Trial Outcomes & Findings for Randomized Trial of Alternative Quadrivalent Human Papilloma Virus (HPV) Vaccination Schedules in a University Setting (NCT NCT00572832)

Last Updated: 2010-08-17

Results Overview

Geomtric mean antibody titers were assessed 1 month following the third dose of human papilloma virus vaccine. Persons with baseline antibody titers that were positive to a particular type were deleted from the analysis for that particular type so that the outcome is excludes those with baseline positives (thus, sample size varies by type). Responses were compared between the two groups after dose 3 by type.

Recruitment status

COMPLETED

Study phase

Target enrollment

200 participants

Primary outcome timeframe

1 month post-dose 3 (i.e., 7 months for standard schedule and 13 months for alternative schedule)

Results posted on

2010-08-17

Participant Flow

Two hundred young women from the university community who met the eligibility criteria were recruited at the Student Health Service.

Participant milestones

Participant milestones
Measure	6 Month Standard Schedule Receipt of three doses of quadrivalent human papillomavirus vaccine according to the regular schedule of 0,2, and 6 months.	12 Month Alternative Group 12 month Alternative Schedule Group with 3 doses of quadrivalent vaccine at 0, 2, and 12 months
Overall Study STARTED	100	100
Overall Study COMPLETED	100	88
Overall Study NOT COMPLETED	0	12

Reasons for withdrawal

Reasons for withdrawal
Measure	6 Month Standard Schedule Receipt of three doses of quadrivalent human papillomavirus vaccine according to the regular schedule of 0,2, and 6 months.	12 Month Alternative Group 12 month Alternative Schedule Group with 3 doses of quadrivalent vaccine at 0, 2, and 12 months
Overall Study Lost to Follow-up	0	11
Overall Study Pregnancy	0	1

Baseline Characteristics

Randomized Trial of Alternative Quadrivalent Human Papilloma Virus (HPV) Vaccination Schedules in a University Setting

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	6 Month Standard Schedule n=100 Participants Receipt of three doses of quadrivalent human papillomavirus vaccine according to the regular schedule of 0,2, and 6 months.	12 Month Alternative Group n=100 Participants 12 month Alternative Schedule Group with 3 doses of quadrivalent vaccine at 0, 2, and 12 months	Total n=200 Participants Total of all reporting groups
Age, Categorical <=18 years	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Age, Categorical Between 18 and 65 years	100 Participants n=5 Participants	100 Participants n=7 Participants	200 Participants n=5 Participants
Age, Categorical >=65 years	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Age Continuous	20.3 years STANDARD_DEVIATION 1.3 • n=5 Participants	20.1 years STANDARD_DEVIATION 1.4 • n=7 Participants	20.2 years STANDARD_DEVIATION 1.3 • n=5 Participants
Sex: Female, Male Female	100 Participants n=5 Participants	100 Participants n=7 Participants	200 Participants n=5 Participants
Sex: Female, Male Male	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) American Indian or Alaska Native	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) Asian	5 Participants n=5 Participants	2 Participants n=7 Participants	7 Participants n=5 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) Black or African American	8 Participants n=5 Participants	8 Participants n=7 Participants	16 Participants n=5 Participants
Race (NIH/OMB) White	83 Participants n=5 Participants	89 Participants n=7 Participants	172 Participants n=5 Participants
Race (NIH/OMB) More than one race	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) Unknown or Not Reported	4 Participants n=5 Participants	1 Participants n=7 Participants	5 Participants n=5 Participants
Region of Enrollment United States	100 participants n=5 Participants	100 participants n=7 Participants	200 participants n=5 Participants
Body Mass Index	24.2 kg/m^2 STANDARD_DEVIATION 4.7 • n=5 Participants	24.5 kg/m^2 STANDARD_DEVIATION 5.1 • n=7 Participants	24.3 kg/m^2 STANDARD_DEVIATION 4.9 • n=5 Participants

PRIMARY outcome

Timeframe: 1 month post-dose 3 (i.e., 7 months for standard schedule and 13 months for alternative schedule)

Population: The analysis was by intention to treat. Participants who had positive baseline antibody titers were excluded from further analyses only for the type(s) for which they were seropositive.

Outcome measures

Outcome measures
Measure	6 Month Standard Schedule n=100 Participants Receipt of three doses of quadrivalent human papillomavirus vaccine according to the regular schedule of 0,2, and 6 months.	12 Month Alternative Group n=88 Participants 12 month Alternative Schedule Group with 3 doses of quadrivalent vaccine at 0, 2, and 12 months
Geometric Mean Antibody Titers Following the Third Dose of Human Papilloma Virus (HPV) Vaccine by Virus Type and by Administration Schedule Type 6	1894 milliMerck units per mL Interval 1564.0 to 2194.0	4221 milliMerck units per mL Interval 2930.0 to 5416.0
Geometric Mean Antibody Titers Following the Third Dose of Human Papilloma Virus (HPV) Vaccine by Virus Type and by Administration Schedule Type 11	1773 milliMerck units per mL Interval 1261.0 to 2252.0	5623 milliMerck units per mL Interval 3939.0 to 7208.0
Geometric Mean Antibody Titers Following the Third Dose of Human Papilloma Virus (HPV) Vaccine by Virus Type and by Administration Schedule Type 16	5534 milliMerck units per mL Interval 3875.0 to 7093.0	11832 milliMerck units per mL Interval 8165.0 to 15223.0
Geometric Mean Antibody Titers Following the Third Dose of Human Papilloma Virus (HPV) Vaccine by Virus Type and by Administration Schedule Type 18	1225 milliMerck units per mL Interval 1038.0 to 1396.0	2052 milliMerck units per mL Interval 1138.0 to 2959.0

Adverse Events

6 Month Standard Schedule

Serious events: 0 serious events

Other events: 57 other events

Deaths: 0 deaths

12 Month Alternative Group

Serious events: 0 serious events

Other events: 55 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Other adverse events
Measure	6 Month Standard Schedule n=100 participants at risk Receipt of three doses of quadrivalent human papillomavirus vaccine according to the regular schedule of 0,2, and 6 months.	12 Month Alternative Group n=100 participants at risk 12 month Alternative Schedule Group with 3 doses of quadrivalent vaccine at 0, 2, and 12 months
Skin and subcutaneous tissue disorders Soreness at the injection site	57.0% 57/100 • Number of events 114	55.0% 55/100 • Number of events 95
General disorders syncope	1.0% 1/100 • Number of events 1	0.00% 0/100

Additional Information

Richard Zimmerman

University of Pittsburgh

Phone: 412-383-2354

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place

Restriction type: LTE60