Status:
COMPLETED
Immunogenicity and Safety of GSK Biologicals' Infanrix Hexa in Infants
Lead Sponsor:
GlaxoSmithKline
Conditions:
Hepatitis B
Tetanus
Eligibility:
All Genders
6-12 years
Phase:
PHASE4
Brief Summary
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 popu...
Detailed Description
This protocol posting has been updated following Protocol amendment 1 (19-MAY-2010).
Eligibility Criteria
Inclusion
- 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
- 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.
Key Trial Info
Start Date :
September 23 2008
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
March 12 2013
Estimated Enrollment :
224 Patients enrolled
Trial Details
Trial ID
NCT00753649
Start Date
September 23 2008
End Date
March 12 2013
Last Update
November 27 2019
Active Locations (3)
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1
GSK Investigational Site
Edmonton, Alberta, Canada, T5M 3Z7
2
GSK Investigational Site
Vancouver, British Columbia, Canada, V5Z 4H4
3
GSK Investigational Site
Truro, Nova Scotia, Canada, B2N 1L2