PATRICIA trial (ph3,2v).

Methods	Phase III randomised, double‐blind, controlled trial
Participants	18,644 women (9319 in the vaccine arm and 9325 in the placebo arm) enrolled for the study from 135 centres in 14 countries in Asia, Pacific, Europe, Latin America and North America Age range: 15 to 25 years Inclusion criteria: women who reported no more than six lifetime sexual partners before study enrolment, agreed to using adequate contraception over the vaccination period, and had an intact cervix were eligible. Enrolled irrespective of their HPV DNA status, HPV serostatus or cytology at baseline Exclusion criteria: women were excluded if they had a history of colposcopy, were pregnant or breastfeeding, or had chronic or autoimmune disease or immunodeficiency
Interventions	Vaccine: HPV16/18 AS04‐adjuvant bivalent vaccine Placebo: Hepatitis A vaccine‐licensed Havrix vaccine
Outcomes	Safety, immunogenicity, efficacy (incident infection, persistent infection, CIN1+, CIN2+, CIN3+, AIS associated with HPV16, HPV18, HPV16/18, other oncogenic HPV types, irrespective of HPV DNA) and cross‐protection
Notes	Main reports: Paavonen 2007; Paavonen 2009; Szarewski 2011 and Lehtinen 2012. Last report average follow‐up time: 34.9 months (Lehtinen 2012)
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	Allocation of treatment numbers was stratified by study site and by age.The trial remained double‐blinded until all individuals had completed 48 months of follow‐up after the first immunisation
Blinding of participants and personnel (performance bias) All outcomes	Low risk	Enrolled women and study investigators were masked to allocated vaccine
Blinding of outcome assessment (detection bias) All outcomes	Low risk	All CIN cases were reviewed by a panel of three pathologists who were blinded to vaccine allocation. Analysis was done by an independent statistician to maintain the trial blinding
Incomplete outcome data (attrition bias) All outcomes	Low risk	Outcomes are assessed in the PP cohort (received 3 doses, seronegative and DNA negative for the corresponding vaccine type at month 0, normal or low‐grade cytology at month 0, no protocol violations) and in the TVC‐naive cohort (at least one vaccine dose, at baseline normal cytology, DNA negative for hrHPV, seronegative for HPV‐16 and HPV‐18) and in the total vaccinated cohort (all women randomised). Reasons for exclusion were presented
Selective reporting (reporting bias)	Low risk	All outcomes (safety, immunogenicity, efficacy and cross‐protection) are presented