Optimising Protection for Pregnant Women with Influenza Vaccinatio

Completed

• Conditions: Influenza vaccination in obese and non-obese pregnant women; Public Health - Other public health; Diet and Nutrition - Obesity; Infection - Other infectious diseases

• Registration Number: ACTRN12614000374662
• Lead Sponsor: Women's and Children's Hospital

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2014-04-08
• Last Update Posted: 5 January 2021

Recruitment & Eligibility

• Status: Completed
• Sex: Female
• Target Recruitment: 300

Inclusion Criteria

*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)

Exclusion Criteria

*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.

Study & Design

• Study Type: Interventional
• Study Design: Not specified