NCT02555618已完成2 期
A Randomized Double-Blind Parallel-Group Comparative Phase 2 Study to Evaluate the Immunogenicity and Safety of a Single Subcutaneous Injection of TAK-850 in Comparison With Influenza HA Vaccine in Healthy Adult Subjects
Takeda0 个研究点目标入组 400 人开始时间: 2015年9月1日最近更新:
适应症
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 发起方
- 入组人数
- 400
- 主要终点
- Seroconversion Rate of Hemagglutination Inhibition (HI) Antibody Titer (Egg-Derived Antigen)
研究概览
简要总结
The purpose of this study is to evaluate the immunogenicity and safety of TAK-850 administered subcutaneously as a single dose versus influenza HA vaccination in an exploratory manner.
详细描述
This study is a phase 2, single dose study of TAK-850 (cell-culture derived TIV) administered subcutaneously in healthy Japanese adults, designed as a randomized, double-blind, parallel-group, comparative study to evaluate the immunogenicity and safety compared to an egg-derived TIV.
The drug being tested in this study is called TAK-850. TAK-850 was tested in healthy volunteers. This study looked at immunogenicity and safety of TAK-850 (cell-derived) compared to an egg-derived influenza vaccine.
The study enrolled 400 patients. Participants were randomly assigned (by chance, like flipping a coin) to one of the two groups-which will remain undisclosed to the patient and study doctor during the study (unless there is an urgent medical need):
- TAK-850
- Influenza HA vaccine All participants received one injection. This single center trial was conducted in Japan. The overall time to participate in this study was 22 days. Participants made multiple visits to the clinic, including a final visit 21 days after the vaccination for a follow-up assessment.
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
- Triple (Participant, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 20 Years 至 49 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •In the opinion of the investigator or subinvestigator, the participant is capable of understanding and complying with protocol requirements.
- •The participant signs and dates a written, informed consent form prior to the initiation of any study procedures.
- •The participant is a healthy Japanese adult male or female.
- •The participant is aged 20 to 49 years, inclusive, at the time of informed consent.
- •The participant has a body mass index (BMI) between 18.5 and 25.0 kg/m^2, inclusive, at the time of the eligibility evaluation.
- •A female participant of childbearing potential who is sexually active with a nonsterilized male partner agreed to routinely use adequate contraception from signing of the informed consent throughout the duration of the study.
排除标准
- •The participant has received any investigational compound within 4 months prior to injection of study vaccine.
- •The participant has been vaccinated with seasonal influenza vaccine within 6 months prior to injection of study vaccine.
- •The participant has a history of influenza infection within 6 months prior to injection of study vaccine.
- •The participant has been vaccinated with TAK-850 before.
- •The participant is a study site employee, an immediate family member of such an employee, or in a dependent relationship with a study site employee who is involved in the conduct of this study (e.g., spouse, parent, child, sibling), or may consent under duress.
- •The participant has uncontrolled, clinically significant manifestations of neurological, cardiovascular, pulmonary, hepatic, renal, metabolic, gastrointestinal, urologic, endocrine, or other disorders, which may impact the ability of the participant to participate or potentially confound the study results.
- •The participant has an oral temperature >= 37.5 °C prior to injection of study vaccine on Day
- •The participant has any medically diagnosed or suspected immune deficient condition.
- •The participant has an immune compromising condition or disease, or is currently undergoing a form of treatment or was undergoing a form of treatment that can be expected to influence immune response within 30 days prior to injection of study vaccine. Such treatments include systemic or high dose inhaled corticosteroids (> 800 µg/day of beclomethasone dipropionate or equivalent; the use of inhaled and nasal steroids that do not exceed this level will be permitted), radiation therapy, and other immunosuppressive and cytotoxic drugs.
- •The participant has received antipyretics within 4 hours prior to the injection of study vaccine.
- •The participant has a history of Guillain-Barré Syndrome, demyelinating disorders (including acute disseminated encephalomyelitis [ADEM] and multiple sclerosis), or convulsions.
- •The participant has a functional or surgical asplenia.
- •The participant has a rash, other dermatologic conditions, or tattoos which may interfere with the evaluation of injection site reaction.
- •The participant has a history of, or is infected with the Hepatitis B Virus (HBsAgs), Hepatitis C Virus (HCV), or Human Immunodeficiency Virus (HIV).
- •The participant has known hypersensitivity to any component of TAK-850 or Influenza HA Vaccine.
