SPECIAL INVESTIGATION FOR ABRYSVO IN INDIVIDUALS AGED 60 YEARS OR OLDER

February 3, 2026 updated by: Pfizer

SPECIAL INVESTIGATION FOR ABRYSVO INTRAMUSCULAR INJECTION -INVESTIGATION IN INDIVIDUALS AGED 60 YEARS OR OLDER-

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.

Study Overview

Status

Active, not recruiting

Conditions

Intervention / Treatment

Study Type

Observational

Enrollment (Estimated)

1100

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Japan
      • Tokyo, Japan
        • Pfizer

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

Yes

Sampling Method

Probability Sample

Study Population

Individuals aged 60 years or older who have been vaccinated with Abrysvo for the first time.

Description

Inclusion Criteria:

  1. 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.
  2. 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.

Exclusion Criteria:

-There are no exclusion criteria for this study.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
RSVpreF vaccine
Individuals aged 60 years or older who has been vaccinated with Abrysvo for the first time.
Biological: RSVpreF vaccine
Injection in the muscle, 1 dose 0.5mL
Other Names:
  • Abrysvo

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Percentage of individuals aged 60 years or older reporting Adverse Reactions for 28 days after vaccination.
Time Frame: From the day of vaccination up to 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.
Time Frame: 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.

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Pfizer

Investigators

  • Study Director: Pfizer CT.gov Call Center, Pfizer

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

May 27, 2025

Primary Completion (Estimated)

October 28, 2027

Study Completion (Estimated)

October 28, 2027

Study Registration Dates

First Submitted

August 6, 2024

First Submitted That Met QC Criteria

August 6, 2024

First Posted (Actual)

August 9, 2024

Study Record Updates

Last Update Posted (Actual)

February 4, 2026

Last Update Submitted That Met QC Criteria

February 3, 2026

Last Verified

February 1, 2026

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • C3671019

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

IPD Plan Description

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.

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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