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NCT05329961 · ClinicalTrials.gov registry record · Early Phase 1
Immunogenicity of the 9vHPV Vaccination 2-dose Regimen Among Children 4 to 8 Years Old
A Early Phase 1 study of Human Papilloma Virus, sponsored by Boston Medical Center.
- Active
- Registry status
- Early Phase 1
- Development phase
- 155
- Enrollment target
- 1
- Study location
NCT05329961: Active Early Phase 1 study of Human Papilloma Virus, sponsored by Boston Medical Center.
NCT05329961 is a Early Phase 1 study of Human Papilloma Virus that is active but no longer recruiting, run by Boston Medical Center. The registered enrollment target is 155 participants, below the 8,437-participant average among 39 other Human Papilloma Virus trials with a reported enrollment target (98% lower). The trial reports 1 study location across 1 state. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT05329961, a Early Phase 1 study of Human Papilloma Virus, is active but no longer recruiting, sponsored by Boston Medical Center.
- ACTIVE NOT RECRUITING
- Registry status
- Early Phase 1
- Development phase
- 155 participants
- Enrollment target
- 1
- Study location
Study Summary
This study is an open-label nonrandomized exploratory proof of concept and descriptive 4-year immunogenicity study to assess immunogenicity after administration of a 2-dose regimen of 9-valent human papillomavirus vaccine (9vHPV) vaccine separated by 12 months (months 0, 12).
Primary Outcome
A serum sample will be analyzed using 9-valent Luminex immunoassay (cLIA, mMU/mL) to assess the geometric mean for HPV antibodies. The results will be considered positive for HPV6 if it is \>30mMu.
Conditions Studied
Interventions
- DRUG Gardasil9
Study Locations (1)
Massachusetts
- Boston Medical Center - Boston
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 155 participants |
| Start Date | 2022-09-26 |
| Est. Completion | 2028-12 |
| Phase | Early Phase 1 |
What the registry record for NCT05329961 still lists
NCT05329961 is an interventional study that assigns participants to a tested intervention. The registered 155 participants enrollment target is mid-sized for trials with a published cap, below the 8,437-participant average among 39 other Human Papilloma Virus trials with a reported enrollment target (98% lower).
The record links to 1 condition, with Human Papilloma Virus appearing as the primary indexed condition, and to 1 intervention - of which Gardasil9 is the first listed.
NCT05329961 reports a single indexed study location in Massachusetts.
Frequently Asked Questions
What is clinical trial NCT05329961 about?
NCT05329961 is a clinical study titled "Immunogenicity of the 9vHPV Vaccination 2-dose Regimen Among Children 4 to 8 Years Old". This study is an open-label nonrandomized exploratory proof of concept and descriptive 4-year immunogenicity study to assess immunogenicity after administration of a 2-dose regimen of 9-valent human papillomavirus vaccine (9vHPV) vaccine separated by 12 months (months 0, 12).
What is the current status of trial NCT05329961?
This trial is currently active not recruiting. It is a Early Phase 1 study. The enrollment target is 155 participants. The study started on 2022-09-26. Estimated completion is 2028-12.
What conditions does trial NCT05329961 study?
This clinical trial studies the following conditions: Human Papilloma Virus.
What interventions are being tested in trial NCT05329961?
The interventions under investigation include: Gardasil9 (DRUG).
Who is sponsoring clinical trial NCT05329961?
This trial is sponsored by Boston Medical Center, which has 253 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT05329961 being conducted?
This trial has 1 study location across Massachusetts. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
Similar trials for Human Papilloma Virus
Matched on the same primary condition, ranked to surface studies in the same phase first, then by recruiting status, no relevance scoring or editorial curation.
Where NCT05329961's enrollment target sits among peer trials
155 20th of 39 higher than 20 of 39 other Human Papilloma Virus trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Human Papilloma Virus 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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