Trials: Influenza Vaccines Efficacy and Safety

Phase 3 N=11,404 Efficacy Study of Two Influenza Vaccines and Placebo in Healthy Adult Subjects

Influenza

Primary: Number of Subjects With Culture-Confirmed Influenza Illness Caused by Vaccine-like Strains — 7; 9; 44; 2 Subjects — p=<0.001

Novartis Vaccines Results Jan 2013 1.0% serious AE View details

Phase 3 N=2,680 Safety and Immunogenicity of Three Influenza Vaccines Adults Ages 18 and Older

Influenza

Primary: 1.Geometric Mean Titres (GMT) in Subjects After Receiving One Dose of Either QIVc, TIV1c or TIV2c — 60.7; 59.6; NA; 302.8 Titer

Novartis Vaccines Results Dec 2015 3.6% serious AE View details

Phase 3 N=10,160 Efficacy, Safety, and Immunogenicity of a Plant-Derived Quadrivalent Virus-Like Particles (VLPs) Influenza Vaccine in Adults

Virus Diseases · RNA Virus Infections · Respiratory Tract Diseases

Primary: Number of Occurrences of Protocol-Defined Respiratory Illness Caused by Vaccine-Matched Influenza Strains — 110; 169 Number of cases

Medicago Results Aug 2023 1.1% serious AE View details

Phase 4 N=120 Safety and Immunogenicity of the 2005-2006 Fluzone® Vaccine

Influenza

Primary: Number of Participants Reporting Solicited Injection Site and Solicited Systemic Reactions After Fluzone® Vaccination — 40; 10; 4; 6 Participants

Sanofi Pasteur, a Sanofi Company Results Jun 2009 0.0% serious AE View details

Phase 4 N=15,044 A Study of the Efficacy, Safety and Tolerability Profile of CSL Limited's Influenza Virus Vaccine (CSL's IVV) Administered Intramuscularly in Healthy Adults

Influenza

Primary: CSL's IVV Overall Vaccine Efficacy (VE) Versus Placebo Through Assessment of Incidence of Laboratory Confirmed Influenza A/B Infection — 2.24; 3.87 Ratio

Seqirus Results Sep 2011 1.0% serious AE View details

Phase 2 N=64 Safety and Immunogenicity of Surface Antigen, Inactivated, Adjuvanted With MF59C.1 Influenza Vaccine, Formulation 2008-2009

Interpandemic Influenza

Primary: Percentage of Participants Who Achieved Seroconversion or Significant Increase in Single Radial Hemolysis (SRH) Area Against Each of Three Vaccine Strains After One…

Novartis Vaccines Results Jan 2016 0.0% serious AE View details

Phase 4 N=1,952 Comparative Study of Influenza Vaccines in Adults, FLUVACS-year 4

Influenza

Primary: Laboratory-confirmed (Culture and/or PCR) Symptomatic Influenza — 28; 56; 35 participants

University of Michigan Results Sep 2011 0.8% serious AE View details

Phase 3 N=12,794 Efficacy of a Plant-derived Quadrivalent Virus-like Particle (VLP) Vaccine in the Elderly

Virus Diseases · RNA Virus Infections · Respiratory Tract Diseases

Primary: Number of Occurrences of Protocol-Defined Influenza-Like Illness (ILI) Due to Any Laboratory-Confirmed Influenza Strains — 118; 130 Number of cases

Medicago Results Jun 2023 4.2% serious AE View details

Phase 4 N=180 Safety and Immunogenicity of Fluzone® Quadrivalent and Fluzone® High-Dose, Influenza Vaccines, 2016-2017 Formulations

Influenza

Primary: Number of Participants Reporting Solicited Injection Site Reactions (Pain, Erythema, and Swelling) and Systemic Reactions (Fever, Headache, Malaise, Myalgia): Group 1 (3…

Sanofi Pasteur, a Sanofi Company Results Jan 2018 1.7% serious AE View details

Phase 4 N=200 Study of Fluzone® Influenza Virus Vaccines 2012-2013 Formulation Among Adults.

