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Immunogenicity and Safety of Havrix™ Co-Administered With a Diphtheria, Tetanus and Pertussis and a Haemophilus b Vaccine in Children Aged 15 Months

NCT00197236 · Status: COMPLETED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 468

Last updated 2018-08-20

Study results available
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Summary

This is a study to evaluate the immune response and safety of GSK Biologicals 2-dose inactivated hepatitis A vaccine when administered with a diphtheria, tetanus and pertussis combination (DTaP) vaccine and a Haemophilus influenza type B (Hib) vaccine in children 15 months of age. The Protocol Posting has been updated in order to comply with the FDA Amendment Act, Sep 2007.

Conditions

  • Hepatitis A

Interventions

BIOLOGICAL

Havrix™

2 intramuscular injections, 6 months apart

BIOLOGICAL

Infanrix™

1 intramuscular injection

BIOLOGICAL

ActHIB™

1 intramuscular injection

Sponsors & Collaborators

Principal Investigators

  • GSK Clinical Trials · GlaxoSmithKline

Study Design

Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
12 Months
Max Age
13 Months
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2003-11-11
Primary Completion
2007-12-03
Completion
2007-12-03

Countries

  • United States

Study Locations

More Related Trials

Entities

Companies

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 NCT00197236 on ClinicalTrials.gov