Status:
COMPLETED
The Safety and Immune Response to Influenza Vaccination in Pregnant Women
Lead Sponsor:
Adimmune Corporation
Conditions:
Influenza
Eligibility:
FEMALE
18+ years
Phase:
PHASE4
Brief Summary
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 ...
Eligibility Criteria
Inclusion
- 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
- 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;
Key Trial Info
Start Date :
November 1 2011
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
August 1 2012
Estimated Enrollment :
46 Patients enrolled
Trial Details
Trial ID
NCT01514708
Start Date
November 1 2011
End Date
August 1 2012
Last Update
July 16 2018
Active Locations (1)
Enter a location and click search to find clinical trials sorted by distance.
1
National Taiwan University Hospital
Taipei, Taiwan, 100