Comment Period Extended to 3/23/2015 for Notice of Proposed Rulemaking (NPRM) for FDAAA 801 and NIH Draft Reporting Policy for NIH-Funded Trials

Immune Memory Evaluation in Children Following a Primary Vaccination With Pneumococcal Conjugate Vaccines.

This study has been completed.
Information provided by:
GlaxoSmithKline Identifier:
First received: June 2, 2006
Last updated: March 1, 2012
Last verified: February 2012

June 2, 2006
March 1, 2012
August 2006
Not Provided
Antibody concentrations against pneumococcal serotypes 1 month post-booster
Same as current
Complete list of historical versions of study NCT00333450 on Archive Site
Immunogenicity pre and post-booster and safety (follow up of SAEs)
Same as current
Not Provided
Not Provided
Immune Memory Evaluation in Children Following a Primary Vaccination With Pneumococcal Conjugate Vaccines.
Multicentre Immune Memory Study in Healthy Children Following a 3 Dose Primary Vaccination With Prevenar or GSK Biologicals' Pneumococcal Conjugate Vaccine Via the Administration of a Single Booster Dose of Pneumovax 23

To evaluate the immunological memory against pneumococcal vaccine serotypes in children primed with conjugate vaccines by administering a booster dose of plain polysaccharide vaccine.

2 groups (60 per group), booster of Pneumovax 23 after priming with Prevnar or GSK Biologicals' pneumococcal vaccine.

Phase 3
Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Prevention
Prophylaxis Pneumococcal Vaccine
Biological: Pneumococcal vaccine
Other Name: Pneumococcal vaccine
Not Provided

*   Includes publications given by the data provider as well as publications identified by Identifier (NCT Number) in Medline.
Not Provided
Not Provided


  • healthy children between 11-14 months old who received primary vaccination with Prevnar or GSK Biologicals' pneumococcal conjugate vaccine.


  • children having received or planning to receive any investigational products, vaccines not foreseen in the protocol and immune modifying drugs;
  • children having received any additional pneumococcal vaccine than in the primary study;
  • children with any disease that affect the immune system and history of seizures and/or allergic disease.
11 Months to 14 Months
Contact information is only displayed when the study is recruiting subjects
Not Provided
Cheri Hudson; Clinical Disclosure Advisor, GSK Clinical Disclosure
Not Provided
Study Director: GSK Clinical Trials GlaxoSmithKline
February 2012

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP