Efficacy Study With QIVc in Pediatric Subjects

Influenza, Human Clinical Trial

Official title:

A Phase 3, Randomized, Observer-blind, Multicenter Study to Evaluate the Efficacy, Immunogenicity and Safety of Seqirus' Cell-Based Quadrivalent Subunit Influenza Virus Vaccine (QIVc) Compared to a Non-Influenza Vaccine When Administrated in Healthy Subjects Aged 6 Months Through 47 Months

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03932682
• Other study ID #: V130_14
• Secondary ID: 2018-001857-29
• Status: Completed
• Phase: Phase 3
• Start date: May 13, 2019
• Est. completion date: February 13, 2024

Study information

• Verified date: March 2024
• Source: Seqirus
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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 Reverse transcription polymerase chain reaction (RT-PCR) confirmed influenza A or B disease in children 6 through 47 months of age, compared to a non-influenza vaccine.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 5723
• Est. completion date: February 13, 2024
• Est. primary completion date: November 30, 2023
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 6 Months to 47 Months

Eligibility

Inclusion Criteria:

In order to participate in this study, all subjects must meet all of the inclusion criteria described.

• Individuals of 6 through 47 months of age on the day of informed consent.
• Individuals whose parent(s)/Legally Acceptable Representative (LAR) have voluntarily given written informed consent after the nature of the study has been explained according to local regulatory requirements, prior to study entry.
• Individuals who can comply with study procedures including follow-up.
• Individuals in generally good health as per the Investigator's medical judgement. 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:

• Acute (severe) febrile illness. Enrollment could be considered if the fever is absent for 72 hours.
• History of any anaphylaxis, serious vaccine reactions or hypersensitivity, including allergic reactions, to any component of vaccine or medical equipment whose use is foreseen in this study.
• Clinical conditions representing a contraindication to intramuscular vaccination and blood draws. These may include known bleeding disorders, or treatment with anticoagulants in the 3 weeks preceding vaccination.
• A known history of Guillain-Barré Syndrome or other demyelinating diseases such as encephalomyelitis and transverse myelitis.
• Abnormal function of the immune system resulting from a clinical condition
• Received influenza vaccination or has had documented influenza disease in the last 6 months prior to informed consent.
• Prior vaccination to prevent Neisseria meningitides serogroup C disease or prior infection caused by this organism. Additional eligibility criteria may be discussed by contacting the site.

Related Conditions & MeSH terms

• Influenza, Human

Intervention

Biological:
• 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.
• Comparator
Meningococcal Group C Polysaccharide Conjugate Vaccine (MenC vaccine, Neisvac-C)

Locations

Country	Name	City	State
Bangladesh	International Centre for Diarrhoeal Disease Research, Bangladesh	Dhaka
Bulgaria	10008-Medical Center Viva Feniks	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	Ruse
Bulgaria	10009-Medical Center Unimed Eood	Sevlievo
Czechia	20303-MUDr. Stefan Hrunka, Prakticky lekar pro deti a dorost	Chlumec Nad Cidlinou
Czechia	20301-MUDr. Daniel Drazan, Prakticky lekar pro deti a dorost	Jindrichuv Hradec
Czechia	20302-MUDr. Daniela Pniakova s.r.o.	Ostrava
Czechia	20304-MUDr. David Zeman s.r.o.	Ostrava-poruba
Czechia	20305-MUDr. Iva Madejova, Prakticky lekar pro deti a dorost	Pardubice
Estonia	23305-Vee Family Doctor's Centre	Paide
Estonia	23303-Al Mare Perearstikeskus OU	Tallin
Estonia	23301-Innomedica OÜ	Tallinn
Estonia	23304-Merelahe Family Doctors Center	Tallinn
Estonia	23307-Tallinn Children's Hospital	Tallinn
Estonia	23302-Clinical Research Centre	Tartu
Honduras	34001-Demedica	San Pedro Sula
Honduras	34002-Inversiones en Investigación Médica (INVERIME)	Tegucigalpa
Honduras	34003-Clínica Médica y Dental CLIMEDENTY	Tegucigalpa
Latvia	42802-OLVI Medical Centre	Daugavpils
Malaysia	45804-Clinical Research Centre (CRC), Hospital Tuanku Fauziah	Kangar	Perlis
Malaysia	45801-University Malaya Medical Centre	Kuala Lumpur
Malaysia	45803-Sarawak General Hospital	Kuching	Sarawak
Malaysia	45805-Klinik Kesihatan Putrajaya Presint 9	Putrajaya	Wilyah Persekutuan Putrajaya
Malaysia	45802-Hospital Sibu	Sibu	Sarawak
New Zealand	55403-Christchurch Clinical Studies Trust	Christchurch
New Zealand	55401-Wellington Hospital	Wellington
Pakistan	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
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	60808-University of the Philippines Manila Development Foundation Inc	Ermita	Manila
Philippines	60806-Mary Chiles General Hospital	Manila
Philippines	60814-Philippine General Hospital	Manila
Philippines	60815-Philippine General Hospital	Manila
Philippines	60818-Philippine General Hospital	Manila
Philippines	60810-UERM Memorial Medical Center	Quezon City	Quezon
Philippines	60811-UERM Memorial Medical Center	Quezon City
Philippines	60813-Philippine Children's Medical Center	Quezon City
Poland	61605-Osrodek Badan Klinicznych IN-VIVO sp. z o.o.	Bydgoszcz
Poland	61603-Jerzy Brzostek Prywatny Gabinet Lekarski	Debica
Poland	61607-Gdanskie Centrum Zdrowia Sp. z o.o.	Gdansk
Poland	61604-Hanna Czajka, Indywidualna Specjalistyczna Praktyka Lekarska	Kraków
Poland	61608-Gabinet Lekarski Bartosz Korczowski	Rzeszów
Poland	61602-Niepubliczny Zaklad Lecznictwa Ambulatoryjnego Michalkowice	Siemianowice Slaskie
Poland	61601-ETG Network- Skierniewice,Clinmed Research	Skierniewice
Poland	61609-Szpital im. Swietej Jadwigi Slaskiej w Trzebnicy	Trzebnica
Romania	64201-SC Sana Monitoring SRL.	Bucuresti
Romania	64205-Sc Med Fam Apolo srl	Calarasi
Romania	64202-Spitalul Municipal Caracal	Caracal
Romania	64206-S.C Centrul Clinic Mediquest S.R.L	Sângeorgiu De Mures
South Africa	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
Thailand	76401-Vaccine Trial Centre, Faculty of Tropical Medicine, Mahidol University	Bangkok
Thailand	76404-Department of Tropical Pediatrics, Faculty of Tropical Medicine, Mahidol University	Bangkok
Thailand	76405-Phramongkutklao Hospital	Ratchathewi	Bangkok
Ukraine	80404-Reg Mun NPE Chernivtsi RCCH Infectious Dept for Infants SHEI of UBSMU	Chernivtsi
Ukraine	80405-CI Dnipro Children's City CH #5 of Dnipro City Council	Dnipro
Ukraine	80401-Vinnytsia RCCH Policlinic Dept Vinnytsia M.I.Pyrogov NMU	Vinnytsia

