Clinical Trial to Evaluate the Immunogenicity of an Adjuvanted Influenza Vaccine Among HCP

NCT06054269 | Active Not Recruiting Phase 3 Results FDA Drug

• 1 other identifier: NAMRU6.2019.0011
• Study Type: interventional
• Target: 192
• Locations: 1 country
• Sites: 2

Brief Summary

This randomized, double-blinded trial will assess humoral immune responses to adjuvanted, egg-based quadrivalent influenza vaccines compared to standard dose, egg-based quadrivalent influenza vaccines among healthcare personnel (HCP). The trial will be conducted at two sites in Lima, Peru during 2022 and 2023.

Conditions

Influenza

Outcome Measures

Primary Outcomes (6)

• Hemagglutination Inhibition (HI) Geometric Mean Titers (GMT) Post-vaccination (Day 28) of Each Vaccine Reference Virus

  The geometric mean of antibody titers after a single dose of FLUAD Quadrivalent (adjuvanted dose, AD) vs. FluQuadri (standard dose, SD) as measured by HI assay for egg-grown influenza A(H1N1)pdm09, A(H3N2), B/Yamagata, and B/Victoria vaccine reference viruses at approximately 28 days post-vaccination

  28 days post-vaccination

• HI GMT Post-vaccination (6 Months) of Each Vaccine Reference Virus

  The geometric mean of antibody titers after a single dose of AD vs SD vaccine as measured by HI assay for egg-grown influenza A(H1N1)pdm09, A(H3N2), B/Yamagata, and B/Victoria vaccine reference viruses at approximately 6 months post-vaccination

  6 months post-vaccination

• Seroconversion Rate (SCR) to Each Vaccine Reference Virus Post-vaccination

  The percent of participants with paired samples that achieved ≥4-fold rises comparing post- (approximately 28 days) versus pre-vaccination titers, and post-vaccination titers ≥40 for each vaccine reference virus (egg-grown influenza A(H1N1)pdm09, A(H3N2), B/Yamagata, and B/Victoria vaccine reference viruses) following a single dose of AD vs. SD vaccine.

  28 days post-vaccination

• SCR to Each Vaccine Reference Virus Post-vaccination

  The percent of participants with paired samples that achieved ≥4-fold rises comparing post- (approximately 6 months) versus pre-vaccination titers, and post-vaccination titers ≥40 for each vaccine reference virus (egg-grown influenza A(H1N1)pdm09, A(H3N2), B/Yamagata, and B/Victoria vaccine reference viruses) following a single dose of AD vs. SD vaccine.

  6 months post-vaccination

• Seroprotection Rate (SPR) to Each Vaccine Reference Virus Post-vaccination

  The percent of participants with post-vaccination titers ≥40 for each vaccine reference virus (egg-grown influenza A(H1N1)pdm09, A(H3N2), B/Yamagata, and B/Victoria vaccine reference viruses) following a single dose of AD vs. SD vaccine.

  28 days post-vaccination

• SPR to Each Vaccine Reference Virus Post-vaccination

  The percent of participants with post-vaccination titers ≥40 for each vaccine reference virus (egg-grown influenza A(H1N1)pdm09, A(H3N2), B/Yamagata, and B/Victoria vaccine reference viruses) following a single dose of AD vs. SD vaccine.

  6 months post-vaccination

Study Arms (2)

FLUAD Quadrivalent

EXPERIMENTAL

Participants administered a single dose of adjuvanted egg-based quadrivalent influenza vaccine (FLUAD Quadrivalent by Seqirus, 15 µg of HA from each strain).

Biological: FLUAD Quadrivalent

FluQuadri

ACTIVE COMPARATOR

Participants administered a single dose of standard dose egg-based quadrivalent influenza vaccine (FluQuadri by Sanofi-Pasteur, 15 µg of HA from each strain).

