Safety,Tolerability and Immunogenicity of Vaccination With VARIVAX in Healthy Indian Children.
This study has been completed.
Sponsor:
Merck
Information provided by:
Merck
ClinicalTrials.gov Identifier:
NCT00496327
First received: July 3, 2007
Last updated: December 9, 2008
Last verified: December 2008
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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:
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 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 May 19, 2013