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Safety of Hib-MenCY-TT Vaccine Versus Licensed Hib Conjugate Vaccine, Given at 12 to 15 Months of Age.

NCT00345683 · Status: COMPLETED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 4021

Last updated 2016-11-29

Study results available
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Summary

The booster phase of the study will evaluate the safety of Hib-MenCY-TT vaccine compared to a control group receiving licensed Hib conjugate vaccine at 12 to 15 months of age.

This protocol posting deals with objectives \& outcome measures of the booster phase. The objectives \& outcome measures of the primary phase are presented in a separate protocol posting (NCT number = NCT00345579).

No new recruitment will take place during this booster phase of the study. 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)

Booster dose by intramuscular injection

BIOLOGICAL

PedvaxHIB

Booster dose by intramuscular injection

BIOLOGICAL

Prevnar

Booster dose by intramuscular injection

BIOLOGICAL

M-M-R II

Single dose by subcutaneous injection

BIOLOGICAL

Varivax

Single dose by subcutaneous injection

Sponsors & Collaborators

Principal Investigators

  • GSK Clinical Trials · GlaxoSmithKline

Study Design

Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
SINGLE
Model
PARALLEL

Eligibility

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

Timeline & Regulatory

Start
2007-07-31
Primary Completion
2008-09-30
Completion
2008-11-30

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 NCT00345683 on ClinicalTrials.gov