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N/A N=200 Randomized Prevention

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

Human Papillomavirus Infection

Bottom Line

View on ClinicalTrials.gov: NCT00572832 ↗
Enrolled (actual)
200
Serious AEs
0.0%
Results posted
Feb 2010
Primary outcome: Primary: Geometric Mean Antibody Titers Following the Third Dose of Human Papilloma Virus (HPV) Vaccine by Virus Type and by Administration Schedule — 1894; 4221; 1773; 5623 milliMerck units per mL — p=.025

Study Design & Population

Study type
Interventional
Phase
N/A
Interventions
Quadrivalent human papillomavirus vaccine on-time administration (Biological); Quadrivalent human papillomavirus vaccine delayed administration (Biological)
Age
Adult · 18+ yrs
Sex
Female
Sponsor
University of Pittsburgh
Primary completion
Apr 2009

Outcome Measures

OutcomeResultp-value
PRIMARY
Geometric Mean Antibody Titers Following the Third Dose of Human Papilloma Virus (HPV) Vaccine by Virus Type and by Administration Schedule		 1894; 4221; 1773; 5623; 5534; 11832 .025 sig

Summary

This is a randomized, open label trial of HPV (human papilloma virus) vaccine, 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 vaccine at 6 months or vaccine at 12 months. Blood will be drawn for titers twice from all participants: pre-dose 1 and one month post third dose. We hypothesize that the GMTs in the 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.

Eligibility Criteria

Inclusion Criteria

  • 18-23 year old college females who are planning to return to the university for the next fall semester.

Exclusion Criteria

  • Pregnancy or planned pregnancy.
  • Prior receipt of HPV vaccine.
  • Greater than four lifetime sexual partners.
  • Immunosuppression.
  • Anti-coagulant therapy.
  • Breastfeeding.
  • History of abnormal pap smear.
  • Allergy to vaccine components.
View full record on ClinicalTrials.gov →

Data sourced from ClinicalTrials.gov (NCT00572832). 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.

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