Clinical Trial Search

Primary: Incidence Rates of First Episode of Respiratory Syncytial Virus (RSV) Respiratory Tract Infection (RTI) [Period 1] — 7.93 Cases per 100 person-years

Primary: Time for Viral Load to Drop Below Assay Quantification Limit (BQL) (Plaque Assay Analysis) — 46.1; 14.2; 5.1; 5.1 hours — p=<0.001

Primary: Percentage of Participants With Progression to Lower Respiratory Tract Infection (LRI) — 8; 30; 10 percentage of participants

Primary: Time-weighted Average Change in Nasal Respiratory Syncytial Viral (RSV) Load From Baseline to Day 9 — -1.00; -0.97 log10 copies/mL — p=0.94

Primary: Circulating RI-001 Titer — 9.24; 4.85; 1.42 Fold Change

Primary: Percentage of Participants With Asthma at 6 Years of Age: Overall and by Prognostic Factor — 6.1; 11.2; 3.1; 9.6 percentage of participants

Primary: Time-Weighted Average Change in Viral Load From Day 1/Baseline Through Day 7 in Participants in the Full Analysis Set — -0.73; -0.90 log10 copies/mL — p=0.72

Primary: Number of Hospital Admissions by Respiratory Syncytial Virus Infection — 2 participants

Primary: Number of Participants With Treatment-related Adverse Events as Assessed by CTCAE v4.0 — 0; 0; 0 participants

Primary: Host Response to RSV Challenge Measured as Change From Baseline of Chemical Mediators in Nasal Fluid — 23 Participants

Primary: Frequency of Grade 1 or Higher Solicited Adverse Events (AEs) by Grade — 14; 7; 27; 11 Participants

Primary: Respiratory Syncytial Virus (RSV) Viral Load-time Curve From Immediately Prior to First Dose of JNJ-53718678 Through Day 5 (AUC [Day 1-5]) — 26.13; 25.10 log10…

Primary: Occurrences of Pneumonia — 4; 3 Participants

Primary: Time-Weighted Average Change in Nasal Respiratory Syncytial Virus (RSV ) Viral Load From Baseline (Day 1) to Day 9 — -1.26; -0.91 log10 copies/mL — p=0.040

Primary: IL-8 Concentrations — 12,795; 14,676 Pg/ml — p=0.6

Primary: Characterization of Participants With Risk Factors for Respiratory Syncytial Virus (RSV) Infection — 134; 449; 46; 160 participants

Primary: Frequency of Adverse Events — 41 participants

Primary: Safety and Tolerability of MEDI8897 as Assessed by the Occurrence of All Treatment Emergent Adverse Events (TEAEs) and Treatment Emergent Serious Adverse Events (TESAEs)…

Primary: Time-Weighted Average Change in Respiratory Syncytial Viral (RSV) Load From Baseline to Day 5 — -0.77; -0.89 log10 copies/mL — p=0.46

Primary: Number of Participants With Solicited Adverse Events (AEs) by Grade - (RSV-seropositive Participants) — 8; 5; 0; 0 Participants

Primary: Number of Participants With Solicited Adverse Events (AEs) by Grade — 17; 9; 3; 1 Participants

Primary: Number of Participants With Solicited Adverse Events (AEs) by Grade (RSV-seropositive Participants) — 10; 9; 4; 0 Participants

Primary: Number of Participants With Solicited Adverse Events (AEs) by Grade — 16; 10; 0; 0 Participants

Primary: Percentage of Placebo Receiving Pediatric Participants With Vaccine Virus Detected in Nasal Swabs After the First Vaccination — 0; 0; 0; 0 percentage of participants

Primary: Respiratory Syncytial Virus (RSV) Load in the Upper Respiratory Tract as Measured by Quantitative Real Time Reverse Transcriptase Polymerase Chain Reaction (RT-PCR) at…

Primary: Area Under the Curve (AUC) for RSV-A Memphis 37b Viral Load Determined by Quantitative Real Time Reverse Transcription Polymerase Chain Reaction (qRT-PCR) — 350.99…

Primary: Lung Function — 0.071; -3.179; 0.186; -3.345 Z score — p=0.0020

Primary: Number of Maternal Subjects With Pregnancy Outcomes — 2088; 18; 8; 5 Participants

Primary: Number of Participants With First Occurrence of Reverse Transcriptase Polymerase Chain Reaction (RT-PCR)-Confirmed Respiratory Syncytial Virus (RSV) Mediated Lower…

Primary: Number of Participants With Adverse Events — 99 Participants