A PHASE 3 STUDY TO EVALUATE THE EFFICACY, IMMUNOGENICITY, AND SAFETY OF RESPIRATORY SYNCYTIAL VIRUS (RSV) PREFUSION F SUBUNIT VACCINE IN ADULTS
试验速览
- 阶段
- 3 期
- 状态
- 进行中（未招募）
- 发起方
- Pfizer
- 入组人数
- 38,861
- 试验地点
- 502
- 主要终点
- Efficacy Study: Number of first episode of RSV-associated lower respiratory tract illness (LRTI-RSV) in the first RSV season
研究概览
简要总结
Efficacy Study: This randomized, double-blinded, placebo-controlled Phase 3 study is designed to assess the safety, immunogenicity, and efficacy of a single dose of RSVpreF in the prevention of LRTI-RSV in adults:
- At a dose of 120µg.
- In adults 60 years of age and older.
- The duration of the study for each participant will be up to approximately 24 months.
- The study will be conducted in the United States, Canada, Netherlands, Finland, Argentina, Japan and South Africa.
Substudy A: This study is an extension of the efficacy study and was designed to evaluate the safety and immunogenicity of a second dose of RSVpreF when administered after a dosing interval of approximately 2 years:
- At a dose of 120µg (as studied in the Phase 3 Efficacy Study)
- Blood samples will be collected for antibody testing.
- The duration of the study for each participant will be up to approximately 18 months.
- The study will be conducted in the United States and Argentina.
Substudy B: This study was designed to evaluate the safety and immunogenicity of a second dose of RSVpreF when administered after a dosing interval of approximately 1 year:
- At a dose of 120µg (as studied in the Phase 3 Efficacy Study)
- Blood samples will be collected for antibody testing.
- The duration of the study for each participant will be up to approximately 18 months.
- The study will be conducted in Argentina.
Substudy C: This study was designed to evaluate the safety and immunogenicity of a second dose of RSVpreF when administered after a dosing interval of either 3 or 4 years:
- At a dose of 120µg (as studied in the Phase 3 Efficacy Study)
- Participants will receive either placebo or a second dose of RSVpreF approximately 3 or 4 years after receiving the initial dose of RSVpreF in the main efficacy study.
- Blood samples will be collected for antibody testing.
- The duration of the study for each participant will be up to approximately 24 months.
- The study will be conducted in the United States and Canada.
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
- Triple (Participant, Care Provider, Investigator)
盲法说明
This is a double-blinded, placebo-controlled study.
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
- •Efficacy Study
- •Inclusion Criteria:
- •Participants who are willing and able to comply with all scheduled visits, vaccination plan, laboratory tests, lifestyle considerations, frequent symptom assessment by mobile device application, and other study procedures, including collection of nasal swabs by themselves and by study staff when indicated.
- •Healthy participants who are determined by medical history, physical examination (if required), and clinical judgment of the investigator to be eligible for inclusion in the study.
- •Note: Healthy participants with preexisting stable disease, defined as disease not requiring significant change in therapy or hospitalization for worsening disease during the 6 weeks before enrollment, can be included. Specific criteria for participants with known stable infection with HIV, HCV, or HBV can be found in the protocol.
- •Adults who are ambulatory and live in the community, or in assisted living or long-term care residential facilities that provide minimal assistance, such that the participant is primarily responsible for self-care and activities of daily living.
- •Capable of giving signed informed consent as described in the protocol, which includes compliance with the requirements and restrictions listed in the ICD and in this protocol.
- •Male or female participants ≥60 years of age.
- •Male participants able to father children must agree to use a highly effective method of contraception from the time of informed consent through at least 28 days after study intervention administration.
- •Female participants must not be of childbearing potential.
排除标准
- •Bleeding diathesis or condition associated with prolonged bleeding that would, in the opinion of the investigator, contraindicate intramuscular injection.
- •History of severe adverse reaction associated with a vaccine and/or severe allergic reaction (eg, anaphylaxis) to any component of the study intervention(s) or any related vaccine.
- •Serious chronic disorder including metastatic malignancy, end-stage renal disease with or without dialysis, clinically unstable cardiac disease, or any other disorder that, in the investigator's opinion, excludes the participant from participating in the study.
- •Immunocompromised individuals with known or suspected immunodeficiency, as determined by history and/or laboratory/physical examination.
- •Other medical or psychiatric condition including recent (within the past year) or active suicidal ideation/behavior or laboratory abnormality that may increase the risk of study participation or, in the investigator's judgment, make the participant inappropriate for the study.
- •Participation in other studies involving an investigational product within 28 days prior to consent and/or through and including the 6-months follow-up visit (Visit 3).
- •Note: This criterion does not apply to participants who are participating in a follow-up period for another study involving a study intervention that is an investigational drug or vaccine, if receipt of the last dose was at least 6 months prior to consenting for this study and there is no further dosing anticipated from the previous study during the participant's participation in this study - Individuals who receive chronic systemic treatment with immunosuppressive therapy, including cytotoxic agents, monoclonal antibodies, systemic corticosteroids, or radiotherapy, eg, for cancer or an autoimmune disease, from 60 days before study intervention administration or planned receipt throughout the study. If systemic corticosteroids have been administered short term (<14 days) for treatment of an acute illness, participants should not be enrolled in the study until corticosteroid therapy has been discontinued for at least 28 days before study intervention administration. Inhaled/nebulized, intra articular, intrabursal, or topical (skin or eyes) corticosteroids are permitted.
- •Note: Participants with COPD or asthma can be enrolled if chronic corticosteroids do not exceed a dose equivalent to 10 mg/day of prednisone.
- •Receipt of blood/plasma products or immunoglobulin within 60 days before study intervention administration.
- •Previous vaccination with any licensed or investigational RSV vaccine or planned receipt during study participation.
- •Investigator site staff or Pfizer employees directly involved in the conduct of the study, site staff otherwise supervised by the investigator, and their respective family members.
- •Inclusion Criteria:
- •Participants who are willing and able to comply with all scheduled visits, vaccination plan, laboratory tests, lifestyle considerations, frequent symptom assessment by mobile device application, and other study procedures, including collection of nasal swabs by themselves and by study staff when indicated.
- •Healthy participants who are determined by medical history, physical examination (if required), and clinical judgment of the investigator to be eligible for inclusion in the study.
- •Note: Healthy participants with preexisting stable disease, defined as disease not requiring significant change in therapy or hospitalization for worsening disease during the 6 weeks before enrollment, can be included. Specific criteria for participants with known stable infection with HIV, HCV, or HBV can be found in the protocol.
- •Adults who are ambulatory and live in the community, or in assisted living or long-term care residential facilities that provide minimal assistance, such that the participant is primarily responsible for self-care and activities of daily living.
- •Capable of giving signed informed consent as described in the protocol, which includes compliance with the requirements and restrictions listed in the ICD and in this protocol.
- •Male or female participants ≥60 years of age.
- •Male participants able to father children must agree to use a highly effective method of contraception from the time of informed consent through at least 28 days after study intervention administration.
- •Female participants must not be of childbearing potential.
- •Participants who received RSVpreF in the efficacy study.
- •Participants who have a Visit 2 serology sample available for testing from the efficacy study, completed the end-of-Season 2 visit (Visit 5), and did not meet exclusion criteria throughout the efficacy study duration.
- •Exclusion Criteria:
- •Bleeding diathesis or condition associated with prolonged bleeding that would, in the opinion of the investigator, contraindicate intramuscular injection.
- •History of severe adverse reaction associated with a vaccine and/or severe allergic reaction (eg, anaphylaxis) to any component of the study intervention(s) or any related vaccine.
- •Serious chronic disorder including metastatic malignancy, end-stage renal disease with or without dialysis, clinically unstable cardiac disease, or any other disorder that, in the investigator's opinion, excludes the participant from participating in the study.
- •Immunocompromised individuals with known or suspected immunodeficiency, as determined by history and/or laboratory/physical examination.
- •Other medical or psychiatric condition including recent (within the past year) or active suicidal ideation/behavior or laboratory abnormality that may increase the risk of study participation or, in the investigator's judgment, make the participant inappropriate for the study.
