Clinical trial • Phase III • Infectious Disease

Pneumococcal polysaccharide conjugate (multiple serotypes) for Prevention of pneumococcal disease

Phase III trial of Pneumococcal polysaccharide conjugate (multiple serotypes) for Prevention of pneumococcal disease.

Overview

Trial Therapeutic Area
Infectious Disease
Trial Disease
Prevention of pneumococcal disease
Trial Stage
Phase III
Drug Modality
Vaccine
Paediatric Trial
Yes

Key dates

Initial CTIS Submission Date
18-11-2024
First CTIS Authorization Date
25-03-2025

Trial design

Randomised, vaxneuvance suspension for injection in pre-filled syringe pneumococcal polysaccharide conjugate vaccine (15-valent, adsorbed) - 0.5 ml intramuscular (comparator product information present).-controlled Phase III trial across 61 sites in Netherlands, Italy, Greece and others.

Randomised
Yes
Comparator
Vaxneuvance suspension for injection in pre-filled syringe Pneumococcal polysaccharide conjugate vaccine (15-valent, adsorbed) - 0.5 ml intramuscular (comparator product information present).
Target Sample Size
1113

Eligibility

Recruits 1113 paediatric patients.

Vulnerable Population
Participants are infants and toddlers (from approximately 2 months of age). The population is flagged as vulnerable; informed consent is obtained from the parent or legally acceptable representative. Parent/legal representative information and ICF documents are provided (local language parental ICFs available per country). No child assent procedures are described for the infant/toddler age group in the available documents.

Inclusion criteria

  • {"criterion_text":"- Aged 42 to 112 days on the day of inclusion"}
  • {"criterion_text":"- Participants who are healthy as determined by medical evaluation including medical history and physical examination"}
  • {"criterion_text":"- Born at full term of pregnancy (≥ 37 weeks) and with a birth weight ≥ 2.5 kg or born after a gestation 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"}

Exclusion criteria

  • {"criterion_text":"- Known or suspected congenital or acquired immunodeficiency; or receipt of immunosuppressive therapy, such as anti-cancer chemotherapy or radiation therapy; or long-term systemic corticosteroid therapy"}
  • {"criterion_text":"- Receipt of any vaccine in the 4 weeks preceding the study intervention administration or planned receipt of any vaccine in the 4 weeks following the study intervention administration, except for oral rotavirus vaccine, which may be received anytime during the study including at study visits and for influenza vaccination or meningococcal b vaccine, which may be received at least 14 days before or 14 days after any study vaccination. This exception includes monovalent pandemic influenza vaccines and multivalent influenza vaccines, as applicable per local recommendations."}
  • {"criterion_text":"- Previous vaccination against S. pneumoniae"}
  • {"criterion_text":"- Previous vaccination against the following antigens: diphtheria, tetanus, pertussis, Haemophilus influenzae type b, and poliovirus"}
  • {"criterion_text":"- Receipt of more than 1 dose of hepatitis B vaccine"}
  • {"criterion_text":"- Receipt of immune globulins, blood or blood-derived products since birth"}
  • {"criterion_text":"- Participation at the time of study enrollment (or in the 6 weeks preceding the first study intervention administration) or planned participation during the present study period in another clinical study investigating a vaccine, drug, medical device, or medical procedure"}
  • {"criterion_text":"- History of microbiologically confirmed Streptococcus pneumoniae infection or disease"}
  • {"criterion_text":"- Any contraindication to the routine pediatric vaccines being administered in the study"}
  • {"criterion_text":"- History of seizure or significant stable or progressive neurological disorders such as infantile spasms, inflammatory nervous system diseases, encephalopathy, cerebral palsy"}
  • {"criterion_text":"- Known systemic hypersensitivity to any of the study interventions 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"}
  • {"criterion_text":"- Laboratory-confirmed or known thrombocytopenia, as reported by the parent/legally acceptable representative (LAR), contraindicating intramuscular (IM) injection"}
  • {"criterion_text":"- Bleeding disorder, or receipt of anticoagulants in the 3 weeks preceding inclusion, contraindicating IM injection"}
  • {"criterion_text":"- Chronic illness that, in the opinion of the investigator, is at a stage where it might interfere with study conduct or completion"}
  • {"criterion_text":"- Moderate or severe acute illness/infection (according to investigator judgment) or febrile illness (temperature ≥ 38.0°C [≥ 100.4°F]) on the day of study intervention administration. A prospective participant should not be included in the study until the condition has resolved or the febrile event has subsided."}

