Den här översättningen är inte klar ännu. Den här sidan är just nu på engelska.

Gå till den engelska sidan

Cure My Disease

Don't miss your cure!

 Log in / Sign up

RSV vaccine safety in pregnancy: new study looks at side effects for moms and infants

NCT ID NCT06482099

Vaccine Sponsor: Pfizer Source: ClinicalTrials.gov ↗

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed This study
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Jun 27, 2026 · Last updated Jun 27, 2026

Summary

This completed study in Japan checked the safety of the RSV vaccine Abrysvo in 497 pregnant women and their infants. Researchers tracked side effects in mothers for 28 days after vaccination and in babies from birth to 28 days old. The goal was to confirm the vaccine's safety in real-world use, not to measure how well it prevents infection.

What this could mean

Our plain-language read of the trial. This is informational only, not medical advice or a prediction.

Active substance
Abrysvo (RSVpreF vaccine)
What this could lead to
If safety is confirmed, this could support the use of the RSV vaccine during pregnancy to protect newborns from severe RSV infection.
What could go wrong
This is a safety-only study with no efficacy results. It was small (497 participants) and conducted only in Japan, so findings may not apply to other populations.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Participants

497 people

The number who actually took part.

Started

Oct 2024

Finished

Feb 2026

Lead sponsor

A company

The lead sponsor is a pharmaceutical, biotech, or medical-device company.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Who is studied

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

Ages

0 years and older

Sex

Anyone

Healthy volunteers

Accepted

You do not need to have the condition being studied to take part.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

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.

Get updates

Get notified about this study

Sign up to get updates when this study changes or when new studies for Respiratory tract infection are added.

Vår säkerhetsrekommendation!

Genom att skicka in godkänner du våra Användarvillkor

Conditions

The condition(s) this trial relates to.

respiratory syncytial virus infectious disease prevention target respiratory tract infectious disorder prevention target

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Respiratory tract infection

Contacts and locations

Locations

  • Pfizer

    Tokyo, Japan

More trials for these conditions

Other studies related to the condition(s) this trial covers.