Randomized, Age-stratified, Double Blind, Controlled Phase 3 Study Comparing a Vero Cell-derived Trivalent Seasonal Influenza Vaccine Made by the Modified Manufacturing Process With Vaccine Made by the Current Manufacturing Process and a Licensed Trivalent Influenza Vaccine in Healthy Adults Aged 18 Years and Older
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 入组人数
- 1,928
- 试验地点
- 20
- 主要终点
- Hemagglutination Inhibition Antibody (HIA) Titer for Each of the Three Antigens Contained in the Vaccine
研究概览
简要总结
The purpose of this study is to determine if a Vero cell-derived trivalent seasonal influenza vaccine produced by the modified manufacturing process:
- induces immune responses comparable to that produced by the current manufacturing process
- has an acceptable safety profile compared to a licensed trivalent seasonal influenza vaccine
- demonstrates consistency of immune response among three different lots.
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
- Double (Participant, Investigator)
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Participant is 18 to 49 years of age, inclusive, at the time of screening (for Cohort 18 to 49 years of age);
- •Participant is 50 years of age, inclusive, or older at the time of screening (for Cohort 50 years of age or older);
- •Participant gave written informed consent prior to study entry
- •Participant is generally healthy without any significant medical risk conditions, as determined by the Investigator's clinical judgment through collection of medical history and performance of a physical examination;
- •Participant is willing and able to comply with the requirements of the protocol;
- •Participant agrees to keep a record of symptoms for the duration of the study;
- •If female and capable of bearing children - participant has a negative urine pregnancy test at the study site, within 36 hours prior to vaccination, and agrees to employ adequate birth control measures for the duration of the study. For the purposes of this study adequate birth control measures incorporate one of the following FDA approved birth control measures for the duration of the study:
- •Hormonal types of birth control (such as implants, birth control pills, patches or other methods) or an intrauterine device, OR
- •A barrier type of birth control measure (i.e., condoms, diaphragms, cervical caps, etc.).
排除标准
- •Participant has been vaccinated with seasonal trivalent influenza vaccine in the current season;
- •Participant has an oral temperature of ≥100.4°F (≥38.0°C) on the day of vaccination in this study;
- •Participant has received a live vaccine within 4 weeks, or an inactivated or subunit vaccine within 2 weeks of study entry;
- •Participant with a known history of infection with Human Immunodeficiency Virus (HIV), Hepatitis B Virus (HBsAgs) or Hepatitis C Virus (HCV);
- •Participant has any medically diagnosed or suspected immune deficient condition based on medical history and physical examination as determined by the Investigator;
- •Participant has an immune compromising condition or disease, or is currently undergoing a form of treatment or was undergoing a form of treatment within 30 days prior to study entry that can be expected to influence immune response. Such treatment includes, but is not limited to, systemic or high dose inhaled corticosteroids (> 800 μg/day of beclomethasone dipropionate or equivalent), radiation treatment or other immunosuppressive or cytotoxic drugs (use of inhaled and nasal steroids will be permitted);
- •Participant has a known history of Guillain Barré Syndrome, demyelinating disorders (including acute demyelinating encephalomyelitis (ADEM), Multiple Sclerosis) or convulsions;
- •Participant has a history of severe allergic reactions or anaphylaxis as determined by the Investigator;
- •Participant has a rash, dermatologic condition or tattoos which may interfere with injection site reaction rating as determined by the Investigator;
- •Participant has received any blood products (e.g. blood transfusion or immunoglobulins) within 90 days prior to study entry;
- •Participant has donated one or more units of blood (approximately 450 mL) or plasma within 30 days prior to study entry;
- •Participant has a functional or surgical asplenia;
- •Participant has a known or suspected problem with alcohol or drug abuse as determined by the Investigator;
- •Participant is a member of the team conducting this study or is in a dependent relationship with one of the study team members. Dependent relationships include close relatives (ie., children, partner/spouse, siblings, parents) as well as employees of the Investigator or study site personnel conducting the study;
- •If female, participant is pregnant or lactating at the time of study enrollment;
- •Participant is currently enrolled or has participated in another clinical study involving an investigational product (IP) or investigational device within 30 days prior to study enrolment or is scheduled to participate in another clinical study involving an IP or investigational device during the course of this study;
- •Participant has any condition that in the opinion of the Investigator would interfere with evaluation of the vaccine or interpretation of study results.
