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Safety and Immunogenicity Study of Hib-MenCY-TT Vaccine Compared to Licensed Hib Conjugate Vaccine

NCT00289783 · Status: COMPLETED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 4441

Last updated 2018-08-24

Study results available
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Summary

This study evaluates the immunogenicity and consistency of 3 Hib-MenCY-TT vaccine lots and the safety and immunogenicity 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. The study will also evaluate the safety and immunogenicity of Hib-MenCY-TT vaccine compared to a control group receiving licensed Hib conjugate vaccine, when each are co-administered with M-M-R® II and Varivax® at 12 to 15 months of age.

Conditions

  • Haemophilus Influenzae Type b
  • Neisseria Meningitidis

Interventions

BIOLOGICAL

GSK Biologicals' Haemophilus influenzae type b and Neisseria meningitidis 792014 vaccine

3-dose intramuscular injection at 2, 4 and 6 months of age, and 1 booster dose by intramuscular injection at 12 to 15 months of age.

BIOLOGICAL

ActHIB

3-dose intramuscular injection at 2, 4 and 6 months of age.

BIOLOGICAL

PedvaxHIB

1 booster dose by intramuscular injection at 12 to 15 months of age.

BIOLOGICAL

Pediarix

3-dose intramuscular injection at 2, 4 and 6 months of age.

BIOLOGICAL

Prevnar

3-dose intramuscular injection at 2, 4 and 6 months of age, and 1 booster dose by intramuscular injection at 12 to 15 months of age.

BIOLOGICAL

M-M-R II

1 booster dose by subcutaneous injection at 12 to 15 months of age.

BIOLOGICAL

Varivax

1 booster dose by subcutaneous injection at 12 to 15 months of age

Sponsors & Collaborators

Principal Investigators

  • GSK Clinical Trials · GlaxoSmithKline

Study Design

Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
TRIPLE
Model
PARALLEL

Eligibility

Min Age
6 Weeks
Max Age
15 Months
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2006-02-22
Primary Completion
2007-08-27
Completion
2008-02-26

Countries

  • United States
  • Australia
  • 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 NCT00289783 on ClinicalTrials.gov