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

This study has been completed.
Sponsor:
Information provided by:
Merck Sharp & Dohme Corp.
ClinicalTrials.gov Identifier:
NCT00496327
First received: July 3, 2007
Last updated: December 9, 2008
Last verified: December 2008
  Purpose

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
Varicella
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.

  Eligibility

Ages Eligible for Study:   12 Years to 12 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00496327

Sponsors and Collaborators
Merck Sharp & Dohme Corp.
Investigators
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.
ClinicalTrials.gov 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:
Chickenpox
Herpes Zoster
Herpesviridae Infections
DNA Virus Infections
Virus Diseases

ClinicalTrials.gov processed this record on April 15, 2014