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NCT01030562

Immunogenicity of Off-Schedule Dosing of HPV Vaccine

Completed Last updated 29 October 2018
What this trial tests

trial in Papilloma Viral Infection in 1,321 participants. Completed in 5 March 2014.

Timeline
2 June 2010
Primary endpoint
5 March 2014
5 March 2014

Quick facts

Lead sponsorNational Institute of Allergy and Infectious Diseases (NIAID)
StatusCompleted
Study typeOBSERVATIONAL
Enrollment1,321
Start date2 June 2010
Primary completion5 March 2014
Estimated completion5 March 2014
Sites7 locations across United States

Conditions studied

Sponsor

National Institute of Allergy and Infectious Diseases (NIAID)

Who can join

Adults 9 to 17, female only, with Papilloma Viral Infection. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

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.

Publications & conference data

No peer-reviewed publications indexed yet for this trial. Completed trials usually publish results within 12-18 months.

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Other National Institute of Allergy and Infectious Diseases (NIAID) trials

Trials by the same sponsor.

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Data sources for this page

Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT01030562.

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