A Phase 1, Dose-escalation, Blinded Study to Evaluate Safety, Reactogenicity, and Immunogenicity of mRNA-1010 in Healthy Children (9 to <18 Years of Age)
ModernaTX, Inc.
Summary
The purpose of this study is to evaluate safety, reactogenicity, and immunogenicity of mRNA-1010 in healthy children (9 to \<18 years of age).
Eligibility
- Age range
- 9–17 years
- Sex
- All
- Healthy volunteers
- Yes
Inclusion Criteria: * 9 to \<18 years of age inclusive, at the time of signing the informed consent/assent. * In the Investigator's opinion, the participants/participant's parent(s)/legally authorized representative (LAR(s)) demonstrate adequate understanding of the study requirements and are willing and physically able to comply with protocol mandated follow-up, including all procedures. * For female participants of childbearing potential: negative pregnancy test, adequate contraception or has abstained from all activities that could result in pregnancy for at least 28 days prior to Day 1, a…
Interventions
- BiologicalmRNA-1010
Suspension for injection
- BiologicalFluarix Trivalent
Suspension for injection
Locations (6)
- Paradigm Clinical Research Centers, LLCModesto, California
- Paradigm Clinical Research Centers, LLCAurora, Colorado
- Clinical Research Institute, IncMinneapolis, Minnesota
- Senders PediatricsSouth Euclid, Ohio
- West Houston Clinical Research ServiceHouston, Texas
- Clinical Research Partners, LLC.Richmond, Virginia