Clinical trial • Phase II • Infectious Disease
RNMB1, RNMB2, NMBPBAS1, RNMB3, NEISSERIA MENINGITIDIS, SEROGROUP C, POLYSACCHARIDE, 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 disease
Phase II trial of RNMB1, RNMB2, NMBPBAS1, RNMB3, NEISSERIA MENINGITIDIS, SEROGROUP C, POLYSACCHARIDE, CONJUGATED TO TETANUS TOXOID, NEISSERIA MENINGITIDIS…
Overview
- Trial Therapeutic Area
- Infectious Disease
- Trial Disease
- Meningococcal disease
- Trial Stage
- Phase II
- Drug Modality
- Vaccine
- Paediatric Trial
- Yes
Key dates
- Initial CTIS Submission Date
- 13-09-2024
- First CTIS Authorization Date
- 21-01-2025
Trial design
Comparator vaccines used in the study: Nimenrix (Meningococcal groups A, C, W and Y conjugate vaccine); MenQuadfi (Meningococcal Group A, C, W and Y conjugate vaccine); Bexsero (Meningococcal group B vaccine). Dose and schedule not specified in the CTIS record.-controlled Phase II trial in Poland, Germany, Czechia and others.
- Comparator
- Comparator vaccines used in the study: Nimenrix (Meningococcal groups A, C, W and Y conjugate vaccine); MenQuadfi (Meningococcal Group A, C, W and Y conjugate vaccine); Bexsero (Meningococcal group B vaccine). Dose and schedule not specified in the CTIS record.
- Target Sample Size
- 500
- Trial Duration For Participant
- 361
Eligibility
Recruits 500 paediatric patients.
- Vulnerable Population
- The study includes vulnerable populations (infants, toddlers, and children). Consent is obtained from parents/legal representatives (parental/legal representative SIS-ICF forms are provided). Assent is used where applicable (e.g., child assent forms such as 'Assent_7-9 yo child' are included). Age-specific parental consent documents are provided (e.g., parental forms for 2 months, 12-15 months, and 2-9 years) and are available in multiple country/language versions as indicated by the submitted SIS-ICF and assent documents.
Inclusion criteria
- {"criterion_text":"- Aged 2 to 9 years (Stage 1) or 12 to 15 months (Stage 2) or 56 to 89 days (Stage 3) on the day of inclusion\n- For infants and toddlers, born at full term of pregnancy (≥37 weeks) and with a birth weight ≥ 2.5 Kg or born after a gestation period of period above 28 (> 28 weeks) through 36 weeks with a birth weight ≥ 1.5 Kg and in both cases medically stable as assessed by the investigator, based on the following definition: “Medically stable” refers to the condition of premature infants who do not require significant medical support or ongoing management for debilitating disease and who have demonstrated a clinical course of sustained recovery by the time they receive the first dose of study intervention\n- Participants who are overtly healthy as determined by medical evaluation including medical history, physical examination, and judgement of the investigator"}
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 since birth for infants; or long-term systemic corticosteroid therapy (prednisone or equivalent for more than 2 consecutive weeks within the past 3 months or since birth for and infants)\n- History of meningococcal meningitis infection, confirmed either clinically, serologically, or microbiologically\n- At high risk of meningococcal infection during the study\n- Known systemic hypersensitivity to any of the study intervention components, or history of a life-threatening reaction to the study interventions used in the study or to a product containing any of the same substances\n- History of Guillain-Barré syndrome\n- For Stage 3 infants: History of intussusception\n- Previous vaccination against meningococcal serogroups A, B, C, W, and/or Y with an investigational or marketed vaccine\n- For Stage 3 infants: receipt of the first dose of rotavirus vaccine less than 28 days before the first trial vaccination"}
Endpoints
Primary endpoints
- {"endpoint_text":"- Number of participants with unsolicited immediate adverse events (AEs)","definition_or_measurement_approach":"Count of participants reporting unsolicited immediate adverse events"}
- {"endpoint_text":"- Number of participants with solicited injection site reactions or systemic reactions","definition_or_measurement_approach":"Count of participants reporting solicited injection site or systemic reactions (solicited reactogenicity)"}
- {"endpoint_text":"- Number of participants with unsolicited AEs","definition_or_measurement_approach":"Count of participants reporting unsolicited adverse events"}
