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| ID | Type | Description | Link |
|---|---|---|---|
| 2004_073 |
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The purpose of this study is to determine the mumps virus strength at the end of shelf-life (expiration date) of an approved vaccine.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Control Group | Active Comparator | M-M-R(TM) II at current release potency |
|
| Mumps Expiry Group 1 | Experimental | M-M-R(TM) II at intermediate expiry potency |
|
| Mumps Expiry Group 2 | Experimental | M-M-R(TM) II at expiry potency |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Comparator: M-M-R(TM) II, measles, mumps, and rubella virus vaccine live | Biological | 0.5 mL subcutaneous injection of one of three sub-lots on Day 0 |
|
| Measure | Description | Time Frame |
|---|---|---|
| Neutralizing antibodies to mumps at 6 weeks postvaccination | 6 weeks postvaccination |
| Measure | Description | Time Frame |
|---|---|---|
| Geometric mean titers to mumps by ELISA at 6 weeks and at 1 year postvaccination | 6 weeks and 1 year postvaccination |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Medical Monitor | Merck Sharp & Dohme LLC | Study Director |
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| Comparator: VARIVAX(TM) Varicella Virus Vaccine Live (Oka-Merck) | Biological | 0.5 mL subcutaneous injection on Day 0 |
|
| ID | Term |
|---|---|
| D008457 | Measles |
| D009107 | Mumps |
| D012409 | Rubella |
| D002644 | Chickenpox |
| ID | Term |
|---|---|
| D018185 | Morbillivirus Infections |
| D018184 | Paramyxoviridae Infections |
| D018701 | Mononegavirales Infections |
| D012327 | RNA Virus Infections |
| D014777 | Virus Diseases |
| D007239 | Infections |
| D019351 | Rubulavirus Infections |
| D010309 | Parotitis |
| D010305 | Parotid Diseases |
| D012466 | Salivary Gland Diseases |
| D009059 | Mouth Diseases |
| D009057 | Stomatognathic Diseases |
| D018355 | Rubivirus Infections |
| D014036 | Togaviridae Infections |
| D000073618 | Varicella Zoster Virus Infection |
| D006566 | Herpesviridae Infections |
| D004266 | DNA Virus Infections |
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| ID | Term |
|---|---|
| D012411 | Rubella Vaccine |
| D053061 | Herpes Zoster Vaccine |
| ID | Term |
|---|---|
| D014765 | Viral Vaccines |
| D014612 | Vaccines |
| D001688 | Biological Products |
| D045424 | Complex Mixtures |
| D019433 | Chickenpox Vaccine |
| D022283 | Herpesvirus Vaccines |
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