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Study on an Investigational Yellow Fever Vaccine Compared With Stamaril in Adults in Europe and Asia

Primary Purpose

Yellow Fever

Status
Active
Phase
Phase 2
Locations
International
Study Type
Interventional
Intervention
Yellow fever vaccine (produced on serum-free Vero cells)
Yellow fever vaccine
Sponsored by
Sanofi Pasteur, a Sanofi Company
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Yellow Fever

Eligibility Criteria

18 Years - 59 Years (Adult)All SexesAccepts Healthy Volunteers

Inclusion Criteria:

  • Aged 18 years up to 60 years* on the day of inclusion
  • A female participant is eligible to participate if she is not pregnant or breastfeeding and one of the following conditions applies:

Is of non-childbearing potential. To be considered of non-childbearing potential, a female must be postmenopausal for at least 1 year, or surgically sterile OR Is of childbearing potential and agrees to use an effective contraceptive method (1) or abstinence (1) from at least 4 weeks prior to study intervention administration until at least 4 weeks (2) after study intervention administration.

*18 to 60 years means from the day of the 18th birthday up to the day before the 60th birthday

  1. Not applicable for Finland
  2. Except for French participants which have to apply 12 weeks contraception after study intervention administration A female participant of childbearing potential must have a negative highly sensitive pregnancy test (urine or serum as required by local regulation) before any dose of study intervention on Day 1 and the test will be repeated on D29 to confirm the participant is still not pregnant within 28 days of vaccine administration.

    - Informed consent form has been signed and dated (3)

  3. For participants aged less than 21 years in Singapore, an informed consent form has been signed and dated by both the participant and the parent(s) or another legally acceptable representative

    • Able to attend all scheduled visits and to comply with all study procedures
    • For participants enrolled in Asian countries as part of the additional cohort only: know Chinese origin, defined as having at least one biological parent of Chinese origin, and will be self-reported by the participant

    Exclusion Criteria:

    Participation at the time of study enrollment (or in the 4 weeks preceding the study vaccination) or planned participation during the first 2 years of the 5-year follow-up in another clinical study investigating a vaccine, drug, medical device, or medical procedure. Enrollment in another study after the first 2 years is permitted, assuming that it does not exclude participation in this study.

    • Receipt of any vaccine in the 4 weeks preceding the study vaccination or planned receipt of any vaccine in the 4 weeks following the study vaccination (prior to visit 4), except for influenza vaccination, which may be received at least 2 weeks before study vaccines (4). This exception includes all influenza vaccines including monovalent pandemic influenza vaccines.
    • Previous vaccination against a FV disease at any time including YF with either the study vaccine or another vaccine.
    • Receipt of immune globulins, blood, or blood-derived products in the past 6 months.
    • Known or suspected congenital or acquired immunodeficiency; or receipt of immunosuppressive therapy, such as anti-cancer chemotherapy, or radiation therapy, within the preceding 6 months; or long-term systemic corticosteroid therapy (prednisone or equivalent for more than 2 consecutive weeks within the past 3 months).
    • Known history of any FV infection.
    • Known systemic hypersensitivity to any of the vaccine components, eggs, or history of a life-threatening reaction to the vaccines used in the study or to a vaccine containing any of the same substances.
    • Known history or laboratory evidence of HIV infection (5).
    • Known history or laboratory evidence of hepatitis B or hepatitis C infection (6).
    • Personal or family history of thymic pathology (thymoma, thymectomy, or myasthenia).
    • Deprived of freedom by an administrative or court order, or in an emergency setting, or hospitalized involuntarily.
    • Alcohol, prescription drug, or substance abuse that, in the opinion of the Investigator, might interfere with the study conduct or completion.
    • Chronic illness (7) that, in the opinion of the Investigator, is at a stage where it might interfere with trial conduct or completion, including malignancy, such as leukemia, or lymphoma.
    • Moderate or severe acute illness/infection (according to Investigator judgment) on the day of vaccination or febrile illness (temperature ≥ 100.4°F or 38°C). A prospective participant should not be included in the study until the condition has resolved or the febrile event has subsided.
    • Administration of any anti-viral within 2 months preceding the vaccination and planned administration up to the 6 weeks following the vaccination.
    • Identified as an Investigator or employee of the Investigator or study center with direct involvement in the proposed study, or identified as an immediate family member (ie, parent, spouse, natural or adopted child) of the Investigator or employee with direct involvement in the proposed study.
    • Planned travel in a YF endemic country within 6 months of investigational or control vaccine administration.
  4. Except for Thai participants
  5. HIV Serology testing will be performed on all German participants if no evidence of seronegativity in the 90 days preceding vaccination
  6. Hepatitis B and Hepatitis C Serology testing will be performed on all German participants if no evidence of seronegativity in the 90 days preceding vaccination
  7. Chronic illness may include, but is not limited to, cardiac disorders, renal disorders, auto-immune disorders, diabetes, psychiatric disorders or chronic infection

