Safety and Immune Response of Candidate H1N1 Influenza Vaccine GSK2340274A Following Seasonal Influenza Vaccination in Adults
Summary
This study is designed to characterize the safety and immunogenicity of a' pandemic influenza (H1N1) candidate vaccine GSK2340274A in adults 19 to 40 years who have never received influenza vaccination.
Study Design
Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Outcomes Assessor), Primary Purpose: Prevention
Conditions
Influenza
Intervention
GSK Biologicals' investigational H1N1 Influenza Vaccine - GSK2340274A, GSK Biologicals' FluLaval®, Placebo (saline), GSK Biologicals' investigational H1N1 Influenza Vaccine - GSK2340273A
Location
GSK Investigational Site
Milford
Massachusetts
United States
01757
Status
Active, not recruiting
Source
GlaxoSmithKline
Results (where available)
Links
- Source: http://clinicaltrials.gov/show/NCT01059617
- Information obtained from ClinicalTrials.gov on July 15, 2010
Medical and Biotech [MESH] Definitions
Influenza A Virus, H1n1 Subtype
A subtype of INFLUENZA A VIRUS comprised of the surface proteins hemagglutinin 1 and neuraminidase 1. The H1N1 subtype was responsible for the Spanish flu pandemic of 1918.
Orphan Drug Production
Production of drugs or biologicals which are unlikely to be manufactured by private industry unless special incentives are provided by others.
Influenza Vaccines
Vaccines used to prevent infection by viruses in the family ORTHOMYXOVIRIDAE. It includes both killed or attenuated vaccines. The composition of the vaccines is changed each year in response to antigenic shifts and changes in prevalence of influenza virus strains. The vaccine is usually bivalent or trivalent, containing one or two INFLUENZAVIRUS A strains and one INFLUENZAVIRUS B strain.
Diphtheria-tetanus Vaccine
A combined vaccine used to prevent infection with diphtheria and tetanus toxoid. This is used in place of DTP vaccine (DIPHTHERIA-TETANUS-PERTUSSIS VACCINE) when PERTUSSIS VACCINE is contraindicated.
Influenza B Virus
Species of the genus INFLUENZAVIRUS B that cause HUMAN INFLUENZA and other diseases primarily in humans. Antigenic variation is less extensive than in type A viruses (INFLUENZA A VIRUS) and consequently there is no basis for distinct subtypes or variants. Epidemics are less likely than with INFLUENZA A VIRUS and there have been no pandemics. Previously only found in humans, Influenza B virus has been isolated from seals which may constitute the animal reservoir from which humans are exposed.
Clinical Trials
The purpose of this study is to show that vaccination with a single dose of GSK Biologicals' pandemic H1N1 vaccine results in an immune response that meets or exceeds European Medicines Ag...
The objective of this study is to evaluate the immunogenicity and safety of GSK Biologicals' investigational influenza vaccine GSK2340274A following one dose and following a second dose, u...
Safety and Immune Response of One-Dose of Candidate H1N1 Influenza Vaccine GSK2340274A in Adults
This study is designed to characterize the safety and immunogenicity of a' pandemic influenza (H1N1) candidate vaccine GSK2340274A in adults 18 to 64 years of age.
Study to Evaluate Immunogenicity and Safety of an Investigational Influenza Vaccine (H1N1)
This trial will assess the immunogenicity and safety elicited by the adjuvanted GSK Biologicals' influenza investigational vaccine GSK2340274A in healthy Japanese adults aged 20-64 years.
Safety and Efficacy of H1N1 Vaccines in Children Aged 6 Months to Less Than 10 Years of Age
The purpose of this study is to characterize the safety and efficacy of GSK Biologicals' H1N1 flu candidate vaccines GSK2346274A and GSK2340273A in children 6 months to less than 10 years...
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