Clinical trial • Phase III • Infectious Disease

Tetanus toxoid; Neisseria meningitidis Group C (strain C11) polysaccharide (de-O-acetylated) conjugated to tetanus toxoid; Neisseria meningitidis Group A polysaccharide conjugated to tetanus toxoid carrier protein; Neisseria meningitidis Group W-135 polysaccharide conjugated to tetanus toxoid carrier protein; Neisseria meningitidis Group Y polysaccharide conjugated to tetanus toxoid carrier protein for Meningococcal infection

Phase III trial of Tetanus toxoid; Neisseria meningitidis Group C (strain C11) polysaccharide (de-O-acetylated) conjugated to tetanus toxoid; Neisseria me…

Overview

Trial Therapeutic Area
Infectious Disease
Trial Disease
Meningococcal infection
Trial Stage
Phase III
Drug Modality
Vaccine
Paediatric Trial
Yes

Key dates

Initial CTIS Submission Date
02-04-2024
First CTIS Authorization Date
01-05-2024

Trial design

open-label, none/not specified-controlled Phase III trial in Spain, Hungary, Germany and others.

Open Label
Yes
Comparator
None/Not specified
Target Sample Size
209
Trial Duration For Participant
62

Eligibility

Recruits 209 paediatric patients.

Vulnerable Population
Participants include children and adolescents (vulnerable population selected). Assent and consent handling: "Assent form (AF) has been signed and dated by the participant (if applicable) and informed consent form (ICF) has been signed and dated by the parent(s) or another LAR and by an independent witness, if required by local regulations". Age-specific information and consent/assent documents are provided (document list includes child and adolescent assent/ICF versions in multiple languages including English, Spanish, Hungarian, Finnish and German).

Inclusion criteria

  • {"criterion_text":"- Received MenACYW vaccine in MET51 study (Groups 1 and 3) and completed the study (attended Visit 2)"}
  • {"criterion_text":"- Participant and parent/ legally acceptable representative (LAR) are able to attend all scheduled visits and to comply with all trial procedures"}
  • {"criterion_text":"- Covered by health insurance, if required by local regulations"}
  • {"criterion_text":"- Assent form (AF) has been signed and dated by the participant (if applicable) and informed consent form (ICF) has been signed and dated by the parent(s) or another LAR and by an independent witness, if required by local regulations"}

Exclusion criteria

  • {"criterion_text":"- Known or suspected congenital or acquired immunodeficiency; or receipt of immunosuppressive therapy, such as anti-cancer chemotherapy or radiation therapy, within the preceding 6 months; or long-term systemic corticosteroid therapy (prednisone or equivalent for more than 2 consecutive weeks within the past 3 months)"}
  • {"criterion_text":"- Receipt of any vaccine in the 4 weeks preceding the trial vaccination or planned receipt of any vaccine in the 4 weeks following trial vaccination except for influenza vaccination, which may be received at least 2 weeks before or after study vaccines. This exception includes monovalent pandemic influenza vaccines and multivalent influenza vaccines"}
  • {"criterion_text":"- Receipt of immune globulins, blood or blood-derived products in the past 3 months"}
  • {"criterion_text":"- Receipt of oral or injectable antibiotic therapy within 72 hours prior to the first blood draw"}
  • {"criterion_text":"- Chronic illness that, in the opinion of the Investigator, is at a stage where it might interfere with trial conduct or completion"}
  • {"criterion_text":"- Moderate or severe acute illness/infection (according to Investigator judgment) on the day of vaccination or febrile illness (temperature ≥ 38.0°C). A prospective participant should not be included in the study until the condition has resolved or the febrile event has subsided"}
  • {"criterion_text":"- Deprived of freedom by an administrative or court order, or in an emergency setting, or hospitalized involuntarily"}
  • {"criterion_text":"- Identified as a natural or adopted child of the Investigator or employee with direct involvement in the proposed study"}
  • {"criterion_text":"- History of meningococcal infection, confirmed either clinically, serologically, or microbiologically"}
  • {"criterion_text":"- At high risk for meningococcal infection during the trial (specifically but not limited to participants with persistent complement deficiency, with anatomic or functional asplenia, or participants traveling to countries with high endemic or epidemic disease)"}
  • {"criterion_text":"- Personal history of Guillain-Barré syndrome (GBS)"}
  • {"criterion_text":"- Personal history of an Arthus-like reaction after vaccination with a tetanus toxoid containing vaccine"}
  • {"criterion_text":"- Known systemic hypersensitivity to any of the vaccine components, or history of a life-threatening reaction to the vaccines used in the trial or to a vaccine containing any of the same substances"}
  • {"criterion_text":"- Verbal report by parent or LAR of thrombocytopenia or suspected thrombocytopenia, contraindicating intramuscular (IM) vaccination"}
  • {"criterion_text":"- Bleeding disorder, or receipt of anticoagulants in the 3 weeks preceding inclusion, contraindicating IM vaccination"}
  • {"criterion_text":"- Previous vaccination against meningococcal disease with either the trial vaccine or another vaccine (ie, mono- or polyvalent, polysaccharide, or conjugate meningococcal vaccine containing serogroups A, C, W, or Y) with the exception of licensed MenC vaccination received during infancy (MET51 Group 3), of the single dose of meningococcal vaccine administered as part of study MET51 (Group 1 and 3) and of Meningococcal B vaccine"}

