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Study in Toddlers to Demonstrate Non-inferiority of GSK Biologicals' Hib-MenC & to Evaluate Persistence up to 5 Years.

NCT00326118 · Status: COMPLETED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 433

Last updated 2018-08-24

Study results available
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Summary

The purpose of the primary phase of the study is to demonstrate the non-inferiority of a single dose of GSK Biologicals' Haemophilus influenzae type b and meningococcal C (Hib-MenC) conjugate vaccine when given in the second year of life to subjects primed in infancy with a Hib vaccine, but not with a meningococcal serogroup C vaccine, versus commercially available Hib and MenC vaccines.

In the extension phase, at Years 1, 2, 3, 4 \& 5, one blood sample is taken at each year to follow the antibody persistence up to 5 years after vaccination. No additional vaccine is administered during the extension phase. The Protocol Posting has been updated in order to comply with the FDA Amendment Act, Sep 2007.

Conditions

  • Haemophilus Influenzae Type b
  • Neisseria Meningitidis

Interventions

BIOLOGICAL

Haemophilus influenzae type b and meningococcal serogroup C (vaccine)

One intramuscular dose at 12-18 months of age

BIOLOGICAL

Priorix™

One subcutaneous dose at 12-18 months of age

BIOLOGICAL

Hiberix™

One intramuscular dose at 12-18 months of age.

BIOLOGICAL

Meningitec™

One intramuscular dose at 12-18 months of age

Sponsors & Collaborators

Principal Investigators

  • GSK Clinical Trials · GlaxoSmithKline

Study Design

Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
NONE
Model
PARALLEL

Eligibility

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

Timeline & Regulatory

Start
2006-06-01
Primary Completion
2007-11-01
Completion
2007-11-06

Countries

  • Australia

Study Locations

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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 NCT00326118 on ClinicalTrials.gov