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
Status and phase
Conditions
Treatments
Details and patient eligibility
About
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 demonstrate in infants who received a birth dose of hepatitis B vaccine that Tritanrix™-HepB/Hib-MenAC vaccine is at least as good as Tritanrix™-HepB/Hiberix™ with respect to immunogenicity of the hepatitis B antigen.
Full 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™
Enrollment
Sex
Ages
Volunteers
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.
Trial design
Primary purpose
Allocation
Interventional model
Masking
Trial contacts and locations
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Data sourced from clinicaltrials.gov
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