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

NCT ID: NCT05494047

Last Updated: 2022-08-09

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: PHASE3
• Total Enrollment: 1600 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2022-07-14
• Study Completion Date: 2023-07-31

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.

Detailed Description

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.

Conditions

Influenza; Vaccines

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: PREVENTION
• Blinding Strategy: QUADRUPLE

Study Groups

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 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.

Group Type: EXPERIMENTAL

Tetravalent influenza vaccine developed by Sinovac Biotech Co.

Intervention Type: DRUG

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

Vaxigrip Tetra TM

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.

Group Type: ACTIVE_COMPARATOR

Tetravalent influenza vaccine developed by Sinovac Biotech Co.

Intervention Type: DRUG

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

Interventions

Tetravalent influenza vaccine developed by Sinovac Biotech Co.

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

Intervention Type: DRUG

Other Intervention Names

Sinovac vaccine

Eligibility Criteria

Inclusion Criteria

1. Volunteers age 3 years and older, in good health or medically stable;

2. Written informed consent obtained from subjects or/and legal guardian;

3. No receipt of influenza vaccines within 6 months or plans to receive any influenza vaccines during the study;

4. 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).

5. 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.

Exclusion Criteria

1. History of seasonal influenza within 6 months prior to the study entry;

2. Axillary temperature ≥37.3℃;

3. History of Guillain-Barré syndrome within 6 weeks of receipt of prior influenza vaccine.

4. History of allergy to any vaccine, or any ingredient of the experimental vaccine.

5. Serious adverse reaction(s) to the vaccine, such as urticaria, dyspnea or angioneurotic edema, etc.;

6. History of serious neurological disorder (such as epilepsy, convulsions, etc.) , or mental illness;

7. Autoimmune disease or immunodeficiency/immunosuppressive, or any immunosuppressant receipt within 6 months prior to the study entry;

8. 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;

9. Acute central nervous system diseases such as encephalitis/myelitis, acute disseminating encephalomyelitis, and related disorders;

10. Absence of spleen, functional absence of spleen, and absence or removal of spleen under any circumstances;

11. Diagnosed coagulation function abnormal (e.g., coagulation factor deficiency, coagulation disorder, or platelet abnormalities), or obvious bruising or coagulation disorders;

12. Alcoholism or history of drug abuse

13. Acute disease or acute stage of chronic disease within 7 days prior to study entry;

14. Received blood products within 3 months prior to study entry;

15. 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;

16. Pregnant women or lactating women;

17. Subjects participate other clinical trials (licensed or unlicensed vaccines, drugs, organisms, devices, blood products or drugs) during the study period;

18. Any other factors which are unsuitable for participation in the clinical trial as judged by the investigator.

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• Minimum Eligible Age: 3 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Sinovac Biotech (Chile) SpA

INDUSTRY

Sponsor Role: collaborator

Sinovac Biotech Co., Ltd

INDUSTRY

Sponsor Role: collaborator

Pontificia Universidad Catolica de Chile

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Pablo A Gonzalez, PhD

Role: PRINCIPAL_INVESTIGATOR

Pontifical Catholic University of Chile

Locations

Hospital Puerto Montt

Port Montt, Los Lagos Region, Chile

Site Status: RECRUITING

Centro de Investigaciones Médicas Respiratorias (CIMER)

Providencia, Santiago Metropolitan, Chile

Site Status: RECRUITING

Hospital Clínico UC Christus

Santiago, Santiago Metropolitan, Chile

Site Status: RECRUITING

Hospital Félix Bulnes

Santiago, Santiago Metropolitan, Chile

Site Status: RECRUITING

Clínica Alemana de Santiago

Vitacura, Santiago Metropolitan, Chile

Site Status: RECRUITING

Countries

Chile

Central Contacts

Pablo A Gonzalez, PhD

Role: CONTACT

pagonzalez@bio.puc.cl

+56226862842

Mario A Calvo, MD

Role: CONTACT

macalvo@uach.cl

+56999676538

Facility Contacts

Loreto I Twele, MD

Role: primary

loreto.twele@gmail.com

+56991391703

Pia E Jara

Role: backup

piaelisaj@gmail.com

+56957557121

Rosa M Feijoo, MD

Role: primary

rmfeijoo@gmail.com

+56998268855

Anyelina Navarrete

Role: backup

anyelinanq21@yahoo.es

+56935251586

Alvaro Rojas, MD

Role: primary

arojas@med.puc.cl

56934056808

María S Navarrete, RN

Role: backup

msnavarr@uc.cl

56975288431

Carlos Pérez, MD

Role: primary

carlos.perez@uss.cl

+56998211521

Loreto Pérez, RN

Role: backup

perezlor@gmail.com

56985959276

Andrea Schilling, MD

Role: primary

dra.andrea.schilling@gmail.com

56996798671

Amy Riviotta, RN

Role: backup

ariviotta@udd.cl

56998186942

References

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

Reference Type: BACKGROUND

PMID: 23210147 (View on PubMed)

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.

Reference Type: BACKGROUND

PMID: 22226861 (View on PubMed)

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.

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PMID: 23084849 (View on PubMed)

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.

Reference Type: BACKGROUND

PMID: 28062552 (View on PubMed)

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.

Reference Type: BACKGROUND

PMID: 25843270 (View on PubMed)

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.

Reference Type: BACKGROUND

PMID: 29573143 (View on PubMed)

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.

Reference Type: BACKGROUND

PMID: 29669531 (View on PubMed)

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.

Reference Type: BACKGROUND

PMID: 23688546 (View on PubMed)

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.

Reference Type: BACKGROUND

PMID: 23228813 (View on PubMed)

Other Identifiers

PRO-QINF-3004

Identifier Type: -

Identifier Source: org_study_id