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Proof of Concept Trial of Adjuvant Activity of SWE, a Squalene-based -Oil-in-water Emulsion

NCT05035680 · Status: WITHDRAWN · Phase: PHASE1 · Type: INTERVENTIONAL

Last updated 2022-11-17

No results posted yet for this study

Summary

The purpose of the study is to characterize safety and tolerability of the squalene-based adjuvant candidate SWE and its potential to enhance the immune response to seasonal influenza vaccine antigens in healthy older adults.

Conditions

Interventions

BIOLOGICAL

Unadjuvanted seasonal influenza vaccine

Single 0.5 mL IM injection

BIOLOGICAL

SWE adjuvant mixed with unadjuvanted seasonal influenza vaccine shortly before dosing (SWE + QIV)

Single 0.8 mL IM injection

BIOLOGICAL

MF59 adjuvanted seasonal influenza vaccine

Single 0.5 mL IM injection of MF59 adjuvanted seasonal influenza vaccine

Sponsors & Collaborators

  • Iqvia Pty Ltd

    collaborator INDUSTRY

  • Gates Medical Research Institute

    lead OTHER

Principal Investigators

  • BM Gates MRI · Gates Medical Research Institute

Study Design

Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
TRIPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2022-07-14
Primary Completion
2023-03-25
Completion
2023-11-25

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Entities

Diseases

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 NCT05035680 on ClinicalTrials.gov