N/A Completed N=220 Randomized Prevention

Randomized Trial of Alternative HPV Vaccination Schedules in Males in a University Setting

Quadrivalent HPV Vaccine · Human Papillomavirus Vaccine

Source: ClinicalTrials.gov NCT01184079 ↗

Enrolled (actual)

220

Serious AEs

0.0%

Results posted

Feb 2014

Primary outcomePrimary: Immunogenicity After Dose 3 — 1063; 794; 1961; 1043 mM units/ml

Summary

The investigators propose a randomized, open label trial of the immunogenicity of HPV vaccine among males 18-24 years old, comparing an on-time administration of the third dose with delayed administration of the third dose. All participants would receive the first and second doses according to schedule. They would be randomized to either Dose 3 at 6 months or Dose 3 at 12 months. Hypothesis: The Geometric mean titers in the 12 month test group (T) are non-inferior to the usual timing control group (C): H0: δ ≤ -δ0 versus H1: δ > -δ0 where δ = log (GMTT )- log (GMTC) and δ0 is the pre-specified non-inferiority margin

Outcome Measures

Outcome	Result	p-value
PRIMARY Immunogenicity After Dose 3	1063; 794; 1961; 1043; 6186; 4555	—
SECONDARY Compliance With 3rd Dose	97; 107	—
SECONDARY Safety Profile	28.9; 24.4	0.26

Eligibility Criteria

Inclusion Criteria

Males age 18-26

Exclusion Criteria

Hospitalization within the past year
Previous HPV vaccination

>/=5 sexual partners (i.e., insertive intercourse) No other drug studies within 30 days of proposed HPV vaccination

History of genital warts
Immunosuppression
Other vaccines within 8 days of proposed HPV vaccination
Hypersensitivity to yeast or HPV vaccine components
Known autoimmune disorders
Receipt of immunoglobulins or blood product within 90 days of enrollment (may defer until 90 days completed)
Serious Adverse Reaction to HPV vaccine

View full record on ClinicalTrials.gov →

Data sourced from ClinicalTrials.gov (NCT01184079). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.