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

This study has been completed.
Sponsor:
Information provided by:
GlaxoSmithKline
ClinicalTrials.gov Identifier:
NCT00333450
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 ClinicalTrials.gov 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.
Interventional
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
Not Provided
Knuf M, Pankow-Culot H, Grunert D, Rapp M, Panzer F, Köllges R, Fanic A, Habib A, Borys D, Dieussaert I, Schuerman L. Induction of immunologic memory following primary vaccination with the 10-valent pneumococcal nontypeable Haemophilus influenzae protein D conjugate vaccine in infants. Pediatr Infect Dis J. 2012 Jan;31(1):e31-6. doi: 10.1097/INF.0b013e3182323ac2.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
120
Not Provided
Not Provided

Inclusion:

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

Exclusion:

  • 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.
Both
11 Months to 14 Months   (Child)
Yes
Contact information is only displayed when the study is recruiting subjects
Germany
 
NCT00333450
106623
Not Provided
Not Provided
Not Provided
Cheri Hudson; Clinical Disclosure Advisor, GSK Clinical Disclosure
GlaxoSmithKline
Not Provided
Study Director: GSK Clinical Trials GlaxoSmithKline
GlaxoSmithKline
February 2012

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