SPECIAL INVESTIGATION FOR ABRYSVO IN INDIVIDUALS AGED 60 YEARS OR OLDER

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

ACTIVE_NOT_RECRUITING

Total Enrollment

1100 participants

Study Classification

OBSERVATIONAL

Study Start Date

2025-05-27

Study Completion Date

2027-10-28

Brief Summary

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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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Detailed Description

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Conditions

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Respiratory Syncytial Virus Infection

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

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RSVpreF vaccine

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

RSVpreF vaccine

Intervention Type BIOLOGICAL

Injection in the muscle, 1 dose 0.5mL

Interventions

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RSVpreF vaccine

Injection in the muscle, 1 dose 0.5mL

Intervention Type BIOLOGICAL

Other Intervention Names

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Abrysvo

Eligibility Criteria

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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.

Minimum Eligible Age

60 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes