A Randomized, Double-blind, Placebo-controlled Phase 1/2a Study for Safety and Immunogenicity Evaluations for Regimen Selection of Ad26.RSV.preF and/or RSV preF Protein Combinations Followed by Expanded Safety Evaluation in Adults Aged 60 Years and Older
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 入组人数
- 669
- 试验地点
- 1
- 主要终点
- Cohort 2 (Groups 14-15): Number of Participants With Serious Adverse Events (SAEs)
研究概览
简要总结
The purpose of this study for:
Cohort 1 and Cohort 2: to assess the safety and reactogenicity of the intramuscular one- and two-dose regimens, with a booster at Month 12 (Cohort 1) and to select a regimen for Cohort 3.
Cohort 2 and part of Cohort 1: to assess respiratory syncytial virus (RSV) neutralizing antibody levels of the regimens containing RSV pre-fusion (preF) protein compared to the one-dose adenovirus serotype 26 respiratory syncytial virus pre-fusion (Ad26.RSV.preF) regimen.
Cohort 3: to assess the safety and reactogenicity of the selected regimen and a booster at Month 12 and/or Month 24.
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)
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
- •Before randomization, a woman must be postmenopausal (postmenopausal state is defined as no menses for 12 months without an alternative medical cause) and not intending to conceive by any methods
- •In the investigator's clinical judgment, participant must be either in good or stable health. Participants may have underlying illnesses such as hypertension, type 2 diabetes mellitus, hyperlipoproteinemia, or hypothyroidism, as long as their symptoms and signs are medically controlled. If they are on medication for a condition, the medication dose must have been stable for at least 12 weeks preceding vaccination and expected to remain stable for the duration of the study. Participants will be included on the basis of physical examination, medical history, vital signs, and 12-lead electrocardiogram (ECG) performed at screening
- •For participants in Cohorts 1 and 2 only: Participant must be healthy on the basis of clinical laboratory tests performed at screening. If the results of the laboratory screening tests are outside the central laboratory normal reference ranges and additionally within the limits of toxicity Grade 2 according to the United States (US) Food and Drug Administration (FDA) toxicity, the participant may be included only if the investigator judges the abnormalities or deviations from normal to be not clinically significant and appropriate and reasonable for the population under study. This determination must be recorded in the participant's source documents and initialed by the investigator
- •From the time of each vaccination through 3 months after each vaccination, participant agrees not to donate blood
- •Participant must be willing to provide verifiable identification, have means to be contacted and to contact the investigator during the study
排除标准
- •Per serology testing in Cohorts 1 and 2 and per medical history in Cohort 3: Participant has chronic active hepatitis B or hepatitis C infection, documented by hepatitis B surface antigen and hepatitis C antibody, respectively
- •Per serology testing in Cohorts 1 and 2 and per medical history in Cohort 3: Participant has human immunodeficiency virus (HIV) type 1 or type 2 infection
- •Participant has had major psychiatric illness and/or drug or alcohol abuse which in the investigator's opinion would compromise the participant's safety and/or compliance with the study procedures
- •Participant has a known allergy, or history of anaphylaxis or other serious adverse reactions to vaccines or vaccine components (including any of the constituents of the study vaccine)
- •Participant has received respiratory syncytial virus (RSV) vaccine in a previous RSV vaccine study at any time prior to randomization
研究组 & 干预措施
Cohort (C)1 Group (G)1: Placebo for RSV preF Protein
Participants will receive intramuscular injection of placebo on Day 1, Day 57 and at Month 12.
干预措施: Placebo (Biological)
C1 G2: RSV preF Protein
Participants will receive intramuscular injection of 50 microgram (mcg) RSV preF protein on Day 1, Day 57 and at Month 12.
干预措施: RSV preF Protein 50 mcg (Biological)
C1 G3: Placebo for Ad26.RSV.preF/RSV preF or RSV preF Protein
Participants will receive intramuscular injection of placebo on Day 1, Day 57 and at Month 12.
