A Phase 3, Randomized, Modified Double-blind, 2-arm Study to Evaluate the Immunogenicity and Safety of High-Dose Inactivated Influenza Vaccine (IIV-HD) Compared With a Standard-dose Inactivated Influenza Vaccine (IIV-SD) in Participants 50 Through 64 Years of Age.
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 入组人数
- 1,180
- 试验地点
- 20
- 主要终点
- Percentage of participants with seroconversion for influenza vaccine antibodies
研究概览
简要总结
The purpose of this study is to evaluate Immunogenicity and Safety of a High-Dose (HD) Influenza Vaccine (IV) in Adults 50 through 64 Years of Age.
详细描述
The study duration will be approximately 180 days (+ 14 days).
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)
盲法说明
Modified double-blind:
-
Participants, Sponsor study staff*, investigators, and study site staff will not know which study vaccine is administered during the study conduct
-
Dedicated study site staff who prepare/administer the study interventions and are not involved in the safety evaluation will know which study vaccine is administered.
-
Select sponsor staff will be unblinded after the code break for primary completion analysis.
入排标准
- 年龄范围
- 50 Years 至 64 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Aged 50 to 64 years on the day of inclusion.
- •A female participant is eligible to participate if she is not pregnant or breastfeeding and one of the following conditions applies:
- •Is of non-childbearing potential. To be considered of non-childbearing potential, a female must be postmenopausal for at least 1 year, or surgically sterile.
- •Is of childbearing potential and agrees to use an effective contraceptive method or abstinence from at least 4 weeks prior to study intervention administration until at least 4 weeks after study intervention administration.
- •A female participant of childbearing potential must have a negative highly sensitive pregnancy test (urine or serum as required by local regulation) at enrollment before the first dose of study intervention.
- •Informed consent form has been signed and dated.
- •Able to attend all scheduled visits and to comply with all study procedures.
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).
- •Personal or family history of Guillain-Barré Syndrome (GBS).
- •Known systemic hypersensitivity to any of the study intervention components (Section 1.1, Section 6.1), or history of a life-threatening reaction to the study intervention used in the study or to a product containing any of the same substances.
- •Self-reported thrombocytopenia, contraindicating intramuscular injection, based on investigator's judgment.
- •Bleeding disorder, or receipt of anticoagulants in the 3 weeks preceding inclusion, contraindicating intramuscular injection, based on investigator's judgment.
- •Chronic illness that, in the opinion of the investigator, is at a stage where it might interfere with study conduct or completion.
- •Moderate or severe acute illness/infection (according to investigator judgment) or febrile illness (temperature ≥ 38.0°C [≥ 100.4°F]) on the day of study intervention administration. A prospective participant should not be included in the study until the condition has resolved or the febrile event has subsided.
- •Alcohol, prescription drug, or substance abuse that, in the opinion of the Investigator, might interfere with the study conduct or completion.
- •Receipt of any vaccine in the 4 weeks preceding the study intervention administration or planned receipt of any vaccine prior to the second blood drawing (ie. approximately 4 weeks after the study intervention administration).
- •Previous vaccination against influenza in the previous 6 months with an investigational or marketed vaccine.
- •Receipt of immune globulins, blood, or blood-derived products in the past 3 months.
- •Participation at the time of study enrollment (or in the 4 weeks preceding the first study intervention administration) or planned participation during the present study period in another clinical study investigating a vaccine, drug, medical device, or medical procedure.
- •Deprived of freedom by an administrative or court order, or being in an emergency setting, or hospitalized involuntarily.
- •Identified as an Investigator or employee of the Investigator or study center with direct involvement in the proposed study, or identified as an immediate family member (ie.
- •parent, spouse, natural or adopted child) of the Investigator or employee with direct involvement in the proposed study.
研究组 & 干预措施
IIV-HD
Participants will receive a single intramuscular (IM) injection of IIV-HD at Day 1
干预措施: High-Dose trivalent influenza vaccine (Split virion, Inactivated) (Biological)
IIV-SD
Participants will receive a single intramuscular (IM) injection of IIV-SD at Day 1
干预措施: Standard-dose trivalent influenza vaccine (Split virion, Inactivated) (Biological)
结局指标
主要结局
Percentage of participants with seroconversion for influenza vaccine antibodies
时间窗: Day 29
Anti-influenza antibodies will be measured using HAI assay for 3 influenza virus strains: A/H1N1, A/H3N2, and B/Victoria lineage. Seroconversion status 28 days after vaccination (ie, preinjection Ab titer \< 10 \[1/dil\] at Day 1 and post-injection Ab titer≥ 40 \[1/dil\] at Day 29 or preinjection Ab titer ≥ 10 \[1/dil\] at Day 1 and a ≥ 4-fold increase in titer \[1/dil\] at Day 29).
Geometric mean titers (GMTs) against influenza vaccine antibodies (Ab)
时间窗: Day 1 and Day 29
GMTs of anti-influenza antibodies were measured using hemagglutination inhibition (HAI) assay for 3 influenza virus strains: A/H1N1, A/H3N2, and B/Victoria lineage.
次要结局
- Number of participants with immediate adverse events (AEs)(Within 30 minutes after vaccination)
- Number of participants with solicited injection site reactions(Up to 7 days after vaccination)
- Percentage of participants with detectable HAI titer (HAI titer ≥ 10 [1/dil])(Day 1 and Day 29)
- Number of participants with solicited systemic reaction(Up to 7 days after vaccination)
- Percentage of participants with HAI titer ≥ 40 (1/dil)(Day 29)
- Geometric Mean of Individual Titer Ratio (GMTR)(Day 1 and Day 29)
- Number of participants with unsolicited AEs(Up to 28 days after vaccination)
- Number of participants with medically attended adverse events (MAAEs)(Throughout the study, approximately 180 days)
- Number of participants with adverse events of special interest (AESIs)(Throughout the study, approximately 180 days)
- Number of participants with serious adverse events (SAEs)(Throughout the study, approximately 180 days)