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| ID | Type | Description | Link |
|---|---|---|---|
| 2018-001857-29 | EudraCT Number |
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This phase 3 clinical study is a randomized, observer-blind, multicenter study of QIVc versus a non-influenza vaccine in subjects 6 months though 47 months of age. The purpose of this study is to evaluate efficacy of QIVc in the prevention of laboratory confirmed influenza A or B disease in children 6 through 47 months of age, compared to a non-influenza vaccine.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| QIVc | Experimental | Cell-derived Quadrivalent Influenza Vaccine |
|
| Comparator | Active Comparator | Non-influenza Comparator |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| QIVc | Biological | QIVc is a quadrivalent vaccine and contains 2 influenza type A strains and 2 influenza type B lineages recommended by World Health Organization (WHO) for inclusion in the quadrivalent vaccine formulation for the influenza season corresponding to the season of conduct of study. |
| Measure | Description | Time Frame |
|---|---|---|
| Efficacy Endpoint: First Occurrence of Reverse Transcription-polymerase Chain Reaction (RT-PCR) Confirmed Influenza, Due to Any Influenza Type A and/or B Virus Regardless of Antigenic Match | First occurrence of RT-PCR confirmed influenza, due to any influenza Type A and/or B virus regardless of antigenic match to the influenza strains selected for the seasonal influenza vaccine, occurring at >14 days after the last vaccination and until the end of the influenza season, in association with protocol-defined influenza-like illness (ILI) symptoms | >14 days after last vaccination in the treatment period up to Day 181 or end of influenza season, whichever was longer (previously vaccinated subjects), or up to Day 209 or end of influenza season, whichever was longer (not previously vaccinated subjects) |
| Efficacy Endpoint: First Occurrence of Culture Confirmed Influenza, Due to Influenza Type A and/or B Virus Antigenically Matched by Ferret Antigenicity Testing to the Strains Selected for the Seasonal Influenza Vaccine | First occurrence of culture confirmed influenza, due to influenza Type A and/or B virus antigenically matched by ferret antigenicity testing to the strains selected for the seasonal influenza vaccine, occurring at >14 days after the last vaccination and until the end of the influenza season, in association with protocol-defined ILI symptoms | >14 days after last vaccination in the treatment period up to Day 181 or end of influenza season, whichever was longer (previously vaccinated subjects), or up to Day 209 or end of influenza season, whichever was longer (not previously vaccinated subjects) |
| Measure | Description | Time Frame |
|---|---|---|
| Efficacy Endpoint: First Occurrence of Culture Confirmed Influenza Caused by Influenza Virus Strains Antigenically Dissimilar to the Influenza Strains Selected for the Seasonal Influenza Vaccine | First occurrence of culture confirmed influenza caused by influenza virus strains antigenically dissimilar to the influenza strains selected for the seasonal vaccine occurring at >14 days after the last vaccination and until the end of the influenza season, in association with protocol-defined ILI symptoms |
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Inclusion Criteria:
In order to participate in this study, all subjects must meet all of the inclusion criteria described.
If applicable, prior to receipt of second study vaccination, subjects must be evaluated to confirm that they are eligible for subsequent vaccination. If subjects do not meet the criteria of the original inclusion criteria listed above, they should not receive additional vaccinations.
Exclusion Criteria:
Additional eligibility criteria are provided in the study protocol.
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| Name | Affiliation | Role |
|---|---|---|
| Clinical Program Director | Seqirus | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| International Centre for Diarrhoeal Disease Research, Bangladesh | Dhaka | Bangladesh | ||||
| 10008-Medical Center Viva Feniks |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 41962984 | Derived | Poder A, Ong-Lim AL, Rivera Medina DM, Zaman K, Makedonska I, de Bruijn M, Matassa V, Fortanier AC, Heijnen E, Hohenboken M, Molrine DC. Efficacy, immunogenicity, and safety of a cell culture-derived quadrivalent influenza vaccine compared with a non-influenza vaccine in infants and children across five influenza seasons: a phase 3, multinational, observer-blind, randomised controlled trial. Lancet Child Adolesc Health. 2026 May;10(5):352-363. doi: 10.1016/S2352-4642(26)00009-X. |
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Seqirus will consider on a case-by-case basis requests to share Individual Patient Data (IPD) with external bona-fide, qualified scientific and medical researchers. For information on the process and requirements for submitting a voluntary data sharing request for IPD, please contact Seqirus at seqirus.clinicaltrials@seqirus.com.
Requests for IPD will generally be considered once review by major regulatory authorities (ie FDA, EMA) is complete and the primary publication is available.
Proposed research should seek to answer a previously unanswered important medical or scientific question.
Applicable country specific privacy and other laws and regulations will be considered and may prevent sharing of IPD.
If the request is approved and the researcher has executed an appropriate data sharing agreement, IPD that has been appropriately anonymized will be available.
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Treatment period: Previously vaccinated subjects: Day of vaccination to 28 days after vaccination (Day 1-Day 29); Not previously vaccinated subjects: Day of first vaccination to 28 days after second vaccination (Day 1-Day 57) Study completion: At end of influenza season and at least 180 days after last vaccination during treatment period, whichever was longer (previously vaccinated subjects: Day 181/end of influenza season; not previously vaccinated subjects: Day 209/end of influenza season)
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| ID | Title | Description |
|---|---|---|
| FG000 | QIVc | Cell-derived Quadrivalent Influenza Vaccine QIVc: QIVc is a quadrivalent vaccine and contains 2 influenza type A strains and 2 influenza type B lineages recommended by World Health Organization (WHO) for inclusion in the quadrivalent vaccine formulation for the influenza season corresponding to the season of conduct of study. |
| Title | Milestones | Reasons Not Completed | ||||
|---|---|---|---|---|---|---|
| Overall Study |
|
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot | Yes | No | No | Study Protocol | Sep 3, 2020 | Nov 25, 2024 |
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The trial is designed as an observer-blind study. During the treatment period of the study, only designated, trained unblinded personnel will be responsible for administering the study vaccines to the subjects.
