Evaluation of Pneumococcal Vaccine Formulations in Young Adults
InfectionsStreptococcalThe purpose of this study is to evaluate the safety, reactogenicity and immunogenicity of pneumococcal vaccines in young adults. Subjects will be vaccinated twice with an interval of two months.
Co-administration of Pneumococcal Conjugate Vaccine With DTPa-IPV-Hib Versus Co-administration With...
InfectionsStreptococcalThe purpose of this trial is to evaluate the immunogenicity and safety of a pneumococcal conjugate vaccine when co-administered with DTPa-IPV-Hib or DTPa-HBV-IPV/Hib in infants as a three-dose primary immunisation course during the first 6 months of life and as a booster dose at 11-12 months of age. The impact of the pneumococcal conjugate vaccine on nasopharyngeal carriage of S. pneumoniae and H. influenzae in children in their first two years of life will also be assessed. The Protocol Posting has been updated in order to comply with the FDA Amendment Act, Sep 2007.
Primary Vaccination Course in Children Receiving Pneumococcal Conjugate Vaccine GSK 1024850A or...
InfectionsStreptococcalThe purposes of this study are: To demonstrate the immunogenicity in terms of antibody response following primary vaccination of Korean infants with the pneumococcal conjugate vaccine GSK 1024850A compared to Prevenar™ when co-administered with a Haemophilus influenzae type b (Hib) vaccine in children during the first 6 months of life. To evaluate the safety/reactogenicity in terms of solicited and unsolicited symptoms and serious adverse events following primary vaccination of Korean infants with the pneumococcal conjugate vaccine GSK 1024850A.
Safety and Immunogenicity Study of a Booster Dose of GSK Biologicals' 10-valent Pneumococcal Conjugate...
InfectionsStreptococcalThis study will evaluate the safety, reactogenicity and immunogenicity of a booster dose of the pneumococcal conjugate vaccine, co-admin with a 1st dose or a 2nd dose of MMRV vaccine at 12-14 or respectively 14-16 months of age in children primed with the pneumococcal conjugate vaccine in study 105553. Antibody persistence will be evaluated at 8-10 months after completion of the 3-dose immunization course in study 105553. The immunogenicity, safety and reactogenicity of the 1st and 2nd dose of MMRV vaccine will also be evaluated when co-admin with the pneumococcal conjugate vaccine between 12-16 months of age. The study has 3 groups. The 1st group will receive the booster dose of pneumococcal conjugate vaccine + 1st dose of MMRV vaccine at 12-14 mo of age and the booster dose of Infanrix hexa™+ 2nd dose of MMRV vaccine at 14-16 mo of age. The 2nd group will receive the booster dose of Infanrix hexa™ + 1st dose of MMRV vaccine at 12-14 mo of age and the booster dose of pneumococcal conjugate vaccine + 2nd dose of MMRV vaccine at 14-16 mo of age. The 3rd group will receive the booster dose of pneumococcal conjugate vaccine + the booster dose of Infanrix hexa™ at 12-14 mo. Subjects will be offered one dose of Priorix™ and Varilrix™ at 14-16 mo of age, outside the study.
Safety and Immunogenicity Study of a Booster Dose of GSK Biologicals' 10-valent Pneumococcal Conjugate...
InfectionsStreptococcalThis study will evaluate the safety, reactogenicity and immunogenicity of a booster dose of GSK Biologicals' pneumococcal conjugate vaccine compared to Prevenar™ given at 12-18 mo of age to children primed with either pneumococcal vaccine or Prevenar™ in study 105553. Antibody persistence will be evaluated at 8-14 mo after completion of the 3-dose immunization course in study 105553 (NCT00307554). The immune response to a booster dose of GSK Biologicals' pneumococcal conjugate vaccine will also be evaluated when given at 12-18 mo to subjects not primed with GSK Biologicals' vaccine but with Prevenar™. The study has 3 groups. 1 group of children primed with GSK Biologicals' pneumococcal conjugate vaccine will receive a booster dose of the same vaccine. 2nd group of children primed with Prevenar™ will receive a booster dose of Prevenar™ (control group). 3rd group of children primed with Prevenar™ will receive a booster dose of GSK Biologicals' pneumococcal conjugate vaccine. All children will receive concomitantly a booster dose of DTPa-HBV-IPV/Hib vaccine.
Study to Evaluate the Safety and Immunogenicity of an Investigational Pneumococcal Vaccine in the...
InfectionsStreptococcalAs the licensed pneumococcal vaccine is not always satisfactory in elderly, new investigational pneumococcal vaccines are evaluated in the healthy elderly population. Note: The study consists of the primary phase (106068): vaccination and follow-up and the extension (106072) of the primary phase: 1 year follow-up. This protocol posting details the procedures of both the primary & extension phase.
Safety & Immunogenicity Study of 10-Valent Pneumococcal Conjugate Vaccine When Administered as a...
InfectionsStreptococcalAssess immuno, reacto of the 10-valent pneumococcal vaccine after 2 doses (2, 4 months of age) and after the complete 2, 4, 11 months schedule when co-administered with DTPa-HBV-IPV/Hib or DTPa-IPV/Hib (according to national recommendations)
A TRIAL TO EVALUATE THE SAFETY, TOLERABILITY, AND IMMUNOGENICITY OF A BOOSTER DOSE OF A GROUP B...
Group B Streptococcal InfectionsThis study is an extension to the completed first-in-human C1091001 study (NCT03170609) and is to evaluate the safety and immunogenicity of a single booster vaccine dose of GBS6, administered approximately 2 years or more after a primary GBS6 dose, to healthy adult males and nonpregnant women. The study will determine whether individuals who received a primary dose of GBS6 have additional benefit following a booster dose.
Safety & Immunogenicity of Pneumococcal Vaccine 2189242A in Children Aged 12-23 Months at the Time...
InfectionsStreptococcalThis study will assess the safety, reactogenicity and immunogenicity of different formulations of GSK Biologicals' pneumococcal vaccine 2189242A when administered alone or in combination with the 10-valent pneumococcal conjugate vaccine (GSK1024850A vaccine) as a 2-dose primary vaccination course followed by a booster dose in healthy children aged 12-23 months at the time of first vaccination. Considering that febrile reactions are frequently observed following pneumococcal vaccination, usually co-administered with other routine paediatric vaccines, the primary study objective will focus on evaluating the increase in grade 3 fever (i.e. rectal temperature >40.0°C).
Immunization of Children Between 8 Weeks and 2 Years of Age With GSK Pneumococcal Vaccine GSK1024850A...
InfectionsStreptococcalThe aim of the study is to evaluate the immunogenicity, safety and reactogenicity of GSK Biologicals' pneumococcal conjugate vaccine GSK1024850A. Children that are below 6 months at the time of enrolment will also receive the DTPw-HBV/Hib and OPV vaccines.