluzone® Quadrivalent vaccine, 2014-2015 formulation
- Biological: Fluzone I®ntradermal vaccine, 2014-2015 formulation
- Biological: Fluzone High Dose vaccine, 2014-2015 formulation
|
Interventional
|
Phase 4 |
- Sanofi Pasteur, a Sanofi Company
- Sanofi
|
Industry |
- Allocation: Randomized
- Intervention Model: Parallel Assignment
- Masking: None (Open Label)
- Primary Purpose: Prevention
|
- Percentage of Participants Reporting Solicited Injection-site and Solicited Systemic Reactions Following Vaccination With the 2014-2015 Formulation of Fluzone® Quadrivalent or Fluzone® Intradermal or Fluzone® High-Dose Vaccine
- Geometric Mean Titers (GMTs) of Antibodies to the 2014-2015 Formulation of Fluzone® Quadrivalent or Fluzone® Intradermal or Fluzone® High-Dose Vaccine Antigens Before and Following Vaccination With the Respective Vaccine.
- Percentage of Participants With Seroprotection Before and Following Vaccination With the 2014-2015 Formulation of Fluzone® Quadrivalent or Fluzone® Intradermal or Fluzone® High-Dose Vaccine.
- (and 2 more...)
|
208 |
All |
18 Years and older (Adult, Older Adult) |
NCT02258334 |
GRC55
U1111-1143-8931 |
|
October 2014 |
November 2014 |
December 2014 |
October 7, 2014 |
October 19, 2015 |
October 19, 2015 |
- Santa Rosa, California, United States
- Council Bluffs, Iowa, United States
- Metairie, Louisiana, United States
- Cincinnati, Ohio, United States
|
|
| 9 |
NCT01946425 |
Completed
Has Results |
Safety and Immunogenicity Among Healthy Children Receiving Fluzone® Quadrivalent Influenza Virus Vaccine |
|
- Biological: Fluzone® Quadrivalent Influenza Virus Vaccine, No Preservative
|
Interventional
|
Phase 4 |
- Sanofi Pasteur, a Sanofi Company
- Sanofi
|
Industry |
- Allocation: Non-Randomized
- Intervention Model: Parallel Assignment
- Masking: None (Open Label)
- Primary Purpose: Prevention
|
- Number of Participants Reporting Solicited Injection-Site or Systemic Reactions Following Vaccination With the 2013-2014 Formulation of Fluzone® Quadrivalent, Influenza Vaccine
- Geometric Mean Titers (GMTs) of Influenza Antibodies Before and Following Vaccination With the 2013-2014 Formulation of Fluzone® Quadrivalent, Influenza Vaccine
- Number of Participants With Seroprotection Before and Following Vaccination With the 2013-2014 Formulation of Fluzone® Quadrivalent, Influenza Vaccine
- (and 2 more...)
|
60 |
All |
6 Months to 8 Years (Child) |
NCT01946425 |
GRC51
U1111-1120-1262 |
|
September 2013 |
December 2013 |
July 2014 |
September 19, 2013 |
September 25, 2014 |
September 25, 2014 |
- Bardstown, Kentucky, United States
- Salt Lake City, Utah, United States
|
|
| 10 |
NCT01427309 |
Completed
Has Results |
A Study of Fluzone® High-Dose Vaccine Compared With Fluzone® Vaccine In Elderly Adults |
|
- Biological: High Dose Trivalent Inactivated Influenza Vaccine
- Biological: Trivalent Inactivated Influenza Vaccine
|
Interventional
|
Phase 4 |
- Sanofi Pasteur, a Sanofi Company
- Sanofi
|
Industry |
- Allocation: Randomized
- Intervention Model: Parallel Assignment
- Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
- Primary Purpose: Prevention
|
- Occurrences of Culture- or Polymerase Chain Reaction (PCR)-Confirmed Influenza Caused by Any Influenza Viral Types/Subtypes, in Association With a Protocol-defined Influenza-like Illness (ILI).
- Occurrences of Culture-confirmed Influenza Caused by Influenza Viral Types/Subtypes That Are Antigenically Similar to Those Contained in the Vaccine Formulations, in Association With a Protocol-defined Influenza-like Illness (ILI)
- Occurrences of Culture-confirmed Influenza Caused by Any Influenza Viral Types/Subtypes, in Association With a Protocol-defined Influenza-like Illness
- (and 4 more...)
|
31989 |
All |
65 Years and older (Older Adult) |
NCT01427309 |
FIM12
U1111-1120-1300 |
|
September 2011 |
May 2013 |
November 2013 |
September 1, 2011 |
April 20, 2015 |
August 6, 2014 |
- Mobile, Alabama, United States
- Chandler, Arizona, United States
- Glendale, Arizona, United States
- (and 110 more...)
|
|
| 11 |
NCT01691326 |
Completed
Has Results |
Safety and Immunogenicity Among Healthy Children Receiving Fluzone® Influenza Virus Vaccine (2012-2013 Formulation) |
|
- Biological: Fluzone®: Influenza Virus Vaccine, No Preservative: Pediatric Dose
- Biological: Fluzone®; Influenza Virus Vaccine, No Preservative
|
Interventional
|
Phase 4 |
- Sanofi Pasteur, a Sanofi Company
- Sanofi
|
Industry |
- Allocation: Non-Randomized
- Intervention Model: Parallel Assignment
- Masking: None (Open Label)
- Primary Purpose: Prevention
|
- Number of Participants Reporting Solicited Injection Site or Systemic Reactions Following Vaccination With Fluzone® Influenza Virus Vaccine (2012-2013 Formulation)
|
60 |
All |
6 Months to 8 Years (Child) |
NCT01691326 |
GRC49
U1111-1124-8218 |
|
September 2012 |
December 2012 |
February 2013 |
September 24, 2012 |
April 16, 2014 |
April 16, 2014 |
- Bardstown, Kentucky, United States
- Salt Lake City, Utah, United States
|
|
| 12 |
NCT00831987 |
Completed
Has Results |
Safety and Immunogenicity of the World Health Organization (WHO) Formulation of the 2004-2005 Fluzone® Vaccine |
|
- Biological: Fluzone®: Influenza virus vaccine 2004-2005 formulation
|
Interventional
|
Phase 4 |
- Sanofi Pasteur, a Sanofi Company
- Sanofi
|
Industry |
- Allocation: Non-Randomized
- Intervention Model: Parallel Assignment
- Masking: None (Open Label)
- Primary Purpose: Prevention
|
- Percentage of Participants With Solicited Local and Systemic Reactions After Fluzone® Vaccination
- Geometric Mean Titers (GMTs) of Hemagglutination Antibodies Pre- and Post-Vaccination With Fluzone® Vaccine
- Percentage of Participants With at Least 40 Serum Hemagglutination Inhibition Antibody Titers Post-Vaccination
- Percentage of Participants With at Least a 4-Fold Increase in Serum Hemagglutination Inhibition Antibody Titers Post-Vaccination
|
120 |
All |
18 Years and older (Adult, Older Adult) |
NCT00831987 |
GRC20 |
|
August 2004 |
February 2006 |
February 2006 |
January 29, 2009 |
April 14, 2016 |
August 27, 2009 |
- Norfolk, Virginia, United States
|
|
| 13 |
NCT01946438 |
Completed
Has Results |
Study of Fluzone® Quadrivalent, Fluzone® Intradermal, and Fluzone® High-Dose Influenza Virus Vaccines in Adults |
|
- Biological: Fluzone® Quadrivalent, Influenza Virus Vaccine (2013-2014 formulation),
- Biological: Fluzone® Intradermal, Influenza Virus Vaccine (2013-2014 formulation),
- Biological: Fluzone® High-Dose, Influenza Virus Vaccine (2013-2014 formulation)
|
Interventional
|
Phase 4 |
- Sanofi Pasteur, a Sanofi Company
- Sanofi
|
Industry |
- Allocation: Randomized
- Intervention Model: Parallel Assignment
- Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
- Primary Purpose: Prevention
|
- Number of Participants Reporting Solicited Injection-Site and Solicited Systemic Reactions Following Vaccination With the 2013-2014 Formulation of Fluzone® Quadrivalent, Fluzone® Intradermal, or Fluzone® High-Dose Vaccine.
- Geometric Mean Titers (GMTs) of Antibodies to the Antigens Contained in the 2013-2014 Formulation of Fluzone® Quadrivalent, Fluzone® Intradermal, or Fluzone® High-Dose Vaccine Before and Following Vaccination With the Respective Vaccine
- Number of Participants With Seroprotection Before and Following Vaccination With the 2013-2014 Formulation of Fluzone® Quadrivalent, Fluzone® Intradermal, or Fluzone® High-Dose Vaccine
- (and 2 more...)
|
208 |
All |
18 Years and older (Adult, Older Adult) |
NCT01946438 |
GRC52
U1111-1127-7587 |
|
September 2013 |
December 2013 |
July 2014 |
September 19, 2013 |
September 25, 2014 |
September 25, 2014 |
- Santa Rosa, California, United States
- Council Bluffs, Iowa, United States
- Metairie, Louisiana, United States
- Cincinnati, Ohio, United States
|
|
| 14 |
NCT00885105 |
Completed
Has Results |
Evaluation of Responses to Fluzone® in Infants ≥ 6 Months of Age Who Did or Did Not Receive Fluzone® at 2 Months of Age |
|
- Biological: Influenza Virus Vaccine
|
Interventional
|
Phase 3 |
- Sanofi Pasteur, a Sanofi Company
- Sanofi
|
Industry |
- Allocation: Non-Randomized
- Intervention Model: Parallel Assignment
- Masking: None (Open Label)
- Primary Purpose: Prevention
|
- Summary of Influenza Seroprotection Post-vaccination With Fluzone® Vaccine.
|
242 |
All |
6 Months to 11 Months (Child) |
NCT00885105 |
GRC32 |
|
October 2005 |
January 2006 |
September 2007 |
April 21, 2009 |
April 14, 2016 |
January 1, 2010 |
- Little Rock, Arkansas, United States
- Marietta, Georgia, United States
- Durham, North Carolina, United States
- (and 3 more...)
|
|
| 15 |
NCT00390884 |
Completed
Has Results |
Safety and Immunogenicity of Fluzone® Vaccine in Children Who Received 2 Doses of the 2005-2006 Fluzone Formulation. |
|
- Biological: Influenza Virus Vaccine, Fluzone®
|
Interventional
|
Phase 4 |
- Sanofi Pasteur, a Sanofi Company
- Sanofi
|
Industry |
- Allocation: Non-Randomized
- Intervention Model: Parallel Assignment
- Masking: None (Open Label)
- Primary Purpose: Prevention
|
- Percentage of Seroprotected Participants Post-vaccination With Fluzone®
- Geometric Mean Titers (GMTs) of Hemagglutination Inhibition Antibodies Post-vaccination With Fluzone®
|
173 |
All |
11 Months to 14 Months (Child) |
NCT00390884 |
GRC29 |
|
October 2006 |
June 2007 |
September 2008 |
October 23, 2006 |
April 14, 2016 |
December 31, 2009 |
- Layton, Utah, United States
- Pleasant Grove, Utah, United States
- Provo, Utah, United States
- (and 2 more...)
|
|
| 16 |
NCT00835926 |
Completed
Has Results |
A Study to Evaluate the Safety and Immune Responses to Fluzone® Vaccination |
|
- Biological: Influenza virus vaccine
|
Interventional
|
Phase 4 |
- Sanofi Pasteur, a Sanofi Company
- Sanofi
|
Industry |
- Allocation: Non-Randomized
- Intervention Model: Parallel Assignment
- Masking: None (Open Label)
- Primary Purpose: Prevention
|
- Percentage of Participants With Solicited Injection Site and Systemic Reactions Post-Vaccination With Fluzone®
- Geometric Mean Titers (GMTs) of Hemagglutination Inhibition Antibodies Before and After Vaccination With Fluzone®
- Percentage of Participants With a ≥ 4-Fold Rise in Serum Hemagglutination Inhibition Antibody Titers Post-Vaccination With Fluzone®
- Percentage of Participants With Serum Hemagglutination Inhibition Antibody Titers ≥ 40 Post-Vaccination With Fluzone®
|
121 |
All |
18 Years and older (Adult, Older Adult) |
NCT00835926 |
GRC16 |
|
July 2003 |
September 2003 |
September 2003 |
February 4, 2009 |
April 14, 2016 |
October 26, 2009 |
- Norfolk, Virginia, United States
|
|
| 17 |
NCT00976027 |
Terminated
Has Results |
Multi-Year Study of Fluzone High-Dose Influenza Vaccine Compared With Fluzone® Vaccine in Adults Aged 65 Years and Older |
|
- Biological: Trivalent inactivated influenza vaccine High Dose
- Biological: Trivalent inactivated influenza vaccine
|
Interventional
|
Phase 3 |
|
Industry |
- Allocation: Randomized
- Intervention Model: Parallel Assignment
- Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
- Primary Purpose: Prevention
|
- Efficacy of Fluzone High Dose Relative to Fluzone in the Prevention of Laboratory Confirmed Influenza Caused by Viral Types and Subtypes That Are Antigenically Similar to Those Contained in the Respective Annual Vaccine Formulations.
|
9172 |
All |
65 Years and older (Older Adult) |
NCT00976027 |
FIM07
UTN: U1111-1111-4478 |
|
September 2009 |
May 2011 |
April 2012 |
September 14, 2009 |
August 1, 2012 |
July 25, 2012 |
- Birmingham, Alabama, United States
- Glendale, Arizona, United States
- Mesa, Arizona, United States
- (and 95 more...)
|
|
| 18 |
NCT00561002 |
Completed
Has Results |
Phase IV Trial to Collect Safety Data and Sera for Immunogenicity Testing in Healthy Children Given Fluzone® Vaccine |
|
- Biological: 2007-2008 Influenza Virus Vaccine
|
Interventional
|
Phase 4 |
- Sanofi Pasteur, a Sanofi Company
- Sanofi
|
Industry |
- Allocation: Non-Randomized
- Intervention Model: Parallel Assignment
- Masking: None (Open Label)
- Primary Purpose: Prevention
|
- Number of Participants Who Had Solicited Injection Site and Systemic Reactions After Vaccination With Fluzone 2007-2008 Formulation
|
34 |
All |
6 Months to 35 Months (Child) |
NCT00561002 |
GRC38 |
|
October 2007 |
May 2008 |
June 2008 |
November 20, 2007 |
April 14, 2016 |
August 27, 2009 |
- Norfolk, Virginia, United States
|
|
| 19 |
NCT01011049 |
Completed
Has Results |
Study of Influenza Vaccine Revaccination in Healthy Adults Previously Vaccinated With Fluzone ID or Fluzone IM |
|
- Biological: Influenza Virus Vaccine USP Trivalent Types A and B
|
Interventional
|
Phase 2 |
- Sanofi Pasteur, a Sanofi Company
- Sanofi
|
Industry |
- Allocation: Randomized
- Intervention Model: Parallel Assignment
- Masking: None (Open Label)
- Primary Purpose: Prevention
|
- Number of Participants Reporting Solicited Injection Site and Systemic Reactions After Vaccination With Fluzone Intradermal or Fluzone Intramuscular Vaccine
- Geometric Mean Titers (GMTs) Before and After Vaccination With Fluzone Intradermal or Fluzone Intramuscular Vaccine
- Percentage of Participants Who Achieved Seroprotection Before and After Vaccination With Fluzone Intradermal or Fluzone Intramuscular Vaccine.
