Last updated: 11/03/2018 08:36:08

Compare immunogenicity & safety of 2 formulations of GSK Biologicals’ DTPa-HBV-IPV/Hib vaccine given in healthy infants

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GSK study ID
105910
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Clinicaltrials.gov ID
NCT00320463
EudraCT ID
2012-002427-15
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: Compare immunogenicity & reactogenicity of 2 formulations of GSK Biologicals’ DTPa-HBV-IPV/Hib vaccine (new vs current) given in healthy infants. The DTPa-HBV-IPV vaccine (new formulation) will also be assessed in a 3rd group of subjects
Trial description: In this study, infants will be randomly allocated into three groups:
- one group of subjects will receive DTPa-HBV-IPV/Hib vaccine (new formulation)
- the second group of subjects will receive DTPa-HBV-IPV/Hib vaccine (current formulation)
- the third group of subjects will receive DTPa-HBV-IPV vaccine
The study will be double-blind for the two groups receiving the DTPa-HBV-IPV/Hib vaccine (new or current formulation). The study will be single-blind for the group receiving DTPa-HBV-IPV vaccine.
Primary purpose:
Prevention
Trial design:
Parallel Assignment
Masking:
Not applicable
Allocation:
Randomized
Primary outcomes:
Not applicable
Secondary outcomes:
Not applicable
Interventions:
Biological/vaccine: DTPa-HBV-IPV/Hib vaccine
Enrollment:
415
Observational study model:
Not applicable
Primary completion date:
Not applicable
Time perspective:
Not applicable
Clinical publications:
Not applicable
Medical condition
Diphtheria, Hepatitis B, Poliomyelitis, Tetanus, acellular pertussis
Product
SB217744
Collaborators
Not applicable
Study date(s)
April 2006 to January 2007
Type
Interventional
Phase
3

Participation criteria

Sex
Female & Male
Age
11 - 17 weeks
Accepts healthy volunteers
Yes
  • A healthy male or female infant between, and including, 11 and 17 weeks of age at the time of the first vaccination.
  • Infant born to known hepatitis B surface antigen (HBsAg) seronegative mother (documented laboratory result of HBsAg assay from the maternal blood sample is available).
  • 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 within six months prior to the first vaccine dose.
Inclusion and exclusion criteria
Inclusion criteria:

    A healthy male or female infant between, and including, 11 and 17 weeks of age at the time of the first vaccination.

    • Infant born to known hepatitis B surface antigen (HBsAg) seronegative mother (documented laboratory result of HBsAg assay from the maternal blood sample is available).
    • Born after a normal gestation period (between 36 and 42 weeks).
    • Written informed consent obtained from the parent or guardian of the subject.
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 within six months prior to the first vaccine dose.
    • Any chronic drug therapy to be continued during the study period.
    • Planned administration/ administration of a vaccine not foreseen by the study protocol during the period starting from 30 days before each dose of study vaccine and ending 30 days after the last vaccine dose.
    • Previous vaccination against diphtheria, tetanus, pertussis, poliomyelitis, hepatitis B and/or Haemophilus influenzae diseases.
    • Known history of or exposure to diphtheria, tetanus, pertussis, poliomyelitis, hepatitis B and/or Haemophilus influenzae diseases since birth.
    • History of allergic disease or reactions likely to be exacerbated by any component of the vaccines. "

Trial location(s)

Location
Status
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Location
GSK Investigational Site
Syktyvkar, Russia, 167011
Status
Study Complete
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Location
GSK Investigational Site
Perm, Russia, 614022
Status
Study Complete
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Location
GSK Investigational Site
Murmansk, Russia, 183046
Status
Study Complete
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Location
GSK Investigational Site
Syktyvkar, Russia, 167002
Status
Terminated/Withdrawn
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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
2007-25-01

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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