Immunogenicity of Off-Schedule Dosing of HPV Vaccine
|The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.|
|ClinicalTrials.gov Identifier: NCT01030562|
Recruitment Status : Unknown
Verified July 2013 by National Institute of Allergy and Infectious Diseases (NIAID).
Recruitment status was: Recruiting
First Posted : December 11, 2009
Last Update Posted : December 30, 2013
|Condition or disease|
|Papilloma Viral Infection|
|Study Type :||Observational|
|Estimated Enrollment :||1400 participants|
|Official Title:||Immunogenicity of the HPV-6, 11, 16, 18 Vaccine Among Adolescent Girls Who Receive Vaccine Doses at Non-recommended Intervals and Factors Related to Non-adherence|
|Study Start Date :||June 2010|
|Estimated Primary Completion Date :||December 2013|
|Estimated Study Completion Date :||December 2014|
Subjects with an on-time interval between Dose 1 and 2 and an on-time interval between Dose 2 and 3.
Experimental/Primary Arm 3
This primary arm will consist of subjects receiving the second dose substantially late/third dose substantially late.
Experimental/Primary Arm 2
This primary arm will consist of subjects receiving the second dose substantially late/third dose on time.
Experimental/Primary Arm 1
This primary arm will consist of subjects receiving the second dose on time/third dose substantially late.
Subjects who meet eligibility requirements but do not fit into any of the primary experimental arms.
- Geometric mean titer (GMT) to vaccine human papillomavirus (HPV) serotypes. [ Time Frame: One month after the third HPV vaccine dose. ]
- Sero-response rate (proportion of subjects developing antibody to vaccine HPV serotypes). [ Time Frame: One month after the third HPV vaccine dose. ]
- GMT to vaccine HPV serotypes as measured by anti-HPV cLIA. [ Time Frame: Prior to the third HPV vaccine dose and six months after the third HPV vaccine dose. ]
- Sero-response rate (proportion of subjects developing antibody to vaccine HPV serotypes). [ Time Frame: Prior to the third HPV vaccine dose and six months after the third HPV vaccine dose. ]
Biospecimen Retention: Samples With DNA
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01030562
|Contact: Lea E Widdice||(513) firstname.lastname@example.org|
|United States, Georgia|
|Kaiser Permanente Crescent Medical Center - Pediatrics/Adolescent Medicine||Recruiting|
|Tucker, Georgia, United States, 30084-7047|
|United States, Maryland|
|University of Maryland School of Medicine - Center for Vaccine Development - Baltimore||Recruiting|
|Baltimore, Maryland, United States, 21201-1509|
|United States, Missouri|
|Children's Mercy Hospital and Clinics - Infectious Diseases||Recruiting|
|Kansas City, Missouri, United States, 64108-4619|
|United States, Ohio|
|Cincinnati Children?s Hospital Medical Center - Adolescent Medicine||Recruiting|
|Cincinnati, Ohio, United States, 45229-3039|
|United States, Pennsylvania|
|Primary Physicians Research Inc. - Pittsburgh||Terminated|
|Pittsburgh, Pennsylvania, United States, 15241-3100|
|United States, Tennessee|
|Monroe Carell Jr. Children's Hospital at Vanderbilt - Adolescent Medicine||Recruiting|
|Nashville, Tennessee, United States, 37232-0001|
|United States, Washington|
|Group Health Research Institute - Seattle||Recruiting|
|Seattle, Washington, United States, 98101-1466|