Trial Outcomes & Findings for Postpartum HPV Vaccination (NCT NCT03451071)

NCT ID: NCT03451071

Last Updated: 2021-10-04

Results Overview

This was established using a survey to indicate willingness to receive vaccine.

• Recruitment status: COMPLETED
• Study phase: PHASE4
• Target enrollment: 195 participants
• Primary outcome timeframe: 1 day (at the time of initial recruitment /survey)
• Results posted on: 2021-10-04

Participant Flow

195 women consented to participate in the study. 139 consented to survey only, 56 consented to survey and Gardasil9 vaccine.

Participant milestones

Measure	Gardasil9 Gardasil9: Gardasil 9
First Vaccine STARTED	56
First Vaccine COMPLETED	55
First Vaccine NOT COMPLETED	1
Second Vaccine STARTED	55
Second Vaccine COMPLETED	36
Second Vaccine NOT COMPLETED	19
Third Vaccine STARTED	36
Third Vaccine COMPLETED	14
Third Vaccine NOT COMPLETED	22
Final Questionnaire and Blood Draw STARTED	14
Final Questionnaire and Blood Draw COMPLETED	10
Final Questionnaire and Blood Draw NOT COMPLETED	4

Reasons for withdrawal

Measure	Gardasil9 Gardasil9: Gardasil 9
First Vaccine Withdrawal by Subject	1
Second Vaccine Lost to Follow-up	19
Third Vaccine Lost to Follow-up	22
Final Questionnaire and Blood Draw Lost to Follow-up	4

Baseline Characteristics

Postpartum HPV Vaccination

Baseline characteristics by cohort

Measure	Gardasil9 n=56 Participants Gardasil9: Gardasil 9
Age, Continuous	21.9 years STANDARD_DEVIATION 2.8 • n=5 Participants
Sex/Gender, Customized Female only	56 Participants n=5 Participants
Race/Ethnicity, Customized White	4 Participants n=5 Participants
Race/Ethnicity, Customized Black	48 Participants n=5 Participants
Race/Ethnicity, Customized Hispanic/Latino	4 Participants n=5 Participants

PRIMARY outcome

Timeframe: 1 day (at the time of initial recruitment /survey)

Population: 56 patients consented to vaccine.

This was established using a survey to indicate willingness to receive vaccine.

Outcome measures

Measure	Gardasil9 n=195 Participants Gardasil9: Gardasil 9
Patient Indication of Willingness to Accept the Vaccine Based on Survey	56 Participants

SECONDARY outcome

Timeframe: at baseline

Population: 1 participant consented to vaccine and then subsequently withdrew

Those that actually received the vaccine and each time point.

Outcome measures

Measure	Gardasil9 n=56 Participants Gardasil9: Gardasil 9
Uptake of the Vaccine Doses	55 Participants

SECONDARY outcome

Timeframe: at 3 months

Population: 1 patient consented to vaccine and then withdrew

Those that actually received the vaccine and each time point.

Outcome measures

Measure	Gardasil9 n=55 Participants Gardasil9: Gardasil 9
Uptake of the Vaccine Doses	36 Participants

SECONDARY outcome

Timeframe: at 6 months

Population: 36 patients received the 2nd vaccine dose

Those that actually received the vaccine and each time point.

Outcome measures

Measure	Gardasil9 n=36 Participants Gardasil9: Gardasil 9
Uptake of the Vaccine Doses	14 Participants

SECONDARY outcome

Timeframe: baseline and 7 months

Population: This data was not collected

Immunogenicity

Outcome measures

Outcome data not reported

Adverse Events

Gardasil9

Serious events: 0 serious events

Other events: 1 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Measure	Gardasil9 n=55 participants at risk Gardasil9: Gardasil 9
General disorders Flu-like symptoms	1.8% 1/55 • Number of events 1 • 7 months

Additional Information

Haller Smith

University of Alabama at Birmingham

Phone: 205-934-4986

Email: hjsmith@uabmc.edu

Results disclosure agreements

• Principal investigator is a sponsor employee
• Publication restrictions are in place