Sites / Locations

  • Investigational Site Number :2460001
  • Investigational Site Number :2460002
  • Investigational Site Number :2460003
  • Investigational Site Number :2500008
  • Investigational Site Number :2500006
  • Investigational Site Number :2500001
  • Investigational Site Number :2500007
  • Investigational Site Number :2500009
  • Investigational Site Number :2500004
  • Investigational Site Number :2760004
  • Investigational Site Number :2760001
  • Investigational Site Number :2760002
  • Investigational Site Number :2760003
  • Investigational Site Number :7020002
  • Investigational Site Number :7020003
  • Investigational Site Number :7020001
  • Investigational Site Number :7240004
  • Investigational Site Number :7240001
  • Investigational Site Number :7240003
  • Investigational Site Number :7240002
  • Investigational Site Number :7640001
  • Investigational Site Number :7640002
  • Investigational Site Number :7640003

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Group 1

Group 2

Arm Description

1 injection of vYF vaccine at Day 1

1 injection of Stamaril vaccine at Day 1

Outcomes

Primary Outcome Measures

Percentage of participants in EU with seroconversion to YF virus in YF-naïve population
Seroconversion is defined as a 4-fold increase in neutralizing antibody (NAb) titers as compared to the pre-vaccination value

Secondary Outcome Measures

Percentage of participants in EU with seroconversion to YF virus in YF-naïve population
Seroconversion is defined as a fourfold increase in NAb titers: i) as compared to the Day 01 titers at each time point up to Month 6; ii) as compared to the last planned previous time point from Y1 onwards
Percentage of participants in EU and in Asia with seroprotection to YF virus
Seroprotection is defined as NAb titers ≥ 10 (1/dil) at the corresponding timepoint
Geometric Mean Titers (GMTs) of neutralizing antibodies against YF virus in all participants in EU and in Asia
Antibody titers are expressed as geometric mean titers
Geometric Mean Titers Ratio (GMTRs) of neutralizing antibodies against YF virus in all participants in EU and in Asia
GMTRs Day 11/Day 01 (subset only), Day 29/Day 01, Month 6/Day 01, Year 1/Month 6, Year 2/Year 1, Year 3/Year 2, Year 4/Year 3, Year 5/Year 4
Number of participants in EU and in Asia with immediate adverse avents
Immediate adverse events are any unsolicited systemic adverse events reported in the 30 minutes after vaccination
Number of participants in EU and in Asia with solicited injection site reactions
Solicited injection site reactions include injection site pain, erythema and swelling
Number of participants in EU and in Asia with solicited systemic reactions
Solicited systemic reactions include fever, headache, malaise and myalgia
Number of participants in EU and in Asia with unsolicited adverse events (AEs)
Unsolicited (spontaneously reported) AEs, not fulfilling criteria for solicited adverse reactions
Number of participants in EU and in Asia with serious adverse events (SAEs) and adverse events of special interest (AESIs)
SAEs and AESIs
Number of participants in EU and in Asia with related SAEs and death
SAEs

Full Information

First Posted
August 17, 2021
Last Updated
May 16, 2023
Sponsor
Sanofi Pasteur, a Sanofi Company
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1. Study Identification

Unique Protocol Identification Number
NCT05011123
Brief Title
Study on an Investigational Yellow Fever Vaccine Compared With Stamaril in Adults in Europe and Asia
Official Title
Controlled Study of Immunogenicity and Safety of the Investigational vYF Candidate Vaccine in Comparison to Stamaril in Adults
Study Type
Interventional

2. Study Status

Record Verification Date
January 2023
Overall Recruitment Status
Active, not recruiting
Study Start Date
October 7, 2021 (Actual)
Primary Completion Date
May 23, 2022 (Actual)
Study Completion Date
April 25, 2028 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Sanofi Pasteur, a Sanofi Company

4. Oversight

Studies a U.S. FDA-regulated Drug Product
Yes
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. Study Description

Brief 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.
Detailed Description
The duration of each participant's participation will be approximately 5 years.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Yellow Fever

7. Study Design

Primary Purpose
Prevention
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Masking Description
Investigators, Sponsor, and Study staff who conduct the safety assessment and the participant will not know which vaccine is administered. Only the study staff who prepare and administer the vaccine and are not involved with the safety evaluation ("vaccinator") will know which vaccine is administered.
Allocation
Randomized
Enrollment
690 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Group 1
Arm Type
Experimental
Arm Description
1 injection of vYF vaccine at Day 1
Arm Title
Group 2
Arm Type
Active Comparator
Arm Description
1 injection of Stamaril vaccine at Day 1
Intervention Type
Biological
Intervention Name(s)
Yellow fever vaccine (produced on serum-free Vero cells)
Other Intervention Name(s)
vYF vaccine
Intervention Description
Powder and diluent for suspension for injection - Subcutaneous
Intervention Type
Biological
Intervention Name(s)
Yellow fever vaccine
Other Intervention Name(s)
Stamaril
Intervention Description
Powder and diluent for suspension for injection - Subcutaneous
Primary Outcome Measure Information:
Title
Percentage of participants in EU with seroconversion to YF virus in YF-naïve population
Description
Seroconversion is defined as a 4-fold increase in neutralizing antibody (NAb) titers as compared to the pre-vaccination value
Time Frame
Day 29
Secondary Outcome Measure Information:
Title
Percentage of participants in EU with seroconversion to YF virus in YF-naïve population
Description
Seroconversion is defined as a fourfold increase in NAb titers: i) as compared to the Day 01 titers at each time point up to Month 6; ii) as compared to the last planned previous time point from Y1 onwards
Time Frame
Day 01, Day 11 in a subset of participants only, and Day 29, Month 6, and yearly from Year 1 to Year 5
Title
Percentage of participants in EU and in Asia with seroprotection to YF virus
Description
Seroprotection is defined as NAb titers ≥ 10 (1/dil) at the corresponding timepoint
Time Frame
Day 01, Day 11 in a subset of participants only, and Day 29, Month 6, and yearly from Year 1 to Year 5
Title
Geometric Mean Titers (GMTs) of neutralizing antibodies against YF virus in all participants in EU and in Asia
Description
Antibody titers are expressed as geometric mean titers
Time Frame
Day 01 and Day 11 in a subset of participants only, and Day 29, Month 6, and yearly from Year 1 to Year 5
Title
Geometric Mean Titers Ratio (GMTRs) of neutralizing antibodies against YF virus in all participants in EU and in Asia
Description
GMTRs Day 11/Day 01 (subset only), Day 29/Day 01, Month 6/Day 01, Year 1/Month 6, Year 2/Year 1, Year 3/Year 2, Year 4/Year 3, Year 5/Year 4
Time Frame
Day 01 and Day 11 in a subset of participants only, and Day 29, Month 6, and yearly from Year 1 to Year 5
Title
Number of participants in EU and in Asia with immediate adverse avents
Description
Immediate adverse events are any unsolicited systemic adverse events reported in the 30 minutes after vaccination
Time Frame
Within 30 minutes after vaccination
Title
Number of participants in EU and in Asia with solicited injection site reactions
Description
Solicited injection site reactions include injection site pain, erythema and swelling
Time Frame
Within 7 days after vaccination
Title
Number of participants in EU and in Asia with solicited systemic reactions
Description
Solicited systemic reactions include fever, headache, malaise and myalgia
Time Frame
Within 14 days after vaccination
Title
Number of participants in EU and in Asia with unsolicited adverse events (AEs)
Description
Unsolicited (spontaneously reported) AEs, not fulfilling criteria for solicited adverse reactions
Time Frame
Within 28 days after vaccination
Title
Number of participants in EU and in Asia with serious adverse events (SAEs) and adverse events of special interest (AESIs)
Description
SAEs and AESIs
Time Frame
From Day 01 to Month 6
Title
Number of participants in EU and in Asia with related SAEs and death
Description
SAEs
Time Frame
From Day 01 up to Year 5