- •The participant has a history of severe allergic reactions or anaphylaxis.
- •The participant has a history of drug abuse (defined as any illicit drug use) or a history of alcohol abuse within 1 year prior to injection of study vaccine or is unwilling to agree to abstain from excessive alcohol and drugs throughout the study.
- •The participant has received any blood products (blood transfusion or immunoglobulin) within 90 days prior to injection of study vaccine.
- •The participant has received a live vaccine within 4 weeks (28 days) or an inactivated vaccine within 2 weeks (14 days) prior to injection of study vaccine.
- •If female, the participant is pregnant or lactating or intending to become pregnant before signing of informed consent, during treatment, or within 12 weeks after injection of study vaccine; or intending to donate ova during this time period.
- •The participant has donated whole blood >= 200 mL within 4 weeks (28 days), >= 400 mL within 12 weeks (84 days), >= 800 mL within 52 weeks (364 days) or blood components within 2 weeks (14 days) prior to injection of study vaccine.
- •The participant has abnormal laboratory values that suggest a clinically significant underlying disease at the assessment prior to the injection of study vaccine, or the participant has the following laboratory abnormalities: alanine aminotransferase (ALT) and/or aspartate aminotransferase (AST) more than 3 times the respective upper limits of normal.
- •In the opinion of the investigator or subinvestigator, the participant is unlikely to comply with protocol requirements or is considered ineligible for any other reasons.
结局指标
主要结局
Seroconversion Rate of Hemagglutination Inhibition (HI) Antibody Titer (Egg-Derived Antigen)
时间窗: Baseline and Day 22
Seroconversion rate was measured by hemagglutination inhibition (HI) antibody titer (egg-derived antigen) for each of the three strains (A/H1N1 strain, A/H3N2 strain, B strain), 21 days after vaccination. Seroconversion rate was defined as the percentage of participants achieving a minimal 4-fold increase from the Baseline HI antibody titer in participants with a Baseline titer ≥10, or achieving an HI antibody titer of ≥40 in participants with a Baseline titer \<10.
Geometric Mean Titer (GMT) of HI Antibody Titer (Egg-Derived Antigen)
时间窗: Days 1 and 22
Geometric mean titer (GMT) of HI antibody titer (egg-derived antigen) for each of the three strains (A/H1N1 strain, A/H3N2 strain, B strain), 21 days after vaccination. Day 1 data is reported for reference.
次要结局
- Seroprotection Rate of SRH Antibody Titer (Egg-Derived Antigen)(Days 1 and 22)
- Geometric Mean Fold Increase in SRH Antibody Titer (Egg-Derived Antigen)(Baseline and Day 22)
- Seroconversion Rate of HI Antibody Titer (Vero-Derived Antigen)(Baseline and Day 22)
- GMT of HI Antibody Titer (Vero-Derived Antigen)(Days 1 and 22)
- Seroconversion Rate of SRH Antibody Titer (Vero-Derived Antigen)(Baseline and Day 22)
- Seroprotection Rate of SRH Antibody Titer (Vero-Derived Antigen)(Days 1 and 22)
- Geometric Mean Fold Increase in SRH Antibody Titer (Vero-Derived Antigen)(Baseline and Day 22)
- Percentage of Participants Reporting One or More Treatment-emergent Adverse Events (TEAE)(22 days)
- Percentage of Participants With Abnormal Safety Laboratory Tests at Least Once Post Dose Reported as AEs(22 Days)
- Seroprotection Rate of HI Antibody Titer (Vero-Derived Antigen)(Days 1 and 22)
- Geometric Mean Fold Increase in HI Antibody Titer (Vero-Derived Antigen)(Baseline and Day 22)
- GMT of SRH Antibody Titer (Vero-Derived Antigen)(Days 1 and 22)
- Percentage of Participants With Solicited Local and Systemic Adverse Events (AEs)(22 Days)
- Seroprotection Rate of HI Antibody Titer (Egg-Derived Antigen)(Days 1 and 22)
- Geometric Mean Fold Increase in HI Antibody Titer (Egg-Derived Antigen)(Baseline and Day 22)
- Seroconversion Rate of Single Radial Hemolysis (SRH) Antibody Titer (Egg-Derived Antigen)(Baseline and Day 22)
- GMT of SRH Antibody Titer (Egg-Derived Antigen)(Days 1 and 22)
研究者
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