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

2014-08-27 03:17:36 | BioPortfolio

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.

Study Design

Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Prevention

Conditions

Influenza

Intervention

Non-adjuvanted A(H1N1)v influenza vaccine

Location

CHU de Besançon-Hôpital Saint-Jacques
Besançon
France
25030

Status

Completed

Source

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

Results (where available)

View Results

Links

Published on BioPortfolio: 2014-08-27T03:17:36-0400

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Medical and Biotech [MESH] Definitions

A subtype of INFLUENZA A VIRUS comprised of the surface proteins hemagglutinin 1 and neuraminidase 1. The H1N1 subtype was responsible for the Spanish flu pandemic of 1918.

Species of the genus INFLUENZAVIRUS B that cause HUMAN INFLUENZA and other diseases primarily in humans. Antigenic variation is less extensive than in type A viruses (INFLUENZA A VIRUS) and consequently there is no basis for distinct subtypes or variants. Epidemics are less likely than with INFLUENZA A VIRUS and there have been no pandemics. Previously only found in humans, Influenza B virus has been isolated from seals which may constitute the animal reservoir from which humans are exposed.

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Infection of domestic and wild fowl and other BIRDS with INFLUENZA A VIRUS. Avian influenza usually does not sicken birds, but can be highly pathogenic and fatal in domestic POULTRY.

Vaccines used to prevent infection by viruses in the family ORTHOMYXOVIRIDAE. It includes both killed or attenuated vaccines. The composition of the vaccines is changed each year in response to antigenic shifts and changes in prevalence of influenza virus strains. The vaccine is usually bivalent or trivalent, containing one or two INFLUENZAVIRUS A strains and one INFLUENZAVIRUS B strain.

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