- {"endpoint_text":"- Number of participants with serious adverse events (SAEs)","definition_or_measurement_approach":"Count of participants with serious adverse events"}
- {"endpoint_text":"- hSBA meningococcal serogroups A, C, W, and Y antibody titers pre-dose and 30 days after the second and third dose in infant participants","definition_or_measurement_approach":"Measurement: hSBA antibody titers against serogroups A, C, W, and Y measured pre-dose and 30 days after 2nd and 3rd doses in infants"}
- {"endpoint_text":"- hSBA meningococcal serogroups A, C, W, and Y vaccine seroresponse pre-dose and 1 month after the second and third dose in infant participants","definition_or_measurement_approach":"Measurement: hSBA seroresponse against serogroups A, C, W, and Y pre-dose and 1 month after 2nd and 3rd doses in infants"}
- {"endpoint_text":"- Geometric mean titers (GMTs) of Antibodies against Meningococcal Serogroups A, C, W and Y pre-dose and 1 month after the second and third dose in infant participants","definition_or_measurement_approach":"Measurement: GMTs by hSBA for serogroups A, C, W, and Y pre-dose and 1 month after 2nd and 3rd doses in infants"}
- {"endpoint_text":"- Percentage of participants with hSBA titers more or equal to lower limit of quantification (LLOQ) against each of serogroups A, C, W, and Y pre-dose and 1 month after the second and third dose in infant participants","definition_or_measurement_approach":"Measurement: Proportion with hSBA titers ≥ LLOQ for each serogroup A, C, W, Y at specified timepoints in infants"}
- {"endpoint_text":"- Percentage of Participants With Meningococcal Antibody Titers against meningococcal serogroup B (reference MenB strains) ≥ 1:4 pre-dose and 1 month after the second dose of vaccination against serogroup B, before and 30 days after third dose in infant participants","definition_or_measurement_approach":"Measurement: Proportion with MenB antibody titers ≥1:4 (reference MenB strains) at specified timepoints in infants"}
- {"endpoint_text":"- Percentage of Participants With Meningococcal Antibody Titers against meningococcal serogroup B (reference MenB strains) ≥ 1:8 pre-dose and 1 month after the second dose of vaccination against serogroup B, before and 30 days after third dose in infant participants","definition_or_measurement_approach":"Measurement: Proportion with MenB antibody titers ≥1:8 (reference MenB strains) at specified timepoints in infants"}
- {"endpoint_text":"- hSBA meningococcal serogroup B seroresponse pre-dose and 1 month after the second dose of vaccination against serogroup B, before and 30 days after third dose in infant participants","definition_or_measurement_approach":"Measurement: hSBA MenB seroresponse at specified timepoints in infants"}
- {"endpoint_text":"- Geometric mean titers (GMTs) of Antibodies against Meningococcal Serogroup B (reference MenB strains) pre-dose and 1 month after the second dose of vaccination against serogroup B, before and 30 days after third dose in infant participants","definition_or_measurement_approach":"Measurement: GMTs by hSBA against reference MenB strains at specified timepoints in infants"}
- {"endpoint_text":"- Percentage of participants with hSBA titers more or equal to lower limit of quantification (LLOQ) against each and all of serogroup B (reference MenB strains) pre-dose and 1 month after the second dose of vaccination against serogroup B, before and 30 days after third dose in infant participants","definition_or_measurement_approach":"Measurement: Proportion with hSBA titers ≥ LLOQ for each/all reference MenB strains at specified infant timepoints"}
- {"endpoint_text":"- Percentage of participants with hSBA titers less than the lower limit of quantification (LLOQ) against all serogroup B (reference MenB strains) pre-dose and 1 month after the second dose of vaccination against serogroup B, before and 30 days after third dose in infant participants","definition_or_measurement_approach":"Measurement: Proportion with hSBA titers < LLOQ for all reference MenB strains at specified infant timepoints"}
- {"endpoint_text":"- hSBA meningococcal serogroups A, C, W, and Y antibody titers in children and toddlers","definition_or_measurement_approach":"Measurement: hSBA antibody titers against serogroups A, C, W, Y in children and toddlers at specified timepoints"}
- {"endpoint_text":"- hSBA meningococcal serogroups A, C, W, and Y vaccine seroresponse in children and toddlers","definition_or_measurement_approach":"Measurement: hSBA seroresponse for serogroups A, C, W, Y in children and toddlers"}
