NCT06087640已完成3 期
A Phase 3/3b, Randomized, Observer-blind, Multicenter Clinical Study to Evaluate the Efficacy, Safety and Immunogenicity of Fluad and Fluad Quadrivalent Compared to a Non-adjuvanted Influenza Vaccine in Adults ≥65 Years of Age
Seqirus465 个研究点 分布在 6 个国家目标入组 38,769 人开始时间: 2023年10月23日最近更新:
适应症
干预措施
相关药物
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 发起方
- 入组人数
- 38,769
- 试验地点
- 465
- 主要终点
- Efficacy Endpoint: First-occurrence of RT-PCR-confirmed influenza, due to any influenza Type A and/or B virus (regardless of antigenic match), using the protocol-defined ILI definition
研究概览
简要总结
This Phase 3 study is a randomized, observer-blind study of MF59-adjuvanted influenza vaccine (aQIV or aTIV) compared with a non-adjuvanted influenza vaccine (QIV or TIV) in adults ≥65 years of age. The aim of the study is to evaluate MF59-adjuvanted influenza vaccine compared with non-adjuvanted influenza vaccine in the prevention of reverse transcription-polymerase chain reaction (RT-PCR)-confirmed influenza A and/or B in subjects ≥65 years of age.
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
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 65 Years 至 —（Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •In order to participate in this study, all subjects must meet ALL of the inclusion criteria described.
- •Adults of ≥65 years of age on the day of vaccination.
- •Individuals who have voluntarily given written informed consent after the nature of the study has been explained according to local regulatory requirements, prior to study entry.
- •Individuals who have the ability to comply with study procedures including follow-up.
排除标准
- •In order to participate in this study, all subjects must not meet any of the exclusion criteria described below:
- •Bedridden subjects (i.e. confined to bed by sickness or old age).
- •Subjects that are incapacitated and because of that in need of a Legally Authorized Representative.
- •Receipt of any influenza vaccine within 6 months prior to enrollment or any plan to receive influenza vaccine while participating in the study.
- •Hypersensitivity, including allergy, to any component of vaccines whose use is foreseen in this study, or severe allergic reaction (e.g. anaphylaxis) to previous influenza vaccination.
- •Known history of Guillain-Barré syndrome or another demyelinating disease such as encephalomyelitis and transverse myelitis.
- •Clinical conditions representing a contra-indication to intramuscular administration of vaccines or blood draw.
- •Abnormal function of the immune system resulting from:
- •Clinical conditions;
- •Systemic administration of corticosteroids (PO/IV/IM) at a dose ≥20 mg/day of prednisone (or equivalent) for more than 14 consecutive days within 90 days prior to informed consent; Topical, inhaled and intranasal corticosteroids are permitted. Intermittent use (one dose in 30 days) of intra-articular corticosteroids are also permitted;
- •Administration of antineoplastic and immunomodulating agents or radiotherapy within 90 days prior to informed consent.
- •Receipt of immunoglobulins or any blood products within 180 days prior to informed consent.
- •Receipt of any investigational or non-registered product (drug or vaccine) other than the study vaccine within 30 days preceding the study vaccination, or planned use during the entire study period.
- •Acute (severe) febrile illness.
- •Any other clinical condition that, in the opinion of the investigator, might interfere with the results of the study or pose additional risk to the subject due to participation in the study.
- •Study personnel or immediate family members (brother, sister, child, parent) or the spouse of study personnel.
研究组 & 干预措施
Non-adjuvanted influenza vaccine
Other
Non-adjuvanted QIV containing 2 influenza type A strains and 2 influenza type B strains or Non-adjuvanted TIV containing 2 influenza type A strains and 1 influenza type B strain
干预措施: QIV or TIV (Biological)
MF59-adjuvanted influenza vaccine
Experimental
MF59-adjuvanted QIV containing 2 influenza type A strains and 2 influenza type B strains or MF59-adjuvanted TIV containing 2 influenza type A strains and 1 influenza type B strain
干预措施: aQIV or aTIV (Biological)
结局指标
主要结局
Efficacy Endpoint: First-occurrence of RT-PCR-confirmed influenza, due to any influenza Type A and/or B virus (regardless of antigenic match), using the protocol-defined ILI definition
时间窗: From 14 days after vaccination (ie study day 15) and until the end of influenza season (typically end of May for Northern Hemisphere [NH] influenza season and end of November for Southern Hemisphere [SH] influenza season)
ILI = influenza-like illness; RT-PCR = reverse transcription-polymerase chain reaction
次要结局
- Efficacy Endpoint: First-occurrence of influenza, due to influenza Type A and/or B virus antigenically matched to the vaccine strains selected for the seasonal vaccine, using the protocol-defined ILI definition(From 14 days after vaccination (ie study day 15) and until the end of influenza season (typically end of May for NH influenza season and end of November for SH influenza season))
