aa Brooks 2016.

Methods	Randomised, placebo‐controlled trial
Participants	Healthy children aged 2 to 4 years
Interventions	Trivalent live attenuated influenza vaccine containing antigens the 2 A strains and 1 B strain recommended by WHO in 2012 the Northern Hemisphere. 0.5 mL nasal spray administration. Placebo was vaccine vehicle without virus component (not better described). Same route of admnistration. Vaccine batch numbers: vaccine: 167E200; placebo: E9001PCB
Outcomes	Symptomatic influenza cases laboratory confirmed by reverse transcription PCR. Mild, moderate, or severe adverse events recorded for 7 days after vaccination.
Funding Source	Gates Foundation
Notes	Immunisation took place between 27 February and 9 April 2013; influenza viruses circulated within study area between February and November 2013. "The per‐protocol analysis set included all children who met the inclusion criteria, were randomised, and received one dose of study vaccine or placebo, and who remained in the study area for at least 8 days after vaccination." This corresponds to the ITT population.
Risk of bias
Bias	Authors' judgement	Support for judgement
Random sequence generation (selection bias)	Low risk	“The random allocation sequence was computer generated by PATH staff not involved with the trial, using a ratio for LAIV and placebo of 2:1 and block sizes of three.”
Allocation concealment (selection bias)	Low risk	The sequence was delivered to the Serum Institute of India, Pune, India, where it was used to label the vaccine and placebo syringes, which were identical in appearance except for the allocation numbers.
Blinding (performance bias and detection bias) All outcomes	Low risk	Vaccine and placebo syringes were identical in appearance except for the allocation numbers.
Incomplete outcome data (attrition bias) All outcomes	Low risk	93 out of 1174 vaccinated (7.9%) and 31 out of 587 placebo recipients (5.3%) were excluded or lost from efficacy/effectiveness follow‐up.
Summary assessments	Low risk