Randomized Controlled Trial, Double Blind, Phase III, to Evaluate the Immunogenicity of an Adjuvanted Influenza Vaccine Among Health Care Personnel (EDUCATE)

NAMRU6.2019.0011

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.

2022-11-04

2023-07-25

2024-03-31

Active (not recruiting)

Early phase I

192

Inclusion Criteria: * ≥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: 1. Have a negative urine pregnancy test performed by the study staff ≤24 hours preceding receipt of the vaccine; 2. 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; 3. Must not be breastfeeding. Exclusion Criteria: * 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.

{'studyType': 'INTERVENTIONAL', 'phases': ['PHASE3'], 'designInfo': {'allocation': 'RANDOMIZED', 'interventionModel': 'PARALLEL', 'primaryPurpose': 'PREVENTION', 'maskingInfo': {'masking': 'QUADRUPLE', 'whoMasked': ['PARTICIPANT', 'CARE_PROVIDER', 'INVESTIGATOR', 'OUTCOMES_ASSESSOR']}}, 'enrollmentInfo': {'count': 192, 'type': 'ACTUAL'}}

2024-02-23