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CDC-9 Inactivated Rotavirus Vaccine (IRV) Microneedle Patch (MNP) in Healthy Adults

StatusActive, Not Recruiting
PhasePhase 1
Started
View on ClinicalTrials.gov ↗
Record status
This record was last updated March 5, 2026 (before its estimated October 6, 2026 completion). Its status may not reflect the trial's current state.

Record History

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  1. Trial status: Recruiting to Active, Not Recruiting
    • Primary and study completion dates: Jul 15, 2027 to Oct 6, 2026
    • Eligibility criteria revised
    • Site details revised
    v5
  2. Start date changed from estimate of Jul 9, 2025 to Jul 7, 2025v4
  3. Trial status: Not Yet Recruiting to Recruiting
    • Primary and study completion dates: Jun 15, 2027 to Jul 15, 2027
    • Start date: Jun 23, 2025 to Jul 9, 2025
    • Site details revised
    v3
  4. Start date: May 19, 2025 to Jun 23, 2025
    • Primary and study completion dates: May 15, 2027 to Jun 15, 2027
    • Study title shortened, about 4 words
    v2
  5. Study First Submitted
  • Stopped: an ongoing trial was terminated, suspended or withdrawn.
  • Notable: the trial’s plan changed such as a big move in its timeline or size, a new primary endpoint, sponsor or phase, or recruiting opened or resumed.
  • Minor: routine progress and housekeeping, such as sites added or enrollment closed.
This is a study of CDC-9 inactivated rotavirus vaccine (IRV) microneedle patch (MNP) for intradermal administration 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.
Trial Details
NCT Number NCT06962904
Lead Sponsor Centers for Disease Control and Prevention
Collaborators: Emory-Children's Center, Children's Hospital Medical Center, Cincinnati, Micron Biomedical, Inc
Conditions
(from sponsor)		 Rotavirus Infections
Related terms Infections, Rotavirus Infections
Enrollment 50 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov