Varicella
Conditions
Brief 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.
Interventions
BIOLOGICALVaricella Virus Vaccine Live (Oka-Merck)
VARIVAX(TM) (Refrigerated) \[Varicella Virus Vaccine Live (Oka/Merck), Refrigerator-Stable Formulation.\] Subjects enrolled in the study received one 0.5 mL subcutaneous dose of VARIVAX(TM). Frequency is single dose.
Sponsors
Merck Sharp & Dohme LLC
Study design
Allocation
NON_RANDOMIZED
Intervention model
SINGLE_GROUP
Primary purpose
PREVENTION
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
12 Years to 12 Years
Healthy volunteers
Yes
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 * Any Other Live Vaccine Administered Within 30 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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Percent of subjects with VZV specific antibody titre>= 5gp ELISA units/ml 6 weeks post-vaccination | 6 weeks post-vaccination |
Outcome results
None listed