Safety, Tolerability, and Immunogenicity of VAL-506440 in Healthy Adult Subjects

Phase 1

Completed

• Conditions: Influenza
• Interventions: Biological: VAL-506440; Other: Placebo

• Registration Number: NCT03076385
• Lead Sponsor: ModernaTX, Inc.

Brief Summary

This clinical study will assess the safety, tolerability and immunogenicity of VAL-506440 in healthy adult subjects.

Detailed Description

Not available

Study Timeline

• Study Start: 2015-12
• Study First Submitted: 2017-03-02
• Study First Submitted QC: 2017-03-06
• Study First Posted: 2017-03-10
• Primary Completion: 2018-10
• Study Completion: 2018-10
• Status Verified: 2022-04
• Last Update Submitted: 2022-04-21
• Last Update Posted: 2022-04-22

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 201

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
VAL-506440	VAL-506440	-
Placebo	Placebo	-

Primary Outcome Measures

Name	Time	Method
Types, frequency, and severity of serious adverse events (SAE), adverse events of special interest (AESI), and adverse events considered related to study drug	Through 13 months of study participation

Secondary Outcome Measures

Name	Time	Method
Frequency of hemagglutinin inhibition (HAI) seroconversion measured by a neutralization assay in comparison with baseline samples	Through 13 months of study participation
Frequency of microneutralization seroconversion measured by a neutralization assay in comparison with baseline samples	Through 13 months of study participation