Skip to main content
OpenTrials
Completed

NCT Number: NCT01024400

Immunogenicity and Safety of an Inactivated Non-adjuvanted A(H1N1)v Influenza Vaccine in Pregnant Women

The purpose of this study is to evaluate the immunogenicity and safety of an inactivated, non adjuvanted A(H1N1)v influenza vaccine in 120 pregnant women.

Study procedures will include 2 doses of vaccine, blood samples, cord blood samples at delivery and recording temperature and vaccine side effects in a memory aid for 7 days following each vaccination. Participants will be involved in study related procedures about 3 at 5 months.

Completed

Looking for future studies?

Notify Me

Key information

Conditions

Influenza Infections Influenza, Human Orthomyxoviridae Infections RNA Virus Infections Respiratory Tract Diseases Respiratory Tract Infections Virus Diseases

Age range

18 year–45 year

Sex eligibility

Female

Study type

Interventional

Phase

Phase 2

Primary location

CHU de Besançon-Hôpital Saint-Jacques, Besançon, France

Loading trial locations.

Who can participate

Healthy volunteers accepted: No

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

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

Treatment and study plan

Non-adjuvanted A(H1N1)v influenza vaccine

Biological

15 mcg HA/0.5 ml

Primary outcomes

  1. Immunogenicity: proportion of subjects achieving a serum HAI antibody titer of greater than or equal to 1:40, proportion of subjects with 4-fold or greater HAI antibody titer increases against H1N1 2009 virus following H1N1 vaccine.

    Time frame: Day 21

Secondary outcomes

  1. Safety: occurence of local and systemic adverse events

    Time frame: Throughout the course of the study

  2. Immunogenicity: proportion of subjects achieving a serum HAI antibody titer of greater than or equal to 1:40, proportion of subjects with 4-fold or greater HAI antibody titer increases against H1N1 2009 virus following H1N1 vaccine.

    Time frame: Day 42 and at delivery

  3. Safety:occurence of vaccine-associated serious adverse events

    Time frame: Throughout the course of the study

Sponsors and collaborators

Lead sponsor

Institut National de la Santé Et de la Recherche Médicale, France

Other Gov

Collaborators

  • MCM Vaccines B.V.

Registry information

Official study title

Etude de Phase II évaluant l'immunogénicité et la tolérance d'un Vaccin inactivé Non adjuvanté Contre la Grippe A(H1N1)v Chez la Femme Enceinte

Acronym: PREFLUVAC

Important dates

Study start
2009
Primary completion
2010
Study completion
2010
First posted
Dec 2, 2009
Registry last updated
Dec 10, 2025

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.

Related clinical trials

Published trials that share one or more normalized conditions with this study.