Status:
COMPLETED
Immunogenicity and Safety Study of GlaxoSmithKline (GSK) Biologicals' 10-valent Pneumococcal Conjugate Vaccine
Lead Sponsor:
GlaxoSmithKline
Conditions:
Infections, Streptococcal
Eligibility:
All Genders
9-60 years
Phase:
PHASE3
Brief Summary
The purpose of this phase IIIb study is to determine whether children who have not received a 3-dose primary vaccination with the pneumococcal conjugate vaccine before their 6 months of age, can recei...
Detailed Description
The Protocol Posting has been updated in order to comply with the FDA Amendment Act, Sep 2007
Eligibility Criteria
Inclusion
- Male or female between, and including
- 9-12 weeks of age at the time of first vaccination for the \<6 Mo group.
- 7-11 months of age at the time of first vaccination for the 7-11 Mo group.
- 12-23 months of age at the time of first vaccination for the 12-23 Mo group.
- 24 months to 5 years at the time of first vaccination for the \>= 24 Mo group.
- Subjects for whom the investigator believes that their parents/guardians can and will comply with the requirements of the protocol
- Written informed consent obtained from the parent or guardian of the subject.
- Free of obvious health problems as established by medical history and clinical examination before entering into the study.
- Born after a gestation period between 36 and 42 weeks.
Exclusion
- Use of any investigational or non-registered product (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 for each age-group.
- Chronic administration (defined as more than 14 days) of immunosuppressants or other immune-modifying drugs within six months prior to the first vaccine dose.
- Planned administration/ administration of a vaccine not foreseen by the study protocol during the period starting one month before and ending one month after each dose of vaccine(s).
- Previous vaccination against S. pneumoniae.
- History of allergic disease or reactions likely to be exacerbated by any component of the vaccines.
- History of seizures (this criterion does not apply to subjects who have had a single, uncomplicated febrile convulsion in the past) or neurological disease.
- Acute disease at the time of enrolment.
- Any confirmed or suspected immunosuppressive or immunodeficient condition based on medical history and physical examination
- A family history of congenital or hereditary immunodeficiency.
- Major congenital defects or serious chronic illness.
- Administration of immunoglobulins and/or any blood products since birth or planned administration during the entire study period.
Key Trial Info
Start Date :
September 18 2006
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
November 15 2007
Estimated Enrollment :
600 Patients enrolled
Trial Details
Trial ID
NCT00345358
Start Date
September 18 2006
End Date
November 15 2007
Last Update
January 15 2019
Active Locations (10)
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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