Last updated: 11/03/2018 00:38:57
Immuno & safety study with 2 formulations of DTPw-HBV/HIB when given at birth with hepatitis B at 2, 4 and 6 mths.age.
Clinicaltrials.gov ID
EudraCT ID
EU CT Number
Not applicable
Trial status
Other
Other
Trial overview
Official title: Study to assess immunogenicity and safety of GlaxoSmithKline Biologicals' Kft’s DTPw-HBV/Hib vs DTPwCSL-HBV/Hib Kft and vs concomitant administration of CSL’s Triple Antigen and GlaxoSmithKline Biologicals’ Hiberix, to infants at 2, 4, 6 months of age, after a birth dose of hepatitis B
Trial description: A trial to characterize the immunogenicity of 2 different formulations of a vaccine from GSK Biologicals, including the following five antigens: diphtheria, tetanus, pertussis, hepatitis B and Haemophilus influenzae type b. A vaccine from Commonwealth Serum Laboratories (diphtheria, tetanus, pertussis) which is co-administered with Haemophilus influenzae type b vaccine will also be used as a comparator. Reactogenicity and safety of all vaccines will be assessed as well.
Primary purpose:
Prevention
Trial design:
Parallel Assignment
Masking:
Not applicable
Allocation:
Randomized
Primary outcomes:
Not applicable
Secondary outcomes:
Not applicable
Interventions:
Enrollment:
288
Primary completion date:
Not applicable
Observational study model:
Not applicable
Time perspective:
Not applicable
Clinical publications:
Not applicable
Medical condition
Haemophilus influenzae type b, Diphtheria, Tetanus, Hepatitis B, Whole Cell Pertussis
Product
GSK323527A
Collaborators
Not applicable
Study date(s)
March 2006 to November 2006
Type
Interventional
Phase
3
Participation criteria
Sex
Female & Male
Age
6 - 12 weeks
Accepts healthy volunteers
Yes
- Inclusion criteria
- Administration of one dose of hepatitis B vaccine at birth.
Inclusion and exclusion criteria
Inclusion criteria:
- Administration of one dose of hepatitis B vaccine at birth.
- A healthy male or female between, and including, 6 and 12 weeks of age at the time of the first DTPw vaccination. Exclusion criteria
- Use of any investigational or non-registered product (drug or vaccine) other than the study vaccine(s) within 30 days preceding the first dose of study vaccine, or planned use during the study period.
- Chronic administration of immunosuppressants or other immune-modifying drugs since birth.
- Planned administration/ administration of a vaccine not foreseen by the study protocol within 30 days before the first vaccine dose or planned administration during the study period with the exception of oral polio vaccine hepatitis B vaccine for the Triple Antigen + Hib group.
- Any confirmed or suspected immunosuppressive or immunodeficient condition based on medical history and physical examination (no laboratory testing is required)
- Administration of immunoglobulins and/or any blood products since birth or planned administration during the study period. •Bacille Calmette-Guérin (BCG) vaccine given after the first 2 weeks of life.
- Previous vaccination against diphtheria, tetanus, pertussis and/or Hib/History of diphteria, tetanus, pertussis, hepatitis B and/ or hib disease.
Inclusion criteria
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
Other
Actual primary completion date
Not applicable
Actual study completion date
2006-09-11
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
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