The Safety and Immune Response to Influenza Vaccination in Pregnant Women

Adimmune

Status and phase

Completed

Phase 4

Conditions

Influenza

Treatments

Biological: AdimFlu-S Influenza Vaccine

Study type

Interventional

Funder types

Industry

Identifiers

NCT01514708

FLU11T12P

Details and patient eligibility

About

The purpose of this study is to evaluate the antibody response to the influenza vaccine (AdimFlu-S), as measured by hemagglutination inhibition (HAI) at 4 weeks post immunization in pregnant women in compliance with the requirements of the current European Union (EU) recommendations for the evaluation of the immunogenicity for a new formulation of a licensed flu vaccine (CPMP/BWP/214/96). Besides, the vaccine safety will also be evaluated.

Enrollment

46 patients

Sex

Female

Ages

18+ years old

Volunteers

Accepts Healthy Volunteers

Inclusion criteria

Pregnant female aged ≥ 18 years old.
Subject is pregnant for at least 3 months, inclusive.
Subject is willing and able to adhere to visit schedules and all study requirements.
Subject has read and signed the study-specific informed consent.

Exclusion criteria

Subject with previous complicated pregnancy or preterm delivery, spontaneous or medical abortion;
Subject with history or concurrent high risk of dangerous gestation such as gestational diabetes mellitus (GDM), pregnant induced hypertension, or preeclampsia;
Subject received any influenza vaccine within the previous 6 months;
Subject has a history of hypersensitivity to eggs or egg protein or similar pharmacological effects to study vaccine;
Subject or her family has the history of Guillain-Barré Syndrome;
Subject has current upper respiratory illness (URI), including the common cold or nasal congestion within 72 hours;
Subject with influenza-like illness as defined by the presence of fever (temperature over 38ºC) and at least two of the following four symptoms: headache, muscle/joint aches and pains (e.g. myalgia/arthralgia), sore throat and cough;
Subject receive any treatment with an investigational drug or device, or participation in a clinical study, within 3 months before consent;
Subject has immunodeficiency or is under immunosuppressive treatment.
Subject received any vaccine within 1 week prior to study vaccination or expected to receive one within 1 week after study vaccination;
Subject received any blood products, including immunoglobulin, in the past 3 months before consent;
Subject has underlying condition in the investigators' opinion may interfere with evaluation of the vaccine;