Endpoints

Primary endpoints

  • {"endpoint_text":"- Vaccine seroresponse against meningococcal serogroups A, C, W, and Y","definition_or_measurement_approach":""}

Secondary endpoints

  • {"endpoint_text":"- Antibody titers against meningococcal serogroups A, C, W, and Y before the administration of a booster dose of MenACYW conjugate vaccine (Group 1 and 2)","definition_or_measurement_approach":"Antibody titers measured against meningococcal serogroups A, C, W and Y prior to booster administration at the specified visits."}
  • {"endpoint_text":"- Antibody titers against meningococcal serogroups A, C, W, and Y at Visit 2 (Group 2)","definition_or_measurement_approach":"Antibody titers measured against meningococcal serogroups A, C, W and Y at Visit 2 for Group 2."}
  • {"endpoint_text":"- Antibody titers against meningococcal serogroups A, C, W, and Y at Visit 3 (Group 1)","definition_or_measurement_approach":"Antibody titers measured against meningococcal serogroups A, C, W and Y at Visit 3 for Group 1."}
  • {"endpoint_text":"- Antibody titers against meningococcal serogroups A, C, W, and Y at Visit 1 and Visit 2 (Group 1)","definition_or_measurement_approach":"Antibody titers measured at Visit 1 and Visit 2 for Group 1."}
  • {"endpoint_text":"- Antibody titers against meningococcal serogroups A, C, W, and Y at Visit 2 and Visit 3 (Group 2)","definition_or_measurement_approach":"Antibody titers measured at Visit 2 and Visit 3 for Group 2."}
  • {"endpoint_text":"- Antibody titers against meningococcal serogroups A, C, W, and Y at Visit 3 and Visit 4 (Group 1)","definition_or_measurement_approach":"Antibody titers measured at Visit 3 and Visit 4 for Group 1."}
  • {"endpoint_text":"- Antibody concentrations against tetanus toxoid at Visit 1 and Visit 2 (Group 1)","definition_or_measurement_approach":"Antibody concentrations to tetanus toxoid measured at Visit 1 and Visit 2 for Group 1."}
  • {"endpoint_text":"- Antibody concentrations against tetanus toxoid at Visit 3 and Visit 4 (Group 1)","definition_or_measurement_approach":"Antibody concentrations to tetanus toxoid measured at Visit 3 and Visit 4 for Group 1."}
  • {"endpoint_text":"- Antibody concentrations against tetanus toxoid at Visit 2 and Visit 3 (Group 2)","definition_or_measurement_approach":"Antibody concentrations to tetanus toxoid measured at Visit 2 and Visit 3 for Group 2."}
  • {"endpoint_text":"- Antibody titers against meningococcal serogroup C Visit 3 and Visit 4 (Group 1)","definition_or_measurement_approach":"Antibody titers against meningococcal serogroup C measured at Visit 3 and Visit 4 for Group 1."}
  • {"endpoint_text":"- Antibody titers against meningococcal serogroup C Visit 2 and Visit 3 (Group 2)","definition_or_measurement_approach":"Antibody titers against meningococcal serogroup C measured at Visit 2 and Visit 3 for Group 2."}
  • {"endpoint_text":"- Number of participants with immediate unsolicited systemic adverse events (AEs)","definition_or_measurement_approach":"Count of participants experiencing immediate unsolicited systemic adverse events."}
  • {"endpoint_text":"- Number of participants with solicited injection site reactions and systemic reactions","definition_or_measurement_approach":"Count of participants with solicited injection-site reactions and solicited systemic reactions (as collected by study solicited AE reporting)."}
  • {"endpoint_text":"- Number of participants with unsolicited AEs","definition_or_measurement_approach":"Count of participants with unsolicited adverse events."}
  • {"endpoint_text":"- Number of participants with serious adverse events (SAEs) and Adverse Event of Special Interest (AESI)","definition_or_measurement_approach":"Count of participants with serious adverse events (SAEs) and adverse events of special interest (AESIs)."}

Recruitment

Planned Sample Size
209
Recruitment Window Months
68
Consent Approach
Assent and consent: "Assent form (AF) has been signed and dated by the participant (if applicable) and informed consent form (ICF) has been signed and dated by the parent(s) or another LAR and by an independent witness, if required by local regulations". Age-specific ICF/assent documents are provided (examples in the document list: adolescent and parent ICFs and assent forms for Spanish (es), Hungarian (hu), Finnish (fi), German (de) and English (en) versions). Parents or another legally acceptable representative provide consent; participants provide assent when applicable. Independent witness required if local regulations require it.

