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Safety, Tolerability, Immunogenicity and Immunological Mechanisms of TETRALITE, a Novel Seasonal Influenza Vaccine

NCT06294262 · Status: ACTIVE_NOT_RECRUITING · Phase: PHASE1/PHASE2 · Type: INTERVENTIONAL · Enrollment: 84

Last updated 2024-07-29

No results posted yet for this study

Summary

The effect of LiteVax Adjuvant supplemented to licensed seasonal influenza vaccine on safety and immunogenicity will be investigated in both younger and older healthy participants. Local and systemic adverse events, and humoral and cellular immune responses will be determined at different time intervals after a single administration. Mode of action of LiteVax Adjuvant will examined by detailed genetic analysis and omics approaches such as transcriptomics, proteomics and metabolomics.

Conditions

  • Vaccination Reaction

Interventions

BIOLOGICAL

TETRALITE

Intramuscular injection of VaxigripTetra with or without LiteVax Adjuvant

Sponsors & Collaborators

  • University Hospital, Ghent

    collaborator OTHER

  • HarmonyCR, Melle, Belgium

    collaborator UNKNOWN

  • LiteVax BV

    lead INDUSTRY

Study Design

Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
TRIPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2024-01-29
Primary Completion
2024-09-30
Completion
2025-03-31

Countries

  • Belgium

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 NCT06294262 on ClinicalTrials.gov