Last updated: 11/07/2018 13:15:54
Immunogenicity and reactogenicity of GSK Bio DTPa-HBV-IPV and Hib vaccines when coadministered to healthy infants
Clinicaltrials.gov ID
EudraCT ID
Not applicable
EU CT Number
Not applicable
Trial status
Study complete
Study complete
Trial overview
Official title: Immunogenicity and reactogenicity of GSK Biologicals’ DTPa-HBV-IPV and Hib vaccines when administered concomitantly to healthy infants administered as a three-dose primary vaccination course at the age of 1.5, 3.5 and 6 months
Trial description: The purpose of this study is to evaluate the immune response and reactogenicity of GSK Biologicals’ DTPa-HBV-IPV combined pentavalent vaccine and Hib tetanus conjugate vaccine, administered concomitantly as a three-dose primary vaccination course.
Primary purpose:
Prevention
Trial design:
Single Group Assignment
Masking:
None (Open Label)
Allocation:
Not applicable
Primary outcomes:
Anti-PT, anti-FHA and anti-PRN antibody titers.
Timeframe: One month after the 3rd dose of the primary vaccination course
Anti-diphtheria toxoid and anti-tetanus toxoid antibody titers
Timeframe: One month after the 3rd dose of the primary vaccination course
Anti-HBs antibody titers
Timeframe: One month after the 3rd dose of the primary vaccination course
Anti-polio virus types 1, 2 and 3 antibody titers
Timeframe: One month after the 3rd dose of the primary vaccination course
Anti-PRP antibody titers
Timeframe: One month after the 3rd dose of the primary vaccination course
Secondary outcomes:
Occurrence of solicited adverse events
Timeframe: During the 4-day follow-up period after each dose
Occurrence of unsolicited adverse events
Timeframe: During the 30-day follow-up period after each dose
Occurrence of Serious Adverse Events
Timeframe: Over the course of the study
Interventions:
Enrollment:
60
Primary completion date:
2001-31-05
Observational study model:
Not applicable
Time perspective:
Not applicable
Clinical publications:
Shao PL et al. (2011) Immunogenicity and reactogenicity of Diphtheria-Tetanus-Acellular Pertussis-Hepatitis B-Inactivated Poliovirus and Haemophilus influenzae type B vaccines administered concomitantly to infants as a three-dose primary course. J Formos Med Assoc.110(5):336-341.
Medical condition
Diphtheria, Poliomyelitis, Hepatitis B, Tetanus, acellular pertussis
Product
Combined Diphtheria, Tetanus, Acellular Pertussis Adsorbed, Hepatitis B (Recombinant), Inactivated Polio Vaccine
Collaborators
Not applicable
Study date(s)
September 2000 to May 2001
Type
Interventional
Phase
3
Participation criteria
Sex
Female & Male
Age
6 - 8 weeks
Accepts healthy volunteers
Yes
- A male or female infant between 6 and 8 weeks of age at the time of the first vaccination.
- Free of obvious health problems as established by medical history and clinical examination before entering into the study.
- Use of any investigational or non-registered drug or vaccine other than the study vaccine(s) during the study period or within 30 days preceding the first dose of study vaccine.
- Administration of chronic immunosuppressants or other immune-modifying drugs since birth or planned administration during the study.
Inclusion and exclusion criteria
Inclusion criteria:
- A male or female infant between 6 and 8 weeks of age at the time of the first vaccination.
- Free of obvious health problems as established by medical history and clinical examination before entering into the study.
- Written informed consent obtained from the parents or guardians of the subject.
- Born after a normal gestation period (between 36 and 42 weeks).
Exclusion criteria:
- Use of any investigational or non-registered drug or vaccine other than the study vaccine(s) during the study period or within 30 days preceding the first dose of study vaccine.
- Administration of chronic immunosuppressants or other immune-modifying drugs since birth or planned administration during the study.
- Planned administration/ administration of a vaccine not foreseen by the study protocol during the period starting from 30 days before each dose of vaccine(s) and ending 30 days after.
- Previous vaccination against diphtheria, tetanus, pertussis, polio or Haemophilus influenzae type b.
- History of, or intercurrent, diphtheria, tetanus, pertussis, hepatitis B, polio and/or Haemophilus influenzae type b.
- Any confirmed or suspected immunosuppressive or immunodeficient condition, including human immunodeficiency virus infection.
- Major congenital defects
- Serious chronic illness
- History of allergic disease or reactions likely to be exacerbated by any component of the vaccines.
- Administration of immunoglobulins and/or any blood products since birth or planned administration during the study period.
- Acute disease at the time of enrollment.
Trial location(s)
This study does not involve prospective enrollment of participants.
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
Study complete
Actual primary completion date
2001-31-05
Actual study completion date
2001-31-05
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.
Additional information about the trial
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