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NCT00767897 Clinical Trial

The Impact of the Human Papilloma Virus in Pediatric Chronic Kidney Disease, Dialysis, and Transplant Patients

Chronic Kidney Disease Clinical Trial

Official title:
The Impact of the Human Papilloma Virus in Pediatric Chronic Kidney Disease, Dialysis, and Transplant Patients

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT00767897
Other study ID # 0807-02
Secondary ID
Status Completed
Phase
First received
Last updated
Start date November 2011
Est. completion date December 2018

Study information
Verified date March 2024
Source Indiana University
Contact n/a
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial Summary

The proposed study is a pilot study and a first step towards developing an optimized HPV vaccination strategy for girls who have CKD, or are on dialysis or have a kidney transplant.

Recruitment information / eligibility
Status Completed
Enrollment 72
Est. completion date December 2018
Est. primary completion date December 2018
Accepts healthy volunteers Accepts Healthy Volunteers
Gender Female
Age group 9 Years to 18 Years
Eligibility Inclusion Criteria: - 9-18-year-old girls who have CKD stages 3 or 4 (Glomerular filtration rates 15-59 mL/min/1.73m2). - 9-18-year-old girls who are on dialysis. - 9-18-year-old girls who have had a functioning kidney transplant for longer than 6 months and are on the same immunosuppression regimen. - Healthy 9-18-year-old girls Exclusion Criteria: - Pregnancy, fever, allergy to any vaccine component, any immune disorder and any blood product received in the previous 6 months.

Study Design

Related Conditions & MeSH terms

Intervention

Drug:
• Human Papillomavirus Vaccine
The HPV vaccination will be administered by intramuscular injection in three separate 0.5mL doses. The recommended schedule is a 3-dose series with dose #2 and #3 administered 2 and 6 months after dose #1, respectively. The minimum interval between dose #1 and #2 of the vaccine is 4 weeks. The minimum recommended interval between dose #2 and #3 of the vaccine is 12 weeks.

Locations
Country Name City State
United States Indiana University/Riley Children's Hospital Indianapolis Indiana

Sponsors (3)
Lead Sponsor Collaborator
Indiana University Merck Sharp & Dohme LLC, National Kidney Foundation

Country where clinical trial is conducted

United States, 

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