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Pregnant women get H1N1 vaccine in new safety trial

NCT ID NCT01024400

Vaccine Sponsor: Institut National de la Santé Et de la Recherche Médicale, France 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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 phase 2 study tested a non-adjuvanted H1N1 flu vaccine in 110 pregnant women to see if it is safe and triggers a good immune response. Participants received two doses of the vaccine and were monitored for side effects. The goal is to protect both mothers and their babies from the flu.

What this could mean

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

Active substance
Non-adjuvanted H1N1 influenza vaccine
What this could lead to
If successful, this could show that the H1N1 flu vaccine is safe and effective for pregnant women, helping protect both mother and baby during flu season.
What could go wrong
This is a small, early-phase study (phase 2) with only 110 participants, so results may not apply to all pregnant women. The vaccine may not produce a strong enough immune response or could cause side effects.

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.

Phase

Phase 2

Tests whether the treatment actually works, and watches for side effects, in a larger group.

Participants

110 people

The number who actually took part.

Start date

Nov 2009

Finished

Jul 2010

Lead sponsor

A government agency

The lead sponsor is a government body.

Who can take part

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

Ages

18 to 45 years

Sex

Female participants only

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

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: * 18 years to 45 years * Pregnancy between 22 and 32 weeks of gestation * Provides written informed consent * Covered by French Social Security Exclusion Criteria: * Allergy to eggs or other components in the vaccine * History of severe reactions following previous influenza vaccines * H1N1 influenza (virologically documented) during the last 6 months * Febrile episode within one week prior to vaccination * Known HIV, HBV, HCV infection * Multiple sclerosis * History of Guillain-Barré syndrome * Organ transplant recipient * Neoplastic disease in the past 3 years * Other vaccine within 3 weeks prior to study entry or planned within the month following the last injection * Systemic corticosteroids,immunotherapy,chemotherapy * Anticoagulant treatment * Immunoglobulin or blood transfusion within the 3 months prior to enrollment in this study * History of cardiac disease * Chronic liver disease * Diabetes before pregnancy * History of premature delivery * History of eclampsia * Fetal morphologic abnormalities

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Conditions

The condition(s) this trial relates to.

influenza swine influenza prevention target

As listed by the trial registrant

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

Influenza

Contacts and locations

Locations

  • CHU de Besançon-Hôpital Saint-Jacques

    Besançon, 25030, France

  • Groupe hospitalier Cochin Saint Vincent de Paul

    Paris, 75679, France

  • Hôpital Antoine Béclère

    Clamart, 92141, France

  • Hôpital Robert Debré

    Paris, 75935, France

  • Hôpital Sud de Rennes

    Rennes, 35056, France

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