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NCT06485258 · ClinicalTrials.gov registry record · Phase 1
CDC-9 Inactivated Rotavirus Vaccine (IRV) Intramuscular (IM) Phase 1 Clinical Trial in Healthy Adults
A Phase 1 study, sponsored by Centers for Disease Control and Prevention.
- Completed
- Registry status
- Phase 1
- Development phase
- 50
- Enrollment target
NCT06485258: Completed Phase 1 study, sponsored by Centers for Disease Control and Prevention.
NCT06485258 is a Phase 1 study that has completed, run by Centers for Disease Control and Prevention. The registered enrollment target is 50 participants, below the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (17% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT06485258, a Phase 1 study, has completed, sponsored by Centers for Disease Control and Prevention.
- COMPLETED
- Registry status
- Phase 1
- Development phase
- 50 participants
- Enrollment target
Study Summary
This is a study of CDC-9 inactivated rotavirus vaccine (IRV) for intramuscular administration (IM) in healthy adults aged 18 to 45 years at two dose levels in a 3-dose series. The purpose is to determine if it is safe and if the recipient's immune system responds to the vaccine.
Primary Outcome
The number of vaccine-related unsolicited adverse events following each vaccination. Unsolicited AEs will be collected continuously from vaccination on Day 1 through 28 days after the last vaccination (Day 85)
Interventions
- OTHER Placebo
- BIOLOGICAL 3.75 µg Dose of CDC-9 Inactivated Rotavirus Vaccine (IRV)
- BIOLOGICAL 7.5 µg Dose of CDC-9 Inactivated Rotavirus Vaccine (IRV)
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 50 participants |
| Start Date | 2024-08-06 |
| Est. Completion | 2026-02-04 |
| Phase | Phase 1 |
What the finished NCT06485258 record still lists
NCT06485258 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 50 participants, a relatively small participant target, below the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (17% lower).
The record links to 0 conditions, and to 3 interventions - of which Placebo is the first listed.
NCT06485258 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT06485258 about?
NCT06485258 is a clinical study titled "CDC-9 Inactivated Rotavirus Vaccine (IRV) Intramuscular (IM) Phase 1 Clinical Trial in Healthy Adults". This is a study of CDC-9 inactivated rotavirus vaccine (IRV) for intramuscular administration (IM) in healthy adults aged 18 to 45 years at two dose levels in a 3-dose series. The purpose is to determine if it is safe and if the recipient's immune system responds to the vaccine.
What is the current status of trial NCT06485258?
This trial is currently completed. It is a Phase 1 study. The enrollment target is 50 participants. The study started on 2024-08-06. Estimated completion is 2026-02-04.
What interventions are being tested in trial NCT06485258?
The interventions under investigation include: Placebo (OTHER), 3.75 µg Dose of CDC-9 Inactivated Rotavirus Vaccine (IRV) (BIOLOGICAL), 7.5 µg Dose of CDC-9 Inactivated Rotavirus Vaccine (IRV) (BIOLOGICAL).
Who is sponsoring clinical trial NCT06485258?
This trial is sponsored by Centers for Disease Control and Prevention, which has 139 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT06485258's enrollment target sits among peer trials
50 973rd of 2000 higher than 984 of 2,000 other Phase 1 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 1 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.
Source ClinicalTrials.gov registry export · 2026-08-08
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