Non-inferiority Study of GSK Biologicals' Influenza Vaccine GSK576389A Using Different Formulations...
InfluenzaThe purpose of this study is to show the non-inferiority of different formulations of GlaxoSmithKline Biologicials' influenza vaccine.
Study to Determine a Preference for Fluzone Vaccine Given Intradermally (ID) and Intramuscularly...
InfluenzaTo describe any degree of preference for the route of administration of Fluzone influenza vaccine, ID versus IM, in healthy adult subjects 18-49 years of age. To collect safety data, injection site reactions, and systemic reactions, through Day 7 post-vaccination; SAEs through day 28 post-vaccination
Randomized, Double-blind, Placebo-controlled, Phase I Dose-escalation Study of Single Dose GHB01L1...
Seasonal Human InfluenzaThe purpose of this phase I trial is to evaluate safety and tolerability of GHB01L1 administered as single dose intranasal aerosol for vaccination against influenza A (H1N1) virus. This study is performed further to assess local and systemic immune response and to analyse pharmacokinetics (shedding) of a single dose GHB01L1 aerosol administered intranasally.
Safety and Efficacy Study of Fluzone® Vaccine Combined With Different Doses of JVRS-100 Adjuvant...
InfluenzaThis study is designed to assess safety, tolerability and immunogenicity of Fluzone® vaccine with four dose levels of JVRS-100 adjuvant compared to Fluzone® vaccine alone in healthy adults 18-49 years of age.
Safety and Immunogenicity of Trivalent Split Influenza Vaccine Using the Strain Composition 2008/2009...
Seasonal InfluenzaVaccineAnnual trial for registration influenza vaccine with the strain composition for season 2008/2009
H5N1 (Clade 2) Vaccination of Adults and Elderly
InfluenzaThe purpose of this research study is to study the safety and effectiveness of vaccinating individuals who have previously received an avian influenza vaccine derived from one type of H5N1 virus with a vaccine derived from a different type of avian influenza virus. A second reason for this study is to compare responses in people who have received two different but similar types of H5N1 vaccine to the responses in subjects who receive 2 doses of only the H5N1 vaccine used in this study. The information obtained may provide important information into the usefulness of a pre-pandemic vaccination. Participants will include 600 healthy adult volunteers, ages 19 and older, in the United States. Study procedures include: physical exams, vaccination with either a low dose (15 micrograms) or high dose (90 micrograms) of vaccine, blood samples, and maintaining a memory aid to record oral temperatures and side effects. Study participation will be approximately 7 months.
Pediatric Safety and Immunogenicity Study of Cell-Culture Derived and Egg-based Subunit Influenza...
InfluenzaThe present study is the first study designed to evaluate safety, tolerability and immunogenicity of the cell culture-derived influenza vaccine in healthy children and adolescents aged 3 to 17 years. A step-down approach is utilized in which reactogenicity and safety will be assessed in children and adolescents 9 to 17 years of age (Cohort 1) prior to enrolling additional children and adolescents 9 to 17 years of age (Cohort 2) and children 3 to 8 years of age (Cohort 3).
Study of the DTaP-IPV-Hep B-PRP~T Combined Vaccine Following a Primary Series of DTacP IPV-HepB-PRP-T...
DiphtheriaTetanus4 moreThis is a follow-up of Study A3L11 (NCT00404651). Immunogenicity To describe the antibody persistence following a primary series vaccination of either DTaP-IPV-Hep B-PRP~T or Infanrix hexa™. To describe the immunogenicity of a booster dose of DTaP-IPV-HepB-PRP~T in a subset of subjects. Safety - To describe the safety profile after a booster dose of DTacP-IPV-HepB-PRP~T.
Immunogenicity and Safety of GSK Biologicals' FluLaval® TF
InfluenzaThe present study is intended to assess a novel formulation of FluLaval. The idea is to obtain preliminary data on the safety and immune response to the FluLaval TF influenza vaccine in adults. These data will serve as a basis for further studies involving different populations. This protocol posting deals with objectives & outcome measures of the primary phase/study.
Pandemic Influenza Plasmid DNA Vaccines (Needle)
InfluenzaThe trial will enroll up to 57 subjects. Qualified normal healthy volunteers will be enrolled in the study to receive the vaccine or placebo vaccine. Subjects will receive 2 vaccinations with a needle and will be followed for 6 months to evaluate the safety of and the immune system's response to the vaccine. The safety and immune system response will be studied throughout the trial.