NCT00370227

Safety and Immunogenicity Study of a Booster Dose of GSK Biologicals' 10-valent Pneumococcal Conjugate Vaccine

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.

• Status: Completed
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 390 (planned)
• Sponsor: GlaxoSmithKline · Industry
• Sex: All
• Age: 12 Months – 14 Months
• Healthy volunteers: Accepted

Summary

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.

Conditions

• Infections, Streptococcal

Interventions

Type	Name	Description
BIOLOGICAL	10 valent pneumococcal conjugate (vaccine)

Timeline

• Start date: 2006-10-01
• Completion: 2007-03-01
• First posted: 2006-08-31
• Last updated: 2016-10-28

Locations

8 sites across 1 country: Finland