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Immunogenicity and Safety of Primary and Booster Vaccination With DTPa-HBV-IPV/Hib Vaccine

NCT00880477 · Status: COMPLETED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 140

Last updated 2016-09-07

No results posted yet for this study

Summary

This study will assess the immunogenicity, safety and reactogenicity of GSK Biological's DTPa-HBV-IPV/ Hib vaccine as compared to GSK's DTPa-IPV/Hib vaccine co-administered with HBV according to a three-dose immunisation course and as a booster dose in infants born to hepatitis B antigen seronegative mothers and previously primed with a birth dose of GSK's HBV vaccine.

Conditions

Interventions

BIOLOGICAL

DTPa-HBV-IPV/Hib vaccine

Vaccination according to a 3-dose schedule at 1 ½, 3 ½ and 6 months of age with booster at 15-18 months of age.

BIOLOGICAL

DTPa-IPV/Hib vaccine

Vaccination according to a 3-dose schedule at at 1 ½, 3 ½ and 6 months of age with booster at 15-18 months of age.

BIOLOGICAL

EngerixTM-B

The vaccine was administered according to a 2-dose schedule at 1½ and 6 months of age with booster at 15-18 months of age.

Sponsors & Collaborators

Principal Investigators

  • GSK Clinical Trials · GlaxoSmithKline

Study Design

Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
6 Weeks
Max Age
8 Weeks
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2001-01-31
Primary Completion
2002-11-30
Completion
2002-11-30

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT00880477 on ClinicalTrials.gov