Study	HPV DNA detection methods	HPV serology method	Definition of per‐protocol population	Definition of intention‐to‐ treat population
Phase2 trial (ph2,1v)	PCR targeting L1, E6 and E7 genes of HPV16.	Competitive radioimmunoassay(cLIA) to detect HPV16 antibodies (Merck Research Laboratories). Cut‐off for sero+ 5.9 mMU/mL At enrolment also an ELISA test was used. At M 7,12,18, 30, 42.	Women who had 3 doses. Seronegative for HPV‐16 and negative for HPV‐16 DNA at day 0, and HPV‐16 DNA negative at M 7. No sexual intercourse within 48 hours before day 0 and M 7 visit. No other non‐study vaccine, no other drugs or involved in other studies.	Efficacy analysis including women with general protocol violations: had 3 doses, seronegative for HPV16 and negative for HPV16 DNA on day 0 and negative for HPV16 DNA at M 7 and in any biopsy specimens obtained between day 0 and M 7.
Japanese trial (ph2,2v)	SPF10 PCR (HPV LiPA‐version 1), to identify 14 hrHPV types (16, 18, 31, 33, 35, 39, 45, 51,52, 56, 58, 59, 66, 68). If sample negative for HPV16 or 18, type‐specific PCR for HPV16 or 18 was performed.	/	Meet eligibility criteria, complied with protocol procedures, received 3 doses and were DNA negative of corresponding HPV types at M 0 and 6, had efficacy endpoints measures available, had no or low‐grade cytological abnormality at M0, and were seronegative for the corresponding HPV type at M 0.	/
Phase2 trial (ph2,2v)	PCR SPF10 primers Typing with DNA immunoenzyme assay (LiPA [Innogenetics, Gent] If LiPA+: type specific PCR: HPV16 (E6/7), HPV18 (L1)	ELISA test using HPV16 & HPV18 VLP as antigen.	Women who have received the 3 scheduled doses and complied with the protocol and were not excluded. ‐ evaluation of safety: 540 versus 541 ‐ evaluation of efficacy: 366 versus 355 (initially seropositive, HPV DNA positive & cytologically positive women are excluded) ‐ evaluation of immunogenicity: 384 vs 344: women with serology results at months 0, 7 and 18, who received all 3 doses, and did not become positive for HPV16/18 DNA during administration period.	Women who had received at least one dose of study vaccine or placebo in the initial efficacy study, and who had any data available for outcome measurement in the extended follow‐up phase. For efficacy study, women who were HPV DNA negative for the specific HPV type at month 0 in the initial study also included.
African_2 country trial (ph3,2v)	/	ELISA	ATP for immunogenicity, which included evaluable participants meeting all eligibility criteria, complying with the procedures and intervals defined in the protocol (including receipt of the scheduled number of doses), with no elimination criteria during the trial, for whom immunogenicity data were available.	TVC included all participants with at least one vaccine/placebo dose administration documented.
Chinese trial (ph3,2v)_young	PCR SPF10‐DEIA‐LiPA25 version 1 test for HPV16,18, 31, 33, 35, 39, 45, 51, 52, 56, 58, 59, 66 and 68.	ELISA	ATP‐E included women who were seronegative at M 0 and DNA negative at M 0 and 6, received all 3 doses and had normal or low‐grade cytology at baseline.	TVC‐E included all vaccinated women for whom efficacy data were available and who had normal or low‐grade cytology at baseline. Included women were seronegative at M 0 and HPV negative at M 0 and 6.
Chinese trial (ph3,2v)_ adolescent	/	ELISA	ATP for immunogenicity included women who met eligibility criteria and were seronegative at M 0.	TVC included all participants with at least one vaccine/placebo dose administration documented.
Chinese trial (ph3,2v)_mid‐adult	/	ELISA	ATP for immunogenicity included women who met eligibility criteria and were seronegative at M 0.	TVC included all participants with at least one vaccine/placebo dose administration documented.
Co‐vaccination_dTpa_IPV trial (ph3,2v)	/	ELISA	ATP for immunogenicity included women who met eligibility criteria and were seronegative at M 0.	TVC included all participants with at least one vaccine/placebo dose administration documented.
