SPECIAL INVESTIGATION FOR ABRYSVO IN PREGNANT WOMEN AND INFANTS

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

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.

Study Overview

• Status: Completed
• Conditions: Respiratory Tract Infection
• Intervention / Treatment: Biological: RSVpreF vaccine

• Study Type: Observational
• Enrollment (Actual): 497

Contacts and Locations

Study Locations

• Japan
  • Tokyo, Japan
    • Pfizer

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Child; Adult; Older Adult
• Accepts Healthy Volunteers: Yes

• Sampling Method: Probability Sample

Study Population

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

Description

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.

Study Plan

How is the study designed?

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
RSVpreF vaccine; Pregnant women who have been vaccinated with Abrysvo for the first time.	Biological: RSVpreF vaccine; Injection in the muscle, 1 dose 0.5mL; Other Names: Abrysvo

What is the study measuring?

Primary Outcome Measures

Outcome 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

Collaborators and Investigators

• Sponsor: Pfizer
• Investigators: Study Director: Pfizer CT.gov Call Center, Pfizer

Publications and helpful links

Helpful Links

• To obtain contact information for a study center near you, click here.

Study record dates

Study Major Dates

• Study Start (Actual): October 1, 2024
• Primary Completion (Actual): February 27, 2026
• Study Completion (Actual): February 27, 2026

Study Registration Dates

• First Submitted: June 26, 2024
• First Submitted That Met QC Criteria: June 26, 2024
• First Posted (Actual): July 1, 2024

Study Record Updates

• Last Update Posted (Actual): April 9, 2026
• Last Update Submitted That Met QC Criteria: April 3, 2026
• Last Verified: April 1, 2026

More Information

Terms related to this study

• Keywords: Infant; Maternal; Respiratory Tract infection; RSV Vaccine; Post Marketing Study
• Additional Relevant MeSH Terms: Infections; Respiratory Tract Diseases; Respiratory Tract Infections; abrysvo
• Other Study ID Numbers: C3671015; NCT06482099 (Registry Identifier: ClinicalTrials.gov)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO
• IPD Plan Description: Pfizer will provide access to individual de-identified participant data and related study documents (e.g. protocol, Statistical Analysis Plan (SAP), Clinical Study Report (CSR)) upon request from qualified researchers, and subject to certain criteria, conditions, and exceptions. Further details on Pfizer's data sharing criteria and process for requesting access can be found at: https://www.pfizer.com/science/clinical_trials/trial_data_and_results/data_requests.