A Phase 3, Randomized, Observer-Blind, Controlled, Multicenter, Clinical Study to Evaluate Immunogenicity and Safety of a High-Dose MF59-Adjuvanted Quadrivalent Subunit Cell-derived Influenza Vaccine (aQIVc HD) in Comparison with a Non-adjuvanted Quadrivalent Recombinant Influenza Vaccine (QIVr) and an MF59-Adjuvanted Quadrivalent Subunit Egg-derived Influenza Vaccine (aQIV), in Adults Aged 50 Years and Older.
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 发起方
- 入组人数
- 2,100
- 试验地点
- 26
- 主要终点
- 1.Immunogenicity responses of 3 lots of aQIVc HD compared in pairs in terms of Day 29 ratio of Geometric Mean Titer (GMTr), from antibodies measured via HI assay using cell-derived target viruses for the 4 vaccine strains. 2. Immunogenicity responses of aQIVc HD vs QIVr and aQIV in terms of: - Day 29 GMT and GMTr - Day 1 to Day 29 Seroconversion rate (SCR) and SCR difference from antibodies measured via HI assay using cell-derived target viruses for the 4 vaccine strains.
研究概览
简要总结
To demonstrate in a sequential manner: First, clinical lot-to-lot consistency of 3 consecutive aQIVc HD lots, in terms of immunogenicity for each vaccine strain in subjects aged 50 years and older, as measured by hemagglutination inhibition (HI)* assay using cell-derived target viruses, at Day 29. Then, immunological noninferiority of aQIVc HD vs QIVr and vs aQIV for each vaccine strain in subjects aged 50 years and older, as measured by HI* geometric mean titers (GMTs) and seroconversion rates (SCRs), using cell-derived target viruses, at Day 29.
入排标准
- 年龄范围
- 18 years 至 65+ years（65+ Years, 18-64 Years）
- 接受健康志愿者
- 是
入选标准
- •Individuals, aged 50 years and older, who are healthy or have stable comorbidities that increase their risk of complications from influenza infection
- •Individuals who can comply with all study procedures
排除标准
- •Progressive, unstable, or uncontrolled clinical conditions
- •Known hypersensitivity or allergy to any study vaccine component
- •Known history of Guillain-Barré syndrome or other demyelinating disease
- •Condition representing a contraindication to vaccination or blood draw
- •Abnormal function of immune system due to know disorder or medication
- •Influenza vaccination within 180 days prior to informed consent or plan to receive influenza vaccine within 9 months from study vaccination (all subjects) or within 12 months (subjects in the long-term subset for immunogenicity)..
结局指标
主要结局
1.Immunogenicity responses of 3 lots of aQIVc HD compared in pairs in terms of Day 29 ratio of Geometric Mean Titer (GMTr), from antibodies measured via HI assay using cell-derived target viruses for the 4 vaccine strains. 2. Immunogenicity responses of aQIVc HD vs QIVr and aQIV in terms of: - Day 29 GMT and GMTr - Day 1 to Day 29 Seroconversion rate (SCR) and SCR difference from antibodies measured via HI assay using cell-derived target viruses for the 4 vaccine strains.
1.Immunogenicity responses of 3 lots of aQIVc HD compared in pairs in terms of Day 29 ratio of Geometric Mean Titer (GMTr), from antibodies measured via HI assay using cell-derived target viruses for the 4 vaccine strains. 2. Immunogenicity responses of aQIVc HD vs QIVr and aQIV in terms of: - Day 29 GMT and GMTr - Day 1 to Day 29 Seroconversion rate (SCR) and SCR difference from antibodies measured via HI assay using cell-derived target viruses for the 4 vaccine strains.
次要结局
- Immunogenicity responses of aQIVc HD in comparison with aQIV vaccine in subjects aged 65 years and older in terms of Day 29 Geometric mean titer (GMT) and GMT ratio of antibodies measured via HI assay using cell-derived target viruses for the A/H1N1, A/H3N2, B/Yamagata, and B/Victoria vaccine strains, and Day 1 to Day 29 Seroconversion rate (SCR) and SCR difference.
- Immunogenicity responses of aQIVc HD, QIVr and aQIV vaccines in terms of Day 29 Geometric mean titer (GMT) and GMT ratio of antibodies measured via HI assay using cell-derived target viruses for the A/H1N1, A/H3N2, B/Yamagata, and B/Victoria vaccine strains, overall and by age subgroup.
- Safety of aQIVc HD, QIVr and aQIV in terms of percentage of subjects with: - Solicited Local and Systemic Reactions from Day 1 to Day 7. - Unsolicited Adverse Events from Day 1 to Day 29. - Serious Adverse Events, AEs Leading to Withdrawal, Adverse Events of Special Interest and Medically Attended Adverse Events from Day 1 to Day 365.
研究者
Clinical Trials Disclosure
Scientific
Seqirus UK Limited