To Evaluate Immunogenicity & Safety of GSK Bio's DTPa-HBV-IPV/Hib (Mixed Vaccine) and DTPa-IPV/Hib + HBV Vaccines

GlaxoSmithKline (GSK)

Status and phase

Completed

Phase 3

Conditions

Hepatitis B

Treatments

Biological: Infanrix-Hexa

Study type

Interventional

Funder types

Industry

Identifiers

NCT00366366

217744/075

Details and patient eligibility

About

This study assessed the immunogenicity and safety of two vaccination regimens that employed either GSK Biologicals' combined DTPa-HBV-IPV/Hib vaccine or DTPa-IPV/Hib vaccine. In the two groups, infants received the DTPa-IPV/Hib vaccine at 3 and 4 months of age, as the first 2 doses of the primary vaccination course. At 5 months of age, they received either the DTPa-IPV/Hib vaccine co-administered with the HBV vaccine or a dose of the DTPa-HBV-IPV/Hib vaccine as a 3rd dose. Infants in the two groups had previously received 2 doses of HBV vaccine at birth and at 1 month of age.

Enrollment

150 patients

Sex

All

Ages

11 to 17 weeks old

Volunteers

Accepts Healthy Volunteers

Inclusion criteria

A male or female infant at the age of 11 - 17 weeks.
Written informed consent obtained from the parents or guardians of the subject.
Free of obvious health problems as established by clinical examination before entering into the study.
Hepatitis B vaccine at birth and one month of age.

Exclusion criteria

Previous vaccination against measles, mumps, rubella and/or varicella.
Use of any investigational or non-registered drug or vaccine other than the study vaccines within 30 days preceding the first dose of study vaccine, or planned use during the study period.
A family history of congenital or hereditary immunodeficiency.
Any confirmed or suspected immunosuppressive or immunodeficient condition, including HIV infection.
Major congenital defects.
History of allergic disease or reactions likely to be exacerbated by any component of the vaccine.