干预措施: Placebo (Biological)
C1 G4: Mixture of Ad26.RSV.preF/RSV preF Protein
Participants will receive intramuscular injection of a mixture of 5*10^10 viral particles (vp) of Ad26.RSV.preF/RSV preF 50 mcg protein on Day 1, Day 57 and at Month 12.
干预措施: Mixture of Ad26.RSV.preF 5*10^10 vp Plus RSV preF Protein 50 mcg (Biological)
C1 G5: RSV preF Protein
Participants will receive intramuscular injection of 150 mcg RSV preF protein on Day 1, Day 57 and at Month 12.
干预措施: RSV preF Protein 150 mcg (Biological)
C1 G6: Mixture of Placebo for Ad26.RSV.preF/RSV preF Protein
Participants will receive intramuscular injection of placebo on Day 1, Day 57 and at Month 12.
干预措施: Placebo (Biological)
C1 G7: Mixture of Ad26.RSV.preF/RSV preF Protein
Participants will receive intramuscular injection of a mixture of 5*10^10 vp of Ad26.RSV.preF plus 150 mcg RSV preF protein on Day 1, Day 57 and at Month 12.
干预措施: Mixture of Ad26.RSV.preF 5*10^10 vp Plus RSV preF Protein 150 mcg (Biological)
C1 G8: Placebo for Ad26.RSV.preF/Placebo for RSV preF Protein
Participants will receive intramuscular injection of placebo on Day 1 and at Month 12 and in only 1 arm on Day 57.
干预措施: Placebo (Biological)
C1 G9: Mixture of Ad26.RSV.preF/RSV preF Protein and Placebo
Participants will receive intramuscular injection of a mixture of 1*10^11 vp of Ad26.RSV.preF plus 150 mcg RSV preF protein in 1 arm on Day 1 and 57 and at Month 12 and placebo in another arm on Day 1 and at Month 12.
干预措施: Placebo (Biological)
C1 G9: Mixture of Ad26.RSV.preF/RSV preF Protein and Placebo
Participants will receive intramuscular injection of a mixture of 1*10^11 vp of Ad26.RSV.preF plus 150 mcg RSV preF protein in 1 arm on Day 1 and 57 and at Month 12 and placebo in another arm on Day 1 and at Month 12.
干预措施: Mixture of Ad26.RSV.preF 1*10^11 vp Plus RSV preF Protein 150 mcg (Biological)
C1 G10: Ad26.RSV.preF, RSV preF Protein and Placebo
Participants will receive separate intramuscular injections of 1*10^11 vp of Ad26.RSV.preF in 1 Arm and 150 mcg RSV preF protein in another arm on Day 1 and at Month 12 and placebo in 1 arm on Day 57.
干预措施: Placebo (Biological)
C1 G10: Ad26.RSV.preF, RSV preF Protein and Placebo
Participants will receive separate intramuscular injections of 1*10^11 vp of Ad26.RSV.preF in 1 Arm and 150 mcg RSV preF protein in another arm on Day 1 and at Month 12 and placebo in 1 arm on Day 57.
干预措施: RSV preF Protein 150 mcg (Biological)
C1 G10: Ad26.RSV.preF, RSV preF Protein and Placebo
Participants will receive separate intramuscular injections of 1*10^11 vp of Ad26.RSV.preF in 1 Arm and 150 mcg RSV preF protein in another arm on Day 1 and at Month 12 and placebo in 1 arm on Day 57.
干预措施: Ad26.RSV.preF 1*10^11 vp (Biological)
C2 G11: Ad26.RSV.preF and Placebo
Participants will receive intramuscular injection of 1*10^11 vp of Ad26.RSV.preF in 1 arm and placebo in another arm on Day 1 and placebo in 1 arm on Day 57.
干预措施: Placebo (Biological)
C2 G11: Ad26.RSV.preF and Placebo
Participants will receive intramuscular injection of 1*10^11 vp of Ad26.RSV.preF in 1 arm and placebo in another arm on Day 1 and placebo in 1 arm on Day 57.
