ab Boyce 2000.

Methods	Open‐label/single‐blind randomised controlled trial to assess the safety and immunogenicity of adjuvanted and unadjuvanted subunit influenza vaccine, prepared with the strains recommended for and isolated in the 1997 to 1998 season.
Participants	74 healthy adults aged between 10 and 40 years, who did not receive influenza immunisation during the 6 months preceding the trial.
Interventions	M‐59 adjuvanted subunit trivalent flu vaccine (prepared with A/Bayern/795 H1N1, A/Wuhan/359/95 H3N2, B/Beijing/184/93‐like strains, each 15 µg/0.5 mL dose) Unadjuvanted vaccine (prepared with the same strains at the same concentrations as the adjuvanted preparation) Placebo (consisting of 0.5 mL sterile saline) All preparations were intranasally administered in 2 doses 28 days apart. 24 participants received their first dose of adjuvanted (n = 12) or unadjuvanted (n = 12) subunit vaccine in an open‐label manner. After it was determined that they tolerated the first dose, the randomised phase of the trial (n = 50) was begun. In this phase, 18 participants received 2 doses of unadjuvanted vaccine, 19 adjuvanted, and 13 placebo.
Outcomes	After each immunisation, participants were observed for 30 minutes, examined after 2 days, and then completed a diary card reporting symptoms that occurred within 7 days after. Local reactions: nasal symptoms, unpleasant taste, bloody nasal discharge, sneezing. Systemic reactions: chills, pulmonary, nausea, malaise, myalgia or arthralgia, urticarial rash, headache, oral temperature >= 38 °C, stay at home, use of analgesic or antipyretic. Data were not given separately for the randomised and open‐label phase of the study.
Notes	It was not possible to consider the safety data separately for the 2 study phases. Safety data only were extracted. Industry funded
Risk of bias
Bias	Authors' judgement	Support for judgement
Random sequence generation (selection bias)	Unclear risk	Unclear
Allocation concealment (selection bias)	Unclear risk	Unclear
Blinding (performance bias and detection bias) All outcomes	Unclear risk	Unclear
Incomplete outcome data (attrition bias) All outcomes	Unclear risk	Unclear
Summary assessment	Unclear risk	Unclear