Co‐vaccination_HAB trial (Ph3, 2v)	/	ELISA	ATP for immunogenicity included women who met eligibility criteria and were seronegative at M 0.	TVC included all participants with at least one vaccine/placebo dose administration documented.
Co‐vaccination_HepB trial (ph3, 2v)	/	ELISA	ATP for immunogenicity included women who met eligibility criteria and were seronegative at M 0.	TVC included all participants with at least one vaccine/placebo dose administration documented.
CVT (ph3,2v)	Broad‐spectrum PCR‐based HPV DNA test, use SPF10 (HPV‐LiPA‐version 1) to ensure HPV16 and HPV18 infections detection.	ELISA used for the detection and quantification of IgG antibodies against HPV16 and 18 separately.	ATP: no protocol violations, received all 3 doses within protocol‐defined period, had no biopsy/treatment before the 6‐month visit, and were HPV DNA‐negative by PCR for the corresponding HPV type at enrolment and the 6‐month visit.	ITT: All randomised women, regardless of compliance or enrolment infection.
Hong Kong trial (ph3,2v)	/	ELISA with cut‐off 8 EL.U/mL for HPV16 and 7 EL.U/mL for HPV 18.	ATP included participants who met eligibility criteria, complied with protocol‐defined procedures, and for whom post‐vaccination assay results were available for antibodies against at least one study vaccine antigen.	TVC included participants who received at least one dose of the vaccine.
Immunobridging(ph3,2v)	/	ELISA	ATP:included participants who met all eligibility criteria, complied with study procedures,and had data available for antibodies against at least 1 antigen component of the bivalent vaccine.	All participants who completed the study without considering protocol violation.
Indian trial (ph3,2v)	/	ELISA with cut‐off 8 EL.U/mL for HPV16 and 7 EL.U/mL for HPV 18.	ATP included all subjects meeting eligibility criteria, complying with the procedures defined in the protocol and for whom assay results were available fro antibodies against at least one study vaccine antigen component after vaccination.	TVC included all subjects with at least one vaccine/placebo dose administration documented.
Korean trial (ph3,2v)	/	ELISA	ATP cohort including all participants meeting eligibility criteria, complying with the procedures defined in the protocol, and for whom assay results were available for antibodies against at least one study antigen component after vaccination.	TVC included all participants with at least one vaccine/placebo dose administration documented.
Korean trial (ph3b,2v)	/	ELISA	ATP: included all eligible participants (those meeting all eligibility criteria, complying with protocol defined procedures, without elimination criteria during the study) for whom immunogenicity data were available.	With at least one dose of vaccine administrated
Malaysian trial (ph3,2v)	/	ELISA with cut‐off 8 EL.U/mL for HPV16 and 7 EL.U/mL for HPV18.	ATP: all evaluable participants (those meeting all eligibility criteria, complying with protocol defined procedures, without elimination code during the study) for whom immunogenicity data were available.	TVC: all participants with at least one documented vaccine dose administration.
PATRICIA trial (ph3,2v)	SPF10 PCR (HPV LiPA‐version 1), to identify 14 hrHPV types (16,18, 31, 33, 35, 39, 45, 51, 52, 56, 58, 59, 66, 68). If multiple infection, causality was attributed to the type also present in a previous cervical sample.	Serology HPV16/18 (ELISA) at M 0,7, 24 for all and at M 6, 12, 36, 48 at selected sites.	ATP‐Efficacy: no protocol violations, received 3 doses, NILM, ASC‐US or LSIL at baseline, evaluable for efficacy, case counting after the 3rd dose; ATP‐Immunogenicity cohort: no protocol violations, received 3 doses, included in sites for study of immunogenicity.	TVC: at least 1 dose received, baseline HPV/cyto exam and at least 1 FU examination (all HPV/cyto+ at baseline included). TVC‐E: idem but HSIL and unknown cyto at baseline excluded. TVC‐N: idem as TVC, but baseline NILM, hrHPV DNA‐ (14 types, M 0 & M 7?) and sero‐ for HPV16/18 (M 0).