|
|
| Comparator | Biological | Meningococcal Group C Polysaccharide Conjugate Vaccine (NeisVac-C) |
|
| >14 days after last vaccination in the treatment period up to Day 181 or end of influenza season, whichever was longer (previously vaccinated subjects), or up to Day 209 or end of influenza season, whichever was longer (not previously vaccinated subjects) |
| Efficacy Endpoint: First Occurrence of Culture Confirmed Influenza Due to Any Influenza Type A and/or Type B Virus Regardless of Antigenic Match to the Influenza Strains Selected for the Seasonal Influenza Vaccine | First occurrence of culture confirmed influenza due to any influenza Type A and/or Type B virus regardless of antigenic match to the influenza strains selected for the seasonal influenza vaccine, occurring at >14 days after the last vaccination and until the end of the influenza season, in association with protocol-defined ILI symptoms | >14 days after last vaccination in the treatment period up to Day 181 or end of influenza season, whichever was longer (previously vaccinated subjects), or up to Day 209 or end of influenza season, whichever was longer (not previously vaccinated subjects) |
| Efficacy Endpoint: First Occurrence of RT-PCR Confirmed Moderate-to-severe Influenza Due to Any Influenza Type A and/or Type B Virus Regardless of Antigenic Match to the Influenza Strains Selected for the Seasonal Influenza Vaccine | First occurrence of RT-PCR confirmed moderate-to-severe influenza due to any influenza Type A and/or Type B virus regardless of antigenic match to the influenza strains selected for the seasonal influenza vaccine, occurring at >14 days after the last vaccination and until the end of the influenza season | >14 days after last vaccination in the treatment period up to Day 181 or end of influenza season, whichever was longer (previously vaccinated subjects), or up to Day 209 or end of influenza season, whichever was longer (not previously vaccinated subjects) |
| Immunogenicity Endpoint: Prevaccination and Postvaccination Geometric Mean Titer (GMT) (HI Assay) | The measures for immunogenicity are determined by a hemagglutination inhibition (HI) assay prior to first vaccination and 28 days after last vaccination for all four influenza strains HI = hemagglutination inhibition Adjusted GMTs are presented | Day 1 and Day 29 for previously vaccinated subjects; Day 1 and Day 57 for not previously vaccinated subjects |
| Immunogenicity Endpoint: Seroconversion Rates (SCR) (HI Assay) | The measures for immunogenicity are determined by a HI assay prior to first vaccination and 28 days after last vaccination for all four influenza strains SCR is defined as the percentage of subjects with either a prevaccination HI titer <1:10 and a postvaccination HI titer ≥1:40, or a prevaccination HI titer ≥1:10 and a ≥4-fold increase in postvaccination HI titer | Day 1 through Day 29 for previously vaccinated subjects; Day 1 through Day 57 for not previously vaccinated subjects |
| Immunogenicity Endpoint: Geometric Mean Ratio (GMR) (HI Assay) | The measures for immunogenicity are determined by a hemagglutination inhibition (HI) assay prior to first vaccination and 28 days after last vaccination for all four influenza strains GMR is the geometric mean of the fold increase of postvaccination HI titer over the prevaccination HI titer Adjusted GMRs are presented | Day 1 through Day 29 for previously vaccinated subjects; Day 1 through Day 57 for not previously vaccinated subjects |
| Immunogenicity Endpoint: Prevaccination and Postvaccination Geometric Mean Titer (GMT) (MN Assay) | The measures for immunogenicity are determined by a microneutralization (MN) assay prior to first vaccination and 28 days after last vaccination for all four influenza strains | Day 1 and Day 29 for previously vaccinated subjects; Day 1 and Day 57 for not previously vaccinated subjects |
| Immunogenicity Endpoint: Seroconversion Rates (SCR) (MN Assay) | The measures for immunogenicity are determined by a MN assay prior to first vaccination and 28 days after last vaccination for all four influenza strains SCR is defined as the percentage of subjects with either a prevaccination MN titer <1:10 and a postvaccination MN titer ≥1:40, or a prevaccination MN titer ≥1:10 and a ≥4-fold increase in postvaccination MN titer | Day 1 through Day 29 for previously vaccinated subjects; Day 1 through Day 57 for not previously vaccinated subjects |
| Immunogenicity Endpoint: Geometric Mean Ratio (GMR) (MN Assay) | The measures for immunogenicity are determined by a MN assay prior to first vaccination and 28 days after last vaccination for all four influenza strains GMR is the geometric mean of the fold increase of post-vaccination MN titer over the pre-vaccination MN titer | Day 1 through Day 29 for previously vaccinated subjects; Day 1 through Day 57 for not previously vaccinated subjects |
| Safety Endpoint: Percentage of Subjects With Solicited Local and Systemic Adverse Events (AEs) | Percentage of subjects with solicited local and systemic AEs assessed for 7 days following each vaccination in the QIVc group and in the comparator group | 7 days following each vaccination in the treatment period, ie, Day 1 to Day 7 for previously vaccinated subjects and Day 1 to Day 7 and Day 29 to Day 35 for not previously vaccinated subjects |
| Safety Endpoint: Percentage of Subjects With Unsolicited AEs | Percentage of subjects with any unsolicited AEs assessed in the QIVc group and in the comparator group until 28 days after each vaccination | 28 days after each vaccination in the treatment period, ie, Day 1 to Day 29 for previously vaccinated subjects and Day 1 to Day 57 for not previously vaccinated subjects |
