Safety,Tolerability and Immunogenicity of Vaccination With Varivax in Healthy Indian Children
Information source: Merck
Information obtained from ClinicalTrials.gov on June 20, 2008
Link to the current ClinicalTrials.gov record.
Condition(s) targeted: Varicella
Intervention: Varicella Virus Vaccine Live (Oka-Merck) (Biological)
Phase: Phase 3
Status: Completed
Sponsored by: Merck Official(s) and/or principal investigator(s):
Medical Monitor, Study Director, Affiliation: Merck
Summary
To observe the safety and tolerability of the administration of varivax in varicella history
negative Indian children 12 months to 12 years of age.
Clinical Details
Official title: Evaluation of Safety,Tolerability and Immunogenicity of Vaccination With Varivax (V210) in Healthy Indian Children
Study design: Prevention, Non-Randomized, Open Label, Uncontrolled, Single Group Assignment, Safety/Efficacy Study
Primary outcome: Percent of subjects with VZV specific antibody titre>= 5gp ELISA units/ml 6 weeks post-vaccination
Detailed description:
Serum samples were obtained for the evaluation of varicella-zoster virus (VZV) antibody
levels prior to and 6 weeks after vaccination.
Eligibility
Minimum age: 12 Years.
Maximum age: 12 Years.
Gender(s): Both.
Criteria:
Inclusion Criteria:
- Healthy children, between 12 months and 12 years of age
- Parent or legal guardian should be willing and able to sign the informed consent form
prior to entry into the study
Exclusion Criteria:
- Any immune impairment or deficiency, neoplastic disease, or depressed immunity,
including that resulting from corticosteroid or other immunosuppressive therapy
- Any immunoglobulin or blood products 5 months prior to or expected within 3 months
after enrollment in this study
- Any medical condition which, in the opinion of the investigator may interfere with the
evaluation of teh study objectives
- Any other inactivated vaccine administered within 14 days before or expected within 42
days after administration of the study vaccination
- Female subjects who are pregnant or nursing
- History of anaphylactic or other immediate allergic reactions
- Hypersensitivity to any of the components of the vaccine administered under this
protocol such as gelatin or neomycin
- Past history of varicella
- Previous vaccination with any varicella vaccine in either monovalent or combination
form
- Recent household, daycare, or school exposure(in the last 4 weeks) to varicella
Locations and Contacts
Additional Information
Starting date: July 2005
Last updated: March 3, 2008
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