VIVIANE trial (ph3,2v)	Broad‐spectrum PCR SPF10‐DEIA‐LiPA test for HPV16, 18 ,31 ,33, 35, 39, 45, 51, 52, 56, 58, 59, 66 and 68/73. Oncogenic HPV‐positive women were tested by multiplex type‐specific PCR and reverse hybridisation assay (MPTS12) to detect HPV16,18, 31,33, 35, 45, 52, 58,and 59.	ELISA used to detect antibody response against HPV16 and 18 at 6M intervals up to 24M and at 12M intervals thereafter.	ATP‐E: no protocol violations, received all 3 doses, data for efficacy endpoints available (baseline PCR or cytology sample and one further sample available); negative or low‐grade cytology at M 0, no history of HPV disease; counting of events after 3rd dose.	TVC: at least 1 dose; data available for efficacy endpoints; HSIL excluded; include participants of women with history of HPV disease (15%); case counting after first dose; Endpoint assessed irrespective of baseline HPV DNA or serostatus; TVC‐E: all the same except that endpoint assessed in women DNA negative and seronegative for corresponding HPV type at month 0.
Japanese trial (ph2,4v)	/	Competitive immunoassay (cLIA, Luminex Crp, Austin,TX,US)	Per‐protocol: women who were naive for the relevant HPV type at enrolment, remained free of infection with the same vaccine HPV type through completion of the vaccination regimen, had 3 doses, no protocol violations. Cases counting start form M 7.	/
Korean trial (ph2,4v)	/	Competitive immunoassay (cLIA, Luminex Crp, Austin,TX,US	Per‐protocol: received all 3‐doses, meet all the eligibility of inclusion, complying with all the protocol procedures	With at least one dose of vaccine administrated
Phase2 trial (ph2,4v)	Type specific PCR for HPV6/11/ 16/18. HC2 triage for ASCUS cases.	Competitive immunoassay (cLIA, Luminex Crp, Austin,TX,US)	Naïve for relevant HPV types at enrolment, still free of infection with HPV types 1 month after completion of vaccination regimen of 3 doses within 1 year, who did not violate protocol (N = 431 for HPV6/11, 404 for HPV16, 456 for HPV18). Cases are counted from M 7.	Naïve to the relevant HPV type (S) at enrolment and had received at least one dose. Protocol violators were included.
African_3 country trial (ph3,4v)	/	Competitive immunoassay (cLIA, Luminex Crp, Austin,TX,US)	ATP for immunogenicity included women who met eligibility criteria and were seronegative at M 0.	TVC included all participants with at least one vaccine/placebo dose administration documented.
FUTURE I trial (ph3,4v)	Type specific PCR for HPV6/11/ 16/18.	Competitive immunoassay (cLIA, Luminex Crp, Austin,TX,US)	Per‐protocol: received all 3 doses within 12M, seronegative and HPV DNA negative for vaccine type from day 1 till 1 month after the 3rd does, remained HPV negative; no protocol violations, include even the first day cytology were abnormal	ITT: included even if they had infection or disease associated with vaccine type before vaccination; protocol violations were present; or results on cervical cytological examination at day 1 were abnormal.
FUTURE II trial (ph3,4v)	Type specific PCR for HPV6/11/ 16/18.	Competitive immunoassay (cLIA, Luminex Crp, Austin,TX,US)	Per‐protocol: received all 3 doses within 12 M, seronegative and HPV DNA negative for vaccine type understudy from day1 till M 7. Have 1 or more follow‐up visit S after M 7. No protocol violations.	/
FUTURE III trial (ph3,4v)	Type specific multiplex PCR for HPV6/11/ 16/18 targeting L1,E6,E7 genes.	Competitive immunoassay (cLIA, Luminex Crp, Austin,TX,US) at month 0,7, 12, 24, 36, 48.	Seronegative for relevant type at day 1, PCR negative for that type in cervicovaginal samples at day 0 and M 7; all 3 doses received within 1 year with 1 or more follow‐up visits after 7 M.	Women who received at least one dose of vaccine or placebo and had one or more follow‐up visits after day 1. Both protocol violators and those with pre‐existing HPV infections were included in ITT analyses. Cases were counted starting at day 1.