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COMPLETED

Immunogenicity of Off-Schedule Dosing of HPV Vaccine

NCT01030562 · View on ClinicalTrials.gov ↗

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 Studied

Study Locations (7)

Georgia

  • Kaiser Permanente Crescent Medical Center - Pediatrics/Adolescent Medicine — Tucker

Maryland

  • University of Maryland School of Medicine - Center for Vaccine Development - Baltimore — Baltimore

Missouri

  • Children's Mercy Hospital and Clinics - Infectious Diseases — Kansas City

Ohio

  • Cincinnati Children?s Hospital Medical Center - Adolescent Medicine — Cincinnati

Pennsylvania

  • Primary Physicians Research Inc. - Pittsburgh — Pittsburgh

Tennessee

  • Monroe Carell Jr. Children's Hospital at Vanderbilt - Adolescent Medicine — Nashville

Washington

  • Kaiser Permanente Washington Health Research Institute - Vaccines and Infectious Diseases — Seattle

Trial Details

FieldValue
Enrollment Target 1,321 participants
Start Date 2010-06-02
Est. Completion 2014-03-05

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Full Details on ClinicalTrials.gov ↗

What the Registry Record Tells You About NCT01030562

The ClinicalTrials.gov registry entry for NCT01030562 describes a study currently listed as completed. It is categorized as an unspecified phase, which is the standard way researchers label where a study sits along the investigational pathway from early safety work through later efficacy and post-marketing evaluation. The registered enrollment target is 1,321 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is National Institute of Allergy and Infectious Diseases (NIAID), which has 1,295 total studies on file at ClinicalTrials.gov, and sponsors are the parties responsible for study design, oversight, and regulatory filings.

The record links to 1 condition, with Papilloma Viral Infection appearing as the primary indexed condition, and to 0 interventions. Interventions can include drugs, devices, procedures, behavioral programs, or observational arms, and each is tracked as a separate registry field so that downstream queries can filter accurately. When a trial lists multiple interventions, it usually reflects a multi-arm design or a comparison protocol rather than a single treatment being tested in isolation. The brief summary published in the registry is the clearest source of protocol intent and should be read before drawing conclusions from any sidebar tags.

Geographic footprint matters for practical reasons: NCT01030562 reports 7 study locations spanning 7 distinct geographic areas — top geographies include Georgia, Maryland, Missouri. A larger site network tends to correlate with broader recruitment capacity, but it does not imply anything about study quality, and site-level enrollment status can diverge from the overall registry status shown above. Every data point on this page comes from the public ClinicalTrials.gov dataset and is reproduced here for reference only; it is not a medical recommendation, an endorsement of the sponsor, or an invitation to enroll. Verify current status, eligibility criteria, and contact details directly at ClinicalTrials.gov, and discuss any participation decision with your own healthcare provider.

Frequently Asked Questions

What is clinical trial NCT01030562 about?

NCT01030562 is a clinical study titled "Immunogenicity of Off-Schedule Dosing of HPV Vaccine". 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 do...

What is the current status of trial NCT01030562?

This trial is currently completed. The enrollment target is 1,321 participants. The study started on 2010-06-02. Estimated completion is 2014-03-05.

What conditions does trial NCT01030562 study?

This clinical trial studies the following conditions: Papilloma Viral Infection. These conditions were identified from the trial registry and reflect the primary focus areas of the research.

Who is sponsoring clinical trial NCT01030562?

This trial is sponsored by National Institute of Allergy and Infectious Diseases (NIAID), which has 1,295 total clinical trials registered on ClinicalTrials.gov. The sponsor is responsible for the study's design, funding, and regulatory compliance.

Where is trial NCT01030562 being conducted?

This trial has 7 study locations across Georgia, Maryland, Missouri, Ohio, Pennsylvania. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.

Related

Data sourced from official U.S. government datasets. See our methodology for details. Retrieved and formatted by PlainTrial Editorial