SPECIAL INVESTIGATION FOR ABRYSVO IN INDIVIDUALS AGED 60 YEARS OR OLDER
1 other identifier
observational
1,100
1 country
1
Brief Summary
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for all trials
Started May 2025
Typical duration for all trials
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
August 6, 2024
CompletedFirst Posted
Study publicly available on registry
August 9, 2024
CompletedStudy Start
First participant enrolled
May 27, 2025
CompletedPrimary Completion
Last participant's last visit for primary outcome
October 28, 2027
ExpectedStudy Completion
Last participant's last visit for all outcomes
October 28, 2027
February 4, 2026
February 1, 2026
2.4 years
August 6, 2024
February 3, 2026
Conditions
Keywords
Outcome Measures
Primary Outcomes (2)
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.
Study Arms (1)
RSVpreF vaccine
Individuals aged 60 years or older who has been vaccinated with Abrysvo for the first time.
Interventions
Eligibility Criteria
Individuals aged 60 years or older who have been vaccinated with Abrysvo for the first time.
You may qualify if:
- Individuals aged 60 years or older who have been vaccinated with Abrysvo for the first time after Abrysvo is launched. Those who have previously participated in the clinical trials of this product will be excluded.
- Vaccinated participants (or his/her legally acceptable representative) who understand the information on this study and have provided written consent regarding their participation in the study.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Pfizerlead
Study Sites (1)
Pfizer
Tokyo, Japan
Related Links
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Study Officials
- STUDY DIRECTOR
Pfizer CT.gov Call Center
Pfizer
Study Design
- Study Type
- observational
- Observational Model
- COHORT
- Time Perspective
- PROSPECTIVE
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
August 6, 2024
First Posted
August 9, 2024
Study Start
May 27, 2025
Primary Completion (Estimated)
October 28, 2027
Study Completion (Estimated)
October 28, 2027
Last Updated
February 4, 2026
Record last verified: 2026-02
Data Sharing
- IPD Sharing
- Will not share
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.