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Immunogenicity of Off-Schedule Dosing of HPV Vaccine

NCT01030562 · Status: COMPLETED · Type: OBSERVATIONAL · Enrollment: 1321

Last updated 2018-10-29

No results posted yet for this study

Summary

The purpose of this study is to gain a better understanding of the body's response to a human papillomavirus (HPV) (sexually transmitted disease), vaccine and booster shot. The study will also determine factors related to adolescents not following vaccination schedules. The HPV vaccine requires 3 doses (shots). Girls sometimes receive the 3 shots at the recommended time and sometimes girls receive the shots at non-recommended times. This study will evaluate if getting the shots at non-recommended times affects the level of protection provided by the vaccine. Participants will include about 1400 girls 9-17 years old receiving a third dose of HPV vaccine from their primary care clinician. The parent/legal guardian of each subject may answer a questionnaire related to the vaccine schedule. Study procedures include: medical history, questionnaires and blood draws. Participants will be involved in the study for about 6 months from time of enrollment.

Conditions

  • Papilloma Viral Infection

Sponsors & Collaborators

  • National Institute of Allergy and Infectious Diseases (NIAID)

    lead NIH

Eligibility

Min Age
9 Years
Max Age
17 Years
Sex
FEMALE
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2010-06-02
Primary Completion
2014-03-05
Completion
2014-03-05

Countries

  • United States

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 NCT01030562 on ClinicalTrials.gov