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
Study complete
Study complete
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:
Enrollment:
192
Primary completion date:
Not applicable
Observational study model:
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
Study complete
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
Participate in clinical trial
Additional information
Researchers can use this site to request access to anonymised patient level data and/or supporting documents from clinical studies to conduct further research.
Click hereAccess to clinical trial data by researchers
Visit website