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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
TRIPLE
Enrollment
38,861
St. Vincent's Birmingham (Pharmacy)
Birmingham, Alabama, United States
St. Vincent's Birmingham
Birmingham, Alabama, United States
Medical Affiliated Research Center
Huntsville, Alabama, United States
Lenzmeier Family Medicine / Avacare
Glendale, Arizona, United States
Phoenix Clinical LLC
Phoenix, Arizona, United States
Efficacy Study: Number of first episode of RSV-associated lower respiratory tract illness (LRTI-RSV) in the first RSV season
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.
Time frame: From Day 15 after vaccination until the end of season 1 visit (an average of 6 months)
Efficacy Study: Proportion of participants reporting prompted local reactions 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
Time frame: Within 7 days after vaccination
Efficacy Study: Proportion of participants reporting prompted systemic events 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.
Time frame: Within 7 days after vaccination
Efficacy Study: Proportion of participants reporting AE within 1-month after vaccination
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.
Time frame: Within 1 month after vaccination (up to 35 days)
Efficacy Study: Proportion of participants reporting SAE throughout the study
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.
Time frame: Throughout the study duration (an average of 30 months)
Efficacy Study: Proportion of participants reporting NDCMC throughout the study
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).
Time frame: Throughout the study duration (an average of 30 months)
SSA: Respiratory Syncytial Virus Subgroup A (RSV A) and RSV B neutralizing titers from participants who received 2-dose of RSVpreF
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.
Time frame: Before revaccination and 1, 6, 12 and 18-months after revaccination with RSVpreF in SSA
SSA: Proportion of participants reporting prompted local reactions 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
Time frame: Within 7 days after revaccination
SSA: 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.
Time frame: Within 7 days after revaccination
SSA: Proportion of participants reporting AE within 1-month after revaccination
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.
Time frame: Within 1 month after revaccination (up to 35 days)
SSA: Proportion of participants reporting SAE throughout the study
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.
Time frame: Throughout the study duration (approximately 18 months)
SSA: Proportion of participants reporting NDCMC throughout the study
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).
Time frame: Throughout the study duration (approximately 18 months)
SSB: Respiratory Syncytial Virus Subgroup A (RSV A) and RSV B neutralizing titers from participants who received 2-dose of RSVpreF
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.
Time frame: Before revaccination and 1, 6, 12 and 18-months after revaccination with RSVpreF in SSB
SSB: Proportion of participants reporting prompted local reactions 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.
Time frame: Within 7 days after revaccination
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.
Time frame: SSB: Proportion of participants reporting prompted systemic events within 7-days after revaccination
SSB: Proportion of participants reporting AE within 1-month after revaccination
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.
Time frame: Within 1 month after revaccination (up to 35 days)
SSB: Proportion of participants reporting SAE throughout the study
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.
Time frame: Throughout the study duration (approximately 18 months)
SSB: Proportion of participants reporting NDCMC throughout the study
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).
Time frame: Throughout the study duration (approximately 18 months)
SSC: Respiratory Syncytial Virus Subgroup A (RSV A) and RSV B neutralizing titers from participants who received RSVpreF or placebo 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.
Time frame: 1 month after revaccination in SSC (Year 3)
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)
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.
Time frame: At preseason 2 (preS2) after receiving the initial vaccination in the efficacy study and 1 month after revaccination in SSC (Year 3)
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)
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.
Time frame: 1 month after receiving the initial vaccination in the efficacy study and 1 month after revaccination in SSC (Year 3)
SSC: Respiratory Syncytial Virus Subgroup A (RSV A) and RSV B neutralizing titers from participants who received RSVpreF or placebo 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.
Time frame: 1 month after revaccination in SSC (Year 4)
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)
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.
Time frame: At preseason 2 (preS2) after receiving the initial vaccination in the efficacy study and 1 month after revaccination in SSC (Year 4)
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)
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.
Time frame: 1 month after receiving the initial vaccination in the efficacy study and 1 month after revaccination in SSC (Year 4)
SSC: Proportion of participants reporting prompted local reactions within 7-days after revaccination (Year 3)
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.
Time frame: Within 7 days after revaccination
SSC: Proportion of participants reporting prompted local reactions within 7-days after revaccination (Year 4)
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.
Time frame: Within 7 days after revaccination
SSC: Proportion of participants reporting prompted systemic events within 7-days after revaccination (Year 3)
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.
