Phase Ⅲ, Clinical Trial to Compare an Inactivated Quadrivalent Influenza Vaccine and a Licensed Vaccine in Chile

NCT05494047 | Unknown Phase 3 DMC

• 1 other identifier: PRO-QINF-3004
• Study Type: interventional
• Target: 1,600
• Locations: 1 country
• Sites: 5

Brief Summary

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.

Conditions

Influenza; Vaccines

Keywords

influenza; vaccine; immunogenicity; clinical-trial

Outcome Measures

Primary Outcomes (1)

• Seroconversion for influenza

  Seroconversion rates and geometric mean titers of human influenza antibody for each of the four antigens.

  28 days after the last dose of vaccination

Secondary Outcomes (4)

• Antibody titer 1:40 or more

  28 days after the last dose of vaccination

• Cellular immunity-ELISPOT

  28 days after the last dose

• Cellular immunity-Cytometry

  28 days after the last dose

• Cellular immunity-Luminex (TM)

  28 days after the last dose

Other Outcomes (2)

• Adverse events (AEs)

  Solicited AEs within 7 days after each dose and unsolicited AEs within 28 days after each dose

• Serious adverse events

  Within 28 days after each dose

Study Arms (2)

Tetravalent influenza vaccine developed by Sinovac Biotech Co.

EXPERIMENTAL

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.

Vaxigrip Tetra TM

ACTIVE COMPARATOR

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.

Interventions

Tetravalent influenza vaccine developed by Sinovac Biotech Co. DRUG

15μg Hemagglutinin Antigen (HA) of each of the four strains

Also known as: Sinovac vaccine

Tetravalent influenza vaccine developed by Sinovac Biotech Co.; Vaxigrip Tetra TM

Eligibility Criteria

• Age: 3 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• Volunteers age 3 years and older, in good health or medically stable;
• Written informed consent obtained from subjects or/and legal guardian;
• No receipt of influenza vaccines within 6 months or plans to receive any influenza vaccines during the study;
• Female subjects of non-childbearing may be enrolled in the study. Nonchildbearing potential is defined as surgically sterile (history of bilateral tubal ligation, bilateral oophorectomy, hysterectomy) or premenarche or postmenopausal (defined as amenorrhea for ≥ 12 consecutive months prior to screening without an alternative medical cause).
• Female subjects of childbearing potential may be enrolled in the study, if the subject:
• Has a negative pregnancy test on the day of the first dose (day 0);
• Has practiced adequate contraception or has abstained from all activities that could result in pregnancy for at least 28 days prior to the first dose and until at least 28 days after vaccination.

You may not qualify if:

• History of seasonal influenza within 6 months prior to the study entry;
• Axillary temperature ≥37.3℃;
• History of Guillain-Barré syndrome within 6 weeks of receipt of prior influenza vaccine.
• History of allergy to any vaccine, or any ingredient of the experimental vaccine.
• Serious adverse reaction(s) to the vaccine, such as urticaria, dyspnea or angioneurotic edema, etc.;
• History of serious neurological disorder (such as epilepsy, convulsions, etc.) , or mental illness;
• Autoimmune disease or immunodeficiency/immunosuppressive, or any immunosuppressant receipt within 6 months prior to the study entry;
• Significant chronic illnesses that, in the opinion of the investigator, is at a stage where it might interfere with trial conduct or completion (may include, but are not limited to cardiovascular disease, hypertension and diabetes that cannot be controlled by drugs, liver or kidney disorders, HIV infection or malignant tumor;
• Acute central nervous system diseases such as encephalitis/myelitis, acute disseminating encephalomyelitis, and related disorders;
• Absence of spleen, functional absence of spleen, and absence or removal of spleen under any circumstances;
• Diagnosed coagulation function abnormal (e.g., coagulation factor deficiency, coagulation disorder, or platelet abnormalities), or obvious bruising or coagulation disorders;
• Alcoholism or history of drug abuse
• Acute disease or acute stage of chronic disease within 7 days prior to study entry;
• Received blood products within 3 months prior to study entry;
• Received any live attenuated vaccine within 14 days prior to study entry or any subunit vaccine or inactivated vaccine within 7 days prior to study entry;

Sponsors & Collaborators

• Pontificia Universidad Catolica de Chile: lead
• Sinovac Biotech (Chile) SpA: collaborator
• Sinovac Biotech Co., Ltd: collaborator

Study Sites (5)

Hospital Puerto Montt

Port Montt, Los Lagos Region, Chile

RECRUITING

Centro de Investigaciones Médicas Respiratorias (CIMER)

Providencia, Santiago Metropolitan, 7500657, Chile

RECRUITING

Hospital Clínico UC Christus

Santiago, Santiago Metropolitan, 8330024, Chile

RECRUITING

Hospital Félix Bulnes

Santiago, Santiago Metropolitan, 9110056, Chile

RECRUITING

Clínica Alemana de Santiago

Vitacura, Santiago Metropolitan, 7650567, Chile

RECRUITING

Related Publications (9)

• Vaccines against influenza WHO position paper - November 2012. Wkly Epidemiol Rec. 2012 Nov 23;87(47):461-76. No abstract available. English, French.

