Immunogenicity and Safety Study in Infants of GlaxoSmithKline Biologicals' Infanrix Hexa™ (DTPa-HBV-IPV/Hib)...
PoliomyelitisTetanus5 moreThis study evaluates the immunogenicity and safety of Infanrix hexa™ (DTPa-HBV-IPV/Hib) when administered as a primary vaccination course to Indian infants according to a 6-10-14 weeks or a 2-4-6 months schedule.
Safety and Immunogenicity of a New Inactivated Polio Vaccine in Healthy Adults
PoliomyelitisThe purpose of this trial is to determine whether the new inactivated polio vaccine that is based on attenuated poliovirus strains is safe and to evaluate the immune response in healthy adults.
Safety and Immunogenicity of a New Inactivated Poliovirus Vaccine in Infants
PoliomyelitisA new inactivated polio vaccine based on attenuated poliovirus strains was developed to transfer the technology to manufacturers in low- and middle-income countries. This vaccine was produced in different dosages and in different formulations. In healthy adults the safety of the highest dose was comparable to that of the existing inactivated polio vaccine. The purpose of this trial is to determine the safety of the different dosages and formulations of the vaccine in infants. The second goal of this study is to analyse the immune response after three doses in infants.
Immunogenicity and Safety of GSK Biologicals' Boostrix Polio Vaccine in 3 and 4-year-old Children...
Acellular PertussisPoliomyelitis2 moreThe purpose of the study is to compare the immunogenicity and safety of a booster dose of BoostrixTM Polio to that of Sanofi Pasteur MSD's RepevaxTM, when co-administered with a second dose of PriorixTM, in healthy 3 and 4-year-old children.
The Clinical Trial Protocol for the Inactivated Poliomyelitis Vaccine Made From Sabin Strains (IPV)...
PoliomyelitisBased on pre-clinical trial and phase 1 clinical data and principle of GCP, the objective of phase Ⅱ clinical trial is to evaluate safety and immunogenicity of Inactivated Poliomyelitis Vaccine made from Sabin Strains(Sabin IPV).
Immunogenicity and Safety of a Fractional Booster Dose of IPV Intradermally Versus Full Dose Intramuscularly...
PoliomyelitisThe purpose of this study is to investigate the use of a fourth fractional booster dose of sanofi pasteur's IMOVAX Polio injected intradermally (using the Mantoux technique) as booster dose between 15 to 18 months of age, in terms of immunogenicity and safety. Objectives: To describe in each group the immunogenicity of IMOVAX Polio administered intradermally or intramuscularly, one month after the booster dose given at 15-18 months of age in toddlers previously primed with three doses of IMOVAX Polio vaccine during the IPV25 study. To describe in each group the safety of the booster dose of IMOVAX Polio vaccine administered intradermally or intramuscularly.
Immunogenicity and Reactogenicity of a Booster Dose of GSK Bio's DTPa-HBV-IPV/Hib Vaccine
Acellular PertussisDiphtheria4 moreThe purpose of this booster study is to evaluate, in subjects primed in the primary study 106786, the persistence, at the time of the booster vaccination, of antibodies elicited by the different formulation of DTPa-HBV-IPV/ Hib vaccine (Infanrix Hexa TM). The study will also evaluate the immune response of these subjects to a DTPa-HBV-IPV/Hib booster. This protocol posting deals with the objectives and outcome measures of the booster phase. The objectives and outcomes measures of the primary phase are presented in a separate protocol posting (NCT = 00376779).
Immunogenicity and Safety Study of GSK Biologicals' GSK2202083A Vaccine in Healthy Infants at 2,...
TetanusDiphtheria5 moreThis study will evaluate the safety and immunogenicity of GSK Biologicals' GSK2202083A vaccine co-administered with GSK Biologicals' 10-valent pneumococcal conjugate (GSK1024850A) vaccine given as a three-dose primary vaccination course at 2, 3 and 4 months of age.
Safety of DTPa-IPV/Hib & DTPa-HBV-IPV/Hib, Followed by DTPa-IPV/Hib Vaccine in Infants Who Received...
Haemophilus Influenzae Type bDiphtheria3 moreTo assess the safety and reactogenicity of the DTPa-HBV-IPV/Hib vaccine and DTPa-IPV/Hib vaccine. This DTPa-IPV/Hib vaccine given at 3 and 4 months of age is co-administered with GSK Biologicals' rotavirus vaccine or Placebo. The Protocol Posting has been updated in order to comply with the FDA Amendment Act, Sep 2007.
Immunogenicity Study of Antibody Persistence and Booster Effect of PENTAXIM™ at 18 Months in Healthy...
DiphtheriaTetanus3 moreThis study will assess both the antibody persistence of the investigational vaccine and the immune response and safety of a booster dose of PENTAXIM™ vaccine in 18 months-old toddlers who participated in an earlier study in order to determine if they are still protected before they receive a booster dose of D, T, IPV, pertussis or Hib vaccines and also to assess the quality of the induced immune memory in response to a booster dose of the same vaccine as in the primary series. Primary Objective: To describe the antibody persistence at 18 months of age and the booster effect of a dose of PENTAXIM™ on immunogenicity. Secondary objective: To describe the safety profile of the booster dose PENTAXIM™ in each vaccine group defined by the vaccines received during the primary series.