Immunogenicity and Safety of Quadrivalent Recombinant Influenza Vaccine (RIV4) in Children and Adolescents Aged 9 to 17 Years and Adults Aged 18 to 49 Years

Sanofi Pasteur Inc0 个研究点目标入组 1,334 人开始时间: 2022年8月29日最近更新: 2023年12月4日

试验速览

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•- Aged 9 to 49 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: 1) Is of non-childbearing potential. To be considered of non-childbearing potential, a female must be pre-menarchec, postmenopausal for at least 1 year, or surgically sterile OR 2) Is of childbearing potential and agrees to use an effective contraceptive method or abstinence from at least 4 weeks prior to the first study intervention administration until at least 4 weeks after the last study intervention administration
•- Assent form or informed consent form has been signed and dated by the participant (based on local regulations), and if applicable informed consent form has been signed and dated by the parent(s) or another legally acceptable representative
•Are the trial subjects under 18? yes
•Number of subjects for this age range: 667
•F.1.2 Adults (18-64 years) yes
•F.1.2.1 Number of subjects for this age range 667
•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:
•- 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 systemic hypersensitivity to any of the vaccine components, or history of a life-threatening reaction to the vaccines used in the trial or to a vaccine containing any of the same substances
•- Thrombocytopenia
•- Bleeding disorder, or receipt of anticoagulants in the 3 weeks preceding inclusion, contraindicating intramuscular vaccination based on the Investigator's judgment
•- Personal or family history of Guillain-Barré Syndrome (GBS)
•- Personal history of clinically significant development delay (at the discretion of the Investigator), neurologic disorder, or seizure disorder
•NOTE: The above information is not intended to contain all considerations relevant to a patient's potential participation in a clinical trial.

发起方

Sanofi Pasteur Inc