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

Varicella Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00496327
• Other study ID #: V210-056
• Secondary ID: 2007_019
• Status: Completed
• Phase: Phase 3
• Start date: June 22, 2005
• Est. completion date: October 6, 2005

Study information

• Verified date: January 2019
• Source: Merck Sharp & Dohme Corp.
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 100
• Est. completion date: October 6, 2005
• Est. primary completion date: October 6, 2005
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 12 Years to 12 Years

Eligibility

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

Related Conditions & MeSH terms

• Varicella

Intervention

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.

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Merck Sharp & Dohme Corp.

References & 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/immuno

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Percent of subjects with VZV specific antibody titre>= 5gp ELISA units/ml 6 weeks post-vaccination		6 weeks post-vaccination

External Links

•   MedWatch - FDA maintained medical product safety Information
•   Merck: Patient & Caregiver U.S. Product Web Site