Influenza, Human

Efficacy Study With QIVc in Pediatric Subjects

NCT03932682 | PHASE 3 | INTERVENTIONAL

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.

74 Sites

5723 Participants

Recruiting

6 Months to 47 Months

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SUBMIT

International Centre for Diarrhoeal Disease Research, Bangladesh

Dhaka,Bangladesh

Medical Center Viva Feniks

Dobrich,Bulgaria

MHAT Dr. Stamen Iliev AD

Montana,Bulgaria

UMHAT Dr. Georgi Stranski EAD

Pleven,Bulgaria

UMHAT Sveti Georgi EAD

Plovdiv,Bulgaria

UMHATPlovdiv AD

Plovdiv,Bulgaria

SHATPPD Dr Dimitar Gramatikov Ruse EOOD

Ruse,Bulgaria

Medical Center Unimed Eood

Sevlievo,Bulgaria

MUDr. Stefan Hrunka, Prakticky lekar pro deti a dorost

Chlumec Nad Cidlinou,Czechia,50351

MUDr. Daniel Drazan, Prakticky lekar pro deti a dorost

Jindřichův Hradec,Czechia,37701

MUDr. David Zeman s.r.o.

Ostrava-poruba,Czechia,70800

MUDr. Daniela Pniakova s.r.o.

Ostrava,Czechia,70030

MUDr. Iva Madejova, Prakticky lekar pro deti a dorost

Pardubice,Czechia,53009

Vee Family Doctor's Centre

Paide,Estonia,72713

Innomedica O

Tallinn,Estonia,10117

Merelahe Family Doctors Center

Tallinn,Estonia,10617

Tallinn Children's Hospital

Tallinn,Estonia

Al Mare Perearstikeskus OU

Tallin,Estonia,10617

Clinical Research Centre

Tartu,Estonia,10117

Demedica

San Pedro Sula,Honduras,21104

Clnica Mdica y Dental CLIMEDENTY

Tegucigalpa,Honduras,11101

Inversiones en Investigacin Mdica (INVERIME)

Tegucigalpa,Honduras,2449

OLVI Medical Centre

Daugavpils,Latvia,LV1004

Clinical Research Centre (CRC), Hospital Tuanku Fauziah

Kangar,Perlis,Malaysia,01000

Sarawak General Hospital

Kuching,Sarawak,Malaysia,93586

Hospital Sibu

Sibu,Sarawak,Malaysia,96000

Klinik Kesihatan Putrajaya Presint

Putrajaya,Wilyah Persekutuan Putrajaya,Malaysia,62250

University Malaya Medical Centre

Kuala Lumpur,Malaysia,59100

Christchurch Clinical Studies Trust

Christchurch,New Zealand,8011

Wellington Hospital

Wellington,New Zealand,6021

Shifa International Hospital

Islamabad,Pakistan

The Aga Khan

Karachi,Pakistan

Avicenna Hospital

Lahore,Pakistan

Central Park Teaching Hospital

Lahore,Pakistan

Al Shifa Research Centre

Rawalpindi,Pakistan

University of the Philippines Manila Development Foundation Inc

Ermita,Manila,Philippines,1000

UERM Memorial Medical Center

Quezon City,Quezon,Philippines

Health Index Multispecialty Clinic

Bacoor,Philippines

Chong Hua Hospital

Cebu City,Philippines

De La Salle Medical and Health Sciences Institute

Dasmariñas,Philippines

De La Salle Medical and Health Sciences Institute

Dasmariñas,Philippines

Mary Chiles General Hospital

Manila,Philippines,1008

Philippine General Hospital

Manila,Philippines

Philippine General Hospital

Manila,Philippines

Philippine General Hospital

Manila,Philippines

UERM Memorial Medical Center

Quezon City,Philippines

Philippine Children's Medical Center

Quezon City,Philippines

Osrodek Badan Klinicznych INVIVO sp. z o.o.

Bydgoszcz,Poland,85-090

Jerzy Brzostek Prywatny Gabinet Lekarski

Dębica,Poland,39-200

Gdanskie Centrum Zdrowia Sp. z o.o.

Gdańsk,Poland,80-542

Hanna Czajka, Indywidualna Specjalistyczna Praktyka Lekarska

Kraków,Poland,31-302

Gabinet Lekarski Bartosz Korczowski

Rzeszów,Poland,35-302

Niepubliczny Zaklad Lecznictwa Ambulatoryjnego Michalkowice

Siemianowice Śląskie,Poland,41-103

ETG Network Skierniewice,Clinmed Research

Skierniewice,Poland,96-100

Szpital im. Swietej Jadwigi Slaskiej w Trzebnicy

Trzebnica,Poland,55-100

SC Sana Monitoring SRL.

Bucuresti,Romania,011025

Spitalul Municipal Caracal

Caracal,Romania,235200

Sc Med Fam Apolo srl

Călăraşi,Romania,910160

S.C Centrul Clinic Mediquest S.R.L

Sângeorgiu De Mureş,Romania,547530

Madibeng Centre for Research

Brits,South Africa

Tread Research

Cape Town,South Africa

Allergy & Immunology Unit

Cape Town,South Africa

Synergy Biomed Research Institute

East London,South Africa

Perinatal HIV Research Unit, Tshepong Hospital

Klerksdorp,South Africa

Be Part Yoluntu Centre

Paarl,South Africa

Clinical Trial Systems

Pretoria,South Africa

Soweto Clinical Trials Centre

Soweto,South Africa

Limpopo Clinical Research Initiative

Thabazimbi,South Africa

Phramongkutklao Hospital

Ratchathewi,Bangkok,Thailand,10400

Vaccine Trial Centre, Faculty of Tropical Medicine, Mahidol University

Bangkok,Thailand,10400

Department of Tropical Pediatrics, Faculty of Tropical Medicine, Mahidol University

Bangkok,Thailand,10400

Reg Mun NPE Chernivtsi RCCH Infectious Dept for Infants SHEI of UBSMU

Chernivtsi,Ukraine,58023

CI Dnipro Children's City CH # of Dnipro City Council

Dnipro,Ukraine,49027

Vinnytsia RCCH Policlinic Dept Vinnytsia M.I.Pyrogov NMU

Vinnytsia,Ukraine,21000

Study 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.
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.

Additional Studies

Additional studies can be found at ClinicalTrials.gov