Table A4.
Summary of case definitions.
| Clinical Trial (Vaccine) | |||||
|---|---|---|---|---|---|
|
NCT03982199 (Ad26.RSV.preF) [82] |
NCT02508194 (MEDI7510) [83] |
NCT04886596 (RSVPreF3) [48,80,81] |
NCT05035212 (RSVpreF) [52,61] |
NCT04886596 (mRNA-1345) [51,85] |
|
| Signs/Symptoms | |||||
| Cough | Any | Any | New or increased |
New or increased |
Any |
| Shortness of breath | Any | Alternative with dyspnea | - | New or increased |
Any |
| Dyspnea | Alternative with decreased oxygen saturation |
Alternative with shortness of breath | New or increased | - | - |
| Decreased oxygen saturation | Alternative with dyspnea | - | Any | - | Any |
| Oxygen requirement | - | - | Any | - | - |
| Wheezing | Any | Any | Any | New or increased |
Any |
| Rales/Ronchi | Any | - | Alternative with crackles | - | Any |
| Crackles | - | - | Alternative with Rales/Ronchi | - | Any |
| Sputum production | Any | Any | New or increased | New or increased |
Any |
| Tachypnea | Any | - | Any | Any | Any |
| Headache | Any | ||||
| Myalgias or Arthralgias |
- | Any | Body aches | - | - |
| Malaise | Any | - | - | - | - |
| Fatigue | Any | Any | - | - | - |
| Fever (>37.8 °C) | Any | - | - | - | - |
| Feverishness | Any | Any | - | - | - |
| Pleuritic chest pain | - | - | - | - | Lasting ≥24 h |
| Radiologic evidence of pneumonia | - | - | - | - | Any |
| Case Definition | |||||
| Low Respiratory Tract Disease | Symptoms Shortness of breath Dyspnea or decreased oxygen saturation Cough Wheezing Rales and/or Rhonchi Sputum production Tachypnea Systemic symptoms Malaise Fatigue Fever 1 Feverishness 2 |
Symptoms Dyspnea or shortness of breath Cough Wheezing Sputum production Systemic symptoms Myalgias or arthralgias Body aches Fatigue (tiredness) Headache Decreased appetite Feverishness |
Symptoms Dyspnea (new or increased) Cough (new or increased) Sputum production (new or increased) Signs Wheezing (new or increased) Crackles and/or Rhonchi (new or increased) Tachypnea Decreased oxygen saturation Oxygen requirement |
Shortness of breath (new or increased) Cough (new or increased) Wheezing (new or increased) Sputum production (new or increased) Tachypnea |
Shortness of breath Cough Fever Wheezing Rales and/or Rhonchi Sputum production Tachypnea Hypoxemia Pleuritic chest pain ≥ 24 h Radiologic evidence of pneumonia |
1 = body temperature > 37.8 °C; 2 = feeling feverishness and having fever were considered 1 symptom.