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Immunogenicity and Reactogenicity of Alternative Schedules of Gardasil

NCT00524745 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 903

Last updated 2017-04-14

Study results available
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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.

Conditions

  • Dose Schedule Study

Interventions

BIOLOGICAL

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

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

Sponsors & Collaborators

  • National Institute of Hygiene and Epidemiology, Vietnam

    collaborator OTHER

  • PATH

    lead OTHER

Principal Investigators

  • Kathy Neuzil, MD, MPH · PATH

Study Design

Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
11 Years
Max Age
13 Years
Sex
FEMALE
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2007-10-31
Primary Completion
2010-01-31
Completion
2010-01-31

Countries

  • Vietnam

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT00524745 on ClinicalTrials.gov