Status:
COMPLETED
Immune Memory Evaluation in Children Following a Primary Vaccination With Pneumococcal Conjugate Vaccines.
Lead Sponsor:
GlaxoSmithKline
Conditions:
Infections, Streptococcal
Eligibility:
All Genders
11-14 years
Phase:
PHASE3
Brief Summary
To evaluate the immunological memory against pneumococcal vaccine serotypes in children primed with conjugate vaccines by administering a booster dose of plain polysaccharide vaccine.
Detailed Description
2 groups (60 per group), booster of Pneumovax 23 after priming with Prevnar or GSK Biologicals' pneumococcal vaccine.
Eligibility Criteria
Inclusion
- 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.
Exclusion
Key Trial Info
Start Date :
August 1 2006
Trial Type :
INTERVENTIONAL
End Date :
December 1 2006
Estimated Enrollment :
120 Patients enrolled
Trial Details
Trial ID
NCT00333450
Start Date
August 1 2006
End Date
December 1 2006
Last Update
October 7 2016
Active Locations (30)
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1
GSK Investigational Site
Mannheim, Baden-Wurttemberg, Germany, 68167
2
GSK Investigational Site
Marbach, Baden-Wurttemberg, Germany, 71672
3
GSK Investigational Site
Nördlingen, Bavaria, Germany, 86720
4
GSK Investigational Site
Tutzing, Bavaria, Germany, 82327