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NCT03023631 · ClinicalTrials.gov registry record · Phase 4
Gardasil 9 Vaccine in Preventing HPV Infection in Patients With Hematologic Malignancies Undergoing Donor Stem Cell Transplant
A Phase 4 study of Hematopoietic and Lymphoid Cell Neoplasm and Allogeneic Hematopoietic Stem Cell Transplant Recipient, sponsored by M.D. Anderson Cancer Center.
- Active
- Registry status
- Phase 4
- Development phase
- 48
- Enrollment target
- 1
- Study location
NCT03023631: Active Phase 4 study of Hematopoietic and Lymphoid Cell Neoplasm and Allogeneic Hematopoietic Stem Cell Transplant Recipient, sponsored by M.D. Anderson Cancer Center.
NCT03023631 is a Phase 4 study of Hematopoietic and Lymphoid Cell Neoplasm and Allogeneic Hematopoietic Stem Cell Transplant Recipient that is active but no longer recruiting, run by M.D. Anderson Cancer Center. The registered enrollment target is 48 participants, below the 952-participant average among 104 other Hematopoietic and Lymphoid Cell Neoplasm trials with a reported enrollment target (95% lower). The trial reports 1 study location across 1 state. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT03023631, a Phase 4 study of Hematopoietic and Lymphoid Cell Neoplasm and Allogeneic Hematopoietic Stem Cell Transplant Recipient, is active but no longer recruiting, sponsored by M.D. Anderson Cancer Center.
- ACTIVE NOT RECRUITING
- Registry status
- Phase 4
- Development phase
- 48 participants
- Enrollment target
- 1
- Study location
Study Summary
This phase IV trial studies how well Gardasil 9 vaccine works in preventing human papillomavirus (HPV) infection in patients with hematologic malignancies who are undergoing donor stem cell transplant. Vaccines, such as Gardasil 9, may help the body build an effective immune response to kill cancer cells.
Primary Outcome
Antibody response at 1 month post-dose 3 (month 7) will be compared with baseline antibody level. The study will use results from the 9-plex competitive Luminex immunoassay (9-plex cLIA) test to estimate the antibody response rate at dose 3 with 95% confidence interval (CI). Will apply Student t-test/Wilcoxon test to compare continuous variables between patients who obtained antibody response as defined in the primary endpoint (responders) and those who did not respond (non-responders), and the
Conditions Studied
Interventions
- BIOLOGICAL Recombinant Human Papillomavirus Nonavalent Vaccine
Study Locations (1)
Texas
- M D Anderson Cancer Center - Houston
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 48 participants |
| Start Date | 2017-04-23 |
| Est. Completion | 2026-07-31 |
| Phase | Phase 4 |
What the registry record for NCT03023631 still lists
NCT03023631 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 48 participants, a relatively small participant target, below the 952-participant average among 104 other Hematopoietic and Lymphoid Cell Neoplasm trials with a reported enrollment target (95% lower).
The record links to 2 conditions, with Hematopoietic and Lymphoid Cell Neoplasm appearing as the primary indexed condition, and to 1 intervention - of which Recombinant Human Papillomavirus Nonavalent Vaccine is the first listed.
NCT03023631 reports a single indexed study location in Texas.
Frequently Asked Questions
What is clinical trial NCT03023631 about?
NCT03023631 is a clinical study titled "Gardasil 9 Vaccine in Preventing HPV Infection in Patients With Hematologic Malignancies Undergoing Donor Stem Cell Transplant". This phase IV trial studies how well Gardasil 9 vaccine works in preventing human papillomavirus (HPV) infection in patients with hematologic malignancies who are undergoing donor stem cell transplant. Vaccines, such as Gardasil 9, may help the body build an effective immune response to kill cancer ...
What is the current status of trial NCT03023631?
This trial is currently active not recruiting. It is a Phase 4 study. The enrollment target is 48 participants. The study started on 2017-04-23. Estimated completion is 2026-07-31.
What conditions does trial NCT03023631 study?
This clinical trial studies the following conditions: Hematopoietic and Lymphoid Cell Neoplasm, Allogeneic Hematopoietic Stem Cell Transplant Recipient.
What interventions are being tested in trial NCT03023631?
The interventions under investigation include: Recombinant Human Papillomavirus Nonavalent Vaccine (BIOLOGICAL).
Who is sponsoring clinical trial NCT03023631?
This trial is sponsored by M.D. Anderson Cancer Center, which has 2,692 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT03023631 being conducted?
This trial has 1 study location across Texas. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
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Where NCT03023631's enrollment target sits among peer trials
48 65th of 104 higher than 40 of 104 other Hematopoietic and Lymphoid Cell Neoplasm trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Hematopoietic and Lymphoid Cell Neoplasm trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
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