The Safety and Immune Response to Influenza Vaccination in Pregnant Women
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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.
The primary endpoint will be the seroprotection rate which is defined as the proportion of subjects with HAI titer ≥ 1:40. The other immunogenicity endpoints include seroconversion rate and geometric mean folds increase in HAI titer. [ Time Frame: Immunogenicity profile was assessed before vaccination, 4 weeks after the vaccination and at the end of gestation period. Moreover, the HAI titer of the cord blood was also measured and compared with the maternal blood sample. ]
The primary endpoint will be the seroprotection rate which is defined as the proportion of subjects with HAI titer ≥ 1:40. The other immunogenicity endpoints include seroconversion rate and geometric mean folds increase in HAI titer. Immunogenicity profile will be assessed before vaccination, 4 weeks after the vaccination and at the end of gestation period.
Secondary Outcome Measures :
The secondary endpoint is to evaluate the safety and tolerability profiles including the presence or absence of the pre-specified reactogenicity events and other serious/non-serious adverse events of the AdimFlu-S. [ Time Frame: The safety information is collected from the day of vaccination to 8 weeks after the delivery. ]
Safety outcomes include immediate reactions at the time of vaccination, solicited local and systemic reactions for 7 days, unsolicited adverse events until the first post-vaccination serum collected (Day 28), and serious adverse events and adverse events of special interest until 8 weeks after the delivery.
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Ages Eligible for Study:
18 Years and older (Adult, Senior)
Sexes Eligible for Study:
Accepts Healthy Volunteers:
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.
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;