Efficacy Study With QIVc in Pediatric Subjects

NCT03932682 | Completed Phase 3 Results DMC FDA Drug

• 2 other identifiers: V130_142018-001857-29
• Study Type: interventional
• Target: 5,723
• Locations: 15 countries
• Sites: 74

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.

Conditions

Influenza, Human

Keywords

Influenza Vaccine

Outcome Measures

Primary Outcomes (2)

• 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)

Secondary Outcomes (13)

• 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

  >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

  >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

  >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)

  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)

  Day 1 through Day 29 for previously vaccinated subjects; Day 1 through Day 57 for not previously vaccinated subjects

Study Arms (2)

QIVc

EXPERIMENTAL

Cell-derived Quadrivalent Influenza Vaccine

Biological: QIVc

Comparator

ACTIVE COMPARATOR

Non-influenza Comparator

Biological: Comparator

Interventions

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.

Also known as: Flucelvax Quadrivalent

QIVc

Comparator BIOLOGICAL

Meningococcal Group C Polysaccharide Conjugate Vaccine (NeisVac-C)

Comparator

Eligibility Criteria

• Age: 6 Months - 47 Months
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Seqirus: lead

Study Sites (74)

International Centre for Diarrhoeal Disease Research, Bangladesh

Dhaka, Bangladesh

Location

10008-Medical Center Viva Feniks

Dobrich, Bulgaria

Location

10007-MHAT Dr. Stamen Iliev AD

Montana, Bulgaria

Location

10003-UMHAT Dr. Georgi Stranski EAD

Pleven, Bulgaria

Location

10002-UMHAT Sveti Georgi EAD

Plovdiv, Bulgaria

Location

10006-UMHAT-Plovdiv AD

Plovdiv, Bulgaria

Location

10004-SHATPPD Dr Dimitar Gramatikov Ruse EOOD

Rousse, Bulgaria

Location

10009-Medical Center Unimed Eood

Sevlievo, Bulgaria

Location

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

Chlumec nad Cidlinou, 503 51, Czechia

Location

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

Jindřichův Hradec, 377 01, Czechia

Location

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

Ostrava, 700 30, Czechia

Location

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

Ostrava-poruba, 708 00, Czechia

Location

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

Pardubice, 530 09, Czechia

Location

23305-Vee Family Doctor's Centre

Paide, 72713, Estonia

Location

23301-Innomedica OÜ

Tallinn, 10117, Estonia

Location

23303-Al Mare Perearstikeskus OU

Tallinn, 10617, Estonia

Location

23304-Merelahe Family Doctors Center

Tallinn, 10617, Estonia

Location

23307-Tallinn Children's Hospital

Tallinn, Estonia

Location

23302-Clinical Research Centre

Tartu, 10117, Estonia

Location

34001-Demedica

San Pedro Sula, 21104, Honduras

Location

34003-Clínica Médica y Dental CLIMEDENTY

Tegucigalpa, 11101, Honduras

Location

34002-Inversiones en Investigación Médica (INVERIME)

