Status:
COMPLETED
Assess the Immunogenicity of GSK Biologicals' 10-valent Pneumococcal Conjugate Vaccine
Lead Sponsor:
GlaxoSmithKline
Conditions:
Infections, Streptococcal
Streptococcus Pneumoniae Vaccines
Eligibility:
All Genders
8-16 years
Phase:
PHASE3
Brief Summary
Evaluate the immune response of GSK Biologicals' 10-valent pneumococcal conjugate vaccine one month after completion of a 3-dose primary vaccination course administered at 2, 3, 4 months of age
Detailed Description
Test groups: 2 groups (60 subjects/group). 10Pn-PD-DiT group receiving GSK Biologicals' 10-valent pneumococcal conjugate vaccine + DTPa-HBV-IPV/Hib; Control group receiving Prevenar + DTPa-HBV-IPV/Hib
Eligibility Criteria
Inclusion
- Inclusion criteria:
- Male or female between, and including, 8 and 16 weeks (56-118 days) of age at the time of the first vaccination, 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 licensed vaccine not foreseen by the study protocol during the period starting from one month before the first dose of vaccine(s) and during the entire study period.
Exclusion
Key Trial Info
Start Date :
October 27 2005
Trial Type :
INTERVENTIONAL
End Date :
April 7 2006
Estimated Enrollment :
120 Patients enrolled
Trial Details
Trial ID
NCT00307541
Start Date
October 27 2005
End Date
April 7 2006
Last Update
January 2 2020
Active Locations (32)
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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