Status:
COMPLETED
Safety and Immunogenicity Study of GlaxoSmithKline (GSK) Biologicals' 10-valent Pneumococcal Conjugate Vaccine.
Lead Sponsor:
GlaxoSmithKline
Conditions:
Infections, Streptococcal
Eligibility:
All Genders
6-16 years
Phase:
PHASE3
Brief Summary
Three dose primary vaccination of healthy infants between 6 to 16 weeks of age at the time of the first vaccination against Streptococcus pneumonia, Neisseria meningitidis and Haemophilus influenzae t...
Eligibility Criteria
Inclusion
- male or female between, and including, 6-16 weeks (42 to 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
- 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 entire study period.
- Planned administration/ administration of a vaccine not foreseen by the study protocol during the period starting one month before each dose of vaccine(s) and ending 7 days after dose 1 and dose 2 or 1 month after dose 3.
- Previous vaccinations against diseases which are targeted by the vaccines used in the study.
Key Trial Info
Start Date :
June 1 2006
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
August 1 2007
Estimated Enrollment :
1572 Patients enrolled
Trial Details
Trial ID
NCT00334334
Start Date
June 1 2006
End Date
August 1 2007
Last Update
November 4 2016
Active Locations (66)
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1
GSK Investigational Site
Bad Saulgau, Baden-Wurttemberg, Germany, 88348
2
GSK Investigational Site
Bönnigheim, Baden-Wurttemberg, Germany, 74357
3
GSK Investigational Site
Bretten, Baden-Wurttemberg, Germany, 75015
4
GSK Investigational Site
Ettenheim, Baden-Wurttemberg, Germany, 77955