SPECIAL INVESTIGATION FOR ABRYSVO IN PREGNANT WOMEN AND INFANTS

NCT06482099 | Completed

• 2 other identifiers: C3671015NCT06482099
• Study Type: observational
• Target: 497
• Locations: 1 country
• Sites: 1

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.

Conditions

Respiratory Tract Infection

Keywords

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

Outcome Measures

Primary Outcomes (5)

• 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

Study Arms (1)

RSVpreF vaccine

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

Biological: RSVpreF vaccine

Interventions

RSVpreF vaccine BIOLOGICAL

Injection in the muscle, 1 dose 0.5mL

Also known as: Abrysvo

RSVpreF vaccine

Eligibility Criteria

• Age: 0 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

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

You may qualify if:

• 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.
• 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.
• 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.

Sponsors & Collaborators

• Pfizer: lead

Study Sites (1)

Pfizer

Tokyo, Japan

Location

Related Links

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

MeSH Terms

Conditions

Respiratory Tract Infections

Interventions

abrysvo

Condition Hierarchy (Ancestors)

Infections; Respiratory Tract Diseases

Study Officials

• Pfizer CT.gov Call Center

  Pfizer

  STUDY DIRECTOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 26, 2024
• First Posted: July 1, 2024
• Study Start: October 1, 2024
• Primary Completion: February 27, 2026
• Study Completion: February 27, 2026
• Last Updated: April 9, 2026

Record last verified: 2026-04

Data Sharing

• IPD Sharing: Will not share

Locations

JP (1)