Geography

Total Number Of Sites
26
Total Number Of Participants
209

Spain

Earliest CTIS Part Ii Submission Date
16-04-2024
Latest Decision Or Authorization Date
09-03-2026
Processing Time Days
692
Number Of Sites
4
Number Of Participants
51

Sites

Site Name
Hospital Universitario La Paz
Department Name
Hospital Universitario La Paz( #1)
Contact Person Name
Cristina Calvo Rey
Contact Person Email
ccalvor@salud.madrid.org
Site Name
Hospital General Universitario Gregorio Maranon
Department Name
Hospital General Universitario Gregorio Mara?on( #1)
Contact Person Name
Maria Luisa Navarro Gomez
Site Name
Instituto Hispalense De Pediatria S.L.
Department Name
Instituto Hispalense de Pediatria (IHP). Fundacion IHP. ( #1)
Contact Person Name
Ignacio Salamanca de la Cueva
Site Name
Complexo Hospitalario Universitario De Santiago
Department Name
Complejo Hospitalario Universitario de Santiago( #1)
Contact Person Name
Federico Martinon Torres

Hungary

Earliest CTIS Part Ii Submission Date
16-04-2024
Latest Decision Or Authorization Date
10-03-2026
Processing Time Days
693
Number Of Sites
4
Number Of Participants
59

Sites

Site Name
Kiraly Utcai Gyermekrendelo
Department Name
Kiraly Utcai Gyermekrendelo( #1)
Contact Person Name
Eva Horzsa
Contact Person Email
horzsae@t-online.hu
Site Name
Pestszentimrei Gyermekrendelo
Department Name
Pestszentimrei Gyermekrendelo (#1)
Contact Person Name
Ildiko Batta
Contact Person Email
drbattaildiko@gmail.com
Site Name
Futurenest Kft.
Department Name
Futurenest Kft. ( #1)
Contact Person Name
Rober Simko
Contact Person Email
bikfic32@gmail.com
Site Name
Vita Verum Medical Bt.
Department Name
Vita Verum Medical Egeszsegugyi Szolgaltato Bt. (#1)
Contact Person Name
Bernadett Zentai
Contact Person Email
bernadett.zentai@pro-smo.com

Germany

Earliest CTIS Part Ii Submission Date
16-04-2024
Latest Decision Or Authorization Date
10-03-2026
Processing Time Days
693
Number Of Sites
9
Number Of Participants
58

Sites

Site Name
Praxis fur Kinder und Jugendliche
Department Name
Praxis fur Kinder und Jugendliche( #1)
Contact Person Name
Ralph Koellges
Contact Person Email
r.koellges@t-online.de
Site Name
Facharzte fur Kinder- und Jugendmedizin
Department Name
Facharzte fur Kinder- und Jugendmedizin( #1)
Contact Person Name
Katja Denneberg
Contact Person Email
k.denneberg@web.de
Site Name
Kinderarztpraxis Dr Kaiser - Dr. Marinesse
Department Name
Kinderarztpraxis Dr Kaiser - Dr. Marinesse( #1)
Contact Person Name
Friedrich Kaiser
Site Name
Ebert & Huebener Kinder- und Jugendmedizin
Department Name
Ebert - Hubener Kinder-und Jugendmedizin( #1)
Contact Person Name
Rolf Ebert
Contact Person Email
dr.rolf.ebert@t-online.de
Site Name
Praxis fur Kinder und Jugendmedizin
Department Name
Praxis fur Kinder und Jugendme
Contact Person Name
Eivy Franke-Beckmann
Site Name
Gemeinschaftspraxis Matthias Donner u. Dr. med. Martin Luchtrath
Department Name
Gemeinschaftspraxis Matthias Donner u. Dr. med. Martin Lucht( #1)
Contact Person Name
Matthias Donner
Contact Person Email
donner@praxis-mit-koepfchen.de
Site Name
Kinder- und Jugendarztliche Gemeinschaftspraxis
Department Name
Kinder- und Jugendarztliche Gemeinschaftspraxis ( #1)
Contact Person Name
Roland Knecht
Contact Person Email
knecht@kinderarzt-bretten.de
Site Name
Kinderarztpraxis Dr. med. Michael Horn
Department Name
Kinderarztpraxis Dr. med. Michael Horn( #1)
Contact Person Name
Michael Horn
Contact Person Email
drhorn@drhorn.de
Site Name
Praxis 3KASEhoch
Department Name
Praxis 3KASEhoch( #1)
Contact Person Name
Matthias Birke
Contact Person Email
birke@praxis-3kaesehoch.de