- •Participation in other studies involving an investigational product within 28 days prior to consent and/or through and including the 6-months follow-up visit (Visit 103).
- •Note: This criterion does not apply to participants who are participating in a follow-up period for another study involving a study intervention that is an investigational drug or vaccine, if receipt of the last dose was at least 6 months prior to consenting for this study and there is no further dosing anticipated from the previous study during the participant's participation in this study
- •- Individuals who receive chronic systemic treatment with immunosuppressive therapy, including cytotoxic agents, monoclonal antibodies, systemic corticosteroids, or radiotherapy, eg, for cancer or an autoimmune disease, from 60 days before study intervention administration or planned receipt throughout the study. If systemic corticosteroids have been administered short term (<14 days) for treatment of an acute illness, participants should not be enrolled in the study until corticosteroid therapy has been discontinued for at least 28 days before study intervention administration. Inhaled/nebulized, intra articular, intrabursal, or topical (skin or eyes) corticosteroids are permitted.
- •Note: Participants with COPD or asthma can be enrolled if chronic corticosteroids do not exceed a dose equivalent to 10 mg/day of prednisone.
- •Receipt of blood/plasma products or immunoglobulin within 60 days before study intervention administration.
- •Previous vaccination with any licensed or investigational RSV vaccine or planned receipt during study participation.
- •Note: This criterion does not include the receipt of RSVpreF in the efficacy study. Per inclusion criterion #6, receipt of RSVpreF in the efficacy study is required to participate in Substudy A.
- •Investigator site staff or Pfizer employees directly involved in the conduct of the study, site staff otherwise supervised by the investigator, and their respective family members.
- •Participant was confirmed by the sponsor to have previously received the study intervention more than once.
- •Inclusion Criteria:
- •Participants who are willing and able to comply with all scheduled visits, vaccination plan, laboratory tests, lifestyle considerations, frequent symptom assessment by mobile device application, and other study procedures, including collection of nasal swabs by themselves and by study staff when indicated.
- •Healthy participants who are determined by medical history, physical examination (if required), and clinical judgment of the investigator to be eligible for inclusion in the study.
- •Note: Healthy participants with preexisting stable disease, defined as disease not requiring significant change in therapy or hospitalization for worsening disease during the 6 weeks before enrollment, can be included. Specific criteria for participants with known stable infection with HIV, HCV, or HBV can be found in the protocol.
- •Adults who are ambulatory and live in the community, or in assisted living or long-term care residential facilities that provide minimal assistance, such that the participant is primarily responsible for self-care and activities of daily living.
- •Capable of giving signed informed consent as described in the protocol, which includes compliance with the requirements and restrictions listed in the ICD and in this protocol.
- •Male or female participants ≥60 years of age.
- •Male participants able to father children must agree to use a highly effective method of contraception from the time of informed consent through at least 28 days after study intervention administration.
- •Female participants must not be of childbearing potential.
- •Participants who received RSVpreF in the efficacy study.
- •Participants who received RSVpreF in the efficacy study.
- •Participants who have a Visit 2 serology sample available for testing from the efficacy study and did not meet exclusion criteria through Visit 4 of the efficacy study.
- •Exclusion Criteria:
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研究组 & 干预措施
Efficacy Study: RSVpreF vaccine
RSVpreF
干预措施: RSVpreF (Biological)
Efficacy Study: Placebo dose
Placebo
干预措施: Placebo (Biological)
SSA: Vaccination of RSVpreF recipients with RSVpreF (Year 2 revaccination)
Participants who originally received RSVpreF in the Efficacy Study and are eligible for SSA will receive RSVpreF in SSA.
干预措施: RSVpreF (Biological)
SSB: Vaccination of RSVpreF recipients with Placebo
Participants who originally received RSVpreF in the Efficacy Study and are eligible for SSB will receive Placebo in SSB.
干预措施: Placebo (Biological)
SSA: Vaccination of RSVpreF recipients with Placebo
Participants who originally received RSVpreF in the Efficacy Study and are eligible for SSA will receive Placebo in SSA.
干预措施: Placebo (Biological)
SSB: Vaccination of RSVpreF recipients with RSVpreF (Year 1 revaccination)
Participants who originally received RSVpreF in the Efficacy Study and are eligible for SSB will receive RSVpreF in SSB.
干预措施: RSVpreF (Biological)
SSC: Vaccination of RSVpreF recipients with RSVpreF (Year 3 revaccination)
Participants who originally received RSVpreF in the Efficacy Study and are eligible for SSC will receive RSVpreF at the Year 3 vaccination followed by placebo at the Year 4 vaccination in SSC.
干预措施: RSVpreF (Biological)
SSC: Vaccination of RSVpreF recipients with RSVpreF (Year 4 revaccination)
Participants who originally received RSVpreF in the Efficacy Study and are eligible for SSC will receive placebo at the Year 3 vaccination followed by RSVpreF at the Year 4 vaccination in SSC.
干预措施: RSVpreF (Biological)
SSC: Vaccination of RSVpreF recipients with Placebo
Participants who originally received RSVpreF in the Efficacy Study and are eligible for SSC will receive placebo at both the Year 3 and Year 4 vaccination in SSC.
干预措施: Placebo (Biological)
结局指标
主要结局
Efficacy Study: Number of first episode of RSV-associated lower respiratory tract illness (LRTI-RSV) in the first RSV season
时间窗: From Day 15 after vaccination until the end of season 1 visit (an average of 6 months)
Reverse Transcriptase-Polymerase Chain Reaction (RT-PCR)-confirmed RSV A and/or RSV B- associated acute respiratory illness (ARI) is assessed. LRTI-RSV is defined as an ARI with 2 or more of the lower respiratory signs/symptoms lasting more than 1 day during the same illness, plus RT-PCR-confirmed RSV infection within 7 days of ARI symptom onset. Reverse Transcriptase-Polymerase Chain Reaction (RT-PCR)-confirmed RSV A and/or RSV B- associated acute respiratory illness (ARI) is assessed. LRTI-RSV is defined as an ARI with 3 or more of the lower respiratory signs/symptoms lasting more than 1 day during the same illness, plus RT-PCR-confirmed RSV infection within 7 days of ARI symptom onset.
Efficacy Study: Proportion of participants reporting prompted local reactions within 7-days after vaccination
时间窗: Within 7 days after vaccination
Local reactions included pain at injection site, redness and swelling recorded by participants in an e-diary. Redness and swelling were measured and recorded in measuring device units. 1 measuring device unit =0.5 cm and graded as mild: 2.5 to 5.0 cm, moderate: \> 5.0 to 10.0 cm and severe: \>10 cm. Pain at injection site was graded as mild: did not interfere with daily activity, moderate: interfere with daily activity and severe: prevented daily activity
Efficacy Study: Proportion of participants reporting prompted systemic events within 7-days after vaccination
时间窗: Within 7 days after vaccination
Systemic reactions:fever, fatigue/tiredness, headache, nausea, muscle pain, joint pain, vomiting, diarrhea and any systemic event recorded by participants in an e-diary. Fever: greater than equal to (\>=)38.0 degrees (deg) Celsius (C), mild (\>=38.0 to 38.4 deg C, \>38.4 to 38.9 deg C), moderate (\>38.9 to 40.0 deg C and \>40.0 deg C), severe (\>38.9 deg C to 40.0 deg C) and grade 4 (\>40.0 deg C). Fatigue, headache, nausea, muscle pain and joint pain were graded as mild: did not interfere with activity, moderate: some interference with activity and severe: prevented daily routine activity. Vomiting was graded as mild: 1 to 2 times in 24 hours(h), moderate: \>2 times in 24h and severe: requires intravenous hydration. Diarrhea was graded as mild: 2 to 3 loose stools in 24h, moderate: 4 to 5 loose stools in 24h and severe: 6 or more loose stools in 24h.
Efficacy Study: Proportion of participants reporting AE within 1-month after vaccination
时间窗: Within 1 month after vaccination (up to 35 days)
An AE was any untoward medical occurrence in a participant who received investigational product without regard to possibility of causal relationship. AEs included both serious and non-serious adverse events.
Efficacy Study: Proportion of participants reporting SAE throughout the study
时间窗: Throughout the study duration (an average of 30 months)
SAE was 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.
