| 1 |
NCT01256931 |
Unknown † |
Antibody Levels Against 2009 Influenza A H1N1 One Year After Vaccination With Pandemrix and 2010 Fluarix Booster in Organ Transplant Recipients. |
|
|
Observational
|
|
- Sahlgrenska University Hospital, Sweden
|
Other |
- Observational Model: Case Control
- Time Perspective: Prospective
|
- Frequency of individuals with remaining protective antibody titers against influenza H1N1 2009 one year after Pandemrix vaccination in organ transplant patients and controls
- Booster effect on antibody titers against influenza 2009 H1N1 of 2010 Fluarix vaccination
|
110 |
All |
18 Years to 80 Years (Adult, Older Adult) |
NCT01256931 |
MMV-305 |
|
December 2010 |
|
|
December 9, 2010 |
December 9, 2010 |
|
- Transplant Institute, Sahlgrenska University Hospital
Gothenburg, Västra Götaland, Sweden
|
|
| 2 |
NCT00510874 |
Completed
Has Results |
Study to Evaluate the Safety and Immune Response of Two-Doses of Candidate Influenza Vaccine GSK 1557484A in Adults |
|
- Biological: Pumarix™
- Biological: Pandemrix ™
|
Interventional
|
Phase 1 |
|
Industry |
- Allocation: Randomized
- Intervention Model: Parallel Assignment
- Masking: Double (Participant, Investigator)
- Primary Purpose: Prevention
|
- Number of Seroconverted Subjects Against the A/Indonesia/5/2005 (H5N1) Strain of Influenza Disease.
- Titers for Serum Hemagglutination Inhibition (HI) Antibodies Against the A/Indonesia/5/2005 (H5N1) Strain of Influenza Disease.
- Number of Seroprotected Subjects Against the A/Indonesia/5/2005 (H5N1) Strain of Influenza Disease.
- (and 7 more...)
|
780 |
All |
18 Years to 64 Years (Adult) |
NCT00510874 |
110028 |
|
July 28, 2007 |
June 17, 2008 |
October 24, 2008 |
August 2, 2007 |
August 17, 2018 |
February 7, 2014 |
- GSK Investigational Site
Huntsville, Alabama, United States - GSK Investigational Site
Anaheim, California, United States - GSK Investigational Site
Miami, Florida, United States - (and 7 more...)
|
|
| 3 |
NCT01196026 |
Completed
Has Results |
Immunogenicity and Safety Study of Fluarix™ Vaccine in Children Who Have Previously Been Vaccinated With Pandemrix™ |
|
- Biological: Fluarix™
- Biological: Havrix™ Junior
|
Interventional
|
Phase 4 |
|
Industry |
- Allocation: Randomized
- Intervention Model: Parallel Assignment
- Masking: None (Open Label)
- Primary Purpose: Prevention
|
- Haemagglutination Inhibition (HI) Antibody Titers Against H1N1 in All Subjects Receiving Fluarix Vaccine
- Number of Subjects Seropositive for HI Antibodies Against H1N1 in All Subjects Receiving Fluarix Vaccine
- Number of Subjects Seroprotected for HI Antibodies Against H1N1 in All Subjects Receiving Fluarix Vaccine
- (and 27 more...)
|
162 |
All |
1 Year to 10 Years (Child) |
NCT01196026 |
114451 |
|
September 15, 2010 |
May 26, 2011 |
May 26, 2011 |
September 8, 2010 |
September 24, 2018 |
June 28, 2012 |
- GSK Investigational Site
Rotterdam, Netherlands - GSK Investigational Site
Karlskrona, Sweden - GSK Investigational Site
Malmö, Sweden - (and 4 more...)
