Immunogenicity and Safety of Quadrivalent Recombinant Influenza Vaccine Compared with Egg-Based Standard-Dose Quadrivalent Influenza Vaccine in Children 3 to 8 Years of Age.

Sanofi Pasteur Inc0 个研究点目标入组 1,412 人开始时间: 2022年7月27日最近更新: 2024年1月8日

试验速览

暂无简介。

•- Aged 3 to 8 years on the day of inclusion
•- Assent form has been signed and dated by the participant (according to local regulations), and informed consent form has been signed and dated by the parent(s) or another legally acceptable representative and by an independent witness, if required by local regulations
•Are the trial subjects under 18? yes
•Number of subjects for this age range: 1412
•F.1.2 Adults (18-64 years) no
•F.1.2.1 Number of subjects for this age range
•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