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

Phase 3

Completed

• Conditions: Hepatitis B

• Registration Number: NCT00366366
• Lead Sponsor: GlaxoSmithKline

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2001-09
• Primary Completion: 2002-09
• Study Completion: 2002-09
• Study First Submitted: 2006-08-18
• Study First Submitted QC: 2006-08-18
• Study First Posted: 2006-08-21
• Status Verified: 2016-09
• Last Update Submitted: 2016-09-15
• Last Update Posted: 2016-09-16

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 150

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.

Read More

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.

Read More

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

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

Secondary Outcome Measures

Name	Time	Method
Ab conc/titers against all vaccine antigens
Safety: Solicited symptoms, unsolicited AEs and SAEs