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Immunogenicity and Safety of GSK Biologicals' Infanrix Hexa in Infants

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00753649
Recruitment Status : Completed
First Posted : September 16, 2008
Results First Posted : November 30, 2016
Last Update Posted : November 27, 2019
Information provided by (Responsible Party):

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.

Condition or disease Intervention/treatment Phase
Hepatitis B Tetanus Poliomyelitis Diphtheria Haemophilus Influenzae Type b Acellular Pertussis Biological: Infanrix™ hexa Phase 4

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

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 224 participants
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Prevention
Official Title: Immunogenicity and Safety Study of GlaxoSmithKline Biologicals' Infanrix Hexa Vaccine in Healthy Infants
Actual Study Start Date : September 23, 2008
Actual Primary Completion Date : March 12, 2013
Actual Study Completion Date : March 12, 2013

Arm Intervention/treatment
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

Primary Outcome Measures :
  1. Number of Seroprotected Subjects Against Polyribosyl-ribitol Phosphate (Anti-PRP) [ Time Frame: One month after (POST) Dose 3. ]
    A seroprotected subject was a subject whose anti-PRP antibody concentration was greater or equal to (≥) 0.15 microgram per milliliter (µg/mL).

Secondary Outcome Measures :
  1. Number of Subjects With Anti-PRP Antibody Concentrations ≥1µg/mL [ Time Frame: One month after (POST) Dose 3. ]
    For this assay, 1 μg/mL was considered as the seropositivity cut-off.

  2. Anti-PRP Antibody Concentrations [ Time Frame: One month after (POST) Dose 3. ]
    Anti-PRP antibody concentrations were presented as Geometric mean Concentrations (GMC), expressed as micrograms per milliliter (μg/mL).

  3. Number of Seroprotected Subjects Against Hepatitis B (Anti-HBs) [ Time Frame: One month after (POST) Dose 3. ]
    A seroprotected subject was a subject with anti-HBs antibody concentrations ≥ 10 milli-International Units ler milliliter (mIU/mL). A decrease in the specificity of the anti-HB ELISA assay had been observed in some studies for low levels of antibody (10-100 mIU/mL). The table shows updated results following partial or complete retesting/reanalysis. Some of the available blood samples initially tested with ELISA were re-tested using the new assay, CLIA.

  4. Number of Subjects With Anti-HBs Antibody Concentrations ≥100 mIU/mL [ Time Frame: One month after (POST) Dose 3. ]
    The testing was done using the Enzyme-Linked Immunosorbent assay (ELISA) assay.

  5. Anti-HBs Antibody Concentrations [ Time Frame: One month after (POST) Dose 3. ]
    Anti-HBs antibody concentrations were assessed by Enzyme-Linked Immunosorbent assay (ELISA) and expressed as geometric mean concentrations (GMCs).

  6. Number of Subjects With Unsolicited Adverse Events (AEs) [ Time Frame: During the 31 day (Days 0-30) post vaccination ]
    An unsolicited AE covers any untoward medical occurrence in a clinical investigation subject temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product and reported in addition to those solicited during the clinical study and any solicited symptom with onset outside the specified period of follow-up for solicited symptoms.

  7. Number of Subjects With Serious Adverse Events (SAEs) [ Time Frame: During the entire study period up to Last subject last visit on 03/12/2013 ]
    Serious adverse events (SAEs) assessed include medical occurrences that result in death, are life threatening, require hospitalization or prolongation of hospitalization or result in disability/incapacity.

Information from the National Library of Medicine

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, Learn About Clinical Studies.

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Ages Eligible for Study:   6 Weeks to 12 Weeks   (Child)
Sexes Eligible for Study:   All
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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT00753649

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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
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Study Director: GSK Clinical Trials GlaxoSmithKline
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Responsible Party: GlaxoSmithKline Identifier: NCT00753649    
Other Study ID Numbers: 103506
2013-003428-34 ( EudraCT Number )
First Posted: September 16, 2008    Key Record Dates
Results First Posted: November 30, 2016
Last Update Posted: November 27, 2019
Last Verified: November 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Yes
Plan Description: IPD is available via the Clinical Study Data Request site (click on the link provided below)
Supporting Materials: Study Protocol
Statistical Analysis Plan (SAP)
Informed Consent Form (ICF)
Clinical Study Report (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.
Keywords provided by GlaxoSmithKline:
First nation
Additional relevant MeSH terms:
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Hepatitis B
Liver Diseases
Digestive System Diseases
Hepadnaviridae Infections
DNA Virus Infections
Virus Diseases
Hepatitis, Viral, Human
Bacterial Infections
Gram-Positive Bacterial Infections
Corynebacterium Infections
Actinomycetales Infections
Enterovirus Infections
Picornaviridae Infections
RNA Virus Infections
Central Nervous System Infections
Central Nervous System Diseases
Nervous System Diseases
Spinal Cord Diseases
Neuromuscular Diseases