Optimising Protection for Pregnant Women with Influenza Vaccination

Women's and Children's Hospital0 sites300 target enrollmentApril 8, 2014

Overview

No summary available.

Registry

who.int

Start Date

April 8, 2014

End Date

TBD

Last Updated

5 years ago

Study Type

Interventional

Sex

Female

Sponsor

Women's and Children's Hospital

•\*Pregnant women aged 18 to 40 years (inclusive) at the time of the vaccination.
•\*Written informed consent obtained from the participant.
•\*Ability to understand the information sheet and provide informed consent
•\*Participants who in the opinion of the study staff can and will comply with the requirements of the protocol (eg return for follow\-up visits, blood collection)

•\*Any major illness that, in the investigator’s judgment, will substantially increase the risk associated with the subject’s participation in the study, or interfere with the evaluation of the study objectives.
•\*History of serious medical conditions (eg cardiac, respiratory, renal, hepatic disorders, diabetes mellitus requiring treatment with insulin).
•\*History of seasonal influenza vaccination within the last six months prior to enrolment.
•\*History of any immunosuppressive condition (eg HIV infection) or on immunosuppressing medication.
•\*Any contraindication to influenza immunisation according to the Australian Immunisation Handbook.
•\*Anaphylaxis following a previous dose of any influenza vaccine
•\*Anaphylaxis following any vaccine component.
•\*History of egg allergy.
•\*History of Gullain Barre syndrome.
•\*Bleeding diathesis or condition associated with prolonged bleeding that may contraindicate intramuscular injection or blood draw, including participants taking anticoagulant medications or antiplatelet therapy (except for low dose daily aspirin therapy) within 30 days before enrolment.