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NCT01101750 · ClinicalTrials.gov registry record · Phase 4
Does the HPV Vaccine Cause the Same Response in Adolescent Kidney and Liver Transplant Patients as in Healthy Controls?
A Phase 4 study, sponsored by Medstar Health Research Institute.
- Completed
- Registry status
- Phase 4
- Development phase
- 25
- Enrollment target
NCT01101750 is a Phase 4 study that has completed, run by Medstar Health Research Institute. The registered enrollment target is 25 participants.
The verdict
NCT01101750, a Phase 4 study, has completed, sponsored by Medstar Health Research Institute.
- COMPLETED
- Registry status
- Phase 4
- Development phase
- 25 participants
- Enrollment target
Study Summary
The purpose of the study is to understand if children with liver and kidney transplants develop the antibodies from the Gardasil vaccine. The Gardasil vaccine protects against Human Papilloma Virus (HPV) types 16 and 18, which cause most types of cancers of the cervix, vagina and vulva. It also protects against Human Papilloma Virus types 6 and 11, which cause genital warts in some people. Gardasil has been approved by the Food and Drug Administration and is recommended for girls and women from ages 9-26 for the prevention of some types of cancer of the cervix, vagina and vulva as well as preventing some types of genital warts. In males that are 9-26 years old, the FDA has approved its use for prevention of some types of genital warts. The Gardasil vaccine is made from a virus like particle and does not contain any live virus. Children with an allergy to yeast should not receive the vaccine since some components of the vaccine are made from yeast. People who have undergone organ transplant are at increased risk of of developing genital warts and cancers related to HPV when compared to the general population. The American Society of Transplantation and the American Society of Transplant Surgeons recommend the vaccine for people with transplants. Studies of other vaccines like Hepatitis B have shown children after transplant have less of a response to this vaccine and are not immune to the Hepatitis B virus. We are interested in seeing if your child will form antibodies (immune response) to the Gardasil vaccine. Your child is being asked to be in the study because he or she is between the ages of 9-17 and has undergone a liver or kidney transplant more than 6 months ago and does not have any signs of organ rejection.
Interventions
- BIOLOGICAL Quadrivalent HPV for types 6, 11, 16 and 18
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 25 participants |
| Start Date | 2010-05 |
| Est. Completion | 2012-12-14 |
| Phase | Phase 4 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT01101750
The ClinicalTrials.gov registry entry for NCT01101750 describes a study currently listed as completed, categorized as Phase 4. The registered enrollment target is 25 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Medstar Health Research Institute, which has 115 total studies on file at ClinicalTrials.gov.
The record links to 0 conditions, and to 1 intervention - of which Quadrivalent HPV for types 6, 11, 16 and 18 is the first listed.
NCT01101750 reports 0 study locations.
Frequently Asked Questions
What is clinical trial NCT01101750 about?
NCT01101750 is a clinical study titled "Does the HPV Vaccine Cause the Same Response in Adolescent Kidney and Liver Transplant Patients as in Healthy Controls?". The purpose of the study is to understand if children with liver and kidney transplants develop the antibodies from the Gardasil vaccine. The Gardasil vaccine protects against Human Papilloma Virus (HPV) types 16 and 18, which cause most types of cancers of the cervix, vagina and vulva. It also pro...
What is the current status of trial NCT01101750?
This trial is currently completed. It is a Phase 4 study. The enrollment target is 25 participants. The study started on 2010-05. Estimated completion is 2012-12-14.
What interventions are being tested in trial NCT01101750?
The interventions under investigation include: Quadrivalent HPV for types 6, 11, 16 and 18 (BIOLOGICAL).
Who is sponsoring clinical trial NCT01101750?
This trial is sponsored by Medstar Health Research Institute, which has 115 total clinical trials registered on ClinicalTrials.gov.
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