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Clinical trial

Optimising Protection for Pregnant Women and Infants With Maternal Vaccination

ID
Name
HREC/17/WCHN/63
Description
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 vaccine impacts on the immunogenicity of the influenza vaccine. 3. If BMI affects transplacental antibody transfer efficiency following maternal vaccinations.
Trial arms
Trial start
2018-08-28
Estimated PCD
2023-09-29
Trial end
2024-03-01
Status
Active (not recruiting)
Treatment
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.
Arms:
Pregnant women
Other names:
FluQuadri
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.
Arms:
Pregnant women
Other names:
Adacel
Size
73
Primary endpoint
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
1 month post vaccination
Eligibility criteria
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.
Protocol
{'studyType': 'OBSERVATIONAL', 'patientRegistry': False, 'designInfo': {'observationalModel': 'COHORT', 'timePerspective': 'PROSPECTIVE'}, 'enrollmentInfo': {'count': 73, 'type': 'ACTUAL'}}
Updated at
2024-01-31

1 organization

2 products

1 indication

Organization
Women's and Children's Hospital
Product
Quadrivalent Influenza Vaccine
Indication
Obesity
Product
DTP Vaccine