- {"endpoint_text":"- Geometric mean titers (GMTs) of Antibodies against Meningococcal Serogroups A, C, W and Y pre-dose and 1 month after the second dose children and toddlers","definition_or_measurement_approach":"Measurement: GMTs by hSBA for serogroups A, C, W, Y pre-dose and 1 month after 2nd dose in children and toddlers"}
- {"endpoint_text":"- Percentage of participants with hSBA titers more or equal to lower limit of quantification (LLOQ) against each of serogroups A, C, W, and Y children and toddlers","definition_or_measurement_approach":"Measurement: Proportion with hSBA titers ≥ LLOQ for serogroups A, C, W, Y in children and toddlers"}
- {"endpoint_text":"- Percentage of Participants With Meningococcal Antibody Titers against meningococcal serogroup B (reference MenB strains) ≥ 1:4 in children and toddlers","definition_or_measurement_approach":"Measurement: Proportion with MenB antibody titers ≥1:4 (reference MenB strains) in children and toddlers"}
- {"endpoint_text":"- Percentage of Participants With Meningococcal Antibody Titers against meningococcal serogroup B (reference MenB strains) ≥ 1:8 in children and toddlers","definition_or_measurement_approach":"Measurement: Proportion with MenB antibody titers ≥1:8 (reference MenB strains) in children and toddlers"}
- {"endpoint_text":"- hSBA meningococcal serogroup B (reference MenB strains) vaccine seroresponse in children and toddlers","definition_or_measurement_approach":"Measurement: hSBA MenB seroresponse in children and toddlers"}
- {"endpoint_text":"- Geometric mean titers (GMTs) of Antibodies against Meningococcal Serogroup B (reference MenB strains) in children and toddlers","definition_or_measurement_approach":"Measurement: GMTs by hSBA for reference MenB strains in children and toddlers"}
- {"endpoint_text":"- Percentage of participants with hSBA titers more or equal to lower limit of quantification (LLOQ) against each and all of serogroup B (reference MenB strains) in children and toddlers","definition_or_measurement_approach":"Measurement: Proportion with hSBA titers ≥ LLOQ for each/all reference MenB strains in children and toddlers"}
- {"endpoint_text":"- Percentage of participants with hSBA titers less than the lower limit of quantification (LLOQ) against all serogroup B (reference MenB strains) in children and toddlers","definition_or_measurement_approach":"Measurement: Proportion with hSBA titers < LLOQ for all reference MenB strains in children and toddlers"}
Secondary endpoints
- {"endpoint_text":"- hSBA meningococcal serogroup B (additional MenB strains) vaccine seroresponse in children, toddler and infant participants","definition_or_measurement_approach":"Measurement: hSBA seroresponse against additional MenB strains in all age groups"}
- {"endpoint_text":"- Percentage of Participants With Meningococcal Antibody Titers against meningococcal serogroup B (additional MenB strains) ≥ 1:4 in children, toddler and infant participants","definition_or_measurement_approach":"Measurement: Proportion with MenB titers ≥1:4 for additional MenB strains"}
- {"endpoint_text":"- Percentage of Participants With Meningococcal Antibody Titers against meningococcal serogroup B (additional MenB strains) ≥ 1:8 in children, toddler and infant participants","definition_or_measurement_approach":"Measurement: Proportion with MenB titers ≥1:8 for additional MenB strains"}
- {"endpoint_text":"- Geometric mean titers (GMTs) of Antibodies against Meningococcal Serogroup B (additional MenB strains) in children, toddler and infant participants","definition_or_measurement_approach":"Measurement: GMTs by hSBA for additional MenB strains"}
- {"endpoint_text":"- Percentage of participants with hSBA composite seroresponse titers more or equal to LLOQ each and all additional MenB strains in children, toddler and infant participants","definition_or_measurement_approach":"Measurement: Proportion with composite hSBA seroresponse ≥ LLOQ for additional MenB strains"}
- {"endpoint_text":"- Percentage of participants with hSBA composite seroresponse titers less than LLOQ all additional MenB strains in children, toddler and infant participants","definition_or_measurement_approach":"Measurement: Proportion with composite hSBA seroresponse < LLOQ for additional MenB strains"}
Recruitment
- Digital Remote Recruitment
- True - Digital methods include social media posts, online AD campaign materials and digital infographics; country-specific digital materials are listed in submitted recruitment documents.