- Efficacy Endpoint: First-occurrence of culture-confirmed influenza, due to any influenza Type A and/or B virus (regardless of antigenic match), using the protocol-defined ILI definition(From 14 days after vaccination (ie study day 15) and until the end of influenza season (typically end of May for NH influenza season and end of November for SH influenza season))
- Immunogenicity Endpoint: Percentage of subjects achieving seroconversion for the A/H1N1, A/H3N2, B/Yamagata, and B/Victoria vaccine strains(Day 1 and Day 22)
- Safety Endpoint: All adverse events (AEs) reported within 30 minutes after vaccination(Day 1)
- Efficacy Endpoint: First-occurrence of RT-PCR-confirmed influenza, due to any influenza Type A and/or B virus (regardless of antigenic match), using the modified CDC ILI definition(From 14 days after vaccination (ie study day 15) and until the end of influenza season (typically end of May for NH influenza season and end of November for SH influenza season))
- Immunogenicity Endpoint: Pre- and post-vaccination hemagglutination inhibition (HI) geometric mean titers (GMTs) for the A/H1N1, A/H3N2, B/Yamagata, and B/Victoria vaccine strains(Day 1 and Day 22)
- Efficacy Endpoint: First-occurrence of RT-PCR-confirmed influenza, due to any influenza Type A and/or B virus (regardless of antigenic match), using the WHO ILI definition(From 14 days after vaccination (ie study day 15) and until the end of influenza season (typically end of May for NH influenza season and end of November for SH influenza season))
- Efficacy Endpoint: First-occurrence of influenza, due to influenza Type A and/or B virus antigenically unmatched to the vaccine strains selected for the seasonal vaccine, using the protocol-defined ILI definition(From 14 days after vaccination (ie study day 15) and until the end of influenza season (typically end of May for NH influenza season and end of November for SH influenza season))
- Immunogenicity Endpoint: Geometric mean fold increase (GMFI, Day 22/Day1) for the A/H1N1, A/H3N2, B/Yamagata, and B/Victoria vaccine strains(Day 1 and Day 22)
- Immunogenicity Endpoint: Percentage of subjects with HI titer ≥1:40 for the A/H1N1, A/H3N2, B/Yamagata, and B/Victoria vaccine strains(Day 1 and Day 22)
- Safety Endpoint: Serious adverse events (SAEs) reported during the entire study period(Day 1 to Day 181 or the end of the influenza season, whichever is longer)
- Safety Endpoint: AEs leading to premature withdrawal from the study during the entire study period(Day 1 to Day 181 or the end of the influenza season, whichever is longer)
- Safety Endpoint: Adverse events of special interest (AESIs) reported during the entire study period(Day 1 to Day 181 or the end of the influenza season, whichever is longer)
- Efficacy Endpoint: First-occurrence of culture-confirmed influenza, due to influenza Type A and/or B virus antigenically matched to the vaccine strains selected for the seasonal vaccine, using the protocol-defined ILI definition(From 14 days after vaccination (ie study day 15) and until the end of influenza season (typically end of May for NH influenza season and end of November for SH influenza season))
- Efficacy Endpoint: First-occurrence of culture-confirmed influenza, due to influenza Type A and/or B virus antigenically unmatched to the vaccine strains selected for the seasonal vaccine, using the protocol-defined ILI definition(From 14 days after vaccination (ie study day 15) and until the end of influenza season (typically end of May for NH influenza season and end of November for SH influenza season))
- Efficacy Endpoint: First-occurrence of RT-PCR-confirmed influenza, due to any influenza Type A and/or B virus (regardless of antigenic match), using the protocol-defined ILI definition(From 14 days after vaccination (ie study day 15) and until the end of influenza season (typically end of May for NH influenza season and end of November for SH influenza season))
研究者
研究点 (465)
Loading locations...
相似试验
已完成
3 期
A Clinical Study to Evaluate the Immunogenicity and Safety of an Adjuvanted Quadrivalent Influenza Vaccine Compared With a Licensed Quadrivalent Vaccine in Adults 50 to 64 Years of AgeInfluenza, HumanNCT05044195Seqirus2,044
已完成
3 期
Efficacy, Safety, and Immunogenicity of a Plant-Derived Quadrivalent Virus-Like Particles (VLPs) Influenza Vaccine in AdultsVirus DiseasesRNA Virus InfectionsRespiratory Tract DiseasesRespiratory Tract InfectionsInfluenzaNCT03301051Medicago10,160
已完成
3 期
A Phase III Clinical Trial of Quadrivalent Influenza Vaccine in Healthy Subjects Aged 6 to 35 MonthsSeasonal InfluenzaNCT06049927Sinovac Biotech Co., Ltd3,300
已完成
3 期
Safety and Immunogenicity of a Cell Culture-derived Influenza Vaccine in Healthy Adults and ElderlyInfluenzaNCT00492063Novartis Vaccines2,654
已完成
3 期
Safety and Immunogenicity of an Adjuvanted Trivalent Influenza Vaccine in Children 6 to <72 Months of Age in Mexico.InfluenzaNCT02255279Novartis Vaccines287