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.

Request patient level data
GSK study ID
104489
See study documents
Clinicaltrials.gov ID
NCT00316680
EudraCT ID
2011-003880-31
EU CT Number
Not applicable
Trial status
Terminated (halted prematurely)
Terminated (halted prematurely)
Overview
Eligibility
Locations
Study documents
Results summary
Plain language summaries
Additional information

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:
Biological/vaccine: Diphtheria, tetanus, pertussis, hepatitis B, Hib vaccine
Enrollment:
288
Observational study model:
Not applicable
Primary completion date:
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:

    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.

Trial location(s)

Location
Status
Contact us
Contact us
Location
GSK Investigational Site
Santo Domingo, Dominican Republic
Status
Study Complete
Contact us

Study documents

Clinical study report
Available language(s): English
Download document(s)
Scientific result summary
Available language(s): English
Download document(s)

If you wish to request for full study report, please contact - [email protected]

Results overview

Refer to study documents

Recruitment status
Terminated (halted prematurely)
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

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 here
Access to clinical trial data by researchers
Visit website