Phase 1 N=75 Influenza A/H5N1 Vaccine Clinical Trial (IVACFLU-A/H5N1) - Phase 1
Influenza A Subtype H5N1 Infection
Primary: Immediate Reactions Occurring Within 60 Minutes of Administration of Any Dose — 0; 0; 0; 0 Participants
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Completed trials with posted results — search by concept, filter by the parameters that matter at the bedside.
Phase 2 N=505 H5N1 Priming and Boosting Strategies
Influenza
Primary: Hemagglutination Inhibition (HAI) Geometric Mean Titer (GMT) Against A/Vietnam/04 Antigen — 14.7; 27.9; 6.7; 13.6 Titer
Phase 2 N=500 A/H5N1/LT Dose Ranging Study
Pandemic Influenza
Primary: Assess the Proportion of Subjects in Each Dose Group Achieving Seroconversion and Seroprotection for HI Antibody Titer Through Day 28. — 35.4; 47.4; 37.6; 53.1…
Phase 1 N=60 Study of a Parenterally Administered H5N1 Influenza Vaccine in Healthy Adults
Influenza · Healthy
Primary: Solicted Adverse Events — 8; 12; 13; 14 participants
Phase 3 N=5,071 Study to Evaluate the Safety and Immunogenicity of a Pandemic Influenza Vaccine in Adults Aged 18 Years and Above
Influenza
Primary: Number of Subjects With Solicited Local Symptoms — 212; 16; 39; 3 Participants
Phase 2 N=50 Systems Biology of Influenza A (H5N1) Virus Monovalent Vaccine With and Without Adjuvant System 03 (AS03)
Influenza A Virus, H5N1 Subtype
Primary: Change in Traditional Immune Parameters Measurements Using Luminex Assays and Gene Expression Measurement Using Microarray Experiments From Baseline With Influenza A…
Phase 2 N=385 Safety Study of Pandemic Candidate Influenza Vaccines in the Elderly Population
Influenza · Influenza Vaccines
Primary: Serum Haemagglutination-inhibition (HI) Antibody Titers Against the Influenza A Virus Strain Subtype H9N2 (Anti-H9N2) — 24.4; 15.6; 14.6; 9.8 Titer
Phase 3 N=300 A Safety and Immunogenicity Study of IVACFLU-A/H5N1
Avian Influenza
Primary: Number and Percentage of Subjects Achieving a Hemagglutination Inhibition (HAI) Titer of ≥1:40 — 0; 0; 0; 0 Participants
Phase 2 N=422 Assess the Safety & Immunogenicity of Stored Inactivated Influenza H5N1 Virus Vaccine Given With & Without Stored MF59 Adjuvant
A/Vietnam/H5N1 Influenza Virus
Primary: Number of Occurences of Mild, Moderate, or Severe Solicited Local Symptoms During the 7 Days After Each Vaccination. — 34; 41; 34; 34 occurrences
Phase 1 N=40 Reactogenicity, Safety, and Immunogenicity of a Live Monovalent H5N2 Influenza Vaccine
Influenza
Primary: Adverse Events by Severity — 20; 8; 25; 8 Participants
Phase 3 N=3,196 A Study to Evaluate Safety, Immunogenicity, and Lot-to-Lot Consistency of H5N1 Subunit Influenza Virus Vaccine in Healthy Adult Subjects ≥18 Years of Age
Avian Influenza
Primary: Primary Immunogenicity Endpoint: Geometric Mean Titer (GMT) at Day 43 by Lot — 16.1; 17.0; 17.0; 128.6 geometric mean titer
Phase 2 N=372 Safety/Efficacy Study of Seqirus A/H7N9 IIV With or Without MF59(R) Adjuvant to Prevent Avian Influenza
Avian Influenza · Influenza Immunisation
Primary: Geometric Mean Titers (GMT) of Serum Hemagglutinin Inhibition (HAI) Antibodies — 23.3; 19.9; 24.2; 6.0 titer
Phase 3 N=50 Safety and Tolerability Study of GlaxoSmithKline (GSK)1557484A Vaccine in Adults at Occupational Risk for Influenza A (H5N1) Exposure
Influenza · Influenza Vaccines
Primary: Number of Subjects Reporting Any and Grade 3 Solicited Local Symptoms Overall and by Age Category (18-64 and >64 Years of Age). — 45; 1; 46; 4 Participants
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
Phase 2 N=979 Safety and Immunogenicity of Two Doses of H5N1 Influenza Vaccine in Healthy Adults
Pandemic H5N1 Influenza
Primary: Percentages Of Subjects Achieving Hemagglutinin Inhibition (HI) Titers ≥40 Against A/H5N1 Strain. — 4; 4; 85; 63 Percentages of subjects
Phase 3 N=889 Seasonal Trivalent Inactivated Split Virion Influenza Vaccine Clinical Trial (IVACFLU-S) - PHASE 2/3
Influenza, Human
Primary: Number and Percentage of Subjects Experiencing Solicited Local Adverse Events (AE) — 1; 0; 1; 0 Participants
