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 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
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 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=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=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=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 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=192 H1N1 Vaccine at Two Dose Levels in HIV Positive Adults
Influenza
Primary: Number of Participants in the CD4 Less Than 200/mL Stratum With 4-Fold or Greater Hemagglutination Inhibition Assay (HAI) Antibody Titer Increases Against the Influenza…
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 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…
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 4 N=120 H1N1 Influenza Vaccine Immunogenicity in HIV-1 Infected Patients
HIV Infections
Primary: Safety — 22; 3; 0; 18 percentage of participants
Phase 2 N=120 H1N1 Vaccine in Pregnant Women
Influenza
Primary: Number of Participants Reporting Solicited Subjective Local Reactions After First Vaccination — 15; 21; 26; 37 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
Phase 2 N=531 Sanofi Pasteur, TIV + H1N1, Pediatric Population
Influenza
Primary: Number of Participants Age 6 Months to Less Than 36 Months With 4-fold or Greater Hemagglutination Inhibition Assay (HAI) Antibody Titer Increases Against the Influenza…
Phase 2 N=805 Sanofi H1N1 + TIV - Adults and Elderly
Influenza
Primary: Number of Participants Age 18 to 64 Years With a Serum Hemagglutination Inhibition Assay (HAI) Antibody Titer of 1:40 or Greater Against the H1N1 2009 Virus 21 Days…
Phase 4 N=300 A Study to Evaluate the Safety of H1N1 Monovalent Vaccine (MEDI3414) in Healthy Adults
Healthy
Primary: Number of Participants With Fever Post Dose 1 (Days 1-8), Defined as an Oral Temperature ≥ 101°F (38.3°C). — 0; 0 Participants
Phase 3 N=131 Immunogenicity and Safety Study of an Investigational Influenza (H1N1 Influenza Virus) Vaccine in Adults
Influenza
Primary: Number of Seroconverted (SCR) Subjects for Hemagglutination Inhibition (HI) Antibodies Against Flu A/California/7/2009 (H1N1) Virus Strain — 60; 44 Participants
Phase 2 N=128 Safety of and Immune Response to an H1N1 Influenza Vaccine in HIV Infected Pregnant Women
HIV Infections · H1N1 Influenza Virus
Primary: The Number of Participants Who Had at Least One Adverse Event (AE) — 118; 11; 8; 0 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=130 Study to Evaluate the Immunogenicity and Safety of an Investigational Influenza Vaccine (H1N1) in Adults
Influenza
Primary: Titers for Serum Hemagglutination Inhibition (HI) Antibodies Against Flu A/California/7/2009 Strain of Influenza Disease — 780.2; 533.6 Titers
Phase 3 N=244 Study to Evaluate the Immunogenicity and Safety of an Investigational Influenza Vaccine (H1N1) in Children
Influenza
Primary: Humoral Immune Response in Terms of Haemagglutination Inhibition (HI) Antibody Titers Against the Flu A/California/7/2009 (H1N1) Vaccine Strain — 5.7; 5.2; 9.9; 192.6…
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 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
Phase 3 N=145 Evaluation of the Immune Response and the Safety of a Pandemic Influenza Candidate Vaccine (H1N1)
Influenza
Primary: Geometric Mean Titers (GMTs) of Antibodies Against Pandemrix Vaccine Strain — 309.8; 227.5 titer
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 4 N=326 A Study to Evaluate the Safety of HIN1 Monovalent Vaccine (MEDI3414) in Children 2 to 17 Years of Age
Influenza
Primary: Number of Participants With Fever Post Dose 1 (Days 1-8), Defined as an Axillary Temperature ≥ 101°F (38.3°C). — 4; 1 participants
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
Phase 2 N=100 Study to Evaluate Immunogenicity and Safety of an Investigational Influenza Vaccine (H1N1)
Influenza
Primary: Titers for Serum Hemagglutination Inhibition (HI) Antibodies Against A/California/7/2009 (H1N1)V-like Antigen — 8.8 Titers