| Safety Endpoint: Percentage of Subjects With SAEs, NOCDs, AEs Leading to Withdrawal From the Study or Vaccination | Percentage of subjects with serious adverse events (SAEs), new onset of chronic disease (NOCD), AEs leading to withdrawal from the study or vaccination, and all medications associated with these events in the QIVc group and in the comparator group Note: The time frame for assessment of these AEs was Day 1 through Study Completion as indicated below. Subjects aged 6 months through 11 months at enrollment in countries without NeisVac-C vaccine marketing authorization had an additional study visit 28 days later (ie, Day 237). | Day 1 through Study Completion, ie, Day 1 to Day 181 or end of influenza season, whichever was longer, for previously vaccinated subjects and Day 1 to Day 209 or end of influenza season, whichever was longer, for not previously vaccinated subjects |
| Safety Endpoint: Percentage of Subjects With Medically-attended AEs | Percentage of subjects with medically-attended AEs within 30 days after ILI onset in the QIVc group and in the comparator group | If a subject experienced an ILI during approximately 8 months of study participation, medically-attended AEs were collected for the 30-day period after onset of the ILI (defined as the first day that a subject meets the criteria for protocol-defined ILI) |
| Dobrich |
| Bulgaria |
| 10007-MHAT Dr. Stamen Iliev AD | Montana | Bulgaria |
| 10003-UMHAT Dr. Georgi Stranski EAD | Pleven | Bulgaria |
| 10002-UMHAT Sveti Georgi EAD | Plovdiv | Bulgaria |
| 10006-UMHAT-Plovdiv AD | Plovdiv | Bulgaria |
| 10004-SHATPPD Dr Dimitar Gramatikov Ruse EOOD | Rousse | Bulgaria |
| 10009-Medical Center Unimed Eood | Sevlievo | Bulgaria |
| 20303-MUDr. Stefan Hrunka, Prakticky lekar pro deti a dorost | Chlumec nad Cidlinou | 503 51 | Czechia |
| 20301-MUDr. Daniel Drazan, Prakticky lekar pro deti a dorost | Jindřichův Hradec | 377 01 | Czechia |
| 20302-MUDr. Daniela Pniakova s.r.o. | Ostrava | 700 30 | Czechia |
| 20304-MUDr. David Zeman s.r.o. | Ostrava-poruba | 708 00 | Czechia |
| 20305-MUDr. Iva Madejova, Prakticky lekar pro deti a dorost | Pardubice | 530 09 | Czechia |
| 23305-Vee Family Doctor's Centre | Paide | 72713 | Estonia |
| 23301-Innomedica OÜ | Tallinn | 10117 | Estonia |
| 23303-Al Mare Perearstikeskus OU | Tallinn | 10617 | Estonia |
| 23304-Merelahe Family Doctors Center | Tallinn | 10617 | Estonia |
| 23307-Tallinn Children's Hospital | Tallinn | Estonia |
| 23302-Clinical Research Centre | Tartu | 10117 | Estonia |
| 34001-Demedica | San Pedro Sula | 21104 | Honduras |
| 34003-ClÃnica Médica y Dental CLIMEDENTY | Tegucigalpa | 11101 | Honduras |
| 34002-Inversiones en Investigación Médica (INVERIME) | Tegucigalpa | 2449 | Honduras |
| 42802-OLVI Medical Centre | Daugavpils | LV 1004 | Latvia |
| 45804-Clinical Research Centre (CRC), Hospital Tuanku Fauziah | Kangar | Perlis | 01000 | Malaysia |
| 45803-Sarawak General Hospital | Kuching | Sarawak | 93586 | Malaysia |
| 45802-Hospital Sibu | Sibu | Sarawak | 96000 | Malaysia |
| 45805-Klinik Kesihatan Putrajaya Presint 9 | Putrajaya | Wilyah Persekutuan Putrajaya | 62250 | Malaysia |
| 45801-University Malaya Medical Centre | Kuala Lumpur | 59100 | Malaysia |
| 55403-Christchurch Clinical Studies Trust | Christchurch | 8011 | New Zealand |
| 55401-Wellington Hospital | Wellington | 6021 | New Zealand |
| 58602-Shifa International Hospital | Islamabad | Pakistan |
| 58604-The Aga Khan | Karachi | Pakistan |
| 58605-Avicenna Hospital | Lahore | Pakistan |
| 58607-Central Park Teaching Hospital | Lahore | Pakistan |
| 58601-Al Shifa Research Centre | Rawalpindi | Pakistan |
| 60808-University of the Philippines Manila Development Foundation Inc | Ermita | Manila | 1000 | Philippines |
| 60810-UERM Memorial Medical Center | Quezon City | Quezon | Philippines |
| 60817-Health Index Multispecialty Clinic | Bacoor | Philippines |
| 60801-Chong Hua Hospital | Cebu City | Philippines |
| 60812-De La Salle Medical and Health Sciences Institute | Dasmariñas | Philippines |
| 60816-De La Salle Medical and Health Sciences Institute | Dasmariñas | Philippines |
| 60806-Mary Chiles General Hospital | Manila | 1008 | Philippines |
| 60814-Philippine General Hospital | Manila | Philippines |
| 60815-Philippine General Hospital | Manila | Philippines |
| 60818-Philippine General Hospital | Manila | Philippines |
| 60811-UERM Memorial Medical Center | Quezon City | Philippines |
| 60813-Philippine Children's Medical Center | Quezon City | Philippines |
| 61605-Osrodek Badan Klinicznych IN-VIVO sp. z o.o. | Bydgoszcz | 85-090 | Poland |
| 61603-Jerzy Brzostek Prywatny Gabinet Lekarski | Dębica | 39-200 | Poland |
| 61607-Gdanskie Centrum Zdrowia Sp. z o.o. | Gdansk | 80-542 | Poland |
| 61604-Hanna Czajka, Indywidualna Specjalistyczna Praktyka Lekarska | Krakow | 31-302 | Poland |
| 61608-Gabinet Lekarski Bartosz Korczowski | Rzeszów | 35-302 | Poland |
| 61602-Niepubliczny Zaklad Lecznictwa Ambulatoryjnego Michalkowice | Siemianowice ÅšlÄ…skie | 41-103 | Poland |
| 61601-ETG Network- Skierniewice,Clinmed Research | Skierniewice | 96-100 | Poland |
| 61609-Szpital im. Swietej Jadwigi Slaskiej w Trzebnicy | Trzebnica | 55-100 | Poland |
| 64201-SC Sana Monitoring SRL. | Bucharest | 011025 | Romania |
| 64205-Sc Med Fam Apolo srl | Calarasi | 910160 | Romania |
| 64202-Spitalul Municipal Caracal | Caracal | 235200 | Romania |
| 64206-S.C Centrul Clinic Mediquest S.R.L | Sângeorgiu de Mureş | 547530 | Romania |
| 71006-Madibeng Centre for Research | Brits | South Africa |
| 71004-Tread Research | Cape Town | South Africa |
| 71007-Allergy & Immunology Unit | Cape Town | South Africa |
| 71002-Synergy Biomed Research Institute | East London | South Africa |
| 71009-Perinatal HIV Research Unit, Tshepong Hospital | Klerksdorp | South Africa |
| 71001-Be Part Yoluntu Centre | Paarl | South Africa |
| 71008-Clinical Trial Systems | Pretoria | South Africa |
| 71003-Soweto Clinical Trials Centre | Soweto | South Africa |
| 71005-Limpopo Clinical Research Initiative | Thabazimbi | South Africa |
| 76405-Phramongkutklao Hospital | Ratchathewi | Bangkok | 10400 | Thailand |
| 76401-Vaccine Trial Centre, Faculty of Tropical Medicine, Mahidol University | Bangkok | 10400 | Thailand |
| 76404-Department of Tropical Pediatrics, Faculty of Tropical Medicine, Mahidol University | Bangkok | 10400 | Thailand |
| 80404-Reg Mun NPE Chernivtsi RCCH Infectious Dept for Infants SHEI of UBSMU | Chernivtsi | 58023 | Ukraine |
