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Safety of Hib-MenCY-TT Vaccine Versus Licensed Hib Conjugate Vaccine, Given at 2, 4, 6 and 12 to 15 Months of Age

NCT00345579 · Status: COMPLETED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 4432

Last updated 2016-12-16

Study results available
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Summary

The primary phase of this study is evaluating the safety of Hib-MenCY-TT vaccine compared to a control group receiving licensed Hib conjugate vaccine, when each are co-administered with Pediarix® to healthy infants at 2, 4, and 6 months of age.

This protocol posting deals with objectives \& outcome measures of the primary phase of the study. The objectives \& outcome measures of the Booster phase are presented in a separate protocol posting (NCT number = 00345683).

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

GSK Biologicals' Haemophilus influenzae type b and Neisseria meningitidis serogroups C and Y-tetanus toxoid conjugate vaccine combined 792014

3-dose intramuscular injection

BIOLOGICAL

ActHIB

3-dose intramuscular injection

BIOLOGICAL

Pediarix/Infanrix Penta

3-dose intramuscular injection

Sponsors & Collaborators

Principal Investigators

  • GSK Clinical Trials · GlaxoSmithKline

Study Design

Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
SINGLE
Model
PARALLEL

Eligibility

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

Timeline & Regulatory

Start
2006-09-30
Primary Completion
2007-10-31
Completion
2008-03-31

Countries

  • United States
  • Mexico

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 NCT00345579 on ClinicalTrials.gov