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

GlaxoSmithKline150 enrolled

Overview

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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

PREVENTION

Masking

NONE

Enrollment

150

Conditions

Hepatitis B

Interventions

Infanrix-Hexa

Eligibility

Sex: ALLMin age: 11 WeeksMax age: 17 WeeksHealthy volunteers:

Medical Language ↔ Plain English

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.

Outcomes

Primary Outcomes

Anti-HBs conc >=10 mIU/ml, 1 month after the last vaccine dose

Secondary Outcomes

Ab conc/titers against all vaccine antigens

Safety: Solicited symptoms, unsolicited AEs and SAEs