At a glance
ClinicalIndex Comparison RecordStandardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.
Vaccination With the Pneumococcal Vaccine GSK 1024850A or Prevenar™ at Approximately 4 Years of Age in Children Primed With 3 Doses of GSK 1024850A Vaccine or Prevenar™ and Boosted With 23-valent Pneumococcal Plain Polysaccharide Vaccine
In Brief
A Phase 3 clinical trial evaluating Pneumococcal conjugate vaccine GSK 1024850A and Pneumococcal conjugate vaccine Prevenar™ (Wyeth Lederle's) for Infections, Streptococcal and Streptococcus Pneumoniae. Completed, enrolled 52 participants across 17 sites.
Detailed Summary
The aim of this study is to assess the immune response, safety and reactogenicity following administration of an additional dose of a pneumococcal conjugate vaccine at approximately 4 years of age in children previously vaccinated with 3 primary doses of GSK 1024850A or Prevenar™ vaccine within the first 6 months of life and a booster dose of plain polysaccharide pneumococcal (Pneumovax 23™) vaccine at 11-14 months of age. Antibody persistence will also be assessed at approximately 4 years of age in children previously vaccinated with 3 doses of either GSK 1024850A or Prevenar™ vaccine followed by a booster dose of Pneumovax 23™. This protocol posting deals with objectives \& outcome measures of the extension phase at year 4. The objectives \& outcome measures of the primary phase are presented in a separate protocol posting (NCT 00307541). The objectives \& outcome measures of the booster phase are presented in a separate protocol posting (NCT 00333450).
Study Details
Timeline
Interventions
One dose of vaccine will be injected intramuscularly into the deltoid.
One dose of vaccine will be injected intramuscularly into the deltoid.