Immunogenicity and Safety of GSK Biologicals' Infanrix Hexa in Infants

Phase 4

Completed

• Conditions: Hepatitis B; Diphtheria; Poliomyelitis; Haemophilus Influenzae Type b; Acellular Pertussis; Tetanus
• Interventions: Biological: Infanrix™ hexa

• Registration Number: NCT00753649
• Lead Sponsor: GlaxoSmithKline

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).

Study Timeline

• Study First Submitted: 2008-09-12
• Study First Submitted QC: 2008-09-15
• Study First Posted: 2008-09-16
• Study Start: 2008-09-23
• Primary Completion: 2013-03-12
• Study Completion: 2013-03-12
• Disposition First Submitted: 2013-04-11
• Disposition First Submitted QC: 2013-04-11
• Disposition First Posted: 2013-04-18
• Results First Submitted: 2016-10-06
• Results First Submitted QC: 2016-10-06
• Results First Posted: 2016-11-30
• Status Verified: 2019-11
• Last Update Submitted: 2019-11-15
• Last Update Posted: 2019-11-27

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 224

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Other Non-Aboriginal infants	Infanrix™ hexa	-
Aboriginal infants group	Infanrix™ hexa	-

Primary Outcome Measures

Name	Time	Method
Number of Seroprotected Subjects Against Polyribosyl-ribitol Phosphate (Anti-PRP)	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

Name	Time	Method
Number of Subjects With Unsolicited Adverse Events (AEs)	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.
Number of Seroprotected Subjects Against Hepatitis B (Anti-HBs)	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.
Number of Subjects With Anti-HBs Antibody Concentrations ≥100 mIU/mL	One month after (POST) Dose 3.	The testing was done using the Enzyme-Linked Immunosorbent assay (ELISA) assay.
Number of Subjects With Serious Adverse Events (SAEs)	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.
Number of Subjects With Anti-PRP Antibody Concentrations ≥1µg/mL	One month after (POST) Dose 3.	For this assay, 1 μg/mL was considered as the seropositivity cut-off.
Anti-PRP Antibody Concentrations	One month after (POST) Dose 3.	Anti-PRP antibody concentrations were presented as Geometric mean Concentrations (GMC), expressed as micrograms per milliliter (μg/mL).
Anti-HBs Antibody Concentrations	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).

Trial Locations

Locations (1)

GSK Investigational Site; 🇨🇦 Truro, Nova Scotia, Canada