Status:
COMPLETED
Safety and Immunogenicity Study of a Booster Dose of GSK Biologicals' 10-valent Pneumococcal Conjugate Vaccine.
Lead Sponsor:
GlaxoSmithKline
Conditions:
Infections, Streptococcal
Eligibility:
All Genders
12-18 years
Phase:
PHASE3
Brief Summary
This study will evaluate the safety, reactogenicity and immunogenicity of a booster dose of GSK Biologicals' pneumococcal conjugate vaccine compared to Prevenar™ given at 12-18 mo of age to children p...
Eligibility Criteria
Inclusion
- a healthy male or female, 12 to 18 months of age at the time of vaccination, who received at least one dose of either pneumococcal conjugate vaccine or Prevenar™ during study 105553 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 vaccination, or planned use during the entire study period (active phase and safety follow-up).
- Planned administration/ administration of a vaccine not foreseen by the study protocol during the period starting one month before vaccination up to Visit 2.
- Administration of any additional pneumococcal vaccine or DTPa-combined vaccine since end of study 105553. Children with a history of seizures or neurological disease, allergic disease, immunosuppressive or immunodeficient condition.
Key Trial Info
Start Date :
September 25 2006
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
November 6 2007
Estimated Enrollment :
1200 Patients enrolled
Trial Details
Trial ID
NCT00370396
Start Date
September 25 2006
End Date
November 6 2007
Last Update
June 10 2019
Active Locations (35)
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1
GSK Investigational Site
Espoo, Finland, 02100
2
GSK Investigational Site
Helsinki, Finland, 00100
3
GSK Investigational Site
Helsinki, Finland, 00930
4
GSK Investigational Site
Jarvenpaa, Finland, 04400