Phase 2 Clinical Trial to Confirm the Dose and Formulation of a Recombinant Quadrivalent Nanoparticle Influenza Vaccine (Quad-NIV) With or Without Matrix-M1™ Adjuvant in Healthy Adults ≥ 65 Years of Age
试验速览
- 阶段
- 2 期
- 状态
- 终止
- 发起方
- Novavax
- 入组人数
- 1,375
- 试验地点
- 28
- 主要终点
- HAI Titers Specific for Antigenically-drifted Influenza Strains Expressed as GMT
研究概览
简要总结
A Phase 2 trial to confirm the dose and formulation, demonstrate adjuvant effect, and evaluate the safety and tolerability of a single intramuscular injection of Quad-NIV with or without Matrix-M1 adjuvant in healthy adults ≥ 65 years of age.
A total of approximately 1375 subjects were to be randomized to seven treatment groups to receive Quad-NIV or an active comparator.
详细描述
This randomized, observer-blind, active-controlled, Phase 2 trial was conducted at multiple sites. The composition of the Quad-NIV Influenza Vaccines used in this trial included recombinant H1, H3, and two B hemagglutinin proteins for the 2018-2019 Northern Hemisphere influenza virus strains.
Approximately 1375 healthy male and female subjects ≥ 65 years were randomized into 7 treatment groups (group A to group G), receiving various formulations of Quad-NIV, with or without Matrix-M1 adjuvant or one of two active comparator influenza vaccines. Within each site, randomization was stratified by history of receipt of 2017-2018 influenza vaccine. Subjects received two injections 28 days apart. On Day 0, subjects received one of the five Quad-NIV formulations or one of the two comparator influenza vaccines. On Day 28, subjects received either placebo or a licensed influenza vaccine rescue dose, depending on his or her initial randomization.
Subjects were followed for safety for approximately 6 months, with primary immunogenicity results at Day 28.
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
- •Clinically-stable adult male or female, ≥ 65 years of age. Subjects may have 1 or more chronic medical diagnoses, but should be clinically stable as assessed by:
- •Absence of changes in medical therapy within 1 month due to treatment failure or toxicity,
- •Absence of medical events qualifying as serious adverse events within 2 months; and
- •Absence of known, current, and life-limiting diagnoses which render survival to completion of the protocol unlikely in the opinion of the investigator.
- •Willing and able to give informed consent prior to trial enrollment, and
- •Living in the community and able to attend trial visits, comply with trial requirements, and provide timely, reliable, and complete reports of adverse events.
排除标准
- •Participation in research involving investigational product (drug / biologic / device) within 45 days before planned date of first injection.
- •Participation in any previous Novavax's influenza vaccine clinical trial(s).
- •History of a serious reaction to prior influenza vaccination, known allergy to constituents of licensed comparator vaccines or polysorbate
- •History of Guillain-Barré Syndrome (GBS) within 6 weeks following a previous influenza vaccine.
- •Received any vaccine in the 4 weeks preceding the trial vaccination and any influenza vaccine within 6 months preceding the trial vaccination.
- •Any known or suspected immunosuppressive illness, congenital or acquired, based on medical history and/or physical examination.
- •Chronic administration (defined as more than 14 continuous days) of immunosuppressants or other immune-modifying drugs within 6 months prior to the administration of the trial vaccine. An immunosuppressant dose of glucocorticoid will be defined as a systemic dose ≥ 10 mg of prednisone per day or equivalent. The use of topical, inhaled, and nasal glucocorticoids will be permitted.
- •Administration of immunoglobulins and/or any blood products within the 3 months preceding the administration of the trial vaccine or during the trial.
- •Acute disease at the time of enrollment (defined as the presence of a moderate or severe illness with or without fever, or an oral temperature ≥ 38.0°C, on the planned day of vaccine administration).
- •Any condition that in the opinion of the investigator would pose a health risk to the subject if enrolled or could interfere with evaluation of the vaccine or interpretation of trial results (including neurologic or psychiatric conditions deemed likely to impair the quality of safety reporting).
- •Known disturbance of coagulation.
- •Suspicion or recent history (within 1 year of planned vaccination) of alcohol or other substance abuse.
结局指标
主要结局
HAI Titers Specific for Antigenically-drifted Influenza Strains Expressed as GMT
时间窗: Day 0 - Day 28
HAI antibody titers specific for at least 2 antigenically-drifted influenza strains, at Days 0 and 28 post-vaccination expressed as geometric man titer (GMT).
Number of Subjects With Adverse Events (AEs)
时间窗: Day 0 - Day 182
Adverse Events over the 7 days post-injection; all adverse events (including adverse changes in clinical laboratory parameters) through 21 days post-injection; and Medically Attended Adverse Events (MAEs), Serious Adverse Events (SAEs), and Significant New Medical Conditions (SNMCs) through 6 months post-injection.
Hemagglutination Inhibition (HAI) Titers Specific for Vaccine Homologous A and B Influenza Strains Expressed as Geometric Man Titer (GMT)
时间窗: Day 0 - Day 28
HAI antibody titers specific for the HA receptor binding domains of vaccine homologous A and B strain(s) at Days 0 and Day 28 post-vaccination expressed as geometric man titer (GMT).
次要结局
- Number of Participants Who Seroconverted as Determined by HAI Titers Specific for Vaccine-homologous A and B Influenza Strains(Day 28 - Day 182)
- Number of Participants Who Seroconverted as Determined by HAI Titers Specific for Antigenically-drifted Influenza Strains(Day 28 - Day 182)
- HAI Titers Specific for Vaccine-homologous A and B Influenza Strains Expressed as GMT(Day 0 - Day 182)
- HAI Titers Specific for Vaccine-homologous A and B Influenza Strains Expressed as Geometric Mean Fold Ratio (GMFR)(Day 28 - Day 182)
- HAI Titer Responses Specific for Antigenically-drifted Influenza Strains Expressed as GMFR(Day 28 - Day 182)
- Number of Participants Who Had Seroprotection as Determined by HAI Titers Specific for Vaccine-homologous A and B Influenza Strains(Day 28 - Day 182)
- Number of Participants Who Had Seroprotection as Determined by HAI Titers of Antigenically-drifted Influenza Strains(Day 28 - Day 182)
- HAI Titers Specific for Antigenically-drifted Influenza Strains Expressed as GMT(Day 0 - Day 182)