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

GlaxoSmithKline1 site in 1 country224 target enrollmentSeptember 23, 2008

ConditionsHepatitis B Tetanus Poliomyelitis Diphtheria Haemophilus Influenzae Type b Acellular Pertussis

Overview

Phase: Phase 4
Intervention: Not specified
Conditions: Hepatitis B
Sponsor: GlaxoSmithKline
Enrollment: 224
Locations: 1
Primary Endpoint: Number of Seroprotected Subjects Against Polyribosyl-ribitol Phosphate (Anti-PRP)
Status: Completed
Last Updated: 6 years ago

Overview Investigators Eligibility Criteria Outcomes Sites Similar Trials

Overview

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).

Registry

clinicaltrials.gov

Start Date

September 23, 2008

End Date

March 12, 2013

Last Updated

6 years ago

Study Type

Interventional

Study Design

Parallel

Sex

All

Investigators

Sponsor

GlaxoSmithKline

Responsible Party

Sponsor

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.

Outcomes

Primary Outcomes

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 Outcomes

Number of Subjects With Unsolicited Adverse Events (AEs)(During the 31 day (Days 0-30) post vaccination)
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.)
Number of Subjects With Serious Adverse Events (SAEs)(During the entire study period up to Last subject last visit on 03/12/2013)
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.)
Anti-HBs Antibody Concentrations(One month after (POST) Dose 3.)