| 80405-CI Dnipro Children's City CH #5 of Dnipro City Council | Dnipro | 49027 | Ukraine |
| 80401-Vinnytsia RCCH Policlinic Dept Vinnytsia M.I.Pyrogov NMU | Vinnytsia | 21000 | Ukraine |
| FG001 |
| Comparator |
Non-influenza Comparator Comparator: Meningococcal Group C Polysaccharide Conjugate Vaccine (NeisVac-C) |
|
| COMPLETED |
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| NOT COMPLETED |
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| ID | Title | Description |
|---|---|---|
| BG000 | QIVc | Cell-derived Quadrivalent Influenza Vaccine QIVc: QIVc is a quadrivalent vaccine and contains 2 influenza type A strains and 2 influenza type B lineages recommended by World Health Organization (WHO) for inclusion in the quadrivalent vaccine formulation for the influenza season corresponding to the season of conduct of study. |
| BG001 | Comparator | Non-influenza Comparator Comparator: Meningococcal Group C Polysaccharide Conjugate Vaccine (NeisVac-C) |
| BG002 | Total | Total of all reporting groups |
| Units | Counts |
|---|---|
| Participants |
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| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes | ||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean | Standard Deviation | months |
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| Age, Customized | Count of Participants | Participants |
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| Sex: Female, Male | Count of Participants | Participants |
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| Ethnicity (NIH/OMB) | Count of Participants | Participants |
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| Race/Ethnicity, Customized | Count of Participants | Participants |
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| Region of Enrollment | Count of Participants | Participants |
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| Previous influenza vaccination | Count of Participants | Participants |
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| Participants enrolled in each influenza season | Season 1 = Southern Hemisphere (SH) 2019; Season 2 = Northern Hemisphere (NH) 2019/2020; Season 3 = NH 2020/2021; Season 4 = NH 2022/2023; Season 5 = SH 2023. | Count of Participants | Participants |
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| Body mass index | Two subjects (one subject in each vaccine group) did not have body mass index data. | Mean | Standard Deviation | kg/m2 |
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| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
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| Primary | Efficacy Endpoint: First Occurrence of Reverse Transcription-polymerase Chain Reaction (RT-PCR) Confirmed Influenza, Due to Any Influenza Type A and/or B Virus Regardless of Antigenic Match | First occurrence of RT-PCR confirmed influenza, due to any influenza Type A and/or B virus regardless of antigenic match to the influenza strains selected for the seasonal influenza vaccine, occurring at >14 days after the last vaccination and until the end of the influenza season, in association with protocol-defined influenza-like illness (ILI) symptoms | Full Analysis Set (FAS) Efficacy, defined as all subjects in the All Enrolled Set who were randomized, received at least one dose of study vaccination, and were evaluated for efficacy at more than 14 days after the last vaccination | Posted | Number | Cases | >14 days after last vaccination in the treatment period up to Day 181 or end of influenza season, whichever was longer (previously vaccinated subjects), or up to Day 209 or end of influenza season, whichever was longer (not previously vaccinated subjects) |
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| Primary | Efficacy Endpoint: First Occurrence of Culture Confirmed Influenza, Due to Influenza Type A and/or B Virus Antigenically Matched by Ferret Antigenicity Testing to the Strains Selected for the Seasonal Influenza Vaccine | First occurrence of culture confirmed influenza, due to influenza Type A and/or B virus antigenically matched by ferret antigenicity testing to the strains selected for the seasonal influenza vaccine, occurring at >14 days after the last vaccination and until the end of the influenza season, in association with protocol-defined ILI symptoms | FAS Efficacy | Posted | Number | Cases | >14 days after last vaccination in the treatment period up to Day 181 or end of influenza season, whichever was longer (previously vaccinated subjects), or up to Day 209 or end of influenza season, whichever was longer (not previously vaccinated subjects) |
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| Secondary | Efficacy Endpoint: First Occurrence of Culture Confirmed Influenza Caused by Influenza Virus Strains Antigenically Dissimilar to the Influenza Strains Selected for the Seasonal Influenza Vaccine | First occurrence of culture confirmed influenza caused by influenza virus strains antigenically dissimilar to the influenza strains selected for the seasonal vaccine occurring at >14 days after the last vaccination and until the end of the influenza season, in association with protocol-defined ILI symptoms | FAS Efficacy | Posted | Number | Cases | >14 days after last vaccination in the treatment period up to Day 181 or end of influenza season, whichever was longer (previously vaccinated subjects), or up to Day 209 or end of influenza season, whichever was longer (not previously vaccinated subjects) |
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| Secondary | Efficacy Endpoint: First Occurrence of Culture Confirmed Influenza Due to Any Influenza Type A and/or Type B Virus Regardless of Antigenic Match to the Influenza Strains Selected for the Seasonal Influenza Vaccine | First occurrence of culture confirmed influenza due to any influenza Type A and/or Type B virus regardless of antigenic match to the influenza strains selected for the seasonal influenza vaccine, occurring at >14 days after the last vaccination and until the end of the influenza season, in association with protocol-defined ILI symptoms | FAS Efficacy | Posted | Number | Cases | >14 days after last vaccination in the treatment period up to Day 181 or end of influenza season, whichever was longer (previously vaccinated subjects), or up to Day 209 or end of influenza season, whichever was longer (not previously vaccinated subjects) |
