EUCTR2018-001857-29-BG进行中（未招募）1 期
A Phase III, 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
相关药物
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 入组人数
- 6,227
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional clinical trial of medicinal product
入排标准
- 性别
- All
入选标准
- •Individuals of 6 through 47 months of age on the day of informed consent.
- •Individuals whose parent(s)/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.
- •Are the trial subjects under 18? yes
- •Number of subjects for this age range: 3830
- •F.1.2 Adults (18-64 years) no
- •F.1.2.1 Number of subjects for this age range
- •F.1.3 Elderly (>=65 years) no
- •F.1.3.1 Number of subjects for this age range
排除标准
- •1. Acute (severe) febrile illness (see Section 4.3 Criteria for Delay of
- •Vaccination). Enrollment could be considered if the fever is absent for 72
- •2. 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.
- •3. 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.
- •4. A known history of Guillain-Barré Syndrome or other demyelinating
- •diseases such as encephalomyelitis and transverse myelitis.
- •5. Abnormal function of the immune system resulting from clinical
- •conditions, which include:
- •a. Known or suspected congenital or acquired immunodeficiency.
- •b. Systemic administration of corticosteroids (PO/IV/IM) at any dose for
- •more than 14 days, within 90 days prior to informed consent. Topical,
- •inhaled and intranasal corticosteroids are permitted. Intermittent use
- •(one dose in 30 days) of intra-articular corticosteroids is also permitted.
- •c. Administration of antineoplastic and immunomodulating agents or
- •radiotherapy within 90 days prior to informed consent.
- •6. Received immunoglobulins or any blood products within 180 days
- •prior to informed consent.
- •7. Received an investigational or non-registered medicinal product
- •within 30 days prior to informed consent, or intend to participate in
- •another clinical trial during the study.
- •8. Participated in this trial in a prior season or is discontinued after
- •randomization in the current season.
- •9. Study personnel, family and household members of study personnel
- •should not participate.
- •10. Any other clinical condition that, in the opinion of the investigator,
- •might interfere with the results of the study or pose additional risk to
- •the subject due to participation in the study.
- •11. Received influenza vaccination or has had documented influenza
- •disease in the last 6 months prior to informed consent.
- •12. Prior vaccination to prevent Neisseria meningitides serogroup C
- •disease or prior infection caused by this organism.
- •13. Received any other vaccines than influenza vaccine within 14 days
- •(for inactivated vaccines) or 28 days (for live vaccines) prior to study
- •vaccination or who are planning to receive any vaccine within 28 days
- •after study vaccination.
研究者
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