RecruitingNot ApplicableNCT06694766
VAC-SIP-YF (Vaccination- Safety & Immunogenicity During Pregnancy- Yellow Fever)
Comparative Study of Tolerance and Immunogenicity Induced by Primary Yellow Fever Vaccination in Pregnant and Non-pregnant Women
Sponsor
Institut Pasteur
Enrollment
270 participants
Start Date
Mar 24, 2025
Study Type
INTERVENTIONAL
Conditions
Summary
The aim of this study is to compare the immunogenicity induced by yellow fever vaccination administered during pregnancy with that induced by vaccination outside pregnancy, and to assess the maternal and fetal tolerance of this vaccination.
Eligibility
Sex: FEMALEMin Age: 18 Years
Inclusion Criteria8
- Common :
- Person over 18 years of age at the time of the first yellow fever vaccination
- Female gender
- Oral consent obtained after subject has been informed
- Subject covered by Social Security with the exception of Aide Médicale d'Etat
- Specific to both groups :
- For women vaccinated during pregnancy (case): Primary yellow fever vaccination during pregnancy
- For women vaccinated outside pregnancy (control): Primary yellow fever vaccination outside pregnancy
Exclusion Criteria8
- Criteria common to both sections (tolerance and immunogenicity):
- Subject having received a second yellow fever vaccination
- Persons unable to give informed consent for participation
- Women born in areas where yellow fever is endemic
- Female adults under legal protection (guardianship or trusteeship)
- Specific criteria for participants in the immunogenicity section:
- Medical condition imcompatible with 18.5 mL blood
- Women who have not given written consent to participate in the study. immunogenicity
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Interventions
PROCEDUREBlood sample collection
A blood sample collection of 18.5 mL will be required for the immunogenicity component.
Locations(1)
View Full Details on ClinicalTrials.gov
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NCT06694766