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

Phase III, Open, Randomised Immunogenicity and Reactogenicity Study to Assess the Interchangeability Between GSK Bios' DTPa-HBV-IPV/Hib and DTPa-IPV/Hib + HBV at 3rd Dose of Primary Vac. Course in Children Who Received HBV Vac. at Birth and One Month of Age and DTPa-IPV/Hib Vac at 3-4 Mth of Age

Status

Completed

Phases

Phase 3

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT00366366

Enrollment

150

Registered

2006-08-21

Start date

2001-09-30

Completion date

2002-09-30

Last updated

2016-09-16

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Hepatitis B

Brief summary

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.

Interventions

BIOLOGICALInfanrix-Hexa

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

PREVENTION

Masking

NONE

Eligibility

Sex/Gender

ALL

Age

11 Weeks to 17 Weeks

Healthy volunteers

Yes

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.

Design outcomes

Primary

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

Secondary

Measure	Time frame
Ab conc/titers against all vaccine antigens	—
Safety: Solicited symptoms, unsolicited AEs and SAEs	—

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026