- Percentage of Subjects Who Achieved Seroconversion After Vaccination With Fluzone Intradermal or Fluzone Intramuscular Vaccine
|
1250 |
All |
18 Years to 64 Years (Adult) |
NCT01011049 |
FID33
UTN: U1111-1111-5095 |
|
September 2009 |
May 2010 |
October 2010 |
November 11, 2009 |
April 14, 2016 |
August 11, 2011 |
- Hoover, Alabama, United States
- Huntsville, Alabama, United States
- Mobile, Alabama, United States
- (and 42 more...)
|
|
| 20 |
NCT01685372 |
Completed
Has Results |
Immunogenicity of Fluzone High Dose in Immunocompromised Children and Young Adults |
- Solid Organ Transplant Recipient (Liver, Kidney, Heart)
- Rheumatologic Disorder
- Human Immunodeficiency Virus (HIV)
- (and 2 more...)
|
- Biological: Fluzone High Dose
- Biological: Fluzone
|
Interventional
|
Phase 2 |
- University of Colorado, Denver
- Colorado Clinical & Translational Sciences Institute
|
Other |
- Allocation: Randomized
- Intervention Model: Parallel Assignment
- Masking: Triple (Participant, Care Provider, Investigator)
- Primary Purpose: Prevention
|
- Number of Episodes of Influenza and Influenza-Like-Illness Reported in High Dose and Standard Dose Vaccination Groups
- Number of Subjects Seroprotected at Timepoint 2 in High Dose and Standard Dose Vaccination Groups
- Number of Adverse Events Definitely or Possibly Related to Vaccination Reported Within 14 Days of Vaccination
- (and 4 more...)
|
16 |
All |
5 Years to 35 Years (Child, Adult) |
NCT01685372 |
12-0829 |
|
September 2012 |
September 2015 |
September 2017 |
September 14, 2012 |
January 23, 2018 |
November 30, 2017 |
- Children's Hospital Colorado
Aurora, Colorado, United States
|
|
| 21 |
NCT00388583 |
Completed
Has Results |
Study of Inactivated, Split-Virion Influenza Vaccine Compared With Standard Fluzone Vaccine in Elderly Subjects |
- Orthomyxoviridae Infection
- Influenza
- Myxovirus Infection
|
- Biological: Split, Inactivated, Trivalent Influenza Vaccine
|
Interventional
|
Phase 2 |
|
Industry |
- Allocation: Randomized
- Intervention Model: Parallel Assignment
- Masking: None (Open Label)
- Primary Purpose: Prevention
|
- Number of Participants With at Least a 4-Fold Increase in Serum HAI Antibody Titer Post-vaccination With Either Fluzone Intradermal or Fluzone Intramuscular Vaccine.
- Number of Participants Who Achieved Seroprotection Post-vaccination With Either Fluzone Intradermal or Fluzone Intramuscular Vaccine.
- Geometric Mean Antibody Titers (GMTs) Before and Post-vaccination With Either Fluzone Intradermal and Fluzone Intramuscular Vaccine.
- Number of Participants Reporting a Solicited Injection Site or Systemic Reaction, Post Vaccination With Either Fluzone Intradermal or Fluzone Intramuscular Vaccine
|
817 |
All |
65 Years and older (Older Adult) |
NCT00388583 |
FID04 |
|
September 2006 |
June 2007 |
September 2008 |
October 17, 2006 |
April 18, 2012 |
September 13, 2011 |
- Alabaster, Alabama, United States
- Tucson, Arizona, United States
- Fountain Valley, California, United States
- (and 14 more...)
|
|
| 22 |
NCT00772109 |
Completed
Has Results |
Study of Fluzone Vaccine Administered by Intradermal Route in Comparison With Standard Fluzone® in Adults |
- Orthomyxoviridae Infection
- Influenza
- Myxovirus Infection
|
- Biological: Influenza Virus Vaccine USP Trivalent Types A and B
|
Interventional
|
Phase 3 |
- Sanofi Pasteur, a Sanofi Company
- Sanofi
|
Industry |
- Allocation: Randomized
- Intervention Model: Parallel Assignment
- Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
- Primary Purpose: Prevention
|
- Geometric Mean Titers (GMTs) at Baseline and Post-vaccination With Either Fluzone Intradermal or Fluzone Intramuscular Vaccines
- Percentage of Participants Who Achieved Seroconversion Post-vaccination With Either Fluzone Intradermal or Fluzone Intramuscular Vaccine
- Percentage of Participants Who Achieved Seroprotection Pre- and Post-vaccination With Either Fluzone ID or Fluzone IM
- Number of Participants Reporting a Solicited Injection Site or Systemic Reactions, Post Vaccination With Either Fluzone Intradermal or Fluzone Intramuscular Vaccine
|
4292 |
All |
18 Years to 64 Years (Adult) |
NCT00772109 |
FID31 |
|
October 2008 |
May 2009 |
July 2009 |
October 15, 2008 |
April 14, 2016 |
August 10, 2011 |
- Hoover, Alabama, United States
- Huntsville, Alabama, United States
- Mobile, Alabama, United States
- (and 46 more...)
|
|
| 23 |
NCT00831675 |
Completed
Has Results |
Study of Safety and Immunogenicity of Fluzone® in Healthy Children |
|
- Biological: Influenza Vaccine 2004-2005 Paediatric Formulation
|
Interventional
|
Phase 4 |
- Sanofi Pasteur, a Sanofi Company
- Sanofi
|
Industry |
- Allocation: Non-Randomized
- Intervention Model: Parallel Assignment
- Masking: None (Open Label)
- Primary Purpose: Prevention
|
- Number of Participants With Solicited Local and Systemic Reactions After Vaccination With Fluzone® 2004-2005 Pediatric Formulation
|
30 |
All |
6 Months to 35 Months (Child) |
NCT00831675 |
GRC21 |
|
September 2004 |
April 2006 |
April 2006 |
January 29, 2009 |
April 14, 2016 |
August 27, 2009 |
- Norfolk, Virginia, United States
|
|
| 24 |
NCT01205581 |
Completed
Has Results |
Immunogenicity of Fluzone HD,A High Dose Influenza Vaccine, In Children With Cancer or HIV |
|
- Biological: Fluzone High Dose Vaccine
- Biological: Fluzone Standard Dose Vaccine
|
Interventional
|
Phase 2 |
- St. Jude Children's Research Hospital
|
Other |
- Allocation: Randomized
- Intervention Model: Parallel Assignment
- Masking: None (Open Label)
- Primary Purpose: Treatment
|
- Rate of Seroconversion After 1 Dose of Vaccine
- Rate of Seroprotection After 1 Dose of Vaccine
- Number of Participants Achieving Seroprotection After Second Dose of Vaccine
- (and 11 more...)
|
85 |
All |
3 Years to 21 Years (Child, Adult) |
NCT01205581 |
FLUHD |
|
September 2010 |
August 2013 |
August 2013 |
September 20, 2010 |
September 23, 2016 |
September 12, 2014 |
- St. Jude Children's Research Hospital
Memphis, Tennessee, United States
|
|
| 25 |
NCT00836953 |
Completed
Has Results |
Study to Collect Sera for Immunogenicity Testing in Children Vaccinated With Fluzone® |
|
- Biological: Influenza virus vaccine (Pediatric formulation)
|
Interventional
|
Phase 4 |
- Sanofi Pasteur, a Sanofi Company
- Sanofi
|
Industry |
- Allocation: Non-Randomized
- Intervention Model: Single Group Assignment
- Masking: None (Open Label)
- Primary Purpose: Prevention
|
- Number of Participants Reporting Solicited Local and Systemic Reactions After Fluzone® Vaccination
|
33 |
All |
6 Months to 36 Months (Child) |
NCT00836953 |
GRC17 |
|
September 2003 |
January 2004 |
July 2004 |
February 4, 2009 |
April 14, 2016 |
August 27, 2009 |
- Norfolk, Virginia, United States
|
|
| 26 |
NCT01691339 |
Completed
Has Results |
Study of Fluzone® Influenza Virus Vaccines 2012-2013 Formulation Among Adults. |
|
- Biological: Influenza Virus Vaccine: Fluzone® 2012-2013 Formulation
- Biological: Influenza Virus Vaccine: Fluzone® Intradermal 2012-2013 Formulation
- Biological: Influenza Virus Vaccine: Fluzone® High-Dose 2012-2013 Formulation
|
Interventional
|
Phase 4 |
- Sanofi Pasteur, a Sanofi Company
- Sanofi
|
Industry |
- Allocation: Randomized
- Intervention Model: Parallel Assignment
- Masking: Single (Outcomes Assessor)
- Primary Purpose: Prevention
|
- Number of Participants Reporting Solicited Injection Site and Systemic Reactions Following Vaccination With Fluzone® or Fluzone® Intradermal or Fluzone® High-Dose Vaccine
|
200 |
All |
18 Years and older (Adult, Older Adult) |
NCT01691339 |
GRC50
U 1111-1124-8310 |
|
September 2012 |
November 2012 |
February 2013 |
September 24, 2012 |
November 4, 2013 |
November 4, 2013 |
- Boca Raton, Florida, United States
- South Miami, Florida, United States
- Council Bluffs, Iowa, United States
- Metairie, Louisiana, United States
|
|
| 27 |
NCT00258817 |
Completed
Has Results |
Phase IV Trial to Collect Safety Data and Sera in Healthy Children Given Fluzone Vaccine |
|
- Biological: Influenza Virus Vaccine (Fluzone®)
|
Interventional
|
Phase 4 |
- Sanofi Pasteur, a Sanofi Company
- Sanofi
|
Industry |
- Allocation: Non-Randomized
- Intervention Model: Parallel Assignment
- Masking: None (Open Label)
- Primary Purpose: Prevention
|
- Geometric Mean Titer (GMT) of Hemagglutination Inhibition Antibodies Pre-vaccination and 14 Days Post-vaccination
|
30 |
All |
6 Months to 36 Months (Child) |
NCT00258817 |
GRC26 |
|
October 2005 |
March 2006 |
August 2007 |
November 28, 2005 |
April 14, 2016 |
March 25, 2009 |
- Norfolk, Virginia, United States
|
|
| 28 |
NCT02242643 |
Completed
Has Results |
Study to Evaluate the Immunogenicity and Safety of GlaxoSmithKline (GSK) Biologicals' Quadrivalent Influenza Vaccine (GSK2282512A) Compared to Fluzone® Quadrivalent in Children 6 to 35 Months of Age |
|
- Biological: FluLaval™ Quadrivalent
- Biological: Fluzone® Quadrivalent
|
Interventional
|
Phase 3 |
|
Industry |
- Allocation: Randomized
- Intervention Model: Parallel Assignment
- Masking: Triple (Participant, Care Provider, Outcomes Assessor)
- Primary Purpose: Prevention
|
- Haemagglutination Inhibition (HI) Antibody Titers Against Each of the 4 Vaccine Influenza Strains
- Humoral Immune Response in Terms of Haemagglutination Inhibition (HI) Antibodies by Calculating Serum Antihaemagglutination (HA) Antibody Titers Against the 4 Vaccine Strains.
- Haemagglutination Inhibition (HI) Antibody Titers Against Each of the 4 Vaccine Influenza Strains, Overall, by Age Group (6-17 and 18-35 Months of Age) and by Priming Status (Vaccine-primed and Vaccine-unprimed)
- (and 11 more...)
|
2432 |
All |
6 Months to 35 Months (Child) |
NCT02242643 |
201234 |
|
October 1, 2014 |
March 16, 2015 |
June 23, 2015 |
September 17, 2014 |
September 7, 2018 |
April 12, 2016 |
- GSK Investigational Site
Birmingham, Alabama, United States - GSK Investigational Site
Dothan, Alabama, United States - GSK Investigational Site
Tucson, Arizona, United States - (and 63 more...)
|
|
| 29 |
NCT01974895 |
Completed
Has Results |
Study to Evaluate Immunogenicity and Safety of GlaxoSmithKline (GSK) Biologicals' Quadrivalent Influenza Vaccine GSK2282512A When Administered to Children From 6 to 35 Months of Age |
|
- Biological: FluLaval® Quadrivalent
- Biological: Fluzone®
|
Interventional
|
Phase 2 |
|
Industry |
- Allocation: Randomized
- Intervention Model: Parallel Assignment
- Masking: Triple (Participant, Care Provider, Outcomes Assessor)
- Primary Purpose: Prevention
|
- Number of Seroconverted Subjects for Haemagglutination Inhibition (HI) Antibodies Against Each of the Four Vaccine Influenza Strains of FluLaval® Quadrivalent Vaccine.