Phase 2 N=326 High-Dose Versus Standard-Dose Oseltamivir to Treat Severe Influenza and Avian Influenza
Influenza · Avian Influenza · Severe Influenza
Primary: Proportion of All Participants Negative for Viral RNA on Day 5 — 115; 105 participants — p=0.42
Phase 2 N=43 Immunogenicity of H5N1 Vaccine Following H5N2
Influenza Vaccine
Primary: Geometric Mean Titer of Serum Hemagglutination Inhibition Antibody Response to A/17/Duck/Potsdam/86/92 (H5N2) LAIV Strain Following Administration of A(H5N1) Inactivated…
Phase 1 N=32 Immunogenicity and Safety Study of Inactivated Subunit H5N1 Influenza Vaccine in Prior Recipients of Live Attenuated H2N2, H6N1 and H9N2 Influenza Vaccines and in H5N1 and Live Attenuated Vaccine Naïve Individuals
Influenza
Primary: Fold Rise in Titer of Anti-group 1 Stalk-antibodies in Recipients of the Pandemic Live Attenuated Influenza Vaccines (pLAIVs) (H2N2, H6N1 and H9N2) Compared to the…
Phase 3 N=844 Immunogenicity of GSK Biologicals' Pandemic Influenza Vaccine (GSK1562902A) at Different Boosting Vaccination Schedules
Influenza
Primary: Number of Subjects Boosted at Month 12 With Haemagglutinin-inhibition (HI) Antibody Concentrations Above the Cut-off Value — 178 Participants
Phase 2 N=1,393 Safety and Immunogenicity of Two Doses of H5N1 Influenza Vaccine in Elderly Subjects
Pandemic H5N1 Influenza
Primary: The Percentages Of Subjects Achieving Hemagglutination Inhibition (HI) Titers ≥40 Against A/H5N1 Strain. — 12; 10; 81; 63 Percentages of subjects
Phase 4 N=12 Durability and Impact of the Seasonal Influenza Vaccine on H5 Induced B Cell Response
Influenza A Subtype H5N1 Infection
Primary: Number of Participants With a Four-fold Increase in Stem-specific Antibody Titers (H5, Hemagglutinin Antibody) Against H5N1 at Day 29 After Vaccination With the Seasonal…
Phase 2 N=260 A Study to Evaluate Safety and Immunogenicity of One or Two Booster Vaccinations With H5N6 Influenza Vaccine in Adults Primed With H5N1 Influenza Vaccine or Unprimed
Influenza, Human · Influenza in Birds · Respiratory Tract Infections
Primary: Geometric Mean Titer (GMT) of Hemagglutination Inhibition (HI) Antibodies Against the H5N6 Strain — 5.48; 5.55; 5.47; 20.39 titer
Phase 2 N=30 H7N9 Vaccination With and Without AS03 and Unadjuvanted H3N2v Vaccination: Standard and Systems Biology Analyses
Avian Influenza · H1N1 Influenza · Influenza
Primary: Percentage of Participants Achieving Seroconversion Based on HAI Titer (A/H7N9 Vaccine, With and Without Adjuvant) — 80.0; 0 percentage of participants
N/A N=46 Characterisation of a New Wild-Type H3N2 Virus for the Human Viral Challenge Model
Influenza
Primary: Area Under the Curve of Virus Load — -2081.98; 18,973.90; 15,944.09; 12,201.14 mins*Eq log10 TCID50/mL
Phase 2 N=720 Assess the Safety & Immunogenicity of Prime-Boost Vaccination Strategies Using H5Nx Virus Vaccine Adjuvanted With AS03 or MF59
Influenza A Virus, H5N1 Subtype
Primary: Number of Local Adverse Reactions to 2-dose and 3-dose H5 Influenza Vaccination Series — 43; 32; 35; 37 Events
Phase 2 N=304 2017 A/H7N9 IIV Revaccination
Avian Influenza · Influenza Immunisation
Primary: Geometric Mean Titers (GMT) of Serum Hemagglutination Inhibition (HAI) Antibodies on Day 22 Against the 2017 Influenza A/H7N9 Vaccine Virus — 22.7; 116.1; 77.7; 190.3…
Phase 2 N=662 Safety and Immunogenicity of Two Doses of H5N1 Influenza Vaccine in Children
Pandemic H5N1 Influenza
Primary: The Percentages Of Subjects Aged 6 to <36 Months, Achieving Hemagglutination Inhibition (HI) Titers ≥40 Against A/H5N1 Strain — 1; 0; 98; 94 Percentages of subjects
Phase 2 N=43 Immune Responses to H5N1 Vaccine With and Without AS03 Adjuvant
Influenza
Primary: Flu Antibody Titers — 10.65; 10.35; 31.09; 10.35 Titers
Phase 1 N=38 Reactogenicity, Safety and Immunogenicity of a Live Monovalent A/17/CALIFORNIA/66/395 (H2N2) Influenza Vaccine
Influenza
Primary: Percentage of Participants With Immediate Reactions — 0; 0; 28; 10 Participants