Trial Outcomes & Findings for Alternate Dosing Schedules Study for HPV Vaccine (NCT NCT00862810)

NCT ID: NCT00862810

Last Updated: 2014-11-20

Results Overview

Participants with Faces Pain Scale - Revised (FPS-R) score higher in arm where HPV received compared to arm where concomitant vaccines received. The Faces Pain Scale Revised is a dimensionless 10 point likert scale used to assess self-reported pain intensity on a scale from 0 (no pain) to 10 (most pain you can imagine). Greater pain scores are indicative of more severe pain.

• Recruitment status: COMPLETED
• Study phase: PHASE4
• Target enrollment: 72 participants
• Primary outcome timeframe: 10 minutes following vaccination
• Results posted on: 2014-11-20

Participant Flow

Participant milestones

Measure	Received HPV Vaccine First Received HPV vaccine first	Received Concomitant Vaccines First Received Concomitant Vaccines First
Overall Study STARTED	33	39
Overall Study COMPLETED	29	35
Overall Study NOT COMPLETED	4	4

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Alternate Dosing Schedules Study for HPV Vaccine

Baseline characteristics by cohort

Measure	Received HPV Vaccine First n=33 Participants Received HPV vaccine first	Received Concomitant Vaccines First n=39 Participants Received concomitant vaccines first	Total n=72 Participants Total of all reporting groups
Age, Categorical <=18 years	33 Participants n=5 Participants	39 Participants n=7 Participants	72 Participants n=5 Participants
Age, Categorical Between 18 and 65 years	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Age, Categorical >=65 years	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Sex: Female, Male Female	33 Participants n=5 Participants	39 Participants n=7 Participants	72 Participants n=5 Participants
Sex: Female, Male Male	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Region of Enrollment United States	33 participants n=5 Participants	39 participants n=7 Participants	72 participants n=5 Participants

PRIMARY outcome

Timeframe: 10 minutes following vaccination

Participants with Faces Pain Scale - Revised (FPS-R) score higher in arm where HPV received compared to arm where concomitant vaccines received.

The Faces Pain Scale Revised is a dimensionless 10 point likert scale used to assess self-reported pain intensity on a scale from 0 (no pain) to 10 (most pain you can imagine). Greater pain scores are indicative of more severe pain.

Outcome measures

Measure	Received HPV Vaccine First n=33 Participants Received HPV vaccine first	Received Concomitant Vaccines First n=39 Participants Received concomitant vaccines first
Pain Following HPV Vaccine	17 participants	32 participants

Adverse Events

Received HPV Vaccine First

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Received Concomitant Vaccines First

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Adverse event data not reported

Additional Information

Emmanuel Walter MD, MPH

Duke University Health System

Phone: 919-620-5346

Email: walte002@mc.duke.edu

Results disclosure agreements

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