Finland

Earliest CTIS Part Ii Submission Date
16-04-2024
Latest Decision Or Authorization Date
10-03-2026
Processing Time Days
693
Number Of Sites
9
Number Of Participants
41

Sites

Site Name
FVR Suomen rokotetutkimus Oy
Department Name
Turku vaccine clinic, FVR.
Contact Person Name
Ulpu Elonsalo
Site Name
FVR Suomen rokotetutkimus Oy
Department Name
Espoo Vaccine Research Clinic( #1)
Contact Person Name
Benita Ukkonen
Contact Person Email
benita.ukkonen@fvr.fi
Site Name
FVR Suomen rokotetutkimus Oy
Department Name
Helsinki East vaccine center, University of Tampere( #1)
Contact Person Name
Susanna Koski
Contact Person Email
Susanna.koski@fvr.fi
Site Name
FVR Suomen rokotetutkimus Oy
Department Name
Kokkola Vaccine Research Clinic( #1)
Contact Person Name
Paulina Paavola
Contact Person Email
pauliina.paavola@fvr.fi
Site Name
FVR Suomen rokotetutkimus Oy
Department Name
Tampere Vaccine Research Clinic, University of Tampere (#1)
Contact Person Name
Oskari Pitkanen
Contact Person Email
oskari.pitkanen@fvr.fi
Site Name
FVR Suomen rokotetutkimus Oy
Department Name
Pori vaccine clinic, University of Tampere( #1)
Contact Person Name
Ulla Otava
Contact Person Email
ulla.otava@fvr.fi
Site Name
FVR Suomen rokotetutkimus Oy
Department Name
Jarvenpaa vaccine center, University of Tampere( #1)
Contact Person Name
Anne Kotaniemi-Syrjänen
Site Name
FVR Suomen rokotetutkimus Oy
Department Name
Turku vaccine clinic, University of Tampere( #1)
Contact Person Name
Ulpu Elonsalo
Contact Person Email
rokotetutkimus.turku@fvr.fi
Site Name
FVR Suomen rokotetutkimus Oy
Department Name
Oulu vaccine center, University of Tampere( #1)
Contact Person Name
Satu Kokko
Contact Person Email
satu.kokko@fvr.fi

Sponsor

Primary sponsor

Full Name
Sanofi Pasteur
Organisation Type
Pharmaceutical company
Country Of Registered Address
France

Contract research organisations

Name
ICON Clinical Research Limited
Responsibilities
Centralized 24-hour Emergency System: eSMS
Name
MARKEN Germany GmbH

Third parties

  • {"country":"United States","full_name":"ICON Clinical Research Limited","duties_or_roles":"Centralized 24-hour Emergency System: eSMS","organisation_type":"Industry"}
  • {"country":"United Kingdom","full_name":"UK Health Security Agency","duties_or_roles":"","organisation_type":"Educational Institution"}
  • {"country":"Finland","full_name":"Oriola Finland Oy","duties_or_roles":"","organisation_type":"Pharmaceutical company"}
  • {"country":"Spain","full_name":"Alcura Health Espana S.A.","duties_or_roles":"","organisation_type":"Pharmaceutical company"}
  • {"country":"Hungary","full_name":"PetMobile Kft.","duties_or_roles":"","organisation_type":"Pharmaceutical company"}
  • {"country":"Germany","full_name":"MARKEN Germany GmbH","duties_or_roles":"","organisation_type":"Pharmaceutical company"}

Investigational products

Investigational Product Name
MenQuadfi solution for injection Meningococcal Group A, C, W and Y conjugate vaccine
Active Substance
Tetanus toxoid; Neisseria meningitidis Group C (strain C11) polysaccharide (de-O-acetylated) conjugated to tetanus toxoid; Neisseria meningitidis Group A polysaccharide conjugated to tetanus toxoid carrier protein; Neisseria meningitidis Group W-135 polysaccharide conjugated to tetanus toxoid carrier protein; Neisseria meningitidis Group Y polysaccharide conjugated to tetanus toxoid carrier protein
Modality
Vaccine
Routes Of Administration
INTRAMUSCULAR INJECTION
Route
INTRAMUSCULAR INJECTION
Authorisation Status
Market authorised (EU/1/20/1483/001)
Starting Dose
0.5 ml
Dose Levels
0.5 ml
Maximum Dose
1 ml

Related trials

Other published trials that may interest you.