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Dose-ranging Study of an Investigational Yellow Fever Candidate Vaccine in Adults

NCT04142086 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 73

Last updated 2025-09-22

No results posted yet for this study

Summary

The primary objectives of the study are:

* To describe the safety profile of each of the 3 dosages of vYF and of YF-VAX® within the 28 days post-vaccination and up to the 6 months (Day 180) post-vaccination visit
* To describe the antibody responses elicited by each of the 3 dosages of vYF and by YF-VAX on Day 0 pre-vaccination and then on Day 10, Day 14, Day 28 and 6 months (Day 180) post-vaccination overall and by baseline flavivirus serostatus
* To quantify the detectable yellow fever (YF) vaccinal viremia in each vaccine groups (vYF and YF-VAX) in a subset of subjects on Day 0 visit, Day 1 visit, Day 3 visit, Day 5 visit, Day 7 visit, Day 10 visit, and Day 14 visit.

Conditions

  • Yellow Fever (Healthy Volunteers)

Interventions

BIOLOGICAL

Yellow fever vaccine (produced on serum-free Vero cells), Dosage 1 vYF vaccine

Pharmaceutical form: Powder and diluent for suspension for injection Route of administration: Subcutaneous

BIOLOGICAL

Yellow fever vaccine (produced on serum-free Vero cells), Dosage 2 vYF vaccine

Pharmaceutical form: Powder and diluent for suspension for injection Route of administration: Subcutaneous

BIOLOGICAL

Yellow fever vaccine (produced on serum-free Vero cells), Dosage 3 vYF vaccine

Pharmaceutical form: Powder and diluent for suspension for injection Route of administration: Subcutaneous

BIOLOGICAL

Yellow fever vaccine

Pharmaceutical form: Powder and diluent for suspension for injection Route of administration: Subcutaneous

Sponsors & Collaborators

  • Sanofi Pasteur, a Sanofi Company

    lead INDUSTRY

Principal Investigators

  • Clinical Sciences & Operations · Sanofi Pasteur, a Sanofi Company

Study Design

Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
60 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2020-01-15
Primary Completion
2021-06-24
Completion
2021-06-24
FDA Drug
Yes

Countries

  • United States

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04142086 on ClinicalTrials.gov