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

Phase 3

Completed

• Conditions: Varicella
• Interventions: Biological: Varicella Virus Vaccine Live (Oka-Merck)

• Registration Number: NCT00496327
• Lead Sponsor: Merck Sharp & Dohme LLC

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.

Detailed Description

Not available

Basic Information
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Recruitment & Eligibility
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Study & Design

Study Timeline

• Study Start: 2005-06-22
• Primary Completion: 2005-10-06
• Study Completion: 2005-10-06
• Study First Submitted: 2007-07-03
• Study First Submitted QC: 2007-07-03
• Study First Posted: 2007-07-04
• Status Verified: 2019-01
• Last Update Submitted: 2019-01-16
• Last Update Posted: 2019-01-18

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 100

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

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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

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
1	Varicella Virus Vaccine Live (Oka-Merck)	Open label

Primary Outcome Measures

Name	Time	Method
Percent of subjects with VZV specific antibody titre>= 5gp ELISA units/ml 6 weeks post-vaccination	6 weeks post-vaccination