- Planned Sample Size
- 500
- Recruitment Window Months
- 35
- Consent Approach
- Informed consent is provided by parents/legal representatives via age-specific parental SIS-ICF forms (documents available for infants, toddlers and children). Child assent is included where applicable (e.g., assent forms for 7-9 year old children). Consent/assent materials are available in multiple country/language versions as submitted (examples include Polish, German, Czech, Finnish, Spanish, Danish and English versions of SIS-ICF and assent documents).
Methods
- Advertising campaign (AD campaign) - Channel: paid/organic ads; Target audience: parents/legal guardians of infants, toddlers and children; Country-specific materials available (documents labelled for Poland, Germany, Czechia, Finland, Spain, Denmark).
- Social media posts - Channel: social media platforms; Target audience: parents/legal guardians and public; Country-specific social media materials submitted (Poland, Germany, Czechia, Finland, Spain, Denmark).
- Patient letters / Recruitment letters - Channel: direct mail/clinic distribution; Target audience: parents/legal representatives; Country-specific patient letters available (documents for Poland, Germany, Czechia, Finland, Spain, Denmark).
- Recruitment flyers / trifold / posters - Channel: printed materials distributed in clinics and community; Target audience: parents/legal guardians; Country-specific flyers/trifolds provided.
- Fact sheet infographics / 'Debunking Vaccine Myths' materials - Channel: print and digital educational materials; Target audience: parents/caregivers to inform about study and vaccines; country-specific versions submitted.
- Recruitment procedure documents (K1) - Channel: procedural guidance for sites on recruitment activities and approvals; country-specific K1 procedures submitted (e.g., K1_PL, K1_DE, K1_CZ, K1_FI, K1_ES, K1_DK).
Geography
- Total Number Of Sites
- 40
- Total Number Of Participants
- 250
Poland
- Earliest CTIS Part Ii Submission Date
- 09-12-2024
- Latest Decision Or Authorization Date
- 27-01-2025
- Processing Time Days
- 49
- Number Of Sites
- 6
- Number Of Participants
- 89
Sites
- Site Name
- In Vivo Sp. z o.o.
- Contact Person Name
- Piotr Korbal
- Contact Person Email
- piotr.korbal@in-vivo.pl
- Site Name
- Niepubliczny Zaklad Lecznictwa Ambulatoryjnego Michalkowice Rybarczyk I Partnerzy Spolka Lekarska sp.p.
- Contact Person Name
- Barbara Pajek
- Contact Person Email
- barbarapajek@interia.pl
- Site Name
- Szpital Im. Sw. Jadwigi Slaskiej W Trzebnicy Samodzielny Publiczny Zaklad Opieki Zdrowotnej
- Department Name
- Oddział Pediatryczny
- Contact Person Name
- Henryk Szymański
- Contact Person Email
- henryktomasz@poczta.onet.pl
- Site Name
- Provita Poliklinika Sp. z o.o.
- Contact Person Name
- Ernest Kuchar
- Contact Person Email
- ernest.kuchar@gmail.com
- Site Name
- Clinical Best Solutions Sp. z o.o. S.K.
