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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

NCT04144348 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 51

Last updated 2023-02-03

No results posted yet for this study

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

BIOLOGICAL

mRNA-1653

Sterile liquid for injection

BIOLOGICAL

Placebo

Sterile liquid for injection

Sponsors & Collaborators

  • ModernaTX, Inc.

    lead INDUSTRY

Study Design

Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
TRIPLE
Model
SEQUENTIAL

Eligibility

Min Age
12 Months
Max Age
49 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2019-11-04
Primary Completion
2022-12-20
Completion
2022-12-20
FDA Drug
Yes

Countries

  • United States

Study Locations

More Related Trials

Entities

Drugs

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04144348 on ClinicalTrials.gov