Status:
ACTIVE_NOT_RECRUITING
Optimising Protection for Pregnant Women and Infants With Maternal Vaccination
Lead Sponsor:
Women's and Children's Hospital, Australia
Collaborating Sponsors:
Sanofi Pasteur, a Sanofi Company
Conditions:
Obesity
Eligibility:
FEMALE
18+ years
Brief Summary
This study has been designed to investigate if: 1. BMI affects the immunogenicity of influenza and pertussis vaccines given during pregnancy. 2. If pertussis vaccine co-administered with influenza va...
Detailed Description
A clinical observation study to determine whether obesity during pregnancy is associated with altered immunogenicity of influenza and pertussis vaccines during pregnancy. The study will also assess va...
Eligibility Criteria
Inclusion
- 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 etc).
- Pregnant women aged 18 years and over at the time of vaccination.
- Able to understand the information sheet and provide a written informed consent.
Exclusion
- 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 requiring treatment with insulin).
- History of seasonal influenza or dTpa vaccination within the last 6 months prior to enrolment.
- History of any immunosuppressive condition or currently on immunosuppressive medication.
- Any contraindication to influenza or dTpa immunisation.
- Anaphylaxis following a previous dose of any influenza or pertussis containing vaccine.
- History of anaphylaxis to egg.
- Past history of Guillain Barre Syndrome.
- Bleeding diathesis or condition associated with prolonged bleeding that may contraindicate intramuscular injection or blood draw.
- Receipt of immunoglobulins, blood or blood products within the past 6 months.
Key Trial Info
Start Date :
August 28 2018
Trial Type :
OBSERVATIONAL
Allocation :
ACTUAL
End Date :
March 1 2024
Estimated Enrollment :
73 Patients enrolled
Trial Details
Trial ID
NCT03457194
Start Date
August 28 2018
End Date
March 1 2024
Last Update
January 31 2024
Active Locations (1)
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1
Women's and Children's Hospital
North Adelaide, South Australia, Australia, 5006