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Efficacy Study With QIVc in Pediatric Subjects

NCT ID: NCT03932682

Last Updated: 2025-03-04

Study Results

Results available

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE3

Total Enrollment

5723 participants

Study Classification

INTERVENTIONAL

Study Start Date

2019-05-13

Study Completion Date

2024-02-13

Brief Summary

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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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Detailed Description

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Conditions

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Influenza, Human

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

PREVENTION

Blinding Strategy

QUADRUPLE

Participants Caregivers Investigators Outcome Assessors
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.

Study Groups

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QIVc

Cell-derived Quadrivalent Influenza Vaccine

Group Type EXPERIMENTAL

QIVc

Intervention Type 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.

Comparator

Non-influenza Comparator

Group Type ACTIVE_COMPARATOR

Comparator

Intervention Type BIOLOGICAL

Meningococcal Group C Polysaccharide Conjugate Vaccine (NeisVac-C)

Interventions

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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.

Intervention Type BIOLOGICAL

Comparator

Meningococcal Group C Polysaccharide Conjugate Vaccine (NeisVac-C)

Intervention Type BIOLOGICAL

Other Intervention Names

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Flucelvax Quadrivalent

Eligibility Criteria

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Inclusion Criteria

* 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.

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.
Minimum Eligible Age

6 Months

Maximum Eligible Age

47 Months

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Seqirus

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Clinical Program Director

Role: STUDY_DIRECTOR

Seqirus

Locations

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60818-Philippine General Hospital

Manila, , Philippines

Site Status

60811-UERM Memorial Medical Center

Quezon City, , Philippines

Site Status

60813-Philippine Children's Medical Center

Quezon City, , Philippines

Site Status

61605-Osrodek Badan Klinicznych IN-VIVO sp. z o.o.

Bydgoszcz, , Poland

Site Status

International Centre for Diarrhoeal Disease Research, Bangladesh

Dhaka, , Bangladesh

Site Status

10008-Medical Center Viva Feniks

Dobrich, , Bulgaria

Site Status

10007-MHAT Dr. Stamen Iliev AD

Montana, , Bulgaria

Site Status

10003-UMHAT Dr. Georgi Stranski EAD

Pleven, , Bulgaria

Site Status

10002-UMHAT Sveti Georgi EAD

Plovdiv, , Bulgaria

Site Status

10006-UMHAT-Plovdiv AD

Plovdiv, , Bulgaria

Site Status

10004-SHATPPD Dr Dimitar Gramatikov Ruse EOOD

Rousse, , Bulgaria

Site Status

10009-Medical Center Unimed Eood

Sevlievo, , Bulgaria

Site Status

20303-MUDr. Stefan Hrunka, Prakticky lekar pro deti a dorost

Chlumec nad Cidlinou, , Czechia

Site Status

20301-MUDr. Daniel Drazan, Prakticky lekar pro deti a dorost

Jindřichův Hradec, , Czechia

Site Status

20302-MUDr. Daniela Pniakova s.r.o.

Ostrava, , Czechia

Site Status

20304-MUDr. David Zeman s.r.o.

Ostrava-poruba, , Czechia

Site Status

20305-MUDr. Iva Madejova, Prakticky lekar pro deti a dorost

Pardubice, , Czechia

Site Status

23305-Vee Family Doctor's Centre

Paide, , Estonia

Site Status

23301-Innomedica OÜ

Tallinn, , Estonia

Site Status

23303-Al Mare Perearstikeskus OU

Tallinn, , Estonia

Site Status

23304-Merelahe Family Doctors Center

Tallinn, , Estonia

Site Status

23307-Tallinn Children's Hospital

Tallinn, , Estonia

Site Status

23302-Clinical Research Centre

Tartu, , Estonia

Site Status

34001-Demedica

San Pedro Sula, , Honduras

Site Status

34003-Clínica Médica y Dental CLIMEDENTY

Tegucigalpa, , Honduras

Site Status

34002-Inversiones en Investigación Médica (INVERIME)

