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

NCT00496327 | Completed Phase 3

• 2 other identifiers: V210-0562007_019
• Study Type: interventional
• Target: 100
• Locations: 0 countries
• Sites: N/A

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

Outcome Measures

Primary Outcomes (1)

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

  6 weeks post-vaccination

Study Arms (1)

1

EXPERIMENTAL

Open label

Biological: Varicella Virus Vaccine Live (Oka-Merck)

Interventions

Varicella Virus Vaccine Live (Oka-Merck) 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.

1

Eligibility Criteria

• Age: 12 Years - 12 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Merck Sharp & Dohme LLC: lead

Related Publications (1)

• 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/

  RESULT

MeSH Terms

Conditions

Chickenpox

Interventions

Herpes Zoster Vaccine

Condition Hierarchy (Ancestors)

Varicella Zoster Virus Infection; Herpesviridae Infections; DNA Virus Infections; Virus Diseases; Infections

Intervention Hierarchy (Ancestors)

Chickenpox Vaccine; Herpesvirus Vaccines; Viral Vaccines; Vaccines; Biological Products; Complex Mixtures

Study Officials

• Medical Monitor

  Merck Sharp & Dohme LLC

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 3, 2007
• First Posted: July 4, 2007
• Study Start: June 22, 2005
• Primary Completion: October 6, 2005
• Study Completion: October 6, 2005
• Last Updated: January 18, 2019

Record last verified: 2019-01

Data Sharing

• IPD Sharing: Will share