Influenza

Primary: Number of Participants Reporting Solicited Injection Site and Systemic Reactions Following Vaccination With Fluzone® or Fluzone® Intradermal or Fluzone® High-Dose…

Sanofi Pasteur, a Sanofi Company Results Nov 2013 1.0% serious AE View details

Phase 4 N=31,983 A Study of Fluzone® High-Dose Vaccine Compared With Fluzone® Vaccine In Elderly Adults

Influenza

Primary: Occurrences of Culture- or Polymerase Chain Reaction (PCR)-Confirmed Influenza Caused by Any Influenza Viral Types/Subtypes, in Association With a Protocol-defined…

Sanofi Pasteur, a Sanofi Company Results Aug 2014 8.6% serious AE View details

Phase 4 N=120 Immunogenicity and Safety of Fluzone® Quadrivalent, Southern Hemisphere 2015 Formulation (Intramuscular Route)

Influenza

Primary: Number of Participants With Seroprotection to Influenza Vaccine Antigens at Day 0 (Pre-vaccination) and Day 21 (Post-vaccination) — 41; 37; 60; 60 Participants

Sanofi Pasteur, a Sanofi Company Results Aug 2018 0.0% serious AE View details

Phase 2 N=817 Study of Inactivated, Split-Virion Influenza Vaccine Compared With Standard Fluzone Vaccine in Elderly Subjects

Orthomyxoviridae Infection · Influenza · Myxovirus Infection

Primary: 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…

Sanofi Results Sep 2011 8.2% serious AE View details

Phase 4 N=276 Efficacy & Safety of Nasal Influenza Immunisation in Children

Influenza Vaccines Efficacy and Safety

Primary: Vaccine Efficacy — 4; 2; 4; 0 Participants

Imperial College London Results Nov 2019 0.0% serious AE View details

Phase 2 N=405 Immunogenicity, Safety and Tolerability of Prepandemic Influenza and Seasonal Influenza Vaccine in Adult Subjects

Pandemic · Avian Influenza

Primary: Number Subjects Who Responded to Two or Three Vaccinations of the MF59-H5N1 Influenza Vaccine — 0; 1; 0; 2 Subjects

Novartis Results Feb 2013 3.5% serious AE View details

Phase 4 N=2,902 Immunogenicity, Safety and Tolerability of a Trivalent Subunit Inactivated Vaccine in Healthy Subjects 50 Years and Above

Influenza

Primary: Hemagglutination Inhibition (HI) Geometric Mean Titers (GMTs) of TIV Group and TIVf Group for All Three Strains, in Healthy Adults Aged ≥50 Years — 315; 581; 697; 1048…

Novartis Results Oct 2014 0.3% serious AE View details

Phase 2 N=671 Safety and Immunogenicity of a Four Influenza Vaccines in Children Ages 6 Months Old to Less Than 48 Months Old

Influenza

Primary: Ratios of Geometric Mean Titer (GMT) in Subjects (6 to <48 Months Old) After Receiving Two Doses of Either TIVc or TIVe Vaccine — 7.82; 5.5; 5.93; 3.69 Ratios

Seqirus Results Jun 2017 4.2% serious AE View details

Phase 2 N=63 Safety and Immunogenicity of a Trivalent Influenza Vaccine When Administered to Elderly Subjects

Human Influenza

Primary: Percentages of Subjects Who Achieved Seroconversion or Significant Increase in SRH Area Against Each of Three Vaccine Strains After One Vaccination of aTIV — 59; 65; 81…

Novartis Vaccines Results Jan 2014 0.0% serious AE View details

Phase 4 N=208 Study of Fluzone® Quadrivalent, Fluzone® Intradermal, and Fluzone® High-Dose Influenza Virus Vaccines in Adults

Influenza

Primary: Number of Participants Reporting Solicited Injection-Site and Solicited Systemic Reactions Following Vaccination With the 2013-2014 Formulation of Fluzone® Quadrivalent…

Sanofi Pasteur, a Sanofi Company Results Sep 2014 1.0% serious AE View details

Phase 2 N=425 Safety Study of Four Candidate Influenza Vaccines to Prevent Influenza Disease in the Elderly Population

Influenza

Primary: Frequency of Influenza-specific Cluster of Differentiation 4+ (CD4+) T-cells Expressing at Least 2 Markers — 3229.25; 1646.05; 3056.06; 2589.31 T-cells/million cells

GlaxoSmithKline Results Aug 2018 5.7% serious AE View details

Phase 3 N=10,644 Clinical Study to Evaluate the Safety, Immunogenicity and Efficacy of Investigational Flu Vaccine Compared to Approved Flu Vaccine in Children.

