Study on an Investigational Yellow Fever Vaccine Compared with Stamaril in Adults in Europe and Asia
- Conditions
- Prevention of yellow feverMedDRA version: 20.0Level: PTClassification code 10048240Term: Yellow feverSystem Organ Class: 10021881 - Infections and infestationsTherapeutic area: Diseases [C] - Virus Diseases [C02]
- Registration Number
- EUCTR2020-005566-33-FI
- Lead Sponsor
- Sanofi Pasteur
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ot Recruiting
- Sex
- All
- Target Recruitment
- 690
-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
Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range 690
F.1.3 Elderly (>=65 years) no
F.1.3.1 Number of subjects for this age range
Participants are excluded from the study if any of the following criteria
apply:
. 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
Study & Design
- Study Type
- Interventional clinical trial of medicinal product
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method
- Secondary Outcome Measures
Name Time Method