Efficacy Study: Proportion of participants reporting NDCMC throughout the study
时间窗: Throughout the study duration (an average of 30 months)
An NDCMC is defined as a disease or medical condition, not previously identified, that is expected to be persistent or otherwise long-lasting in its effects (eg, asthma).
SSA: Respiratory Syncytial Virus Subgroup A (RSV A) and RSV B neutralizing titers from participants who received 2-dose of RSVpreF
时间窗: Before revaccination and 1, 6, 12 and 18-months after revaccination with RSVpreF in SSA
RSV A and RSV B neutralizing titers (NT), expressed as Geometric Mean Titers (GMTs), and geometric mean fold rise (GMFR). The NTs were calculated as the interpolated reciprocal of the serum dilution resulting in 50% reduction in the number of viral focus forming units when compared to the control without test serum.
SSA: Proportion of participants reporting prompted local reactions within 7-days after revaccination
时间窗: Within 7 days after revaccination
Local reactions included pain at injection site, redness and swelling recorded by participants in an e-diary. Redness and swelling were measured and recorded in measuring device units. 1 measuring device unit =0.5 cm and graded as mild: 2.5 to 5.0 cm, moderate: \> 5.0 to 10.0 cm and severe: \>10 cm. Pain at injection site was graded as mild: did not interfere with daily activity, moderate: interfere with daily activity and severe: prevented daily activity
SSA: Proportion of participants reporting prompted systemic events within 7-days after revaccination
时间窗: Within 7 days after revaccination
Systemic reactions:fever, fatigue/tiredness, headache, nausea, muscle pain, joint pain, vomiting, diarrhea and any systemic event recorded by participants in an e-diary. Fever: greater than equal to (\>=)38.0 degrees (deg) Celsius (C), mild (\>=38.0 to 38.4 deg C, \>38.4 to 38.9 deg C), moderate (\>38.9 to 40.0 deg C and \>40.0 deg C), severe (\>38.9 deg C to 40.0 deg C) and grade 4 (\>40.0 deg C). Fatigue, headache, nausea, muscle pain and joint pain were graded as mild: did not interfere with activity, moderate: some interference with activity and severe: prevented daily routine activity. Vomiting was graded as mild: 1 to 2 times in 24 hours(h), moderate: \>2 times in 24h and severe: requires intravenous hydration. Diarrhea was graded as mild: 2 to 3 loose stools in 24h, moderate: 4 to 5 loose stools in 24h and severe: 6 or more loose stools in 24h.
SSA: Proportion of participants reporting AE within 1-month after revaccination
时间窗: Within 1 month after revaccination (up to 35 days)
An AE was any untoward medical occurrence in a participant who received investigational product without regard to possibility of causal relationship. AEs included both serious and non-serious adverse events.
SSA: Proportion of participants reporting SAE throughout the study
时间窗: Throughout the study duration (approximately 18 months)
SAE was 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.
SSA: Proportion of participants reporting NDCMC throughout the study
时间窗: Throughout the study duration (approximately 18 months)
An NDCMC is defined as a disease or medical condition, not previously identified, that is expected to be persistent or otherwise long-lasting in its effects (eg, asthma).
SSB: Respiratory Syncytial Virus Subgroup A (RSV A) and RSV B neutralizing titers from participants who received 2-dose of RSVpreF
时间窗: Before revaccination and 1, 6, 12 and 18-months after revaccination with RSVpreF in SSB
RSV A and RSV B neutralizing titers (NT), expressed as Geometric Mean Titers (GMTs), and geometric mean fold rise (GMFR). The NTs were calculated as the interpolated reciprocal of the serum dilution resulting in 50% reduction in the number of viral focus forming units when compared to the control without test serum.
SSB: Proportion of participants reporting prompted local reactions within 7-days after revaccination
时间窗: Within 7 days after revaccination
Local reactions included pain at injection site, redness and swelling recorded by participants in an e-diary. Redness and swelling were measured and recorded in measuring device units. 1 measuring device unit =0.5 cm and graded as mild: 2.5 to 5.0 cm, moderate: \> 5.0 to 10.0 cm and severe: \>10 cm. Pain at injection site was graded as mild: did not interfere with daily activity, moderate: interfere with daily activity and severe: prevented daily activity.