干预措施: Ad26.RSV.preF 1*10^11 vp (Biological)
C2 G12: Mixture of Ad26.RSV.preF/RSV preF Protein and Placebo
Participants will receive intramuscular injection of a mixture of 5*10^10 vp Ad26.RSV.preF plus 50 mcg RSV preF protein in 1 arm and placebo in another arm on Day 1 and placebo in 1 arm on Day 57.
干预措施: Placebo (Biological)
C2 G12: Mixture of Ad26.RSV.preF/RSV preF Protein and Placebo
Participants will receive intramuscular injection of a mixture of 5*10^10 vp Ad26.RSV.preF plus 50 mcg RSV preF protein in 1 arm and placebo in another arm on Day 1 and placebo in 1 arm on Day 57.
干预措施: Mixture of Ad26.RSV.preF 5*10^10 vp Plus RSV preF Protein 50 mcg (Biological)
C2 G13: Mixture of Ad26.RSV.preF/RSV preF Protein and Placebo
Participants will receive intramuscular injection of a mixture of 1*10^11 vp Ad26.RSV.preF plus 50 mcg RSV preF protein in 1 arm and placebo in another arm on Day 1 and placebo in 1 arm on Day 57.
干预措施: Placebo (Biological)
C2 G13: Mixture of Ad26.RSV.preF/RSV preF Protein and Placebo
Participants will receive intramuscular injection of a mixture of 1*10^11 vp Ad26.RSV.preF plus 50 mcg RSV preF protein in 1 arm and placebo in another arm on Day 1 and placebo in 1 arm on Day 57.
干预措施: Mixture of Ad26.RSV.preF 1*10^11 vp Plus RSV preF Protein 50 mcg (Biological)
C2 G14: Mixture of Ad26.RSV.preF/RSV preF Protein and Placebo
Participants will receive intramuscular injection of a mixture of 1*10^11 vp Ad26.RSV.preF plus 150 mcg RSV preF protein in 1 arm and placebo in another arm on Day 1 and placebo in 1 arm on Day 57.
干预措施: Placebo (Biological)
C2 G14: Mixture of Ad26.RSV.preF/RSV preF Protein and Placebo
Participants will receive intramuscular injection of a mixture of 1*10^11 vp Ad26.RSV.preF plus 150 mcg RSV preF protein in 1 arm and placebo in another arm on Day 1 and placebo in 1 arm on Day 57.
干预措施: Mixture of Ad26.RSV.preF 1*10^11 vp Plus RSV preF Protein 150 mcg (Biological)
C2 G15: Mixture of Ad26.RSV.preF/RSV preF Protein and Placebo
Participants will receive intramuscular injection of a mixture of 5*10^10 vp Ad26.RSV.preF plus 150 mcg RSV preF protein in 1 arm and placebo in another arm on Day 1 and placebo in 1 arm on Day 57.
干预措施: Placebo (Biological)
C2 G15: Mixture of Ad26.RSV.preF/RSV preF Protein and Placebo
Participants will receive intramuscular injection of a mixture of 5*10^10 vp Ad26.RSV.preF plus 150 mcg RSV preF protein in 1 arm and placebo in another arm on Day 1 and placebo in 1 arm on Day 57.
干预措施: Mixture of Ad26.RSV.preF 5*10^10 vp Plus RSV preF Protein 150 mcg (Biological)
C2 G16: Ad26.RSV.preF, RSV preF Protein and Placebo
Data from C1 G10 will be pooled with those of C2 G16. Participants will receive separate intramuscular injections of 1*10^11 vp of Ad26.RSV.preF in 1 Arm and 150 mcg RSV preF protein in another arm on Day 1 and placebo in 1 arm on Day 57.
干预措施: Placebo (Biological)
C2 G16: Ad26.RSV.preF, RSV preF Protein and Placebo
Data from C1 G10 will be pooled with those of C2 G16. Participants will receive separate intramuscular injections of 1*10^11 vp of Ad26.RSV.preF in 1 Arm and 150 mcg RSV preF protein in another arm on Day 1 and placebo in 1 arm on Day 57.
干预措施: RSV preF Protein 150 mcg (Biological)
C2 G16: Ad26.RSV.preF, RSV preF Protein and Placebo
Data from C1 G10 will be pooled with those of C2 G16. Participants will receive separate intramuscular injections of 1*10^11 vp of Ad26.RSV.preF in 1 Arm and 150 mcg RSV preF protein in another arm on Day 1 and placebo in 1 arm on Day 57.
干预措施: Ad26.RSV.preF 1*10^11 vp (Biological)
C2 G17: Mixture of Ad26.RSV.preF/RSV preF Protein and Placebo
Data from C1 G9 will be pooled with those of C2 G17. Participants will receive intramuscular injection of a mixture of 1*10^11 vp of Ad26.RSV.preF plus 150 mcg RSV preF protein in 1 arm on Day 1 and 57 and placebo in another arm on Day 1.
干预措施: Placebo (Biological)
C2 G17: Mixture of Ad26.RSV.preF/RSV preF Protein and Placebo
Data from C1 G9 will be pooled with those of C2 G17. Participants will receive intramuscular injection of a mixture of 1*10^11 vp of Ad26.RSV.preF plus 150 mcg RSV preF protein in 1 arm on Day 1 and 57 and placebo in another arm on Day 1.
干预措施: Mixture of Ad26.RSV.preF 1*10^11 vp Plus RSV preF Protein 150 mcg (Biological)
C2 G18: Placebo for Ad26.RSV.preF/Placebo for RSV preF Protein
Participants will receive intramuscular injection of placebo in separate arms on Day 1 and in only 1 arm on Day 57.
干预措施: Placebo (Biological)
C3 G19: Selected Regimen (SR)
If a one-dose regimen is selected, participants in this group will receive SR on Day 1 and a booster (the SR) at Month 12 and month 24. The participants who are randomized to two-dose regimen will receive SR on Day 1 and Day 57, and a booster (the selected regimen) at Month 12.
干预措施: Selected Regimen (Biological)
C3 G20: SR + Placebo for SR
If a one-dose regimen is selected, participants in this group will receive SR on Day 1 and Month 24, and a placebo at Month 12. The participants who are randomized to two-dose regimen will receive selected regimen on Day 1 and Day 57, and a placebo at Month 12.
干预措施: Placebo (Biological)
C3 G20: SR + Placebo for SR
If a one-dose regimen is selected, participants in this group will receive SR on Day 1 and Month 24, and a placebo at Month 12. The participants who are randomized to two-dose regimen will receive selected regimen on Day 1 and Day 57, and a placebo at Month 12.
干预措施: Selected Regimen (Biological)
C3 G21: Placebo for SR
If a one-dose regimen is selected, participants in this group will receive placebo for SR on Day 1 and at Month 12 and Month 24. The participants who are randomized to two-dose regimen will receive placebo for SR on Day 1, Day 57, and Month 12.
干预措施: Placebo (Biological)
结局指标
主要结局
Cohort 2 (Groups 14-15): Number of Participants With Serious Adverse Events (SAEs)
时间窗: From Day 1 up to Day 1095
An AE is any untoward medical occurrence in a participant participating in a clinical study that does not necessarily have a causal relationship with the pharmaceutical/biological agent under study. An SAE is an AE resulting in any of the following outcomes or deemed significant for any other reason: death; initial or prolonged inpatient hospitalization; life-threatening experience (immediate risk of dying); persistent or significant disability/incapacity; congenital anomaly/birth defect; suspected transmission of any infectious agent via a medicinal product or medically important. The outcome measure was planned to be analyzed for specified arms only.
