SPECIAL INVESTIGATION FOR ABRYSVO IN INDIVIDUALS AGED 60 YEARS OR OLDER

Not yet recruiting

• Conditions: Respiratory Syncytial Virus Infection
• Interventions: Biological: RSVpreF vaccine

• Registration Number: NCT06546800
• Lead Sponsor: Pfizer

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2024-08-06
• Study First Submitted QC: 2024-08-06
• Study First Posted: 2024-08-09
• Status Verified: 2025-04
• Last Update Submitted: 2025-04-09
• Last Update Posted: 2025-04-11
• Study Start: 2025-04-30
• Primary Completion: 2028-09-25
• Study Completion: 2028-09-25

Recruitment & Eligibility

• Status: NOT_YET_RECRUITING
• Sex: All
• Target Recruitment: 1100

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 & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
RSVpreF vaccine	RSVpreF vaccine	Individuals aged 60 years or older who has been vaccinated with Abrysvo for the first time.

Primary Outcome Measures

Name	Time	Method
Percentage of individuals aged 60 years or older reporting Serious Adverse Reactions from the day of vaccination up to 28 days after vaccination.	From the day of vaccination up to 28 days after vaccination.	Serious adverse reaction in individuals aged 60 years or older will be assessed.
Percentage of individuals aged 60 years or older reporting Adverse Reactions for 28 days after vaccination.	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.

Trial Locations

Locations (1)

Pfizer; 🇯🇵 Tokyo, Japan