A Phase 3 interventional study of Tetravalent influenza vaccine developed by Sinovac Biotech Co. in Influenza and Vaccines, sponsored by Pontificia Universidad Catolica de Chile. Status unknown at 5 sites in Chile. Open to participants aged 3 Years and older, including healthy volunteers. Per ClinicalTrials.gov, last updated 2022-08-09.
Sponsored by Pontificia Universidad Catolica de Chile · Phase 3, Interventional, and Prevention
This study compares the immunogenity and safety of quadrivalent inactivated influenza vaccines. The experimental group receives the quadrivalent influenza vaccine developed by Sinovac Biotech Co., Ltd and the control group immunized with Vaxigrip Tetra™. The group has 1600 persons from general population 3 years and older. The design is double-blind and randomized. The primary outcome is the immunogenicity against the 4 strains of influenza included in both vaccines.
The study is designed to evaluate the immunogenicity of the quadrivalent inactivated-virus influenza vaccine developed by Sinovac Biotech Co., Ltd against Vaxigrip Tetra™. The population included in the study is healthy subjects 3 years and older, being 800 individuals 10 years old or less and 800 over 18 years, randomized 1:1 to experimental vaccine or Vaxigrip Tetra™. Volunteers 8 years old or less, without history of previous influenza infection will receive 2 doses of vaccine, al other individuals will receipt 1 dose of vaccine. Immunogenicity will be assessed one month after the last dose of vaccine, humoral responses will be determined for all patients meanwhile ome subgroup of patients will have a determination of cellular immunity also. Subjects will be follow up for one month, adverse events will be assessed during this time.
2,214 studies on the registry are indexed under Influenza, Human; 163 are open to participants now.
This study's planned enrollment of 1,600 is above the median of 238 across 1,853 interventional studies indexed under Influenza, Human.
Browse Influenza, Human studies →Pontificia Universidad Catolica de Chile is the lead sponsor of 215 studies on the registry; 56 are open to participants now.
Counted across the registry records on this site, refreshed daily.
Female subjects of childbearing potential may be enrolled in the study, if the subject:
Exclusion Criteria:
Any other factors which are unsuitable for participation in the clinical trial as judged by the investigator.
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The group will be formed by 800 individuals. 200 from 3 to 8 years old, 200 from 9 to 17 years old, 200 from 18 to 64 years old and 200 subjects 65 years and older. They will receive an unique dose of the tetravalent influenza vaccine developed by Sinovac Biotech Co.(H1N1, H3N2 and 2 strains of influenza B). Subjects 3 to 8 years will receive 2 doses of influenza vaccine unless they have receipt of 2 previous doses of any influenza vaccine or they have an history of previous influenza.
Drug: Tetravalent influenza vaccine developed by Sinovac Biotech Co.
The group will be formed by 800 individuals. 200 from 3 to 8 years old, 200 from 9 to 17 years old, 200 from 18 to 64 years old and 200 subjects 65 years and older. They will receive an unique dose of the tetravalent influenza vaccine Vaxigrip Tetra TM(H1N1, H3N2 and 2 strains of influenza B). Subjects 3 to 8 years will receive 2 doses of influenza vaccine unless they have receipt of 2 previous doses of any influenza vaccine or they have an history of previous influenza.
Drug: Tetravalent influenza vaccine developed by Sinovac Biotech Co.
15μg Hemagglutinin Antigen (HA) of each of the four strains
Also known as: Sinovac vaccine
Seroconversion for influenza
Seroconversion rates and geometric mean titers of human influenza antibody for each of the four antigens.
Time frame: 28 days after the last dose of vaccination
Antibody titer 1:40 or more
Proportion of subjects with antibody titer ≥1:40
Time frame: 28 days after the last dose of vaccination
Cellular immunity-ELISPOT
Quantification by ELISPOT of specific Spot Forming Cells for cytokines, molecules and immunoglobulins induced by both vaccines
Time frame: 28 days after the last dose
Cellular immunity-Cytometry
Quantification by flow cytometry of CD3+CD4+ and CD3+CD8+ cells positive for Activation Induced Markers, induced by both vaccines.
Time frame: 28 days after the last dose
Cellular immunity-Luminex (TM)
• Quantification by Luminex® of cytokines secreted by specific CD3+CD4+ and CD3+CD8+ cells induced by each vaccine
Time frame: 28 days after the last dose
Adverse events (AEs)
Local and systemic AEs
Time frame: Solicited AEs within 7 days after each dose and unsolicited AEs within 28 days after each dose
Serious adverse events
Ocurrence and relationship of serious adverse events
Time frame: Within 28 days after each dose
Plan to share: No
This study is status unknown, as verified in Aug 2022. You cannot join it, but the record below documents what was studied.
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Pontificia Universidad Catolica de Chile