InfluenzaPhase 3TetraFluVacNCT05494047
Phase Ⅲ, Clinical Trial to Compare an Inactivated Quadrivalent Influenza Vaccine and a Licensed Vaccine in Chile
A Phase 3 study testing Tetravalent influenza vaccine developed by Sinovac Biotech Co. in people with Influenza and Vaccines, run by Pontificia Universidad Catolica de Chile at 5 sites in Chile.
Trial 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™. Read more about this study
- Who is it for?
- Ages 3 years and olderHealthy volunteers can take part
- What is being tested?
- Tetravalent influenza vaccine developed by Sinovac Biotech Co.
- Type of treatment
- Vaccines
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 1,600 participants
- Where
- 5 sitesChile
- Study dates
- 14 Jul 2022to 31 Jul 2023
- Phase
- Phase 3
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 3 years and older
- All sexes
- Healthy volunteers accepted
- Child, Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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;
Show all 19Show fewer
- 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;
- Pregnant women or lactating women;
- Subjects participate other clinical trials (licensed or unlicensed vaccines, drugs, organisms, devices, blood products or drugs) during the study period;
- Any other factors which are unsuitable for participation in the clinical trial as judged by the investigator.
- -
Trial locations and contacts
5 sites in 1 country.
5 sites in 1 country
Chile5 sites, 5 recruiting
- Recruiting
Hospital Puerto Montt
Port Montt, Los Lagos Region
Loreto I Twele, MD, +56991391703, loreto.twele@gmail.com
Pia E Jara, +56957557121, piaelisaj@gmail.com
- Recruiting
Centro de Investigaciones Médicas Respiratorias (CIMER)
Providencia, Santiago Metropolitan, 7500657
Rosa M Feijoo, MD, +56998268855, rmfeijoo@gmail.com
Anyelina Navarrete, +56935251586, anyelinanq21@yahoo.es
- Recruiting
Hospital Clínico UC Christus
Santiago, Santiago Metropolitan, 8330024
Alvaro Rojas, MD, 56934056808, arojas@med.puc.cl
María S Navarrete, RN, 56975288431, msnavarr@uc.cl
- Recruiting
Hospital Félix Bulnes
Santiago, Santiago Metropolitan, 9110056
Carlos Pérez, MD, +56998211521, carlos.perez@uss.cl
Loreto Pérez, RN, 56985959276, perezlor@gmail.com
- Recruiting
Clínica Alemana de Santiago
Vitacura, Santiago Metropolitan, 7650567
Andrea Schilling, MD, 56996798671, dra.andrea.schilling@gmail.com
Amy Riviotta, RN, 56998186942, ariviotta@udd.cl
About this study
Official title: A Phase III, Randomized, Double-blind and Controlled Clinical Trial to Evaluate the Immunogenicity and Safety of Influenza Vaccine, Inactivated, Quadrivalent Developed by Sinovac Biotech Co., Ltd. Compared to a Licensed Quadrivalent Influenza Vaccine, VaxigripTetra™, in Individuals Aged 3 Years and Older in Chile
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.
Read the 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.
- Being tested
- Tetravalent influenza vaccine developed by Sinovac Biotech Co.
- Keywords
- influenza, vaccine, immunogenicity, clinical-trial
- Medical subject headings
- Influenza, Human
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Tetravalent influenza vaccine developed by Sinovac Biotech Co.Drug
Also called Sinovac vaccine
15μg Hemagglutinin Antigen (HA) of each of the four strains
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. Receives: Drug: Tetravalent influenza vaccine developed by Sinovac Biotech Co. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Seroconversion for influenza
Seroconversion rates and geometric mean titers of human influenza antibody for each of the four antigens.
Measured: 28 days after the last dose of vaccination
Secondary outcomes (4)
Antibody titer 1:40 or more
Proportion of subjects with antibody titer ≥1:40
Measured: 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
Measured: 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.
Measured: 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
Measured: 28 days after the last dose
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Aug 2022
- Study start14 Jul 2022
- Primary completion31 May 2023 (estimated)
- Study completion31 Jul 2023 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (9)Papers the sponsor has linked to this study.
- Other trials for InfluenzaStudies of the same condition, open and under way.
- More trials run by Pontificia Universidad Catolica de ChileThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 3
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- 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.