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| Secondary | Efficacy Endpoint: First Occurrence of RT-PCR Confirmed Moderate-to-severe Influenza Due to Any Influenza Type A and/or Type B Virus Regardless of Antigenic Match to the Influenza Strains Selected for the Seasonal Influenza Vaccine | First occurrence of RT-PCR confirmed moderate-to-severe influenza due to any influenza Type A and/or Type B virus regardless of antigenic match to the influenza strains selected for the seasonal influenza vaccine, occurring at >14 days after the last vaccination and until the end of the influenza season | FAS Efficacy | Posted | Number | Cases | >14 days after last vaccination in the treatment period up to Day 181 or end of influenza season, whichever was longer (previously vaccinated subjects), or up to Day 209 or end of influenza season, whichever was longer (not previously vaccinated subjects) |
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| Secondary | Immunogenicity Endpoint: Prevaccination and Postvaccination Geometric Mean Titer (GMT) (HI Assay) | The measures for immunogenicity are determined by a hemagglutination inhibition (HI) assay prior to first vaccination and 28 days after last vaccination for all four influenza strains HI = hemagglutination inhibition Adjusted GMTs are presented | FAS Immunogenicity, defined as all subjects in the All Enrolled Set who were randomized, received at least one study vaccination, and provided evaluable serum samples at both baseline (Day 1) and 28 days after last vaccination (Day 29/57) | Posted | Geometric Mean | 95% Confidence Interval | Geometric mean titer | Day 1 and Day 29 for previously vaccinated subjects; Day 1 and Day 57 for not previously vaccinated subjects |
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| Secondary | Immunogenicity Endpoint: Seroconversion Rates (SCR) (HI Assay) | The measures for immunogenicity are determined by a HI assay prior to first vaccination and 28 days after last vaccination for all four influenza strains SCR is defined as the percentage of subjects with either a prevaccination HI titer <1:10 and a postvaccination HI titer ≥1:40, or a prevaccination HI titer ≥1:10 and a ≥4-fold increase in postvaccination HI titer | FAS Immunogenicity | Posted | Number | 95% Confidence Interval | Percentage of participants | Day 1 through Day 29 for previously vaccinated subjects; Day 1 through Day 57 for not previously vaccinated subjects |
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| Secondary | Immunogenicity Endpoint: Geometric Mean Ratio (GMR) (HI Assay) | The measures for immunogenicity are determined by a hemagglutination inhibition (HI) assay prior to first vaccination and 28 days after last vaccination for all four influenza strains GMR is the geometric mean of the fold increase of postvaccination HI titer over the prevaccination HI titer Adjusted GMRs are presented | FAS Immunogenicity | Posted | Geometric Mean | 95% Confidence Interval | Geometric mean ratio | Day 1 through Day 29 for previously vaccinated subjects; Day 1 through Day 57 for not previously vaccinated subjects |
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| Secondary | Immunogenicity Endpoint: Prevaccination and Postvaccination Geometric Mean Titer (GMT) (MN Assay) | The measures for immunogenicity are determined by a microneutralization (MN) assay prior to first vaccination and 28 days after last vaccination for all four influenza strains | FAS Immunogenicity | Posted | Geometric Mean | 95% Confidence Interval | Geometric mean titer | Day 1 and Day 29 for previously vaccinated subjects; Day 1 and Day 57 for not previously vaccinated subjects |
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| Secondary | Immunogenicity Endpoint: Seroconversion Rates (SCR) (MN Assay) | The measures for immunogenicity are determined by a MN assay prior to first vaccination and 28 days after last vaccination for all four influenza strains SCR is defined as the percentage of subjects with either a prevaccination MN titer <1:10 and a postvaccination MN titer ≥1:40, or a prevaccination MN titer ≥1:10 and a ≥4-fold increase in postvaccination MN titer | FAS Immunogenicity | Posted | Number | 95% Confidence Interval | Percentage of participants | Day 1 through Day 29 for previously vaccinated subjects; Day 1 through Day 57 for not previously vaccinated subjects |
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| Secondary | Immunogenicity Endpoint: Geometric Mean Ratio (GMR) (MN Assay) | The measures for immunogenicity are determined by a MN assay prior to first vaccination and 28 days after last vaccination for all four influenza strains GMR is the geometric mean of the fold increase of post-vaccination MN titer over the pre-vaccination MN titer | FAS Immunogenicity | Posted | Geometric Mean | 95% Confidence Interval | Geometric mean ratio | Day 1 through Day 29 for previously vaccinated subjects; Day 1 through Day 57 for not previously vaccinated subjects |
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| Secondary | Safety Endpoint: Percentage of Subjects With Solicited Local and Systemic Adverse Events (AEs) | Percentage of subjects with solicited local and systemic AEs assessed for 7 days following each vaccination in the QIVc group and in the comparator group | Solicited Safety Set, defined as all subjects in the All Exposed Set with any solicited AE data indicating the occurrence or lack of occurrence of solicited AEs, ie, a subject does not have to have any solicited AEs to be included in this population | Posted | Number | Percentage of participants | 7 days following each vaccination in the treatment period, ie, Day 1 to Day 7 for previously vaccinated subjects and Day 1 to Day 7 and Day 29 to Day 35 for not previously vaccinated subjects |
