Status:
COMPLETED
A Lot-to-lot Consistency (3 Lots of GSK Biologicals' 10-valent Pneumococcal Conjugate Vaccine) & Non-inferiority Study
Lead Sponsor:
GlaxoSmithKline
Conditions:
Infections, Streptococcal
Eligibility:
All Genders
6-12 years
Phase:
PHASE3
Brief Summary
Evaluate lot-to-lot consistency, safety and reactogenicity of 3 doses of GSK Biologicals' 10-valent pneumococcal conjugate vaccine and non-inferiority with respect to Prevenar.
Detailed Description
Test groups: 4 (400 subjects/group). 3 groups receiving 10-valent pneumococcal conjugate vaccine (3 different lots) as follows: - 10-valent vaccine (lot 1, 2 or 3) + DTPa combined vaccine; Control gro...
Eligibility Criteria
Inclusion
- Inclusion criteria:
- Male or female between, and including, 6 and 12 weeks (42-90 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 preceeding 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 :
November 1 2005
Trial Type :
INTERVENTIONAL
End Date :
June 1 2006
Estimated Enrollment :
1600 Patients enrolled
Trial Details
Trial ID
NCT00307554
Start Date
November 1 2005
End Date
June 1 2006
Last Update
September 26 2016
Active Locations (35)
Enter a location and click search to find clinical trials sorted by distance.
1
GSK Investigational Site
Espoo, Finland, 02100
2
GSK Investigational Site
Helsinki, Finland, 00930
3
GSK Investigational Site
Jarvenpaa, Finland, 04400
4
GSK Investigational Site
Jyväskylä, Finland, 40100