|
|
| 4 |
NCT01039623 |
Unknown † |
Assessment of Safety and Immunogenicity of Intradermal Unadjuvanted Portion of Pandemrix® Via a Microneedle Device With Intramuscular Adjuvanted Pandemrix® as Reference |
|
- Biological: Pandemrix® (H1N1 pandemic influenza)
|
Interventional
|
Not Applicable |
- Hadassah Medical Organization
|
Other |
- Allocation: Randomized
- Intervention Model: Parallel Assignment
- Masking: None (Open Label)
- Primary Purpose: Prevention
|
|
200 |
All |
18 Years to 64 Years (Adult) |
NCT01039623 |
Vaccine-HMO-CTIL |
|
January 2010 |
December 2011 |
April 2012 |
December 25, 2009 |
December 25, 2009 |
|
- Hadassah Medical Organization
Jerusalem, Israel
|
|
| 5 |
NCT01715792 |
Completed |
Assess the Risk of Solid Organ Transplant Rejection Following Vaccination With Pandemrix™ in UK |
|
|
Observational
|
|
|
Industry |
- Time Perspective: Retrospective
|
- Assessment of the risk of solid organ transplant rejection (liver, kidney, lung, heart, pancreas).
|
587 |
All |
Child, Adult, Older Adult |
NCT01715792 |
116602 |
|
October 2012 |
August 2013 |
August 2013 |
October 29, 2012 |
February 10, 2014 |
|
- GSK Investigational Site
London, United Kingdom
|
|
| 6 |
NCT02719743 |
Completed |
A Dose Ranging Safety and Immunogenicity Study of GlaxoSmithKline (GSK) Biologicals' GSK1557484A Vaccine in Children 6 to Less Than 36 Months of Age |
|
- Biological: Influenza A (H5N1) Virus monovalent vaccine (GSK1557484A).
|
Interventional
|
Phase 2 |
|
Industry |
- Allocation: Randomized
- Intervention Model: Parallel Assignment
- Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
- Primary Purpose: Prevention
|
- Calculation of immunogenicity-fever indices based on evaluation of humoral immune response in terms of vaccine-homologous hemagglutination Inhibition (HI) and microneutralization (MN) antibodies for each group
- Evaluation of Mean Geometric Increase (MGI), in terms of HI and MN antibodies against vaccine-homologous antigen.
- Evaluation of humoral immune response in terms of HI antibodies against vaccine-homologous/heterologous antigens post primary immunization.
- (and 8 more...)
|
185 |
All |
6 Months to 35 Months (Child) |
NCT02719743 |
116938
2015-003458-42 |
|
July 7, 2016 |
February 13, 2018 |
February 13, 2018 |
March 25, 2016 |
May 7, 2018 |
|
- GSK Investigational Site
Taichung, Taiwan - GSK Investigational Site
Taichung, Taiwan - GSK Investigational Site
Taipei, Taiwan - (and 4 more...)
|
|
| 7 |
NCT01160237 |
Terminated
Has Results |
Study to Evaluate the Immune Response and the Safety of Fluarix TM/ Influsplit SSW® 2010/2011 or Pandemrix TM |
|
- Biological: PandemrixTM
- Biological: FluarixTM/ Influsplit SSW® 2010/2011
|
Interventional
|
Phase 3 |
|
Industry |
- Allocation: Randomized
- Intervention Model: Parallel Assignment
- Masking: None (Open Label)
- Primary Purpose: Prevention
|
- Humoral Immune Response in Terms of Haemagglutination Inhibition (HI) Antibodies for Each Vaccine Strain, in Subjects Aged 18-60 and Above 60 Years
- Solicited Local and General Symptoms
- Number of Subjects Reporting Unsolicited Adverse Events
- (and 3 more...)
|
7 |
All |
18 Years and older (Adult, Older Adult) |
NCT01160237 |
114454 |
|
August 2010 |
February 2011 |
February 2011 |
July 12, 2010 |
October 20, 2016 |
March 23, 2012 |
- GSK Investigational Site
Tuebingen, Baden-Wuerttemberg, Germany - GSK Investigational Site
Wuerzburg, Bayern, Germany - GSK Investigational Site
Goch, Nordrhein-Westfalen, Germany - (and 2 more...)
