Immunogenicity and Safety of GSK Biologicals' Infanrix Hexa in Infants

NCT ID: NCT00753649

Last Updated: 2019-11-27

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE4
• Total Enrollment: 224 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2008-09-23
• Study Completion Date: 2013-03-12

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 population of infants residing in Canada.

Detailed Description

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

Conditions

Hepatitis B; Tetanus; Poliomyelitis; Diphtheria; Haemophilus Influenzae Type b; Acellular Pertussis

Study Design

• Allocation Method: NON_RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: PREVENTION
• Blinding Strategy: NONE

Study Groups

Aboriginal infants group

Group Type: EXPERIMENTAL

Infanrix™ hexa

Intervention Type: BIOLOGICAL

Intramuscular, three doses

Other Non-Aboriginal infants

Group Type: ACTIVE_COMPARATOR

Infanrix™ hexa

Intervention Type: BIOLOGICAL

Intramuscular, three doses

Interventions

Infanrix™ hexa

Intramuscular, three doses

Intervention Type: BIOLOGICAL

Other Intervention Names

DTPa-HBV-IPV/Hib

Eligibility 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.
• Current febrile illness or axillary temperature of ≥ 37.5 ºC or other moderate to severe illness within 24 hours of study vaccine administration.

• Minimum Eligible Age: 6 Weeks
• Maximum Eligible Age: 12 Weeks
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

GlaxoSmithKline

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

GSK Clinical Trials

Role: STUDY_DIRECTOR

GlaxoSmithKline

Locations

GSK Investigational Site

Edmonton, Alberta, Canada

GSK Investigational Site

Vancouver, British Columbia, Canada

GSK Investigational Site

Truro, Nova Scotia, Canada

Countries

Canada

References

Scheifele DW, Ferguson M, Predy G, Dawar M, Assudani D, Kuriyakose S, Van Der Meeren O, Han HH. Immunogenicity and safety of 3-dose primary vaccination with combined DTPa-HBV-IPV/Hib vaccine in Canadian Aboriginal and non-Aboriginal infants. Vaccine. 2015 Apr 15;33(16):1897-900. doi: 10.1016/j.vaccine.2015.02.015. Epub 2015 Feb 18.

Reference Type: BACKGROUND

PMID: 25701314 (View on PubMed)

Other Identifiers

2013-003428-34

Identifier Type: EUDRACT_NUMBER

Identifier Source: secondary_id

103506

Identifier Type: -

Identifier Source: org_study_id