Last updated: 11/04/2018 04:09:16
Assess immune response following primary vaccination with Tritanrix™-HepB vaccine mixed with 3 formulations of Hib-MenAC vaccine to infants
GSK study ID
759346
Clinicaltrials.gov ID
EudraCT ID
Not applicable
EU CT Number
Not applicable
Trial status
Study complete
Study complete
Trial overview
Official title: Evaluate the feasibility of GSK Biologicals’ Tritanrix™-HepB/Hib-MenAC vaccine administered as a 3 dose primary vaccination course at 6, 10 & 14 weeks of age
Trial description: To compare three formulations of Hib-MenAC vaccines mixed with Tritanrix™-HepB vaccine with that of Tritanrix™-HepB vaccine concomitantly administered with GSK Biologicals’ Hiberix™ vaccine and Tritanrix™-HepB vaccine mixed with Hiberix™ vaccine and concomitantly administered with Wyeth Lederle’s meningococcal C conjugate vaccine (Meningitec™), with respect to antibody response to vaccine antigens (meningococcal serogroups A and C and PRP) after a three-dose primary vaccination course.
Primary purpose:
Prevention
Trial design:
Parallel Assignment
Masking:
None (Open Label)
Allocation:
Randomized
Primary outcomes:
Not applicable
Secondary outcomes:
Not applicable
Interventions:
Enrollment:
525
Primary completion date:
Not applicable
Observational study model:
Not applicable
Time perspective:
Not applicable
Clinical publications:
Not applicable
Medical condition
Diphtheria, Tetanus, Pertussis, Hepatitis B, Hib Diseases, Neisseria meningitidis serogroups A & C diseases
Product
Combined Diphtheria, Tetanus, Whole Cell Pertussis, Hepatitis B, Haemophilus influenzae Type b Vaccine
Collaborators
Not applicable
Study date(s)
November 2002 to November 2002
Type
Interventional
Phase
2
Participation criteria
Sex
Female & Male
Age
6 - 10 Weeks
Accepts healthy volunteers
Yes
- Healthy infant between 6 and 10 weeks of age at the time of the first vaccination, written informed consent obtained from the parents, born after a gestation period of 36 to 42 weeks.
- Use of any investigational or non-registered product (drug or vaccine) other than the study vaccine(s) or planned administration/ administration of vaccine not foreseen by the study protocol within 30 days preceding the first dose of study vaccine during study period, or planned use during study period with exception of oral polio vaccine (OPV).
- Chronic administration of immunosuppressants or other immune-modifying drugs since birth.
Inclusion and exclusion criteria
Inclusion criteria:
- Healthy infant between 6 and 10 weeks of age at the time of the first vaccination, written informed consent obtained from the parents, born after a gestation period of 36 to 42 weeks.
Exclusion criteria:
- Use of any investigational or non-registered product (drug or vaccine) other than the study vaccine(s) or planned administration/ administration of vaccine not foreseen by the study protocol within 30 days preceding the first dose of study vaccine during study period, or planned use during study period with exception of oral polio vaccine (OPV).
- Chronic administration of immunosuppressants or other immune-modifying drugs since birth.
- Hepatitis B and Bacille Calmette-Guérin (BCG) vaccine received after the first 2 weeks of life.
- Any confirmed or suspected immunosuppressive or immunodeficient condition based on medical history and physical examination.
- Administration of immunoglobulins and/or any blood products since birth or planned administration during the study period.
- Previous vaccination against diphtheria, tetanus, pertussis, hepatitis B, Haemophilus influenzae type b, and/or meningococcal disease with the exception of a birth dose of hepatitis B vaccine.
Trial location(s)
Study documents
No study documents available.
Results overview
Study Results yet to be posted
Recruitment status
Study complete
Actual primary completion date
Not applicable
Actual study completion date
2002-30-11
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
Additional information
Not applicable
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