Safety,Tolerability and Immunogenicity of Vaccination With VARIVAX in Healthy Indian Children. - Full Text View

Sponsored by:	Merck
Information provided by:	Merck
ClinicalTrials.gov Identifier:	NCT00496327

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 III

MedlinePlus related topics: Chickenpox Shingles

Drug Information available for: Chickenpox Vaccine

Study Type:	Interventional
Study Design:	Prevention, Non-Randomized, Open Label, Uncontrolled, Single Group Assignment, Safety/Efficacy Study
Official Title:	Evaluation of Safety,Tolerability and Immunogenicity of Vaccination With VARIVAX (V210)in Healthy Indian Children

Further study details as provided by Merck:

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
1: Experimental 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

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

Investigators

Study Director:

Medical Monitor

Merck

More Information

Additional Information:

Merck: Patient & Caregiver U.S. Product Web Site This link exits the ClinicalTrials.gov site

No publications provided

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

Study placed in the following topic categories:

Virus Diseases
Herpes Zoster
Chickenpox

DNA Virus Infections
Healthy
Herpesviridae Infections

Additional relevant MeSH terms:

Virus Diseases
Chickenpox
DNA Virus Infections
Herpesviridae Infections

ClinicalTrials.gov processed this record on May 07, 2009