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.
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 入组人数
- 1,308
- 试验地点
- 35
- 主要终点
- Geometric Mean Titers (GMTs) Against Influenza Vaccine Antibodies at Day 29
研究概览
简要总结
The purpose of this study was to demonstrate the non-inferiority (NI) of the HAI immune response of RIV4 in participants aged 9 to 17 years vs participants aged 18 to 49 years and to describe the immunogenicity and safety profile of RIV4 in all participants.
详细描述
The participation duration was approximately 6 months for each participant.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Parallel
- 主要目的
- Prevention
- 盲法
- None
入排标准
- 年龄范围
- 9 Years 至 49 Years（Child, Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Aged 9 to 49 years on the day of inclusion
- •A female participant was eligible to participate if she was not pregnant or breastfeeding and one of the following conditions applies: 1) was of non-childbearing potential. To be considered of non-childbearing potential, a female should have been pre-menarche, post-menopausal for at least 1 year, or surgically sterile OR 2) was of childbearing potential and agreed 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 had been signed and dated by the participant (based on local regulations), and if applicable informed consent form had been signed and dated by the parent(s) or another legally acceptable representative
排除标准
- •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-Barre Syndrome (GBS)
- •Personal history of clinically significant development delay (at the discretion of the Investigator), neurologic disorder, or seizure disorder NOTE: The above information was not intended to contain all considerations relevant to a patient's potential participation in a clinical trial.
研究组 & 干预措施
Group 9 to 17 years old
Participants of 9 to 17 years old who received RIV4 single intramuscular (IM) injection at D01
干预措施: Quadrivalent Recombinant influenza vaccine (RIV4) season/2022-2023/NH (Biological)
Group 18 to 49 years old
Participants of 18 to 49 years old who received RIV4 single intramuscular (IM) injection at D01
干预措施: Quadrivalent Recombinant influenza vaccine (RIV4) season/2022-2023/NH (Biological)
结局指标
主要结局
Geometric Mean Titers (GMTs) Against Influenza Vaccine Antibodies at Day 29
时间窗: Day 29
GMTs of anti-influenza antibodies were measured using individual hemagglutination inhibition (HAI) assay for 4 influenza virus strains: A/H1N1, A/H3N2, B/Victoria, and B/Yamagata lineages.
Percentage of Participants With Seroconversion for Influenza Vaccine Antibodies at Day 29
时间窗: Day 29
Anti-influenza antibodies were measured using HAI assay for 4 influenza virus strains: A/H1N1, A/H3N2, B/Victoria, and B/Yamagata lineages. Seroconversion was defined as either a pre-vaccination titer less than (\<) 1:10 (1/dilution) at Day 1 and a post-vaccination titer greater than or equal to (\>=) 1: 40 (1/dilution) at Day 29 or a pre-vaccination titer \>= 1:10 at Day 1 and a \>= 4-fold increase in post-vaccination titer.
次要结局
- Number of Participants With Immediate Unsolicited Adverse Events (AEs)(Within 30 minutes post-vaccination on Day 1)
- Number of Participants With Solicited Injection Site Reactions and Systemic Reactions(From Day 1 up to 7 days post-vaccination (up to Day 8))
- Number of Participants With Medically Attended Adverse Events (MAAEs)(From Day 1 up to 28 days post-vaccination (up to Day 29))
- GMTs Against Influenza Vaccine Antibodies at Day 1(Pre-vaccination on Day 1)
- Percentage of Participants With Detectable HAI Titers >=10 and >=40 for Influenza Vaccine Antibodies at Days 1 and 29(On Days 1 and 29)
- Geometric Mean Titer Ratio (GMTR) of Influenza Vaccine Antibodies(On Days 1 and 29)
- Number of Participants With Unsolicited AEs(From Day 1 up to 28 days post-vaccination (up to Day 29))
- Number of Participants With Serious Adverse Events (SAEs) And Adverse Events of Special Interest (AESI)(From Day 1 up to 6 months post-vaccination, 181 days)