Clinical trial NCT03932682: Efficacy Study With QIVc in Pediatric Subjects
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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Influenza, Human
Keywords: Influenza Vaccine
Lead sponsor: Seqirus
Sponsor class: INDUSTRY
First posted: 2019-05-01
Enrollment: 5723
Sex: ALL
Minimum age (years): 6
Maximum age (years): 47
Standard ages: CHILD
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief 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 laboratory confirmed influenza A or B disease in children 6 through 47 months of age, compared to a non-influenza vaccine.


Eligibility criteria: 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.

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:

* 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 are provided in the study protocol.

Primary outcomes:
measure: 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
timeFrame: >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: 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
timeFrame: >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)
Secondary outcomes:
measure: 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
timeFrame: >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: 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
timeFrame: >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: 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
timeFrame: >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: Immunogenicity Endpoint: Prevaccination and Postvaccination Geometric Mean Titer (GMT) (HI Assay)
timeFrame: Day 1 and Day 29 for previously vaccinated subjects; Day 1 and Day 57 for not previously vaccinated subjects
measure: Immunogenicity Endpoint: Seroconversion Rates (SCR) (HI Assay)
timeFrame: Day 1 through Day 29 for previously vaccinated subjects; Day 1 through Day 57 for not previously vaccinated subjects
measure: Immunogenicity Endpoint: Geometric Mean Ratio (GMR) (HI Assay)
timeFrame: Day 1 through Day 29 for previously vaccinated subjects; Day 1 through Day 57 for not previously vaccinated subjects
measure: Immunogenicity Endpoint: Prevaccination and Postvaccination Geometric Mean Titer (GMT) (MN Assay)
timeFrame: Day 1 and Day 29 for previously vaccinated subjects; Day 1 and Day 57 for not previously vaccinated subjects
measure: Immunogenicity Endpoint: Seroconversion Rates (SCR) (MN Assay)
timeFrame: Day 1 through Day 29 for previously vaccinated subjects; Day 1 through Day 57 for not previously vaccinated subjects
measure: Immunogenicity Endpoint: Geometric Mean Ratio (GMR) (MN Assay)
timeFrame: Day 1 through Day 29 for previously vaccinated subjects; Day 1 through Day 57 for not previously vaccinated subjects
measure: Safety Endpoint: Percentage of Subjects With Solicited Local and Systemic Adverse Events (AEs)
timeFrame: 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
measure: Safety Endpoint: Percentage of Subjects With Unsolicited AEs
timeFrame: 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
measure: Safety Endpoint: Percentage of Subjects With SAEs, NOCDs, AEs Leading to Withdrawal From the Study or Vaccination
timeFrame: 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
measure: Safety Endpoint: Percentage of Subjects With Medically-attended AEs
timeFrame: 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)
Other outcomes:
Locations:
city: Dhaka
country: Bangladesh
facility: International Centre for Diarrhoeal Disease Research, Bangladesh
city: Dobrich
country: Bulgaria
facility: 10008-Medical Center Viva Feniks
city: Montana
country: Bulgaria
facility: 10007-MHAT Dr. Stamen Iliev AD
city: Pleven
country: Bulgaria
facility: 10003-UMHAT Dr. Georgi Stranski EAD
city: Plovdiv
country: Bulgaria
facility: 10002-UMHAT Sveti Georgi EAD
city: Plovdiv
country: Bulgaria
facility: 10006-UMHAT-Plovdiv AD
city: Ruse
country: Bulgaria
facility: 10004-SHATPPD Dr Dimitar Gramatikov Ruse EOOD
city: Sevlievo
country: Bulgaria
facility: 10009-Medical Center Unimed Eood
city: Chlumec Nad Cidlinou
country: Czechia
facility: 20303-MUDr. Stefan Hrunka, Prakticky lekar pro deti a dorost
city: Jindřichův Hradec
country: Czechia
facility: 20301-MUDr. Daniel Drazan, Prakticky lekar pro deti a dorost
city: Ostrava-poruba
country: Czechia
facility: 20304-MUDr. David Zeman s.r.o.
city: Ostrava
country: Czechia
facility: 20302-MUDr. Daniela Pniakova s.r.o.
city: Pardubice
country: Czechia
facility: 20305-MUDr. Iva Madejova, Prakticky lekar pro deti a dorost
city: Paide
country: Estonia
facility: 23305-Vee Family Doctor's Centre
city: Tallinn
country: Estonia
facility: 23301-Innomedica OÜ
city: Tallinn
country: Estonia
facility: 23304-Merelahe Family Doctors Center
city: Tallinn
country: Estonia
facility: 23307-Tallinn Children's Hospital
city: Tallin
country: Estonia
facility: 23303-Al Mare Perearstikeskus OU
city: Tartu
country: Estonia
facility: 23302-Clinical Research Centre
city: San Pedro Sula
