At a glance
ClinicalIndex Comparison RecordStandardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.
To Assess the Safety, Reactogenicity and Immunogenicity of GSK Biologicals' Pneumococcal Conjugate Vaccine Compared to Prevenar™, Co-administered With DTPw-HBV/Hib & OPV or IPV Vaccines as a 3-dose Primary Immunization Course During the First 6 Months of Age
In Brief
A Phase 3 clinical trial evaluating Pneumococcal conjugate vaccine GSK1024850A, Prevenar, and 4 other interventions for Infections, Streptococcal. Completed, enrolled 806 participants across 7 sites in 2 countries.
Detailed Summary
This study will evaluate safety, reactogenicity and immunogenicity of GSK Biologicals' pneumococcal conjugate vaccine compared to Prevenar™ when co-administered with DTPw-HBV/Hib and OPV or IPV vaccines, according to 2 different schedules: 6-10-14 weeks or 2-4-6 months of age. The study has 2 groups. * One group of subjects will receive a 3-dose primary vaccination with the GSK Biologicals' pneumococcal conjugate vaccine (three different lots will be used and randomly allocated). * The 2nd group of subjects will receive a 3-dose primary vaccination with Prevenar™. All children will receive concomitantly DTPw-HBV/Hib and OPV or IPV vaccines. This protocol posting deals with objectives \& outcome measures of the primary study. The objectives \& outcome measures of the Booster study are presented in a separate protocol posting (NCT number =00547248).
Study Details
Timeline
Interventions
3 Intramuscular injections.
3 Intramuscular injections
3 Intramuscular injections
Reconstituted with Tritanrix before injection
3 oral doses.
3 intramuscular injections