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

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00333450
First Posted: June 5, 2006
Last Update Posted: October 7, 2016
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by (Responsible Party):
GlaxoSmithKline
June 2, 2006
June 5, 2006
October 7, 2016
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
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Prevention
Infections, Streptococcal
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
December 2006
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.
Sexes Eligible for Study: All
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
Plan to Share IPD: Yes
Plan Description: Patient-level data for this study will be made available through www.clinicalstudydatarequest.com following the timelines and process described on this site.
GlaxoSmithKline
GlaxoSmithKline
Not Provided
Study Director: GSK Clinical Trials GlaxoSmithKline
GlaxoSmithKline
October 2016

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