A Phase 3, Randomized, Observer-blind, Multicenter Study to Evaluate the Efficacy, Immunogenicity and Safety of Seqirus' Cell-Based Quadrivalent Subunit Influenza Virus Vaccine (QIVc) Compared to a Non-Influenza Vaccine When Administrated in Healthy Subjects Aged 6 Months Through 47 Months
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 发起方
- 入组人数
- 5,723
- 试验地点
- 74
- 主要终点
- Efficacy Endpoint: First Occurrence of Reverse Transcription-polymerase Chain Reaction (RT-PCR) Confirmed Influenza, Due to Any Influenza Type A and/or B Virus Regardless of Antigenic Match
研究概览
简要总结
This phase 3 clinical study is a randomized, observer-blind, multicenter study of QIVc versus a non-influenza vaccine in subjects 6 months though 47 months of age. The purpose of this study is to evaluate efficacy of QIVc in the prevention of laboratory confirmed influenza A or B disease in children 6 through 47 months of age, compared to a non-influenza vaccine.
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
The trial is designed as an observer-blind study. During the treatment period of the study, only designated, trained unblinded personnel will be responsible for administering the study vaccines to the subjects.
入排标准
- 年龄范围
- 6 Months 至 47 Months（Child）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •In order to participate in this study, all subjects must meet all of the inclusion criteria described.
- •Individuals of 6 through 47 months of age on the day of informed consent.
- •Individuals whose parent(s)/Legally Acceptable Representative (LAR) have voluntarily given written informed consent after the nature of the study has been explained according to local regulatory requirements, prior to study entry.
- •Individuals who can comply with study procedures including follow-up.
- •Individuals in generally good health as per the Investigator's medical judgement.
- •If applicable, prior to receipt of second study vaccination, subjects must be evaluated to confirm that they are eligible for subsequent vaccination. If subjects do not meet the criteria of the original inclusion criteria listed above, they should not receive additional vaccinations.
排除标准
- •Acute (severe) febrile illness. Enrollment could be considered if the fever is absent for 72 hours.
- •History of any anaphylaxis, serious vaccine reactions or hypersensitivity, including allergic reactions, to any component of vaccine or medical equipment whose use is foreseen in this study.
- •Clinical conditions representing a contraindication to intramuscular vaccination and blood draws. These may include known bleeding disorders, or treatment with anticoagulants in the 3 weeks preceding vaccination.
- •A known history of Guillain-Barré Syndrome or other demyelinating diseases such as encephalomyelitis and transverse myelitis.
- •Abnormal function of the immune system resulting from a clinical condition
- •Received influenza vaccination or has had documented influenza disease in the last 6 months prior to informed consent.
- •Prior vaccination to prevent Neisseria meningitides serogroup C disease or prior infection caused by this organism.
- •Additional eligibility criteria are provided in the study protocol.
研究组 & 干预措施
QIVc
Cell-derived Quadrivalent Influenza Vaccine
干预措施: QIVc (Biological)
Comparator
Non-influenza Comparator
干预措施: Comparator (Biological)
结局指标
主要结局
Efficacy Endpoint: First Occurrence of Reverse Transcription-polymerase Chain Reaction (RT-PCR) Confirmed Influenza, Due to Any Influenza Type A and/or B Virus Regardless of Antigenic Match
时间窗: >14 days after last vaccination in the treatment period up to Day 181 or end of influenza season, whichever was longer (previously vaccinated subjects), or up to Day 209 or end of influenza season, whichever was longer (not previously vaccinated subjects)
First occurrence of RT-PCR confirmed influenza, due to any influenza Type A and/or B virus regardless of antigenic match to the influenza strains selected for the seasonal influenza vaccine, occurring at \>14 days after the last vaccination and until the end of the influenza season, in association with protocol-defined influenza-like illness (ILI) symptoms
Efficacy Endpoint: First Occurrence of Culture Confirmed Influenza, Due to Influenza Type A and/or B Virus Antigenically Matched by Ferret Antigenicity Testing to the Strains Selected for the Seasonal Influenza Vaccine