- Number of Seroconverted Subjects for HI Antibodies Against Each of the Four Vaccine Influenza Strains.
- Haemagglutination Inhibition (HI) Antibody Titers Against Each of the Four Vaccine Influenza Strains
- (and 10 more...)
|
316 |
All |
6 Months to 35 Months (Child) |
NCT01974895 |
200806 |
|
October 23, 2013 |
February 27, 2014 |
July 3, 2014 |
November 4, 2013 |
September 7, 2018 |
April 13, 2015 |
- GSK Investigational Site
Sacramento, California, United States - GSK Investigational Site
West Covina, California, United States - GSK Investigational Site
Altamonte Springs, Florida, United States - (and 9 more...)
|
|
| 30 |
NCT00812110 |
Completed
Has Results |
Influenza Vaccination for Parents and Other Caregivers in the Pediatric Medical Home |
|
|
Interventional
|
Phase 4 |
- Akron Children's Hospital
|
Other |
- Intervention Model: Single Group Assignment
- Masking: None (Open Label)
- Primary Purpose: Prevention
|
- Number of Participants Who Received Influenza Vaccine.
- Background Rate of Influenza Vaccination in the Parents/Caregivers of High Risk Pediatric Patients in a Low Income Population?
|
336 |
All |
18 Years and older (Adult, Older Adult) |
NCT00812110 |
081105 |
|
December 2008 |
September 2009 |
September 2009 |
December 19, 2008 |
January 23, 2013 |
January 23, 2013 |
- Akron Children's Hospital
Akron, Ohio, United States
|
|
| 31 |
NCT00389532 |
Completed
Has Results |
Phase IV Trial to Determine the Safety and Immunogenicity of the WHO Formulation of the 2006-2007 Fluzone® Vaccine |
|
- Biological: Influenza Virus Vaccine (2006-2007 Fluzone® vaccine)
|
Interventional
|
Phase 4 |
- Sanofi Pasteur, a Sanofi Company
- Sanofi
|
Industry |
- Allocation: Non-Randomized
- Intervention Model: Parallel Assignment
- Masking: None (Open Label)
- Primary Purpose: Prevention
|
- Percentage of Participants With Solicited Injection Site or Systemic Reaction(s) After Fluzone® Vaccination
- Geometric Mean Titers (GMTs) of Serum Hemagglutination Inhibition Antibodies Pre-vaccination and Post-vaccination
|
116 |
All |
18 Years and older (Adult, Older Adult) |
NCT00389532 |
GRC35 |
|
October 2006 |
April 2008 |
September 2008 |
October 19, 2006 |
April 14, 2016 |
March 30, 2009 |
- Norfolk, Virginia, United States
|
|
| 32 |
NCT00389857 |
Completed
Has Results |
Trial to Collect Safety Data and Sera for Immunogenicity Testing |
|
- Biological: Influenza Virus Vaccine (Fluzone®)
|
Interventional
|
Phase 4 |
- Sanofi Pasteur, a Sanofi Company
- Sanofi
|
Industry |
- Allocation: Non-Randomized
- Intervention Model: Parallel Assignment
- Masking: None (Open Label)
- Primary Purpose: Prevention
|
- Geometric Mean Titers (GMTs) of Hemagglutination Inhibition (HI) Antibodies Before and After Fluzone® Vaccination
|
31 |
All |
6 Months to 36 Months (Child) |
NCT00389857 |
GRC34 |
|
October 2006 |
September 2007 |
July 2008 |
October 19, 2006 |
April 14, 2016 |
March 24, 2009 |
- Norfolk, Virginia, United States
|
|
| 33 |
NCT01720277 |
Completed
Has Results |
High Dose Influenza Vaccine in Nursing Home - Pilot Study |
|
- Biological: HD Fluzone Vaccine
- Biological: SD Fluzone Vaccine
|
Interventional
|
Phase 4 |
- Insight Therapeutics, LLC
- Brown University
|
Other |
- Allocation: Randomized
- Intervention Model: Parallel Assignment
- Masking: Single (Outcomes Assessor)
- Primary Purpose: Prevention
|
- Total All-cause Hospitalizations
- Change in Residents' Functional Status
|
2957 |
All |
65 Years and older (Older Adult) |
NCT01720277 |
GRC75-HD Nursing Home Pilot |
|
September 2012 |
May 2013 |
May 2016 |
November 2, 2012 |
May 23, 2018 |
April 18, 2018 |
- Brown Univeristy
Providence, Rhode Island, United States - Insight Therapeutics
Norfolk, Virginia, United States
|
|
| 34 |
NCT00258830 |
Completed
Has Results |
Safety and Immunogenicity of the 2005-2006 Fluzone® Vaccine |
|
- Biological: Fluzone®: Influenza Virus Vaccine
|
Interventional
|
Phase 4 |
- Sanofi Pasteur, a Sanofi Company
- Sanofi
|
Industry |
- Allocation: Non-Randomized
- Intervention Model: Parallel Assignment
- Masking: None (Open Label)
- Primary Purpose: Prevention
|
- Number of Participants Reporting Solicited Injection Site and Solicited Systemic Reactions After Fluzone® Vaccination
- Geometric Mean Titers (GMTs) of Hemagglutination Antibodies Before and After Fluzone® Vaccination
|
120 |
All |
18 Years and older (Adult, Older Adult) |
NCT00258830 |
GRC25 |
|
September 2005 |
February 2006 |
March 2007 |
November 28, 2005 |
April 14, 2016 |
June 3, 2009 |
- Norfolk, Virginia, United States
|
|
| 35 |
NCT01712984 |
Completed
Has Results |
Study of Intradermal Quadrivalent Influenza Vaccine in Adults Aged 18 Through 64 Years |
|
- Biological: Influenza Virus Vaccine USP Quadrivalent, (Zonal Purified Subvirion) 2012 2013 Formulation
- Biological: Influenza Virus Vaccine USP Trivalent Types A and B (Zonal Purified Subvirion) Fluzone® Intradermal
- Biological: Influenza Virus Vaccine USP Trivalent Types A and B (Zonal Purified Subvirion) Fluzone Intradermal
|
Interventional
|
Phase 3 |
- Sanofi Pasteur, a Sanofi Company
- Sanofi
|
Industry |
- Allocation: Randomized
- Intervention Model: Parallel Assignment
- Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
- Primary Purpose: Prevention
|
- Geometric Mean Titers Against the Influenza Virus Antigens Following Vaccination With Either a Quadrivalent Influenza Vaccine or a Trivalent Influenza Vaccine Administered by Intradermal Route
- Number of Participants With Seroconversion to Influenza Virus Vaccine Antigens Following Vaccination With Either a Quadrivalent Influenza Vaccine or a Trivalent Influenza Vaccine Administered by Intradermal Route
- Geometric Mean Titers Against the Influenza Virus Antigens Before and Following Vaccination With Either a Quadrivalent Influenza Vaccine or a Trivalent Influenza Vaccine Administered by Intradermal Route
- (and 2 more...)
|
3360 |
All |
18 Years to 64 Years (Adult) |
NCT01712984 |
QID01
U1111-1124-8066 |
|
October 2012 |
June 2013 |
October 2013 |
October 24, 2012 |
May 7, 2015 |
February 10, 2014 |
- Hoover, Alabama, United States
- Huntsville, Alabama, United States
- Chandler, Arizona, United States
- (and 35 more...)
|
|
| 36 |
NCT03020472 |
Terminated
Has Results |
Kinetics of B-Cell Responses to Live, Attenuated Influenza Vaccine (LAIV) in Young Children Two Years of Age |
|
- Biological: 2008-2009 FluMist LAIV (Intranasal)
|
Interventional
|
Phase 4 |
- Stanford University
- National Institute of Allergy and Infectious Diseases (NIAID)
|
Other / NIH |
- Intervention Model: Single Group Assignment
- Masking: None (Open Label)
- Primary Purpose: Basic Science
|
- Number of Participants Who Received Influenza Vaccine
- Number of Participants With Related Adverse Events
|
6 |
All |
24 Months to 35 Months (Child) |
NCT03020472 |
SU-15086
U19AI057229 |
SLVP016 |
November 2008 |
January 2009 |
January 2009 |
January 13, 2017 |
April 17, 2017 |
March 3, 2017 |
|
|
| 37 |
NCT00743275 |
Completed
Has Results |
A Study to Evaluate the Safety and Immune Responses to Fluzone® Vaccination |
|
- Biological: Split, Inactivated, Trivalent Influenza vaccine (Fluzone®)
|
Interventional
|
Phase 4 |
- Sanofi Pasteur, a Sanofi Company
- Sanofi
|
Industry |
- Intervention Model: Single Group Assignment
- Masking: None (Open Label)
- Primary Purpose: Prevention
|
- Number of Participants With at Least 1 Solicited Injection Site Solicited Systemic Reactions Post-vaccination With Fluzone® Vaccine.
- Geometric Mean Titers (GMTs) for the 3 Influenza Strains Pre- and Post-vaccination With Fluzone® Vaccine 2008-2009 Formulation
- Percentage of Participants With at Least 1:40 Hemagglutination Inhibition Antibody Titer Post-Vaccination With Fluzone® Vaccine (Seroprotection)
- Percentage of Participants With at Least a 4-Fold Rise in Hemagglutination Inhibition Antibody Titer Post-Vaccination With Fluzone Vaccine (Seroconversion)
|
120 |
All |
18 Years and older (Adult, Older Adult) |
NCT00743275 |
GRC41 |
|
August 2008 |
November 2008 |
November 2008 |
August 28, 2008 |
May 16, 2016 |
February 23, 2010 |
- Norfolk, Virginia, United States
|
|
| 38 |
NCT03158038 |
Completed
Has Results |
Study to Evaluate the Safety of 1 New 6:2 Influenza Virus Reassortant in Adults for the 2017-2018 Season |
|
- Biological: Monovalent Influenza Vaccine
- Other: Placebo
|
Interventional
|
Phase 4 |
|
Industry |
- Allocation: Randomized
- Intervention Model: Parallel Assignment
- Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
- Primary Purpose: Prevention
|
- Percentage of Participants With Fever Greater Than or Equal to (>=) 101 Degrees Fahrenheit (F)
- Percentage of Participants With Solicited Symptoms
- Number of Participants With Treatment-Emergent Adverse Events (TEAEs)
- (and 2 more...)
|
300 |
All |
18 Years to 49 Years (Adult) |
NCT03158038 |
D2560C00014 |
FluMist |
May 30, 2017 |
December 14, 2017 |
December 14, 2017 |
May 17, 2017 |
January 4, 2019 |
January 4, 2019 |
- Research Site
Stockbridge, Georgia, United States - Research Site
Portland, Oregon, United States
|
|
| 39 |
NCT01666782 |
Completed
Has Results |
Study Comparing High-Dose Flu Vaccine to Standard Vaccine in Cancer Patients Less Than 65 Receiving Chemotherapy |
- Cancer
- Influenza Viral Infections
|
- Biological: Standard Trivalent Influenza Vaccine
- Biological: High-Dose Influenza Vaccine
|
Interventional
|
Phase 2 |
- Saad Jamshed MD
- Sanofi
- Rochester General Hospital
|
Other / Industry |
- Allocation: Randomized
- Intervention Model: Parallel Assignment
- Masking: Double (Participant, Care Provider)
- Primary Purpose: Prevention
|
- The Geometric Mean Titer (GMT) of High-dose Influenza Vaccine vs the Standard Trivalent Influenza Vaccine in Adult Subjects on Chemotherapy Who Are Less Than 65 Years Old.
- The Seroprotection Rate of High-dose Influenza Vaccine vs Standard Trivalent Influenza Vaccine in Adult Subjects on Chemotherapy Less Than 65 Years Old.
- The Seroconversion Rate of High-dose Influenza Vaccine Versus Standard Trivalent Influenza Vaccine in Adult Subjects on Chemotherapy Less Than 65 Years Old.
- (and 3 more...)
|
105 |
All |
18 Years to 64 Years (Adult) |
NCT01666782 |
CIC 1336-B12-1 |
IMMUNE |
August 2012 |
June 2015 |
December 2015 |
August 16, 2012 |
June 24, 2016 |
May 24, 2016 |
- Rochester General Hospital
Rochester, New York, United States - Lipson Cancer Center Linden Oaks Medical Campus
Rochester, New York, United States
|
|
| 40 |
NCT01258595 |
Completed
Has Results |
A Study of High-Dose Trivalent Inactivated Influenza Vaccine in Adults 50 to 64 Years of Age |
|
- Biological: High-Dose Trivalent Inactivated Influenza Vaccine
- Biological: Trivalent Inactivated Influenza Vaccine
|
Interventional
|
Phase 2 |
- Sanofi Pasteur, a Sanofi Company
- Sanofi
|
Industry |
- Allocation: Randomized
- Intervention Model: Parallel Assignment
- Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
- Primary Purpose: Prevention
|
- Geometric Mean Titers (GMTs) of Vaccine Antibodies Before and After Vaccination With Either Fluzone® High-Dose or Fluzone® Vaccine.
- Geometric Mean of Individual Titer Ratios (GMTRs) of Vaccine Antibodies Before and After Vaccination With Either Fluzone® High-Dose or Fluzone® Vaccine
- Percentage of Participants With Seroconversion After Vaccination With Either Fluzone® High-Dose or Fluzone® Vaccine
- (and 2 more...)
|
300 |
All |
50 Years to 64 Years (Adult) |
NCT01258595 |
FIM09
UTN: U1111-1113-3648 |
|
November 2010 |
March 2011 |
April 2011 |
December 13, 2010 |
May 16, 2016 |
October 27, 2011 |
- Idaho Falls, Idaho, United States
- Columbia, Maryland, United States
- Ellicott City, Maryland, United States
- (and 2 more...)
|
|
| 41 |
NCT02212106 |
Completed
Has Results |
A Study to Evaluate the Safety and Tolerability of Trivalent Influenza Virus Vaccine in Children Aged 5 Years to < 9 Years |
|
- Biological: bioCSL Trivalent Influenza Virus Vaccine (CSL TIV)
- Biological: Comparator Quadrivalent Influenza Virus Vaccine
|
Interventional
|
Phase 4 |
|
Industry |
- Allocation: Randomized
- Intervention Model: Parallel Assignment
- Masking: Triple (Participant, Investigator, Outcomes Assessor)
- Primary Purpose: Prevention
|
- The Frequency and Intensity of Fever Events Occurring During the 7 Days After Each Administration of CSL TIV Vaccine.