  PMID: 23210147 BACKGROUND

• Reed C, Meltzer MI, Finelli L, Fiore A. Public health impact of including two lineages of influenza B in a quadrivalent seasonal influenza vaccine. Vaccine. 2012 Mar 2;30(11):1993-8. doi: 10.1016/j.vaccine.2011.12.098. Epub 2012 Jan 5.

  PMID: 22226861 BACKGROUND

• Lee BY, Bartsch SM, Willig AM. The economic value of a quadrivalent versus trivalent influenza vaccine. Vaccine. 2012 Dec 14;30(52):7443-6. doi: 10.1016/j.vaccine.2012.10.025. Epub 2012 Oct 19.

  PMID: 23084849 BACKGROUND

• Jain VK, Domachowske JB, Wang L, Ofori-Anyinam O, Rodriguez-Weber MA, Leonardi ML, Klein NP, Schlichter G, Jeanfreau R, Haney BL, Chu L, Harris JS, Sarpong KO, Micucio AC, Soni J, Chandrasekaran V, Li P, Innis BL. Time to Change Dosing of Inactivated Quadrivalent Influenza Vaccine in Young Children: Evidence From a Phase III, Randomized, Controlled Trial. J Pediatric Infect Dis Soc. 2017 Mar 1;6(1):9-19. doi: 10.1093/jpids/piw068.

  PMID: 28062552 BACKGROUND

• Cadorna-Carlos JB, Nolan T, Borja-Tabora CF, Santos J, Montalban MC, de Looze FJ, Eizenberg P, Hall S, Dupuy M, Hutagalung Y, Pepin S, Saville M. Safety, immunogenicity, and lot-to-lot consistency of a quadrivalent inactivated influenza vaccine in children, adolescents, and adults: A randomized, controlled, phase III trial. Vaccine. 2015 May 15;33(21):2485-92. doi: 10.1016/j.vaccine.2015.03.065. Epub 2015 Apr 2.

  PMID: 25843270 BACKGROUND

• Mallory RM, Yu J, Kameo S, Tanaka M, Rito K, Itoh Y, Dubovsky F. The safety and efficacy of quadrivalent live attenuated influenza vaccine in Japanese children aged 2-18 years: Results of two phase 3 studies. Influenza Other Respir Viruses. 2018 Jul;12(4):438-445. doi: 10.1111/irv.12555. Epub 2018 Apr 10.

  PMID: 29573143 BACKGROUND

• Claeys C, Drame M, Garcia-Sicilia J, Zaman K, Carmona A, Tran PM, Miranda M, Martinon-Torres F, Thollot F, Horn M, Schwarz TF, Behre U, Merino JM, Sadowska-Krawczenko I, Szymanski H, Schu P, Neumeier E, Li P, Jain VK, Innis BL. Assessment of an optimized manufacturing process for inactivated quadrivalent influenza vaccine: a phase III, randomized, double-blind, safety and immunogenicity study in children and adults. BMC Infect Dis. 2018 Apr 18;18(1):186. doi: 10.1186/s12879-018-3079-8.

  PMID: 29669531 BACKGROUND

• Beran J, Peeters M, Dewe W, Raupachova J, Hobzova L, Devaster JM. Immunogenicity and safety of quadrivalent versus trivalent inactivated influenza vaccine: a randomized, controlled trial in adults. BMC Infect Dis. 2013 May 20;13:224. doi: 10.1186/1471-2334-13-224.

  PMID: 23688546 BACKGROUND

• Greenberg DP, Robertson CA, Noss MJ, Blatter MM, Biedenbender R, Decker MD. Safety and immunogenicity of a quadrivalent inactivated influenza vaccine compared to licensed trivalent inactivated influenza vaccines in adults. Vaccine. 2013 Jan 21;31(5):770-6. doi: 10.1016/j.vaccine.2012.11.074. Epub 2012 Dec 8.

  PMID: 23228813 BACKGROUND

MeSH Terms

Conditions

Influenza, Human

Interventions

sinovac COVID-19 vaccine

Condition Hierarchy (Ancestors)

Respiratory Tract Infections; Infections; Orthomyxoviridae Infections; RNA Virus Infections; Virus Diseases; Respiratory Tract Diseases

Study Officials

• Pablo A Gonzalez, PhD

  Pontifical Catholic University of Chile

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Pablo A Gonzalez, PhD

CONTACT

+56226862842; pagonzalez@bio.puc.cl

Mario A Calvo, MD

CONTACT

+56999676538; macalvo@uach.cl

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Masking Details: Subjects will be randomized by a computer system. Investigators and care providers will not be able to know the vaccine administered. Statistical analysis will not have access to the information of immunization. Nonetheless, personnel study who will administer the vaccine will know the group because they will have access to the envelope of the vaccine then this personnel will not have any other responsibility during the study moreover, they will not have mantain regular contact with investigational team.
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: Individuals will be randomized to receive Vaxigrip Tetrs TM or equivalent vaccine developed by Sinovac Biotech Co. It is a a comparative, double blind, propsective clinical trial with 2 active compunds.

Study Record Dates

• First Submitted: August 7, 2022
• First Posted: August 9, 2022
• Study Start: July 14, 2022
• Primary Completion: May 31, 2023
• Study Completion: July 31, 2023
• Last Updated: August 9, 2022

Record last verified: 2022-08

Data Sharing

• IPD Sharing: Will not share

Locations

CL (5)