Tegucigalpa, 2449, Honduras

Location

42802-OLVI Medical Centre

Daugavpils, LV 1004, Latvia

Location

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

Kangar, Perlis, 01000, Malaysia

Location

45803-Sarawak General Hospital

Kuching, Sarawak, 93586, Malaysia

Location

45802-Hospital Sibu

Sibu, Sarawak, 96000, Malaysia

Location

45805-Klinik Kesihatan Putrajaya Presint 9

Putrajaya, Wilyah Persekutuan Putrajaya, 62250, Malaysia

Location

45801-University Malaya Medical Centre

Kuala Lumpur, 59100, Malaysia

Location

55403-Christchurch Clinical Studies Trust

Christchurch, 8011, New Zealand

Location

55401-Wellington Hospital

Wellington, 6021, New Zealand

Location

58602-Shifa International Hospital

Islamabad, Pakistan

Location

58604-The Aga Khan

Karachi, Pakistan

Location

58605-Avicenna Hospital

Lahore, Pakistan

Location

58607-Central Park Teaching Hospital

Lahore, Pakistan

Location

58601-Al Shifa Research Centre

Rawalpindi, Pakistan

Location

60808-University of the Philippines Manila Development Foundation Inc

Ermita, Manila, 1000, Philippines

Location

60810-UERM Memorial Medical Center

Quezon City, Quezon, Philippines

Location

60817-Health Index Multispecialty Clinic

Bacoor, Philippines

Location

60801-Chong Hua Hospital

Cebu City, Philippines

Location

60812-De La Salle Medical and Health Sciences Institute

Dasmariñas, Philippines

Location

60816-De La Salle Medical and Health Sciences Institute

Dasmariñas, Philippines

Location

60806-Mary Chiles General Hospital

Manila, 1008, Philippines

Location

60814-Philippine General Hospital

Manila, Philippines

Location

60815-Philippine General Hospital

Manila, Philippines

Location

60818-Philippine General Hospital

Manila, Philippines

Location

60811-UERM Memorial Medical Center

Quezon City, Philippines

Location

60813-Philippine Children's Medical Center

Quezon City, Philippines

Location

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

Bydgoszcz, 85-090, Poland

Location

61603-Jerzy Brzostek Prywatny Gabinet Lekarski

Dębica, 39-200, Poland

Location

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

Gdansk, 80-542, Poland

Location

61604-Hanna Czajka, Indywidualna Specjalistyczna Praktyka Lekarska

Krakow, 31-302, Poland

Location

61608-Gabinet Lekarski Bartosz Korczowski

Rzeszów, 35-302, Poland

Location

61602-Niepubliczny Zaklad Lecznictwa Ambulatoryjnego Michalkowice

Siemianowice Śląskie, 41-103, Poland

Location

61601-ETG Network- Skierniewice,Clinmed Research

Skierniewice, 96-100, Poland

Location

61609-Szpital im. Swietej Jadwigi Slaskiej w Trzebnicy

Trzebnica, 55-100, Poland

Location

64201-SC Sana Monitoring SRL.

Bucharest, 011025, Romania

Location

64202-Spitalul Municipal Caracal

Caracal, 235200, Romania

Location

64205-Sc Med Fam Apolo srl

Călăraşi, 910160, Romania

Location

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

Sângeorgiu de Mureş, 547530, Romania

Location

71006-Madibeng Centre for Research

Brits, South Africa

Location

71004-Tread Research

Cape Town, South Africa

Location

71007-Allergy & Immunology Unit

Cape Town, South Africa

Location

71002-Synergy Biomed Research Institute

East London, South Africa

Location

71009-Perinatal HIV Research Unit, Tshepong Hospital

Klerksdorp, South Africa

Location

71001-Be Part Yoluntu Centre

Paarl, South Africa

Location

71008-Clinical Trial Systems

Pretoria, South Africa

Location

71003-Soweto Clinical Trials Centre

Soweto, South Africa

Location

71005-Limpopo Clinical Research Initiative

Thabazimbi, South Africa

Location

76405-Phramongkutklao Hospital

Ratchathewi, Bangkok, 10400, Thailand

Location

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

Bangkok, 10400, Thailand

Location

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

Bangkok, 10400, Thailand

Location

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

Chernivtsi, 58023, Ukraine

Location

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

Dnipro, 49027, Ukraine

Location

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

Vinnytsia, 21000, Ukraine

Location

MeSH Terms

Conditions

Influenza, Human

Condition Hierarchy (Ancestors)

Respiratory Tract Infections; Infections; Orthomyxoviridae Infections; RNA Virus Infections; Virus Diseases; Respiratory Tract Diseases

Results Point of Contact

• Title: Clinical Trial Disclosure Manager
• Organization: Seqirus

seqirus.clinicaltrials@seqirus.com

+1 855 358 8966

Study Officials

• Clinical Program Director

  Seqirus

  STUDY DIRECTOR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: OTHER
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Masking Details: 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.
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 22, 2019
• First Posted: May 1, 2019
• Study Start: May 13, 2019
• Primary Completion: November 30, 2023
• Study Completion: February 13, 2024
• Last Updated: March 4, 2025
• Results First Posted: March 4, 2025

Record last verified: 2025-02

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP
• Time Frame: Requests for IPD will generally be considered once review by major regulatory authorities (ie FDA, EMA) is complete and the primary publication is available.
• Access Criteria: 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.

Locations

PH (12); BA (1); HO (3); TH (3); PL (8); BU (7); UA (3); ES (6); NZ (2); CZ (5); PA (5); RO (4); MY (5); ZA (9); LA (1)