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Safety and Immunogenicity of the Monovalent Influenza Vaccine A (H5N8) (Inactivated, Fragmented and Adjuvanted) in Adults and Older Adults

NCT06842173 · Status: RECRUITING · Phase: PHASE1/PHASE2 · Type: INTERVENTIONAL · Enrollment: 700

Last updated 2026-04-02

No results posted yet for this study

Summary

This study aims to demonstrate the safety and immunogenicity of two formulations of the monovalent influenza vaccine candidate A (H5N8) (inactivated, fragmented, and adjuvanted with IB160) from the Instituto Butantan in adults and older adults, to be developed for situations of pandemic, epidemic or outbreak of avian type A/H5 in humans, in the context of pandemic preparedness.

Conditions

  • Avian Influenza A Virus

Interventions

BIOLOGICAL

Monovalent Influenza Vaccine A (H5N8) (Inactivated, Fragmented, and Adjuvanted) 7.5 mcg

Monovalent Influenza Vaccine A (H5N8) (Inactivated, Fragmented, and Adjuvanted) 7.5 mcg + IB160 adjuvant (0.5mL total)

BIOLOGICAL

Monovalent influenza vaccine type A (H5N8) 15 mcg

Monovalent influenza vaccine type A (H5N8) 15 mcg + IB160 adjuvant (0.5mL total)

OTHER

Placebo

Phosphate buffered saline (PBS) (0.5 mL/dose).

Sponsors & Collaborators

  • Butantan Foundation

    collaborator OTHER

  • Butantan Institute

    lead OTHER_GOV

Study Design

Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2025-09-10
Primary Completion
2027-08-10
Completion
2027-10-10

Countries

  • Brazil

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 NCT06842173 on ClinicalTrials.gov