| Study characteristics |
| Methods |
Prospective cohort study conducted in Italy during the 2002 to 2003 influenza season, in the community. Data sources were self administered questionnaire and phone interviews. Follow‐up period went from enrolment to April 2003. Ambulatory patients were enrolled at random to undergo either adjuvant or subunit influenza vaccine plus antipneumococcal vaccine. A control group of unvaccinated patients was also enrolled. Only flu vaccinated were included in analysis. |
| Participants |
235 ambulatory patients (166 vaccinated with adjuvant vaccine, 69 controls; all included in analysis), 65 years or older |
| Interventions |
Adjuvant virosomal vaccine. Vaccine strains probably matched the circulating strain. |
| Outcomes |
Clinically defined ILI (fever 38 °C or more + at least 1 systemic symptom: headache, discomfort, myalgia, chills or sweating, weakness + at least 1 respiratory symptom: cough, sore throat, nasal congestion), hospitalisation for all respiratory diseases, all deaths. Acute respiratory infection was also defined. |
| Notes |
Vaccinated people had higher impairment. No information about flu activity; probably not epidemic year. |
| Risk of bias |
| Bias |
Authors' judgement |
Support for judgement |
| Allocation concealment (selection bias) |
Unclear risk |
B ‐ Unclear |
