Infections, Streptococcal Clinical Trial
Official title:
To Assess Safety, Reactogenicity & Immunogenicity of a Booster Dose of Pneumococcal Conjugate Vaccine, Co-admin With GSK Biologicals' MMRV Vaccine in Children (2nd yr of Life) Primed With the Pneumococcal Conjugate Vaccine in Study 105553.
This 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.
n/a
Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Prevention
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