Biological: FluQuadri

Interventions

FLUAD Quadrivalent BIOLOGICAL

0.5 mL intramuscular dose of FLUAD Quadrivalent

FLUAD Quadrivalent

FluQuadri BIOLOGICAL

0.5 mL intramuscular dose of FluQuadri

FluQuadri

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• ≥18 years old;
• Have participated in the healthcare personnel cohort study at Hospital Nacional Cayetano Heredia or Hospital Nacional Arzobispo Loayza during 2016-2021;
• Work at the facility full-time (≥30 hours per week);
• Have routine, direct, hands-on or face-to-face contact with patients (≤1 meter) as part of a typical work shift, including, but not limited to, physicians, nurses, respiratory therapists, physical therapists, unit clerks, radiograph technicians, medical assistants, and transporters;
• Work at the facility for ≥1 year prior to enrollment and planning to continue working at the facility for one year after enrollment;
• Willing to receive influenza vaccination (adjuvanted or standard dose);
• Women of childbearing age must complete the following criteria to be eligible:
• Have a negative urine pregnancy test performed by the study staff ≤24 hours preceding receipt of the vaccine;
• Be willing to use a reliable form of contraception approved by the Investigator for ≤2 months after receiving the vaccine. If they are not currently using an approved contraceptive, study staff will provide access to contraceptives;
• Must not be breastfeeding.

You may not qualify if:

• Have received a vaccine against influenza during the 2022 influenza season (season of clinical trial);
• Have a severe, life-threatening allergy to influenza vaccines, eggs, or influenza vaccine components;
• Have a history of Guillain-Barre Syndrome or other autoimmune diseases;
• Received blood or blood products within 3 months of enrollment;
• Be pregnant, confirmed by rapid pregnancy test.

Sponsors & Collaborators

• Centers for Disease Control and Prevention: lead
• Peruvian Clinical Research: collaborator
• Hospital Nacional Cayetano Heredia: collaborator
• Hospital Nacional Arzobispo Loayza: collaborator
• U.S. Naval Medical Research Unit No.6 (NAMRU-6): collaborator

Study Sites (2)

Hospital Nacional Arzobispo Loayza

Lima, 15082, Peru

Location

Hospital Nacional Cayetano Heredia

Lima, 15102, Peru

Location

Related Publications (1)

• Marcenac P, Soto G, Yau T, Carreon JD, Romero C, Gonzales M, La Rosa S, Arriola CS, Prouty M, Diaz RAH, Romero FA, Llanos-Cuentas A, Prado EDM, Silva M, Fowlkes A, Levine MZ, Azziz-Baumgartner E, Duca LM, Neyra J. Comparison of the immunogenicity of adjuvanted and conventional egg-based quadrivalent influenza vaccines among healthcare personnel in Lima, Peru: A randomized controlled trial. Int J Infect Dis. 2026 Jan;162:108205. doi: 10.1016/j.ijid.2025.108205. Epub 2025 Nov 11.

  PMID: 41232749 DERIVED

MeSH Terms

Conditions

Influenza, Human

Condition Hierarchy (Ancestors)

Respiratory Tract Infections; Infections; Orthomyxoviridae Infections; RNA Virus Infections; Virus Diseases; Respiratory Tract Diseases

Results Point of Contact

• Title: Perrine Marcenac
• Organization: CDC

pmarcenac@cdc.gov

6782830242

Study Officials

• Giselle Soto, MD, MPH

  Naval Medical Research Unit- 6

  PRINCIPAL INVESTIGATOR

• Roger Antonio Hernandez Diaz, MD, MSc

  Hospital Nacional Cayetano Heredia

  PRINCIPAL INVESTIGATOR

• Eduardo Demetrio Matos Prado, MD

  Hospital Nacional Arzobispo Loayza

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: FED
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 19, 2023
• First Posted: September 26, 2023
• Study Start: November 4, 2022
• Primary Completion: July 25, 2023
• Study Completion: March 31, 2026
• Last Updated: May 29, 2025
• Results First Posted: May 29, 2025

Record last verified: 2025-05

Data Sharing

• IPD Sharing: Will not share

Locations

PE (2)