Status:
COMPLETED
Multicentre Booster & Immune Memory Study of a Booster Dose of GSK Biologicals' 10-valent Pneumococcal Conjugate Vaccine or a Single Dose of 23-valent Plain Polysaccharide Vaccine in Healthy Children Aged 11-18 Mths, Previously Vaccinated in Study 103488
Lead Sponsor:
GlaxoSmithKline
Conditions:
Acellular Pertussis
Tetanus
Eligibility:
All Genders
11-18 years
Phase:
PHASE2
Brief Summary
Booster and immune memory study
Detailed Description
Total: All 689 subjects enrolled in study 103488. 23PS group: Aventis Pasteurs' 23-valent polysaccharide pneumococcal vaccine (Pneumovax 23) + DTPa-HBV-IPV/Hib; 10V group: GSK Biologicals' 10-valent p...
Eligibility Criteria
Inclusion
- Inclusion criteria: Male or female between, and including, 11-18 months of age at the time of vaccination and who previously participated in the study 11PN-PD-DIT-002 and received at least one dose of pneumococcal conjugate vaccine during the primary study, free of obvious health problems and with written informed consent obtained from the parent/guardian of the subject. Exclusion criteria: Use of any investigational or non-registered drug or vaccine other than the study vaccine within 30 days preceding the first dose of study vaccine, or planned use during the study period. Planned administration/ administration of a vaccine not foreseen by the study protocol during the period starting one month before the first dose of vaccine(s) and during the entire study period. Administration of any additional pneumococcal vaccine or DTPa combined vaccine since study end of 11PN-PD-DIT-002 study
Exclusion
Key Trial Info
Start Date :
November 1 2005
Trial Type :
INTERVENTIONAL
End Date :
March 1 2006
Estimated Enrollment :
689 Patients enrolled
Trial Details
Trial ID
NCT00307567
Start Date
November 1 2005
End Date
March 1 2006
Last Update
September 23 2016
Active Locations (51)
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1
GSK Investigational Site
Bad Saulgau, Baden-Wurttemberg, Germany, 88348
2
GSK Investigational Site
Bretten, Baden-Wurttemberg, Germany, 75015
3
GSK Investigational Site
Eppelheim, Baden-Wurttemberg, Germany, 69214
4
GSK Investigational Site
Kehl, Baden-Wurttemberg, Germany, 77694