Time frame: Within 7 days after revaccination
SSC: Proportion of participants reporting prompted systemic events within 7-days after revaccination (Year 4)
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.
Time frame: Within 7 days after revaccination
SSC: Proportion of participants reporting AE within 1-month after revaccination (Year 3)
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.
Time frame: Within 1 month after revaccination (up to 35 days)
SSC: Proportion of participants reporting AE within 1-month after revaccination (Year 4)
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.
Time frame: Within 1 month after revaccination (up to 35 days)
SSC: Proportion of participants reporting SAE after revaccination (Year 3)
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.
Time frame: Following revaccination and throughout the study duration (approximately 24 months)
SSC: Proportion of participants reporting SAE after revaccination (Year 4)
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.
Time frame: Following revaccination and throughout the study duration (approximately 12 months)
SSC: Proportion of participants reporting NDCMC after revaccination (Year 3)
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).
Time frame: Following revaccination and throughout the study duration (approximately 24 months)
SSC: Proportion of participants reporting NDCMC after revaccination (Year 4)
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).
Time frame: Following revaccination and throughout the study duration (approximately 12 months)
Efficacy Study: Number of first episode of RSV-associated severe LRTI (sLRTI-RSV) in the first RSV season
Reverse Transcriptase-Polymerase Chain Reaction (RT-PCR)-confirmed RSV A and/or RSV B- associated acute respiratory illness (ARI) is assessed. sLRTI-RSV is defined as LRTI-RSV with at least 1 of the conditions: 1)Hospitalization due to LRTI-RSV; 2)New/increased oxygen supplementation; 3)New/increased mechanical ventilation
Time frame: 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
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.
Time frame: During the second RSV season (an average of 6 months)
Efficacy Study: Number of first episode of LRTI-RSV across 2 RSV seasons
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.
Time frame: 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
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Reverse Transcriptase-Polymerase Chain Reaction (RT-PCR)-confirmed RSV A and/or RSV B- associated acute respiratory illness (ARI) is assessed. ARI-RSV is defined as an ARI with at least 1 signs/symptoms lasting more than 1 day, plus RT-PCR-confirmed RSV infection within 7 days of ARI symptom onset.
Time frame: 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
Reverse Transcriptase-Polymerase Chain Reaction (RT-PCR)-confirmed RSV A and/or RSV B- associated acute respiratory illness (ARI) is assessed. ARI-RSV is defined as an ARI with at least 1 signs/symptoms lasting more than 1 day, plus RT-PCR-confirmed RSV infection within 7 days of ARI symptom onset.
Time frame: During the second RSV season (an average of 6 months)
Efficacy Study: Number of first episode of ARI-RSV across 2 RSV seasons
Reverse Transcriptase-Polymerase Chain Reaction (RT-PCR)-confirmed RSV A and/or RSV B- associated acute respiratory illness (ARI) is assessed. ARI-RSV is defined as an ARI with at least 1 signs/symptoms lasting more than 1 day, plus RT-PCR-confirmed RSV infection within 7 days of ARI symptom onset.
Time frame: 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
Reverse Transcriptase-Polymerase Chain Reaction (RT-PCR)-confirmed RSV A and/or RSV B- associated acute respiratory illness (ARI) is assessed. sLRTI-RSV is defined as LRTI-RSV with at least 1 of the conditions: 1)Hospitalization due to LRTI-RSV; 2)New/increased oxygen supplementation; 3)New/increased mechanical ventilation
Time frame: During the second RSV season (an average of 6 months)
Efficacy Study: Number of first episode of sLRTI-RSV across 2 RSV seasons
Reverse Transcriptase-Polymerase Chain Reaction (RT-PCR)-confirmed RSV A and/or RSV B- associated acute respiratory illness (ARI) is assessed. sLRTI-RSV is defined as LRTI-RSV with at least 1 of the conditions: 1)Hospitalization due to LRTI-RSV; 2)New/increased oxygen supplementation; 3)New/increased mechanical ventilation
Time frame: 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
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.
Time frame: 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.
RSV A and RSV B neutralizing titers (NT), expressed as Geometric Mean Titers (GMTs). 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.
Time frame: 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
RSV A and RSV B neutralizing titers (NT), expressed as Geometric Mean Titers (GMTs). 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.
Time frame: 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.
RSV A and RSV B neutralizing titers (NT), expressed as Geometric Mean Titers (GMTs). 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.
Time frame: Participants receiving placebo at the Year 3 vaccination: 1 month, 3 and 3.5 years after efficacy study vaccination