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
59 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria: Aged 18 years up to 60 years* on the day of inclusion A female participant is eligible to participate if she is not pregnant or breastfeeding and one of the following conditions applies: Is of non-childbearing potential. To be considered of non-childbearing potential, a female must be postmenopausal for at least 1 year, or surgically sterile OR Is of childbearing potential and agrees to use an effective contraceptive method (1) or abstinence (1) from at least 4 weeks prior to study intervention administration until at least 4 weeks (2) after study intervention administration. *18 to 60 years means from the day of the 18th birthday up to the day before the 60th birthday Not applicable for Finland Except for French participants which have to apply 12 weeks contraception after study intervention administration A female participant of childbearing potential must have a negative highly sensitive pregnancy test (urine or serum as required by local regulation) before any dose of study intervention on Day 1 and the test will be repeated on D29 to confirm the participant is still not pregnant within 28 days of vaccine administration. - Informed consent form has been signed and dated (3) For participants aged less than 21 years in Singapore, an informed consent form has been signed and dated by both the participant and the parent(s) or another legally acceptable representative Able to attend all scheduled visits and to comply with all study procedures For participants enrolled in Asian countries as part of the additional cohort only: know Chinese origin, defined as having at least one biological parent of Chinese origin, and will be self-reported by the participant Exclusion Criteria: Participation at the time of study enrollment (or in the 4 weeks preceding the study vaccination) or planned participation during the first 2 years of the 5-year follow-up in another clinical study investigating a vaccine, drug, medical device, or medical procedure. Enrollment in another study after the first 2 years is permitted, assuming that it does not exclude participation in this study. Receipt of any vaccine in the 4 weeks preceding the study vaccination or planned receipt of any vaccine in the 4 weeks following the study vaccination (prior to visit 4), except for influenza vaccination, which may be received at least 2 weeks before study vaccines (4). This exception includes all influenza vaccines including monovalent pandemic influenza vaccines. Previous vaccination against a FV disease at any time including YF with either the study vaccine or another vaccine. Receipt of immune globulins, blood, or blood-derived products in the past 6 months. Known or suspected congenital or acquired immunodeficiency; or receipt of immunosuppressive therapy, such as anti-cancer chemotherapy, or radiation therapy, within the preceding 6 months; or long-term systemic corticosteroid therapy (prednisone or equivalent for more than 2 consecutive weeks within the past 3 months). Known history of any FV infection. Known systemic hypersensitivity to any of the vaccine components, eggs, or history of a life-threatening reaction to the vaccines used in the study or to a vaccine containing any of the same substances. Known history or laboratory evidence of HIV infection (5). Known history or laboratory evidence of hepatitis B or hepatitis C infection (6). Personal or family history of thymic pathology (thymoma, thymectomy, or myasthenia). Deprived of freedom by an administrative or court order, or in an emergency setting, or hospitalized involuntarily. Alcohol, prescription drug, or substance abuse that, in the opinion of the Investigator, might interfere with the study conduct or completion. Chronic illness (7) that, in the opinion of the Investigator, is at a stage where it might interfere with trial conduct or completion, including malignancy, such as leukemia, or lymphoma. Moderate or severe acute illness/infection (according to Investigator judgment) on the day of vaccination or febrile illness (temperature ≥ 100.4°F or 38°C). A prospective participant should not be included in the study until the condition has resolved or the febrile event has