MedTrace Logo

Study to Assess Safety and Immunogenicity of an Egg-based H5N8 Influenza Vaccine at Multiple Dose Levels Adjuvanted With Matrix-M in Healthy Participants 18 Years of Age and Above.

NCT07779408 · Status: NOT_YET_RECRUITING · Phase: PHASE1/PHASE2 · Type: INTERVENTIONAL · Enrollment: 640

Last updated 2026-08-21

No results posted yet for this study

Summary

The study aims to evaluate an egg-based H5N8 influenza vaccine up to 3 dose levels (low, medium, and high dose) given with or without adjuvant to see if the adjuvant improves vaccine effectiveness.

The study will enroll healthy adults aged 18 years and over. Participants will receive 2 injections in their arm of either one of the 3 dose levels of the study vaccine (low, medium, or high dose) with the adjuvant or the unadjuvanted vaccine (high dose).

Study duration per participant: approximately 14 months (including screening visit).

Conditions

Interventions

BIOLOGICAL

Flu H5 egg pandemic low dose vaccine, with adjuvant

Pharmaceutical form: Suspension for injection Route of administration: Intramuscular (IM)

BIOLOGICAL

Flu H5 Egg Pandemic medium dose vaccine, with adjuvant

Pharmaceutical form: Suspension for injection Route of administration: Intramuscular (IM)

BIOLOGICAL

Flu H5 Egg Pandemic high dose vaccine, with adjuvant

Pharmaceutical form: Suspension for injection Route of administration: Intramuscular (IM)

BIOLOGICAL

Flu H5 Egg Pandemic high dose vaccine, without adjuvant

Pharmaceutical form: Suspension for injection Route of administration: Intramuscular (IM)

Sponsors & Collaborators

Study Design

Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
DOUBLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2026-08-10
Primary Completion
2028-02-22
Completion
2028-02-22
FDA Drug
Yes

More Related Trials

Entities

Diseases
Companies

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 NCT07779408 on ClinicalTrials.gov