Cohort 2: Number of Participants With Solicited Local (Injection Site) and Systemic AEs at 7 Days Post-vaccination 2
时间窗: 7 days post-vaccination 2 on Day 57 (Day 64)
Number of participants with solicited local and systemic AEs at 7 days post-vaccination 2 in Cohort 2 were reported. An AE is any untoward medical occurrence in a participant participating in a clinical study that does not necessarily have a causal relationship with the pharmaceutical/biological agent under study. Solicited local AEs that included injection site pain/tenderness, erythema and swelling at the study vaccine injection site, are used to assess the reactogenicity of the study vaccine and are pre-defined local (injection site). Systemic events included events such as fatigue, headache, nausea, and myalgia, for which participants were specifically questioned and which will be noted by participants in their participant diary for 7 days post vaccination (day of vaccination and the subsequent 7 days).
Cohort 3: Number of Participants With Solicited Local (Injection Site) and Systemic AEs at 7 Days Post-vaccination 1
时间窗: 7 days post-vaccination 1 on Day 1 (Day 8)
Number of participants with solicited local and systemic AEs at 7 days post-vaccination 1 in Cohort 3 were reported. An AE is any untoward medical occurrence in a participant participating in a clinical study that does not necessarily have a causal relationship with the pharmaceutical/biological agent under study. Solicited local AEs that included injection site pain/tenderness, erythema and swelling at the study vaccine injection site, are used to assess the reactogenicity of the study vaccine and are pre-defined local (injection site). Systemic events included events such as fatigue, headache, nausea, and myalgia, for which participants were specifically questioned and which will be noted by participants in their participant diary for 7 days post vaccination (day of vaccination and the subsequent 7 days).
Cohort 2 (Groups 11-13 and 16-18): Number of Participants With Serious Adverse Events (SAEs)
时间窗: From Day 1 up to Day 730
An AE is any untoward medical occurrence in a participant participating in a clinical study that does not necessarily have a causal relationship with the pharmaceutical/biological agent under study. An SAE is an AE resulting in any of the following outcomes or deemed significant for any other reason: death; initial or prolonged inpatient hospitalization; life-threatening experience (immediate risk of dying); persistent or significant disability/incapacity; congenital anomaly/birth defect; suspected transmission of any infectious agent via a medicinal product or medically important. The outcome measure was planned to be analyzed for specified arms only.
Cohort 1: Number of Participants With Serious Adverse Events (SAEs)
时间窗: From Day 1 up to Day 730
An AE is any untoward medical occurrence in a participant participating in a clinical study that does not necessarily have a causal relationship with the pharmaceutical/biological agent under study. An SAE is an AE resulting in any of the following outcomes or deemed significant for any other reason: death; initial or prolonged inpatient hospitalization; life-threatening experience (immediate risk of dying); persistent or significant disability/incapacity; congenital anomaly/birth defect; suspected transmission of any infectious agent via a medicinal product or medically important. The outcome measure was planned to be analyzed for specified arms only.
Cohort 1: Number of Participants With Solicited Local (Injection Site) and Systemic AEs at 7 Days Post-vaccination 3
时间窗: 7 days post-vaccination 3 on Day 365 (Day 372)
Number of participants with solicited local and systemic AEs at 7 days post-vaccination 3 in Cohort 1 were reported. An AE is any untoward medical occurrence in a participant participating in a clinical study that does not necessarily have a causal relationship with the pharmaceutical/biological agent under study. Solicited local AEs that included injection site pain/tenderness, erythema and swelling at the study vaccine injection site, are used to assess the reactogenicity of the study vaccine and are pre-defined local (injection site). Systemic events included events such as fatigue, headache, nausea, and myalgia, for which participants were specifically questioned and which will be noted by participants in their participant diary for 7 days post vaccination (day of vaccination and the subsequent 7 days).
