drugset / Trial / NCT02263703

Immunogenicity of HPV Vaccine in Immunosuppressed Children

NCT02263703

NaSingle-groupOpen-labelPrevention

Summary

Genital HPV is the necessary cause for cervical cancer, as well as a major contributing cause of several other cancers and conditions. There are now effective vaccines against the main oncogenic HPV types, HPV16 and 18. Most research and discussion has focused on targeting the vaccine to young women and older adolescents. Based on this, a national free HPV vaccination program for adolescent girls commenced in 2007, in Australia. However, at the time of commencement, there had been no research on the use of this vaccine in immunosuppressed. Therefore, information on the immunogenicity, safety and duration of efficacy of HPV vaccine when administered to immunosuppressed children is needed. This trial looked at a 3 dose schedule of quadrivalent HPV vaccine in a range of immunosuppressed children, with the endpoint being immunogenicity, followed for 5 years for duration of immunity.

Timeline

Start
2007-05
Primary completion
2016-02
Completion
2016-12

Drugs

EvaluationDrugModalityDoseRoute
Subject Gardasil Vaccine 0.5 ml