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Local authorities no longer require routine PMS studies; GSK does not believe the study would add meaningfully to the safety data already available for MMRV.
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This study will collect data on the safety of the MMRV vaccine (Priorix-Tetraâ„¢) used in routine practice in children aged 12 months to 12 years living in the Philippines.
The participating physicians will enroll only those subjects for whom they would prescribe Priorix-Tetra in the course of their normal clinical practice.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Cohort Group | Children aged 12 months to 12 years will receive Priorix-Tetra as prescribed by the physician. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Priorix-Tetraâ„¢ | Biological | Single dose, subcutaneous injection |
| |
| Measure | Description | Time Frame |
|---|---|---|
| Occurrence of Grade 3 adverse events (AEs) with a causal relationship to vaccination | Between Day 0 and Day 42 |
| Measure | Description | Time Frame |
|---|---|---|
| Occurrence of Grade 3 AEs | Between Day 0 and Day 42 | |
| Occurrence of medically-attended AEs | Between Day 0 and Day 42 | |
| Occurrence of Serious Adverse Events (SAEs) |
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Inclusion Criteria:
Subjects who the investigator believes that parent(s)/Legally Acceptable Representative(s) [LAR(s)] can and will comply with the requirements of the protocol.
Written informed consent obtained from the parent(s)/LAR(s) of the subject.
Male or female subjects living in the Philippines between, and including, the ages of 12 months and 12 years at the time of the vaccination.
Female subjects of child bearing potential may be enrolled in the study, if the subject:
Exclusion Criteria:
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Children aged 12 months to 12 years living in Philippines will receive Priorix-Tetra as prescribed by the physician.
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| Name | Affiliation | Role |
|---|---|---|
| GSK Clinical Trials | GlaxoSmithKline | Study Director |
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| ID | Term |
|---|---|
| D009107 | Mumps |
| D012409 | Rubella |
| D008457 | Measles |
| D002644 | Chickenpox |
| ID | Term |
|---|---|
| D019351 | Rubulavirus Infections |
| D018184 | Paramyxoviridae Infections |
| D018701 | Mononegavirales Infections |
| D012327 | RNA Virus Infections |
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| ID | Term |
|---|---|
| C577557 | Priorix-Tetra vaccine |
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| Safety data collection |
| Other |
Recording of adverse events, using diary cards |
|
| From the time of vaccination (Week 0) to study end (Week 6) |
| Occurrence of febrile convulsions | Between Day 0 and Day 42 |
| D014777 | Virus Diseases |
| D007239 | Infections |
| D010309 | Parotitis |
| D010305 | Parotid Diseases |
| D012466 | Salivary Gland Diseases |
| D009059 | Mouth Diseases |
| D009057 | Stomatognathic Diseases |
| D018355 | Rubivirus Infections |
| D014036 | Togaviridae Infections |
| D018185 | Morbillivirus Infections |
| D000073618 | Varicella Zoster Virus Infection |
| D006566 | Herpesviridae Infections |
| D004266 | DNA Virus Infections |