Outcomes
co-infections, HPV infection, syphilis, HSV-2, chlamydia, gonorrhea
INFECTIOUS DISEASES, ALLERGY, PERSISTENT HPV INFECTION, HPV INFECTION, SYPHILIS, ADVERSE EVENT, TRICHOMONIASIS, GONORRHEA
The primary trial end point was incident-persistent cervical vaccine type-specific HPV infection among participants who were vaccine-type HPV naive at enrollment. Persistent HPV infection, a surrogate marker for cervical dysplasia/precancer, was defined as high-risk vaccine-type-specific HPV (HPV 16/18 for the bivalent vaccine and HPV 16/18/31/33/45/52/58 for the nonavalent vaccine) detected at two consecutive visits after the month 3 visit, which were obtained no less than 4 months apart (with the same HPV type at both time points). Cervical swabs were tested for the primary end point; vaginal swabs were substituted if necessary. This analysis included follow-up through month 36 to evaluate the durability of VE.Secondary analyses assessed VE in the sensitivity cohorts and subgroup analyses. The prespecified subgroups were the presence of co-infections (chlamydia, gonorrhea, HSV-2, trichomoniasis, syphilis and BV), self-reported condom use, number of self-reported lifetime sexual partners (1 versus 2+) and contraception method use.Safety was assessed through adverse event reporting following Division of Allergy and Infectious Diseases Guidelines