研究组 & 干预措施
VCIV - Modified manufacturing process (18-49 Years Old) Lot 1
Vero cell-derived trivalent influenza vaccine (VCIV)
干预措施: Vero cell-derived trivalent influenza vaccine manufactured with the modified manufacturing process (VCIV modified) (Biological)
VCIV - Modified manufacturing process (18-49 Years Old) Lot 2
Vero cell-derived trivalent influenza vaccine (VCIV)
干预措施: Vero cell-derived trivalent influenza vaccine manufactured with the modified manufacturing process (VCIV modified) (Biological)
VCIV - Modified manufacturing process (18-49 Years Old) Lot 3
Vero cell-derived trivalent influenza vaccine (VCIV)
干预措施: Vero cell-derived trivalent influenza vaccine manufactured with the modified manufacturing process (VCIV modified) (Biological)
VCIV manufactured with current process (18-49 Years Old)
Vero cell-derived trivalent influenza vaccine (VCIV)
干预措施: VCIV manufactured with the current manufacturing process (VCIV current) (Biological)
Fluzone® (18-49 Years Old)
Fluzone®, licensed trivalent influenza vaccine (TIV)
干预措施: Fluzone®, licensed trivalent influenza vaccine (TIV) (Biological)
VCIV - Modified manufacturing process (≥50 Years Old) Lot 1
Vero cell-derived trivalent influenza vaccine (VCIV)
干预措施: Vero cell-derived trivalent influenza vaccine manufactured with the modified manufacturing process (VCIV modified) (Biological)
VCIV - Modified manufacturing process (≥50 Years Old) Lot 2
Vero cell-derived trivalent influenza vaccine (VCIV)
干预措施: Vero cell-derived trivalent influenza vaccine manufactured with the modified manufacturing process (VCIV modified) (Biological)
VCIV - Modified manufacturing process (≥50 Years Old) Lot 3
Vero cell-derived trivalent influenza vaccine (VCIV)
干预措施: Vero cell-derived trivalent influenza vaccine manufactured with the modified manufacturing process (VCIV modified) (Biological)
Fluzone® (≥50 Years Old)
Fluzone®, licensed trivalent influenza vaccine (TIV)
干预措施: Fluzone®, licensed trivalent influenza vaccine (TIV) (Biological)
结局指标
主要结局
Hemagglutination Inhibition Antibody (HIA) Titer for Each of the Three Antigens Contained in the Vaccine
时间窗: 21 days post vaccination
Hemagglutination Inhibition Antibody (HIA) Titer for Each of the Three Antigens Contained in the Vaccine Two co-primary analyses relating to this primary immunogenicity outcome measure were also performed: Outcome Measure 2 - Noninferiority Outcome Measure 3 - Lot Consistency
Non-inferiority of Modified Manufacturing Process Compared to the Current Process
时间窗: 21 days post vaccination
Non-inferiority of modified manufacturing process compared to the current process. Co-primary analysis of HIA Titer for each of the three antigens (Outcome Measure 1) was performed on a subset of the Per Protocol analysis dataset for participants 18-49 Years Old treated with Vero cell-derived trivalent influenza vaccine (VCIV) from the modified manufacturing process and VCIV manufactured with the current process
Lot Consistency of the Three Modified Manufacturing Process Lots
时间窗: 21 days post vaccination
Lot consistency of the three modified manufacturing process lots Co-primary analysis of HIA Titer for each of the three antigens (Outcome Measure 1) was performed on a subset of the Per Protocol Analysis Dataset for participants of all ages treated with three Vero cell-derived trivalent influenza vaccine (VCIV) lots manufactured from the modified process.
Percentage of Participants With Fever
时间窗: onset within 7 days post vaccination
Percentage of participants with fever
次要结局
- Number and Severity of Each Solicited Systemic Reaction and Injection Site Reaction(within 7 days post vaccination)
- Percentage of Participants With Adverse Events(within 21 days post vaccination)
- Percentage of Participants With Seroprotective Antibody Titer for Each of the Three Antigens(21 days post vaccination)
- Percentage of Participants Demonstrating Seroconversion to Each of the Three Antigens Contained in the Vaccine(21 days post vaccination)
- Fold Increase of HIA Titer for Each of the Three Antigens Contained in the Vaccine as Compared to Baseline(21 days post vaccination)
- Percentage of Participants With Solicited Systemic Reactions(within 7 days post vaccination)
- Percentage of Participants With Injection Site Reactions(within 7 days post vaccination)
- Frequency and Severity of Related Adverse Events(within 21 days post vaccination)