CI

At a glance

ClinicalIndex Comparison Record
Phase 1Completed· 122 enrolled
Drug / intervention
Sing2016 M2SR H3N2 influenza vaccine +1 morebiological
Likely dose
Not stated in record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT04785794
NCT04785794Phase 1Completed
CompareCT.gov

Phase 1b Clinical Study to Investigate the Safety and Immunogenicity of the Sing2016 (A/Singapore/INFIMH-16-0019/2016) M2SR H3N2 Monovalent Influenza Vaccine in Adults Ages 50 to 85 Years Old.

FluGen Inc·interventional·Posted Mar 8, 2021·Updated Jun 15, 2023

In Brief

A Phase 1 clinical trial evaluating Sing2016 M2SR H3N2 influenza vaccine and Placebo for Influenza Vaccine. Completed, enrolled 122 participants across 3 sites.

Detailed 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.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsInfluenza Vaccine
CountriesUnited States
CollaboratorsNational Institute of Allergy and Infectious Diseases (NIAID)

Timeline

Phase 1CompletedFinished
20222023202420252026
First PostedMar 8, 2021
Enrollment StartJun 30, 2021
Primary CompletionNov 30, 2021
TodayJul 2, 2026
Enrollment to primary: 5 monthsPosted 5.3 years ago

Interventions

Sing2016 M2SR H3N2 influenza vaccinebiological

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.

Placeboother

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