Safety of a Quadrivalent Influenza Vaccine (VaxigripTetra™) in Subjects Aged 6 Months and Older in Vietnam
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 入组人数
- 230
- 试验地点
- 1
- 主要终点
- Number of participants reporting solicited injection site reactions or systemic reactions
研究概览
简要总结
The primary objective of this study is to describe the safety of the Quadrivalent Influenza Vaccine (QIV). Safety is assessed throughout the study period, and includes solicited injection site and systemic reactions (Day 0 to Day 7 post-vaccination); unsolicited adverse events up to Day 28, and serious adverse events occurring throughout the study.
详细描述
Study duration for previously unvaccinated participants aged 6 months to 8 years is approximately 56 days. Study duration for previously vaccinated participants aged 6 months to 8 years and any participant aged 9 years and older is approximately 28 days.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Prevention
- 盲法
- None
入排标准
- 年龄范围
- 6 Months 至 —（Child, Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Aged 6 months and older on the day of inclusion
- •Participants aged < 18 years: ICF has been signed and dated by the parent or another legally acceptable representative; Assent form has been signed and dated by the participant aged 12 to 15 years.
- •Participants aged ≥ 16 years: ICF signed and dated by the participant.
- •Participants are able to attend all scheduled visits and to comply with all study procedures. For participants aged 6 months to 17 years, parent/legally acceptable representative are able to attend all scheduled visits and to comply with all study procedures
- •For participants < 2 years: Born at full term of pregnancy (≥ 37 weeks) and/or with a birth weight ≥ 2.5 kg
排除标准
- •Participant is pregnant, or lactating, or of childbearing potential and not using an effective method of contraception or abstinence from at least 4 weeks prior to vaccination until at least 4 weeks after vaccination. To be considered of non-childbearing potential, a woman must be pre-menarche or post-menopausal for at least 1 year, or surgically sterile
- •Participation at the time of study enrollment (or in the 4 weeks preceding study vaccination) or planned participation during the present study period in another clinical study investigating a vaccine, drug, device, or medical procedure
- •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.
- •Receipt of immune globulins, blood or blood-derived products in the past 3 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 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
- •Known thrombocytopenia, contraindicating intramuscular vaccination based on investigator's judgment
- •Bleeding disorder, or receipt of anticoagulants in the 3 weeks preceding inclusion, contraindicating IM vaccination based on investigator's judgment
- •Deprived of freedom by an administrative or court order, or in an emergency setting, or hospitalized involuntarily
- •Current alcohol abuse or drug addiction
- •Chronic illness that, in the opinion of the investigator, is at a stage where it might interfere with study conduct or completion
- •Moderate or severe acute illness/infection (according to Investigator judgment) on the day of vaccination or febrile illness/body temperature (temperature ≥ 37.5 C or ≤ 35.5 C). A prospective subject should not be included in the study until the condition has resolved or the febrile event has subsided
- •Identified as Investigator or employee of the Investigator or study center with direct involvement in the proposed study, or identified as an immediate family member (i.e. parent, spouse, natural or adopted child) of the Investigator or employee with direct involvement in the proposed study
- •The above information is not intended to contain all considerations relevant to a patient's potential participation in a clinical trial.
研究组 & 干预措施
Quadrivalent Influenza Vaccine
Quadrivalent Influenza Vaccine (split-virion, inactivated) Northern hemisphere seasonal formulation 2018-2019
干预措施: Quadrivalent Influenza Vaccine (Biological)
结局指标
主要结局
Number of participants reporting solicited injection site reactions or systemic reactions
时间窗: Within 7 days after vaccination
Injection site reactions: tenderness/pain, erythema, swelling, induration, and haemorrhage. Systemic reactions: participants ≤ 23 months: fever, vomiting, crying abnormal, drowsiness, appetite lost, and irritability; participants 2 years and older: fever, headache, malaise, myalgia, and shivering.
次要结局
未报告次要终点