SSB: Proportion of participants reporting prompted systemic events within 7-days after revaccination
时间窗: SSB: Proportion of participants reporting prompted systemic events within 7-days after revaccination
Systemic reactions:fever, fatigue/tiredness, headache, nausea, muscle pain, joint pain, vomiting, diarrhea and any systemic event recorded by participants in an e-diary. Fever: greater than equal to (\>=)38.0 degrees (deg) Celsius (C), mild (\>=38.0 to 38.4 deg C, \>38.4 to 38.9 deg C), moderate (\>38.9 to 40.0 deg C and \>40.0 deg C), severe (\>38.9 deg C to 40.0 deg C) and grade 4 (\>40.0 deg C). Fatigue, headache, nausea, muscle pain and joint pain were graded as mild: did not interfere with activity, moderate: some interference with activity and severe: prevented daily routine activity. Vomiting was graded as mild: 1 to 2 times in 24 hours(h), moderate: \>2 times in 24h and severe: requires intravenous hydration. Diarrhea was graded as mild: 2 to 3 loose stools in 24h, moderate: 4 to 5 loose stools in 24h and severe: 6 or more loose stools in 24h.
SSB: Proportion of participants reporting AE within 1-month after revaccination
时间窗: Within 1 month after revaccination (up to 35 days)
An AE was any untoward medical occurrence in a participant who received investigational product without regard to possibility of causal relationship. AEs included both serious and non-serious adverse events.
SSB: Proportion of participants reporting SAE throughout the study
时间窗: Throughout the study duration (approximately 18 months)
SAE was 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.
SSB: Proportion of participants reporting NDCMC throughout the study
时间窗: Throughout the study duration (approximately 18 months)
An NDCMC is defined as a disease or medical condition, not previously identified, that is expected to be persistent or otherwise long-lasting in its effects (eg, asthma).
SSC: Respiratory Syncytial Virus Subgroup A (RSV A) and RSV B neutralizing titers from participants who received RSVpreF or placebo in SSC (Year 3)
时间窗: 1 month after revaccination in SSC (Year 3)
RSV A and RSV B neutralizing titers (NT), expressed as Geometric Mean NT ratios. The NTs were calculated as the interpolated reciprocal of the serum dilution resulting in 50% reduction in the number of viral focus forming units when compared to the control without test serum.
SSC: Respiratory Syncytial Virus Subgroup A (RSV A) and RSV B neutralizing titers from participants who received 1 dose in the Main Efficacy Study (preS2) and revaccination in SSC (Year 3)
时间窗: At preseason 2 (preS2) after receiving the initial vaccination in the efficacy study and 1 month after revaccination in SSC (Year 3)
RSV A and RSV B neutralizing titers (NT), expressed as Geometric Mean NT ratios. The NTs were calculated as the interpolated reciprocal of the serum dilution resulting in 50% reduction in the number of viral focus forming units when compared to the control without test serum.
SSC: Respiratory Syncytial Virus Subgroup A (RSV A) and RSV B neutralizing titers from participants who received 1 dose in the Main Efficacy Study and revaccination in SSC (Year 3)
时间窗: 1 month after receiving the initial vaccination in the efficacy study and 1 month after revaccination in SSC (Year 3)
RSV A and RSV B neutralizing titers (NT), expressed as Geometric Mean of individual NT ratios (GMIR). The NTs were calculated as the interpolated reciprocal of the serum dilution resulting in 50% reduction in the number of viral focus forming units when compared to the control without test serum.
SSC: Respiratory Syncytial Virus Subgroup A (RSV A) and RSV B neutralizing titers from participants who received RSVpreF or placebo in SSC (Year 4)
时间窗: 1 month after revaccination in SSC (Year 4)
RSV A and RSV B neutralizing titers (NT), expressed as Geometric Mean NT ratios. The NTs were calculated as the interpolated reciprocal of the serum dilution resulting in 50% reduction in the number of viral focus forming units when compared to the control without test serum.
