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

Korean trial (ph3,2v).

Methods Phase III randomised, double‐blind, placebo‐controlled trial
Participants Participants: 321 females (160 in the vaccine arm and 161 in the placebo arm)
Age range: 10 to 14 years.
Inclusion criteria: include healthy Korean women who were using no other investigational products or immune‐modifying drugs, not pregnant or planning to become pregnant, not breastfeeding during the study. Use effective contraception or abstinent from sexual relations
Exclusion criteria: women who had received previous HPV vaccination
Interventions Vaccine: HPV16/18 bivalent vaccine
Placebo: hepatitis A vaccine
Outcomes Immunogenicity and safety outcomes
Notes Main report: Kim 2010;
Last report average follow‐up time: 7 months
Risk of bias
Bias Authors' judgement Support for judgement
Random sequence generation (selection bias) Low risk Participants were randomly allocated to two groups in a 1:1 ratio using an Internet‐based randomisation system
Allocation concealment (selection bias) Low risk Syringes were prepared and administered by qualified medical personnel not otherwise involved in the study
Blinding of participants and personnel (performance bias) 
 All outcomes Low risk See above
Blinding of outcome assessment (detection bias) 
 All outcomes Low risk The assessment of symptoms were conducted by personnel not involved in study
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