CI

At a glance

ClinicalIndex Comparison Record
N/ACompleted· 903 enrolled
Drug / intervention
Biological: quadrivalent human papillomavirus (types 6, 11, 16, 18) recombinant vaccinebiological
Likely dose
Not stated in record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT00524745
NCT00524745N/ACompleted
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Comparison of the Immunogenicity and Reactogenicity of Alternative Schedules of Gardasil Vaccine to Prevent HPV Infection

PATH·interventional·Posted Sep 5, 2007·Updated Apr 14, 2017

In Brief

A clinical study evaluating Biological: quadrivalent human papillomavirus (types 6, 11, 16, 18) recombinant vaccine for Dose Schedule Study. Completed, enrolled 903 participants across 1 site.

Detailed Summary

To demonstrate that Gardasil® vaccine, when given to girls 11-13 years of age according to 1 of 3 alternative 3-dose schedules (0, 3, 9 months; 0, 6, 12 months; or 0, 12, 24 months), results in anti-HPV type 16 and anti-HPV type 18 responses 28 days post-dose 3 that are similar to those obtained when the vaccine is given on the standard 3-dose schedule of 0, 2, 6 months.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsDose Schedule Study
CountriesVietnam
CollaboratorsNational Institute of Hygiene and Epidemiology, Vietnam

Timeline

N/ACompletedFinished
20082009201020112012201320142015201620172018201920202021202220232024202520262027
First PostedSep 5, 2007
Enrollment StartOct 1, 2007
Primary CompletionJan 1, 2010
TodayJul 2, 2026
Enrollment to primary: 2.3 yearsPosted 18.8 years ago

Interventions

Biological: quadrivalent human papillomavirus (types 6, 11, 16, 18) recombinant vaccinebiological

Three doses of quadrivalent HPV recombinant vaccine administered at different dosing intervals in each of four study arms.