Sponsors (1)

Lead Sponsor	Collaborator
Seqirus

Countries where clinical trial is conducted

Bangladesh,  Bulgaria,  Czechia,  Estonia,  Honduras,  Latvia,  Malaysia,  New Zealand,  Pakistan,  Philippines,  Poland,  Romania,  South Africa,  Thailand,  Ukraine, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Efficacy Endpoint: First occurrence of 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	Day 14 to Day 180
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	Day 14 to Day 180
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	Day 14 to Day 180
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	Day 14 to Day 180
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	Day 14 to Day 180
Secondary	Immunogenicity Endpoint: a) Prevaccination and postvaccination Geometric Mean Titer (GMT)	The measures for immunogenicity are determined by a haemagglutination inhibition [HI] and/or a microneutralization [MN] assay prior to first vaccination and 28 days after last vaccination for all four influenza strains	Day 1 and 28 days after last vaccination
Secondary	Immunogenicity Endpoint: Seroconversion rates (SCR)	The measures for immunogenicity are determined by a HI and/or 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 HI (or MN) titer < 1:10 and a postvaccination HI (or MN) titer = 1:40, or a prevaccination HI (or MN) titer = 1:10 and a = 4-fold increase in postvaccination HI (or MN) titer	Day 1 and 28 days after last vaccination
Secondary	Immunogenicity endpoint: Geometric Mean Ratio (GMR)	The measures for immunogenicity are determined by a haemagglutination inhibition [HI] and/or a micro neutralization [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 HI (or MN) titer over the pre-vaccination HI (or MN) titer	Day 1 and 28 days after last vaccination
Secondary	Safety Endpoint: Percentage of subjects with solicited local and systemic adverse events (AE)	Percentage of subjects with solicited local and systemic AEs will be assessed for 7 days following each vaccination in the QIVc group and in the comparator group	7 days following each vaccination
Secondary	Safety Endpoint: Percentage of subjects with unsolicited AEs	Percentage of subjects with any unsolicited AEs will be assessed in the QIVc group and in the comparator group until 28 days after each vaccination	28 days following each vaccination
Secondary	Safety Endpoint: Percentage of subjects with SAEs, NOCDs, AEs leading to withdrawal from the study or vaccination	Percentage of subjects with serious AEs (SAE), new onset of chronic disease (NOCD), AEs leading to withdrawal from the study or vaccination, and all medications associated with these events will be reported in the QIVc group and in the comparator group	Day 1 to Day 180
Secondary	Safety Endpoint: Percentage of subjects with medically-attended AEs	Percentage of subjects with medically-attended AEs within 30 days after ILI onset will be reported in the QIVc group and in the comparator group	30 days following ILI onset