CTRI/2021/11/037841已完成3 期
Immunogenicity and Safety of the Quadrivalent Inactivated Split-Virion Influenza Vaccine in Participants 6 Months of Age and Older in India
Sanofi Healthcare India Private Limited SHIP0 个研究点目标入组 400 人开始时间: 待定最近更新:
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 发起方
- 入组人数
- 400
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional
入排标准
入选标准
- •1. Aged 6 months and older on the day of inclusion.
- •2. Participants who are overtly healthy as determined by medical evaluation including medical history.
- •3. For participants < 2 years of age: born at full term of pregnancy (ââ?°Â¥37 weeks) or born after a gestation period of 27 through 36 weeks and medically stable as assessed by the investigator, based on the following definition: ââ?¬Å?Medically stableââ?¬? refers to the condition of premature infants who do not require significant medical support or ongoing management for debilitating disease and who have demonstrated a clinical course of sustained recovery by the time they receive the first dose of study vaccine.
- •4. 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 pre-menarchea or post-menopausal for at least 1 year, or surgically sterile
- •Is of childbearing potential and agrees to use an effective contraceptive method or abstinence from at least 4 weeks prior to vaccination until at least 4 weeks after vaccination. A participant of childbearing potential must have a negative highly sensitive pregnancy test (urine or serum as required by local regulation) within 24 hours.
- •5. 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 (and by an independent witness if required by local regulations).
- •6. Participant or participant and parent/legally acceptable representative are able to attend
排除标准
- •1. 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).
- •2. Known systemic hypersensitivity to any of the vaccine components, or history of a life-threatening reaction to the vaccine used in the study or to a vaccine containing any of the same substances.
- •3. Self-reported thrombocytopenia, contraindicating intramuscular vaccination.
- •4.Bleeding disorder, or receipt of anticoagulants in the 3 weeks preceding inclusion.
- •5. Alcohol, prescription drug, or substance abuse that, in the opinion of the Investigator, might interfere with the study conduct or completion.
- •6. Chronic illness that, in the opinion of the investigator, is at a stage where it might interfere with study conduct or completion.
- •7. Moderate or severe acute illness/infection (according to investigator judgment) on the day of vaccination or febrile illness (temperature ââ?°Â¥ 38.0Ã?°C [ââ?°Â¥ 100.4Ã?°F]). A prospective participant should not be included in the study until the condition has resolved or the Prior/concomitant therapy.
- •8. Receipt of any vaccine in the 4 weeks preceding the first study vaccination or planned receipt of any vaccine before Visit 2 for participants receiving 1 dose of influenza vaccine or Visit 3 for participants receiving 2 doses of influenza vaccine (except Oral Poliomyelitis vaccine received during National Immunization Days).
- •9. Receipt of the coronavirus vaccine (severe acute respiratory syndrome coronavirus 2 [SARS-CoV-2]) in the 4 weeks preceding the first study vaccination.
- •10. Previous vaccination against influenza (in the previous 9 months) with either the study vaccine or another vaccine.
- •11. Receipt of immune globulins, blood, or blood-derived products in the past 3 months.
- •12. participation at the time of study enrollment (or in the 4 weeks preceding vaccination) or planned participation during the present study period in another clinical study investigating a vaccine, drug, medical device, or medical procedure.
- •13. Deprived of freedom by an administrative or court order, or in an emergency setting, or hospitalized involuntarily.
- •14. 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.
研究者
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