Cohort 2: Number of Participants With Solicited Local (Injection Site) and Systemic AEs at 7 Days Post-vaccination 1
时间窗: 7 days post-vaccination 1 on Day 1 (Day 8)
Number of participants with solicited local and systemic AEs at 7 days post-vaccination 1 in Cohort 2 were reported. An AE is any untoward medical occurrence in a participant participating in a clinical study that does not necessarily have a causal relationship with the pharmaceutical/biological agent under study. Solicited local AEs that included injection site pain/tenderness, erythema and swelling at the study vaccine injection site, are used to assess the reactogenicity of the study vaccine and are pre-defined local (injection site). Systemic events included events such as fatigue, headache, nausea, and myalgia, for which participants were specifically questioned and which will be noted by participants in their participant diary for 7 days post vaccination (day of vaccination and the subsequent 7 days).
Cohort 3: Number of Participants With Unsolicited AEs at 28 Days Post-vaccination 3
时间窗: 28 days post-vaccination 3 on Day 730 (Day 758)
Number of participants with unsolicited AEs post-vaccination 3 in Cohort 3 were reported. An AE is any untoward medical occurrence in a participant participating in a clinical study that does not necessarily have a causal relationship with the pharmaceutical/biological agent under study. Unsolicited AEs are all AEs for which the participant is not specifically questioned in the participant diary.
Cohort 3: Number of Participants With Serious Adverse Events (SAEs)
时间窗: From Day 1 up to Day 1095
An AE is any untoward medical occurrence in a participant participating in a clinical study that does not necessarily have a causal relationship with the pharmaceutical/biological agent under study. An SAE is an AE resulting in any of the following outcomes or deemed significant for any other reason: death; initial or prolonged inpatient hospitalization; life-threatening experience (immediate risk of dying); persistent or significant disability/incapacity; congenital anomaly/birth defect; suspected transmission of any infectious agent via a medicinal product or medically important. The outcome measure was planned to be analyzed for specified arms only.
Cohort 1: Number of Participants With Solicited Local (Injection Site) and Systemic AEs at 7 Days Post-vaccination 1
时间窗: 7 days post-vaccination 1 on Day 1 (Day 8)
Number of participants with solicited local and systemic AEs at 7 days post-vaccination 1 in Cohort 1 were reported. An AE is any untoward medical occurrence in a participant participating in a clinical study that does not necessarily have a causal relationship with the pharmaceutical/biological agent under study. Solicited local (injection site) AEs that included injection site pain/tenderness, erythema and swelling at the study vaccine injection site, are used to assess the reactogenicity of the study vaccine and are pre-defined local (injection site). Systemic events included events such as fatigue, headache, nausea, and myalgia, for which participants were specifically questioned and which will be noted by participants in their participant diary for 7 days post-vaccination (day of vaccination and the subsequent 7 days).
Cohort 1: Number of Participants With Solicited Local (Injection Site) and Systemic AEs at 7 Days Post-vaccination 2
时间窗: 7 days post-vaccination 2 on Day 57 (Day 64)
Number of participants with solicited local and systemic AEs at 7 days post-vaccination 2 in Cohort 1 were reported. An AE is any untoward medical occurrence in a participant participating in a clinical study that does not necessarily have a causal relationship with the pharmaceutical/biological agent under study. Solicited local AEs that included injection site pain/tenderness, erythema and swelling at the study vaccine injection site, are used to assess the reactogenicity of the study vaccine and are pre-defined local (injection site). Systemic events included events such as fatigue, headache, nausea, and myalgia, for which participants will be specifically questioned and which were noted by participants in their participant diary for 7 days post vaccination (day of vaccination and the subsequent 7 days).