SSC: Respiratory Syncytial Virus Subgroup A (RSV A) and RSV B neutralizing titers from participants who received 1 dose in the Main Efficacy Study (preS2) and revaccination in SSC (Year 4)
时间窗: At preseason 2 (preS2) after receiving the initial vaccination in the efficacy study and 1 month after revaccination in SSC (Year 4)
RSV A and RSV B neutralizing titers (NT), expressed as Geometric Mean NT ratios. The NTs were calculated as the interpolated reciprocal of the serum dilution resulting in 50% reduction in the number of viral focus forming units when compared to the control without test serum.
SSC: Respiratory Syncytial Virus Subgroup A (RSV A) and RSV B neutralizing titers from participants who received 1 dose in the Main Efficacy Study and revaccination in SSC (Year 4)
时间窗: 1 month after receiving the initial vaccination in the efficacy study and 1 month after revaccination in SSC (Year 4)
RSV A and RSV B neutralizing titers (NT), expressed as Geometric Mean of individual NT ratios (GMIR). The NTs were calculated as the interpolated reciprocal of the serum dilution resulting in 50% reduction in the number of viral focus forming units when compared to the control without test serum.
SSC: Proportion of participants reporting prompted local reactions within 7-days after revaccination (Year 3)
时间窗: Within 7 days after revaccination
Local reactions included pain at injection site, redness and swelling recorded by participants in an e-diary. Redness and swelling were measured and recorded in measuring device units. 1 measuring device unit =0.5 cm and graded as mild: 2.5 to 5.0 cm, moderate: \> 5.0 to 10.0 cm and severe: \>10 cm. Pain at injection site was graded as mild: did not interfere with daily activity, moderate: interfere with daily activity and severe: prevented daily activity.
SSC: Proportion of participants reporting prompted local reactions within 7-days after revaccination (Year 4)
时间窗: Within 7 days after revaccination
Local reactions included pain at injection site, redness and swelling recorded by participants in an e-diary. Redness and swelling were measured and recorded in measuring device units. 1 measuring device unit =0.5 cm and graded as mild: 2.5 to 5.0 cm, moderate: \> 5.0 to 10.0 cm and severe: \>10 cm. Pain at injection site was graded as mild: did not interfere with daily activity, moderate: interfere with daily activity and severe: prevented daily activity.
SSC: Proportion of participants reporting prompted systemic events within 7-days after revaccination (Year 3)
时间窗: Within 7 days after revaccination
Systemic reactions:fever, fatigue/tiredness, headache, nausea, muscle pain, joint pain, vomiting, diarrhea and any systemic event recorded by participants in an e-diary. Fever: greater than equal to (\>=)38.0 degrees (deg) Celsius (C), mild (\>=38.0 to 38.4 deg C, \>38.4 to 38.9 deg C), moderate (\>38.9 to 40.0 deg C and \>40.0 deg C), severe (\>38.9 deg C to 40.0 deg C) and grade 4 (\>40.0 deg C). Fatigue, headache, nausea, muscle pain and joint pain were graded as mild: did not interfere with activity, moderate: some interference with activity and severe: prevented daily routine activity. Vomiting was graded as mild: 1 to 2 times in 24 hours(h), moderate: \>2 times in 24h and severe: requires intravenous hydration. Diarrhea was graded as mild: 2 to 3 loose stools in 24h, moderate: 4 to 5 loose stools in 24h and severe: 6 or more loose stools in 24h.
SSC: Proportion of participants reporting prompted systemic events within 7-days after revaccination (Year 4)
时间窗: Within 7 days after revaccination
Systemic reactions:fever, fatigue/tiredness, headache, nausea, muscle pain, joint pain, vomiting, diarrhea and any systemic event recorded by participants in an e-diary. Fever: greater than equal to (\>=)38.0 degrees (deg) Celsius (C), mild (\>=38.0 to 38.4 deg C, \>38.4 to 38.9 deg C), moderate (\>38.9 to 40.0 deg C and \>40.0 deg C), severe (\>38.9 deg C to 40.0 deg C) and grade 4 (\>40.0 deg C). Fatigue, headache, nausea, muscle pain and joint pain were graded as mild: did not interfere with activity, moderate: some interference with activity and severe: prevented daily routine activity. Vomiting was graded as mild: 1 to 2 times in 24 hours(h), moderate: \>2 times in 24h and severe: requires intravenous hydration. Diarrhea was graded as mild: 2 to 3 loose stools in 24h, moderate: 4 to 5 loose stools in 24h and severe: 6 or more loose stools in 24h.