Endpoints

Primary endpoints

  • {"endpoint_text":"- Seroresponse rate for PCV21 and 15vPCV serotypes","definition_or_measurement_approach":"Measured as seroresponse rate for the listed serotypes; main objectives specify assessment at 30 days post-toddler dose (PTD) using seroresponse rate comparisons between PCV21 and 15vPCV."}
  • {"endpoint_text":"- IgG concentration for PCV21 and 15vPCV serotypes","definition_or_measurement_approach":"Measured as serotype-specific IgG antibody concentration; main objectives specify assessment at 30 days post-toddler dose (PTD) using geometric mean concentration (GMC) comparisons between PCV21 and 15vPCV."}

Secondary endpoints

  • {"endpoint_text":"- Anti- hepatitis B surface antigen (HBsAg) Ab","definition_or_measurement_approach":"Measured antibody concentrations/titers against hepatitis B surface antigen (HBsAg) per protocol time points (serology)."}
  • {"endpoint_text":"- Anti- polyribosylribitol phosphate (PRP) Ab","definition_or_measurement_approach":"Measured antibody concentrations against PRP (Haemophilus influenzae type b) per protocol time points (serology)."}
  • {"endpoint_text":"- Anti-poliovirus types (1, 2, and 3) Ab","definition_or_measurement_approach":"Measured neutralizing antibody titers against poliovirus types 1, 2 and 3 per protocol time points."}
  • {"endpoint_text":"- Anti-diphtheria Ab concentrations","definition_or_measurement_approach":"Measured anti-diphtheria IgG concentrations per protocol time points (serology)."}
  • {"endpoint_text":"- Anti-tetanus Ab concentrations","definition_or_measurement_approach":"Measured anti-tetanus IgG concentrations per protocol time points (serology)."}
  • {"endpoint_text":"- Anti-pertussis Ab concentrations (Pertussis toxin (PT) and Filamentous Hemagglutinin (FHA))","definition_or_measurement_approach":"Measured anti-pertussis antibody concentrations against PT and FHA per protocol time points (serology)."}
  • {"endpoint_text":"- Anti-measles Ab concentrations","definition_or_measurement_approach":"Measured anti-measles antibody concentrations per protocol time points (serology)."}
  • {"endpoint_text":"- Anti-mumps Ab concentrations","definition_or_measurement_approach":"Measured anti-mumps antibody concentrations per protocol time points (serology)."}
  • {"endpoint_text":"- Anti-rubella Ab concentrations","definition_or_measurement_approach":"Measured anti-rubella antibody concentrations per protocol time points (serology)."}
  • {"endpoint_text":"- Anti-varicella Ab concentrations","definition_or_measurement_approach":"Measured anti-varicella (chickenpox) antibody concentrations per protocol time points (serology)."}
  • {"endpoint_text":"- Anti HBsAg concentrations","definition_or_measurement_approach":"Measured concentrations of anti-HBsAg antibodies per protocol time points (serology)."}
  • {"endpoint_text":"- Anti-PRP Ab concentrations","definition_or_measurement_approach":"Measured anti-PRP antibody concentrations per protocol time points (serology)."}
  • {"endpoint_text":"- Anti-poliovirus types (1, 2, and 3) Ab titers","definition_or_measurement_approach":"Measured neutralizing antibody titers against poliovirus types 1, 2 and 3 at defined time points."}
  • {"endpoint_text":"- Anti-diphtheria Ab concentrations","definition_or_measurement_approach":"Measured anti-diphtheria IgG concentrations per protocol time points (serology)."}
  • {"endpoint_text":"- Anti-tetanus Ab concentrations","definition_or_measurement_approach":"Measured anti-tetanus IgG concentrations per protocol time points (serology)."}
  • {"endpoint_text":"- Anti-pertussis Ab concentrations (PT and FHA)","definition_or_measurement_approach":"Measured anti-pertussis antibody concentrations against PT and FHA per protocol time points (serology)."}
  • {"endpoint_text":"- Serotype specific OPA titers for all serotypes included in PCV21","definition_or_measurement_approach":"Measured opsonophagocytic activity (OPA) titers specific to each serotype included in PCV21 at protocol-specified time points (subset of participants for some assessments)."}
  • {"endpoint_text":"- Serotype specific OPA titers for all serotypes included in PCV21","definition_or_measurement_approach":"Measured opsonophagocytic activity (OPA) titers specific to each serotype included in PCV21 at protocol-specified time points (duplicate/related endpoint as listed)."}
  • {"endpoint_text":"- Presence of any immediate adverse events (AEs)","definition_or_measurement_approach":"Monitoring and recording of any immediate AEs following vaccination, per protocol-defined observation window."}
  • {"endpoint_text":"- Presence of solicited injection site and systemic reactions through 7 days after each vaccine injection","definition_or_measurement_approach":"Solicited local and systemic reactions collected for 7 days after each vaccine injection (diary/ eDiary)."}
  • {"endpoint_text":"- Presence of unsolicited (spontaneously reported) injection site reactions and unsolicited systemic AEs through 30 days after each vaccine injection","definition_or_measurement_approach":"Unsolicited injection site and systemic AEs recorded through 30 days after each vaccine injection."}
  • {"endpoint_text":"- Presence of serious adverse events (SAEs) throughout the study (through 6 months post- last vaccine injection)","definition_or_measurement_approach":"SAEs collected throughout study duration, including follow-up through 6 months after last vaccine injection."}
  • {"endpoint_text":"- Presence adverse events of special interest (AESIs) throughout the study (through 6 months post- last vaccine injection)","definition_or_measurement_approach":"AESIs monitored and recorded throughout the study, including follow-up through 6 months after last vaccine injection."}

