NCT03457194

Optimising Protection for Pregnant Women and Infants With Maternal Vaccination

• Status: Unknown
• Phase: —
• Study type: Observational
• Enrollment: 73 (actual)
• Sponsor: Women's and Children's Hospital, Australia · Other Government
• Sex: Female
• Age: 18 Years
• Healthy volunteers: Accepted

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 vaccine impacts on the immunogenicity of the influenza vaccine. 3. If BMI affects transplacental antibody transfer efficiency following maternal vaccinations.

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 vaccine specific antibody concentrations in cord blood collected from vaccinated women at the time of delivery to estimate any effect of obesity on transplacental transfer of antibodies and will measure and compare cytokine profiles between obese and non-obese participants to determine any correlation with immune responses. This study will enrol 150 pregnant women (50 obese and 100 non-obese) during 2017-2019 to receive a recommended, licensed influenza vaccine (FluQuadri) as well as pertussis vaccination (Adacel) for women enrolled in their third trimester, as part of routine antenatal care. Local and systemic adverse events will be captured using a 7 day diary card and unexpected or serious adverse events will be recorded for the duration of the study. Blood samples will be collected to measure antigen specific vaccine antibody responses. The proportion of influenza vaccine recipients achieving seroprotective antibody titres at 4 weeks post vaccination and persisting at 6 months post vaccination be compared between obese and non-obese recipients.

Conditions

• Obesity

Interventions

Type	Name	Description
BIOLOGICAL	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.
BIOLOGICAL	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.

Timeline

• Start date: 2018-08-28
• Primary completion: 2023-09-29
• Completion: 2024-03-01
• First posted: 2018-03-07
• Last updated: 2024-01-31

Locations

1 site across 1 country: Australia

Regulatory

• FDA-regulated drug study