Status:
COMPLETED
Safety Study of a Vaccine Against Meningitis in Infants ( 2,4 & 6 Months Age) After a Birth Dose of Hepatitis B.
Lead Sponsor:
GlaxoSmithKline
Conditions:
Diphtheria
Hepatitis B
Eligibility:
All Genders
Up to 3 years
Phase:
PHASE3
Brief Summary
The purpose of this study is to compare the reactogenicity \& safety of Tritanrix™-HepB/Hib-MenAC vaccine to the international standard of care, Tritanrix™-HepB/Hiberix™.
Detailed Description
Randomized study with four groups to receive one of the following vaccination regimens after a dose of hepatitis B vaccine given at birth: \- One of the 3 lots of GSK Biologicals' Hib-MenAC mixed wit...
Eligibility Criteria
Inclusion
- Inclusion criteria at study entry:
- Healthy infants aged less than or equal to 3 days of age, written informed consent obtained from the parents, born after a gestation period of 36 to 42 weeks.
- Exclusion criteria at study entry:
- Any confirmed immunodeficient condition, based on medical history \& physical examination.
- A family history of congenital or hereditary immunodeficiency.
- Major congenital defects or serious chronic illness.
- History of any neurologic disorders or seizures.
- Administration of immunoglobulins and/or any blood products since birth or planned administration during the study period.
- Acute disease at the time of enrolment.
Exclusion
Key Trial Info
Start Date :
December 11 2003
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
October 23 2004
Estimated Enrollment :
500 Patients enrolled
Trial Details
Trial ID
NCT00317135
Start Date
December 11 2003
End Date
October 23 2004
Last Update
August 15 2018
Active Locations (1)
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1
GSK Investigational Site
City of Muntinlupa, Philippines, 1781