- The Frequency and Intensity of Fever Events Occurring During the 7 Days After Each Administration of the Comparator Influenza Virus Vaccine.
- The Frequency and Intensity of Vaccine-related Fever Events Occurring During the 7 Days After Each Administration of CSL TIV Vaccine or Comparator Influenza Virus Vaccine.
- (and 4 more...)
|
402 |
All |
5 Years to 8 Years (Child) |
NCT02212106 |
CSLCT-USF-10-69
2015-000175-27 |
|
September 2014 |
December 2014 |
December 2014 |
August 8, 2014 |
October 16, 2015 |
October 16, 2015 |
- Site 286
Los Angeles, California, United States - Site 289
Boise, Idaho, United States - Site 287
Saint Louis, Missouri, United States - (and 8 more...)
|
|
| 42 |
NCT00623181 |
Completed
Has Results |
Study to Determine a Preference for Fluzone Vaccine Given Intradermally (ID) and Intramuscularly (IM) in Healthy Adults |
|
- Biological: Fluzone: Influenza virus vaccine
|
Interventional
|
Phase 2 |
- Sanofi Pasteur, a Sanofi Company
- Sanofi
|
Industry |
- Allocation: Randomized
- Intervention Model: Parallel Assignment
- Masking: None (Open Label)
- Primary Purpose: Prevention
|
- Categorical Summary of Pain or Other Discomfort Immediately After Vaccination and on Days 3 and 7 Post-vaccination
- Continuous Summary of Pain or Other Discomfort Immediately After Vaccination and on Days 3 and 7 Post-vaccination
|
110 |
All |
18 Years to 49 Years (Adult) |
NCT00623181 |
FID30 |
|
January 2008 |
May 2008 |
June 2008 |
February 25, 2008 |
April 14, 2016 |
August 11, 2011 |
- Grove City, Pennsylvania, United States
- Pittsburgh, Pennsylvania, United States
|
|
| 43 |
NCT03028987 |
Terminated
Has Results |
Adaptive Immune Responses and Repertoire in Influenza Vaccination and Infection (SLVP031) |
|
- Biological: Fluzone®
- Biological: FluMist®
|
Interventional
|
Phase 4 |
- Stanford University
- National Institute of Allergy and Infectious Diseases (NIAID)
|
Other / NIH |
- Allocation: Randomized
- Intervention Model: Parallel Assignment
- Masking: None (Open Label)
- Primary Purpose: Basic Science
|
- Number of Participants Who Received Influenza Vaccine
- Number of Participants With Related Adverse Events
|
10 |
All |
18 Years to 49 Years (Adult) |
NCT03028987 |
SU-31434-2014-2019
2U19AI057229-11 |
|
November 19, 2014 |
November 18, 2015 |
November 18, 2015 |
January 23, 2017 |
September 12, 2017 |
September 12, 2017 |
- Stanford University School of Medicine
Stanford, California, United States
|
|
| 44 |
NCT02285998 |
Completed
Has Results |
Protective Efficacy of Flublok® Quadrivalent Versus Licensed Inactivated Influenza Vaccine in Adults ≥50 Years of Age |
|
- Biological: Flublok Quadrivalent Influenza Vaccine
- Biological: Inactivated Influenza Vaccine
|
Interventional
|
Phase 3 |
- Protein Sciences Corporation
|
Industry |
- Allocation: Randomized
- Intervention Model: Parallel Assignment
- Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
- Primary Purpose: Prevention
|
- Number of Participants With rtPCR-confirmed Influenza-Like Illness
- Number of Participants With Culture-confirmed Influenza-Like Illness
- Number of Participants With Culture-confirmed CDC-defined Influenza-Like Illness
- (and 7 more...)
|
9003 |
All |
50 Years and older (Adult, Older Adult) |
NCT02285998 |
PSC12 |
|
October 2014 |
May 2015 |
May 2015 |
November 7, 2014 |
October 27, 2017 |
October 4, 2016 |
- Coastal Clinical Research
Mobile, Alabama, United States - Clinical Research Consortium Arizona
Tempe, Arizona, United States - Baptist Health Center for Clinical Research
Little Rock, Arkansas, United States - (and 35 more...)
|
|
| 45 |
NCT02133781 |
Completed
Has Results |
B-cell Immunity to Influenza (SLVP017)- Year 1, 2009 |
|
- Biological: Fluzone® 2009-2010 Formula
- Biological: FluMist® 2009-2010 Formula
|
Interventional
|
Phase 4 |
- Stanford University
- National Institute of Allergy and Infectious Diseases (NIAID)
|
Other / NIH |
- Allocation: Randomized
- Intervention Model: Parallel Assignment
- Masking: None (Open Label)
- Primary Purpose: Basic Science
|
- Number of Participants From Each Arm Who Received Influenza Vaccine
- Number of Participants With Related Adverse Events
|
51 |
All |
8 Years to 100 Years (Child, Adult, Older Adult) |
NCT02133781 |
SU-17218- 2009
2U19AI057229-06 |
|
July 2009 |
December 2009 |
December 2009 |
May 8, 2014 |
June 6, 2018 |
March 10, 2017 |
- Stanford LPCH Vaccine Program
Stanford, California, United States
|
|
| 46 |
NCT02743117 |
Completed
Has Results |
Study to Evaluate the Safety of 1 New 6:2 Influenza Virus Reassortant in Adults for the 2016-2017 Season |
|
- Biological: Monovalent Influenza Vaccine
- Other: Placebo
|
Interventional
|
Phase 4 |
|
Industry |
- Allocation: Randomized
- Intervention Model: Parallel Assignment
- Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
- Primary Purpose: Prevention
|
- Percentage of Participants With Fever Greater Than or Equal to (>=) 101 Degrees Fahrenheit (F)
- Percentage of Participants With Solicited Symptoms
- Number of Participants With Treatment-Emergent Adverse Events (TEAEs)
- (and 2 more...)
|
301 |
All |
18 Years to 49 Years (Adult) |
NCT02743117 |
D2560C00012 |
FluMist |
May 2, 2016 |
November 30, 2016 |
November 30, 2016 |
April 19, 2016 |
October 4, 2017 |
October 4, 2017 |
- Research Site
South Miami, Florida, United States - Research Site
Stockbridge, Georgia, United States - Research Site
Portland, Oregon, United States
|
|
| 47 |
NCT00858468 |
Completed
Has Results |
Safety and Immunogenicity Testing of Influenza Vaccine in Healthy Children 2 Months and 6 Months of Age |
|
- Biological: Influenza virus vaccine (2004-2005 Formulation)
|
Interventional
|
Phase 1
Phase 2 |
- Sanofi Pasteur, a Sanofi Company
- Sanofi
|
Industry |
- Allocation: Randomized
- Intervention Model: Parallel Assignment
- Masking: None (Open Label)
- Primary Purpose: Prevention
|
- Percentage of Participants With Solicited Local and Systemic Reactions After Vaccination With Fluzone® 2004-2005 Pediatric Formulation.
|
394 |
All |
2 Months to 9 Months (Child) |
NCT00858468 |
GRC27 |
|
April 2005 |
June 2006 |
December 2006 |
March 9, 2009 |
April 14, 2016 |
July 31, 2009 |
- Little Rock, Arkansas, United States
- Marietta, Georgia, United States
- Durham, North Carolina, United States
- (and 5 more...)
|
|
| 48 |
NCT00905125 |
Completed
Has Results |
Influenza Vaccine in Pregnant Women |
|
- Biological: Fluzone®
- Biological: Fluarix®
|
Interventional
|
Phase 2 |
- National Institute of Allergy and Infectious Diseases (NIAID)
|
NIH |
- Allocation: Randomized
- Intervention Model: Parallel Assignment
- Masking: Triple (Participant, Investigator, Outcomes Assessor)
- Primary Purpose: Prevention
|
- Number of Participants With a Serum Hemagglutination Inhibition Assay (HAI) Antibody Titer Greater Than or Equal to 40 Against Each Antigen Included in the 2008-2009 Seasonal Inactivated Trivalent Influenza Vaccine (TIV)
- Number of Participants Reporting Maternal Complications of Pregnancy, Labor and Delivery.
- Number of Participants Reporting Neonatal Complications.
- (and 11 more...)
|
102 |
Female |
18 Years to 39 Years (Adult) |
NCT00905125 |
09-0033
N01AI80002C |
|
June 2009 |
March 2010 |
March 2010 |
May 20, 2009 |
June 13, 2012 |
April 6, 2011 |
- Emory University School of Medicine - Gynecology and Obstetrics
Atlanta, Georgia, United States - University of Iowa
Iowa City, Iowa, United States - University of Maryland Baltimore
Baltimore, Maryland, United States - (and 6 more...)
|
|
| 49 |
NCT03023553 |
Completed
Has Results |
The Human Mucosal Immune Responses to Influenza Virus (SLVP026) |
|
- Biological: Fluzone®
- Biological: FluMist®
|
Interventional
|
Phase 4 |
- Stanford University
- National Institute of Allergy and Infectious Diseases (NIAID)
|
Other / NIH |
- Allocation: Non-Randomized
- Intervention Model: Parallel Assignment
- Masking: None (Open Label)
- Primary Purpose: Basic Science
|
- Number of Participants From Each Arm Who Received Influenza Vaccine
- Number of Participants With Related Adverse Events
|
13 |
All |
18 Years to 30 Years (Adult) |
NCT03023553 |
SU-25537
U19AI090019 |
|
December 2012 |
February 2013 |
February 2013 |
January 18, 2017 |
April 21, 2017 |
March 9, 2017 |
|
|
| 50 |
NCT01654224 |
Completed
Has Results |
Randomized Trial of High Dose Influenza Vaccine in Long Term Care Setting |
|
- Biological: High Dose Inactivated Influenza Vaccine
- Biological: Standard Dose Inactivated Influenza Vaccine
|
Interventional
|
Phase 4 |
- University of Pittsburgh
- Sanofi Pasteur, a Sanofi Company
|
Other / Industry |
- Allocation: Randomized
- Intervention Model: Parallel Assignment
- Masking: Single (Participant)
- Primary Purpose: Prevention
|
- Non-inferiority of High-dose Inactivated Influenza Vaccine(HDIV) Versus Standard Dose Inactivated Influenza Vaccine(SDIV) Among Residents of Long Term Care(LTC) Settings
- Non-inferiority and Immunoprotection Persistence at 6 Months
|
205 |
All |
65 Years and older (Older Adult) |
NCT01654224 |
PRO10110247 |
|
November 2011 |
June 2014 |
June 2014 |
July 31, 2012 |
July 2, 2017 |
July 14, 2016 |
- University of Pittsburgh, Division of Geriatric Medicine
Pittsburgh, Pennsylvania, United States
|
|
| 51 |
NCT00755274 |
Completed
Has Results |
Annual Study for Serum Collection for Immunogenicity and Safety Evaluation in Healthy Children Receiving Fluzone® |
- Influenza
- Orthomyxoviridae Infections
|
- Biological: Influenza Virus Vaccine No Preservative: Pediatric Dose
|
Interventional
|
Phase 4 |
- Sanofi Pasteur, a Sanofi Company
- Sanofi
|
Industry |
- Allocation: Non-Randomized
- Intervention Model: Parallel Assignment
- Masking: None (Open Label)
- Primary Purpose: Prevention
|
- Number of Participants With Solicited Local and Systemic Reactions After Fluzone® Vaccination 1
- Number of Participants With Solicited Local and Systemic Reactions After Fluzone® Vaccination 2
|
32 |
All |
6 Months to 5 Years (Child) |
NCT00755274 |
GRC40 |
|
September 2008 |
January 2009 |
January 2009 |
September 18, 2008 |
April 14, 2016 |
April 1, 2010 |
- Norfolk, Virginia, United States
|
|
| 52 |
NCT02473510 |
Completed
Has Results |
Study to Evaluate the Safety of 3 New 6:2 Influenza Virus Reassortants in Adults for the 2015-2016 Season |
|
- Biological: Trivalent Influenza Vaccine
- Other: Placebo
|
Interventional
|
Phase 4 |
|
Industry |
- Allocation: Randomized
- Intervention Model: Parallel Assignment
- Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
- Primary Purpose: Prevention
|
- Percentage of Participants With Fever Greater Than or Equal to (>=) 101 Degrees Fahrenheit (F)
- Percentage of Participants With Solicited Symptoms
- Number of Participants With Treatment Emergent Adverse Events (TEAEs)
- (and 2 more...)
|
301 |
All |
18 Years to 49 Years (Adult) |
NCT02473510 |
D2560C00009 |
FluMist |
June 2015 |
January 2016 |
January 2016 |
June 16, 2015 |
November 28, 2016 |
November 28, 2016 |
- Research Site
South Miami, Florida, United States - Research Site
Stockbridge, Georgia, United States - Research Site
Portland, Oregon, United States
|
|
| 53 |
NCT01218308 |
Completed
Has Results |
A Study to Evaluate the Efficacy of GSK Biologicals' Influenza Vaccine in Children |
|
- Biological: FluLaval® Quadrivalent
- Biological: Havrix™
|
Interventional
|
Phase 3 |
|
Industry |
- Allocation: Randomized
- Intervention Model: Parallel Assignment
- Masking: Double (Participant, Investigator)
- Primary Purpose: Prevention
|
- Number of Subjects Reporting at Least One Confirmed Occurrence of Influenza A or B.
- Number of Subjects Reporting at Least One Moderate to Severe Occurrence of Influenza A or B.
- Number of Subjects Reporting at Least One Culture Confirmed Occurrence of Influenza A or B Due to Antigenically Matched Strain.
- (and 16 more...)
|
5220 |
All |
3 Years to 8 Years (Child) |
NCT01218308 |
114541 |
|
December 9, 2010 |
January 9, 2012 |
January 9, 2012 |
October 11, 2010 |
August 1, 2018 |
April 2, 2013 |
- GSK Investigational Site
Dhaka, Bangladesh - GSK Investigational Site
Santo Domingo, Dominican Republic - GSK Investigational Site
Tegucigalpa, Honduras - (and 9 more...)
|
|
| 54 |
NCT02141581 |
Completed
Has Results |
Plasmablast Trafficking and Antibody Response in Influenza Vaccination (SLVP021 2011-2014) |
|
- Biological: Fluzone® (IM)
- Biological: Fluzone® Intradermal (ID)
- Biological: 2011-2012 FluMist®
|
Interventional
|
Phase 4 |
- Stanford University
- National Institute of Allergy and Infectious Diseases (NIAID)
|
Other / NIH |
- Allocation: Randomized
- Intervention Model: Parallel Assignment
- Masking: None (Open Label)
- Primary Purpose: Basic Science
|
- Number of Participants From Each Arm Who Received Influenza Vaccine
- Number of Participants With Related Adverse Events
|
86 |
All |
8 Years to 34 Years (Child, Adult) |
NCT02141581 |
SU-21987- 2011
1U19AI090019-01 |
|
August 2011 |
December 2014 |
December 2014 |
May 19, 2014 |
May 7, 2018 |
May 11, 2017 |
- Stanford LPCH Vaccine Program
Stanford, California, United States
|
|
| 55 |
NCT00570037 |
Completed
Has Results |
Feasibility of Cocooning Immunization Strategy With Influenza Vaccine |
|
- Biological: Trivalent inactivated influenza vaccine
|
Interventional
|
Not Applicable |
- Duke University
- Centers for Disease Control and Prevention
|
Other / U.S. Fed |
- Allocation: Non-Randomized
- Intervention Model: Parallel Assignment
- Masking: None (Open Label)
- Primary Purpose: Prevention
|
- Influenza Vaccine Coverage (Percent) for New Mothers of Newborns
- Influenza Vaccine Coverage (Percent) for New Fathers of Newborns
- Influenza Vaccine Coverage (Percent) for All Household Contacts of Newborns
|
544 |
Female |
18 Years and older (Adult, Older Adult) |
NCT00570037 |
Pro00004990
1U01IP000074-01 |
Piiitch |
October 2007 |
April 2008 |
April 2008 |
December 10, 2007 |
June 24, 2013 |
February 1, 2011 |
- Durham Regional Hospital
Durham, North Carolina, United States - Duke University Hospital
Durham, North Carolina, United States
|
|
| 56 |
NCT03020537 |
Completed
Has Results |
B-cell Immunity to Influenza (SLVP017)- Year 5, 2013 |
|
|
Interventional
|
Phase 4 |
- Stanford University
- National Institute of Allergy and Infectious Diseases (NIAID)
|
Other / NIH |
- Allocation: Non-Randomized
- Intervention Model: Parallel Assignment
- Masking: None (Open Label)
- Primary Purpose: Basic Science
|
- Number of Participants Who Received Influenza Vaccine
- Number of Participants With Related Adverse Events
|
8 |
All |
1 Year to 30 Years (Child, Adult) |
NCT03020537 |
SU-17218-2013
2U19AI057229-06 |
|
October 2013 |
December 2013 |
December 2013 |
January 13, 2017 |
June 6, 2018 |
March 9, 2017 |
|
|
| 57 |
NCT00551031 |
Completed
Has Results |
Study of Inactivated, Split-Virion Influenza Vaccine and Standard Fluzone® Vaccine in Adult and Elderly Subjects |
- Influenza
- Myxovirus Infection
|
- Biological: Split, Inactivated, Trivalent Influenza Vaccine (Intradermal Formulation 1)
- Biological: Split, Inactivated, Trivalent Influenza Vaccine (Intradermal Formulation 2)
- Biological: Split, Inactivated, Trivalent Influenza Vaccine (Standard dose)
- Biological: Split, Inactivated, Trivalent Influenza Vaccine (High-dose)
|
Interventional
|
Phase 2 |
|
Industry |
- Allocation: Randomized
- Intervention Model: Parallel Assignment
- Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
- Primary Purpose: Prevention
|
- Geometric Mean Titers (GMTs) Before and After Vaccination With Fluzone Intradermal or Fluzone High Dose or Fluzone Intramuscular Vaccine.
- Percentage of Participants Who Achieved Seroconversion Post-Vaccination With Fluzone Intradermal or Fluzone High Dose or Fluzone Intramuscular Vaccine
- Percentage of Participants Who Achieved Seroprotection Before and Post-vaccination With Fluzone Intradermal or Fluzone High Dose or Fluzone Intramuscular Vaccine.
- Number of Participants Reporting Solicited Injection Site or Systemic Reactions Post-vaccination With Either Fluzone Intradermal or Fluzone High Dose or Fluzone Intramuscular Vaccine.
|
2098 |
All |
18 Years and older (Adult, Older Adult) |
NCT00551031 |
FID29 |
|
October 2007 |
June 2008 |
November 2008 |
October 30, 2007 |
May 16, 2016 |
November 24, 2011 |
- Alabaster, Alabama, United States
- Mobile, Alabama, United States
- Chandler, Arizona, United States
- (and 26 more...)
|
|
| 58 |
NCT03020498 |
Completed
Has Results |
B-cell Immunity to Influenza (SLVP017) - Years 2 (2010) & 3 (2011) |
|
- Biological: Fluzone
- Biological: FluMist
|
Interventional
|
Phase 4 |
- Stanford University
- National Institute of Allergy and Infectious Diseases (NIAID)
|
Other / NIH |
- Allocation: Randomized
- Intervention Model: Parallel Assignment
- Masking: None (Open Label)
- Primary Purpose: Basic Science
|
- Number of Participants Who Received Influenza Vaccine
- Number of Participants With Related Adverse Events
|
91 |
All |
8 Years to 100 Years (Child, Adult, Older Adult) |
NCT03020498 |
SU-17218-2010-2011
2U19AI057229-06 |
|
September 2010 |
December 2011 |
December 2011 |
January 13, 2017 |
June 6, 2018 |
March 9, 2017 |
|
|
| 59 |
NCT03023176 |
Completed
Has Results |
T-cell And General Immune Response to Seasonal Influenza Vaccine (SLVP018) Year 5, 2013 |
|
- Biological: Fluzone® standard IIV3
- Biological: Fluzone® standard IIV3 Pediatric Dose
|
Interventional
|
Phase 4 |
- Stanford University
- National Institute of Allergy and Infectious Diseases (NIAID)
|
Other / NIH |
- Intervention Model: Single Group Assignment
- Masking: None (Open Label)
- Primary Purpose: Basic Science
|
- Number of Participants Who Received Influenza Vaccine
- Number of Participants With Related Adverse Events
|
20 |
All |
1 Year to 8 Years (Child) |
NCT03023176 |
SU-17219-2013
2U19AI057229-06 |
|
September 2013 |
November 2013 |
November 2013 |
January 18, 2017 |
April 21, 2017 |
March 9, 2017 |
|
|
| 60 |
NCT03023709 |
Terminated
Has Results |
Tissue-specific Responses to Influenza Immunization and Their Relation to Blood Biomarkers (SLVP032) |
|
- Biological: Fluzone®
- Biological: FluMist®
|
Interventional
|
Phase 4 |
- Stanford University
- National Institute of Allergy and Infectious Diseases (NIAID)
|
Other / NIH |
- Allocation: Non-Randomized
- Intervention Model: Sequential Assignment
- Masking: None (Open Label)
- Primary Purpose: Basic Science
|
- Number of Participants Who Received Influenza Vaccine
- Number of Participants With Related Adverse Events
|
3 |
All |
18 Years to 49 Years (Adult) |
NCT03023709 |
SU-33722
2U19AI057229-11 |
|
September 2015 |
December 2015 |
December 2015 |
January 18, 2017 |
May 10, 2017 |
May 10, 2017 |
|
|
| 61 |
NCT01933048 |
Completed
Has Results |
Self-Administered Nasal Influenza Feasibility Study |
|
|
Interventional
|
Phase 4 |
- Uniformed Services University of the Health Sciences
|
U.S. Fed |
- Allocation: Randomized
- Intervention Model: Parallel Assignment
- Masking: None (Open Label)
- Primary Purpose: Other
|
- Post-vaccination Geometric Mean Titer (GMT) Ratios Between HCWA and SA Subjects
- Difference and Proportion in Seroresponse of Subjects
- Difference and Proportion in Seroconversion of Subjects
|
1077 |
All |
18 Years to 49 Years (Adult) |
NCT01933048 |
IDCRP-070 |
SNIF |
September 2012 |
October 2013 |
October 2013 |
August 30, 2013 |
September 12, 2017 |
September 12, 2017 |
- Naval Medical Center San Diego
San Diego, California, United States - San Antonio Military Health System
Fort Sam Houston, Texas, United States
|
|
| 62 |
NCT00391053 |
Completed
Has Results |
Immunogenicity of High-dose Inactivated, Split-virion Influenza Vaccine Versus Standard Fluzone Vaccine in the Elderly |
- Orthomyxoviridae Infection
- Influenza
- Myxovirus Infection
|
- Biological: High-Dose Inactivated, Split-Virion Influenza Vaccine
- Biological: Inactivated, Split-Virion Influenza Vaccine
|
Interventional
|
Phase 3 |
- Sanofi Pasteur, a Sanofi Company
- Sanofi
|
Industry |
- Allocation: Randomized
- Intervention Model: Parallel Assignment
- Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
- Primary Purpose: Prevention
|
- Geometric Mean Titers (GMTs) of Hemagglutination Inhibition Antibody Titers Pre- and Post-vaccination With Fluzone® High Dose or Standard Fluzone® Vaccines.
- Percentage of Participants With Seroconversion Post-vaccination With Fluzone® High-Dose or Standard Fluzone® Vaccines.
- Percentage of Participants With Seroprotection Pre- and Post-Vaccination With Fluzone® High-Dose or Standard Fluzone® Vaccines.
- Percentage of Participants Reporting Solicited Injection Site and Systemic Reactions After Fluzone® High-Dose or Standard Fluzone® Vaccination
|
3851 |
All |
65 Years and older (Older Adult) |
NCT00391053 |
FIM05 |
|
October 2006 |
July 2007 |
February 2008 |
October 23, 2006 |
April 14, 2016 |
April 30, 2010 |
- Mesa, Arizona, United States
- Phoenix, Arizona, United States
- Tempe, Arizona, United States
- (and 25 more...)
|
|
| 63 |
NCT01737710 |
Completed
Has Results |
Atopic Dermatitis Research Network (ADRN) Influenza Vaccine Study |
|
- Biological: Fluzone® Intradermal Vaccine
- Biological: Fluzone® (Intramuscular) vaccine
|
Interventional
|
Not Applicable |
- National Institute of Allergy and Infectious Diseases (NIAID)
- Atopic Dermatitis Research Network
|
NIH / Other |
- Allocation: Randomized
- Intervention Model: Parallel Assignment
- Masking: None (Open Label)
- Primary Purpose: Prevention
|
- Seroprotection, Non-Atopic Dermatitis (AD), Intradermal vs. Moderate to Severe Atopic Dermatitis, Intradermal - Influenza B
- Seroprotection, Non-Atopic Dermatitis (AD), Intradermal vs. Moderate to Severe Atopic Dermatitis, Intradermal - Influenza H1N1
- Seroprotection, Non-Atopic Dermatitis (AD), Intradermal vs. Moderate to Severe Atopic Dermatitis, Intradermal - Influenza H3N2
- (and 12 more...)
|
368 |
Female |
18 Years to 64 Years (Adult) |
NCT01737710 |
DAIT ADRN-05 |
|
October 2012 |
May 2013 |
May 2013 |
November 29, 2012 |
March 29, 2017 |
January 6, 2017 |
- National Jewish Health
Denver, Colorado, United States - Northwestern University
Chicago, Illinois, United States - Boston Children's Hospital
Boston, Massachusetts, United States - (and 2 more...)
|
|
| 64 |
NCT02369341 |
Completed
Has Results |
Immunogenicity and Reactogenicity of GlaxoSmithKline (GSK) Biologicals' Quadrivalent Split Virion Influenza Vaccine Fluarix Tetra (2015 Season Southern Hemisphere) in Adults 18 Years of Age and Above |
|
- Biological: Fluarix Tetra
|
Interventional
|
Phase 3 |
|
Industry |
- Allocation: Non-Randomized
- Intervention Model: Parallel Assignment
- Masking: None (Open Label)
- Primary Purpose: Prevention
|
- Humoral Immune Response for Each Vaccine Strain in Terms of Haemagglutination Inhibition (HI) Antibody Titers.
- Number of Seropositive Subjects for HI Antibodies Against Each of the 4 Vaccine Strains.
- Number of Subjects Who Were Seroprotected for Anti-HI Antibodies Against Each of the 4 Vaccine Influenza Strains.
