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

Chinese trial (ph3,2v)_young.

Methods Phase II/III randomised, double‐blind, controlled trial
Participants Participants: 3819 women (3026 in the vaccine arm and 3025 in the placebo arm) enrolled at four sites in JiangSu Province
Age range: 18 to 25 years
Inclusion criteria: women were agreed to use contraceptive precautions 30 days before the 1st vaccine dose and 2 months after completion of the vaccine series
Exclusion criteria: women who were pregnant or breastfeeding, had an immunosuppressive or immunodeficient condition, a history of colposcopy, an allergic disease likely to be exacerbated by any component of the vaccine or previously received HPV vaccination or adjuvant were excluded
Interventions Vaccine: bivalent vaccine
Placebo: aluminium hydroxide placebo
Outcomes Efficacy (incident and persistent HPV infection, CIN), safety and immunogenicity outcomes
Notes Report: Zhu 2014.
Follow‐up of 15 months
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 an Internet‐based centralised randomisation system
Allocation concealment (selection bias) Low risk Treatment allocation at the investigation site were using an Internet‐based system
Blinding of participants and personnel (performance bias) 
 All outcomes Low risk All participants, investigators and study staff were blinded to individual participant treatment assignments and results
Blinding of outcome assessment (detection bias) 
 All outcomes Low risk All participants, investigators and study staff were blinded to individual participants treatment assignments and results
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