Last updated: 11/03/2018 09:10:49
Immunogenicity and safety of a DTPa-HBV-IPV/Hib vaccine given at 2, 3 and 4 months of age
Clinicaltrials.gov ID
EudraCT ID
EU CT Number
Not applicable
Trial status
Completed
Completed
Trial overview
Official title: A phase II, observer-blind, randomized study to evaluate the immunogenicity, safety and reactogenicity of GlaxoSmithKline (GSK) Biologicals’ combined DssiTgdPa-HBV-IPV/Hib vaccine containing diphtheria toxoid from the Statens Serum Institute (SSI) of Denmark and tetanus toxoid from GSK Biologicals’ Kft [GD], compared to the currently licensed GSK Biologicals’ DTPa-HBV-IPV/Hib vaccine (Infanrix hexa TM) when administered to healthy infants at 2, 3 and 4 months of age.
Trial description: The purpose of this study is to show that the immunogenicity of newly formulated DTPa-HBV-IPV/Hib vaccine is as good as the immunogenicity of the currently licensed formulation of the vaccine. The vaccine will be administered as a primary vaccination course to healthy infants at 2, 3 and 4 months of age and its safety and reactogenicity will also be assessed.
Primary purpose:
Prevention
Trial design:
Parallel Assignment
Masking:
Not applicable
Allocation:
Randomized
Primary outcomes:
Not applicable
Secondary outcomes:
Not applicable
Interventions:
Biological/vaccine: Infanrix hexa Vaccine
Enrollment:
450
Observational study model:
Not applicable
Primary completion date:
2007-31-05
Time perspective:
Not applicable
Clinical publications:
Not applicable
Medical condition
acellular pertussis, Tetanus, Diphtheria, Hepatitis B, Poliomyelitis, Haemophilus influenzae type b
Product
SB217744
Collaborators
Not applicable
Study date(s)
October 2006 to May 2007
Type
Interventional
Phase
2
Participation criteria
Sex
Female & Male
Age
8 - 12 weeks
Accepts healthy volunteers
Yes
- A healthy male or female between, and including, 8 and 12 weeks of age at the time of the first vaccination.
- Written informed consent obtained from the parents/guardians of the subject.
- 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 (defined as more than 14 days) of immunosuppressants or other immune-modifying drugs from birth until first primary vaccination dose.
Inclusion and exclusion criteria
Inclusion criteria:
- A healthy male or female between, and including, 8 and 12 weeks of age at the time of the first vaccination.
- Written informed consent obtained from the parents/guardians of the subject.
- Born after a normal gestation period of 36 to 42 weeks.
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 (defined as more than 14 days) of immunosuppressants or other immune-modifying drugs from birth until first primary vaccination dose.
- Administration of immunoglobulins and/or any blood products since birth or planned administration during the study period.
- Administration/planned administration of a vaccine not foreseen by the study protocol during the period starting 30 days before the administration of the first dose and ending 30 days after the last dose, with the exception of the human rotavirus (HRV) vaccine.
- Concurrently participating in another clinical study, at any time during the study period, in which the subject has been or will be exposed to an investigational or a non-investigational product (pharmaceutical product or device).
- Evidence of previous or intercurrent diphtheria, tetanus, pertussis, polio, hepatitis B and/or Haemophilus influenza type b (Hib) vaccination or disease.
- Hepatitis B virus (HBV) vaccination at birth.
- History of seizures or progressive neurological disease.
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
Completed
Actual primary completion date
2007-31-05
Actual study completion date
2007-31-05
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.
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