Status:
COMPLETED
Assess if Immune Response of GSK Biologicals' Tritanrix™-HepB/Hib-MenAC Given Without or With Hepatitis B Vaccine at Birth is at Least as Good as Tritanrix™-HepB/Hiberix™ Without Hepatitis B Vaccine at Birth, When Given to Healthy Infants
Lead Sponsor:
GlaxoSmithKline
Conditions:
Haemophilus Influenzae Type b
Diphtheria
Eligibility:
All Genders
3+ years
Phase:
PHASE3
Brief Summary
The purpose of this study is to compare the immune response, safety and reactogenicity of Tritanrix™-HepB/Hib-MenAC vaccine given either with or without a birth dose of hepatitis B vaccine to Tritanri...
Detailed Description
Randomized study with three groups (subjects born to mothers who do not carry hepatitis B virus) to receive one of the following vaccination regimens: - GSK Biologicals' Tritanrix™-HepB/Hib-MenAC and ...
Eligibility Criteria
Inclusion
- Inclusion criteria:
- Healthy infants aged 3 days or less, written informed consent obtained from the parents, born after a gestation period of 36 to 42 weeks.
- Result of the maternal blood sample (presence/not of hepatitis B virus) is available.
- Exclusion criteria:
- 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.
- History of any neurologic disorders or seizures.
- Administration of immunoglobulins and/or any blood products since birth or planned administration during the study period (except for immunoglobulins given at birth to infants born to HBsAg seropositive mothers).
- Acute disease at the time of enrolment.
- Known exposure to diphtheria, tetanus, pertussis, hepatitis B, Haemophilus influenzae type b and/or meningococcal disease.
- Hepatitis B vaccine given at birth outside the study.
Exclusion
Key Trial Info
Start Date :
May 1 2004
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
March 1 2005
Estimated Enrollment :
996 Patients enrolled
Trial Details
Trial ID
NCT00290303
Start Date
May 1 2004
End Date
March 1 2005
Last Update
September 16 2016
Active Locations (3)
Enter a location and click search to find clinical trials sorted by distance.
1
GSK Investigational Site
Manila, Philippines, 1000
2
GSK Investigational Site
Quezon City, Philippines, 1109
3
GSK Investigational Site
Sampaloc, Manila, Philippines, 1008