drugset / Trial / NCT01153893

Immunization of Children Previously Primed With GSK Pneumococcal Vaccine GSK1024850A and of Unprimed Children in Nigeria

NCT01153893

Phase 3 Completed 105 enrolled GlaxoSmithKline
Non-randomizedParallel-groupOpen-labelPrevention

Summary

The purpose of this trial is to assess the safety, reactogenicity and immunogenicity of GSK Biologicals' pneumococcal conjugate vaccine GSK1024850A when administered either as a booster dose or as a two dose catch-up vaccination in the second year of life to the Nigerian subjects previously enrolled in the primary vaccination study NCT00678301. This protocol posting deals with objectives \& outcome measures of the booster phase. The objectives \& outcome measures of the primary phase are presented in a separate protocol posting (NCT number = NCT00678301).

Timeline

Start
2010-10-04
Primary completion
2011-02-16
Completion
2011-02-16

Drugs

EvaluationDrugModalityDoseRoute
Subject GSK1024850A Vaccine Intramuscular
Background InfanrixTM Vaccine Intramuscular