country: Honduras
facility: 34001-Demedica
city: Tegucigalpa
country: Honduras
facility: 34003-Clínica Médica y Dental CLIMEDENTY
city: Tegucigalpa
country: Honduras
facility: 34002-Inversiones en Investigación Médica (INVERIME)
city: Daugavpils
country: Latvia
facility: 42802-OLVI Medical Centre
city: Kangar
country: Malaysia
facility: 45804-Clinical Research Centre (CRC), Hospital Tuanku Fauziah
state: Perlis
city: Kuching
country: Malaysia
facility: 45803-Sarawak General Hospital
state: Sarawak
city: Sibu
country: Malaysia
facility: 45802-Hospital Sibu
state: Sarawak
city: Putrajaya
country: Malaysia
facility: 45805-Klinik Kesihatan Putrajaya Presint 9
state: Wilyah Persekutuan Putrajaya
city: Kuala Lumpur
country: Malaysia
facility: 45801-University Malaya Medical Centre
city: Christchurch
country: New Zealand
facility: 55403-Christchurch Clinical Studies Trust
city: Wellington
country: New Zealand
facility: 55401-Wellington Hospital
city: Islamabad
country: Pakistan
facility: 58602-Shifa International Hospital
city: Karachi
country: Pakistan
facility: 58604-The Aga Khan
city: Lahore
country: Pakistan
facility: 58605-Avicenna Hospital
city: Lahore
country: Pakistan
facility: 58607-Central Park Teaching Hospital
city: Rawalpindi
country: Pakistan
facility: 58601-Al Shifa Research Centre
city: Ermita
country: Philippines
facility: 60808-University of the Philippines Manila Development Foundation Inc
state: Manila
city: Quezon City
country: Philippines
facility: 60810-UERM Memorial Medical Center
state: Quezon
city: Bacoor
country: Philippines
facility: 60817-Health Index Multispecialty Clinic
city: Cebu City
country: Philippines
facility: 60801-Chong Hua Hospital
city: Dasmariñas
country: Philippines
facility: 60812-De La Salle Medical and Health Sciences Institute
city: Dasmariñas
country: Philippines
facility: 60816-De La Salle Medical and Health Sciences Institute
city: Manila
country: Philippines
facility: 60806-Mary Chiles General Hospital
city: Manila
country: Philippines
facility: 60814-Philippine General Hospital
city: Manila
country: Philippines
facility: 60815-Philippine General Hospital
city: Manila
country: Philippines
facility: 60818-Philippine General Hospital
city: Quezon City
country: Philippines
facility: 60811-UERM Memorial Medical Center
city: Quezon City
country: Philippines
facility: 60813-Philippine Children's Medical Center
city: Bydgoszcz
country: Poland
facility: 61605-Osrodek Badan Klinicznych IN-VIVO sp. z o.o.
city: Dębica
country: Poland
facility: 61603-Jerzy Brzostek Prywatny Gabinet Lekarski
city: Gdańsk
country: Poland
facility: 61607-Gdanskie Centrum Zdrowia Sp. z o.o.
city: Kraków
country: Poland
facility: 61604-Hanna Czajka, Indywidualna Specjalistyczna Praktyka Lekarska
city: Rzeszów
country: Poland
facility: 61608-Gabinet Lekarski Bartosz Korczowski
city: Siemianowice Śląskie
country: Poland
facility: 61602-Niepubliczny Zaklad Lecznictwa Ambulatoryjnego Michalkowice
city: Skierniewice
country: Poland
facility: 61601-ETG Network- Skierniewice,Clinmed Research
city: Trzebnica
country: Poland
facility: 61609-Szpital im. Swietej Jadwigi Slaskiej w Trzebnicy
city: Bucuresti
country: Romania
facility: 64201-SC Sana Monitoring SRL.
city: Caracal
country: Romania
facility: 64202-Spitalul Municipal Caracal
city: Călăraşi
country: Romania
facility: 64205-Sc Med Fam Apolo srl
city: Sângeorgiu De Mureş
country: Romania
facility: 64206-S.C Centrul Clinic Mediquest S.R.L
city: Brits
country: South Africa
facility: 71006-Madibeng Centre for Research
city: Cape Town
country: South Africa
facility: 71004-Tread Research
city: Cape Town
country: South Africa
facility: 71007-Allergy & Immunology Unit
city: East London
country: South Africa
facility: 71002-Synergy Biomed Research Institute
city: Klerksdorp
country: South Africa
facility: 71009-Perinatal HIV Research Unit, Tshepong Hospital
city: Paarl
country: South Africa
facility: 71001-Be Part Yoluntu Centre
city: Pretoria
country: South Africa
facility: 71008-Clinical Trial Systems
city: Soweto
country: South Africa
facility: 71003-Soweto Clinical Trials Centre
city: Thabazimbi
country: South Africa
facility: 71005-Limpopo Clinical Research Initiative
city: Ratchathewi
country: Thailand
facility: 76405-Phramongkutklao Hospital
state: Bangkok
city: Bangkok
country: Thailand
facility: 76401-Vaccine Trial Centre, Faculty of Tropical Medicine, Mahidol University
city: Bangkok
country: Thailand
facility: 76404-Department of Tropical Pediatrics, Faculty of Tropical Medicine, Mahidol University
city: Chernivtsi
country: Ukraine
facility: 80404-Reg Mun NPE Chernivtsi RCCH Infectious Dept for Infants SHEI of UBSMU
city: Dnipro
country: Ukraine
facility: 80405-CI Dnipro Children's City CH #5 of Dnipro City Council
city: Vinnytsia
country: Ukraine
facility: 80401-Vinnytsia RCCH Policlinic Dept Vinnytsia M.I.Pyrogov NMU
Study officials:
affiliation: Seqirus
name: Clinical Program Director
role: STUDY_DIRECTOR
References: