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

NCT00370396 PHASE3 COMPLETED Results posted

This 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.

Details

Lead sponsor	GlaxoSmithKline
Phase	PHASE3
Status	COMPLETED
Enrolment	1200
Start date	Mon Sep 25 2006 00:00:00 GMT+0000 (Coordinated Universal Time)
Completion	Tue Nov 06 2007 00:00:00 GMT+0000 (Coordinated Universal Time)

Conditions

• Infections, Streptococcal

Interventions

• Synflorix
• Prevenar
• Infanrix hexa

Countries

France, Finland, Poland