- Contact Person Name
- Magdalena Szuflińska-Sidorowicz
- Contact Person Email
- magda.szuflinska@gmail.com
- Site Name
- Gravita Diagnostyka I Leczenie Nieplodnosci
- Contact Person Name
- Ewa Majda Stanislawska
- Contact Person Email
- emajda@lodz.home.pl
Germany
- Earliest CTIS Part Ii Submission Date
- 02-12-2024
- Latest Decision Or Authorization Date
- 24-01-2025
- Processing Time Days
- 53
- Number Of Sites
- 8
- Number Of Participants
- 12
Sites
- Site Name
- Kinderpneumologische Praxis Dr. Funck
- Department Name
- Pediatric clinic
- Contact Person Name
- Jürgen FUNCK
- Contact Person Email
- juergen.funck@arcor.de
- Site Name
- Office of Dr. med. Andreas Petri
- Department Name
- Pediatric clinic
- Contact Person Name
- Andreas Petri
- Contact Person Email
- dr.andreas.petri@gmail.com
- Site Name
- Kinder- und Jugendärzte Hürth- Park, Dr. med. Ludwig Stapenhorst
- Department Name
- Pediatric clinic
- Contact Person Name
- Ludwig STAPENHORST
- Contact Person Email
- dr-stapenhorst@kinderaerzte-huerth.de
- Site Name
- Kinderarztpraxis Dr. med. Michael Horn
- Department Name
- Pediatric clinic
- Contact Person Name
- Michael Rudy HORN
- Contact Person Email
- drhorn@drhorn.de
- Site Name
- WeMaMed -c/o Prax. für Kinder- und Jugendmedizin
- Department Name
- Pediatric clinic
- Contact Person Name
- Sören WESTERHOLT
- Contact Person Email
- westerholt@wolfsburg.de
- Site Name
- Kinderarztpraxis Ralph Köllges
- Department Name
- Pediatric clinic
- Contact Person Name
- Ralph KOLLGES
- Contact Person Email
- r.koellges@t-online.de
- Site Name
- Praxis Dr. K. Jünger
- Department Name
- Pediatric clinic
- Contact Person Name
- Karsten JUENGER
- Contact Person Email
- dr.karsten.juenger@gmx.de
- Site Name
- Kinderarztpraxis Leyental
- Department Name
- Pediatric clinic
- Contact Person Name
- Robert Primke
- Contact Person Email
- info@kinderarzt-primke.de
Czechia
- Earliest CTIS Part Ii Submission Date
- 02-10-2024
- Latest Decision Or Authorization Date
- 14-03-2025
- Processing Time Days
- 163
- Number Of Sites
- 6
- Number Of Participants
- 33
Sites
- Site Name
- Nemocnice Pardubickeho kraje a.s.
- Department Name
- Paediatrics and newborn department
- Contact Person Name
- Marian Šenkeřík
- Contact Person Email
- marian.senkerik@nempk.cz
- Site Name
- MUDr. Daniela Verdánová, MBA
- Department Name
- Private Praxis
- Contact Person Name
- Daniela Verdánová
- Contact Person Email
- daniela.verdanova@seznam.cz
- Site Name
- Pediatrie Slunicko s.r.o.
- Department Name
- Private Praxis
- Contact Person Name
- Martina Farolfi
- Contact Person Email
- pediatrieslunicko@gmail.com
- Site Name
- Pediatrie Jakoubkovi s.r.o.
- Department Name
- Private Praxis
- Contact Person Name
- Vít Jakoubek
- Contact Person Email
- vit-jakoubek@post.cz
- Site Name
- Detska doktorka Plzen s.r.o.
- Department Name
- Private Praxis
- Contact Person Name
- Lenka Emmerová
- Contact Person Email
- detska.doktorka@seznam.cz
- Site Name
- Neopediatrie s.r.o.
