Status:
COMPLETED
Safety and Immunogenicity Study of GlaxoSmithKline (GSK) Biologicals' 10-valent Pneumococcal Conjugate Vaccine
Lead Sponsor:
GlaxoSmithKline
Conditions:
Infections, Streptococcal
Eligibility:
All Genders
6-12 years
Phase:
PHASE3
Brief Summary
This study will evaluate safety, reactogenicity and immunogenicity of GSK Biologicals' pneumococcal conjugate vaccine compared to Prevenar™ when co-administered with DTPw-HBV/Hib and OPV or IPV vaccin...
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, 6-12 weeks (42 to 90 days) of age at the time of the first vaccination.
- 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(s) within 30 days preceding the first dose of study vaccine, or planned use during the study period
- 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 each dose of vaccine(s) and ending 7 days after dose 1 and dose 2 or 1 month after dose 3.
- Previous vaccination against diphtheria, tetanus, pertussis, polio, hepatitis B, Haemophilus influenzae type b, and/or S. pneumoniae with the exception of vaccines where the first dose can be given within the first two weeks of life according to the national recommendations
- History of or intercurrent diphtheria, tetanus, pertussis, hepatitis B, polio, and Haemophilus influenzae type b diseases.
- 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
- 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 active phase of the study.
Key Trial Info
Start Date :
August 7 2006
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
October 17 2007
Estimated Enrollment :
806 Patients enrolled
Trial Details
Trial ID
NCT00344318
Start Date
August 7 2006
End Date
October 17 2007
Last Update
December 7 2018
Active Locations (7)
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1
GSK Investigational Site
City of Muntinlupa, Philippines, 1781
2
GSK Investigational Site
Gdansk, Poland, 80-394
3
GSK Investigational Site
Lodz, Poland, 91-347
4
GSK Investigational Site
Trzebnica, Poland, 55-100