SPECIAL INVESTIGATION FOR ABRYSVO IN INDIVIDUALS AGED 60 YEARS OR OLDER

N/AActive Not RecruitingNCT06546800

Pfizer1,100 enrolled

Overview

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 Type

OBSERVATIONAL

Enrollment

1,100

Conditions

Respiratory Syncytial Virus Infection

Interventions

RSVpreF vaccineBIOLOGICAL

Injection in the muscle, 1 dose 0.5mL

Eligibility

Sex: ALLMin age: 60 YearsHealthy volunteers:

Medical Language ↔ Plain English

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.

Locations (1)

Pfizer

Tokyo, Japan

Outcomes

Primary Outcomes

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.

Time frame: 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.

Time frame: From the day of vaccination up to 28 days after vaccination.

Data from ClinicalTrials.gov

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