NCT05089123已完成3 期
Prospective, Multicenter, Double-blind, Randomized, Comparative Immunogenicity and Safety Trial of Flu-M [Inactivated Split Influenza Vaccine], Solution for Intramuscular Injection, 0.5 ml (FSUE SPbSRIVS FMBA), vs. Ultrix®, Solution for Intramuscular Injection, 0.5 ml (FORT LLC) in Volunteers Aged Over 60 Years
St. Petersburg Research Institute of Vaccines and Sera2 个研究点 分布在 1 个国家目标入组 320 人开始时间: 2020年3月3日最近更新:
适应症
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 入组人数
- 320
- 试验地点
- 2
- 主要终点
- Immunogenicity assessment
研究概览
简要总结
This trial by its design was a prospective, multicenter, double blind, randomized comparative clinical trial of the IIIb-IV phase which was carried out in parallel groups of volunteers over the age of 60
详细描述
The volunteers will include in the trial will divide into two groups:
Group 1: volunteers who will receive one dose of Flu-M, solution for intramuscular injection, 0.5 mL, intramuscularly.
Group 2: volunteers who will receive one dose of Ultrix®, solution for intramuscular administration, 0.5 mL, intramuscularly.
The trial include the following periods and visits:
- Screening period (up to 7 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
- Double (Participant, Investigator)
入排标准
- 年龄范围
- 60 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Presence of signed informed consent to participate in the trial.
- •Volunteers (both male and female) over the age of 60 who could meet the Protocol requirements.
- •Negative pregnancy test obtained from female volunteers with preserved childbearing potential.
- •Consent to use adequate contraception methods (contraception methods with degree of reliability of more than 90%: a nonhormonal intrauterine device; a spermicide condom; a spermicide cervical cap; spermicide diaphragms) or total sexual abstinence during the clinical trial (until Visit 5 (day 28(+2)).
排除标准
- •Allergic reactions to chicken protein or any previous influenza vaccination.
- •Anamnestic data on the episodes of severe allergic reactions and/or diseases (anaphylaxis, Quincke's edema, polymorphic exudative erythema, serum disease etc.)
- •Acute reaction (temperature above 38.5оС, edema and hyperemia over 5 cm in diameter at the injection site) or complications caused by previous administration of the drug.
- •Previous vaccination 6 months before the start of the trial.
- •History of leucosis, blood cancer, malignant oncological diseases.
- •Guillain-Barré syndrome (acute polyneuropathy) in the medical history.
- •Positive screening for HIV infection, B and C hepatitis, syphilis.
- •Any confirmed or suspected immunosuppressive or immunodeficiency condition;
- •Administration of immunoglobulin or blood products within the last three months before the study.
- •Long-term use (more than 14 days) of immunosuppressants (including systemic corticosteroids, cytotoxic, radioactive preparations) or other immunomodulatory drugs for six months before the trial.
- •Chronic diseases at the decompensation stage or in debilitating form, which can make it dangerous for the volunteer to take part in the trial.
- •Progressive neurological disorders, dementia.
- •Blood disorders which serve as a contradiction for intramuscular injection.
- •History of alcohol or drug addiction.
- •Pregnancy, breastfeeding in women with preserved reproductive performance.
- •Current participation in another clinical trial or within the previous 3 months before the screening.
- •Mental, physical and other problems which do not allow for appropriate assessment of own behavior and following the requirements set out in the trial protocol.
- •Any other conditions which in the reasonable opinion of the clinical investigator complicate the participation of the volunteer in the trial
结局指标
主要结局
Immunogenicity assessment
时间窗: 21 days
Seroconversion rate defined as the percentage of subjects who have a pre-vaccination titer of influenza haemagglutinin antibody titer (HA titer) \< 1:10 and a post-vaccination HA titer \>1:40 or a pre-vaccination HA titer \> 1:10 and at least a fourfold increase in post-vaccination HA titer vs. the baseline for each strain (A/H1N1, A/H3N2 and B)
次要结局
- Increasing of geometric mean titer in > 2.0 times(21 days)
- The percentage with protective antibody titer ≥ 1:40(21 days)
- The percentage of subjects with protective titer of antibodies ≥ 1:40 on the 21(+2) day after the vaccination for each strain (A/H1N1, A/H3N2 and B).(21 days)
- Increasing of geometric mean titer on the 21(+2) day against the value observed before the use of vaccine for each strain (A/H1N1, A/H3N2 and B)(21 days)
- The percentage of volunteers with a pre-vaccination HA titer <1:10 and a post-vaccination HA titer >1:40 or a pre-vaccination HA titer > 1:10 and at least a fourfold increase in a post-vaccination HA titer vs. the baseline should be > 30%(21 days)
研究者
研究点 (2)
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