The purpose of this study is to evaluate the safety and immunogenicity of a single dose of the recombinant live-attenuated respiratory syncytial virus (RSV) vaccines, RSV ΔNS2/Δ1313/I1314L, RSV 6120/ΔNS2/1030s, and RSV 276, in RSV-seronegative children 6 to 24 months of age.
Name: RSV ΔNS2/Δ1313/I1314L Vaccine
Description: 10^6 plaque-forming units (PFU); administered as nose dropsType: BiologicalRSV ΔNS2/Δ1313/I1314L Vaccine
Name: RSV 6120/ΔNS2/1030s Vaccine
Description: 10^5 plaque-forming units (PFU); administered as nose dropsType: BiologicalRSV 6120/ΔNS2/1030s Vaccine
Name: RSV 276 Vaccine
Description: 10^5 plaque-forming units (PFU); administered as nose dropsType: BiologicalRSV 276 Vaccine
Name: Placebo
Description: Administered as nose dropsType: BiologicalPlacebo
Description: Solicited adverse events include fever; otitis media; upper respiratory illness (URI); lower respiratory illness (LRI) and are graded following a protocol-defined grading system for solicited events.
Measure: Frequency of Grade 1 or higher solicited adverse events (AEs) Time: Measured through Day 28Description: Graded following a protocol-defined grading system for solicited events
Measure: Frequency of Grade 2 or higher lower respiratory illnesses (LRIs) Time: Measured through Day 28Description: Serious adverse events are defined according to Version 2.0 of the DAIDS EAE Manual.
Measure: Frequency of serious AEs Time: Measured through Day 56Description: Determined from immunologic assays
Measure: Frequency of a greater than or equal to 4-fold rise in serum RSV-neutralizing antibody titer Time: Measured through Day 56Description: Determined from immunologic assays
Measure: Frequency of a greater than or equal to 4-fold rise in serum RSV F immunoglobulin G (IgG) Time: Measured through Day 56Description: Determined from immunologic assays
Measure: Titer of serum RSV F IgG Time: Measured at the Day 56 VisitDescription: Determined from immunologic assays
Measure: Titer of serum RSV-neutralizing antibodies Time: Measured at the Day 56 VisitDescription: Graded following a protocol-defined grading system for solicited events
Measure: Frequency of RSV-associated medically attended acute respiratory illness (RSV-MAARI) Time: Measured through the last day of the RSV season, which will occur between 5 and 12 months after study entry, depending on when the participant enrolls in the studyDescription: Graded following a protocol-defined grading system for solicited events
Measure: Maximum grade (if more than one illness within a participant) of RSV-MAARI Time: Measured through the last day of the RSV season, which will occur between 5 and 12 months after study entry, depending on when the participant enrolls in the studyDescription: Graded following a protocol-defined grading system for solicited events
Measure: Frequency of RSV-associated medically attended acute lower respiratory illness (RSV-MAALRI) Time: Measured through the last day of the RSV season, which will occur between 5 and 12 months after study entry, depending on when the participant enrolls in the studyDescription: Graded following a protocol-defined grading system for solicited events
Measure: Maximum grade (if more than one illness within a participant) of RSV-MAALRI Time: Measured through the last day of the RSV season, which will occur between 5 and 12 months after study entry, depending on when the participant enrolls in the studyAllocation: Randomized
Parallel Assignment
There is one SNP
Randomized Phase I/II Study of the Safety and Immunogenicity of a Single Dose of the Recombinant Live-Attenuated Respiratory Syncytial Virus (RSV) Vaccines RSV ΔNS2/Δ1313/I1314L, RSV 6120/ΔNS2/1030s, RSV 276 or Placebo, Delivered as Nose Drops to RSV-Seronegative Children 6 to 24 Months of Age. --- I1314L ---
Safety and Immunogenicity of a Single Dose of the Recombinant Live-Attenuated Respiratory Syncytial Virus (RSV) Vaccines RSV ΔNS2/Δ1313/I1314L, RSV 6120/ΔNS2/1030s, RSV 276 or Placebo, Delivered as Nose Drops to RSV-Seronegative Children 6 to 24 Months of Age The purpose of this study is to evaluate the safety and immunogenicity of a single dose of the recombinant live-attenuated respiratory syncytial virus (RSV) vaccines, RSV ΔNS2/Δ1313/I1314L, RSV 6120/ΔNS2/1030s, and RSV 276, in RSV-seronegative children 6 to 24 months of age. --- I1314L ---
Safety and Immunogenicity of a Single Dose of the Recombinant Live-Attenuated Respiratory Syncytial Virus (RSV) Vaccines RSV ΔNS2/Δ1313/I1314L, RSV 6120/ΔNS2/1030s, RSV 276 or Placebo, Delivered as Nose Drops to RSV-Seronegative Children 6 to 24 Months of Age The purpose of this study is to evaluate the safety and immunogenicity of a single dose of the recombinant live-attenuated respiratory syncytial virus (RSV) vaccines, RSV ΔNS2/Δ1313/I1314L, RSV 6120/ΔNS2/1030s, and RSV 276, in RSV-seronegative children 6 to 24 months of age. --- I1314L --- --- I1314L ---
Respiratory Syncytial Virus (RSV) This study will evaluate the safety and immunogenicity of a single dose of the recombinant live-attenuated respiratory syncytial virus (RSV) vaccines, RSV ΔNS2/Δ1313/I1314L, RSV 6120/ΔNS2/1030s, and RSV 276, in RSV-seronegative children 6 to 24 months of age. --- I1314L ---
Participants will be randomly assigned to receive a single dose of RSV ΔNS2/Δ1313/I1314L vaccine, RSV 6120/ΔNS2/1030s vaccine, RSV 276 vaccine, or placebo intranasally at study entry. --- I1314L ---