Last updated: 11/03/2018 00:26:43

Immunogenicity & safety of GSK’s combined DTPa-HBV-IPV/Hib vaccine in Indian infants at 2 diff vaccination schedules

Request patient level data
GSK study ID
104005
See study documents
Clinicaltrials.gov ID
NCT00316147
EudraCT ID
2012-002426-70
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: Phase IIIb, open, randomized, multicenter study to assess the immunogenicity & safety of GSK Biologicals’ combined DTPa-HBV-IPV/Hib vaccine in Indian infants when given at 6-10-14 weeks of age or at 2-4-6 months of age
Trial description: In this study, infants who were previously vaccinated with hepatitis B vaccine at birth will be randomly allocated into two groups:
- one group of subjects will receive diphtheria, tetanus, acellular pertussis- hepatitis B virus-inactivated poliovirus/Haemophilus influenzae type b (DTPa-HBV-IPV/Hib) vaccine at 6-10-14 weeks of age
- the second group of subjects will receive DTPa-HBV-IPV/Hib vaccine at 2-4-6 months of 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: DTPa-HBV-IPV/Hib vaccine
Enrollment:
224
Observational study model:
Not applicable
Primary completion date:
Not applicable
Time perspective:
Not applicable
Clinical publications:
Not applicable
Medical condition
Diphtheria, acellular pertussis, Tetanus, Haemophilus influenzae type b, Hepatitis B, Poliomyelitis
Product
SB217744
Collaborators
Not applicable
Study date(s)
December 2005 to August 2006
Type
Interventional
Phase
3

Participation criteria

Sex
Female & Male
Age
6 - 10 weeks
Accepts healthy volunteers
Yes
  • A healthy male or female infant between, and including, 6 to 10 weeks of age at the time of the first vaccination.
  • Written informed consent obtained from the parent or guardian of the subject.
  • Use of any investigational or non-registered product (vaccine or drug) other than the study vaccine within 30 days preceding the first dose of study vaccine, or planned use during the study period.
  • Chronic administration (defined as more than 14 days) of immunosuppressants or other immune-modifying drugs prior to the first vaccine dose.
Inclusion and exclusion criteria
Inclusion criteria:

    A healthy male or female infant between, and including, 6 to 10 weeks of age at the time of the first vaccination.

    • Written informed consent obtained from the parent or guardian of the subject.
    • Born after a normal gestation period (between 36 and 42 weeks).
    • Should have received a birth dose of hepatitis B vaccine, as evidenced by vaccination/immunisation certificate.
Exclusion criteria:

    Use of any investigational or non-registered product (vaccine or drug) other than the study vaccine within 30 days preceding the first dose of study vaccine, or planned use during the study period.

    • Chronic administration (defined as more than 14 days) of immunosuppressants or other immune-modifying drugs 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 30 days before the administration of the first vaccine dose and ending 30 days after the last dose (with the exception of oral polio vaccine as a birth dose or for a pulse polio program, as per local, regional, or national requirements).
    • Previous vaccination against diphtheria, tetanus, pertussis, poliomyelitis and Haemophilus influenzae type b diseases.
    • Known exposure to diphtheria, tetanus, Bordetella pertussis, hepatitis B, poliomyelitis and Haemophilus influenzae type b diseases since birth.

Trial location(s)

Location
Status
Contact us
Contact us
Location
GSK Investigational Site
Bangalore, India, 560034
3.9 miles (6.2 km) away from your location
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
2006-14-08

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