SPECIAL INVESTIGATION FOR ABRYSVO IN PREGNANT WOMEN AND INFANTS

Pfizer

Status: Active, not recruiting

Conditions: Respiratory Tract Infection

Treatments: Biological: RSVpreF vaccine

Study type: Observational

Funder types: Industry

Identifiers

NCT06482099

C3671015

Details and patient eligibility

About

This post-marketing study is a multicenter cohort study in pregnant women vaccinated with Abrysvo (RSV vaccine）designed to confirm the safety in pregnant women and their infants under actual clinical practice in Japan.

Enrollment: 490 estimated patients

Sex: All

Ages: Under 99 years old

Volunteers: Accepts Healthy Volunteers

Inclusion criteria

1. Pregnant women who have been vaccinated with Abrysvo for the first time after Abrysvo is launched. Pregnant women who have previously participated in the clinical trials of Abrysvo will be excluded.
2. Vaccinated participants who have provided written consent regarding their participation in the study and entry of symptoms to ePRO with the use of their devices (smartphones, tablets PC, etc.) (or paper-PRO if there is any compelling reason) upon understanding the explanatory document. For a minor vaccinated participant, the parent(s) or legally acceptable representatives shall provide written consent.
3. Pregnant women who have provided written consent to the participation of their infants in the study. For a minor vaccinated participant, the parent(s) or legally acceptable representatives shall provide written consent.

Exclusion criteria

• There are no exclusion criteria for this study.

Trial design

490 participants in 1 patient group

RSVpreF vaccine

Description:

Pregnant women who have been vaccinated with Abrysvo for the first time.

Treatment:

Biological: RSVpreF vaccine