Status:
ACTIVE_NOT_RECRUITING
Clinical Trial to Evaluate the Immunogenicity of an Adjuvanted Influenza Vaccine Among HCP
Lead Sponsor:
Centers for Disease Control and Prevention
Collaborating Sponsors:
Peruvian Clinical Research
Hospital Nacional Cayetano Heredia
Conditions:
Influenza
Eligibility:
All Genders
18+ years
Phase:
PHASE3
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...
Detailed Description
The trial will be conducted at two hospital sites in Lima, Peru during 2022-2023 among HCP who were previously enrolled in the Cohort study of Influenza and other Respiratory Viruses among HCP in Peru...
Eligibility Criteria
Inclusion
- ≥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.
Exclusion
- 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.
Key Trial Info
Start Date :
November 4 2022
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
March 31 2026
Estimated Enrollment :
192 Patients enrolled
Trial Details
Trial ID
NCT06054269
Start Date
November 4 2022
End Date
March 31 2026
Last Update
May 29 2025
Active Locations (2)
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1
Hospital Nacional Arzobispo Loayza
Lima, Peru, 15082
2
Hospital Nacional Cayetano Heredia
Lima, Peru, 15102