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Safety of the Acne mRNA Vaccine in Adolescents 12 to 17 Years of Age With Moderate to Severe Acne

StatusNot Yet Recruiting
PhasePhase 2
SponsorSanofi
Started
View on ClinicalTrials.gov ↗

Record History

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  1. Notable Sponsor changed: Sanofi Pasteur, a Sanofi Company to Sanofi
    • Eligibility criteria expanded, about 11 words
  2. Minor 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  • Stopped: an ongoing trial was terminated, suspended or withdrawn.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.
284 trials monitored
See 12 trials at risk
The purpose of this study is to assess the safety profile of intramuscular injections of the Acne mRNA vaccine at 3 dose levels compared with placebo in 12 to 17 years old participants with moderate to severe acne. An early safety data review (ESDR) will be conducted after each subcohort has completed an injection round; enrollment of the next higher dose level subcohort or progression of a subcohort to the subsequent injection round will only proceed if no safety concerns are identified. This sequential process will allow a cautious approach to vaccine injection in the adolescent population. Study details are as follows: * Before being enrolled in the study, participants complete a 4-week (ie, 1-month) screening period during which they will be called over the telephone approximately in the middle of the screening period to check they are not using prohibited medications and to remind them about the facial hygiene requirements. * Once the screening period has been completed, the study duration will be up to 13 months for each participant * Participants will be invited to a long-term extension study through a separate protocol.
Trial Details
NCT Number NCT07756957
Lead Sponsor Sanofi
Conditions
(from sponsor)
Acne
Related terms Acne Vulgaris
Enrollment 410 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov