The Safety and Immune Response to Influenza Vaccination in Pregnant Women

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;