- Department Name
- Private Praxis
- Contact Person Name
- Renáta Poláčková
- Contact Person Email
- rekol@seznam.cz
Finland
- Earliest CTIS Part Ii Submission Date
- 02-12-2024
- Latest Decision Or Authorization Date
- 04-06-2025
- Processing Time Days
- 184
- Number Of Sites
- 7
- Number Of Participants
- 63
Sites
- Site Name
- FVR Suomen rokotetutkimus Oy (Seinajoki)
- Department Name
- NAP
- Contact Person Name
- Hilkka Liitsola
- Contact Person Email
- rokotetutkimus.seinajoki@fvr.fi
- Site Name
- FVR Suomen rokotetutkimus Oy (Oulu)
- Department Name
- NAP
- Contact Person Name
- Satu Kokko
- Contact Person Email
- rokotetutkimus.oulu@fvr.fi
- Site Name
- Meilahti Hospital
- Department Name
- NAP
- Contact Person Name
- Anu Maria Kantele-Hakkinen
- Contact Person Email
- anu.kantele@hus.fi
- Site Name
- FVR Suomen rokotetutkimus Oy (Espoo)
- Department Name
- NAP
- Contact Person Name
- Benita Ukkonen
- Contact Person Email
- rokotetutkimus.espoo@fvr.fi
- Site Name
- FVR Suomen rokotetutkimus Oy (Jarvenpaa)
- Department Name
- NAP
- Contact Person Name
- Miia Virta
- Contact Person Email
- rokotetutkimus.jarvenpaa@fvr.fi
- Site Name
- FVR Suomen rokotetutkimus Oy (Tampere)
- Department Name
- NAP
- Contact Person Name
- Oskari Pitkänen
- Contact Person Email
- rokotetutkimus.tampere@fvr.fi
- Site Name
- FVR Suomen rokotetutkimus Oy (Helsinki, Kluuvikatu)
- Department Name
- NAP
- Contact Person Name
- Ulpu Elonsalo
- Contact Person Email
- rokotetutkimus.etela-helsinki@fvr.fi
Spain
- Earliest CTIS Part Ii Submission Date
- 10-01-2025
- Latest Decision Or Authorization Date
- 23-05-2025
- Processing Time Days
- 133
- Number Of Sites
- 9
- Number Of Participants
- 32
Sites
- Site Name
- Hospital 9 De Octubre S.A.
- Department Name
- Pediatrics Department
- Contact Person Name
- Javier Miranda
- Contact Person Email
- MirandaMJ@vithas.es
- Site Name
- Instituto Hispalense De Pediatria S.L.
- Department Name
- Pediatrics Department
- Contact Person Name
- Ignacio Salamanca de la Cueva
- Contact Person Email
- ignaciosalamanca@ihppediatria.com
- Site Name
- Hospital General Universitario Gregorio Maranon
- Department Name
- Pediatrics Department
- Contact Person Name
- Maria Luisa Navarro
- Contact Person Email
- marisa.navarro.gomez@gmail.com
- Site Name
- Hospital Universitario La Paz
- Department Name
- Pediatría
- Contact Person Name
- Ana Mendez Echevarría
- Contact Person Email
- amendezes@yahoo.es
- Site Name
- Hospital Universitario Hm Puerta Del Sur
- Department Name
- Vaccines Research Unit
- Contact Person Name
- Silvina Natalini
- Contact Person Email
- slnatalini@hmhospitales.com
- Site Name
- Hospital Clinico Universitario De Valencia
- Department Name
- Pediatríc Unit
- Contact Person Name
- Angel Valls Arevalo
- Contact Person Email
- anvallsa@gmail.com
- Site Name
- Complexo Hospitalario Universitario De Santiago
- Department Name
- Pediatric Unit
- Contact Person Name
- Federico Martinón
- Contact Person Email
- federico.martinon.torres@sergas.es
- Site Name
- Hospital Universitari General De Catalunya
- Department Name
- Pediatric Unit
- Contact Person Name
- Isidre Casals
- Contact Person Email
- casalsisidre@gmail.com
- Site Name
- Hospital Universitario 12 De Octubre
- Department Name
- Pediatrics Department
- Contact Person Name
- Pablo Rojo Conejo
- Contact Person Email
- projo01@ucm.es
Denmark
- Earliest CTIS Part Ii Submission Date
- 14-01-2025
- Latest Decision Or Authorization Date
- 18-07-2025
- Processing Time Days
- 185
- Number Of Sites
- 4
- Number Of Participants
- 21
Sites
- Site Name
- Region Midtjylland
- Department Name
- Department of Child and Adolescent Medicine
- Contact Person Name
- Luise Borch
- Contact Person Email
- luise.borch@rm.dk
- Site Name
- Odense University Hospital
- Department Name
- Department of Gynecology and Obstetrics
- Contact Person Name
- Pernille Ravn
- Contact Person Email
- Pernille.Ravn@rsyd.dk
- Site Name
- Region Sjaelland
- Department Name
- Department of Medicine
- Contact Person Name
- Lothar Wiese
- Contact Person Email
- low@regionsjaelland.dk
- Site Name
- Amager Hospital
- Department Name
- Department of Infectious Diseases
- Contact Person Name
- Thomas Benfield
- Contact Person Email
- Thomas.Lars.Benfield@regionh.dk
Sponsor
Primary sponsor
- Full Name
- Sanofi Pasteur Inc.
