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Hib-MenCY-TT Vaccine Study Compared to Licensed Hib and Meningococcal Serogroup C Conjugate Vaccines

NCT00134719 · Status: COMPLETED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 1104

Last updated 2018-07-19

Study results available
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Summary

This study is evaluating the safety and immunogenicity of Hib-MenCY-TT vaccine compared to control groups receiving licensed Hib or MenC conjugate vaccines, each administered at 2, 4, 6, and 12 to 15 months of age. Co-administration with live, attenuated measles, mumps, and rubella combination vaccine; and with live, attenuated varicella vaccine will be assessed with administration of the booster dose. The Protocol Posting has been updated in order to comply with the FDA Amendment Act, September 2007.

Conditions

  • Neisseria Meningitidis
  • Haemophilus Influenzae Type b

Interventions

BIOLOGICAL

MenHibrix (Hib-MenCY-TT)

One intramuscular dose at 2, 4 and 6 months of age ( group A) and one intramuscular dose at 12 to 15 months of age (groups A and B)

BIOLOGICAL

Infanrix® Penta

One intramuscular dose at 2, 4 and 6 months of age

BIOLOGICAL

Prevenar®

One intramuscular dose at 2, 4 and 6 months of age

BIOLOGICAL

ActHIB®

One intramuscular dose at 2, 4 and 6 months of age

BIOLOGICAL

Meningitec®

One intramuscular dose at 2, 4 and 6 months of age

BIOLOGICAL

M-M-R®II

One subcutaneous dose at 12-15 months of age

BIOLOGICAL

Varivax®

One subcutaneous dose at 12 to 15 months of age

BIOLOGICAL

PedvaxHIB®

One intramuscular dose at 12 to 15 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
12 Weeks
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2005-04-11
Primary Completion
2006-07-24
Completion
2007-02-21

Countries

  • Australia

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 NCT00134719 on ClinicalTrials.gov