An Extended Follow-Up Study of the HPV Vaccine Delayed Booster Trial
An Extended Follow-Up Study of the HPV Vaccine Delayed Booster Trial
This is an extended follow-up study to follow-up study participants who received 1 booster
 dose of Gardasil 9 in the "HPV vaccine delayed booster trial." This was a prospective,
 single-arm, open-label, non-randomized, phase IIa trial among 9-11 year-old girls and boys to
 determine the immunogenicity after a single dose of the nonavalent HPV vaccine (Gardasil 9)
 over 24 months, with a delayed booster dose at 24 months and an optional booster at 30 months
 after the first dose. Participants provided blood specimens at 6, 12, 18, 24, and 30 months
 after the first dose. Serologic geometric mean titers (GMT) of the nine vaccine types (HPV
 16/18/ 6/11/31/33/45/52/58) were measured at each time point. One hundred and thirty-three
 (133) participants received one booster dose at month 24 and elected not to receive the
 second booster at month 30.

 For this follow-up study, we anticipate that we will be able to accrue 120 participants from
 the original study who received just one booster dose. Participants who received one booster
 dose of Gardasil 9 will be contacted to return to the clinic to provide blood specimens at 48
 (±3), 60 (±3), and 72 (±3) months after the priming dose. Serologic geometric mean titers
 (GMT) of the nine vaccine types (HPV 16/18/ 6/11/31/33/45/52/58) will be measured at each
 time point.
Inclusion Criteria:

 -  Study participants who received one booster dose of Gardasil 9 at month 24 and elected
 not to receive the second booster at month 30 in the original "HPV vaccine delayed
 booster trial"

 -  Ability to understand and the willingness to sign a written informed consent document
 by the legal representative(s) of the participant.

 -  Ability to understand and the willingness to sign a written assent document by the
 participant.

 Exclusion Criteria:

 - Has received any HPV vaccine dose from an external source at any point during or after
 participation in the HPV vaccine delayed booster trial.