SPECIAL INVESTIGATION FOR ABRYSVO 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.

Active, Not Recruiting

This study is active but is not currently recruiting participants.

Key information

Conditions

Respiratory Syncytial Virus Infection Infections Mononegavirales Infections Paramyxoviridae Infections Pneumovirus Infections RNA Virus Infections Respiratory Syncytial Virus Infections Virus Diseases

Age range

60 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Pfizer

Tokyo, Japan

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

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.

Exclusion criteria

-There are no exclusion criteria for this study.

Treatment and study plan

RSVpreF vaccine

Biological

Injection in the muscle, 1 dose 0.5mL

Other names: Abrysvo

Primary outcomes

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.
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.

Sponsors and collaborators

Lead sponsor

Pfizer

Industry

Registry information

Official study title

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

Important dates

Study start: 2025
Primary completion: 2027
Study completion: 2027
First posted: Aug 9, 2024
Registry last updated: Feb 4, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.

Active, Not Recruiting