- (and 12 more...)
|
121 |
All |
18 Years and older (Adult, Older Adult) |
NCT02369341 |
201959 |
|
April 29, 2015 |
June 3, 2015 |
June 3, 2015 |
February 23, 2015 |
October 9, 2017 |
August 29, 2016 |
- GSK Investigational Site
Belo Horizonte, Minas Gerais, Brazil - GSK Investigational Site
São Paulo, Brazil
|
|
| 65 |
NCT01194297 |
Terminated
Has Results |
Study of Live, Attenuated Influenza Vaccination in Preterm and Full-Term Infants |
|
- Biological: Live attenuated influenza vaccine
- Biological: Inactivated influenza vaccine
|
Interventional
|
Phase 4 |
|
Other |
- Allocation: Randomized
- Intervention Model: Parallel Assignment
- Masking: None (Open Label)
- Primary Purpose: Prevention
|
- Humoral Immunogenicity
- Medically-attended Wheezing
|
3 |
All |
24 Months to 35 Months (Child) |
NCT01194297 |
25914 |
|
August 2010 |
May 2012 |
May 2012 |
September 2, 2010 |
August 22, 2014 |
August 22, 2014 |
|
|
| 66 |
NCT01673425 |
Terminated
Has Results |
Evaluating Immune Response to Seasonal FluMist in Healthy Adults |
|
- Drug: Live Attenuated Influenza Vaccine
|
Interventional
|
Not Applicable |
- National Center for Occupational Health and Infection Control
- US Department of Veterans Affairs
|
U.S. Fed |
- Intervention Model: Single Group Assignment
- Masking: None (Open Label)
- Primary Purpose: Basic Science
|
- IgA Antibody Titers
- Serum Antibody Response to LAIV
|
5 |
All |
20 Years to 49 Years (Adult) |
NCT01673425 |
IRB 604-2010 |
|
September 2012 |
December 2012 |
December 2012 |
August 28, 2012 |
September 4, 2014 |
September 4, 2014 |
- Malcom Randall VA Medical Center
Gainesville, Florida, United States
|
|
| 67 |
NCT00968890 |
Completed
Has Results |
Immunogenicity and Safety of Vaccine GSK2340272A (H1N1) and GSK Biologicals Fluarix™ Vaccine When Co-administered in Elderly |
|
- Biological: Pandemrix (Influenza vaccine GSK2340272A)
- Biological: Fluarix™
- Biological: Placebo
|
Interventional
|
Phase 2 |
|
Industry |
- Allocation: Randomized
- Intervention Model: Parallel Assignment
- Masking: Triple (Participant, Investigator, Outcomes Assessor)
- Primary Purpose: Prevention
|
- Number of Seroconverted Subjects After the Second Dose of Pandemrix and After Vaccination With Fluarix
- Number of Seroprotected Subjects After the Second Dose of Pandemrix and After Vaccination With Fluarix
- Geometric Mean Fold Rise (GMFR) After the Second Dose of Pandemrix and After Vaccination With Fluarix
- (and 9 more...)
|
168 |
All |
61 Years and older (Adult, Older Adult) |
NCT00968890 |
113525 |
|
September 12, 2009 |
September 23, 2010 |
September 23, 2010 |
August 31, 2009 |
August 20, 2018 |
March 16, 2011 |
- GSK Investigational Site
Eskilstuna, Sweden - GSK Investigational Site
Örebro, Sweden
|
|
| 68 |
NCT00383123 |
Completed
Has Results |
Study Comparing the Immune Response and Safety of Fluarix and Fluzone Influenza Vaccines in Children |
|
- Biological: Fluarix™
- Biological: Fluzone
|
Interventional
|
Phase 3 |
|
Industry |
- Allocation: Randomized
- Intervention Model: Parallel Assignment
- Masking: Single (Participant)
- Primary Purpose: Prevention
|
- Geometric Mean Titer (GMT) of Serum Haemagglutination-inhibition (HI) Antibodies
- Number of Seroconverted Subjects
- Number of Subjects Reporting Rare Serious Events
- (and 5 more...)
|
3327 |
All |
6 Months to 17 Years (Child) |
NCT00383123 |
104858 |
|
November 2, 2006 |
October 1, 2007 |
October 19, 2007 |
October 2, 2006 |
June 8, 2018 |
December 4, 2008 |
- GSK Investigational Site
Antioch, California, United States - GSK Investigational Site
Fairfield, California, United States - GSK Investigational Site
Fresno, California, United States - (and 37 more...)
|
|
| 69 |
NCT00988143 |
Completed
Has Results |
A Study of Influenza Virus Vaccines in Children and Adults |
|
- Biological: 2009-2010 Trivalent Influenza Virus Vaccine
- Biological: 2008-2009 Trivalent Influenza Virus Vaccine
- Biological: Quadrivalent Influenza Virus Vaccine
|
Interventional
|
Phase 2 |
- Sanofi Pasteur, a Sanofi Company
- Sanofi
|
Industry |
- Allocation: Randomized
- Intervention Model: Parallel Assignment
- Masking: None (Open Label)
- Primary Purpose: Prevention
|
- Number of Participants Reporting Solicited Injection Site and Systemic Reactions Following Vaccination With Quadrivalent Influenza Vaccine or Fluzone® Trivalent Influenza Vaccines.
- Geometric Mean Titers (GMTs) Against Influenza B Strains After Vaccination With Fluzone® Quadrivalent Influenza Vaccine or Trivalent Influenza Vaccine in Adult Participants.
- Geometric Mean Titers (GMTs) Against Influenza A Strains After Vaccination With Fluzone® Quadrivalent Influenza Vaccine or Trivalent Influenza Vaccine in Adult Participants.
|
600 |
All |
6 Months and older (Child, Adult, Older Adult) |
NCT00988143 |
GRC43
UTN: U1111-1111-5427 |
|
October 2009 |
December 2009 |
March 2010 |
October 2, 2009 |
December 12, 2013 |
December 12, 2013 |
- Durham, North Carolina, United States
- Cincinnati, Ohio, United States
- Jefferson Hills, Pennsylvania, United States
- Norfolk, Virginia, United States
|
|
| 70 |
NCT01218646 |
Completed
Has Results |
Study of Quadrivalent Influenza Vaccine Among Adults |
|
- Biological: Investigational Quadrivalent Inactivated Influenza Vaccine, No Preservative
- Biological: Investigational Trivalent Inactivated Influenza Vaccine, No Preservative
- Biological: Fluzone®: 2010-2011 Trivalent Inactivated Influenza Vaccine, No Preservative
|
Interventional
|
Phase 3 |
- Sanofi Pasteur, a Sanofi Company
- Sanofi
|
Industry |
- Allocation: Randomized
- Intervention Model: Parallel Assignment
- Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
- Primary Purpose: Prevention
|
- Geometric Mean Titers Against Influenza B Strains After Vaccination With Fluzone® Quadrivalent Influenza Vaccine or With Trivalent Influenza Vaccines With Corresponding B Strain in Participants Aged 65 Years and Older.
- Geometric Mean Titers Against Influenza B Strains After Vaccination With Fluzone® Quadrivalent Influenza Vaccine or After Trivalent Influenza Vaccines Without Corresponding B Strain in Participants Aged 65 Years and Older.
- Geometric Mean Titers Against the Influenza Virus Antigens After Vaccination With Fluzone® Quadrivalent Influenza Vaccine or Trivalent Influenza Vaccines (TIV) in Participants Aged 18 Years or Older
|
739 |
All |
18 Years and older (Adult, Older Adult) |
NCT01218646 |
QIV03
UTN: U1111-1113-3619 |
|
October 2010 |
March 2011 |
April 2011 |
October 11, 2010 |
October 23, 2013 |
September 12, 2013 |
- Hoover, Alabama, United States
- South Miami, Florida, United States
- Springfield, Missouri, United States
- (and 9 more...)
|
|
| 71 |
NCT00391391 |
Completed
Has Results |
Study of Inactivated, Split-Virion Influenza Vaccine Compared With Standard Fluzone Vaccine in Infants and Children |
- Orthomyxoviridae Infection
- Influenza
- Myxovirus Infection
|
- Biological: Split, Inactivated, Trivalent Influenza Vaccine
- Biological: Split, Inactivated, Trivalent Influenza Vaccine ( Fluzone® 2006/2007 Formulation)
|
Interventional
|
Phase 2 |
|
Industry |
- Allocation: Randomized
- Intervention Model: Parallel Assignment
- Masking: None (Open Label)
- Primary Purpose: Prevention
|
- Geometric Mean Titers (GMTs) Before and Post Vaccination With Either a Fluzone Intradermal or a Fluzone Intramuscular Vaccine
- Percentage of Participants That Achieved A 4-Fold Rise in Serum HAI Antibody Titer Post-vaccination With Either a Fluzone Intradermal or a Fluzone Intramuscular Vaccine
- Percentage of Participants That Achieved Seroprotection Before and Post-vaccination With Either a Fluzone Intradermal or a Fluzone Intramuscular Vaccine
- (and 3 more...)
|
520 |
All |
6 Months to 8 Years (Child) |
NCT00391391 |
FID07 |
|
October 2006 |
March 2007 |
October 2007 |
October 24, 2006 |
December 1, 2011 |
November 22, 2011 |
- Harrisburg, Arkansas, United States
- Little Rock, Arkansas, United States
- Trumann, Arkansas, United States
- (and 16 more...)
|
|
| 72 |
NCT01978262 |
Completed
Has Results |
Immune and Hormone Response to Influenza Vaccine |
|
- Biological: Seasonal Inactivated Influenza Vaccine
|
Interventional
|
Phase 4 |
- Johns Hopkins Bloomberg School of Public Health
- Centers for Disease Control and Prevention
|
Other / U.S. Fed |
- Intervention Model: Single Group Assignment
- Masking: None (Open Label)
- Primary Purpose: Other
|
- Change in Levels of Progesterone After Influenza Vaccination
|
103 |
Female |
18 Years to 39 Years (Adult) |
NCT01978262 |
CIR 292
200-2012-53664-002 |
|
October 2013 |
August 2017 |
August 2017 |
November 7, 2013 |
December 27, 2018 |
October 11, 2018 |
- Center for Immunization Research; Johns Hopkins Bloomberg School of Public Health
Baltimore, Maryland, United States
|
|
| 73 |
NCT00363077 |
Completed
Has Results |
Study to Evaluate the Immunogenicity and the Safety of an Adjuvanted Influenza Vaccine Candidate |
|
- Biological: GSK1247446A Group
- Biological: Fluarix™
|
Interventional
|
Phase 2 |
|
Industry |
- Allocation: Randomized
- Intervention Model: Parallel Assignment
- Masking: Single (Participant)
- Primary Purpose: Prevention
|
- Titers for Serum Hemagglutination Inhibition (HI) Antibodies Against 3 Strains of Influenza Disease.
- Number of Seroconverted Subjects Against 3 Strains of Influenza Disease.
- Number of Seroprotected Subjects Against 3 Strains of Influenza Disease.
- (and 7 more...)
|
150 |
All |
60 Years and older (Adult, Older Adult) |
NCT00363077 |
107975 |
|
October 2, 2006 |
November 1, 2006 |
November 17, 2006 |
August 15, 2006 |
June 8, 2018 |
May 7, 2013 |
- GSK Investigational Site
Gent, Belgium
|
|
| 74 |
NCT00784784 |
Completed
Has Results |
Zanamivir Versus Trivalent Split Virus Influenza Vaccine |
|
- Biological: Fluviral
- Drug: Zanamivir
|
Interventional
|
Phase 3 |
- Mount Sinai Hospital, Canada
- GlaxoSmithKline
|
Other / Industry |
- Allocation: Randomized
- Intervention Model: Parallel Assignment
- Masking: None (Open Label)
- Primary Purpose: Prevention
|
- Number of Laboratory Confirmed Influenza Infections
- Number of Subjects Adhering to Long-term Zanamivir Prophylaxis
|
64 |
All |
18 Years to 69 Years (Adult, Older Adult) |
NCT00784784 |
08-0189-A
CRT113936 |
Stop-Flu-2 |
November 2008 |
May 2009 |
June 2009 |
November 4, 2008 |
November 21, 2014 |
September 2, 2011 |
- Mount Sinai Hospital
Toronto, Ontario, Canada
|
|
| 75 |
NCT03308825 |
Completed
Has Results |
Safety and Immunogenicity of Fluzone® Quadrivalent and Fluzone® High-Dose, Influenza Vaccines |
|
- Biological: Fluzone Quadrivalent vaccine
- Biological: Fluzone High-Dose vaccine
|
Interventional
|
Phase 4 |
- Sanofi Pasteur, a Sanofi Company
- Sanofi
|
Industry |
- Allocation: Non-Randomized
- Intervention Model: Parallel Assignment
- Masking: None (Open Label)
- Primary Purpose: Prevention
|
- Number of Participants Reporting Solicited Injection Site (Tenderness/Pain, Erythema, Swelling) and Systemic Reactions (Fever, Vomiting, Crying Abnormal, Drowsiness, Appetite Lost, Irritability): Group 1 (6 to < 36 Months)
- Number of Participants Reporting Solicited Injection Site (Pain, Erythema, Swelling) and Systemic Reactions(Fever, Headache, Malaise, Myalgia): Group 2 (3 to < 9 Years), Group 3 (18 to < 65 Years) and Group 4(=< 65 Years)
- Geometric Mean Titers (GMTs) of Influenza Vaccine Antibodies in Children: Group 1 (6 to < 36 Months) and Group 2 (3 to < 9 Years)
- (and 7 more...)
|
240 |
All |
6 Months and older (Child, Adult, Older Adult) |
NCT03308825 |
GRC73
U1111-1183-5816 |
|
September 11, 2017 |
November 22, 2017 |
November 22, 2017 |
October 13, 2017 |
December 17, 2018 |
December 17, 2018 |
- Sanofi Pasteur Investigational Site 003
Council Bluffs, Iowa, United States - Sanofi Pasteur Investigational Site 002
Bardstown, Kentucky, United States - Sanofi Pasteur Investigational Site 001
Metairie, Louisiana, United States
|
|
| 76 |
NCT00524940 |
Completed
Has Results |
Trial to Describe the Safety and Immunogenicity of Fluzone® |
|
- Biological: Inactivated, Split-Virion Influenza Virus
|
Interventional
|
Phase 2 |
- Sanofi Pasteur, a Sanofi Company
- Sanofi
|
Industry |
- Allocation: Non-Randomized
- Intervention Model: Single Group Assignment
- Masking: None (Open Label)
- Primary Purpose: Prevention
|
- Solicited Injection Site and Solicited Systemic Reactions Post-vaccination.
