Immunogenicity and Safety of GSK Biologicals' Infanrix Hexa in Infants

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

Official Title
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Immunogenicity and Safety Study of GlaxoSmithKline Biologicals' Infanrix Hexa Vaccine in Healthy Infants

Conditions
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Hepatitis B, Tetanus, Poliomyelitis, Diphtheria, Haemophilus Influenzae Type b, Acellular Pertussis

Intervention / Treatment
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* Biological: Infanrix™ hexa


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 6 Weeks
Maximum Age: 12 Weeks

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Prevention
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Aboriginal infants group<br> | Biological: Infanrix™ hexa<br>* Intramuscular, three doses<br>* Other names: DTPa-HBV-IPV/Hib;|
| Active Comparator: Other Non-Aboriginal infants<br> | Biological: Infanrix™ hexa<br>* Intramuscular, three doses<br>* Other names: DTPa-HBV-IPV/Hib;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Number of Subjects With Anti-PRP Antibody Concentrations ≥1µg/mL | For this assay, 1 μg/mL was considered as the seropositivity cut-off. | One month after (POST) Dose 3. | 
| Anti-PRP Antibody Concentrations | Anti-PRP antibody concentrations were presented as Geometric mean Concentrations (GMC), expressed as micrograms per milliliter (μg/mL). | One month after (POST) Dose 3. | 
| Number of Seroprotected Subjects Against Hepatitis B (Anti-HBs) | 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. | One month after (POST) Dose 3. | 
| Number of Subjects With Anti-HBs Antibody Concentrations ≥100 mIU/mL | The testing was done using the Enzyme-Linked Immunosorbent assay (ELISA) assay. | One month after (POST) Dose 3. | 
| Anti-HBs Antibody Concentrations | Anti-HBs antibody concentrations were assessed by Enzyme-Linked Immunosorbent assay (ELISA) and expressed as geometric mean concentrations (GMCs). | One month after (POST) Dose 3. | 
| Number of Subjects With Unsolicited Adverse Events (AEs) | 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. | During the 31 day (Days 0-30) post vaccination | 
| Number of Subjects With Serious Adverse Events (SAEs) | 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. | During the entire study period up to Last subject last visit on 03/12/2013 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Infant, First nation, Aboriginal, Canada