J10 NULL NULL
Conditions
Interventions
Participants will receive
a single 0.5 mL dose for
intramuscular injection
of the VAXIGRIPTETRA
vaccine (Sanofi
Pasteur) -
Participants will receive
a single 0.5 mL dose for
int
Sponsors
PERUVIAN CLINICAL RESEARCH S.A.C.
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: - 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
Exclusion criteria
Exclusion criteria: -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.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 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. NAME OF THE RESULT: Immunogenicity (seroconversion) PERIOD OF TIME WHERE TE MEASUREMENT WILL BE CONDUCTED AND WHICH WILL ALLOW OBTAINING THE PRIMARY RESULT: At the end of the season | — |
Secondary
| Measure | Time frame |
|---|---|
| Wilcoxon signed rank test NAME OF THE RESULT: Post-vaccination immune responses, approximately 28 days after vaccination and at the end of the season, among HCPs without a history of influenza infection confirmed by PCR. PERIOD OF TIME WHERE TE MEASUREMENT WILL BE CONDUCTED AND WHICH WILL ALLOW OBTAINING THE PRIMARY RESULT: At the end of the follow-up ;Descriptive statistics. Generalized linear models (GLM) with Poisson or binomial functions as appropriate NAME OF THE RESULT: Risk factors for suboptimal response (lack of seroconversion/ seroprotection PERIOD OF TIME WHERE TE MEASUREMENT WILL BE CONDUCTED AND WHICH WILL ALLOW OBTAINING THE PRIMARY RESULT: At the end of the follow-up ;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. NAME OF THE RESULT: Immunogenicity (seroconversion) PERIOD OF TIME WHERE TE MEASUREMENT WILL BE CONDUCTED AND WHICH WILL ALLOW OBTAINING THE PRIMARY RESULT: At the end of the season ;Wilcoxon signed rank test NAME OF THE RESULT: Post-vaccination immune responses, approximately 28 days after vaccination and at the end of the season, among HCPs with a history of influenza infection confirmed by PCR PERIOD OF TIME WHERE TE MEASUREMENT WILL BE CONDUCTED AND WHICH WILL ALLOW OBTAINING THE PRIMARY RESULT: At the end of the follow-up ;Descriptive statistics. Multivariable logistic regression model NAME OF THE | — |
Countries
Peru
Contacts
Public ContactRAUL FLORENTINO HERNAN YEPEZ
PERUVIAN CLINICAL RESEARCH S.A.C.
Outcome results
None listed