NCT06118151|CompletedPhase 1FDA Drug

Safety and Immunogenicity of a Monovalent mRNA Vaccine Encoding Influenza Hemagglutinin in Adult Participants 18 Years of Age and Older

A Phase I, Parallel, Randomized, Active-controlled, Multi-center, Dose-escalation Study With Early Safety Data Reviews to Assess Safety and Immunogenicity of a Monovalent mRNA Vaccine Encoding Influenza Hemagglutinin in Adults 18 Years of Age and Older

Sanofi Pasteur, a Sanofi Company ClinicalTrials.gov

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2 other identifiers

VAV00018U1111-1271-2001

Study Type

interventional

Target

388

Locations

1 country

Sites

Timeline

RegisteredNov 2023

StartedApr 2022

CompletionFeb 2023

Brief Summary

The purpose of this study is to evaluate the safety and immunogenicity of a single intramuscular (IM) injection of different dose levels of messenger ribonucleic acid (mRNA) vaccine encoding influenza hemagglutinin compared to an active control quadrivalent recombinant influenza vaccine (RIV4) in adults 18 years of age and older. Study details include: Study Duration: approximately 6 months Treatment Duration: 1 injection of mRNA vaccine encoding influenza hemagglutinin encoding influenza hemagglutinin or control. Visit Frequency: Screening visit, Day 01, Day 02, Day 03, Day 09, Day 29, Day 91, Day 181

Trial Health

On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment

388

participants targeted

Target at P75+ for phase_1

Timeline

Completed

Started Apr 2022

Geographic Reach

1 country

20 active sites

Status

completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

10 months study duration

Study Start

First participant enrolled

April 11, 2022

Completed

10 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 17, 2023

Completed

Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

February 17, 2023

Completed

9 months until next milestone

First Submitted

Initial submission to the registry

October 31, 2023

Completed

7 days until next milestone

First Posted

Study publicly available on registry

November 7, 2023

Completed

Last Updated

November 7, 2023

Status Verified

October 1, 2023

Enrollment Period

10 months

First QC Date

October 31, 2023

Last Update Submit

October 31, 2023

Conditions

Influenza Influenza Immunization

Outcome Measures

Primary Outcomes (7)

Presence of any unsolicited systemic adverse events (AEs) reported in the 30 minutes after injection
Number of participants with unsolicited systemic immediate adverse events (AEs)
Within 30 minutes after injection
Presence of solicited injection site reactions (ie, pre listed in the participant's diary card [DC] and in the electronic case report form [eCRF]) occurring up to 7 days after injection
Number of participants with solicited injection site reactions
Up to 7 days after injection
Presence of solicited systemic reactions (ie, pre-listed in the participant's DC and in the eCRF) occurring up to 7 days after injection
Number of participants with solicited systemic reactions
Up to 7 days after injection
Presence of unsolicited AEs reported up to 28 days after injection
Number of participants with unsolicited AEs
Up to 28 days after injection
Presence of medically attended AEs (MAAEs) reported up to 28 days after injection
Number of participants with medically attended adverse events (MAAE)s
Up to 28 days after injection
Presence of serious adverse events (SAEs) and adverse events of special interest (AESIs) throughout the study
Number of participants with serious adverse events (SAEs)
From baseline up to 6 months
Presence of out-of-range biological test results (including shift from baseline values) up to 28 days after injection
Number of participants with out-of-range biological test results
Up to 28 days after injection

Secondary Outcomes (9)

Hemagglutination inhibition (HAI) antibody (Ab) titers to homologous H3 strain at D29, D91, and D181
At Day 29, Day 91, and Day 181
Individual HAI Ab titer ratio D29/D01, D91/D01, D91/D29, D181/D01, and D181/D29
From baseline up to 6 months
HAI Ab titer ≥ 40 [1/dil] at D29, D91, and D181
At Day 29, Day 91 and Day 181
2-fold and 4-fold rise in HAI titers from D01 to D91 and D01 to D181
From Day 01 through Day 91 and Day 01 through Day 181
Neutralizing Ab titers to homologous H3 strain at D29, D91, and D181
At Day 29, Day 91, and Day 181
+4 more secondary outcomes

Study Arms (6)

sentinel cohort 1

EXPERIMENTAL

20 Participants in each age group will receive either Influenza hemagglutinin mRNA vaccine candidate dose 1 or dose 2 and half number of the participants in each age group also receiving the RIV4 control