- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT03457194
Optimising Protection for Pregnant Women and Infants With Maternal Vaccination (OPTIWIN)
This study has been designed to investigate if:
- BMI affects the immunogenicity of influenza and pertussis vaccines given during pregnancy.
- If pertussis vaccine co-administered with influenza vaccine impacts on the immunogenicity of the influenza vaccine.
- If BMI affects transplacental antibody transfer efficiency following maternal vaccinations.
Study Overview
Status
Conditions
Intervention / Treatment
Detailed Description
Study Type
Enrollment (Actual)
Contacts and Locations
Study Contact
- Name: Michelle F Clarke, MLS,GDSC,MPH
- Phone Number: (08) 81618105
- Email: michelle.clarke@adelaide.edu.au
Study Locations
-
-
South Australia
-
North Adelaide, South Australia, Australia, 5006
- Women's and Children's Hospital
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-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Sampling Method
Study Population
Description
Inclusion Criteria:
- 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 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 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.
Study Plan
How is the study designed?
Design Details
- Observational Models: Cohort
- Time Perspectives: Prospective
Cohorts and Interventions
Group / Cohort |
Intervention / Treatment |
---|---|
Pregnant women
150 participants (pregnant women at least 18 years of age and meeting eligibility criteria) will be enrolled and administered the FluQuadri, the quadrivalent influenza vaccine which will be administered by single-dose intramuscular injection. Single-dose intramuscular injection of Adacel - DTP vaccine (multiple actives) will also be administered to all enrolled pregnant women who are at gestation 28 weeks or greater at the time of enrolment. Where the vaccines are to be co-administered, FluQuadri will be administered into the dominant arm and Adacel into the non-dominant arm. Pregnant women will be at a gestation of 20 weeks or greater at the time of enrolment. The vaccines administered are currently licensed and recommended in Australia to be given during pregnancy. |
Inactivated quadrivalent influenza vaccine that is used for active immunisation against influenza A, B virus strains (contained in vaccine).
Single dose administration by intramuscular injection to all enrolled pregnant women as part of routine antenatal care.
Other Names:
Pertussis vaccine acellular combined with diphtheria and tetanus toxoids.
Single dose administration by intramuscular injection, to all enrolled pregnant women who are 28 weeks or greater gestation at time of enrolment, as part of routine antenatal care.
Other Names:
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Immunogenicity against the 4 influenza strains included in the 2017-2019 Southern Hemisphere Influenza vaccine pre and post vaccination in obese and non-obese women
Time Frame: 1 month post vaccination
|
1. Hl titres (as measured by Haemagglutination Inhibition Assay). 1. Proportion with antibody titres (HI>=40) following vaccination. |
1 month post vaccination
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Antibodies to pertussis antigens
Time Frame: 1 month post vaccination compared with baseline (pre vaccination).
|
1. antibody titres to PRN, PT, FHA (measured by ELISA)
|
1 month post vaccination compared with baseline (pre vaccination).
|
Persistence of antibodies to pertussis antigens
Time Frame: 6 months post vaccination.
|
1. antibody titres to PRN, PT, FHA (measured by ELISA)
|
6 months post vaccination.
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Persistence of antibodies to the 4 influenza strains included in the 2017-2019
Time Frame: 6 months post vaccination
|
1. Hl titres (as measured by Haemagglutination Inhibition Assay). 1. Proportion with antibody titres (HI>=40) following vaccination. |
6 months post vaccination
|
Other Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Serum cytokines
Time Frame: 1 month post vaccination
|
Serum cytokine (TNF, IL6, IFNg) concentration (as measured by flow cytometry/ bead array).
|
1 month post vaccination
|
Serum cytokines
Time Frame: 6 month post vaccination.
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Serum cytokine (TNF, IL6, IFNg) concentration (as measured by flow cytometry/ bead array)
|
6 month post vaccination.
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birthweight
Time Frame: delivery of infant
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weight in grams
|
delivery of infant
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haemagglutination Inhibition Antibody Titres in cord blood
Time Frame: at delivery of infant
|
HI Titre (as measured by Haemagglutination Inhibition Assay)
|
at delivery of infant
|
Collaborators and Investigators
Collaborators
Investigators
- Principal Investigator: Helen S Marshall, MBBS,MD,MPH, Vaccinology and Immunology Research Trials Unit (VIRTU)
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Estimated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- HREC/17/WCHN/63
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
IPD Plan Description
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
product manufactured in and exported from the U.S.
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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