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Report for Clinical Trial NCT03916185

Developed by Shray Alag, 2020.
SNP Clinical Trial Gene

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

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.

NCT03916185 Respiratory Syncytial Virus (RSV)
MeSH:Virus Diseases

4 Interventions

Name: RSV ΔNS2/Δ1313/I1314L Vaccine

Description: 10^6 plaque-forming units (PFU); administered as nose drops
Type: Biological
Group Labels: 1

RSV ΔNS2/Δ1313/I1314L Vaccine

Name: RSV 6120/ΔNS2/1030s Vaccine

Description: 10^5 plaque-forming units (PFU); administered as nose drops
Type: Biological
Group Labels: 1

RSV 6120/ΔNS2/1030s Vaccine

Name: RSV 276 Vaccine

Description: 10^5 plaque-forming units (PFU); administered as nose drops
Type: Biological
Group Labels: 1

RSV 276 Vaccine

Name: Placebo

Description: Administered as nose drops
Type: Biological
Group Labels: 1

Placebo


Primary Outcomes

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 28

Description: 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 28

Description: Serious adverse events are defined according to Version 2.0 of the DAIDS EAE Manual.

Measure: Frequency of serious AEs

Time: Measured through Day 56

Description: 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 56

Secondary Outcomes

Description: 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 56

Description: Determined from immunologic assays

Measure: Titer of serum RSV F IgG

Time: Measured at the Day 56 Visit

Description: Determined from immunologic assays

Measure: Titer of serum RSV-neutralizing antibodies

Time: Measured at the Day 56 Visit

Description: 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 study

Description: 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 study

Description: 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 study

Description: 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 study

Purpose: Prevention

Allocation: Randomized

Parallel Assignment


There is one SNP

SNPs


1 I1314L

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) Virus Diseases 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 ---



HPO Nodes