Clinical trial · Interventional
Randomized Trial of Alternative Quadrivalent Human Papilloma Virus (HPV) Vaccination Schedules in a University Setting
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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.
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Human Papillomavirus Infection | — | UNRESOLVED | — |
Interventions
Interventions (2)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Quadrivalent human papillomavirus vaccine delayed administration | Biological | — | UNRESOLVED |
| Quadrivalent human papillomavirus vaccine on-time administration | Biological | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- type
- ACTIVE_COMPARATOR
- label
- 6 mon. 3rd dose of quadrivalent human papillomavirus vaccine
- description
- Receipt of three doses of quadrivalent human papillomavirus vaccine according to the regular schedule of 0,2, and 6 months.
- interventionNames
- Biological: Quadrivalent human papillomavirus vaccine on-time administration
- type
- ACTIVE_COMPARATOR
- label
- 12 mon. 3rd dose of quadrivalent human papillomavirus vaccine
- description
- Receipt of three doses of quadrivalent human papillomavirus vaccine on a delayed schedule of 0,2, and 12 months.
- interventionNames
- Biological: Quadrivalent human papillomavirus vaccine delayed administration
Primary outcomes (1)
- measure
Eligibility
Eligibility (as posted)
- Sex
- Female
- Minimum age
- 18 Years
- Maximum age
- 23 Years
Show eligibility criteria text
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.
References
Publications (1)
- RESULTZimmerman RK, Nowalk MP, Lin CJ, Fox DE, Ko FS, Wettick E, Cost G, Hand L, Hayes J, Michaels M. Randomized trial of an alternate human papillomavirus vaccine administration schedule in college-aged women. J Womens Health (Larchmt). 2010 Aug;19(8):1441-7. doi: 10.1089/jwh.2009.1753. PMID 20629576