subsided. Administration of any anti-viral within 2 months preceding the vaccination and planned administration up to the 6 weeks following the vaccination. Identified as an Investigator or employee of the Investigator or study center with direct involvement in the proposed study, or identified as an immediate family member (ie, parent, spouse, natural or adopted child) of the Investigator or employee with direct involvement in the proposed study. Planned travel in a YF endemic country within 6 months of investigational or control vaccine administration. Except for Thai participants HIV Serology testing will be performed on all German participants if no evidence of seronegativity in the 90 days preceding vaccination Hepatitis B and Hepatitis C Serology testing will be performed on all German participants if no evidence of seronegativity in the 90 days preceding vaccination Chronic illness may include, but is not limited to, cardiac disorders, renal disorders, auto-immune disorders, diabetes, psychiatric disorders or chronic infection
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Clinical Sciences & Operations
Organizational Affiliation
Sanofi
Official's Role
Study Director
Facility Information:
Facility Name
Investigational Site Number :2460001
City
Helsinki
ZIP/Postal Code
00290
Country
Finland
Facility Name
Investigational Site Number :2460002
City
Tampere
ZIP/Postal Code
33100
Country
Finland
Facility Name
Investigational Site Number :2460003
City
Turku
ZIP/Postal Code
20520
Country
Finland
Facility Name
Investigational Site Number :2500008
City
Lyon
ZIP/Postal Code
69004
Country
France
Facility Name
Investigational Site Number :2500006
City
Montpellier
ZIP/Postal Code
34295
Country
France
Facility Name
Investigational Site Number :2500001
City
Nantes
ZIP/Postal Code
44093
Country
France
Facility Name
Investigational Site Number :2500007
City
Nimes
ZIP/Postal Code
30029
Country
France
Facility Name
Investigational Site Number :2500009
City
Paris
ZIP/Postal Code
75014
Country
France
Facility Name
Investigational Site Number :2500004
City
Pierre Benite
ZIP/Postal Code
69495
Country
France
Facility Name
Investigational Site Number :2760004
City
Berlin
ZIP/Postal Code
10117
Country
Germany
Facility Name
Investigational Site Number :2760001
City
Hamburg
ZIP/Postal Code
20359
Country
Germany
Facility Name
Investigational Site Number :2760002
City
München
ZIP/Postal Code
80802
Country
Germany
Facility Name
Investigational Site Number :2760003
City
Rostock
ZIP/Postal Code
18057
Country
Germany
Facility Name
Investigational Site Number :7020002
City
Singapore
ZIP/Postal Code
119074
Country
Singapore
Facility Name
Investigational Site Number :7020003
City
Singapore
ZIP/Postal Code
169608
Country
Singapore
Facility Name
Investigational Site Number :7020001
City
Singapore
Country
Singapore
Facility Name
Investigational Site Number :7240004
City
Barcelona
ZIP/Postal Code
08035
Country
Spain
Facility Name
Investigational Site Number :7240001
City
Barcelona
ZIP/Postal Code
08036
Country
Spain
Facility Name
Investigational Site Number :7240003
City
Hospitalet de Llobregat
ZIP/Postal Code
08907
Country
Spain
Facility Name
Investigational Site Number :7240002
City
Madrid
ZIP/Postal Code
28046
Country
Spain
Facility Name
Investigational Site Number :7640001
City
Bangkok
ZIP/Postal Code
10330
Country
Thailand
Facility Name
Investigational Site Number :7640002
City
Bangkok
Country
Thailand
Facility Name
Investigational Site Number :7640003
City
Nonthaburi
ZIP/Postal Code
11000
Country
Thailand

12. IPD Sharing Statement

Plan to Share IPD
Yes
IPD Sharing Plan Description
Qualified researchers may request access to patient level data and related study documents including the clinical study report, study protocol with any amendments, blank case report form, statistical analysis plan, and dataset specifications. Patient level data will be anonymized and study documents will be redacted to protect the privacy of trial participants. Further details on Sanofi's data sharing criteria, eligible studies, and process for requesting access can be found at: https://vivli.org

Learn more about this trial

Study on an Investigational Yellow Fever Vaccine Compared With Stamaril in Adults in Europe and Asia

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