Cohort 3: Number of Participants With Solicited Local (Injection Site) and Systemic AEs at 7 Days Post-vaccination 3
时间窗: 7 days post-vaccination 3 on Day 730 (Day 737)
Number of participants with solicited local and systemic AEs at 7 days post-vaccination 3 in Cohort 3 were reported. An AE is any untoward medical occurrence in a participant participating in a clinical study that does not necessarily have a causal relationship with the pharmaceutical/biological agent under study. Solicited local AEs that included injection site pain/tenderness, erythema and swelling at the study vaccine injection site, are used to assess the reactogenicity of the study vaccine and are pre-defined local (injection site). Systemic events included events such as fatigue, headache, nausea, and myalgia, for which participants were specifically questioned and which will be noted by participants in their participant diary for 7 days post vaccination (day of vaccination and the subsequent 7 days).
Cohort 1: Number of Participants With Unsolicited AEs at 28 Days Post-vaccination 1
时间窗: 28 days post-vaccination 1 on Day 1 (Day 29)
Number of participants with unsolicited AEs post-vaccination 1 in Cohort 1 were reported. An AE is any untoward medical occurrence in a participant participating in a clinical study that does not necessarily have a causal relationship with the pharmaceutical/biological agent under study. Unsolicited AEs are all AEs for which the participant is not specifically questioned in the participant diary.
Cohort 2 (Group 11 to 15): Respiratory Syncytial Virus (RSV) A2 Strain Neutralization Antibody Titers on Day 29
时间窗: Day 29
RSV A2 Strain neutralization antibody titers on Day 29 was reported. Geometric mean titers (GMTs) of RSV A2 neutralizing antibodies were measured using the neutralization assay. The outcome measure was planned to be analyzed for specified arms only.
Cohort 3: Number of Participants With Solicited Local (Injection Site) and Systemic AEs at 7 Days Post-vaccination 2
时间窗: 7 days post-vaccination 2 on Day 365 (Day 372)
Number of participants with solicited local and systemic AEs at 7 days post-vaccination 2 in Cohort 3 were reported. An AE is any untoward medical occurrence in a participant participating in a clinical study that does not necessarily have a causal relationship with the pharmaceutical/biological agent under study. Solicited local AEs that included injection site pain/tenderness, erythema and swelling at the study vaccine injection site, are used to assess the reactogenicity of the study vaccine and are pre-defined local (injection site). Systemic events included events such as fatigue, headache, nausea, and myalgia, for which participants were specifically questioned and which will be noted by participants in their participant diary for 7 days post vaccination (day of vaccination and the subsequent 7 days).
Cohort 2: Number of Participants With Unsolicited AEs at 28 Days Post-vaccination 1
时间窗: 28 days post-vaccination 1 on Day 1 (Day 29)
Number of participants with unsolicited AEs post-vaccination 1 in Cohort 2 were reported. An AE is any untoward medical occurrence in a participant participating in a clinical study that does not necessarily have a causal relationship with the pharmaceutical/biological agent under study. Unsolicited AEs are all AEs for which the participant is not specifically questioned in the participant diary.
Cohort 2: Number of Participants With Unsolicited AEs at 28 Days Post-vaccination 2
时间窗: 28 days post-vaccination 2 on Day 57 (Day 85)
Number of participants with unsolicited AEs post-vaccination 2 in Cohort 2 were reported. An AE is any untoward medical occurrence in a participant participating in a clinical study that does not necessarily have a causal relationship with the pharmaceutical/biological agent under study. Unsolicited AEs are all AEs for which the participant is not specifically questioned in the participant diary.
Cohort 3: Number of Participants With Unsolicited AEs at 28 Days Post-vaccination 2
时间窗: 28 days post-vaccination 2 on Day 365 (Day 393)
Number of participants with unsolicited AEs post-vaccination 2 in Cohort 3 were reported. An AE is any untoward medical occurrence in a participant participating in a clinical study that does not necessarily have a causal relationship with the pharmaceutical/biological agent under study. Unsolicited AEs are all AEs for which the participant is not specifically questioned in the participant diary.
Cohort 1: Number of Participants With Unsolicited AEs at 28 Days Post-vaccination 2
时间窗: 28 days post-vaccination 2 on Day 57 (Day 85)
Number of participants with unsolicited AEs post-vaccination 2 in Cohort 1 were reported. An AE is any untoward medical occurrence in a participant participating in a clinical study that does not necessarily have a causal relationship with the pharmaceutical/biological agent under study. Unsolicited AEs are all AEs for which the participant is not specifically questioned in the participant diary.
