Randomized, double-blind, phase III clinical study to evaluate the immunogenicity of an influenza vaccine with adjuvant in health personnel (EDUCATE)
- Conditions
- J10 NULL
- Registration Number
- PER-015-21
- Lead Sponsor
- PERUVIAN CLINICAL RESEARCH S.A.C.
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Enrollment closed
- Sex
- All
- Target Recruitment
- 274
- Have participated in the health personnel cohort study between 2016 and 2021
- Be of legal age = 18 years
- Work at the facility full time (=30 hours per week)
- Have routine, direct, practical or face-to-face contact with patients (within 1 meter) as part of a typical work shift, including but not limited to doctors, nurses, respiratory therapists, physiotherapists, unit employees, X-ray technicians, medical assistants, and transporters
- Work at the facility for = 1 year prior to enrollment and plan to continue working at the facility for one year after enrollment
- Willing to receive the influenza vaccine (AD / SD)
- Female participants must meet the following criteria:
• Negative urine pregnancy test, performed by study staff within 24 hours prior to vaccination.
• Be willing to use an effective form of contraception, provided by the Investigator (eg oral or injectable contraceptive), for at least two months after receiving the vaccine. If you are not using, we will facilitate access to contraceptives.
• Not be breastfeeding
-Be vaccinated against influenza in the current season (20212influenza season or season)
- You have severe and life-threatening allergies to influenza vaccines, eggs, or components of the influenza vaccine.
- You have a history of Guillain-Barre Syndrome or other autoimmune diseases.
- Have received blood or blood products within the 3 months prior to enrollment.
- Being pregnant, confirmed by urine test.
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Hemagglutination inhibition (HI) geometric titer (GMT) of =1: 40 in the case of pre-vaccination HI GMT <1:10 or have a four-fold increase in titer in the case of HI vaccination GMT =1 : 10. We will also measure HI GMT at the end of the season. Seroprotection will be defined as having a GMT HI =1: 40.<br> NAME OF THE RESULT: Immunogenicity<br>(seroconversion)<br> PERIOD OF TIME WHERE TE MEASUREMENT WILL BE CONDUCTED AND WHICH WILL ALLOW OBTAINING THE<br> PRIMARY RESULT: At the end of the season
- Secondary Outcome Measures
Name Time Method