Influenza Virus

Primary: Efficacy Endpoint: First-Occurrence Reverse Transcription-Polymerase Chain Reaction (RT-PCR) Confirmed Influenza A and/or B of Any Influenza Strain in Subjects ≥6 to <72…

Seqirus Results Mar 2023 4.5% serious AE View details

Phase 3 N=2,333 Safety and Immunogenicity of Three Influenza Vaccines in Children Aged 4 Years Old to Less Than 18 Years Old

Influenza

Primary: Geometric Mean Titre (GMT) in Subjects After Receiving One or Two Doses of Either QIVc, TIV1c or TIV2c — 96; 100; NA; 1090 Titers

Novartis Vaccines Results Dec 2015 0.7% serious AE View details

Phase 3 N=135 Safety and Immunogenicity of Trivalent Subunit Influenza Vaccine Produced in Mammalian Cell Culture Using the Strain Composition 2007/2008

Seasonal Influenza Vaccine

Primary: Geometric Mean Titers (GMT) After 1 Dose of Cell Culture Derived Vaccine (cTIV). — 22; 23; 624; 199 Titer

Novartis Vaccines Results Jan 2013 0.0% serious AE View details

Phase 4 N=1,000 A Randomized Study to Compare the Safety and Immunogenicity of Fluviral® Made With New Versus Aged Bulk

Influenza Vaccines

Primary: Geometric Mean Titers (GMTs) of Anti-H3 and B Strains — 369.6; 331.2; 269.6; 245.0 Titer

GlaxoSmithKline Results May 2009 0.4% serious AE View details

Phase 4 N=208 Study of Fluzone® Quadrivalent, Fluzone® Intradermal, and Fluzone® High-Dose, Influenza Vaccines in Adults

Influenza

Primary: Percentage of Participants Reporting Solicited Injection-site and Solicited Systemic Reactions Following Vaccination With the 2014-2015 Formulation of Fluzone®…

Sanofi Pasteur, a Sanofi Company Results Oct 2015 0.5% serious AE View details

Phase 3 N=300 Immunogenicity and Safety of a Quadrivalent Influenza Vaccine Given by Intramuscular Route in Subjects Aged 18 to 60 Years

Influenza

Primary: Geometric Mean Titers of Influenza Antibodies Before and After Vaccination With a Quadrivalent Influenza Vaccine Administered Via the Intramuscular Route — 142; 116…

Sanofi Pasteur, a Sanofi Company Results Nov 2016 0.0% serious AE View details

Phase 3 N=3,208 Immunogenicity and Safety Study of an Inactivated Influenza Vaccine (Split Virus, Vero Cell Derived) in Adults Aged 50 Years and Older

Influenza

Primary: Percentage of Subjects With Seroconversion Antibody Titer — 47.1; 36.8; 63.8; 37.3 percentage of participants

Alachua Government Services, Inc. Results Jan 2026 4.1% serious AE View details

Phase 4 N=120 A Study to Evaluate the Safety and Immune Responses to Fluzone® Vaccination

Influenza

Primary: Number of Participants With at Least 1 Solicited Injection Site Solicited Systemic Reactions Post-vaccination With Fluzone® Vaccine. — 35; 18; 34; 16 Participants

Sanofi Pasteur, a Sanofi Company Results Feb 2010 0.0% serious AE View details

Phase 3 N=1,893 Safety, and Immunogenicity of Two Influenza Vaccines in Healthy Subjects 3 to 64 Years Old

Influenza

Primary: Percentage of Subjects With Seroprotection, in Healthy Adults 18 to 64 Years of Age — 93; 96; 91; 99 Percentages of participants

Novartis Results May 2010 1.0% serious AE View details

Phase 3 N=125 Safety and Immunogenicity of One Dose of Seasonal Trivalent Influenza Virus Vaccine (TIVf, Purified Surface Antigen, Inactivated, Egg Derived) in Adults, Aged 18 Years and Above

Human Influenza

Primary: Percentage of Subjects With Single Radial Hemolysis (SRH) Areas ≥25mm2, Against Each of Three Vaccine Strains After Receiving One Dose of TIVf — 17; 36; 95; 80…

Novartis Vaccines Results Mar 2014 0.0% serious AE View details

Clinical Trial Search

Phase 3 N=11,404 Efficacy Study of Two Influenza Vaccines and Placebo in Healthy Adult Subjects

Phase 3 N=2,680 Safety and Immunogenicity of Three Influenza Vaccines Adults Ages 18 and Older

