A Phase 4 Double-blind Study to Evaluate the Shedding and Immunogenicity of Trivalent and Quadrivalent Formulations of FluMist in Children 24 to < 48 Months of Age
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 入组人数
- 200
- 试验地点
- 12
- 主要终点
- Percentage of Participants With B/Yamagata HAI Antibody Seroconversion Rate at Day 28
研究概览
简要总结
This study is being conducted to compare the immunogenicity, safety, and viral shedding of a new A/H1N1 strain that will be incorporated into the FluMist quadrivalent formulation for the 2017-2018 influenza season with the previous A/H1N1 strain that was included in the vaccine in the 2015-2016 influenza season.
详细描述
This randomized, double-blind, multi-center study will enroll approximately 200 children 24 to less than (<) 48 months of age. Participants will be randomized in a 1:1:1 ratio to receive two doses of either FluMist quadrivalent 2017-2018, FluMist quadrivalent 2015-2016 formulation, or FluMist trivalent 2015-2016 formulation.
Participants will be screened within 30 days prior to randomization. Randomization will be stratified according to whether the participant ever received prior influenza vaccination. Approximately 50% of the participants will not have been previously vaccinated. All participants will receive two doses of investigational product on Study Days 1 and 28, and followed for a 28-day follow-up period after each dose. Blood and nasal samples will be collected and safety evaluations perfomed.
The duration of participants participation is approximately 2 to 3 months. The study will be conducted during the influenza "off-season" in the US. After completion of the study all participants will be offered and strongly encouraged to receive an inactivated influenza vaccine approved for use in the US for the 2017-2018 influenza season.
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
Double-blind
入排标准
- 年龄范围
- 24 Months 至 47 Months（Child）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Age 24 months to < 48 months of age
- •Healthy by medical history and physical examination or presence of stable underlying chronic medical condition for which hospitalization has not been required in the previous year
排除标准
- •History of allergic disease or reactions likely to be exacerbated by any component of the investigational product
- •Acute illness or evidence of significant active infection (including fever >= 100.4 degrees Fahrenheit (38.0 degrees Celsius) at randomization
- •History of asthma or history of recurrent wheezing
- •Any known immunosuppressive condition or immune deficiency disease
- •Current or expected receipt of immunosuppressive medications within a 28 day window around vaccination
- •Use of aspirin or salicylate-containing medications within 28 days prior to randomization or expected receipt thru 28 days after vaccination
- •Use of antiviral agents with activity against influenza viruses within 48 hours prior to first dose of investigational product or anticipated use of such agents through the end of the study follow-up period
- •Receipt of any non-study seasonal influenza vaccine within 90 days of Dose 1 or planned receipt of non-study seasonal influenza vaccine prior to 28 days after last vaccination
- •Receipt of immunoglobulin or blood products within 90 days before randomization into the study or expected receipt during study participation
- •Known or suspected mitochondrial encephalomyopathy
- •History of Guillian-Barre syndrome
- •Administration of intranasal medications within 10 days prior to randomization, for expected receipt through 10 days after administration of each dose of investigational product
研究组 & 干预措施
FluMist trivalent (2015-2016)
Participants will receive intranasal spray of 0.2 milliliter (mL) (total dose in both nostrils) FluMist trivalent vaccine on Days 1 and 28. Each 0.2 mL dose contained 10^7±0.5 fluorescent focus units (FFU) of each vaccine strain. Strains included in the trivalent vaccine were: A/H1N1 (A/Bolivia/559/2013), A/H3N2 (A/Switzerland/9715293/2013), and B/Phuket/3073/2013 (B/Yamagata-lineage).
干预措施: FluMist trivalent (2015-2016) (Biological)
FluMist Quadrivalent (2015-2016)
Participants will receive intranasal spray of 0.2 mL (total dose in both nostrils) FluMist quadrivalent vaccine on Days 1 and 28. Each 0.2 mL dose contained 10^7±0.5 FFU of each vaccine strain. Strains included in the vaccine were A/H1N1 (A/Bolivia/559/2013), A/H3N2 (A/Switzerland/9715293/2013), B/Phuket/3073/2013 (B/Yamagata-lineage), and B/Brisbane/60/2008 (B/Victoria-lineage).
干预措施: FluMist Quadrivalent (2015-2016) (Biological)
FluMist Quadrivalent (2017-2018)
Participants will receive intranasal spray of 0.2 mL (total dose in both nostrils) FluMist quadrivalent vaccine on Days 1 and 28. Each 0.2 mL dose contained 10^7±0.5 FFU of each vaccine strain. Strains included in the vaccine were the new A/H1N1 (A/Slovenia/2903/2015), A/H3N2 (A/New Caledonia/71/2014), B/Phuket/3073/2013 (B/Yamagata-lineage), and B/Brisbane/60/2008 (B/Victoria-lineage).
