A Phase 2b, Randomized, Observer-Blind, Antigen and Adjuvant Dose-Confirmation Clinical Study to Evaluate Safety and Immunogenicity of Different Formulations of MF59-Adjuvanted Quadrivalent Subunit Inactivated Cell-derived Influenza Vaccine (aQIVc) in Older Adults ≥50 Years of Age
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 发起方
- 入组人数
- 1,056
- 试验地点
- 88
- 主要终点
- The Percentage of Subjects with Serious Adverse Events (SAEs), AEs Leading to Withdrawal, Adverse Events of Special Interest (AESI) and Medically Attended Adverse Events (MAAEs)
研究概览
简要总结
This Phase 2, randomized, observer-blind, dose-confirmation clinical study evaluated different formulations of MF59-Adjuvanted Quadrivalent Subunit Inactivated Influenza Vaccine. Approximately 1000 subjects were randomized into 1 of 4 possible treatment groups with approximately 250 participants per group. Every participant received an influenza vaccine injection on Day 1 and were to be followed up for approximately 6 months following injection. The primary immunogenicity analysis is based on Day 29 serology data.
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
- 50 Years 至 —（Adult, 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.
- •Individuals ≥50 years of age on the day of informed consent.
- •Individuals who have voluntarily given written consent after the nature of the study has been explained according to local regulatory requirements, prior to study entry.
- •Individuals who can comply with study procedures including follow-up .
- •Males, females of non-childbearing potential or females of childbearing potential who are using an effective birth control method, at least 30 days prior to informed consent, which they intend to use for at least 2 months after the study vaccination.
排除标准
- •In order to participate in this study, all subjects must not meet ANY of the exclusion criteria described below:
- •Females of childbearing potential who are pregnant, lactating, or who have not adhered to a specified set of contraceptive methods from at least 30 days prior to informed consent and who do not plan to do so for at least 2 months after the study vaccination.
- •Progressive, unstable or uncontrolled clinical conditions.
- •Hypersensitivity, including allergy, to any component of vaccines whose use is foreseen in this study.
- •History of any medical condition considered an adverse event of special interest (AESI).
- •Known history of Guillain-Barré syndrome or another demyelinating disease such as encephalomyelitis and transverse myelitis.
- •Clinical conditions representing a contraindication 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 of ≥20 mg/day of prednisone or equivalent for more than 14 consecutive days within 90 days prior to informed consent
- •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 an investigational or non-registered medicinal product within 30 days prior to informed consent.
- •Receipt of any COVID-19 vaccine within 14 days (non-replicating vaccines) or 28 days (replicating vaccines) prior to informed consent or plan to receive any COVID-19 vaccine within 7 days from study vaccination
- •Individuals who received any other vaccines within 14 days (for inactivated vaccines) or 28 days (for live vaccines) prior to informed consent or who are planning to receive any vaccine within 28 days from the study vaccines.
- •Study personnel or immediate family or household member of study personnel.
- •Receipt of any influenza vaccine within 6 months prior to informed consent, or plan to receive an influenza vaccine during the 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.
结局指标
主要结局
The Percentage of Subjects with Serious Adverse Events (SAEs), AEs Leading to Withdrawal, Adverse Events of Special Interest (AESI) and Medically Attended Adverse Events (MAAEs)
时间窗: 180 days post-vaccination
Immunogenicity Endpoint: Hemagglutination inhibition (HI) titers against vaccine A and B influenza strains
时间窗: 28 days post-vaccination
The Percentage of Subjects with Unsolicited Adverse Events
时间窗: 28 days post-vaccination
The Percentage of Subjects with Solicited Local and Systemic Reactions
时间窗: 7 days post-vaccination
Immunogenicity Endpoint: Geometric Mean Titer (GMT): Geometric Mean of Hemagglutination Inhibition (HI) Antibodies at Day 1 and Day 29
时间窗: Day 1 and Day 29
GMTs on Day 1 (prior to vaccination) and Day 29 as determined by HI assay against each of the 4 vaccine strains. No hypothesis testing was performed for the primary immunogenicity objectives.
Immunogenicity Endpoint: Geometric Mean Fold Increase (GMFI) (HI Assay)
时间窗: Day 1 to Day 29
Geometric mean of the fold increase in serum HI titer postvaccination (Day 29) compared to prevaccination (Day 1) for each of the 4 vaccine strains.
Immunogenicity Endpoint: Percentages of Subjects With HI Titers ≥1:40 at Day 1 and Day 29
时间窗: Day 1 and Day 29
Percentages of subjects with HI titers ≥1:40 at Day 1 and Day 29 for each of the 4 vaccine strains.
Immunogenicity Endpoint: Percentage of Subjects With Seroconversion at Day 29 (HI Assay)
时间窗: Day 1 to Day 29
Seroconversion is defined as ≥4-fold increase in titer postvaccination in those with prevaccination titer equal to or above the lower limit of quantitation (LLOQ; 1:10), or a postvaccination titer ≥1:40 for subjects with baseline titer below the LLOQ (1:10) for HI antibodies.
Immunogenicity Endpoint: GMT Ratio (HI Assay)
时间窗: Day 29
The GMT ratio is the geometric mean of the postvaccination HI titer for the investigational vaccine over the geometric mean of the postvaccination HI titer for the licensed IIV vaccine. The Day 29 GMT ratios are calculated for the investigational vaccines with reference to the licensed vaccine, ie, the Day 29 GMT ratios are the ratio of the Day 29 GMTs in the Investigational group (IIV-A Investigational, aIIV-B Investigational, or aIIV-C Investigational) compared with the Day 29 GMTs in the Licensed IIV group (ie, Investigational group/Licensed IIV group). As the licensed vaccine is the reference for the GMT ratio, this parameter is presented as "1" for the Licensed IIV group (ie, Licensed IIV group/Licensed IIV group).
Solicited Local or Systemic AEs
时间窗: Day 1 through Day 7
Number and percentage of subjects with solicited local or systemic AEs for 7 days following vaccination, based on the subject reported data (electronic Diary \[eDiary\]). No hypothesis testing was performed for the primary safety objectives.
Severe Solicited Local or Systemic AEs
时间窗: Day 1 through Day 7
Number and percentage of subjects with severe solicited local or systemic AEs for 7 days following vaccination, based on the subject reported data (eDiary).
Unsolicited AEs
时间窗: Day 1 to Day 29
Number and percentage of subjects with unsolicited AEs for 28 days following vaccination
Subjects With Serious Adverse Events (SAEs), AEs Leading to Withdrawal, Adverse Events of Special Interest (AESIs) and Medically-attended Adverse Events (MAAEs)
时间窗: Day 1 to Day 181
Number and percentage of subjects with SAEs, AEs leading to withdrawal from the study, AESIs and non-serious MAAEs
次要结局
- Immunogenicity Endpoint: Microneutralization (MN) titers against vaccine A and B influenza strains(28 days post-vaccination)
- Immunogenicity Endpoint: GMT: Geometric Mean of Microneutralization (MN) Antibodies Titer at Days 1 and 29(Day 1 and Day 29)
- Immunogenicity Endpoint: GMFI (MN Assay)(Day 1 to Day 29)
- Immunogenicity Endpoint: Percentages of Subjects With Seroconversion at Day 29 (MN Assay)(Day 1 to Day 29)
- Immunogenicity Endpoint: GMT Ratio (MN Assay)(Day 29)