A prospective, single-arm, open-label, non-randomized, phase IIa trial of a nonavalent prophylactic HPV vaccine to assess immunogenicity of a prime and deferred-booster dosing schedule among 9–11 year-old girls and boys – clinical protocol

Table 1 Schedule of study events

Evaluation/Procedure	Pre-study Evaluation	Baseline Visit^a	Months 1–6	Month 6 Visit^d	Months 7–12	Month 12 Visit^d	Months 13–18	Month 18 Visit^d	Months 19–24	Month 24 Visit^d	Months 24–30	Month 30 Visit^d	Follow-up^b
Informed Consent/Assent	X
Parental/Household Questionnaire	X
Assess Eligibility	X
Medical History	X
Age of Menarche, if applicable	X	X		X		X		X		X		X
Urine Pregnancy Test^e	X	X								X		X^g
Baseline signs and symptoms	X
Vital Signs	X	X^f								X		X^g
Weight, Height	X	X^f				X				X
Concomitant Medications	X	X		X		X		X		X		X
Blood Collection		X		X		X		X		X		X
Priming Vaccine Injection		X
Booster Injection										X		X^g
Adverse Events		X	X	X	X	X	X	X	X	X	X	X	X
Telephone/email/text Contact^c			X		X		X		X		X		X

^aBaseline visit should occur within 90 days of enrollment and can be combined with the pre-study evaluation
^bParticipants will be followed for 2 weeks after completing the last Gardasil 9 injection
^cParticipants and their legal representative(s) will be contacted once a month to remind them to refrain from non-study HPV vaccination during the study period and also within two weeks prior to each study visit to remind them of their upcoming visit
^dStudy visits will occur +/− 2 weeks of the scheduled times unless significant scheduling problems arise
^eFor girls who have started their periods
^eNot required, if the baseline visit occurs within one month of the pre-study evaluation
^gThe booster injection is optional at the Month 30 visit. Urine pregnancy test and vital signs are not required at this visit for participants who do not receive the 3rd injection

ISSN: 1471-2407