Last updated: 07/17/2024 15:08:00
Immunogenicity and safety of GSK Biologicals' Infanrix hexa in infantsN/A
EudraCT ID
EU CT Number
Not applicable
Trial status
Completed
Completed
Trial overview
Official title: Immunogenicity and safety study of GlaxoSmithKline Biologicals’ Infanrix hexa vaccine in healthy infants
Trial description: This study will evaluate GSK Biologicals’ DTPa-HBV-IPV/Hib vaccine given as a three-dose primary vaccination course at 2, 4 and 6 months of age, in terms of safety and immunogenicity in different population of infants residing in Canada.
Primary purpose:
Prevention
Trial design:
Parallel Assignment
Masking:
None (Open Label)
Allocation:
Non-randomized
Primary outcomes:
Number of seroprotected subjects against Polyribosyl-ribitol phosphate (anti-PRP)
Timeframe: One month after (POST) Dose 3.
Secondary outcomes:
Number of subjects with anti-PRP antibody concentrations ≥1µg/mL
Timeframe: One month after (POST) Dose 3.
Anti-PRP antibody concentrations
Timeframe: One month after (POST) Dose 3.
Number of seroprotected subjects against Hepatitis B (anti-HBs)
Timeframe: One month after (POST) Dose 3.
Number of subjects with Anti-HBs antibody concentrations ≥100 mIU/mL
Timeframe: One month after (POST) Dose 3.
Anti-HBs antibody concentrations
Timeframe: One month after (POST) Dose 3.
Number of subjects with unsolicited adverse events (AEs)
Timeframe: During the 31 day (Days 0-30) post vaccination
Number of subjects with serious adverse events (SAEs)
Timeframe: During the entire study period up to Last subject last visit on 03/12/2013
Interventions:
Biological/vaccine: Infanrix™ hexa
Enrollment:
224
Observational study model:
Not applicable
Primary completion date:
2013-12-03
Time perspective:
Not applicable
Clinical publications:
Scheifele D et al (2015) Immunogenicity and Safety of 3-Dose Primary Vaccination with Combined DTPa-HBV-IPV/Hib Vaccine in Canadian Aboriginal and Non-Aboriginal Infants. Vaccine. 33(16):1897-1900.
Medical condition
Hepatitis B, Tetanus, Poliomyelitis, Diphtheria, Haemophilus influenzae type b, acellular pertussis
Product
SB217744
Collaborators
Not applicable
Study date(s)
September 2008 to March 2013
Type
Interventional
Phase
4
Participation criteria
Sex
Female & Male
Age
6 - 12 weeks
Accepts healthy volunteers
Yes
- Subjects who the investigator believes that their parent/guardian can and will comply with the requirements of the protocol should be enrolled in the study.
- A male or female between, and including, 6 and 12 weeks of age at the time of the first vaccination.
- Use of any investigational or non-registered product 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 from birth until first primary vaccination dose..
Inclusion and exclusion criteria
Inclusion criteria:
- Subjects who the investigator believes that their parent/guardian can and will comply with the requirements of the protocol should be enrolled in the study.
- A male or female between, and including, 6 and 12 weeks of age at the time of the first vaccination.
- Born after a gestation period of 36 to 42 weeks inclusive.
- Healthy subjects as established by medical history before entering into the study.
- Written informed consent obtained from the parent or guardian of the subject.
Exclusion criteria:
- Use of any investigational or non-registered product 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 from birth until first primary vaccination dose..
- Administration of immunoglobulins and/or any blood products since birth or planned administration during the study period.
- 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.
- Major congenital defects or serious chronic illness.
- Evidence of previous or intercurrent diphtheria, tetanus, pertussis, poliomyelitis, hepatitis B and/or Hib vaccination or disease.
- Any confirmed or suspected immunosuppressive or immunodeficient condition, based on medical history.
- History of allergic disease or reactions likely to be exacerbated by any component of the vaccines.
- The following condition is temporary or self limiting and a subject may be vaccinated once the condition has resolved and no other exclusion criteria are met:
- Current febrile illness or axillary temperature of ≥ 37.5 ºC or other moderate to severe illness within 24 hours of study vaccine administration.
Trial location(s)
Location
GSK Investigational Site
Vancouver, British Columbia, Canada, V5Z 4H4
Status
Study Complete
Study documents
Scientific result summary
Available language(s): English
Clinical study report
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
2013-12-03
Actual study completion date
2013-12-03
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
Additional information
Not applicable
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