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The study is an interventional, non-randomized assessment of safety and efficacy of live Measles, Mumps and Rubella (MMR) vaccine in subjects aged 12-months to 17 years who have undergone heart transplantation. Subjects who provide permission/assent will receive the commercial MMR vaccine according to product indication and labeling.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Measles, Mumps, Rubella Vaccination | Experimental | Patients receiving MMR vaccination due to no historical vaccine OR a seronegativity for measles |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Commercial measles, mumps, and rubella (MMR) vaccine | Drug | Participants will receive the commercial MMR vaccine if they are deemed eligible for the study. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Number of participants who experience adverse reactions to the measles, mumps, and rubella vaccination | Patients will be screened for adverse reactions following vaccine administration | Between 0-240 days after vaccine administration |
| Number of participants with resultant initial seropositivity against measles after vaccination | Serologic response will be measured after vaccine administration. | Between 60-240 days after vaccine administration. |
| Measure | Description | Time Frame |
|---|---|---|
| Number of participants who experience prolonged seropositivity after vaccine administration | Serologic response will be tested at least 365 days after final vaccine administration | Minimum of 365 days after vaccine administration |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Victoria Blazek, PharmD, BCPPS | Children's Mercy Hospital Kansas City | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Children's Mercy Hospital | Recruiting | Kansas City | Missouri | 64108 | United States |
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| ID | Term |
|---|---|
| D008457 | Measles |
| D009107 | Mumps |
| D012409 | Rubella |
| ID | Term |
|---|---|
| D018185 | Morbillivirus Infections |
| D018184 | Paramyxoviridae Infections |
| D018701 | Mononegavirales Infections |
| D012327 | RNA Virus Infections |
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| ID | Term |
|---|---|
| D014612 | Vaccines |
| ID | Term |
|---|---|
| D001688 | Biological Products |
| D045424 | Complex Mixtures |
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| 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 |