NCT04528719

A Dose Escalation Study to Evaluate Safety, Reactogenicity, and Immunogenicity of mRNA-1345 in Healthy Adults and in Children Who Are Respiratory Syncytial Virus (RSV)-Seropositive

A Phase 1, Randomized, Observer-Blind, Placebo-Controlled, Dose Escalation Study to Evaluate the Safety, Reactogenicity, and Immunogenicity of mRNA-1345, an mRNA Vaccine Targeting Respiratory Syncytial Virus (RSV), in Healthy Younger Adults Aged 18 to 49 Years, Women of Child-Bearing Potential Aged 18 to 40 Years, Healthy Older Adults Aged 65 to 79 Years, Japanese Older Adults Aged ≥ 60 Years, and RSV-Seropositive Children Aged 12 to 59 Months

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 651 (actual)
• Sponsor: ModernaTX, Inc. · Industry
• Sex: All
• Age: 12 Months – 79 Years
• Healthy volunteers: Accepted

Summary

The primary objectives of this study are to evaluate the tolerability and reactogenicity of a single injection of up to 5 dose levels of mRNA-1345 in younger adults, women of child-bearing potential, and older adults including Japanese older adults; of 3 injections of the middle dose level of mRNA-1345 given 56 days apart in younger adults; of a booster injection of mRNA-1345 given approximately 12 and 24 months after the primary injection in older adults; and of 3 injections of 1 of 2 dose levels of mRNA-1345 given 56 days apart in children who are RSV-seropositive.

Conditions

• Respiratory Syncytial Virus

Interventions

Type	Name	Description
BIOLOGICAL	mRNA-1345	Formulation for injection
DRUG	Placebo	0.9% sodium chloride (normal saline) injection

Timeline

• Start date: 2020-09-30
• Primary completion: 2024-07-18
• Completion: 2024-07-18
• First posted: 2020-08-27
• Last updated: 2024-08-07

Locations

31 sites across 1 country: United States

Regulatory

• FDA-regulated drug study