Immunogenicity and Safety of GSK Biologicals' Infanrix Hexa in Infants

NCT00753649 | Completed Phase 4 Results

• 2 other identifiers: 1035062013-003428-34
• Study Type: interventional
• Target: 224
• Locations: 1 country
• Sites: 3

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.

Conditions

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

Keywords

Infant; First nation; Aboriginal; Canada

Outcome Measures

Primary Outcomes (1)

• Number of Seroprotected Subjects Against Polyribosyl-ribitol Phosphate (Anti-PRP)

  A seroprotected subject was a subject whose anti-PRP antibody concentration was greater or equal to (≥) 0.15 microgram per milliliter (µg/mL).

  One month after (POST) Dose 3.

Secondary Outcomes (7)

• Number of Subjects With Anti-PRP Antibody Concentrations ≥1µg/mL

  One month after (POST) Dose 3.

• Anti-PRP Antibody Concentrations

  One month after (POST) Dose 3.

• Number of Seroprotected Subjects Against Hepatitis B (Anti-HBs)

  One month after (POST) Dose 3.

• Number of Subjects With Anti-HBs Antibody Concentrations ≥100 mIU/mL

  One month after (POST) Dose 3.

• Anti-HBs Antibody Concentrations

  One month after (POST) Dose 3.

Study Arms (2)

Aboriginal infants group

EXPERIMENTAL

Biological: Infanrix™ hexa

Other Non-Aboriginal infants

ACTIVE COMPARATOR

Biological: Infanrix™ hexa

Interventions

Infanrix™ hexa BIOLOGICAL

Intramuscular, three doses

Also known as: DTPa-HBV-IPV/Hib

Aboriginal infants group; Other Non-Aboriginal infants

Eligibility Criteria

• Age: 6 Weeks - 12 Weeks
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• GlaxoSmithKline: lead

Study Sites (3)

GSK Investigational Site

Edmonton, Alberta, T5M 3Z7, Canada

Location

GSK Investigational Site

Vancouver, British Columbia, V5Z 4H4, Canada

Location

GSK Investigational Site

Truro, Nova Scotia, B2N 1L2, Canada

Location

Related Publications (1)

• 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.

  PMID: 25701314 BACKGROUND

MeSH Terms

Conditions

Hepatitis B; Tetanus; Poliomyelitis; Diphtheria; Haemophilus Infections

Condition Hierarchy (Ancestors)

Blood-Borne Infections; Communicable Diseases; Infections; Hepadnaviridae Infections; DNA Virus Infections; Virus Diseases; Hepatitis, Viral, Human; Hepatitis; Liver Diseases; Digestive System Diseases; Clostridium Infections; Gram-Positive Bacterial Infections; Bacterial Infections; Bacterial Infections and Mycoses; Myelitis; Central Nervous System Infections; Enterovirus Infections; Picornaviridae Infections; RNA Virus Infections; Central Nervous System Diseases; Nervous System Diseases; Spinal Cord Diseases; Neuroinflammatory Diseases; Neuromuscular Diseases; Corynebacterium Infections; Actinomycetales Infections; Pasteurellaceae Infections; Gram-Negative Bacterial Infections

Limitations and Caveats

None reported.

Results Point of Contact

• Title: GSK Response Center
• Organization: GlaxoSmithKline

866-435-7343

Study Officials

• GSK Clinical Trials

  GlaxoSmithKline

  STUDY DIRECTOR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: OTHER
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 12, 2008
• First Posted: September 16, 2008
• Study Start: September 23, 2008
• Primary Completion: March 12, 2013
• Study Completion: March 12, 2013
• Last Updated: November 27, 2019
• Results First Posted: November 30, 2016

Record last verified: 2019-11

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ICF, CSR
• Time Frame: IPD is available via the Clinical Study Data Request site (click on the link provided below)
• Access Criteria: Access is provided after a research proposal is submitted and has received approval from the Independent Review Panel and after a Data Sharing Agreement is in place. Access is provided for an initial period of 12 months but an extension can be granted, when justified, for up to another 12 months.

Locations

CA (3)