CI

At a glance

ClinicalIndex Comparison Record
Phase 2Active· 690 enrolled / 690 target
Drug / intervention
Yellow fever vaccine (produced on serum-free Vero cells) +1 morebiological
Likely dose
Not stated in record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT05011123
NCT05011123Phase 2ActiveUpdate Overdue (12.2/mo)Completion was 49mo ago
CompareCT.gov

Controlled Study of Immunogenicity and Safety of the Investigational vYF Candidate Vaccine in Comparison to Stamaril in Adults

Sanofi Pasteur, a Sanofi Company·interventional·Posted Aug 18, 2021·Updated Jun 1, 2026

In Brief

A Phase 2 clinical trial evaluating Yellow fever vaccine (produced on serum-free Vero cells) and Yellow fever vaccine for Yellow Fever. Active but no longer recruiting, targeting 690 participants across 23 sites in 6 countries.

Signals

Enrollment appears stalled

Detailed Summary

VYF03 is a phase II, randomized, parallel-group prevention study with 2 arms, active-controlled (Stamaril), observer-blind, multi-center study to assess the non-inferiority of the immune response, in terms of seroconversion rates of the investigational vaccine candidate vYF to the licensed Stamaril, in adults aged 18 years up to 60 years in Europe (EU). The safety and immunogenicity profile of vYF in a cohort of Asian population of Chinese origin outside of China will also be described. The study will also assess the immunogenicity profiles and the safety profiles of vYF and Stamaril. Participants will be randomized in a 2:1 ratio to receive a single subcutaneous injection of either the vYF vaccine (380 participants in EU and 80 participants of Chinese origin in Asia) or Stamaril (190 participants in EU and 40 participants of Chinese origin in Asia), on Day 01. The duration of each participant's participation will be approximately 5 years.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsYellow Fever
CountriesFinland, France, Germany, Singapore, Spain, Thailand
Collaborators--

Timeline

Phase 2Active
202220232024202520262027
First PostedAug 18, 2021
Enrollment StartOct 7, 2021
Primary CompletionMay 23, 2022
Study CompletionApr 23, 2027
TodayJul 2, 2026
Enrollment to primary: 8 monthsPosted 4.9 years ago

Arms & Interventions

Group 1experimental

1 injection of vYF vaccine at Day 1

Biological: Yellow fever vaccine (produced on serum-free Vero cells)
Group 2active_comparator

1 injection of Stamaril vaccine at Day 1

Biological: Yellow fever vaccine

Interventions

Yellow fever vaccine (produced on serum-free Vero cells)biological

Powder and diluent for suspension for injection - Subcutaneous

Yellow fever vaccinebiological

Powder and diluent for suspension for injection - Subcutaneous