Ignite Creation Date:
2025-12-25 @ 1:43 AM
Ignite Modification Date:
2025-12-26 @ 4:51 AM
Study NCT ID:
NCT03457194
Status:
ACTIVE_NOT_RECRUITING
Last Update Posted:
2024-01-31
First Post:
2017-09-17
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Optimising Protection for Pregnant Women and Infants With Maternal Vaccination
Sponsor:
Women's and Children's Hospital, Australia
Organization:
Study Overview
Official Title:
Optimising Protection for Pregnant Women and Infants With Maternal Vaccination
Status:
ACTIVE_NOT_RECRUITING
Status Verified Date:
2024-01
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
OPTIWIN
Brief 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.
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.
Study Oversight
Has Oversight DMC:
False
Is a FDA Regulated Drug?:
True
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
False
Is an FDA AA801 Violation?: