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

NCT ID: NCT00496327

Last Updated: 2019-01-18

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE3
• Total Enrollment: 100 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2005-06-22
• Study Completion Date: 2005-10-06

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.

Conditions

Varicella

Study Design

• Allocation Method: NON_RANDOMIZED
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: PREVENTION
• Blinding Strategy: NONE

Study Groups

1

Open label

Group Type: EXPERIMENTAL

Varicella Virus Vaccine Live (Oka-Merck)

Intervention Type: BIOLOGICAL

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.

Interventions

Varicella 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.

Intervention Type: BIOLOGICAL

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

• Minimum Eligible Age: 12 Years
• Maximum Eligible Age: 12 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Merck Sharp & Dohme LLC

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Medical Monitor

Role: STUDY_DIRECTOR

Merck Sharp & Dohme LLC

References

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/

Reference Type: RESULT

Study Documents

Document Type: CSR Synopsis

View Document

Other Identifiers

2007_019

Identifier Type: -

Identifier Source: secondary_id

V210-056

Identifier Type: -

Identifier Source: org_study_id