Immunogenicity of Off-Schedule Dosing of HPV Vaccine
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
1 other identifier
observational
1,321
1 country
7
Brief 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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for all trials
Started Jun 2010
Typical duration for all trials
7 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
December 10, 2009
CompletedFirst Posted
Study publicly available on registry
December 11, 2009
CompletedStudy Start
First participant enrolled
June 2, 2010
CompletedPrimary Completion
Last participant's last visit for primary outcome
March 5, 2014
CompletedStudy Completion
Last participant's last visit for all outcomes
March 5, 2014
CompletedOctober 29, 2018
July 31, 2013
3.8 years
December 10, 2009
October 25, 2018
Conditions
Keywords
Outcome Measures
Primary Outcomes (2)
Geometric mean titer (GMT) to vaccine human papillomavirus (HPV) serotypes as measured by HPV4-plex IgG ELISA.
One month after the third HPV vaccine dose.
Sero-response rate (proportion of subjects developing antibody to vaccine HPV serotypes).
One month after the third HPV vaccine dose.
Secondary Outcomes (2)
GMT to vaccine HPV serotypes as measured by HPV4-plex IgG ELISA
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).
Prior to the third HPV vaccine dose and six months after the third HPV vaccine dose.
Study Arms (5)
Alternate Arm
Subjects who meet eligibility requirements but do not fit into any of the primary experimental arms.
Control Arm
Subjects with an on-time interval between Dose 1 and 2 and an on-time interval between Dose 2 and 3.
Experimental/Primary Arm 1
This primary arm will consist of subjects receiving the second dose on time/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 3
This primary arm will consist of subjects receiving the second dose substantially late/third dose substantially late.
Eligibility Criteria
Girls 9-17 years old receiving third dose of HPV vaccine from primary care clinician. Parent/legal guardian will participate by answering a questionnaire to determine factors related to non-adherence to recommended vaccine schedule.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (7)
Kaiser Permanente Crescent Medical Center - Pediatrics/Adolescent Medicine
Tucker, Georgia, 30084-7047, United States
University of Maryland School of Medicine - Center for Vaccine Development - Baltimore
Baltimore, Maryland, 21201-1509, United States
Children's Mercy Hospital and Clinics - Infectious Diseases
Kansas City, Missouri, 64108-4619, United States
Cincinnati Children?s Hospital Medical Center - Adolescent Medicine
Cincinnati, Ohio, 45229-3039, United States
Primary Physicians Research Inc. - Pittsburgh
Pittsburgh, Pennsylvania, 15241-3100, United States
Monroe Carell Jr. Children's Hospital at Vanderbilt - Adolescent Medicine
Nashville, Tennessee, 37232-0001, United States
Kaiser Permanente Washington Health Research Institute - Vaccines and Infectious Diseases
Seattle, Washington, 98101-1466, United States
Related Publications (1)
Widdice LE, Hoagland R, Callahan ST, Kahn JA, Harrison CJ, Pahud BA, Frey SE, Berry AA, Kotloff KL, Edwards KM, Mulligan MJ, Sudman J, Nakamura A, Bernstein DI. Caregiver and adolescent factors associated with delayed completion of the three-dose human papillomavirus vaccination series. Vaccine. 2018 Mar 7;36(11):1491-1499. doi: 10.1016/j.vaccine.2017.12.060. Epub 2018 Feb 7.
PMID: 29428177DERIVED
Biospecimen
Serum samples.
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Design
- Study Type
- observational
- Observational Model
- COHORT
- Time Perspective
- OTHER
- Sponsor Type
- NIH
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
December 10, 2009
First Posted
December 11, 2009
Study Start
June 2, 2010
Primary Completion
March 5, 2014
Study Completion
March 5, 2014
Last Updated
October 29, 2018
Record last verified: 2013-07-31