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| Secondary | Safety Endpoint: Percentage of Subjects With Unsolicited AEs | Percentage of subjects with any unsolicited AEs assessed in the QIVc group and in the comparator group until 28 days after each vaccination | Unsolicited Safety Set, defined as all subjects in the All Exposed Set with unsolicited AE data | Posted | Number | Percentage of participants | 28 days after each vaccination in the treatment period, ie, Day 1 to Day 29 for previously vaccinated subjects and Day 1 to Day 57 for not previously vaccinated subjects |
|
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| Secondary | Safety Endpoint: Percentage of Subjects With SAEs, NOCDs, AEs Leading to Withdrawal From the Study or Vaccination | Percentage of subjects with serious adverse events (SAEs), new onset of chronic disease (NOCD), AEs leading to withdrawal from the study or vaccination, and all medications associated with these events in the QIVc group and in the comparator group Note: The time frame for assessment of these AEs was Day 1 through Study Completion as indicated below. Subjects aged 6 months through 11 months at enrollment in countries without NeisVac-C vaccine marketing authorization had an additional study visit 28 days later (ie, Day 237). | Unsolicited Safety Set | Posted | Number | Percentage of participants | Day 1 through Study Completion, ie, Day 1 to Day 181 or end of influenza season, whichever was longer, for previously vaccinated subjects and Day 1 to Day 209 or end of influenza season, whichever was longer, for not previously vaccinated subjects |
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| Secondary | Safety Endpoint: Percentage of Subjects With Medically-attended AEs | Percentage of subjects with medically-attended AEs within 30 days after ILI onset in the QIVc group and in the comparator group | Unsolicited Safety Set | Posted | Number | Percentage of participants | If a subject experienced an ILI during approximately 8 months of study participation, medically-attended AEs were collected for the 30-day period after onset of the ILI (defined as the first day that a subject meets the criteria for protocol-defined ILI) |
|
|
Unsolicited AEs: Day 1 through Study Completion, ie, Day 1 to Day 181/end of influenza season for previously vaccinated subjects and Day 1 to Day 209/end of influenza season for not previously vaccinated subjects Solicited AEs: 7 days following each vaccination in the treatment period, ie, Day 1 to Day 7 for previously vaccinated subjects and Day 1 to Day 7 and Day 29 to Day 35 for not previously vaccinated subjects
Number and percentage of subjects with SAEs and other AEs (ie, nonserious unsolicited AEs and solicited AEs)
All-cause mortality, SAEs, and nonserious AEs are reported for the Unsolicited Safety Set; solicited AEs are reported for the Solicited Safety Set
None of the deaths in the study were assessed as related to study vaccine
All AEs are reported according to the intervention subjects received in the treatment period
Not provided
| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | QIVc | Cell-derived Quadrivalent Influenza Vaccine QIVc: QIVc is a quadrivalent vaccine and contains 2 influenza type A strains and 2 influenza type B lineages recommended by World Health Organization (WHO) for inclusion in the quadrivalent vaccine formulation for the influenza season corresponding to the season of conduct of study. | 1 | 2,856 | 64 | 2,856 | 2,050 | 2,856 |
| EG001 | Comparator | Non-influenza Comparator Comparator: Meningococcal Group C Polysaccharide Conjugate Vaccine (NeisVac-C) | 2 | 2,841 | 84 | 2,841 | 2,126 | 2,841 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Pneumonia | Infections and infestations | MedDRA version 26.1 | Systematic Assessment |
| |
| Gastroenteritis | Infections and infestations | MedDRA version 26.1 | Systematic Assessment |
| |
| Dengue fever | Infections and infestations | MedDRA version 26.1 | Systematic Assessment |
| |
| Viral infection | Infections and infestations | MedDRA version 26.1 | Systematic Assessment |
| |
| Influenza | Infections and infestations | MedDRA version 26.1 | Systematic Assessment |
| |
| Bronchiolitis | Infections and infestations | MedDRA version 26.1 | Systematic Assessment |
| |
| Otitis media acute | Infections and infestations | MedDRA version 26.1 | Systematic Assessment |
| |
| Pneumonia viral | Infections and infestations | MedDRA version 26.1 | Systematic Assessment |
| |
| Respiratory syncytial virus bronchitis | Infections and infestations | MedDRA version 26.1 | Systematic Assessment |
| |
| Sepsis | Infections and infestations | MedDRA version 26.1 | Systematic Assessment |
| |
| Typhoid fever | Infections and infestations | MedDRA version 26.1 | Systematic Assessment |
| |
| Abscess neck | Infections and infestations | MedDRA version 26.1 | Systematic Assessment |
| |
| Amoebic dysentery | Infections and infestations | MedDRA version 26.1 | Systematic Assessment |
| |
| Bronchitis | Infections and infestations | MedDRA version 26.1 | Systematic Assessment |
| |
| Febrile infection | Infections and infestations | MedDRA version 26.1 | Systematic Assessment |
| |
| Gastroenteritis rotavirus | Infections and infestations | MedDRA version 26.1 | Systematic Assessment |
| |
| Gastroenteritis viral | Infections and infestations | MedDRA version 26.1 | Systematic Assessment |
| |
| Laryngitis | Infections and infestations | MedDRA version 26.1 | Systematic Assessment |
| |
| Norovirus infection | Infections and infestations | MedDRA version 26.1 | Systematic Assessment |
| |
| Parainfluenzae virus infection | Infections and infestations | MedDRA version 26.1 | Systematic Assessment |
| |
| Pharyngitis | Infections and infestations | MedDRA version 26.1 | Systematic Assessment |
| |
| Pneumonia bacterial | Infections and infestations | MedDRA version 26.1 | Systematic Assessment |
| |
