| Methods |
RCT |
| Participants |
Adults, Kaiser Permanente Health Plan, USA |
| Interventions |
12‐valent PPV (n = 6782) or saline placebo (n = 6818) |
| Outcomes |
A1. IPD
A2. Pneumonia (all causes)
A3. Mortality (all causes)
A5. Definitive pneumococcal pneumonia
A6. Definitive pneumococcal pneumonia (vaccine‐type)
A9. Mortality due to pneumonia |
| Notes |
Average follow‐up 2.5 years
Participants randomly allocated by colour codes |
| Risk of bias |
| Bias |
Authors' judgement |
Support for judgement |
| Random sequence generation (selection bias) |
Low risk |
Computer‐generated random sequence |
| Allocation concealment (selection bias) |
Low risk |
Participants randomly assigned by colour codes |
| Confounding
All outcomes |
Unclear risk |
NA |
| Blinding of participants and personnel (performance bias)
All outcomes |
Low risk |
"Contents of vials not known to person administering injection, nor to participants" |
| Blinding of outcome assessment (detection bias)
All outcomes |
Low risk |
As above |
| Incomplete outcome data (attrition bias)
All outcomes |
Unclear risk |
Participant withdrawals not described |
| Selective reporting (reporting bias) |
Low risk |
No evidence of selective outcome reporting |