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 1,600 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Pontificia Universidad Catolica de Chile
- Sponsor type
- University, hospital or other
- Collaborators
- Sinovac Biotech (Chile) SpA, Sinovac Biotech Co., Ltd
- Responsible party
- Sponsor
- Investigators
- Pablo A Gonzalez, PhD, Principal investigator, Pontifical Catholic University of Chile
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05494047
- Sponsor's protocol ID
- PRO-QINF-3004
- Acronym
- TetraFluVac
- Status last verified
- Aug 2022
- First submitted
- 7 Aug 2022
- Last updated
- 9 Aug 2022
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Vaccines against influenza WHO position paper - November 2012. Wkly Epidemiol Rec. 2012 Nov 23;87(47):461-76. No abstract available. English, French.
PubMed 23210147Reed 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.
PubMed 22226861Lee 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.
PubMed 23084849Jain 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.
PubMed 28062552Cadorna-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.
PubMed 25843270Mallory 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.
PubMed 29573143Claeys 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.
PubMed 29669531Beran 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.
PubMed 23688546Greenberg 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.
PubMed 23228813
Study at a glance
From the registry record, last updated by the sponsor on 9 Aug 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase III, Randomized, Double-blind and Controlled Clinical Trial to Evaluate the Immunogenicity and Safety of Influenza Vaccine, Inactivated, Quadrivalent Developed by Sinovac Biotech Co., Ltd. Compared to a Licensed Quadrivalent Influenza Vaccine, VaxigripTetra™, in Individuals Aged 3 Years and Older in Chile
- ClinicalTrials.gov ID
- NCT05494047
- Acronym / sponsor ID
- TetraFluVac / PRO-QINF-3004
- Keywords
- influenza, vaccine, immunogenicity, clinical-trial
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 1,600 participants (estimated)
- Lead sponsor
- Pontificia Universidad Catolica de ChileUniversity, hospital or other
- Collaborators
- Sinovac Biotech (Chile) SpA, Sinovac Biotech Co., Ltd
- Study start
- 14 Jul 2022 (actual)
- Primary completion
- 31 May 2023 (estimated)
- Study completion
- 31 Jul 2023 (estimated)
- First posted
- 9 Aug 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
- Model description
- 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.
| Arm | Type | Receives |
|---|---|---|
| Tetravalent influenza vaccine developed by Sinovac Biotech Co. | Experimental | 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 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. |
| Vaxigrip Tetra TM | Active comparator | 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. |
Who may qualify
- Ages
- 3 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (7 listed)
- 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:
Key exclusion criteria (19 listed)
- 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.;
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Tetravalent influenza vaccine developed by Sinovac Biotech Co.Also: Sinovac vaccine15μg Hemagglutinin Antigen (HA) of each of the four strains | Drug | Tetravalent influenza vaccine developed by Sinovac Biotech Co., Vaxigrip Tetra TM |
Primary outcome
Seroconversion for influenza
Time frame: 28 days after the last dose of vaccination
Seroconversion rates and geometric mean titers of human influenza antibody for each of the four antigens.
4 secondary outcomes
Antibody titer 1:40 or more
Time frame: 28 days after the last dose of vaccination
Cellular immunity-ELISPOT
Time frame: 28 days after the last dose
Cellular immunity-Cytometry
Time frame: 28 days after the last dose
Cellular immunity-Luminex (TM)
Time frame: 28 days after the last dose
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Aug 2022.
- Background: PubMed 23210147Vaccines against influenza WHO position paper - November 2012. Wkly Epidemiol Rec. 2012 Nov 23;87(47):461-76. No abstract available. English, French.
- Background: PubMed 22226861Reed 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.
- Background: PubMed 23084849Lee 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.
- Background: PubMed 28062552Jain 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.
- Background: PubMed 25843270Cadorna-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.
- Background: PubMed 29573143Mallory 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.
- Background: PubMed 29669531Claeys 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.
- Background: PubMed 23688546Beran 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.
- Background: PubMed 23228813Greenberg 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.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Pablo A Gonzalez, PhD principal investigator
Pontifical Catholic University of Chile
5 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Tetravalent influenza vaccine developed by Sinovac Biotech Co. in people with Influenza and Vaccines, run by Pontificia Universidad Catolica de Chile at 5 sites in Chile.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 19 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 9 Aug 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 5 sites in Chile. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Pablo A Gonzalez, PhD (+56226862842, pagonzalez@bio.puc.cl), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Seroconversion for influenza (time frame: 28 days after the last dose of vaccination). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05494047, which also lists 9 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 9 Aug 2022.