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This post-marketing study is a multicenter cohort study in individuals aged 60 years or older vaccinated with Abrysvo (RSV vaccine)designed to confirm the safety in individuals aged 60 years or older under actual clinical practice in Japan.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| RSVpreF vaccine | Individuals aged 60 years or older who has been vaccinated with Abrysvo for the first time. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| RSVpreF vaccine | Biological | Injection in the muscle, 1 dose 0.5mL |
|
| Measure | Description | Time Frame |
|---|---|---|
| Percentage of individuals aged 60 years or older reporting Adverse Reactions for 28 days after vaccination. | Adverse reaction (including serious) in individuals aged 60 years or older will be assessed. | From the day of vaccination up to 28 days after vaccination. |
| Percentage of individuals aged 60 years or older reporting Serious Adverse Reactions from the day of vaccination up to 28 days after vaccination. | Serious adverse reaction in individuals aged 60 years or older will be assessed. | From the day of vaccination up to 28 days after vaccination. |
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Inclusion Criteria:
Exclusion Criteria:
-There are no exclusion criteria for this study.
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Individuals aged 60 years or older who have been vaccinated with Abrysvo for the first time.
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| Name | Affiliation | Role |
|---|---|---|
| Pfizer CT.gov Call Center | Pfizer | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Pfizer | Tokyo | Japan |
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| Label | URL |
|---|---|
| To obtain contact information for a study center near you, click here. | View source |
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Pfizer will provide access to individual de-identified participant data and related study documents (e.g. protocol, Statistical Analysis Plan (SAP), Clinical Study Report (CSR)) upon request from qualified researchers, and subject to certain criteria, conditions, and exceptions. Further details on Pfizer's data sharing criteria and process for requesting access can be found at: https://www.pfizer.com/science/clinical\_trials/trial\_data\_and\_results/data\_requests.
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| ID | Term |
|---|---|
| D018357 | Respiratory Syncytial Virus Infections |
| ID | Term |
|---|---|
| D018186 | Pneumovirus Infections |
| D018184 | Paramyxoviridae Infections |
| D018701 | Mononegavirales Infections |
| D012327 | RNA Virus Infections |
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| ID | Term |
|---|---|
| C000729228 | abrysvo |
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| D014777 | Virus Diseases |
| D007239 | Infections |