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

NCT01024400 · Status: COMPLETED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 110

Last updated 2025-12-10

No results posted yet for this study

Summary

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.

Conditions

Interventions

BIOLOGICAL

Non-adjuvanted A(H1N1)v influenza vaccine

15 mcg HA/0.5 ml

Sponsors & Collaborators

  • MCM Vaccines B.V.

    collaborator INDUSTRY

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

    lead OTHER_GOV

Principal Investigators

  • Odile Launay, MD · Groupe hospitalier Cochin Saint Vincent de Paul

  • Vassilis Tsatsaris, MD · Groupe hospitalier Cochin Saint Vincent de Paul

Study Design

Allocation
NA
Purpose
PREVENTION
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Max Age
45 Years
Sex
FEMALE
Healthy Volunteers
No

Timeline & Regulatory

Start
2009-11-30
Primary Completion
2010-01-31
Completion
2010-07-31

Countries

  • France

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01024400 on ClinicalTrials.gov