时间窗: >14 days after last vaccination in the treatment period up to Day 181 or end of influenza season, whichever was longer (previously vaccinated subjects), or up to Day 209 or end of influenza season, whichever was longer (not previously vaccinated subjects)
First occurrence of culture confirmed influenza, due to influenza Type A and/or B virus antigenically matched by ferret antigenicity testing to the strains selected for the seasonal influenza vaccine, occurring at \>14 days after the last vaccination and until the end of the influenza season, in association with protocol-defined ILI symptoms
次要结局
- Efficacy Endpoint: First Occurrence of Culture Confirmed Influenza Caused by Influenza Virus Strains Antigenically Dissimilar to the Influenza Strains Selected for the Seasonal Influenza Vaccine(>14 days after last vaccination in the treatment period up to Day 181 or end of influenza season, whichever was longer (previously vaccinated subjects), or up to Day 209 or end of influenza season, whichever was longer (not previously vaccinated subjects))
- Efficacy Endpoint: First Occurrence of Culture Confirmed Influenza Due to Any Influenza Type A and/or Type B Virus Regardless of Antigenic Match to the Influenza Strains Selected for the Seasonal Influenza Vaccine(>14 days after last vaccination in the treatment period up to Day 181 or end of influenza season, whichever was longer (previously vaccinated subjects), or up to Day 209 or end of influenza season, whichever was longer (not previously vaccinated subjects))
- Efficacy Endpoint: First Occurrence of RT-PCR Confirmed Moderate-to-severe Influenza Due to Any Influenza Type A and/or Type B Virus Regardless of Antigenic Match to the Influenza Strains Selected for the Seasonal Influenza Vaccine(>14 days after last vaccination in the treatment period up to Day 181 or end of influenza season, whichever was longer (previously vaccinated subjects), or up to Day 209 or end of influenza season, whichever was longer (not previously vaccinated subjects))
- Immunogenicity Endpoint: Prevaccination and Postvaccination Geometric Mean Titer (GMT) (HI Assay)(Day 1 and Day 29 for previously vaccinated subjects; Day 1 and Day 57 for not previously vaccinated subjects)
- Immunogenicity Endpoint: Seroconversion Rates (SCR) (HI Assay)(Day 1 through Day 29 for previously vaccinated subjects; Day 1 through Day 57 for not previously vaccinated subjects)
- Immunogenicity Endpoint: Geometric Mean Ratio (GMR) (HI Assay)(Day 1 through Day 29 for previously vaccinated subjects; Day 1 through Day 57 for not previously vaccinated subjects)
- Immunogenicity Endpoint: Prevaccination and Postvaccination Geometric Mean Titer (GMT) (MN Assay)(Day 1 and Day 29 for previously vaccinated subjects; Day 1 and Day 57 for not previously vaccinated subjects)
- Immunogenicity Endpoint: Seroconversion Rates (SCR) (MN Assay)(Day 1 through Day 29 for previously vaccinated subjects; Day 1 through Day 57 for not previously vaccinated subjects)
- Immunogenicity Endpoint: Geometric Mean Ratio (GMR) (MN Assay)(Day 1 through Day 29 for previously vaccinated subjects; Day 1 through Day 57 for not previously vaccinated subjects)
- Safety Endpoint: Percentage of Subjects With Solicited Local and Systemic Adverse Events (AEs)(7 days following each vaccination in the treatment period, ie, Day 1 to Day 7 for previously vaccinated subjects and Day 1 to Day 7 and Day 29 to Day 35 for not previously vaccinated subjects)
- Safety Endpoint: Percentage of Subjects With Unsolicited AEs(28 days after each vaccination in the treatment period, ie, Day 1 to Day 29 for previously vaccinated subjects and Day 1 to Day 57 for not previously vaccinated subjects)
- Safety Endpoint: Percentage of Subjects With SAEs, NOCDs, AEs Leading to Withdrawal From the Study or Vaccination(Day 1 through Study Completion, ie, Day 1 to Day 181 or end of influenza season, whichever was longer, for previously vaccinated subjects and Day 1 to Day 209 or end of influenza season, whichever was longer, for not previously vaccinated subjects)
- Safety Endpoint: Percentage of Subjects With Medically-attended AEs(If a subject experienced an ILI during approximately 8 months of study participation, medically-attended AEs were collected for the 30-day period after onset of the ILI (defined as the first day that a subject meets the criteria for protocol-defined ILI))