Immunogenicity and Reactogenicity of GSK Bio DTPa-HBV-IPV and Hib Vaccines When Coadministered to Healthy Infants

GlaxoSmithKline (GSK)

Status and phase

Completed

Phase 3

Conditions

Poliomyelitis

Diphtheria

Tetanus

Hepatitis B

Acellular Pertussis

Treatments

Biological: Pediarix TM, Infanrix penta TM

Biological: Hiberix TM

Study type

Interventional

Funder types

Industry

Identifiers

NCT00879827

217744/049

Details and patient eligibility

About

The purpose of this study is to evaluate the immune response and reactogenicity of GSK Biologicals' DTPa-HBV-IPV combined pentavalent vaccine and Hib tetanus conjugate vaccine, administered concomitantly as a three-dose primary vaccination course.

Enrollment

60 patients

Sex

All

Ages

6 to 8 weeks old

Volunteers

Accepts Healthy Volunteers

Inclusion criteria

A male or female infant between 6 and 8 weeks of age at the time of the first vaccination.
Free of obvious health problems as established by medical history and clinical examination before entering into the study.
Written informed consent obtained from the parents or guardians of the subject.
Born after a normal gestation period (between 36 and 42 weeks).

Exclusion criteria

Use of any investigational or non-registered drug or vaccine other than the study vaccine(s) during the study period or within 30 days preceding the first dose of study vaccine.
Administration of chronic immunosuppressants or other immune-modifying drugs since birth or planned administration during the study.
Planned administration/ administration of a vaccine not foreseen by the study protocol during the period starting from 30 days before each dose of vaccine(s) and ending 30 days after.
Previous vaccination against diphtheria, tetanus, pertussis, polio or Haemophilus influenzae type b.
History of, or intercurrent, diphtheria, tetanus, pertussis, hepatitis B, polio and/or Haemophilus influenzae type b.
Any confirmed or suspected immunosuppressive or immunodeficient condition, including human immunodeficiency virus infection.
Major congenital defects
Serious chronic illness
History of allergic disease or reactions likely to be exacerbated by any component of the vaccines.
Administration of immunoglobulins and/or any blood products since birth or planned administration during the study period.
Acute disease at the time of enrollment.