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
12-14 years
Phase:
PHASE3
Brief Summary
This study will evaluate the safety, reactogenicity and immunogenicity of a booster dose of the pneumococcal conjugate vaccine, co-admin with a 1st dose or a 2nd dose of MMRV vaccine at 12-14 or respe...
Eligibility Criteria
Inclusion
- a healthy male or female, 12-14 months of age at the time of first vaccination, who received at least one dose of pneumococcal conjugate vaccine 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 the first dose of vaccine(s) and ending 42-56 days after the last dose of vaccine(s).
- Administration of any additional pneumococcal vaccine since end of study 105553.
- Previous vaccination against measles, mumps, rubella and/or varicella. History of, or intercurrent measles, mumps, rubella and/or varicella/zoster diseases.
- Known exposure to measles, mumps, rubella and/or varicella/zoster within 30 days prior to study start.
- Immunosuppressive or immunodeficient condition.
- A history of seizures or neurological disease.
Key Trial Info
Start Date :
October 1 2006
Trial Type :
INTERVENTIONAL
End Date :
March 1 2007
Estimated Enrollment :
390 Patients enrolled
Trial Details
Trial ID
NCT00370227
Start Date
October 1 2006
End Date
March 1 2007
Last Update
October 28 2016
Active Locations (8)
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1
GSK Investigational Site
Helsinki, Finland, 00930
2
GSK Investigational Site
Jarvenpaa, Finland, 04400
3
GSK Investigational Site
Oulu, Finland, 90100
4
GSK Investigational Site
Pori, Finland, 28120