|
|
| 8 |
NCT01298102 |
Completed |
Influenza A/H1N1/2009-adjuvanted Vaccine in Renal Disease Patients |
- Decreased Immunologic Activity [PE]
- Influenza
- Rejection
|
- Biological: Influenza A/H1N1 2009-AS03 adjuvanted (Pandemrix)
|
Interventional
|
Phase 4 |
- Erasme University Hospital
|
Other |
- Intervention Model: Single Group Assignment
- Masking: None (Open Label)
- Primary Purpose: Prevention
|
- to determine the efficacy aand safety of influenza A/H1N1 adjuvanted-vaccination among renal transplant and haemodialyzed patients as compared to controls
- to controls and to assess the safety of the vaccine among renal transplanted patients by studying HLA or MICA sensitization before and following vaccination
|
185 |
All |
18 Years and older (Adult, Older Adult) |
NCT01298102 |
Etude 2009/INT044 |
|
October 2009 |
March 2010 |
March 2010 |
February 17, 2011 |
February 17, 2011 |
|
- Hospital Erasme
Brussels, Brabant, Belgium
|
|
| 9 |
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
|
|
| 10 |
NCT02143882 |
Completed |
A Phase III/IV Open-label Study of the Immunogenicity and Safety of a Single Dose of a Live Attenuated Influenza Vaccine (LAIV) (FluenzTM) for Each of Three Successive Years in Children naïve to, or in Previous Receipt of the AS03B Adjuvanted H1N1 (2009) Influenza Vaccine (Pandemrix ™). |
- Live Attenuated Influenza Vaccine
|
|
Interventional
|
Phase 4 |
- Public Health England
- Institute of Child Health
|
Other |
- Intervention Model: Single Group Assignment
- Masking: None (Open Label)
- Primary Purpose: Treatment
|
- Immune responses to LAIV
- Incidence of influenza
- safety and tolerability of LAIV
|
300 |
All |
5 Years to 10 Years (Child) |
NCT02143882 |
LAIV Immuno |
LAIV Immuno |
September 2014 |
March 31, 2017 |
March 31, 2017 |
May 21, 2014 |
January 16, 2018 |
|
- Gloucestershire
Gloucestershire, United Kingdom - Hertfordshire
Hertfordshire, United Kingdom
|
|
| 11 |
NCT00971425 |
Completed
Has Results |
Evaluation of the Immune Response and the Safety of a Pandemic Influenza Candidate Vaccine (H1N1) |
|
- Biological: Pandemrix (GSK investigational influenza GSK2340272A vaccine)
- Biological: Fluarix™
- Biological: Placebo
|
Interventional
|
Phase 3 |
|
Industry |
- Allocation: Randomized
- Intervention Model: Parallel Assignment
- Masking: Single (Participant)
- Primary Purpose: Prevention
|
- Geometric Mean Titers (GMTs) of Antibodies Against Pandemrix Vaccine Strain
- Number of Subjects With a Titer Greater Than or Equal to 1:10 for Antibodies Against Pandemrix Vaccine Strain
- Number of Seroconverted Subjects for Antibodies Against Pandemrix Vaccine Strain
- (and 12 more...)
|
145 |
All |
61 Years and older (Adult, Older Adult) |
NCT00971425 |
113572 |
|
September 8, 2009 |
November 16, 2009 |
October 8, 2010 |
September 3, 2009 |
August 17, 2018 |
March 4, 2011 |
- GSK Investigational Site
Rednitzhembach, Bayern, Germany - GSK Investigational Site
Mainz, Rheinland-Pfalz, Germany - GSK Investigational Site
Freital, Sachsen, Germany - (and 3 more...)
|
|
| 12 |
NCT01310413 |
Completed
Has Results |
Monovalent H5N1 Vaccine GSK1557484A in Children 6 Months to < 18 Years of Age |
|
- Biological: Influenza A (H5N1) Virus monovalent vaccine
- Biological: Saline placebo
|
Interventional
|
Phase 3 |
|
Industry |
- Allocation: Randomized
- Intervention Model: Parallel Assignment
- Masking: Triple (Participant, Investigator, Outcomes Assessor)
- Primary Purpose: Prevention
|
- Number of Subjects Seroprotected for Haemagglutination Inhibition (HI) Antibody Titers Against the H5N1 A/Indonesia Virus Strain.
- Haemagglutination Inhibition (HI) Antibody Titers Against the H5N1 A/Indonesia Virus Strain.
- Number of Seroconverted Subjects for Haemagglutination Inhibition (HI) Antibodies Against the H5N1 A/Indonesia Virus Strain.