- Geometric Mean Titers (GMTs) of Hemagglutination Inhibition Antibodies Pre-vaccination and Post-vaccination.
|
124 |
All |
18 Years and older (Adult, Older Adult) |
NCT00524940 |
GRC37 |
|
August 2007 |
September 2007 |
December 2007 |
September 5, 2007 |
April 14, 2016 |
March 30, 2009 |
- Norfolk, Virginia, United States
|
|
| 77 |
NCT03143101 |
Completed
Has Results |
Evaluate the Shedding and Immunogencity of Different Formulations of FluMist in Children 24 to <48 Months of Age |
|
- Biological: FluMist trivalent (2015-2016)
- Biological: FluMist Quadrivalent (2015-2016)
- Biological: FluMist Quadrivalent (2017-2018)
|
Interventional
|
Phase 4 |
|
Industry |
- Allocation: Randomized
- Intervention Model: Parallel Assignment
- Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
- Primary Purpose: Prevention
|
- Percentage of Participants With A/H1N1 Hemagglutination Inhibition (HAI) Antibody Seroconversion Rate at Day 28
- Percentage of Participants With A/H3N2 HAI Antibody Seroconversion Rate at Day 28
- Percentage of Participants With B/Yamagata HAI Antibody Seroconversion Rate at Day 28
- (and 13 more...)
|
200 |
All |
24 Months to 47 Months (Child) |
NCT03143101 |
D2560C00013 |
FluMist |
May 8, 2017 |
September 29, 2017 |
September 29, 2017 |
May 8, 2017 |
December 11, 2018 |
December 11, 2018 |
- Research Site
Savannah, Georgia, United States - Research Site
Bardstown, Kentucky, United States - Research Site
Saint Louis, Missouri, United States - (and 9 more...)
|
|
| 78 |
NCT01827462 |
Completed
Has Results |
Comparison of Immune Responses to Influenza Vaccine In Adults of Different Ages (SLVP015 2007-2017) |
|
- Biological: Trivalent, inactivated influenza vaccine (TIV)
- Biological: Quadrivalent, inactivated influenza vaccine (IIV4)
- Biological: High-Dose Trivalent, inactivated influenza vaccine (TIV High-Dose)
|
Interventional
|
Phase 4 |
- Stanford University
- National Institute of Allergy and Infectious Diseases (NIAID)
|
Other / NIH |
- Allocation: Non-Randomized
- Intervention Model: Parallel Assignment
- Masking: None (Open Label)
- Primary Purpose: Prevention
|
- Number of Participants Who Received the Influenza Vaccine
- Number of Participants With Related Adverse Events
|
136 |
All |
18 Years to 100 Years (Adult, Older Adult) |
NCT01827462 |
SU-03192011-7599
1U19AI090019-01
51731
AG-NS-0792-11 |
|
October 2007 |
December 2015 |
March 2017 |
April 9, 2013 |
July 11, 2017 |
June 12, 2017 |
- Stanford University School of Medicine
Stanford, California, United States
|
|
| 79 |
NCT03022422 |
Completed
Has Results |
T-cell And General Immune Response to Seasonal Influenza Vaccine (SLVP018) Year 3, 2011 |
|
- Biological: TIV
- Biological: High-Dose TIV
|
Interventional
|
Phase 4 |
- Stanford University
- National Institute of Allergy and Infectious Diseases (NIAID)
|
Other / NIH |
- Allocation: Non-Randomized
- Intervention Model: Parallel Assignment
- Masking: None (Open Label)
- Primary Purpose: Basic Science
|
- Number of Individual Twins Who Received Influenza Vaccine
- Number of Individual Twins With Related Adverse Events
|
63 |
All |
18 Years to 100 Years (Adult, Older Adult) |
NCT03022422 |
SU-17219-2011
2U19AI057229-06 |
|
September 2011 |
December 2011 |
December 2011 |
January 16, 2017 |
August 21, 2017 |
May 11, 2017 |
|
|
| 80 |
NCT01938170 |
Completed
Has Results |
Home Administration of FluMist by Parents/Caregivers |
|
|
Interventional
|
Not Applicable |
- University of North Carolina, Chapel Hill
- University of North Carolina
- MedImmune LLC
|
Other / Industry |
- Intervention Model: Single Group Assignment
- Masking: None (Open Label)
- Primary Purpose: Treatment
|
- Number of Subjects That Reported Successful Home Vaccination With no Adverse Events
- Number of Subjects That Reported Ability to Successfully Administer FluMist Vaccine at Home
|
41 |
All |
2 Years to 17 Years (Child) |
NCT01938170 |
13-2769 |
|
September 2014 |
April 2015 |
September 2015 |
September 10, 2013 |
May 26, 2016 |
May 26, 2016 |
- University of North Carolina
Chapel Hill, North Carolina, United States
|
|
| 81 |
NCT00845429 |
Completed
Has Results |
Immunogenicity of a Split, Cell-Based, Inactivated, Trivalent Influenza Vaccine in Healthy Adult Subjects |
- Influenza
- Orthomyxoviruses
- Myxovirus Infection
|
- Biological: Influenza virus vaccine - cell based (2007-2008 Formulation)
- Biological: Influenza virus vaccine - cell-based (2007-2008 Formulation)
- Biological: Influenza virus vaccine (2007-2008 Formulation)
|
Interventional
|
Phase 2 |
|
Industry |
- Allocation: Randomized
- Intervention Model: Parallel Assignment
- Masking: Single (Outcomes Assessor)
- Primary Purpose: Prevention
|
- Summary of the Pre- and Post-Vaccination Geometric Mean Titers (GMTs) for Each of the Influenza Vaccine Antigens.
- Percentage of Participants With Seroprotection to Each of the Influenza Vaccine Antigen Before and Post-vaccination.
- Percentage of Participants Achieving Seroconversion or Significant Increase at Day 21 Following Vaccination With Influenza Vaccine.
- Number of Participants Reporting at Least 1 Solicited Injection Site or Systemic Reaction Post-vaccination With Influenza Vaccine.
|
729 |
All |
18 Years to 49 Years (Adult) |
NCT00845429 |
GCE03 |
|
October 2007 |
August 2008 |
November 2008 |
February 18, 2009 |
December 19, 2012 |
December 17, 2012 |
- Hoover, Alabama, United States
- Mobile, Alabama, United States
- Tucson, Arizona, United States
- (and 12 more...)
|
|
| 82 |
NCT02290691 |
Completed
Has Results |
Inactivated Influenza Via Jet Injection |
|
- Biological: Influenza Vaccine
|
Interventional
|
Phase 4 |
|
Industry |
- Allocation: Randomized
- Intervention Model: Parallel Assignment
- Masking: Single (Outcomes Assessor)
- Primary Purpose: Prevention
|
- Anti Influenza Hemagglutination Inhibition (HAI) Antibody Geometric Mean Titers (GMT)
- The Number of Evaluable Participants Achieving Seroconversion or Significant Increase in Antibody Titer.
- Percentage of Subjects With Immediate Complaints
- (and 2 more...)
|
985 |
All |
18 Years to 64 Years (Adult) |
NCT02290691 |
PJ-501-14 |
IIJI |
November 2014 |
January 2015 |
January 2015 |
November 14, 2014 |
November 30, 2017 |
November 30, 2017 |
- Optimal Research LLC
Huntsville, Alabama, United States - Optimal Research, LLC
San Diego, California, United States - Optimal Research, LLC
Melbourne, Florida, United States - (and 3 more...)
|
|
| 83 |
NCT01232868 |
Completed
Has Results |
Systems Biology of Trivalent Influenza Vaccine (TIV) in Young and Elderly |
|
- Biological: trivalent Influenza vaccine (TIV)
|
Interventional
|
Not Applicable |
|
Other |
- Allocation: Non-Randomized
- Intervention Model: Parallel Assignment
- Masking: None (Open Label)
- Primary Purpose: Basic Science
|
- Efficacy, Measured by the Number of Subjects With a Change in Innate Immune Signatures
- Number of Participants With Specific B Cell Responses That Correlate With the Innate Immune Signatures
|
66 |
All |
25 Years and older (Adult, Older Adult) |
NCT01232868 |
IRB00046787
NIH
VAX-001 |
|
October 2010 |
October 2011 |
October 2011 |
November 2, 2010 |
November 30, 2015 |
November 30, 2015 |
- Hope Clinic of the Emory Vaccine Center
Decatur, Georgia, United States
|
|
| 84 |
NCT01262846 |
Completed
Has Results |
Improving Immunogenicity of Influenza Vaccine in HIV Infected Individuals |
|
|
Interventional
|
Phase 4 |
- University of Pennsylvania
|
Other |
- Allocation: Randomized
- Intervention Model: Parallel Assignment
- Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
- Primary Purpose: Prevention
|
|
195 |
All |
18 Years and older (Adult, Older Adult) |
NCT01262846 |
UPenn FLU 02 |
|
November 2010 |
April 2011 |
April 2011 |
December 17, 2010 |
April 13, 2017 |
April 13, 2017 |
- Clinical Trials Unit. University of Pennsylvania
Philadelphia, Pennsylvania, United States
|
|
| 85 |
NCT02263040 |
Completed
Has Results |
A Pilot Study to Assess the Immunogenicity and Reactogenicity of High Versus Standard Dose TIV |
|
- Biological: Fluzone High-Dose
- Biological: Fluzone (standard dose)
|
Interventional
|
Phase 1
Phase 2 |
- Mount Sinai Hospital, Canada
|
Other |
- Allocation: Randomized
- Intervention Model: Parallel Assignment
- Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
- Primary Purpose: Prevention
|
- Number of Participants With Seroconversion to A/California/07/2009 (H1N1)
- Number of Participants With Seroconversion to A/Texas/50/2012 (H3N2)
- Number of Participants With Seroconversion to Influenza B/Phuket/3073/2013
- (and 9 more...)
|
170 |
All |
18 Years to 64 Years (Adult) |
NCT02263040 |
14-0909 |
|
October 2014 |
July 2016 |
December 31, 2016 |
October 13, 2014 |
January 28, 2019 |
January 28, 2019 |
- Mount Sinai Hospital
Toronto, Ontario, Canada
|
|
| 86 |
NCT01189123 |
Completed
Has Results |
Cell Mediated Immunity in Older Adults |
- Immunity to Influenza Vaccine
|
- Biological: High dose influenza vaccine Sanofi-Pasteur
- Biological: fluzone by sanofi pasteur
|
Interventional
|
Not Applicable |
- Vanderbilt University
- Centers for Disease Control and Prevention
|
Other / U.S. Fed |
- Allocation: Randomized
- Intervention Model: Parallel Assignment
- Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
- Primary Purpose: Basic Science
|
- Cellular Immune Response
- Antibody Responses
|
105 |
All |
65 Years and older (Older Adult) |
NCT01189123 |
080925
5U18IP000184-03 |
CMI |
August 2010 |
August 2011 |
August 2013 |
August 26, 2010 |
April 24, 2014 |
March 3, 2014 |
- Vanderbilt University Medical Center
Nashville, Tennessee, United States
|
|
| 87 |
NCT01173211 |
Completed
Has Results |
2010-2011 Trivalent Influenza Vaccine (TIV) in Pregnant Women |
|
- Biological: Trivalent inactivated influenza vaccine
|
Interventional
|
Phase 2 |
- National Institute of Allergy and Infectious Diseases (NIAID)
|
NIH |
- Allocation: Randomized
- Intervention Model: Parallel Assignment
- Masking: Triple (Participant, Investigator, Outcomes Assessor)
- Primary Purpose: Prevention
|
- Number of Participants Reporting Vaccine-associated Unsolicited Non-serious Adverse Events
- Number of Participants Reporting Maternal Complications of Pregnancy, Labor and Delivery
- Number of Participants Reporting Neonatal Complications
- (and 16 more...)
|
183 |
Female |
18 Years to 39 Years (Adult) |
NCT01173211 |
09-0005
HHSN272200800002C |
|
September 2010 |
November 2011 |
November 2011 |
July 30, 2010 |
December 24, 2014 |
January 31, 2013 |
- Saint Louis University - Center for Vaccine Development
Saint Louis, Missouri, United States - Duke University Medical Center - Duke Perinatal Clinic
Durham, North Carolina, United States - Vanderbilt University - Pediatric - Vanderbilt Vaccine Research Center
Nashville, Tennessee, United States - (and 2 more...)
|
|
| 88 |
NCT00844051 |
Completed
Has Results |
Study to Evaluate Impact of School-based Influenza Vaccination on School Populations |
|
- Biological: School-based influenza vaccination program
|
Interventional
|
Not Applicable |
- Children's Hospital Los Angeles
- Los Angeles County Department of Public Health
|
Other |
- Allocation: Non-Randomized
- Intervention Model: Parallel Assignment
- Masking: Single (Outcomes Assessor)
- Primary Purpose: Prevention
|
- Rates of Confirmed Influenza Illness in Vaccinated and Non-vaccinated Children Attending Schools With and Without School-based Influenza Vaccination Programs
- Rates of Absenteeism Among Children Attending Schools With and Without School-based Influenza Vaccination Programs
|
4455 |
All |
4 Years to 18 Years (Child, Adult) |
NCT00844051 |
CHLA-08-00229 |
|
January 2009 |
June 2011 |
June 2011 |
February 13, 2009 |
September 12, 2016 |
August 1, 2016 |
- Los Angeles County Department of Public Health
Los Angeles, California, United States - Childrens Hospital Los Angeles
Los Angeles, California, United States
|
|
| 89 |
NCT01440387 |
Completed
Has Results |
A Study of Immunogenicity and Safety of GSK Biologicals' Influenza Vaccine FLU-Q-QIV in Adults Aged 18 Years and Older |
|
- Biological: FLULAVAL® QUADRIVALENT
|
Interventional
|
Phase 3 |
|
Industry |
- Allocation: Non-Randomized
- Intervention Model: Parallel Assignment
- Masking: None (Open Label)
- Primary Purpose: Prevention
|
- Humoral Immune Response in Terms of Hemagglutination Inhibition (HI) Antibodies Against Each of the 4 Vaccine Influenza Strains.
- Number of Subjects Who Were Seroprotected for HI Antibodies Against Each of the 4 Vaccine Influenza Strains.
- Number of Seroconverted Subjects for HI Antibodies Against Each of the 4 Vaccine Influenza Strains.
