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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/study/NCT03457194




Registration number
NCT03457194
Ethics application status
Date submitted
17/09/2017
Date registered
7/03/2018

Titles & IDs
Public title
Optimising Protection for Pregnant Women and Infants With Maternal Vaccination
Scientific title
Optimising Protection for Pregnant Women and Infants With Maternal Vaccination
Secondary ID [1] 0 0
HREC/17/WCHN/63
Universal Trial Number (UTN)
Trial acronym
OPTIWIN
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Obesity 0 0
Condition category
Condition code
Diet and Nutrition 0 0 0 0
Obesity
Metabolic and Endocrine 0 0 0 0
Other metabolic disorders

Intervention/exposure
Study type
Observational
Patient registry
Target follow-up duration
Target follow-up type
Description of intervention(s) / exposure
Treatment: Other - Quadrivalent Influenza Vaccine
Treatment: Other - DTP Vaccine (Multiple Actives)

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.


Treatment: Other: Quadrivalent Influenza Vaccine
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.

Treatment: Other: DTP Vaccine (Multiple Actives)
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.
Intervention code [1] 0 0
Treatment: Other
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
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
Timepoint [1] 0 0
1 month post vaccination
Secondary outcome [1] 0 0
Antibodies to pertussis antigens
Timepoint [1] 0 0
1 month post vaccination compared with baseline (pre vaccination).
Secondary outcome [2] 0 0
Persistence of antibodies to pertussis antigens
Timepoint [2] 0 0
6 months post vaccination.
Secondary outcome [3] 0 0
Persistence of antibodies to the 4 influenza strains included in the 2017-2019
Timepoint [3] 0 0
6 months post vaccination

Eligibility
Key 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.
Minimum age
18 Years
Maximum age
No limit
Sex
Females
Can healthy volunteers participate?
Yes
Key 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 design
Purpose
Duration
Selection
Timing
Prospective
Statistical methods / analysis

Recruitment
Recruitment status
Active, not recruiting
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
28/08/2018
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
1/03/2024
Actual
Sample size
Target
Accrual to date
Final
73
Recruitment in Australia
Recruitment state(s)
SA
Recruitment hospital [1] 0 0
Women's and Children's Hospital - North Adelaide
Recruitment postcode(s) [1] 0 0
5006 - North Adelaide

Funding & Sponsors
Primary sponsor type
Government body
Name
Women's and Children's Hospital, Australia
Address
Country
Other collaborator category [1] 0 0
Commercial sector/industry
Name [1] 0 0
Sanofi Pasteur, a Sanofi Company
Address [1] 0 0
Country [1] 0 0

Ethics approval
Ethics application status

Summary
Brief summary
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 0 0
Helen S Marshall, MBBS,MD,MPH
Address 0 0
Vaccinology and Immunology Research Trials Unit (VIRTU)
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for public queries
Name 0 0
Address 0 0
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for scientific queries

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
No
No/undecided IPD sharing reason/comment
Individual participant data (IPD) will not be made available to share with other researchers


What supporting documents are/will be available?

No Supporting Document Provided



Results publications and other study-related documents

No documents have been uploaded by study researchers.


Results not provided in https://clinicaltrials.gov/study/NCT03457194