- (and 22 more...)
|
842 |
All |
6 Months to 17 Years (Child) |
NCT01310413 |
114464 |
|
March 2011 |
July 2011 |
January 2014 |
March 8, 2011 |
September 23, 2016 |
March 31, 2014 |
- GSK Investigational Site
Paramount, California, United States - GSK Investigational Site
Sacramento, California, United States - GSK Investigational Site
Newton, Kansas, United States - (and 14 more...)
|
|
| 13 |
NCT01788228 |
Completed
Has Results |
Safety and Tolerability Study of GlaxoSmithKline (GSK)1557484A Vaccine in Adults at Occupational Risk for Influenza A (H5N1) Exposure |
|
- Biological: Influenza A (H5N1) Virus Monovalent Vaccine, Adjuvanted (A/Indonesia)
|
Interventional
|
Phase 3 |
|
Industry |
- Allocation: Non-Randomized
- Intervention Model: Parallel Assignment
- Masking: None (Open Label)
- Primary Purpose: Prevention
|
- Number of Subjects Reporting Any and Grade 3 Solicited Local Symptoms Overall and by Age Category (18-64 and >64 Years of Age).
- Number of Subjects Reporting Any, Grade 3 and Related Solicited General Symptoms Overall and by Age Category (18-64 and >64 Years of Age).
- Number of Subjects Reporting Any Unsolicited AEs, Overall and by Age Category (18-64 and >64 Years of Age)
- (and 4 more...)
|
50 |
All |
18 Years and older (Adult, Older Adult) |
NCT01788228 |
116861 |
|
March 2013 |
March 2014 |
February 2015 |
February 11, 2013 |
May 12, 2016 |
April 7, 2015 |
- GSK Investigational Site
Stockbridge, Georgia, United States - GSK Investigational Site
Rockville, Maryland, United States - GSK Investigational Site
St. Louis, Missouri, United States - (and 3 more...)
|
|
| 14 |
NCT01254955 |
Completed |
Antibody Production Following H1N1 Influenza Vaccination in Organ Transplant Patients |
|
- Biological: H1N1 vaccine Pandemrix
|
Observational
|
|
- Sahlgrenska University Hospital, Sweden
|
Other |
- Observational Model: Cohort
- Time Perspective: Retrospective
|
- Frequency of responders in organ transplant patients and controls
- Frequency of >4-fold titre rise in organ transplant patients and controls
|
|
All |
18 Years and older (Adult, Older Adult) |
NCT01254955 |
ALFGBG-141031 |
|
October 2009 |
January 2011 |
August 2011 |
December 7, 2010 |
January 16, 2012 |
|
- Transplant Institute, Sahlgrenska University Hospital
Gothenburg, Västra Götaland, Sweden
|
|
| 15 |
NCT01239537 |
Completed |
Swine Flu (Influenza A H1N1) Follow on Vaccine Study |
|
- Drug: Seasonal Flu vaccine
|
Observational
|
|
|
Other |
- Observational Model: Case-Only
- Time Perspective: Prospective
|
- Persistence of MICRONEUTRALISING antibody titres against H1N1v
- Immunogenicity of trivalent seasonal influenza vaccine
- Reactogenicity of trivalent seasonal influenza vaccine
- (and 4 more...)
|
560 |
All |
17 Months to 14 Years (Child) |
NCT01239537 |
2010/03 |
|
November 2010 |
December 2010 |
December 2010 |
November 11, 2010 |
December 8, 2017 |
|
- Bristol Children's Vaccine Centre, University of Bristol
Bristol, United Kingdom - Royal Devon and Exeter NHS Foundation Trust
Exeter, United Kingdom - St George's Vaccine Institute, University of London
London, United Kingdom - (and 2 more...)
