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. 2018 May 9;2018(5):CD009069. doi: 10.1002/14651858.CD009069.pub3

Indian trial (ph3,2v).

Methods Phase III, double‐blind, randomised, controlled and multicentre trial
Participants 354 women (176 in the vaccine arm and 178 in the placebo arm) from Hong Kong
Age range: women aged 18 to 35 years
Inclusion criteria: healthy women not taking any other investigational products or steroids and not pregnant or planning to become pregnant
Interventions Vaccine: HPV16/18 AS04‐adjuvant bivalent vaccine
Placebo: visually indistinguishable aluminium‐containing placebo
Outcomes Safety and immunogenicity
Notes Last report average follow‐up time: 7 months (Indian trial (ph3,2v))
Risk of bias
Bias Authors' judgement Support for judgement
Random sequence generation (selection bias) Low risk Women were randomised in a 1:1 ratio with SAS analysis system
Allocation concealment (selection bias) Low risk Throughout the study, a single treatment number was used to uniquely identify the vaccine doses to be given to the same participant
Blinding of participants and personnel (performance bias) 
 All outcomes Unclear risk Not described in the paper
Blinding of outcome assessment (detection bias) 
 All outcomes Unclear risk Not described in the paper
Incomplete outcome data (attrition bias) 
 All outcomes Low risk All outcomes (safety and immunogenicity) were reported on the total vaccinated cohort. Reason for exclusion was noted and balanced between vaccine group and placebo group
Selective reporting (reporting bias) Low risk All outcomes (safety and immunogenicity) were presented