Status:
COMPLETED
Safety of Hib-MenCY-TT Vaccine Versus Licensed Hib Conjugate Vaccine, Given at 12 to 15 Months of Age.
Lead Sponsor:
GlaxoSmithKline
Conditions:
Haemophilus Influenzae Type b
Neisseria Meningitidis
Eligibility:
All Genders
12-15 years
Phase:
PHASE3
Brief 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 d...
Detailed Description
Hib-MenCY-TT = GSK Biologicals' Haemophilus influenzae type b and Neisseria meningitidis serogroups C and Y-tetanus toxoid conjugate vaccine. The study will be conducted in a single blind manner up t...
Eligibility Criteria
Inclusion
- Subjects enrolled in the primary study (NCT00345579) are eligible for participating in the booster study
Exclusion
- 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
Key Trial Info
Start Date :
July 1 2007
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
November 1 2008
Estimated Enrollment :
4021 Patients enrolled
Trial Details
Trial ID
NCT00345683
Start Date
July 1 2007
End Date
November 1 2008
Last Update
November 29 2016
Active Locations (57)
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1
GSK Investigational Site
Birmingham, Alabama, United States, 35205
2
GSK Investigational Site
Birmingham, Alabama, United States, 35244
3
GSK Investigational Site
Benton, Arkansas, United States, 72015
4
GSK Investigational Site
Jonesboro, Arkansas, United States, 72401