|
|
| 16 |
NCT01003288 |
Completed
Has Results |
Studies of Pandemic Influenza (H1N1) 2009 Vaccine in Bergen |
|
- Biological: Adjuvanted influenza H1N1split virion vaccine
|
Interventional
|
Not Applicable |
- University of Bergen
- Haukeland University Hospital
|
Other |
- Intervention Model: Single Group Assignment
- Masking: None (Open Label)
- Primary Purpose: Prevention
|
- Number of Participants With Local and Systemic Adverse Events
- Number of Participants With Immunogenicity as Determined Using Haemagglutination Inhibition Assay
|
255 |
All |
19 Years to 70 Years (Adult, Older Adult) |
NCT01003288 |
H1N1VAC-2009, Version 1
2009-016456-43 |
H1N1VAC |
October 2009 |
January 2010 |
December 2014 |
October 28, 2009 |
November 7, 2016 |
August 24, 2016 |
- Haukeland University Hospital
Bergen, Norway
|
|
| 17 |
NCT00771615 |
Completed
Has Results |
Immunogenicity & Safety of GSK's Avian Flu Vaccine 1557484A Given to Adults Aged 18-64 Years |
|
- Biological: GSK A/turkey H5N1 Influenza vaccine
|
Interventional
|
Phase 2 |
|
Industry |
- Allocation: Randomized
- Intervention Model: Parallel Assignment
- Masking: Double (Participant, Investigator)
- Primary Purpose: Prevention
|
- Number of Seroconverted Subjects for Haemagglutination Inhibition (HI) Antibodies Against the A/Turkey/Turkey/1/2005 (A/Turkey) Virus Strain.
- Number of Subjects Seroprotected for Haemagglutination Inhibition (HI) Antibodies Against the A/Turkey/Turkey/1/2005 (A/Turkey) Virus Strain
- Haemagglutination Inhibition (HI) Antibody Titers Against the A/Turkey/Turkey/1/2005 (A/Turkey) Virus Strain.
- (and 16 more...)
|
469 |
All |
18 Years to 64 Years (Adult) |
NCT00771615 |
111729 |
|
October 16, 2008 |
May 26, 2009 |
December 4, 2009 |
October 13, 2008 |
September 21, 2018 |
September 4, 2014 |
- GSK Investigational Site
Huntsville, Alabama, United States - GSK Investigational Site
Anaheim, California, United States - GSK Investigational Site
Miami, Florida, United States - (and 7 more...)
|
|
| 18 |
NCT01008813 |
Completed |
Clinical Trial to Evaluate the Immunogenicity and Safety of an Adjuvanted A(H1N1)v Influenza Vaccine and a Non-adjuvanted A(H1N1)v Influenza Vaccine in HIV-infected Patients (ANRS 151 Hifluvac) |
|
- Biological: adjuvanted A(H1N1)v influenza vaccine
- Biological: non-adjuvanted A(H1N1)v influenza vaccine
|
Interventional
|
Phase 2 |
- French National Agency for Research on AIDS and Viral Hepatitis
- GlaxoSmithKline
|
Other / Industry |
- Allocation: Randomized
- Intervention Model: Parallel Assignment
- Masking: Single (Participant)
- Primary Purpose: Prevention
|
- To evaluate the immunogenicity and safety of a A(H1N1)v influenza vaccine, administered with or without adjuvant, in HIV-infected patients after two injections.
- To evaluate the safety (local and general adverse events) between the two study vaccines
- To evaluate the immunogenicity of a A(H1N1)v influenza vaccine, administered with or without adjuvant, in HIV-infected patients receiving antiretroviral therapy or not
- (and 5 more...)
|
306 |
All |
18 Years and older (Adult, Older Adult) |
NCT01008813 |
2009-016226-13 |
|
October 2009 |
February 2010 |
December 2010 |
November 6, 2009 |
December 22, 2011 |
|
- Hôpital Henri Mondor
Créteil, France - Hopital du Kremlin Bicêtre Service de médecine interne
Kremlin Bicëtre, France - Hôpital Saint-Louis
Paris, France - (and 3 more...)
|
|
| 19 |
NCT01045564 |
Withdrawn |
Safety and Immunogenicity of Vaccine in Adults at Occupational Risk for Influenza A (H5N1) Exposure |
|
- Biological: GSK influenza virus H5N1 vaccine 1557484A
|
Interventional
|
Phase 2 |
- GlaxoSmithKline
- United States Department of Health and Human Services, Center for Disease Control and Prevention, National Institutes of Health, Department of Defense
|
Industry / Other |
- Allocation: Randomized
- Intervention Model: Parallel Assignment
- Masking: None (Open Label)
- Primary Purpose: Prevention
|
- Booster humoral immune response in terms of Hemagglutination Inhibition (HI) antibodies (after second vaccination).