- Organisation Type
- Pharmaceutical company
- Country Of Registered Address
- United States
Contract research organisations
- Name
- Icon Clinical Research Limited
- Responsibilities
- Centralized 24-Hour Emergency System: eSMS (sponsorDuties code 15)
- Name
- Pharmaceutical Product Development LLC
- Responsibilities
- sponsorDuties code 4 (role detailed in CTIS third parties list)
Third parties
- {"country":"Sweden","full_name":"Tamro AB","duties_or_roles":"sponsorDuties codes: [14]","organisation_type":"Pharmaceutical company"}
- {"country":"Spain","full_name":"Alcura Health Espana S.A.","duties_or_roles":"sponsorDuties codes: [14]","organisation_type":"Pharmaceutical company"}
- {"country":"Finland","full_name":"Oriola Finland Oy","duties_or_roles":"sponsorDuties codes: [14]","organisation_type":"Pharmaceutical company"}
- {"country":"Ireland","full_name":"Icon Clinical Research Limited","duties_or_roles":"Centralized 24-Hour Emergency System: eSMS (sponsorDuties code 15)","organisation_type":"Pharmaceutical company"}
- {"country":"Poland","full_name":"Centrala Farmaceutyczna Cefarm S.A.","duties_or_roles":"sponsorDuties codes: [14]","organisation_type":"Pharmaceutical company"}
- {"country":"United States","full_name":"Medidata Solutions Inc.","duties_or_roles":"sponsorDuties codes: [7]","organisation_type":"Non-Pharmaceutical company"}
- {"country":"Germany","full_name":"Nexelis Marburg GmbH","duties_or_roles":"sponsorDuties codes: [4]","organisation_type":"Pharmaceutical company"}
- {"country":"United States","full_name":"Pharmaceutical Product Development LLC","duties_or_roles":"sponsorDuties codes: [4]","organisation_type":"Pharmaceutical company"}
- {"country":"Czechia","full_name":"PHOENIX lekarensky velkoobchod s.r.o.","duties_or_roles":"sponsorDuties codes: [14]","organisation_type":"Pharmaceutical company"}
Investigational products
- Investigational Product Name
- MenPenta SD
- Active Substance
- RNMB1, RNMB2, NMBPBAS1, RNMB3, NEISSERIA MENINGITIDIS, SEROGROUP C, POLYSACCHARIDE, 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
- Not authorised (prodAuthStatus=1)
- Starting Dose
- 0.5 ml
- Frequency
- Vaccination schedule includes doses given in infancy (e.g., infant stage: dose at 2 months, second dose at ~4 months, third dose at 12-15 months) when administered per stage; exact dose schedule per age group provided in protocol.
- Maximum Dose
- 1 ml
- Investigational Product Name
- MenPenta fHD
- Active Substance
- RNMB1, RNMB2, NMBPBAS1, RNMB3, NEISSERIA MENINGITIDIS, SEROGROUP C, POLYSACCHARIDE, 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
- Not authorised (prodAuthStatus=1)
- Starting Dose
- 0.5 ml
- Frequency
- Vaccination schedule includes doses given in infancy (e.g., infant stage: dose at 2 months, second dose at ~4 months, third dose at 12-15 months) when administered per stage; exact dose schedule per age group provided in protocol.
- Maximum Dose
- 1 ml
- Combination Treatment
- Yes
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