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OpenTrials
Completed

NCT Number: NCT06482099

SPECIAL INVESTIGATION FOR ABRYSVO 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.

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Key information

Conditions

Respiratory Tract Infection Infections Respiratory Tract Diseases Respiratory Tract Infections

Age range

0 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Pfizer

Tokyo, Japan

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 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.

Exclusion criteria

  • There are no exclusion criteria for this study.

Treatment and study plan

RSVpreF vaccine

Biological

Injection in the muscle, 1 dose 0.5mL

Other names: Abrysvo

Primary outcomes

  1. Percentage of pregnant women reporting Adverse Reactions for 28 days after vaccination

    Time frame: up to 28 days after vaccination

  2. Percentage of pregnant women reporting Serious Adverse Reactions from the day of vaccination up to 28 days after delivery

    Time frame: up to 28 days after delivery

  3. Percentage of pregnant women reporting reactogenicity events (local reactions and systemic events) from day of vaccination up to 7 days after vaccination

    Time frame: up to 7 days after vaccination

  4. Percentage of infants reporting Adverse Reactions from the birthday up to 28 days after birth

    Time frame: up to 28 days after birth

  5. Percentage of infants reporting Serious Adverse Reactions from the birthday up to 28 days after birth

    Time frame: up to 28 days after birth

Sponsors and collaborators

Lead sponsor

Pfizer

Industry

Registry information

Official study title

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

Important dates

Study start
2024
Primary completion
2026
Study completion
2026
First posted
Jul 1, 2024
Registry last updated
Apr 9, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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