SPECIAL INVESTIGATION FOR ABRYSVO IN PREGNANT WOMEN AND INFANTS

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

ACTIVE_NOT_RECRUITING

Total Enrollment

497 participants

Study Classification

OBSERVATIONAL

Study Start Date

2024-10-01

Study Completion Date

2026-03-11

Brief Summary

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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.

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Detailed Description

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Conditions

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Respiratory Tract Infection

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

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RSVpreF vaccine

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

RSVpreF vaccine

Intervention Type BIOLOGICAL

Injection in the muscle, 1 dose 0.5mL

Interventions

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RSVpreF vaccine

Injection in the muscle, 1 dose 0.5mL

Intervention Type BIOLOGICAL

Other Intervention Names

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Abrysvo

Eligibility Criteria

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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.

Minimum Eligible Age

0 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes