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Safety and Immunogenicity of the Sing2016 M2SR H3N2 Monovalent Influenza Vaccine in Adults Ages 50 to 85 Years Old

NCT04785794 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 122

Last updated 2023-06-15

Study results available
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Summary

This is a randomized, double-blind, placebo-controlled Phase 1b study to evaluate safety and immunogenicity of the investigational Sing2016 M2SR H3N2 influenza vaccine delivered intranasally to a healthy adult population age 50 to 85 years.

Conditions

  • Influenza Vaccine

Interventions

BIOLOGICAL

Sing2016 M2SR H3N2 influenza vaccine

This group will receive a dose of the Sing2016 M2SR H3N2 monovalent influenza vaccine administered intranasally on Day 1 followed by IIV at least 28 days later.

OTHER

Placebo

This group will receive saline placebo administered intranasally on Day 1 followed by IIV at least 28 days later.

Sponsors & Collaborators

  • National Institute of Allergy and Infectious Diseases (NIAID)

    collaborator NIH

  • FluGen Inc

    lead INDUSTRY

Principal Investigators

  • Pamuk Bilsel · FluGen Inc

Study Design

Allocation
RANDOMIZED
Purpose
BASIC_SCIENCE
Masking
QUADRUPLE
Model
SEQUENTIAL

Eligibility

Min Age
50 Years
Max Age
85 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2021-06-30
Primary Completion
2021-11-30
Completion
2021-11-30
FDA Drug
Yes

Countries

  • United States

Study Locations

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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 NCT04785794 on ClinicalTrials.gov