Active — Not RecruitingNot Applicable

SPECIAL INVESTIGATION FOR ABRYSVO IN INDIVIDUALS AGED 60 YEARS OR OLDER

Japan1,100 participantsStarted 2025-05-27

Plain-language 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.

Who can participate

Age range60 Years

SexALL

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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.

What they're measuring

Percentage of individuals aged 60 years or older reporting Adverse Reactions for 28 days after vaccination.

Timeframe: 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.

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

Trial details

NCT IDNCT06546800

SponsorPfizer

Sponsor typeINDUSTRY

Study typeOBSERVATIONAL

Primary completion2027-10-28

View on ClinicalTrials.gov More Respiratory Syncytial Virus Infection trials