Cohort 3: Number of Participants With Unsolicited AEs at 28 Days Post-vaccination 1
时间窗: 28 days post-vaccination 1 on Day 1 (Day 29)
Number of participants with unsolicited AEs post-vaccination 1 in Cohort 3 were reported. An AE is any untoward medical occurrence in a participant participating in a clinical study that does not necessarily have a causal relationship with the pharmaceutical/biological agent under study. Unsolicited AEs are all AEs for which the participant is not specifically questioned in the participant diary.
Cohort 1: Number of Participants With Unsolicited AEs at 28 Days Post-vaccination 3
时间窗: 28 days post-vaccination 3 on Day 365 (Day 393)
Number of participants with unsolicited AEs post-vaccination 3 in Cohort 1 were reported. An AE is any untoward medical occurrence in a participant participating in a clinical study that does not necessarily have a causal relationship with the pharmaceutical/biological agent under study. Unsolicited AEs are all AEs for which the participant is not specifically questioned in the participant diary.
次要结局
- Cohort 1: RSV A2 Strain Neutralization Antibody Titers at Specified Timepoints(Days 1, 15, 29, 57, 85, 183, 365, 393, and 547)
- Cohort 3: RSV A2 Strain Neutralization Antibody Titers at Specified Timepoints(Days 1, 15, 29, 57, 85, 183, 365, 393, 547, 730, 744, 758)
- Cohort 2 (Group 17): RSV A2 Strain Neutralization Antibody Titers on Day 85(Day 85)
- Cohort 2: Pre-Fusion RSV Fusion Protein (F-protein) Geometric Mean Titers (GMTs) as Assessed by Enzyme-linked Immunosorbent Assay (ELISA) at Specified Timepoints(Days 1, 15, 29, 57, 85, 183, 365, and 547)
- Cohort 1: Pre-Fusion RSV Fusion Protein (F-protein) Geometric Mean Titers (GMTs) as Assessed by Enzyme-linked Immunosorbent Assay (ELISA) at Specified Timepoints(Days 1, 15, 29, 57, 85, 183, 365, 393, and 547)
- Cohort 2 (Group 16): RSV A2 Strain Neutralization Antibody Titers on Day 29(Day 29)
- Cohort 3: Breadth of Interferon-gamma (IFN-gamma) T-Cells Responses Against RSV Analyzed by Enzyme-linked Immunospot (ELISpot) Assay at Specified Timepoints(Days 1, 15, 29, 57, 85, 183, 365, 393, 730, 744, and 758)
- Cohort 1: Post-Fusion RSV Fusion Protein (F-protein) Geometric Mean Titers (GMTs) as Assessed by Enzyme-linked Immunosorbent Assay (ELISA) at Specified Timepoints(Days 1, 15, 29, 57, 85, 183, 365, 393, and 547)
- Cohort 2: Post-Fusion RSV Fusion Protein (F-protein) Geometric Mean Titers (GMTs) as Assessed by Enzyme-linked Immunosorbent Assay (ELISA) at Specified Timepoints(Days 1, 15, 29, 57, 85, 183, 365, and 547)
- Cohort 1: Breadth of Interferon-gamma (IFN-gamma) T-Cells Responses Against RSV Analyzed by Enzyme-linked Immunospot (ELISpot) Assay at Specified Timepoints(Days 1, 15, 29, 57, 85, 183, 365, 393, and 547)
- Cohort 2 (Group 11-16): Breadth of IFN-gamma T-Cells Responses Against RSV Analyzed by ELISpot Assay on Day 29(Day 29)
- Cohort 2 (Group 17): Breadth of IFN-gamma T-Cells Responses Analyzed by ELISpot Assay on Day 85(Day 85)