CompletedNot Applicable

SPECIAL INVESTIGATION FOR ABRYSVO IN PREGNANT WOMEN AND INFANTS

Japan497 participantsStarted 2024-10-01

Plain-language 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.

Who can participate

Age range0 Years

SexALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

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.

What they're measuring

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

Timeframe: 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

Timeframe: 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

Timeframe: up to 7 days after vaccination

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

Timeframe: up to 28 days after birth

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

Timeframe: up to 28 days after birth

Trial details

NCT IDNCT06482099

SponsorPfizer

Sponsor typeINDUSTRY

Study typeOBSERVATIONAL

Primary completion2026-02-27

View on ClinicalTrials.gov More Respiratory Tract Infection trials

Who can participate

Age range0 Years

SexALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

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.

What they're measuring

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

Timeframe: 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

Timeframe: 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

Timeframe: up to 7 days after vaccination

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

Timeframe: up to 28 days after birth

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

Timeframe: up to 28 days after birth