Status:
COMPLETED
Assess the Immune Response Following Primary Vaccination With GSK Biologicals' Tritanrix™-HepB/Hib-MenAC vs Tritanrix™-HepB/Hiberix™ Given at 6,10 & 14 Wks of Age to Infants Who Received Hepatitis B Vaccine at Birth
Lead Sponsor:
GlaxoSmithKline
Conditions:
Diphtheria; Haemophilus Influenzae Type b; Hepatitis B; Tetanus; Whole Cell Pertussis
Eligibility:
All Genders
4-10 years
Phase:
PHASE3
Brief Summary
This study will only include infants born to mothers who are tested as seronegative for human immunodeficiency virus (HIV) \& hepatitis B surface antigen (HBsAg). The purpose of this study is to demon...
Detailed Description
Randomized study with two groups to receive one of the following vaccination regimens: * GSK Biologicals' Tritanrix™-HepB/Hib-MenAC * GSK Biologicals' Tritanrix™-HepB/Hiberix™
Eligibility Criteria
Inclusion
- Inclusion criteria:
- Healthy infants aged 7 days +/- 3 days old born to mothers who are tested as seronegative for HIV \& HBsAg, written informed consent obtained from the parents, born after a gestation period of 36 to 42 weeks.
- Exclusion criteria:
- Known exposure to diphtheria, tetanus, pertussis, hepatitis B, Haemophilus influenzae type b and/or meningococcal disease since birth.
- Any confirmed or suspected immunosuppressive or immunodeficient condition, based on physical examination.
- A family history of congenital or hereditary immunodeficiency.
- Major congenital defects or serious illness.
- Any neurologic disorders or seizures.
- Acute disease at the time of enrolment.
- Administration of immunoglobulins and/or any blood products since birth or planned administration during the study period.
- A birth dose of hepatitis B vaccine given outside the frame of this study.
Exclusion
Key Trial Info
Start Date :
October 1 2004
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
July 1 2005
Estimated Enrollment :
192 Patients enrolled
Trial Details
Trial ID
NCT00317122
Start Date
October 1 2004
End Date
July 1 2005
Last Update
September 21 2016
Active Locations (4)
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1
GSK Investigational Site
Brits, South Africa, 0250
2
GSK Investigational Site
Brits, South Africa
3
GSK Investigational Site
Centurion, South Africa
4
GSK Investigational Site
Ga-Rankuwa, South Africa, 0208