Table 2.
Summary of outcome definition for lower respiratory tract disease (LRTD). Note: RT-qPCR = real-time quantitative polymerase chain reaction; NAAT = nucleic acid amplification test (i.e., isothermal amplification tests). Likewise: nicking endonuclease amplification reaction, NEAR; transcription mediated amplification, TMA; loop-mediated isothermal amplification, LAMP; helicase-dependent amplification, HAD; clustered regularly interspaced short palindromic repeats, CRISPR; strand displacement amplification, SDA.
| Trial (Vaccine) | RSV Confirmation |
Endpoint | Characteristics |
|---|---|---|---|
|
NCT03982199 (Ad26.RSV.preF) |
RT-qPCR | 1 | VE against first episode of LRTD defined as 3 or more symptoms of LRTD |
| 2 | VE against first episode of LRTD defined as 2 or more symptoms of LRTD | ||
| 3 | VE against first episode of LRTD defined as 1 or more symptoms of LRTD + systemic symptoms | ||
|
NCT02508194 (MEDI7510) |
RT-qPCR | 1 | VE against first episode of ARI plus ≥ 1 symptoms from any 2 or 3 locations |
| 2 | VE against first episode of LRTD defined as 2 or more symptoms of LRTD | ||
|
NCT04886596 (RSVPreF3) |
RT-qPCR | VE against first episode of LRTD defined as at least 1 sign + 1 further sign or symptom of LRTD OR VE against first episode of LRTD defined as at least 3 signs OR symptoms of LRTD |
|
|
NCT05035212 (RSVpreF) |
RT-qPCR OR NAAT |
1 | VE against first episode of LRTD defined as at least 2 signs/symptoms of LRTD |
| 2 | VE against first episode of LRTD defined as at least 3 signs/symptoms of LRTD | ||
|
NCT04886596 (mRNA-1345) |
RT-qPCR | 1 | VE against first episode of LRTD defined as at least 2 signs/symptoms of LRTD |
| 2 | VE against first episode of LRTD defined as at least 3 signs/symptoms of LRTD |