Last updated: 11/04/2018 01:14:15
Safety of DTPa-IPV/Hib & DTPa-HBV-IPV/Hib, followed by DTPa-IPV/Hib vaccine in infants who received hepatitis B vaccine
EudraCT ID
EU CT Number
Not applicable
Trial status
Completed
Completed
Trial overview
Official title: Assess safety & reactogenicity of DTPa-IPV/Hib vaccine admnd at 3 & 4 mths & DTPa-HBV-IPV/Hib vaccine admnd at 5 mths, followed by DTPa-IPV/Hib vaccine at 18 mths in infants who received hepatitisB vaccine at birth & at one month of age
Trial description: To assess the safety and reactogenicity of the DTPa-HBV-IPV/Hib vaccine and DTPa-IPV/Hib vaccine. This DTPa-IPV/Hib vaccine given at 3 and 4 months of age is co-administered with GSK Biologicals' rotavirus vaccine or Placebo. The Protocol Posting has been updated in order to comply with the FDA Amendment Act, Sep 2007.
Primary purpose:
Prevention
Trial design:
Single Group Assignment
Masking:
None (Open Label)
Allocation:
Non-randomized
Primary outcomes:
Number of subjects reporting any solicited local symptoms
Timeframe: During the 4-day (Days 0-3) post-vaccination period following each dose and across doses
Number of subjects reporting any solicited general symptoms
Timeframe: During the 4-day (Days 0-3) post-vaccination period following each dose and across doses
Secondary outcomes:
Number of subjects reporting any unsolicited adverse events (AEs)
Timeframe: During the 31-day (Days 0-30) post-vaccination period
Number of subjects reporting any large swelling reactions
Timeframe: At Month 15, post-booster dose
Number of subjects reporting any serious adverse events (SAEs)
Timeframe: During the entire study period (from Month 0 up to Month 21)
Interventions:
Biological/vaccine: DTPa-HBV-IPV/Hib
Biological/vaccine: DTPa-IPV/Hib vaccine
Enrollment:
702
Observational study model:
Not applicable
Primary completion date:
2007-01-02
Time perspective:
Not applicable
Clinical publications:
Lim FS et al. (2011) Safety and reactogenicity of DTPa-HBV-IPV/Hib and DTPa-IPV/Hib vaccines in post-marketing surveillance setting. Southeast Asian J Trop Med Public Health. 42(1):138-47.
Medical condition
Haemophilus influenzae type b, Diphtheria, Tetanus, Poliomyelitis, acellular pertussis
Product
SB217744
Collaborators
Not applicable
Study date(s)
December 2003 to February 2007
Type
Interventional
Phase
3
Participation criteria
Sex
Female & Male
Age
11 - 17 weeks
Accepts healthy volunteers
Yes
- Inclusion criteria
- Subjects must have been enrolled in the Rota-028 study.
Inclusion and exclusion criteria
Inclusion criteria:
- Inclusion criteria
- Subjects must have been enrolled in the Rota-028 study.
- Subjects for whom the investigator believes that their parents/guardians can and will comply with the requirements of the protocol should be enrolled in the study.
- A male or female between, and including, 11 and 17 weeks of age at the time of the first vaccination.
- Written informed consent obtained from the parent or guardian of the subject.
- Free of obvious health problems as established by medical history and clinical examination before entering into the study.
- Subjects should have received two doses of hepatitis B vaccine: at birth and at approximately one month of age. Exclusion criteria
- Chronic administration (defined as more than 14 days) of immunosuppressants or other immune-modifying drugs 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 the vaccine and ending 30 days after.
- Any confirmed or suspected immunosuppressive or immunodeficient condition, including human immunodeficiency virus (HIV) infection.
- A family history of congenital or hereditary immunodeficiency.
- History of allergic disease or reactions likely to be exacerbated by any component of the vaccine.
- Major congenital defects or serious chronic illness.
- History of any neurologic disorders or seizures.
- Acute disease at the time of enrolment.
- Administration of immunoglobulins and/or any blood products since birth or planned administration during the study period.
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
Results posted on ClinicalTrials.gov
Recruitment status
Completed
Actual primary completion date
2007-01-02
Actual study completion date
2007-01-02
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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