Phase 3 N=10,160 Efficacy, Safety, and Immunogenicity of a Plant-Derived Quadrivalent Virus-Like Particles (VLPs) Influenza Vaccine in Adults

Phase 4 N=120 Safety and Immunogenicity of the 2005-2006 Fluzone® Vaccine

Phase 4 N=15,044 A Study of the Efficacy, Safety and Tolerability Profile of CSL Limited's Influenza Virus Vaccine (CSL's IVV) Administered Intramuscularly in Healthy Adults

Phase 2 N=64 Safety and Immunogenicity of Surface Antigen, Inactivated, Adjuvanted With MF59C.1 Influenza Vaccine, Formulation 2008-2009

Phase 4 N=1,952 Comparative Study of Influenza Vaccines in Adults, FLUVACS-year 4

Phase 3 N=12,794 Efficacy of a Plant-derived Quadrivalent Virus-like Particle (VLP) Vaccine in the Elderly

Phase 4 N=180 Safety and Immunogenicity of Fluzone® Quadrivalent and Fluzone® High-Dose, Influenza Vaccines, 2016-2017 Formulations

Phase 4 N=200 Study of Fluzone® Influenza Virus Vaccines 2012-2013 Formulation Among Adults.

Phase 4 N=31,983 A Study of Fluzone® High-Dose Vaccine Compared With Fluzone® Vaccine In Elderly Adults

Phase 4 N=120 Immunogenicity and Safety of Fluzone® Quadrivalent, Southern Hemisphere 2015 Formulation (Intramuscular Route)

Phase 2 N=817 Study of Inactivated, Split-Virion Influenza Vaccine Compared With Standard Fluzone Vaccine in Elderly Subjects

Phase 4 N=276 Efficacy & Safety of Nasal Influenza Immunisation in Children

Phase 2 N=405 Immunogenicity, Safety and Tolerability of Prepandemic Influenza and Seasonal Influenza Vaccine in Adult Subjects

Phase 4 N=2,902 Immunogenicity, Safety and Tolerability of a Trivalent Subunit Inactivated Vaccine in Healthy Subjects 50 Years and Above

Phase 2 N=671 Safety and Immunogenicity of a Four Influenza Vaccines in Children Ages 6 Months Old to Less Than 48 Months Old

Phase 2 N=63 Safety and Immunogenicity of a Trivalent Influenza Vaccine When Administered to Elderly Subjects

Phase 4 N=208 Study of Fluzone® Quadrivalent, Fluzone® Intradermal, and Fluzone® High-Dose Influenza Virus Vaccines in Adults

Phase 2 N=425 Safety Study of Four Candidate Influenza Vaccines to Prevent Influenza Disease in the Elderly Population

Phase 3 N=10,644 Clinical Study to Evaluate the Safety, Immunogenicity and Efficacy of Investigational Flu Vaccine Compared to Approved Flu Vaccine in Children.

Phase 3 N=2,333 Safety and Immunogenicity of Three Influenza Vaccines in Children Aged 4 Years Old to Less Than 18 Years Old

Phase 3 N=135 Safety and Immunogenicity of Trivalent Subunit Influenza Vaccine Produced in Mammalian Cell Culture Using the Strain Composition 2007/2008

Phase 4 N=1,000 A Randomized Study to Compare the Safety and Immunogenicity of Fluviral® Made With New Versus Aged Bulk

Phase 4 N=208 Study of Fluzone® Quadrivalent, Fluzone® Intradermal, and Fluzone® High-Dose, Influenza Vaccines in Adults

Phase 3 N=300 Immunogenicity and Safety of a Quadrivalent Influenza Vaccine Given by Intramuscular Route in Subjects Aged 18 to 60 Years

Phase 3 N=3,208 Immunogenicity and Safety Study of an Inactivated Influenza Vaccine (Split Virus, Vero Cell Derived) in Adults Aged 50 Years and Older

Phase 4 N=120 A Study to Evaluate the Safety and Immune Responses to Fluzone® Vaccination

Phase 3 N=1,893 Safety, and Immunogenicity of Two Influenza Vaccines in Healthy Subjects 3 to 64 Years Old

Phase 3 N=125 Safety and Immunogenicity of One Dose of Seasonal Trivalent Influenza Virus Vaccine (TIVf, Purified Surface Antigen, Inactivated, Egg Derived) in Adults, Aged 18 Years and Above