Sex: F
Vaccine: HPV4
Symptoms: Exposure during pregnancy
Clinical narrative: Information has been received from a literature article, concerning a pregnant female who on an unknown date, was vaccinated with a dose of GARDASIL. On an unknown date, the patient had an elective termination. This report was part of a post-marketing surveillance program. The primary investigator felt that elective termination was not related to the study therapy. Upon internal review elective termination was considered to be an other important medical event. Follow-up information has been received from another published article on 02-MAR-2015. The observer-blind, randomized, age-stratified, head-to-head study (NCT00423046) comparing immunogenicity and safety of HPV-16/18 and HPV-6/11/16/18 vaccines in healthy women aged 18-45 years(y) old was completed. Five years after vaccination, in subjects from the Month 60 according -to-protocol cohort (seronegative and DNA negative for HPV type analyzed at baseline), serum neutralizing antibody (nAB) responses included by HPV-16/18 vaccine remained 7.8-fold (18-26-7 stratum) and 2.3-fold (36-45-y stratum) higher than those induced by H PV-6/11/16/18 vaccine for HPV-16. For HPV-18, the fold differences were 12.1, 13.0 and 7.8, respectively. At Month 60, all (100%) subjects in HPV-16/18 vaccine group and the majority (95.7%-97.5%) in HPV- 6/11/16/18 vaccine group were seropositive for HPV-16. For HPV-18, the majority (98.1%-100%) of subjects in HPV-16/18 vaccine group were seropositive; however, seropositivity rates in HPV-6/11/16/18 vaccine group decreased considerably (61.1%-76.9%) across the 3 age strata. In the total vaccinated cohort (received=1 dose regardless of baseline HPV serostatus and DNA status), geometric mean titers for anti-HPV-16 and anti HPV-18 nAB were higher in HPV-16/18 vaccine group than in HPV-6/11116/18 group. Based on the 5-y data, piece-wise and modified power-law models predicted a longer durability of nAB response for HPV-16/18 vaccine compared to HPV-6/11/16/18 vaccine. Beyond the differences apparent between the vaccines in terms of immunogenicity and modeled persistence of antibody responses, comparative studies including clinical endpoints would be needed to determine whether differences exist in duration of vaccine induced protection. Safety: From Month 0 to Month 60, the proportion of subjects reporting events in the HPV-16/18 and HPV-6/11/18 vaccine groups (TVC) were comparable: Serious adverse events (SAEs), 8% (n=44) in HPV-16/18 vaccine group and 6.7% (n=37) I HPV-6/11/16/18 vaccine group; medically significant conditions (MSCs), 46.8% (n=259) in HPV-16/18 vaccine group and 40.9% (n=226) in HPV-6/11116/18 vaccine group; and new onset chronic diseases (NOCDS), 7.1% (n=39) in HPV-16/18 vaccine group and 7.8% (n=43) in HPV-6/11/16/18 vaccine group; and new onset autoimmune diseases (NOADs), 1.3% (n=7) in HPV-16/18 vaccine group and 2.4% (n=13) in HPV-6/11/16/18 vaccine group. Two SAEs were considered to be possibly related to vaccination: one was a grand mal convulsion in a subject in the HPV-16/18 vaccine group and one was a spontaneous abortion in a subject in the HPV-6/11/16/18 vaccine group. A total of 172 pregnancies were reported up to Month 60, with similar outcomes between vaccine groups. There were 71.9% (n=69) and 73.7% (n=56) live infants, respectively, in the HPV-16/18 and HPV-6/11/16/18 vaccine groups, with no unanticipated anomalies or outcomes. Fifteen (15.6%) and 11 cases (14.5%) of spontaneous abortion with no apparent congenital anomaly were reported in the HPV-16/18 and HPV-6/11/16/18 vaccine groups, respectively. Six (6.3%) and 3 cases (3.9%) of elective termination with no apparent congenital anomaly were reported in the HPV-16/18 and HPV-6/11/18 vaccine groups, respectively. This report refers to a3 pregnancy patients who experienced elective termination with no apparent congenital anomaly. This is one of several reports from the same literature. A copy of the published article is attached as further documentation of the patient's experience. Additional information has been requested. Reporter, literature information, AD information and the narrative have been updated. This case has been downgraded. The serious adverse event "elective termination" was deleted.