Phase 2 N=48 Influenza A 2009 H1N1 Challenge Study in Healthy Adults
Influenza
Primary: Percent MMID — 0; 0; 20; 47 percentage of participants
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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
N/A N=6,525 Surveillance for Adverse Events Following Pandemic H1N1 Immunization
Novel Influenza A/H1N1
Primary: Number of Participants Who Had Experienced a New Health Problem or the Worsening of an Existing Health Condition That Resulted in a Medical Consultation. — 234…
Phase 1 N=48 Safety Trial of Monovalent Whole Virus Influenza (H1N1) Vaccine
Influenza
Primary: Number of Participants With Maximum Systemic Reaction After Vaccination 1 — 16; 15; 9; 6 Participants
N/A N=107 Immunologic Response to Inactivated Vaccine for Novel H1N1 Virus
Influenza
Primary: Determination of Immune Response to Vaccination. — 45 participants
Phase 2 N=179 A Phase 2 Influenza A Challenge Study Following Oral Administration of an H1N1 HA Ad-Vector Seasonal Flu Vaccine
Influenza
Primary: Number of Subjects With Influenza-like Clinical Illness and Laboratory Confirmed Infection Post Challenge With a Homologous A Strain Influenza Virus — 17; 19; 15…
Phase 3 N=468 Does Seasonal Influenza Vaccination Affect the Incidence of pH1N1 Influenza?
Influenza
Primary: Number of pH1N1 Influenza Infections as Diagnosed by PCR From Mid-turbinate Swab — 2; 4 participants — p=0.685
Phase 1 N=76 H1N1v Virus Challenge Study in Healthy Subjects
Influenza
Primary: Percentage of Healthy Participants Reporting Mild-to-Moderate Influenza Disease (MMID) by Baseline A/Bethesda/MM2/H1N1 Hemagglutination Inhibition (HAI) Antibody…
Phase 3 N=654 Pivotal, Multicenter, Observer-Blind, Randomized Study of Influenza A (H1N1)2009 Monovalent Subunit Vaccine With and Without Adjuvant in Children Ages 6 to <36 Months
Influenza
Primary: Antibody Responses After the First and Second Vaccinations — 19; 9; 15; 19 Percentages of Subjects
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
N/A N=24 Risk of Narcolepsy Associated With Administration of H1N1 Vaccine
Narcolepsy
Primary: Incidence of Narcolepsy Among Narcoleptic Subjects Exposed or Unexposed to Vaccine — 0.52; 0.11 events per 100,000 person-years
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=1,340 Safety and Immunogenicity of H1N1 Vaccines in Adults Aged 18 Years and Older
Influenza
Primary: Number of Subjects Seropositive for Haemagglutination Inhibition (HI) Antibodies Against the A/California Virus Strain — 91; 48; 168; 75 Participants
Phase 1 N=133 Safety and Immune Response of Candidate H1N1 Influenza Vaccine GSK2340274A Following Seasonal Influenza Vaccination in Adults
Influenza
Primary: Number of Seroconverted Subjects for Hemagglutination Inhibition (HI) Antibodies Against A/California/7/2009 (H1N1)V-like Virus-homologous Vaccine Strain. — 21; 28; 25…
Phase 2 N=34 Effects of Age on Response to the 2009 H1N1 Virus Vaccine
2009 H1N1 Influenza Virus
Primary: Number of Participants Who Shed Virus — 0 participants
N/A N=178 Evaluating Modes of Influenza Transmission Observational Study of Community Acquired Influenza
Influenza Virus Infection Transmission in Humans
Primary: Viral Copy Number in 30-minute Exhaled Breath Sample — 38,000; 12,000 Fine aerosol RNA copy number
Phase 2 N=611 Safety and Immunogenicity of H1N1 Vaccine With Trivalent Inactivated Seasonal Influenza Vaccine in Adults
Influenza
Primary: Hemagglutination Inhibition (HI) Antibody Titers Against A/California/7/2009 H1N1 Vaccine Strain. — 589.8; 933.1 Titers
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 2 N=157 Safety, Immunogenicity Study of GSK Biologicals' Pandemic Influenza Candidate Vaccine (H1N1) (GSK2340272A)
Influenza
Primary: Number of Seropositive Subjects for H1N1 Haemagglutination Inhibition (HI) Antibodies — 5; 6 Participants
Phase 2 N=322 Safety and Immunogenicity of H1N1 Vaccines in Children Aged 6 Months to Less Than 9 Years of Age
Influenza
Primary: Number of Seroconverted Subjects Against Flu A/CAL/7/09 Influenza Strain - Preliminary Analysis — 60; 53; 45; 36 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=84 Novartis H1N1 Vaccine in Pregnant Women
Influenza
Primary: Number of Participants Reporting Maternal Complications of Pregnancy, Labor and Delivery — 0; 0; 0; 0 participants
N/A N=1,575 Relenza® Sentinel Site Monitoring Program in Japan
Influenza, Human
Primary: Number of Participants With Any Adverse Drug Reaction — 4 participants
Phase 2 N=390 Safety and Efficacy of an H1N1 Influenza Vaccine in People With Asthma
H1N1 Influenza Virus
Primary: Percentage of Participants With Serious Adverse Events (SAEs) Attributed To Vaccination — 1; 0; 3; 0 percentage of participants
Phase 2 N=155 Safety of and Immune Response to an H1N1 Influenza Virus Vaccine in HIV Infected Children and Youth
HIV Infections · H1N1 Influenza Virus
Primary: The Number of Participants Who Had at Least One Adverse Event (AE) — 113; 0; 7; 6 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 3 N=130 Study to Evaluate the Immunogenicity & Safety of an Investigational Influenza Vaccine (H1N1) in Adults
Influenza
Primary: Number of Seroconverted Subjects for Hemagglutination Inhibition (HI) Antibodies — 58 Participants
Phase 2 N=310 Study of GSK Biologicals' Pandemic Influenza (H1N1) Candidate Vaccine in Children Aged 10 to Less Than 18 Years
Influenza
Primary: Number of Subjects Seroconverted for HI Antibodies Against Flu A/CAL/7/09 H1N1 Strain — 63; 58; 61; 96 Subjects
Phase 3 N=240 Study to Evaluate Immunogenicity and Safety of an Investigational Influenza Vaccine (H1N1) in Adults
Influenza
Primary: Number of Seroconverted (SCR) Subjects for Hemagglutination Inhibition (HI) Antibodies — 63; 53 Participants
Phase 2 N=60 Safety and Immunogenocity Study of GSK Biologicals' Pandemic Influenza (H1N1) Candidate Vaccine in Japanese Children
Influenza
Primary: Number of Subjects With Haemagglutination Inhibition (HI) Antibody Concentrations Above the Cut-off Value — 28; 30 Subjects