| 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 |
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
|
|
| 3 |
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
|
|
| 4 |
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
|
|
| 5 |
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
|
|
| 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 |
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
|
|
| 8 |
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
|
|
| 9 |
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...)
|
|
| 10 |
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
|
|
| 11 |
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
|
|
| 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 |
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...)
|
|
| 14 |
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...)
|
|
| 15 |
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
|
|
| 16 |
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...)
|
|
| 17 |
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...)
|
|
| 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 |
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
|
|
| 20 |
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...)
|
|
| 21 |
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...)
|
|
| 22 |
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
|
|
| 23 |
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
|
|
| 24 |
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
|
|
| 25 |
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
|
|
| 26 |
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 |
November 27, 2017 |
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...)
|
|
| 27 |
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 2013 |
February 2014 |
July 2014 |
November 4, 2013 |
September 23, 2016 |
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...)
|
|
| 28 |
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
|
|
| 29 |
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
|
|
| 30 |
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
|
|
| 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 |
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...)
|
|
| 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 |
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 |
|
|
| 36 |
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
|
|
| 37 |
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...)
|
|
| 38 |
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
|
|
| 39 |
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...)
|
|
| 40 |
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
|
|
| 41 |
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
|
|
| 42 |
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...)
|
|
| 43 |
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
|
|
| 44 |
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
|
|
| 45 |
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...)
|
|
| 46 |
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 |
|
|
| 47 |
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...)
|
|
| 48 |
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
|
|
| 49 |
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
|
|
| 50 |
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
|
|
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