SPECIAL INVESTIGATION FOR ABRYSVO IN PREGNANT WOMEN AND INFANTS

Special Investigation for ABRYSVO Intramuscular Injection -Investigation in Pregnant Women and Infants-

Status

Completed

Phases

Unknown

Study type

Observational

Source

ClinicalTrials.gov

Registry ID

NCT06482099

Enrollment

497

Registered

2024-07-01

Start date

2024-10-01

Completion date

2026-02-27

Last updated

2026-04-09

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Respiratory Tract Infection

Keywords

Respiratory Tract infection, RSV Vaccine, Maternal, Infant, Post Marketing Study

Brief summary

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.

Interventions

BIOLOGICALRSVpreF vaccine

Injection in the muscle, 1 dose 0.5mL

Study design

Observational model

COHORT

Time perspective

PROSPECTIVE

Eligibility

Sex/Gender

ALL

Age

0 Years to No maximum

Healthy volunteers

Yes

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

Design outcomes

Primary

Measure	Time frame
Percentage of pregnant women reporting Adverse Reactions for 28 days after vaccination	up to 28 days after vaccination
Percentage of pregnant women reporting Serious Adverse Reactions from the day of vaccination up to 28 days after delivery	up to 28 days after delivery
Percentage of pregnant women reporting reactogenicity events (local reactions and systemic events) from day of vaccination up to 7 days after vaccination	up to 7 days after vaccination
Percentage of infants reporting Adverse Reactions from the birthday up to 28 days after birth	up to 28 days after birth
Percentage of infants reporting Serious Adverse Reactions from the birthday up to 28 days after birth	up to 28 days after birth

Countries

Japan

Contacts

STUDY_DIRECTORPfizer CT.gov Call Center

Pfizer

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Apr 10, 2026