Immunogenicity and Safety of GSK Biologicals' Infanrix Hexa in Infants

GlaxoSmithKline (GSK)

Status and phase

Completed

Phase 4

Conditions

Poliomyelitis

Haemophilus Influenzae Type b

Diphtheria

Tetanus

Hepatitis B

Acellular Pertussis

Treatments

Biological: Infanrix™ hexa

Study type

Interventional

Funder types

Industry

Identifiers

NCT00753649

103506

2013-003428-34 (EudraCT Number)

Details and patient eligibility

About

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.

Full description

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

Enrollment

224 patients

Sex

All

Ages

6 to 12 weeks old

Volunteers

Accepts Healthy Volunteers

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.