NCT04144348

Safety and Immunogenicity of mRNA-1653, a Combined Human Metapneumovirus (hMPV) and Parainfluenza Virus Type 3 (PIV3) Vaccine, in Healthy Adults, and Children 12 to 59 Months of Age With Serologic Evidence of Prior Exposure

A Phase 1b, Randomized, Observer-Blind, Placebo-Controlled, Dose Ranging Trial to Evaluate the Safety and Immunogenicity of mRNA-1653, a Combined Human Metapneumovirus (hMPV) and Parainfluenza Virus Type 3 (PIV3) Vaccine When Administered to Adults, and to Children 12 to 59 Months of Age With Serologic Evidence of Prior Exposure

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 51 (actual)
• Sponsor: ModernaTX, Inc. · Industry
• Sex: All
• Age: 12 Months – 49 Years
• Healthy volunteers: Accepted

Summary

This clinical study will assess the safety and immunogenicity of 2 dose levels of mRNA-1653, a combined human metapneumovirus and human parainfluenza virus type 3 vaccine, in healthy adults (18 to 49 years of age) and 2 dose levels in children (12 to 59 months of age) with serologic evidence of prior exposure. The safety profile of the adult cohort will permit enrollment of the pediatric cohort.

Conditions

• Human Metapneumovirus and Human Parainfluenza Infection

Interventions

Type	Name	Description
BIOLOGICAL	mRNA-1653	Sterile liquid for injection
BIOLOGICAL	Placebo	Sterile liquid for injection

Timeline

• Start date: 2019-11-04
• Primary completion: 2022-12-20
• Completion: 2022-12-20
• First posted: 2019-10-30
• Last updated: 2023-02-03

Locations

19 sites across 1 country: United States

Regulatory

• FDA-regulated drug study