- Booster humoral immune response in terms of Hemagglutination Inhibition (HI) antibodies.on secondary readouts (after second vaccination)
- Primary humoral immune response in terms of Hemagglutination Inhibition (HI) antibodies (after first vaccination)
- (and 5 more...)
|
0 |
All |
18 Years and older (Adult, Older Adult) |
NCT01045564 |
112576 |
|
January 2011 |
February 2013 |
February 2013 |
January 11, 2010 |
March 23, 2015 |
|
- GSK Investigational Site
Atlanta, Georgia, United States - GSK Investigational Site
Bethesda, Maryland, United States - GSK Investigational Site
Silver Spring, Maryland, United States
|
|
| 20 |
NCT00980850 |
Completed |
Swine Flu (Novel Influenza A H1N1) Vaccine Study |
|
- Biological: Baxter Novel Influenza A H1N1 Whole Virus Vaccine
- Biological: GlaxoSmithKline Novel Influenza A H1N1 Split Virion Vaccine
|
Interventional
|
Phase 2 |
|
Other |
- Allocation: Randomized
- Intervention Model: Parallel Assignment
- Masking: None (Open Label)
- Primary Purpose: Prevention
|
- Percentage of subjects with a 4 fold rise in MN titre between the pre-vaccination sample and sample taken 3 weeks after the second dose
- Percentage of participants experiencing each of fever (≥ 38°C per axilla), local tenderness, local swelling or local erythema within the 7 days following each immunisation with the study vaccines
- Percentage of subjects with an HAI titre ≥ 1 in 32
- (and 7 more...)
|
1000 |
All |
6 Months to 12 Years (Child) |
NCT00980850 |
2009/08 H1N1 |
|
September 2009 |
December 2009 |
December 2009 |
September 21, 2009 |
May 9, 2013 |
|
- Bristol Children's Vaccine Centre
Bristol, United Kingdom - Royal Devon and Exeter NHS Foundation Trust
Exeter, United Kingdom - St Georges Vaccine Institute
London, United Kingdom - (and 2 more...)
|
|
| 21 |
NCT01022905 |
Completed |
Vaccine Responses to Influenza A H1N1/09 Immunization in High-risk Patients |
- HIV Infection
- Rheumatic Disease
- Cancer
- (and 2 more...)
|
- Biological: Adjuvanted influenza A(H1N1) vaccines
|
Interventional
|
Phase 4 |
- University Hospital, Geneva
|
Other |
- Allocation: Non-Randomized
- Intervention Model: Parallel Assignment
- Masking: None (Open Label)
- Primary Purpose: Prevention
|
- Antibody responses (inhibition of hemagglutination)
- Antibody responses (neutralization)
- Vaccine safety : - Solicited adverse events - graft function before / after immunization - influence of immunization on underlying disease (HIV infection, autoimmune diseases)
- T cell responses
|
1141 |
All |
6 Months and older (Child, Adult, Older Adult) |
NCT01022905 |
CER-09-234 |
|
November 2009 |
February 2010 |
February 2010 |
December 1, 2009 |
March 1, 2010 |
|
- University Hospitals of Geneva
Geneva, Switzerland
|
|
| 22 |
NCT01190215 |
Completed
Has Results |
Immunogenicity and Safety Study of FluarixTM Vaccine in Children Who Have Previously Been Vaccinated With PandemrixTM |
|
- Biological: FluarixTM
- Biological: HavrixTM Junior (in subjects of 15 years old or below) or HavrixTM (in subjects above 15 years old)
|
Interventional
|
Phase 4 |
|
Industry |
- Allocation: Randomized
- Intervention Model: Parallel Assignment
- Masking: None (Open Label)
- Primary Purpose: Prevention
|
- Geometric Mean Antibody Titres for Haemagglutination Inhibition (HI) Antibodies Against Fluarix Vaccine Containing H1N1 Strain.
- Number of Seropositive Subjects for Haemagglutination Inhibition (HI) Antibodies Against Fluarix Vaccine Containing H1N1 Strain.
- Number of Seroconverted Subjects for Haemagglutination Inhibition (HI) Antibodies Against Fluarix Vaccine Containing H1N1 Strain.
- (and 20 more...)
|
77 |
All |
10 Years to 18 Years (Child, Adult) |
NCT01190215 |
114452 |
|
October 4, 2010 |
July 7, 2011 |
July 7, 2011 |
August 27, 2010 |
September 7, 2018 |
July 13, 2012 |
- GSK Investigational Site
Tampere, Finland
|
|
| 23 |
NCT00742885 |
Completed
Has Results |
Immunogenicity and Safety of GSK Biologicals' (Pre-) Pandemic Influenza Candidate Vaccine |
|
- Biological: Influenza A (H5N1) Virus Monovalent Vaccine, Adjuvanted
|
Interventional
|
Phase 2 |
|
Industry |
- Allocation: Non-Randomized
- Intervention Model: Single Group Assignment
- Masking: None (Open Label)
- Primary Purpose: Prevention
|
- Haemagglutination Inhibition (HI) Antibody Titers for the H5N1 Vaccine Strain
- Number of Subjects Seroconverted for H5N1 HI Antibodies
- HI Antibody Seroconversion Factors for H5N1 HI Antibodies
- (and 12 more...)
|
100 |
All |
20 Years to 64 Years (Adult) |
NCT00742885 |
111756 |
|
September 1, 2008 |
March 7, 2009 |
March 7, 2009 |
August 28, 2008 |
August 20, 2018 |
February 24, 2014 |
- GSK Investigational Site
Fukuoka, Japan - GSK Investigational Site
Tokyo, Japan
|
|
| 24 |
NCT01416571 |
Completed
Has Results |
Immunogenicity and Safety Study of GlaxoSmithKline (GSK) Biologicals' Monovalent Pandemic H5N1 Vaccine in Adults |
|
- Biological: Influenza A (H5N1) Virus Monovalent Vaccine, Adjuvanted
|
Interventional
|
Phase 2 |
|
Industry |
- Intervention Model: Single Group Assignment
- Masking: None (Open Label)
- Primary Purpose: Prevention
|
- Number of Seroconverted Subjects Against the H5N1 Strain of Influenza Disease.
- Mean Geometric Increase (MGI) for the H5N1 Strain of Influenza Disease.
- Number of Seroprotected Subjects Against the H5N1 Strain of Influenza Disease.
- (and 11 more...)
|
78 |
All |
18 Years to 64 Years (Adult) |
NCT01416571 |
112691 |
|
August 12, 2011 |
November 29, 2011 |
September 28, 2012 |
August 15, 2011 |
September 21, 2018 |
April 16, 2014 |
- GSK Investigational Site
Mesa, Arizona, United States
|
|
| 25 |
NCT01161160 |
Completed
Has Results |
Safety and Immune Response of Candidate H1N1 Influenza Vaccines GSK2340274A and GSK234072A in Children 3 to Less Than 10 Years Old |
|
- Biological: GSK Biologicals' GSK2340274A (two different formulations)
- Biological: GSK Biologicals' - GSK2340272A
|
Interventional
|
Phase 2 |
|
Industry |
- Allocation: Randomized
- Intervention Model: Parallel Assignment
- Masking: Double (Participant, Outcomes Assessor)
- Primary Purpose: Prevention
|
- Number of Seroconverted Subjects for Haemagglutination Inhibition (HI) Antibodies Against Flu A/CAL/7/09 H1N1 Strain
- Number of Seroprotected Subjects for HI Antibodies Against Flu A/CAL/7/09 H1N1 Strain
- Geometric Mean Fold Rise (GMFR) for HI Antibodies Against Flu A/CAL/7/09 H1N1 Strain
- (and 11 more...)
|
209 |
All |
3 Years to 9 Years (Child) |
NCT01161160 |
114495 |
|
July 1, 2010 |
August 23, 2010 |
January 31, 2011 |
July 13, 2010 |
September 6, 2018 |
August 4, 2017 |
- GSK Investigational Site
Sampaloc, Manila, Philippines - GSK Investigational Site
Bangkok, Thailand
|
|
| 26 |
NCT00695669 |
Completed
Has Results |
A Trial to Test the Response to Different Vaccination Regimens With an H5N1 Vaccine With AS03 in Adults Aged 18-64 |
|
- Biological: Influenza A (H5N1) Virus Monovalent Vaccine
|
Interventional
|
Phase 2 |
|
Industry |
- Allocation: Randomized
- Intervention Model: Parallel Assignment
- Masking: None (Open Label)
- Primary Purpose: Prevention
|
- Number of Seroconverted Subjects Against the A/Indonesia/5/2005 (H5N1) Strain of Influenza Disease.
