Safety,Tolerability and Immunogenicity of Vaccination With VARIVAX in Healthy Indian Children (V210-056)

Merck Sharp & Dohme (MSD)

Status and phase

Completed

Phase 3

Conditions

Varicella

Treatments

Biological: Varicella Virus Vaccine Live (Oka-Merck)

Study type

Interventional

Funder types

Industry

Identifiers

2007_019

V210-056

Details and patient eligibility

About

To observe the safety and tolerability of the administration of VARIVAX in varicella history negative Indian children 12 months to 12 years of age.

Enrollment

100 patients

Sex

All

Ages

12 to 12 years old

Volunteers

Accepts Healthy Volunteers

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