| Rotavirus infection | Infections and infestations | MedDRA version 26.1 | Systematic Assessment |
| |
| Urinary tract infection | Infections and infestations | MedDRA version 26.1 | Systematic Assessment |
| |
| Abscess limb | Infections and infestations | MedDRA version 26.1 | Systematic Assessment |
| |
| Adenovirus infection | Infections and infestations | MedDRA version 26.1 | Systematic Assessment |
| |
| Amoebiasis | Infections and infestations | MedDRA version 26.1 | Systematic Assessment |
| |
| Cellulitis | Infections and infestations | MedDRA version 26.1 | Systematic Assessment |
| |
| Gastroenteritis adenovirus | Infections and infestations | MedDRA version 26.1 | Systematic Assessment |
| |
| Gastroenteritis norovirus | Infections and infestations | MedDRA version 26.1 | Systematic Assessment |
| |
| Human herpesvirus 6 infection | Infections and infestations | MedDRA version 26.1 | Systematic Assessment |
| |
| Infectious mononucleosis | Infections and infestations | MedDRA version 26.1 | Systematic Assessment |
| |
| Meningitis bacterial | Infections and infestations | MedDRA version 26.1 | Systematic Assessment |
| |
| Nasopharyngitis | Infections and infestations | MedDRA version 26.1 | Systematic Assessment |
| |
| Otitis media | Infections and infestations | MedDRA version 26.1 | Systematic Assessment |
| |
| Pharyngotonsillitis | Infections and infestations | MedDRA version 26.1 | Systematic Assessment |
| |
| Pneumonia respiratory syncytial viral | Infections and infestations | MedDRA version 26.1 | Systematic Assessment |
| |
| Respiratory syncytial virus bronchiolitis | Infections and infestations | MedDRA version 26.1 | Systematic Assessment |
| |
| Respiratory syncytial virus infection | Infections and infestations | MedDRA version 26.1 | Systematic Assessment |
| |
| Tonsillitis | Infections and infestations | MedDRA version 26.1 | Systematic Assessment |
| |
| Febrile convulsion | Nervous system disorders | MedDRA version 26.1 | Systematic Assessment |
| |
| Seizure | Nervous system disorders | MedDRA version 26.1 | Systematic Assessment |
| |
| Dehydration | Metabolism and nutrition disorders | MedDRA version 26.1 | Systematic Assessment |
| |
| Hypoglycaemia | Metabolism and nutrition disorders | MedDRA version 26.1 | Systematic Assessment |
| |
| Failure to thrive | Metabolism and nutrition disorders | MedDRA version 26.1 | Systematic Assessment |
| |
| Hypokalaemia | Metabolism and nutrition disorders | MedDRA version 26.1 | Systematic Assessment |
| |
| Asthma | Respiratory, thoracic and mediastinal disorders | MedDRA version 26.1 | Systematic Assessment |
| |
| Wheezing | Respiratory, thoracic and mediastinal disorders | MedDRA version 26.1 | Systematic Assessment |
| |
| Intussusception | Gastrointestinal disorders | MedDRA version 26.1 | Systematic Assessment |
| |
| Vomiting | Gastrointestinal disorders | MedDRA version 26.1 | Systematic Assessment |
| |
| Constipation | Gastrointestinal disorders | MedDRA version 26.1 | Systematic Assessment |
| |
| Enteritis | Gastrointestinal disorders | MedDRA version 26.1 | Systematic Assessment |
| |
| Craniocerebral injury | Injury, poisoning and procedural complications | MedDRA version 26.1 | Systematic Assessment |
| |
| Accidental exposure to product | Injury, poisoning and procedural complications | MedDRA version 26.1 | Systematic Assessment |
| |
| Foreign body in gastrointestinal tract | Injury, poisoning and procedural complications | MedDRA version 26.1 | Systematic Assessment |
| |
| Hand fracture | Injury, poisoning and procedural complications | MedDRA version 26.1 | Systematic Assessment |
| |
| Limb traumatic amputation | Injury, poisoning and procedural complications | MedDRA version 26.1 | Systematic Assessment |
| |
| Thermal burn | Injury, poisoning and procedural complications | MedDRA version 26.1 | Systematic Assessment |
| |
| Anaemia | Blood and lymphatic system disorders | MedDRA version 26.1 | Systematic Assessment |
| |
| Hypertransaminasaemia | Hepatobiliary disorders | MedDRA version 26.1 | Systematic Assessment |
| |
| Kawasaki's disease | Vascular disorders | MedDRA version 26.1 | Systematic Assessment |
| |
| Cardio-respiratory arrest | Cardiac disorders | MedDRA version 26.1 | Systematic Assessment |
| |
| Ventricular dysfunction | Cardiac disorders | MedDRA version 26.1 | Systematic Assessment |
| |
| Phimosis | Congenital, familial and genetic disorders | MedDRA version 26.1 | Systematic Assessment |
|
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Upper respiratory tract infection | Infections and infestations | MedDRA version 26.1 | Systematic Assessment |
| |
| Rhinitis | Infections and infestations | MedDRA version 26.1 | Systematic Assessment |
| |
| Nasopharyngitis | Infections and infestations | MedDRA version 26.1 | Systematic Assessment |
| |
| Respiratory tract infection | Infections and infestations | MedDRA version 26.1 | Systematic Assessment |
| |
| Injection site pain | General disorders | Solicited AE | Systematic Assessment |
| |
| Injection site erythema | General disorders | Solicited AE | Systematic Assessment |
| |
| Injection site induration | General disorders | Solicited AE | Systematic Assessment |
| |
| Injection site bruising | General disorders | Solicited AE | Systematic Assessment |
| |
| Pyrexia | General disorders | Solicited AE | Systematic Assessment |
| |
| Irritability | Psychiatric disorders | Solicited AE | Systematic Assessment |
| |
| Eating disorder | Psychiatric disorders | Solicited AE | Systematic Assessment |
| |
| Somnolence | Nervous system disorders | Solicited AE | Systematic Assessment |
| |
| Diarrhoea | Gastrointestinal disorders | Solicited AE | Systematic Assessment |
| |
| Vomiting | Gastrointestinal disorders | Solicited AE | Systematic Assessment |
|
Any publication by Institution or Investigator shall not be made before the first multicenter publication of the entire study results. Seqirus must be notified of any intent to publish data collected from the study and prior approval from Seqirus must be obtained prior to submission for publication.
