Immunogenicity and Safety of GSK Biologicals' Infanrix Hexa in Infants

This study has been completed.
Information provided by (Responsible Party):
GlaxoSmithKline Identifier:
First received: September 12, 2008
Last updated: February 20, 2014
Last verified: December 2013
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.

Condition Intervention Phase
Hepatitis B
Haemophilus Influenzae Type b
Acellular Pertussis
Biological: Infanrix™ hexa
Phase 4

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Prevention
Official Title: Immunogenicity and Safety Study of GlaxoSmithKline Biologicals' Infanrix Hexa Vaccine in Healthy Infants

Resource links provided by NLM:

Further study details as provided by GlaxoSmithKline:

Primary Outcome Measures:
  • Anti-polyribosyl-ribitol-phosphate (PRP) antibody concentrations [ Time Frame: One month after the third dose of primary vaccination course ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Anti-PRP antibody concentration more than or equal to the specified value. [ Time Frame: One month after the third dose of primary vaccination course ] [ Designated as safety issue: No ]
  • Anti-hepatitis B surface antigen (HBs) antibody concentration. [ Time Frame: One month after the third dose of primary vaccination course ] [ Designated as safety issue: No ]
  • Anti-PRP and anti-HBs antibody concentrations more than or equal to the specified value [ Time Frame: One month after the third dose of primary vaccination course ] [ Designated as safety issue: No ]
  • Occurrence of medically attended adverse events and serious adverse events. [ Time Frame: at Month 2, Month 4 and Month 5 ] [ Designated as safety issue: No ]

Enrollment: 224
Study Start Date: September 2008
Study Completion Date: March 2013
Primary Completion Date: March 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Aboriginal infants group Biological: Infanrix™ hexa
Intramuscular, three doses
Other Name: DTPa-HBV-IPV/Hib
Active Comparator: Other Non-Aboriginal infants Biological: Infanrix™ hexa
Intramuscular, three doses
Other Name: DTPa-HBV-IPV/Hib

Detailed Description:
This protocol posting has been updated following Protocol amendment 1 (19-MAY-2010).

Ages Eligible for Study:   6 Weeks to 12 Weeks
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes

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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its identifier: NCT00753649

Canada, Alberta
GSK Investigational Site
Edmonton, Alberta, Canada, T5M 3Z7
Canada, British Columbia
GSK Investigational Site
Vancouver, British Columbia, Canada, V5Z 4H4
Canada, Nova Scotia
GSK Investigational Site
Truro, Nova Scotia, Canada, B2N 1L2
Sponsors and Collaborators
Study Director: GSK Clinical Trials GlaxoSmithKline
  More Information

Publications automatically indexed to this study by Identifier (NCT Number):
Responsible Party: GlaxoSmithKline Identifier: NCT00753649     History of Changes
Other Study ID Numbers: 103506 
Study First Received: September 12, 2008
Last Updated: February 20, 2014
Health Authority: Canada: Health Canada

Keywords provided by GlaxoSmithKline:
First nation

Additional relevant MeSH terms:
Central Nervous System Diseases
Central Nervous System Infections
Enterovirus Infections
Nervous System Diseases
Neuromuscular Diseases
Picornaviridae Infections
RNA Virus Infections
Spinal Cord Diseases
Virus Diseases processed this record on May 30, 2016