Tegucigalpa, , Honduras

Site Status

42802-OLVI Medical Centre

Daugavpils, , Latvia

Site Status

45804-Clinical Research Centre (CRC), Hospital Tuanku Fauziah

Kangar, Perlis, Malaysia

Site Status

45803-Sarawak General Hospital

Kuching, Sarawak, Malaysia

Site Status

45802-Hospital Sibu

Sibu, Sarawak, Malaysia

Site Status

45805-Klinik Kesihatan Putrajaya Presint 9

Putrajaya, Wilyah Persekutuan Putrajaya, Malaysia

Site Status

45801-University Malaya Medical Centre

Kuala Lumpur, , Malaysia

Site Status

55403-Christchurch Clinical Studies Trust

Christchurch, , New Zealand

Site Status

55401-Wellington Hospital

Wellington, , New Zealand

Site Status

58602-Shifa International Hospital

Islamabad, , Pakistan

Site Status

58604-The Aga Khan

Karachi, , Pakistan

Site Status

58605-Avicenna Hospital

Lahore, , Pakistan

Site Status

58607-Central Park Teaching Hospital

Lahore, , Pakistan

Site Status

58601-Al Shifa Research Centre

Rawalpindi, , Pakistan

Site Status

60808-University of the Philippines Manila Development Foundation Inc

Ermita, Manila, Philippines

Site Status

60810-UERM Memorial Medical Center

Quezon City, Quezon, Philippines

Site Status

60817-Health Index Multispecialty Clinic

Bacoor, , Philippines

Site Status

60801-Chong Hua Hospital

Cebu City, , Philippines

Site Status

60812-De La Salle Medical and Health Sciences Institute

Dasmariñas, , Philippines

Site Status

60816-De La Salle Medical and Health Sciences Institute

Dasmariñas, , Philippines

Site Status

60806-Mary Chiles General Hospital

Manila, , Philippines

Site Status

60814-Philippine General Hospital

Manila, , Philippines

Site Status

60815-Philippine General Hospital

Manila, , Philippines

Site Status

61603-Jerzy Brzostek Prywatny Gabinet Lekarski

Dębica, , Poland

Site Status

61607-Gdanskie Centrum Zdrowia Sp. z o.o.

Gdansk, , Poland

Site Status

61604-Hanna Czajka, Indywidualna Specjalistyczna Praktyka Lekarska

Krakow, , Poland

Site Status

61608-Gabinet Lekarski Bartosz Korczowski

Rzeszów, , Poland

Site Status

61602-Niepubliczny Zaklad Lecznictwa Ambulatoryjnego Michalkowice

Siemianowice Śląskie, , Poland

Site Status

61601-ETG Network- Skierniewice,Clinmed Research

Skierniewice, , Poland

Site Status

61609-Szpital im. Swietej Jadwigi Slaskiej w Trzebnicy

Trzebnica, , Poland

Site Status

64201-SC Sana Monitoring SRL.

Bucharest, , Romania

Site Status

64202-Spitalul Municipal Caracal

Caracal, , Romania

Site Status

64205-Sc Med Fam Apolo srl

Călăraşi, , Romania

Site Status

64206-S.C Centrul Clinic Mediquest S.R.L

Sângeorgiu de Mureş, , Romania

Site Status

71006-Madibeng Centre for Research

Brits, , South Africa

Site Status

71004-Tread Research

Cape Town, , South Africa

Site Status

71007-Allergy & Immunology Unit

Cape Town, , South Africa

Site Status

71002-Synergy Biomed Research Institute

East London, , South Africa

Site Status

71009-Perinatal HIV Research Unit, Tshepong Hospital

Klerksdorp, , South Africa

Site Status

71001-Be Part Yoluntu Centre

Paarl, , South Africa

Site Status

71008-Clinical Trial Systems

Pretoria, , South Africa

Site Status

71003-Soweto Clinical Trials Centre

Soweto, , South Africa

Site Status

71005-Limpopo Clinical Research Initiative

Thabazimbi, , South Africa

Site Status

76405-Phramongkutklao Hospital

Ratchathewi, Bangkok, Thailand

Site Status

76401-Vaccine Trial Centre, Faculty of Tropical Medicine, Mahidol University

Bangkok, , Thailand

Site Status

76404-Department of Tropical Pediatrics, Faculty of Tropical Medicine, Mahidol University

Bangkok, , Thailand

Site Status

80404-Reg Mun NPE Chernivtsi RCCH Infectious Dept for Infants SHEI of UBSMU

Chernivtsi, , Ukraine

Site Status

80405-CI Dnipro Children's City CH #5 of Dnipro City Council

Dnipro, , Ukraine

Site Status

80401-Vinnytsia RCCH Policlinic Dept Vinnytsia M.I.Pyrogov NMU

Vinnytsia, , Ukraine

Site Status

Countries

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

Provided Documents

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Document Type: Study Protocol

View Document

Document Type: Statistical Analysis Plan

View Document

Other Identifiers

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2018-001857-29

Identifier Type: EUDRACT_NUMBER

Identifier Source: secondary_id

V130_14

Identifier Type: -

Identifier Source: org_study_id

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