干预措施: FluMist Quadrivalent (2017-2018) (Biological)
结局指标
主要结局
Percentage of Participants With B/Yamagata HAI Antibody Seroconversion Rate at Day 28
时间窗: Day 28
Seroconversion rate is defined as \>= 4-fold rise from baseline in B/Yamagata HAI antibody titer. Percentage of participants with \>= 4-fold rise in B/Yamagata HAI antibody titer at Day 28 is reported.
Percentage of Participants With A/H3N2 HAI Antibody Seroconversion Rate at Day 28
时间窗: Day 28
Seroconversion rate is defined as \>= 4-fold rise from baseline in A/H3N2 HAI antibody titer. Percentage of participants with \>= 4-fold rise in A/H3N2 HAI antibody titer at Day 28 is reported.
Percentage of Participants With A/H3N2 HAI Antibody Seroconversion Rate at Day 56
时间窗: Day 56
Seroconversion rate is defined as \>= 4-fold rise from baseline in A/H3N2 HAI antibody titer. Percentage of participants with \>= 4-fold rise in A/H3N2 HAI antibody titer at Day 56 is reported.
Percentage of Participants With A/H1N1 Hemagglutination Inhibition (HAI) Antibody Seroconversion Rate at Day 28
时间窗: Day 28
Seroconversion rate is defined as at least (\>=) 4-fold rise from baseline in A/H1N1 HAI antibody titer. Percentage of participants with \>= 4-fold rise in A/H1N1 HAI antibody titer at Day 28 is reported. Comparative statistical analysis was planned only for 'FluMist Quadrivalent (2015-2016)' and 'FluMist Quadrivalent (2017-2018)' arms.
Percentage of Participants With B/Victoria HAI Antibody Seroconversion Rate at Day 28
时间窗: Day 28
Seroconversion rate is defined as \>= 4-fold rise from baseline in B/Victoria HAI antibody titer. Percentage of participants with \>= 4-fold rise in B/Victoria HAI antibody titer at Day 28 is reported.
Percentage of Participants With B/Victoria HAI Antibody Seroconversion Rate at Day 56
时间窗: Day 56
Seroconversion rate is defined as \>= 4-fold rise from baseline in B/Victoria HAI antibody titer. Percentage of participants with \>= 4-fold rise in B/Victoria HAI antibody titer at Day 56 is reported.
Percentage of Participants With B/Yamagata HAI Antibody Seroconversion Rate at Day 56
时间窗: Day 56
Seroconversion rate is defined as \>= 4-fold rise from baseline in B/Yamagata HAI antibody titer. Percentage of participants with \>= 4-fold rise in B/Yamagata HAI antibody titer at Day 56 is reported.
Percentage of Participants With A/H1N1 HAI Antibody Seroconversion Rate at Day 56
时间窗: Day 56
Seroconversion rate is defined as \>= 4-fold rise from baseline in A/H1N1 HAI antibody titer. Percentage of participants with \>= 4-fold rise in A/H1N1 HAI antibody titer at Day 56 is reported. Comparative statistical analysis was planned only for 'FluMist Quadrivalent (2015-2016)' and 'FluMist Quadrivalent (2017-2018)' arms.
次要结局
- Percentage of Participants With Strain-specific Nasal Immunoglobulin A (IgA) Seroconversion Rate From Baseline Through Days 28 and 56(Days 28 and 56)
- Percentage of Participants With Any Solicited Symptoms(Day 1 through Day 14 after Dose 1 (Day 1 dose) and Dose 2 (Day 28 dose))
- Percentage of Participants Who Shed Vaccine Virus by Formulation, Strain, Dose Number, and Baseline Serostatus as Measured by Quantitative Reverse Transcriptase Polymerase Chain Reaction (qRT-PCR)(Days 2, 3, 4, 5, and 7 after Dose 1 (Day 1 dose) and on Days 2, 4, and 6 after Dose 2 (Day 28 dose))
- Number of Days of Vaccine Virus Shedding by Formulation, Strain, Dose Number, and Baseline Serostatus as Measured by qRT-PCR(Days 2, 3, 4, 5, and 7 after Dose 1 (Day 1 dose) and on Days 2, 4 and 6 after Dose 2 (Day 28 dose))
- Viral Titer by Day, Strain, Dose Number, and Baseline Serostatus as Measured by qRT-PCR(Day (D) 2, D3, D4, D5, and D7 after Dose 1 (D1 dose) and on D2, D4 and D6 after Dose 2 (D28 dose))
- Number of Participants With Treatment-emergent Adverse Events (TEAEs) and Treatment-emergent Serious Adverse Events (TESAEs)(Day 1 through Day 28 after Dose 1 (Day 1 dose) and Dose 2 (Day 28 dose))
- Percentage of Participants With Strain-specific Neutralizing Antibody Seroconversion Rates From Baseline Through Days 28 and 56 by Baseline Serostatus(Days 28 and 56)
- Percentage of Participants With Any Post Dose Strain-specific Antibody Response(Days 28 and 56)