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Clinical Trials in Japan / NCT06546800
Active, not recruiting Observational

SPECIAL INVESTIGATION FOR ABRYSVO IN INDIVIDUALS AGED 60 YEARS OR OLDER

NCT06546800 · tracked via the Priya Life Science Japan tracker
Sponsor
Pfizer
Phase
Observational
Started
2025-05-27
Last updated
2026-02-04

Condition(s) studied

Respiratory Syncytial Virus Infection

Investigational drug(s) / intervention(s)

RSVpreF vaccine →

RSVpreF vaccine: Injection in the muscle, 1 dose 0.5mL

Study 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.

Eligibility

Sex
ALL
Min age
60 Years
Max age
—
Healthy volunteers
Accepted
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.

Primary outcome measure(s)

  • 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.
  • 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.

Trial sites (1)

FacilityCityRegionStatus
Pfizer Tokyo Japan

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Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT06546800 on ClinicalTrials.gov ↗ ← All trials in Japan