2022-502047-35-00招募中2 期
Controlled Study of Immunogenicity and Safety of the Investigational vYF Candidate Vaccine in Comparison to Stamaril® in Adults
适应症
试验速览
- 阶段
- 2 期
- 状态
- 招募中
- 入组人数
- 570
- 试验地点
- 18
- 主要终点
- 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.
研究概览
简要总结
To demonstrate the non-inferiority of the antibody response in terms of seroconversion rates 28 days after vaccine administration of one dose of vYF (administered on Day 01) compared to the antibody response after one dose of the Stamaril control vaccine (administered on Day 01) in participants enrolled in EU in YF-naïve participants
入排标准
- 年龄范围
- 18 years 至 64 years（18-64 Years）
- 接受健康志愿者
- 是
入选标准
- •Aged 18 years up to 60 years on the day of inclusion. 18 to 60 years means from the day of the 18th birthday up to the day before the 60th birthday.
- •Able to attend all scheduled visits and to comply with all study procedures
- •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.
- •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. (1) Not applicable for Finland (2) Except for French participants which have to apply 12 weeks contraception after study intervention administration
- •Informed consent form has been signed and dated. 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.
- •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.
排除标准
- •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.
- •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 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. Chronic illness may include, but is not limited to, cardiac disorders, renal disorders, auto-immune disorders, diabetes, psychiatric disorders or chronic infection.
- •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.
- •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 (except for Thai participants). 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. HIV Serology testing will be performed on all German participants if no evidence of seronegativity in the 90 days preceding vaccination.
- •Known history or laboratory evidence of hepatitis B or hepatitis C infection. 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.
结局指标
主要结局
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.
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.
次要结局
- Percentage of participants in EU with seroconversion to YF virus in YF-naïve population. Seroconversion is defined as a 4-fold 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 avents (AEs). Unsolicited (spontaneously reported) AEs, not fulfilling criteria for solicited adverse reactions.
- Number of participants in EU and in Asia with serious adverse avents (SAEs) and adverse events of special interest (AESIs). SAEs and AESIs.
- Number of participants in EU and in Asia with related SAEs and death.
研究者
Clinical Sciences and Operations
Scientific
Sanofi Pasteur
研究点 (18)
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