Last updated: 11/04/2018 04:10:16
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
Clinicaltrials.gov ID
EudraCT ID
Not applicable
EU CT Number
Not applicable
Trial status
Completed
Completed
Trial overview
Official title: Demonstrate non-inferiority of GSK Biologicals’ Tritanrix™-HepB/Hib-MenAC vs Tritanrix™-HepB/Hiberix™ with respect to anti-HBs immune response, when given to healthy infants at 6,10 & 14 weeks age, after a birth dose of hepatitis B vaccine
Trial description: 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.
Primary purpose:
Prevention
Trial design:
Parallel Assignment
Masking:
None (Open Label)
Allocation:
Randomized
Primary outcomes:
Not applicable
Secondary outcomes:
Not applicable
Interventions:
Biological/vaccine: DTPw-HBV/Hib-MenAC conjugate vaccine
Enrollment:
192
Observational study model:
Not applicable
Primary completion date:
Not applicable
Time perspective:
Not applicable
Clinical publications:
Not applicable
Medical condition
Diphtheria; Haemophilus influenzae type b; Hepatitis B; Tetanus; Whole Cell Pertussis
Product
SB759346
Collaborators
Not applicable
Study date(s)
October 2004 to July 2005
Type
Interventional
Phase
3
Participation criteria
Sex
Female & Male
Age
4 - 10 days
Accepts healthy volunteers
Yes
- 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.
- 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.
Inclusion and exclusion criteria
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 location(s)
Study documents
Clinical study report
Available language(s): English
Scientific result summary
Available language(s): English
If you wish to request for full study report, please contact - [email protected]
Results overview
Refer to study documents
Recruitment status
Completed
Actual primary completion date
Not applicable
Actual study completion date
2005-26-07
Plain language summaries
Plain language summaries of clinical trial results for Phase 2-4 clinical trials that were initiated on or after January 2022 will be posted by GSK within one year following study completion.
Additional information about the trial
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