Immunogenicity and Safety Study of a GlaxoSmithKline Biologicals' Candidate Influenza Vaccine in...
InfluenzaThe purpose of the present study is to assess the immunogenicity and safety of vaccine GSK2321138A in children.
A Study of Different Formulations of an A/H1N1 Pandemic Vaccine in Healthy Children Aged 6 Months...
InfluenzaSwine-origin A/H1N1 InfluenzaThe purpose of the study is to evaluate different doses of the Influenza A/H1N1 pandemic vaccine in toddlers and children. Primary Objectives: To describe the immunogenicity of the candidate vaccines after each injection. To describe the safety of the candidate vaccines after each injection.
A Study of Swine-origin A/H1N1 Influenza Vaccines in Healthy European Adults and the Elderly
InfluenzaSwine-origin A/H1N1 InfluenzaThe purpose of this study is to generate data on immunogenicity and safety of the monovalent H1N1 vaccine in support of the development and registration. Primary objectives: To describe the immune response to study vaccine 21 days after each vaccination. To describe the antibody persistence 8 months after the first vaccine administration using hemagglutination inhibition (HAI) method in a randomized subset of adult subjects who received two injections. To describe the immune response against the A/H1N1 strain using HAI method 21 days after a vaccination with the 2010-2011 Northern Hemisphere (NH) seasonal trivalent influenza vaccine (TIV) administered 13 months after the first vaccination in a subset subjects who received the A/H1N1 influenza vaccine and in subjects naïve to the swine origin A/H1N1 strain. To describe the safety profiles of study vaccines in all participants.
A Study of Different Formulations of an A/H1N1 Pandemic Vaccine in Healthy Adults and the Elderly...
InfluenzaSwine-origin A/H1N1 InfluenzaThe purpose of the study is to evaluate different doses of the Influenza A/H1N1 pandemic vaccine. Primary Objectives: To describe the immunogenicity of the candidate vaccines after each injection. To describe the safety of the candidate vaccines after each injection.
Immunogenicity and Safety Study of an Investigational Influenza (H1N1 Influenza Virus) Vaccine in...
InfluenzaThe objective of this study is to evaluate the immunogenicity and safety of GSK Biologicals' investigational vaccine GSK2340272A in adults aged 18 to 60 years.
Immunogenicity and Safety of Influenza Virus Vaccine, AdimFlu-S (A/H1N1), in Pediatric Population...
InfluenzaThis is a laboratory-blinded study in healthy toddlers, children, and teenagers designed to investigate the safety, reactogenicity, and immunogenicity of an inactivated influenza H1N1 vaccine (AdimFlu-S). There are 3 age strata, and each contains at least 50 subjects: greater than or equal to 1 year to less than 3 years, greater than or equal to 3 years to less than 6 years, and greater than or equal to 6 years to less than 18 years. In each age strata, all eligible subjects received 2 injections of AdimFlu-S (A/H1N1) at a designated dosage level (7.5 μg, 15 μg and 15 μg for 1~<3, 3~<6 and 6~<18 years, respectively) at 3 weeks apart. Following immunization, safety is measured by assessment of adverse events for 6 weeks following the first vaccination, serious adverse events and new-onset chronic medical conditions through 7 months post first vaccination, and reactogenicity to the vaccines for 7 days following each vaccination. Immunogenicity testing includes hemagglutination inhibition (HAI) testing on serum obtained before first vaccination, and three and six weeks after first vaccination.
Safety of and Immune Response to an H1N1 Influenza Vaccine in HIV Infected Pregnant Women
HIV InfectionsH1N1 Influenza VirusBoth pregnant women and people infected with HIV are at increased risk of viral infection, including influenza infection. Pregnant women infected with HIV may be at particular risk of infection from the new H1N1 influenza virus. This study tested the safety and immunogenicity of an H1N1 influenza vaccine in pregnant women infected with HIV.
Study to Evaluate the Immunogenicity and Safety of an Investigational Influenza (H1N1 Influenza...
InfluenzaThe objective of this study is to evaluate the immunogenicity and safety of one or two doses of GSK Biologicals' investigational influenza vaccine GSK2340272A, manufactured using two different processes, in adults aged 18 to 60 years.
Safety of and Immune Response to an H1N1 Influenza Virus Vaccine in HIV Infected Children and Youth...
HIV InfectionsH1N1 Influenza VirusChildren and people infected with HIV are particularly susceptible to influenza infections. This study testED the safety and effectiveness of a vaccine for the new H1N1 influenza virus in children and youth infected with HIV.
Study to Evaluate Immunogenicity & Safety of an Investigational Influenza Vaccine in Adults
InfluenzaThe objective of this study is to evaluate the immunogenicity and safety of GSK Biologicals' investigational vaccine GSK2340272A.