SSC: Proportion of participants reporting AE within 1-month after revaccination (Year 3)
时间窗: Within 1 month after revaccination (up to 35 days)
An AE was any untoward medical occurrence in a participant who received investigational product without regard to possibility of causal relationship. AEs included both serious and non-serious adverse events.
SSC: Proportion of participants reporting AE within 1-month after revaccination (Year 4)
时间窗: Within 1 month after revaccination (up to 35 days)
An AE was any untoward medical occurrence in a participant who received investigational product without regard to possibility of causal relationship. AEs included both serious and non-serious adverse events.
SSC: Proportion of participants reporting SAE after revaccination (Year 3)
时间窗: Following revaccination and throughout the study duration (approximately 24 months)
SAE was 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.
SSC: Proportion of participants reporting SAE after revaccination (Year 4)
时间窗: Following revaccination and throughout the study duration (approximately 12 months)
SAE was 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.
SSC: Proportion of participants reporting NDCMC after revaccination (Year 3)
时间窗: Following revaccination and throughout the study duration (approximately 24 months)
An NDCMC is defined as a disease or medical condition, not previously identified, that is expected to be persistent or otherwise long-lasting in its effects (eg, asthma).
SSC: Proportion of participants reporting NDCMC after revaccination (Year 4)
时间窗: Following revaccination and throughout the study duration (approximately 12 months)
An NDCMC is defined as a disease or medical condition, not previously identified, that is expected to be persistent or otherwise long-lasting in its effects (eg, asthma).
次要结局
- Efficacy Study: Number of first episode of RSV-associated severe LRTI (sLRTI-RSV) in the first RSV season(From Day 15 after vaccination until the end of season 1 visit (an average of 6 months))
- Efficacy Study: Number of first episode of LRTI-RSV in the second RSV season(During the second RSV season (an average of 6 months))
- Efficacy Study: Number of first episode of LRTI-RSV across 2 RSV seasons(From Day 15 after vaccination until the end of season 2 visit (an average of 12 months of surveillance))
- Efficacy Study: Number of first episode of RSV-associated ARI (ARI-RSV) in the first RSV season(From Day 15 after vaccination until the end of season 1 visit (an average of 6 months))
- Efficacy Study: Number of first episode of ARI-RSV in the second RSV season(During the second RSV season (an average of 6 months))
- Efficacy Study: Number of first episode of ARI-RSV across 2 RSV seasons(From Day 15 after vaccination until the end of season 2 visit (an average of 12 months of surveillance))
- Efficacy Study: Number of first episode of sLRTI-RSV in the second RSV season(During the second RSV season (an average of 6 months))
- Efficacy Study: Number of first episode of sLRTI-RSV across 2 RSV seasons(From Day 15 after vaccination until the end of season 2 visit (an average of 12 months of surveillance))
- Efficacy Study: Respiratory Syncytial Virus Subgroup A (RSV A) and RSV B neutralizing titers(Before vaccination, 1-month after vaccination, before season 2 (approximately 12 months after vaccination))
- SSA: Respiratory Syncytial Virus Subgroup A (RSV A) and RSV B neutralizing titers from participants who received placebo in SSA.(Before revaccination and 1, 6, 12 and 18-months after revaccination with placebo in SSA)
- SSB: Respiratory Syncytial Virus Subgroup A (RSV A) and RSV B neutralizing titers from participants who received placebo in SSB(Before revaccination and 1, 6, 12 and 18-months after revaccination with placebo in SSB)
- SSC: Respiratory Syncytial Virus Subgroup A (RSV A) and RSV B neutralizing titers from participants who received placebo in SSC.(Participants receiving placebo at the Year 3 vaccination: 1 month, 3 and 3.5 years after efficacy study vaccination)