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.
试验速览
- 阶段
- 3 期
- 状态
- 终止
- 入组人数
- 366
- 试验地点
- 31
- 主要终点
- Percentage of Participants With Seroconversion (SC) Against Antigens 28 Days After the Last Vaccination
研究概览
简要总结
The purpose of this study was to demonstrate the non-inferior HAI immune response of quadrivalent recombinant influenza vaccine (RIV4) vs licensed Egg-Based Quadrivalent Influenza Vaccine (IIV4) for the 4 strains based on the egg-derived antigen in all participants aged 3 to 8 years and to describe the immunogenicity and safety profile of RIV4 compared to IIV4 in participants aged 3 to 8 years.
详细描述
Participants were enrolled on the day of their first vaccination and received 1 or 2 doses 28 days apart of either RIV4 or IIV4; depending on if they were previously vaccinated against influenza or previously unvaccinated against influenza, respectively; and were followed for 6 months after the last vaccination.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Prevention
- 盲法
- Triple (Participant, Investigator, Outcomes Assessor)
盲法说明
Modified double-blind (participant, Sponsor, and Investigator blinded)
入排标准
- 年龄范围
- 3 Years 至 8 Years（Child）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •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
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 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
RIV4 cohort
RIV4 single injection at Day 1
干预措施: Recombinant influenza vaccine (RIV4) (Biological)
IIV4 cohort
IIV4, single injection at Day 1
干预措施: Quadrivalent influenza vaccine (IIV4) (Biological)
结局指标
主要结局
Percentage of Participants With Seroconversion (SC) Against Antigens 28 Days After the Last Vaccination
时间窗: Day 29 [participants previously vaccinated] or Day 57 [participants previously unvaccinated]
Anti-influenza antibodies were measured using HAI assay for 4 influenza virus strains: A/H1N1 strain, A/H3N2 strain, B/Victoria lineage strain, and B/Yamagata lineage strain. SC was defined as either a pre-vaccination HAI titer less than (\<) 10 (1/dilution) and a post-vaccination titer greater than or equal to (≥) 40 (1/dilution) or a pre-vaccination titer ≥ 10 (1/dilution) and a ≥ 4-fold increase in post-vaccination titer.
Geometric Mean Titers (GMTs) of Influenza Vaccine Antibodies 28 Days After the Last Vaccination
时间窗: Day 29 [participants previously vaccinated] or Day 57 [participants previously unvaccinated]
GMTs of influenza vaccine antibodies were measured using individual hemagglutination inhibition (HAI) assay for 4 influenza virus strains: A/H1N1 strain, A/H3N2 strain, B/Victoria lineage strain, and B/Yamagata lineage strain.
次要结局
- Number of Participants With Unsolicited AEs(Up to Day 29 (all participants); Up to Day 57 (participants previously unvaccinated))
- Number of Participants With Medically Attended Adverse Events (MAAEs)(Up to Day 29 (all participants); Up to Day 57 (participants previously unvaccinated))
- Number of Participants With Serious Adverse Events (SAEs) And Adverse Events of Special Interest (AESI)(From the first vaccination up to 6 months after the last vaccination, 209 days)
- GMTs of Influenza Vaccine Antibodies at Day 1(Pre-vaccination on Day 1)
- Geometric Mean Titer Ratio (GMTR) of Influenza Vaccine Antibodies(Day 1 (all participants) and Day 29 (participants previously vaccinated) or Day 57 (participants previously unvaccinated))
- Number of Participants With Immediate Unsolicited Adverse Events (AEs)(Within 30 minutes post-vaccination on Day 1 (all participants) and Day 29 (participants previously unvaccinated))
- Number of Participants With Solicited Injection Site Reactions and Systemic Reactions(Day 1 to Day 8 (all participants); Day 29 to Day 36 (participants previously unvaccinated))
- Percentage of Participants With Detectable HAI Titer ≥ 10 and ≥ 40 for Influenza Vaccine Antibodies at Day 1 and 28 Days After the Last Vaccination(Day 1 (all participants) and Day 29 (participants previously vaccinated) or Day 57 (participants previously unvaccinated))