- (and 5 more...)
|
112 |
All |
18 Years and older (Adult, Older Adult) |
NCT01440387 |
115418 |
|
September 30, 2011 |
October 22, 2011 |
October 22, 2011 |
September 26, 2011 |
September 7, 2018 |
November 19, 2013 |
- GSK Investigational Site
Sherbrooke, Quebec, Canada
|
|
| 90 |
NCT01240746 |
Completed
Has Results |
Study of Quadrivalent Influenza Vaccine Among Children |
|
- Biological: Licensed 2010-2011 Trivalent Influenza Vaccine, No Preservative
- Biological: Investigational Trivalent Influenza Vaccine with alternate B strain, No Preservative
- Biological: Quadrivalent Influenza Vaccine, No Preservative
|
Interventional
|
Phase 3 |
- Sanofi Pasteur, a Sanofi Company
- Sanofi
|
Industry |
- Allocation: Randomized
- Intervention Model: Parallel Assignment
- Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
- Primary Purpose: Prevention
|
- Geometric Mean Titers Against Influenza A Strains After Vaccination With Fluzone® Quadrivalent Influenza Vaccine or Trivalent Influenza Vaccines in All Participants
- Geometric Mean Titers Against Influenza B Strains After Vaccination With Fluzone® Quadrivalent Influenza Vaccine or Trivalent Influenza Vaccines With Corresponding B Strain in All Participants
- Geometric Mean Titers Against Influenza B Strains After Vaccination With Fluzone® Quadrivalent Influenza Vaccine or Trivalent Influenza Vaccines Without Corresponding B Strain in All Participants
- (and 2 more...)
|
4363 |
All |
6 Months to 8 Years (Child) |
NCT01240746 |
QIV04
UTN: U1111-1114-3713 |
|
November 2010 |
December 2011 |
February 2012 |
November 15, 2010 |
July 14, 2015 |
January 14, 2014 |
- Dothan, Alabama, United States
- Chandler, Arizona, United States
- Chandler, Arizona, United States
- (and 64 more...)
|
|
| 91 |
NCT03022396 |
Completed
Has Results |
T-cell And General Immune Response to Seasonal Influenza Vaccine (SLVP018) Year 2, 2010 |
|
- Biological: High Dose Fluzone® (intramuscular)
- Biological: Fluzone® (intramuscular)
|
Interventional
|
Phase 4 |
- Stanford University
- National Institute of Allergy and Infectious Diseases (NIAID)
|
Other / NIH |
- Allocation: Non-Randomized
- Intervention Model: Parallel Assignment
- Masking: None (Open Label)
- Primary Purpose: Basic Science
|
- Number of Individual Twins Who Received Influenza Vaccine
- Number of Individual Twins With Related Adverse Events
|
82 |
All |
8 Years to 100 Years (Child, Adult, Older Adult) |
NCT03022396 |
SU-17219-2010
2U19AI057229-06 |
|
September 2010 |
January 2011 |
January 2011 |
January 16, 2017 |
August 21, 2017 |
August 21, 2017 |
|
|
| 92 |
NCT01987349 |
Completed
Has Results |
T-cell And General Immune Response to Seasonal Influenza Vaccine (SLVP018) - Year 1, 2009 |
|
- Biological: Fluzone® (intramuscular)
- Biological: FluMist® (intranasal)
|
Interventional
|
Phase 4 |
- Stanford University
- National Institute of Allergy and Infectious Diseases (NIAID)
|
Other / NIH |
- Allocation: Non-Randomized
- Intervention Model: Parallel Assignment
- Masking: None (Open Label)
- Primary Purpose: Basic Science
|
- Number of Participants From Each Arm Who Received Influenza Vaccine Vaccine
- Number of Participants With Related Adverse Events
|
72 |
All |
8 Years to 100 Years (Child, Adult, Older Adult) |
NCT01987349 |
SU-17219-2009
2U19AI057229-06 |
|
September 2009 |
January 2010 |
January 2010 |
November 19, 2013 |
May 12, 2017 |
May 12, 2017 |
- Stanford University School of Medicine
Stanford, California, United States
|
|
| 93 |
NCT02451358 |
Completed
Has Results |
Study of a Single Dose or Two Doses of a Quadrivalent Influenza Vaccine in Subjects Aged 6 Months or Older in India |
|
- Biological: Quadrivalent Inactivated Influenza Vaccine (2016-2017 NH formulation), No Preservative
- Biological: Quadrivalent Inactivated Influenza Vaccine (2016 SH formulation), No Preservative
- Biological: Quadrivalent Inactivated Influenza Vaccine (2015-2016 NH formulation), No Preservative
- Biological: Quadrivalent Inactivated Influenza Vaccine (2015 SH formulation), No Preservative
|
Interventional
|
Phase 3 |
- Sanofi Pasteur, a Sanofi Company
- Sanofi
|
Industry |
- Allocation: Randomized
- Intervention Model: Parallel Assignment
- Masking: None (Open Label)
- Primary Purpose: Prevention
|
- Geometric Mean Titers (GMTs) of Influenza Vaccine Antibodies
- Number of Participants With Seroprotection to Influenza Vaccine Antigens
- Number of Participants With Seroconversion or Significant Increase to Influenza Vaccine Antigens
- Number of Participants Reporting Solicited Injection Site and Systemic Reactions After Vaccination With Influenza Vaccine
|
400 |
All |
6 Months and older (Child, Adult, Older Adult) |
NCT02451358 |
QIV06
U1111-1143-8370
CTRI/2015/05/005770 |
|
July 27, 2015 |
January 28, 2017 |
January 28, 2017 |
May 22, 2015 |
March 1, 2018 |
March 1, 2018 |
- Vadodara, Gujarat, India
- Mandya, Karnataka, India
- Pune, Maharashtra, India
- (and 5 more...)
|
|
| 94 |
NCT01579916 |
Completed
Has Results |
A Study to Evaluate the Safety of 3 New 6:2 Influenza Virus Reassortants in Adults |
|
- Biological: Trivalent Influenza Virus Vaccine
- Other: Placebo
|
Interventional
|
Phase 4 |
|
Industry |
- Allocation: Randomized
- Intervention Model: Single Group Assignment
- Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
- Primary Purpose: Prevention
|
- Percentage of Participants Reporting Fever Within 7 Days Post Vaccination
- Percentage of Participants Reporting Other Solicited Symptoms Within 7 Days Post Vaccination
- Percentage of Participants Reporting Any Adverse Event (AE) Within 7 Days Post Vaccination
- (and 8 more...)
|
303 |
All |
18 Years to 49 Years (Adult) |
NCT01579916 |
CD-VA-FluMist-1114 |
|
May 2012 |
November 2012 |
November 2012 |
April 18, 2012 |
February 3, 2014 |
February 3, 2014 |
- Research Site
Miami, Florida, United States - Research Site
Stockbridge, Georgia, United States - Research Site
Portland, Oregon, United States
|
|
| 95 |
NCT03022435 |
Completed
Has Results |
T-cell And General Immune Response to Seasonal Influenza Vaccine (SLVP018) Year 4, 2012 |
|
- Biological: TIV
- Biological: High-Dose TIV
- Biological: LAIV
|
Interventional
|
Phase 4 |
- Stanford University
- National Institute of Allergy and Infectious Diseases (NIAID)
|
Other / NIH |
- Allocation: Non-Randomized
- Intervention Model: Parallel Assignment
- Masking: None (Open Label)
- Primary Purpose: Basic Science
|
- Number of Participants Who Received Influenza Vaccine
- Number of Participants With Related Adverse Events
|
22 |
All |
18 Years to 100 Years (Adult, Older Adult) |
NCT03022435 |
SU-17219-2012
2U19AI057229-06 |
|
October 2012 |
January 2013 |
January 2013 |
January 16, 2017 |
May 22, 2017 |
March 9, 2017 |
|
|
| 96 |
NCT00775450 |
Completed
Has Results |
Influenza Vaccine Revaccination in Ambulatory Elderly Subjects |
- Influenza
- Orthomyxovirus Infection
- Myxovirus Infection
|
- Biological: Influenza Virus Vaccine USP Trivalent Types A and B
|
Interventional
|
Phase 2 |
- Sanofi Pasteur, a Sanofi Company
- Sanofi
|
Industry |
- Allocation: Randomized
- Intervention Model: Parallel Assignment
- Masking: None (Open Label)
- Primary Purpose: Prevention
|
- Number of Participants Reporting Solicited Injection Site and Systemic Reactions After Fluzone Intradermal or Fluzone Intramuscular or Fluzone High-dose Vaccine Injection
- Geometric Mean Titers (GMTs) Before and After Vaccination With Fluzone Intradermal or Fluzone Intramuscular or Fluzone High-dose Vaccine Injection
- Percentage of Participants Who Achieved Seroprotection Post-Vaccination With Fluzone Intradermal or Fluzone Intramuscular or Fluzone High-dose Vaccine
- Percentage of Participants Who Achieved Seroconversion Post-Vaccination With Fluzone Intradermal or Fluzone Intramuscular or Fluzone High-dose Vaccine
|
807 |
All |
65 Years and older (Older Adult) |
NCT00775450 |
FID21 |
|
October 2008 |
June 2009 |
July 2009 |
October 20, 2008 |
December 31, 2013 |
August 11, 2011 |
- Hoover, Alabama, United States
- Mobile, Alabama, United States
- Chandler, Arizona, United States
- (and 25 more...)
|
|
| 97 |
NCT00753272 |
Completed
Has Results |
Trial to Evaluate the Efficacy of GSK Biologicals' Influenza Vaccine GSK2186877A in Adults 65 Year of Age and Older |
|
- Biological: GSK Bio's influenza vaccine GSK2186877A
- Biological: Fluarix TM
|
Interventional
|
Phase 3 |
|
Industry |
- Allocation: Randomized
- Intervention Model: Parallel Assignment
- Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
- Primary Purpose: Prevention
|
- Number of Subjects Reporting Polymerase Chain Reaction (PCR)-Confirmed Influenza A and/or B Infection.
- Serum Hemagglutination-inhibition (HI) Antibody Titers, Against Each of the 3 Vaccine Influenza Strains, in the FluNG Groups.
- Number of Subjects Reporting Culture-confirmed Influenza A and/or B Infection.
- (and 19 more...)
|
43695 |
All |
65 Years and older (Older Adult) |
NCT00753272 |
106372 |
|
September 15, 2008 |
June 18, 2010 |
January 5, 2011 |
September 16, 2008 |
June 8, 2018 |
June 19, 2012 |
- GSK Investigational Site
Alabaster, Alabama, United States - GSK Investigational Site
Huntsville, Alabama, United States - GSK Investigational Site
Mobile, Alabama, United States - (and 271 more...)
|
|
| 98 |
NCT02987374 |
Completed
Has Results |
Pilot Study in Young Adults to Examine the Kinetics of Changes in the B-cell Repertoire Following TIV Immunization |
|
- Biological: 2011-2012 Fluzone IIV3 (IM)
|
Interventional
|
Phase 4 |
- Stanford University
- National Institute of Allergy and Infectious Diseases (NIAID)
|
Other / NIH |
- Intervention Model: Single Group Assignment
- Masking: None (Open Label)
- Primary Purpose: Basic Science
|
- Number of Participants Who Received Influenza Vaccine
- Number of Participants With Related Adverse Events
|
10 |
All |
18 Years to 30 Years (Adult) |
NCT02987374 |
SU-24167
U19AI057229-06 |
SLVP023 |
May 2012 |
December 2012 |
December 2012 |
December 8, 2016 |
April 21, 2017 |
December 26, 2016 |
|
|
| 99 |
NCT01626820 |
Completed
Has Results |
Immunogenicity and Safety Study of GlaxoSmithKline (GSK) Biologicals' Fluviral® (2012/2013 Season) in Adults |
|
|
Interventional
|
Phase 3 |
|
Industry |
- Allocation: Non-Randomized
- Intervention Model: Single Group Assignment
- Masking: None (Open Label)
- Primary Purpose: Prevention
|
- Haemagglutination Inhibition (HI) Antibody Titers, Against Each of the Vaccine Influenza Virus Strains.
- Number of Subjects Seroprotected for HI Antibodies Against Each of the Three Vaccine Influenza Strains.
- Number of Seroconverted Subjects for HI Antibodies Against Each of the Three Vaccine Influenza Strains.
- (and 5 more...)
|
113 |
All |
18 Years and older (Adult, Older Adult) |
NCT01626820 |
116664 |
|
July 19, 2012 |
August 10, 2012 |
August 10, 2012 |
June 25, 2012 |
September 7, 2018 |
October 14, 2013 |
- GSK Investigational Site
Sherbrooke, Quebec, Canada
|
|
| 100 |
NCT01854632 |
Completed
Has Results |
Clinical Efficacy of Trivalent Live-Attenuated Influenza Vaccine (LAIV) Among Children in Senegal |
|
- Biological: SIIL Live Attenuated Influenza Vaccine
- Biological: Matched placebo
|
Interventional
|
Phase 3 |
- PATH
- Institut de Recherche pour le Developpement
- Institut Pasteur de Dakar
- Centers for Disease Control and Prevention
|
Other / U.S. Fed |
- Allocation: Randomized
- Intervention Model: Parallel Assignment
- Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
- Primary Purpose: Prevention
|
- Percentage of Participants With Symptomatic, Laboratory-confirmed Influenza Virus Infection (Regardless of Vaccine Match)
- Safety Profile of LAIV: Immediate Reactions Occurring Within 30 Minutes of Administration of Study Vaccine.
- Safety Profile of LAIV: Solicited and Unsolicited Local and Systemic Reactions
- (and 8 more...)
|
1761 |
All |
24 Months to 71 Months (Child) |
NCT01854632 |
LAIV-SEN-01 |
|
May 2013 |
December 2013 |
December 2013 |
May 15, 2013 |
June 3, 2015 |
June 3, 2015 |
- Institut de Recherche pour le Développement (IRD), Niakhar station
Niakhar, Senegal
|
|
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