Treanor 1992.

Methods	Duration: 3 years Withdrawals: 8; 7 from intranasal group; deaths due to unrelated causes, discharges from institutions Follow‐up schedule: days 1 to 3 after each vaccination for adverse reactions and nasal sheddings; then daily staff nursing reports were used
Participants	Setting: 1987‐90, 3 large nursing homes in Rochester, NY, USA; St Ann's Home, St John's Home and Monroe Community Hospital Number: 523; 345 participant years in the intranasal group and 346 participant years in the control Characteristics: older adults; Mean age of 84.2 years. 32% had cardiac or pulmonary conditions; 75% female Baseline characteristics: Relatively well matched for disabilities, age, sex ratios. Mean age in the vaccine group was 84.1 years with 26% of participants randomised to this group suffering either a cardiac or pulmonary condition; 4% of the vaccine group had both a cardiac and pulmonary condition . Mean age in the placebo group was 83.8 years with 23% of participants in this group suffering either a cardiac or pulmonary condition; 2%of participants in this group had both a cardiac and pulmonary condition Comorbidities: only details of cardiovascular and pulmonary complications Diagnostic criteria: none; all residents at these institutions were invited Exclusion criteria: Acutely ill at time of enrolment On current immunosuppressant therapy Egg product allergy Refusal of inactivated influenza vaccination
Interventions	Vaccination type: Live attenuated, cold‐adapted, monovalent influenza virus vaccination (A/Bethseda/1/85 (H3N2), A/Los Angeles/2 /87 (H3N2), A/Ann Arbor/6/60) intranasally in 0.5 mL doses Inactivated, trivalent, subvirion influenza vaccine containing 9 different HAs intramuscular in 0.5 mL doses Control: Intranasal placebo of sterile veal infusion broth Trivalent inactivated subvirion influenza vaccine identical to treatment group
Outcomes	Early: days 1 to 3 post vaccination; adverse effects Late: years 1, 2, 3: serum antibody responses measured and occurrence of respiratory and flu‐like illnesses were measured to evaluate the efficacy of adding live intranasal vaccination to the inactivated type
Notes	Not specifically people with COPD
Risk of bias
Bias	Authors' judgement	Support for judgement
Random sequence generation (selection bias)	Unclear risk	Insufficient details on randomisation sequence provided. Re‐randomisation occurred every year
Allocation concealment (selection bias)	Unclear risk	Insufficient information to make determination
Blinding of participants and personnel (performance bias) All outcomes	Unclear risk	Insufficient detail provided, although it is stated that this study was double‐blind
Blinding of outcome assessment (detection bias) All outcomes	Unclear risk	See above
Incomplete outcome data (attrition bias) All outcomes	Low risk	A low number of dropouts reported per year, evenly across groups. Independent analysis each study year
Selective reporting (reporting bias)	Unclear risk	Insufficient information to make determination
Other bias	Unclear risk	Insufficient information to make determination