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| ID | Type | Description | Link |
|---|---|---|---|
| 2007_019 |
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To observe the safety and tolerability of the administration of VARIVAX in varicella history negative Indian children 12 months to 12 years of age.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 1 | Experimental | Open label |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Varicella Virus Vaccine Live (Oka-Merck) | Biological | 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. |
| Measure | Description | Time Frame |
|---|---|---|
| Percent of subjects with VZV specific antibody titre>= 5gp ELISA units/ml 6 weeks post-vaccination | 6 weeks post-vaccination |
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Inclusion Criteria:
Exclusion Criteria:
Any Medical Condition Which, In The Opinion Of The Investigator May Interfere With The Evaluation Of Teh Study Objectives
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| Name | Affiliation | Role |
|---|---|---|
| Medical Monitor | Merck Sharp & Dohme LLC | Study Director |
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| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| Result | 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/immunogenicity-and-safety-of-oka-varicella-zoster-virus-vaccine-varipedtm-in-indian-children/ |
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| ID | Type | URL | Comment |
|---|---|---|---|
| CSR Synopsis | View IPD |
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| ID | Term |
|---|---|
| D002644 | Chickenpox |
| ID | Term |
|---|---|
| D000073618 | Varicella Zoster Virus Infection |
| D006566 | Herpesviridae Infections |
| D004266 | DNA Virus Infections |
| D014777 | Virus Diseases |
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| ID | Term |
|---|---|
| D053061 | Herpes Zoster Vaccine |
| ID | Term |
|---|---|
| D019433 | Chickenpox Vaccine |
| D022283 | Herpesvirus Vaccines |
| D014765 | Viral Vaccines |
| D014612 | Vaccines |
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| D007239 | Infections |
| D001688 |
| Biological Products |
| D045424 | Complex Mixtures |