Evaluation of the Immunogenicity, Relative Efficacy, Safety and Reactogenicity of Flublok Quadrivalent® (Quadrivalent Recombinant Influenza Vaccine, Seasonal Formulation) Compared With a Marketed Quadrivalent Vaccine in Healthy Children and Adolescents Aged 3 to 17 Years-old.
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 发起方
- 入组人数
- 1,556
- 试验地点
- 22
- 主要终点
- Seroconversion
研究概览
简要总结
Multicentric study, Phase III; this study is a randomized, participant- and observer-blind, parallel group evaluation to evaluate the immunogenicity, relative efficacy, safety and reactogenicity of a recombinant quadrivalent hemagglutinin influenza vaccine versus an inactivated quadrivalent influenza vaccine in pediatric subjects and adolescents of 3-17 years of age. Investigational vaccine is indicated for active immunization against influenza A and B for strains contained in the vaccine marketed in the United States for persons 18 years of age or older.
详细描述
Abbreviated title Evaluation of immunogenicity, relative efficacy, safety and reactogenicity of Flublok Quadrivalent® in healthy children and adolescents aged 3 to17 years.
Sponsor Product Identifiers Flublok® Quadrivalent of Laboratories Liomont, S.A. de C.V.
Flublok Quadrivalent consists of 180 μg total recombinant hemagglutinins Study Phase Phase 3 Study National multicentric Participating sites: Mexico: At least 10 research sites distributed in different states.
Clinical indication Vaccine indicated for active immunization against influenza A and B for strains contained in the vaccine; authorized in the United States for persons 18 years of age or older.
It will be evaluated in a population aged 3 to 17 years. Treatment Groups Flublok® Quadrivalent (research product) Fluzone® Quadrivalent (active comparator) Number of participants in the study 1,556 Estimated study duration: 25 months Duration of participation 6 months Randomization ratio 1:1 Study visits Visit 1: It corresponds to the screening visit, baseline blood sampling and administration of the study vaccine that can be performed on Day 0.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Other
- 盲法
- Double (Participant, Investigator)
盲法说明
Participant- and observer-blind, the vaccine will be administered by a non-blinded vaccinator that will not participate in the clinical evaluation.
入排标准
- 年龄范围
- 3 Years 至 17 Years（Child）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Male or female age 3 to 17 years.
- •History of two previous influenza immunizations at any time, or influenza infection during the previous year.
- •Female subjects of child-bearing potential (as defined by the onset of menses) must agree to prevent pregnancy and usage of an effective contraception, or having practiced sexual abstinence for at least 28 day prior to the first study vaccine administration. Female subjects of child-bearing potential must be tested for pregnancy within 24 hours prior to vaccine administration.
- •In good general health, healthy or medically stable, as determined by the medical history, physical examination and the Investigator's judgment.
- •Parent(s) or legal representative of each potential subject must comprehend the study requirements, sign the informed consent before any procedure, and agree to comply with planned study procedures and visits. Provide written consent prior to enrollment and initiation of any study procedure.
- •Pediatric consent will be attained as per the Research Ethics Committee's determination when subject is aged 8 or older.
排除标准
- •Known allergy to eggs (anaphylaxis, angioedema, respiratory distress), severe allergy (e.g. anaphylaxis) to other components of the vaccine or contraindications to receive the comparator IIV
- •Use of systemic steroids at doses of 2mg/kg/day for more than 10 days of prednisone or its equivalent.
- •(The use of nasal or topical steroids will be allowed).
- •Active neoplastic disease or a history of any malignancy.
- •History of receiving the influenza vaccine within the previous 6 months.
- •Plan to receive another influenza vaccine, during the study term.
- •History of receiving immunoglobulin or another blood product within the 3 months prior to enrollment in this study.
- •Acute or chronic medical condition that, in the opinion of the Investigator, would render immunization unsafe or would interfere with the evaluation of efficacy or the immune response to the vaccine.
- •An acute illness, including a body temperature greater than 37.7°C, within 3 days prior to immunization.
- •Receive an experimental vaccine or medication within 1 month prior to enrollment in this study, or the expectation to receive an experimental vaccine, medication, or blood product during the study period.
- •Developmental delay, neurologic disorder, or seizure disorder requiring ongoing medical assistance (note: history of febrile seizure is not considered an exclusion criterion).
- •History of Guillain-Barré syndrome within 6 weeks after the application a previous influenza vaccine.
- •Concurrent participation in another clinical trial (active or follow-up phase).
- •Any other condition or situation that would, in the opinion of the investigator, place them at an unacceptable risk of injury or render the subject unable to meet the requirements of the protocol.
结局指标
主要结局
Seroconversion
时间窗: To be evaluated against each of the 4 vaccine antigens, on Day 28 (or Day 56 for 2-dose subjects), by category aged
Proportion of subjects with seroconversion defined as (a) a \>4-fold rise in HAI antibody titer in subjects seropositive (titer \>10) at baseline or (b) an HAI titer of \>40 in those seronegative at baseline.
次要结局
未报告次要终点