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Clinical Trial Disclosure Manager | Seqirus | +1 855 358 8966 | seqirus.clinicaltrials@seqirus.com |
| Prot_000.pdf |
| SAP | No | Yes | No | Statistical Analysis Plan | Sep 7, 2021 | Nov 25, 2024 | SAP_001.pdf |
Not provided
| ID | Term |
|---|---|
| D007251 | Influenza, Human |
| ID | Term |
|---|---|
| D012141 | Respiratory Tract Infections |
| D007239 | Infections |
| D009976 | Orthomyxoviridae Infections |
| D012327 | RNA Virus Infections |
| D014777 | Virus Diseases |
| D012140 | Respiratory Tract Diseases |
Not provided
Not provided
|
| 24 months through 47 months |
|
|
|
|
|
| Asian |
|
|
| Black or African American |
|
|
| Native Hawaiian or Other Pacific Islander |
|
|
| White |
|
|
| Other |
|
|
|
| Czechia |
|
|
| Philippines |
|
|
| Ukraine |
|
|
| Malaysia |
|
|
| Thailand |
|
|
| New Zealand |
|
|
| Bangladesh |
|
|
| Latvia |
|
|
| Pakistan |
|
|
| Poland |
|
|
| Honduras |
|
|
| South Africa |
|
|
| Bulgaria |
|
|
| Estonia |
|
|
|
| Not previously vaccinated |
|
|
|
| Season 2 |
|
|
| Season 3 |
|
|
| Season 4 |
|
|
| Season 5 |
|
|
|
| Units | Counts |
|---|---|
| Participants |
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|
| Units | Counts |
|---|---|
| Participants |
|
|
|
| Units | Counts |
|---|---|
| Participants |
|
|
|
| Units | Counts |
|---|---|
| Participants |
|
|
|
Comparator vaccine immunogenicity analyses (Season 2) |
| OG004 | QIVc (Season 3) | QIVc immunogenicity analyses (Season 3) |
| OG005 | Comparator (Season 3) | Comparator vaccine immunogenicity analyses (Season 3) |
| OG006 | QIVc (Season 4) | QIVc immunogenicity analyses (Season 4) |
| OG007 | Comparator (Season 4) | Comparator vaccine immunogenicity analyses (Season 4) |
| OG008 | QIVc (Season 5) | QIVc immunogenicity analyses (Season 5) |
| OG009 | Comparator (Season 5) | Comparator vaccine immunogenicity analyses (Season 5) |
|
|
| OG004 | QIVc (Season 3) | QIVc immunogenicity analyses (Season 3) |
| OG005 | Comparator (Season 3) | Comparator vaccine immunogenicity analyses (Season 3) |
| OG006 | QIVc (Season 4) | QIVc immunogenicity analyses (Season 4) |
| OG007 | Comparator (Season 4) | Comparator vaccine immunogenicity analyses (Season 4) |
| OG008 | QIVc (Season 5) | QIVc immunogenicity analyses (Season 5) |
| OG009 | Comparator (Season 5) | Comparator vaccine immunogenicity analyses (Season 5) |
|
|
| OG004 | QIVc (Season 3) | QIVc immunogenicity analyses (Season 3) |
| OG005 | Comparator (Season 3) | Comparator vaccine immunogenicity analyses (Season 3) |
| OG006 | QIVc (Season 4) | QIVc immunogenicity analyses (Season 4) |
| OG007 | Comparator (Season 4) | Comparator vaccine immunogenicity analyses (Season 4) |
| OG008 | QIVc (Season 5) | QIVc immunogenicity analyses (Season 5) |
| OG009 | Comparator (Season 5) | Comparator vaccine immunogenicity analyses (Season 5) |
|
|
| QIVc (Season 3) |
QIVc immunogenicity analyses (Season 3) |
| OG005 | Comparator (Season 3) | Comparator vaccine immunogenicity analyses (Season 3) |
| OG006 | QIVc (Season 4) | QIVc immunogenicity analyses (Season 4) |
| OG007 | Comparator (Season 4) | Comparator vaccine immunogenicity analyses (Season 4) |
| OG008 | QIVc (Season 5) | QIVc immunogenicity analyses (Season 5) |
| OG009 | Comparator (Season 5) | Comparator vaccine immunogenicity analyses (Season 5) |
|
|
| OG004 | QIVc (Season 3) | QIVc immunogenicity analyses (Season 3) |
| OG005 | Comparator (Season 3) | Comparator vaccine immunogenicity analyses (Season 3) |
| OG006 | QIVc (Season 4) | QIVc immunogenicity analyses (Season 4) |
| OG007 | Comparator (Season 4) | Comparator vaccine immunogenicity analyses (Season 4) |
| OG008 | QIVc (Season 5) | QIVc immunogenicity analyses (Season 5) |
| OG009 | Comparator (Season 5) | Comparator vaccine immunogenicity analyses (Season 5) |
|
|
| OG004 |
| QIVc (Season 3) |
QIVc immunogenicity analyses (Season 3) |
| OG005 | Comparator (Season 3) | Comparator vaccine immunogenicity analyses (Season 3) |
| OG006 | QIVc (Season 4) | QIVc immunogenicity analyses (Season 4) |
| OG007 | Comparator (Season 4) | Comparator vaccine immunogenicity analyses (Season 4) |
| OG008 | QIVc (Season 5) | QIVc immunogenicity analyses (Season 5) |
| OG009 | Comparator (Season 5) | Comparator vaccine immunogenicity analyses (Season 5) |
|
|
| Units |
|---|
| Counts |
|---|
| Participants |
|
|
|
|
|
|