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

Completed · Phase 3

Conditions studied: Haemophilus Influenzae Type b, Neisseria Meningitidis

In brief

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.

Key facts

Study ID

NCT00345683

Run by

GlaxoSmithKline

People needed

4021

Starts

2007-07-01

Expected to finish

2008-11-01

Last updated by the study team

2016-11-29

Who can join

Age: 1 and older, up to 1. Sex: any. Healthy volunteers: accepted.

You may qualify if…

• Subjects enrolled in the primary study (NCT00345579) are eligible for participating in the booster study

You may not qualify if…

• Subjects should not be administered M-M-R II and Varivax if any of these criteria apply:
• History of measles, mumps, rubella or varicella.
• Previous vaccination against measles, mumps, rubella or varicella.
• Hypersensitivity to any component of the vaccines, including gelatin or neomycin.
• Patients receiving immunosuppressive therapy.
• Individuals with blood dyscrasias, leukemia, lymphomas of any type, or other malignant neoplasms affecting the bone marrow or lymphatic systems.
• Individuals with primary and acquired immunodeficiency states.
• Individuals with a family history of congenital or hereditary immunodeficiency, until the immune competence of the potential vaccine recipient is demonstrated.
• Individuals with active tuberculosis.
• Acute disease at time of booster vaccination

Where it is running

• GSK Investigational Site — Birmingham, Alabama, United States
• GSK Investigational Site — Benton, Arkansas, United States
• GSK Investigational Site — Jonesboro, Arkansas, United States
• GSK Investigational Site — Little Rock, Arkansas, United States
• GSK Investigational Site — Fountain Valley, California, United States
• GSK Investigational Site — Fresno, California, United States
• GSK Investigational Site — Fresno, California, United States
• GSK Investigational Site — Madera, California, United States
• GSK Investigational Site — Slinas, California, United States
• GSK Investigational Site — West Covina, California, United States
• GSK Investigational Site — Boulder, Colorado, United States
• GSK Investigational Site — Longmont, Colorado, United States
• GSK Investigational Site — Plantation, Florida, United States
• GSK Investigational Site — Nampa, Idaho, United States
• GSK Investigational Site — Waukee, Iowa, United States
• GSK Investigational Site — West Desmoines, Iowa, United States
• GSK Investigational Site — Bardstown, Kentucky, United States
• GSK Investigational Site — Lexington, Kentucky, United States
• GSK Investigational Site — Bossier City, Louisiana, United States
• GSK Investigational Site — Boston, Massachusetts, United States
• GSK Investigational Site — Nies, Michigan, United States
• GSK Investigational Site — Portage, Michigan, United States
• GSK Investigational Site — Stevensville, Michigan, United States
• GSK Investigational Site — Saint Paul, Minnesota, United States
• GSK Investigational Site — Birmingham, Alabama, United States

Full record on ClinicalTrials.gov

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