Last updated: 11/02/2018 23:06:23

Assess if immune response of GSK Biologicals' Tritanrix™-HepB/Hib-MenAC given without or with hepatitis B vaccine at birth is at least as good as Tritanrix™-HepB/Hiberix™ without hepatitis B vaccine at birth, when given to healthy infants

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GSK study ID
100478
See study documents
Clinicaltrials.gov ID
NCT00290303
EudraCT ID
Not applicable
EU CT Number
Not applicable
Trial status
Completed
Completed
Overview
Eligibility
Locations
Study documents
Results summary
Plain language summaries
Additional information

Trial overview

Official title: Study to show non-inferiority of Tritanrix™-HepB/Hib-MenAC (+/- hepatitis B vaccine at birth) versus Tritanrix™-HepB/Hiberix™ without hepatitis B vacc. at birth for antibody response to all vaccine antigens given in healthy infants
Trial description: The purpose of this study is to compare the immune response, safety and reactogenicity of Tritanrix™-HepB/Hib-MenAC vaccine given either with or without a birth dose of hepatitis B vaccine to Tritanrix™-HepB/Hiberix™ when given to healthy infants (born to mothers who do not carry hepatitis B virus) at 6, 10 & 14 weeks of age. This study will also include a small group of infants born to mothers who do carry hepatitis B virus; these infants will receive a birth dose of hepatitis B vaccine and will be vaccinated with Tritanrix™ HepB/Hib-MenAC at 6, 10 & 14 weeks age.
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:
996
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, Whole Cell Pertussis, Hepatitis B, Tetanus
Product
SB759346
Collaborators
Not applicable
Study date(s)
May 2004 to March 2005
Type
Interventional
Phase
3

Participation criteria

Sex
Female & Male
Age
3+ years
Accepts healthy volunteers
Yes
  • Healthy infants aged 3 days or less, written informed consent obtained from the parents, born after a gestation period of 36 to 42 weeks.
  • Result of the maternal blood sample (presence/not of hepatitis B virus) is available.
  • Any confirmed or suspected immunosuppressive or immunodeficient condition, based on medical history and physical examination.
  • A family history of congenital or hereditary immunodeficiency.
Inclusion and exclusion criteria
Inclusion criteria:
  • Healthy infants aged 3 days or less, written informed consent obtained from the parents, born after a gestation period of 36 to 42 weeks.
  • Result of the maternal blood sample (presence/not of hepatitis B virus) is available.
Exclusion criteria:
  • Any confirmed or suspected immunosuppressive or immunodeficient condition, based on medical history and physical examination.
  • A family history of congenital or hereditary immunodeficiency.
  • Major congenital defects or serious chronic illness.
  • History of any neurologic disorders or seizures.
  • Administration of immunoglobulins and/or any blood products since birth or planned administration during the study period (except for immunoglobulins given at birth to infants born to HBsAg seropositive mothers).
  • Acute disease at the time of enrolment.
  • Known exposure to diphtheria, tetanus, pertussis, hepatitis B, Haemophilus influenzae type b and/or meningococcal disease.
  • Hepatitis B vaccine given at birth outside the study.

Trial location(s)

Location
Status
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Location
GSK Investigational Site
Sampaloc, Manila, Philippines, 1008
Status
Study Complete
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Location
GSK Investigational Site
Manila, Philippines, 1000
Status
Study Complete
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Location
GSK Investigational Site
Quezon CIty, Philippines, 1109
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
Completed
Actual primary completion date
Not applicable
Actual study completion date
2005-28-03

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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