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Optimising Protection for Pregnant Women and Infants With Maternal Vaccination

UnknownN/A

Sponsor: Women's and Children's Hospital, Australia

Conditions: Obesity

Interventions: Quadrivalent Influenza Vaccine, DTP Vaccine (Multiple Actives)

Countries: Australia

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.

Eligibility overview

Sex: FEMALE

Age: 18 Years to —

Healthy volunteers: Yes

Study type: OBSERVATIONAL

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.

Locations (1)

North Adelaide, South Australia, Australia