Volume 16, Issue 7, Pages (July 2015)

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Volume 16, Issue 7, Pages 775-786 (July 2015) Efficacy of fewer than three doses of an HPV-16/18 AS04-adjuvanted vaccine: combined analysis of data from the Costa Rica Vaccine and PATRICIA trials Dr Aimée R Kreimer, PhD, Frank Struyf, MD, Maria Rowena Del Rosario-Raymundo, MD, Prof Allan Hildesheim, PhD, S Rachel Skinner, PhD, Prof Sholom Wacholder, PhD, Prof Suzanne M Garland, PhD, Rolando Herrero, PhD, Marie-Pierre David, MSc, Dr Prof Cosette M Wheeler, PhD The Lancet Oncology Volume 16, Issue 7, Pages 775-786 (July 2015) DOI: 10.1016/S1470-2045(15)00047-9 Copyright © 2015 Elsevier Ltd Terms and Conditions

Figure 1 Trial profile for the Costa Rica Vaccine Trial (CVT) and PATRICIA trial combined Women who were randomly assigned into both trials were stratified by vaccine group and number of doses received.*Women were excluded if they had less than 12 months' follow-up (time total vaccinated cohort, T-TVC). †Women were additionally excluded if their enrolment cervical status was HPV-16 and HPV-18 DNA-positive (or missing) or if they had fewer than 300 days between first and last PCR result; modified total vaccinated cohort (M-TVC) for assessment of HPV-16/18-related endpoints. ‡Women were further excluded from the total vaccinated naive cohort (TVC-naive) if their cervical status at enrolment was HPV DNA-positive for any oncogenic type (or missing), or HPV-16 or HPV-18 seropositive (or missing), or had enrolment cytology abnormal (or missing). The Lancet Oncology 2015 16, 775-786DOI: (10.1016/S1470-2045(15)00047-9) Copyright © 2015 Elsevier Ltd Terms and Conditions

Figure 2 Vaccine efficacy by study (CVT and PATRICIA) for multiple endpoints in the modified total vaccinated cohort, by dose in the modified total vaccinated cohort for one dose (A), two doses (B), or three doses (C) CVT=Costa Rica Vaccine Trial. The Lancet Oncology 2015 16, 775-786DOI: (10.1016/S1470-2045(15)00047-9) Copyright © 2015 Elsevier Ltd Terms and Conditions

Figure 3 Vaccine efficacy for individual HPV types by dose, for incident HPV infections that were detected one time (A), that persisted for more than 6 months (B), and that persisted for more than 12 months (C) in the modified total vaccinated cohort The Lancet Oncology 2015 16, 775-786DOI: (10.1016/S1470-2045(15)00047-9) Copyright © 2015 Elsevier Ltd Terms and Conditions