Clinical trial NCT00753649: Immunogenicity and Safety of GSK Biologicals' Infanrix Hexa in Infants
Official title: Immunogenicity and Safety Study of GlaxoSmithKline Biologicals' Infanrix Hexa Vaccine in Healthy Infants
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Hepatitis B
Tetanus
Poliomyelitis
Diphtheria
Haemophilus Influenzae Type b
Acellular Pertussis
Keywords: Infant
First nation
Aboriginal
Canada
Lead sponsor: GlaxoSmithKline
Sponsor class: INDUSTRY
First posted: 2008-09-16
Enrollment: 224
Sex: ALL
Minimum age (years): 6
Maximum age (years): 12
Standard ages: CHILD
Accepts healthy volunteers: yes
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

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).

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.
* 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.

Primary outcomes:
measure: Number of Seroprotected Subjects Against Polyribosyl-ribitol Phosphate (Anti-PRP)
timeFrame: One month after (POST) Dose 3.
Secondary outcomes:
measure: Number of Subjects With Anti-PRP Antibody Concentrations ≥1µg/mL
timeFrame: One month after (POST) Dose 3.
measure: Anti-PRP Antibody Concentrations
timeFrame: One month after (POST) Dose 3.
measure: Number of Seroprotected Subjects Against Hepatitis B (Anti-HBs)
timeFrame: One month after (POST) Dose 3.
measure: Number of Subjects With Anti-HBs Antibody Concentrations ≥100 mIU/mL
timeFrame: One month after (POST) Dose 3.
measure: Anti-HBs Antibody Concentrations
timeFrame: One month after (POST) Dose 3.
measure: Number of Subjects With Unsolicited Adverse Events (AEs)
timeFrame: During the 31 day (Days 0-30) post vaccination
measure: Number of Subjects With Serious Adverse Events (SAEs)
timeFrame: During the entire study period up to Last subject last visit on 03/12/2013
Other outcomes:
Locations:
city: Edmonton
country: Canada
facility: GSK Investigational Site
state: Alberta
city: Vancouver
country: Canada
facility: GSK Investigational Site
state: British Columbia
city: Truro
country: Canada
facility: GSK Investigational Site
state: Nova Scotia
Study officials:
affiliation: GlaxoSmithKline
name: GSK Clinical Trials
role: STUDY_DIRECTOR
References:
citation: 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.