- Titers for Serum Hemagglutination Inhibition (HI) Antibodies Against the A/Indonesia/5/2005 (H5N1) Strain of Influenza Disease.
- Number of Seroprotected Subjects Against 3 Strains the A/Indonesia/5/2005 (H5N1) Strain of Influenza Disease.
- (and 12 more...)
|
312 |
All |
18 Years to 64 Years (Adult) |
NCT00695669 |
111626 |
|
June 5, 2008 |
August 13, 2008 |
January 8, 2009 |
June 12, 2008 |
July 31, 2018 |
February 7, 2014 |
- GSK Investigational Site
Sudbury, Ontario, Canada - GSK Investigational Site
Toronto, Ontario, Canada - GSK Investigational Site
Quebec, Canada
|
|
| 27 |
NCT00616928 |
Completed
Has Results |
Immunogenicity & Safety of GSK's Influenza Vaccine 1557484A Given to Adults Aged ≥18 Years |
|
- Biological: Influenza A (H5N1) Virus Monovalent Vaccine, Adjuvanted
- Biological: Placebo
|
Interventional
|
Phase 3 |
|
Industry |
- Allocation: Randomized
- Intervention Model: Parallel Assignment
- Masking: Triple (Participant, Care Provider, Investigator)
- Primary Purpose: Prevention
|
- Number of Seroconverted Subjects Against A/Indonesia/5/2005 (H5N1)
- Number of Seroprotected Subjects Against A/Indonesia/5/2005 (H5N1)
- Number of Subjects With Any Solicited Local Symptoms.
- (and 9 more...)
|
4561 |
All |
18 Years and older (Adult, Older Adult) |
NCT00616928 |
110464 |
|
January 23, 2008 |
October 15, 2008 |
March 19, 2009 |
February 15, 2008 |
June 8, 2018 |
February 7, 2014 |
- GSK Investigational Site
Huntsville, Alabama, United States - GSK Investigational Site
Phoenix, Arizona, United States - GSK Investigational Site
Anaheim, California, United States - (and 37 more...)
|
|
| 28 |
NCT00719043 |
Completed
Has Results |
Immunogenicity & Safety of GSK's Avian Flu Vaccine 1557484A Given to Adults Aged ≥18 Years |
|
- Biological: A/turkey H5N1 vaccine
- Biological: Influenza A (H5N1) Virus Monovalent Vaccine, Adjuvanted (A/Indonesia)
- Biological: Placebo
|
Interventional
|
Phase 2 |
|
Industry |
- Allocation: Randomized
- Intervention Model: Parallel Assignment
- Masking: Double (Participant, Investigator)
- Primary Purpose: Prevention
|
- Number of Seroconverted Subjects for Haemagglutination Inhibition (HI) Antibodies Against the A/Turkey/Turkey/1/2005 (A/Turkey) Virus Strain.
- Haemagglutination Inhibition (HI) Antibody Titers Against the A/Turkey/Turkey/1/2005 (A/Turkey) Strain.
- Number of Seroprotected Subjects for Haemagglutination Inhibition (HI) Antibodies Against the A/Turkey/Turkey/1/2005 (A/Turkey) Virus Strain.
- (and 12 more...)
|
841 |
All |
18 Years and older (Adult, Older Adult) |
NCT00719043 |
110624 |
|
July 11, 2008 |
April 22, 2010 |
February 18, 2011 |
July 21, 2008 |
July 9, 2018 |
February 7, 2014 |
- GSK Investigational Site
Denver, Colorado, United States - GSK Investigational Site
Chicago, Illinois, United States - GSK Investigational Site
Metairie, Louisiana, United States - (and 10 more...)
|
|
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