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

Primary Purpose

Varicella

Status

Completed

Phase

Phase 3

Locations

Study Type

Interventional

Intervention

Varicella Virus Vaccine Live (Oka-Merck)

About this trial

This is an interventional prevention trial for Varicella

Eligibility Criteria

12 Years - 12 Years (Child)All SexesAccepts 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

Sites / Locations

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Arm Description

Open label

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

Full Information

NCT ID

NCT00496327

First Posted

July 3, 2007

Last Updated

January 16, 2019

Sponsor

Merck Sharp & Dohme LLC

1. Study Identification

Unique Protocol Identification Number

NCT00496327

Brief Title

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

Official Title

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

Study Type

Interventional

2. Study Status

Record Verification Date

January 2019

Overall Recruitment Status

Completed

Study Start Date

June 22, 2005 (Actual)

Primary Completion Date

October 6, 2005 (Actual)

Study Completion Date

October 6, 2005 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

Merck Sharp & Dohme LLC

4. Oversight

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Varicella

7. Study Design

Primary Purpose

Prevention

Study Phase

Phase 3

Interventional Study Model

Single Group Assignment

Masking

None (Open Label)

Allocation

Non-Randomized

Enrollment

100 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Arm Type

Experimental

Arm Description

Open label

Intervention Type

Biological

Intervention Name(s)

Varicella Virus Vaccine Live (Oka-Merck)

Intervention Description

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.

Primary Outcome Measure Information:

Title

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

Time Frame

6 weeks post-vaccination

10. Eligibility

Sex

All

Minimum Age & Unit of Time

12 Years

Maximum Age & Unit of Time

12 Years

Accepts Healthy Volunteers

Eligibility 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 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

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Medical Monitor

Organizational Affiliation

Merck Sharp & Dohme LLC

Official's Role

Study Director

12. IPD Sharing Statement

Plan to Share IPD

Yes

IPD Sharing Plan Description

http://engagezone.msd.com/doc/ProcedureAccessClinicalTrialData.pdf

IPD Sharing URL

http://engagezone.msd.com/ds_documentation.php

Citations:

Citation

Subba Rao SD, Panday S, Maiya PP, Samdani PG, Lokeshwar MR, Bhave S, Bafna S. Immunogenecity and safety of Oka varicella-zoster virus vaccine (VaripedTM) in Indian children. New Indian Journal of Pediatrics. 2018;7.1(Jan-Mar):7-14. https://nijp.org/immunogenicity-and-safety-of-oka-varicella-zoster-virus-vaccine-varipedtm-in-indian-children/

Results Reference

result

Available IPD and Supporting Information:

Available IPD/Information Type

CSR Synopsis

Available IPD/Information URL

http://www.merck.com/clinical-trials/policies-perspectives.html

Learn more about this trial

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

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