Safety,Tolerability and Immunogenicity of Vaccination With VARIVAX in Healthy Indian Children.

This study has been completed.
Information provided by:
Merck Sharp & Dohme Corp. Identifier:
First received: July 3, 2007
Last updated: December 9, 2008
Last verified: December 2008

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

Condition Intervention Phase
Biological: Varicella Virus Vaccine Live (Oka-Merck)
Phase 3

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Prevention
Official Title: Evaluation of Safety,Tolerability and Immunogenicity of Vaccination With VARIVAX (V210)in Healthy Indian Children

Resource links provided by NLM:

Further study details as provided by Merck Sharp & Dohme Corp.:

Primary Outcome Measures:
  • Percent of subjects with VZV specific antibody titre>= 5gp ELISA units/ml 6 weeks post-vaccination [ Time Frame: 6 weeks post-vaccination ] [ Designated as safety issue: No ]

Enrollment: 100
Study Start Date: June 2005
Study Completion Date: October 2005
Primary Completion Date: October 2005 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: 1
Open label
Biological: 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.


Ages Eligible for Study:   12 Years to 12 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes

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
  Contacts and Locations
Please refer to this study by its identifier: NCT00496327

Sponsors and Collaborators
Merck Sharp & Dohme Corp.
Study Director: Medical Monitor Merck Sharp & Dohme Corp.
  More Information

Additional Information:
No publications provided

Responsible Party: Executive Vice President, Clinical and Quantitative Sciences, Merck & Co., Inc. Identifier: NCT00496327     History of Changes
Other Study ID Numbers: 2007_019, V210-056
Study First Received: July 3, 2007
Last Updated: December 9, 2008
Health Authority: India: Ministry of Health

Additional relevant MeSH terms:
Herpes Zoster
Herpesviridae Infections
DNA Virus Infections
Virus Diseases processed this record on April 15, 2014