Recruitment

Planned Sample Size
1113
Recruitment Window Months
36
Consent Approach
Informed consent is obtained from the parent or legally acceptable representative (parental/legal representative ICFs provided). Subject information and parental consent documents (SIS-ICF / parental ICF) exist and are provided in local languages across countries (examples: Dutch, Italian, Greek, Czech, German, French, Finnish, Polish, Estonian, English). Participant-facing materials include diaries/eDiary guides and memory aids. No child assent process is described for the infant/toddler population in the provided documents.

Methods

  • Country-specific recruitment procedures (documents labelled 'K1_<COUNTRY>_Recruitment Procedure')
  • Letters to paediatricians (e.g., 'K2_IT_Recruitment Material_Letter to pediatricians') to engage referring clinicians
  • Letters to parents (e.g., 'K2_IT_Recruitment Material_Letter to parents') and patient flyers/leaflets for parents/caregivers (e.g., K2_BE patient flyer) distributed in local languages
  • Site-based recruitment via participating hospitals/clinics and pediatric practices (site contact details provided in Part II submissions)

Geography

Total Number Of Sites
61
Total Number Of Participants
1113

Netherlands

Earliest CTIS Part Ii Submission Date
19-03-2025
Latest Decision Or Authorization Date
28-03-2025
Processing Time Days
9
Number Of Sites
1
Number Of Participants
50

Sites

Site Name
Spaarne Gasthuis Stichting
Department Name
Pediatrics
Contact Person Name
Marlies van Houten
Contact Person Email
MavanHouten@spaarnegasthuis.nl

Italy

Earliest CTIS Part Ii Submission Date
03-12-2024
Latest Decision Or Authorization Date
11-03-2026
Processing Time Days
463
Number Of Sites
10
Number Of Participants
157

Sites

Site Name
Azienda Universitaria Ospedaliera Consorziale Policlinico Bari
Department Name
U.O.C Hygiene
Contact Person Name
Silvio TAFURI
Contact Person Email
silvio.tafuri@uniba.it
Site Name
Fondazione IRCCS Ca Granda Ospedale Maggiore Policlinico
Department Name
Maternal and infant department ediatrics pneumoinfectiology
Contact Person Name
Samantha BOSIS
Site Name
ASST Fatebenefratelli Sacco
Department Name
Infectious paediatrics
Contact Person Name
Vania GIACOMET
Contact Person Email
vania.giacomet@unimi.it
Site Name
Azienda Ospedaliero Universitaria Parma
Department Name
Pediatric clinical unit at Pietro Barilla Children’s Hospital
Contact Person Name
Susanna Maria Roberta Esposito
Site Name
Azienda Ospedaliero Universitaria Ospedali Riuniti
Department Name
S.C. Polyclinic Hygiene Foggia
Contact Person Name
Rosa PRATO
Contact Person Email
rosa.prato@unifg.it
Site Name
Universita Degli Studi Di Roma La Sapienza
Department Name
Maternal Science
Contact Person Name
Fabio MIDULLA
Contact Person Email
midulla@uniroma1.it
Site Name
Azienda Sanitaria Locale Della Provincia Di Lecce
Department Name
ASL e Polimabulatorio
Contact Person Name
Alberto Fedele
Contact Person Email
alberto.fedele@asl.lecce.it
Site Name
Azienda Ospedaliera Universitaria Meyer IRCCS
Department Name
SOC pediatric clinic
Contact Person Name
Clementina CANESSA
Contact Person Email
clementina.canessa@meyer.it
Site Name
Fondazione Policlinico Universitario Agostino Gemelli IRCCS
Department Name
Department of Woman and Child Health and Public Health
Contact Person Name
Danilo BUONSENSO
Site Name
ASST Fatebenefratelli Sacco (Milan site)
Department Name
Ambulatory of allergology and vaccination, department of clinic pediatric
Contact Person Name
Chiara Gasparini

Greece

Earliest CTIS Part Ii Submission Date
23-01-2025
Latest Decision Or Authorization Date
10-03-2026
Processing Time Days
411
Number Of Sites
8
Number Of Participants
92

Sites

Site Name
General University Hospital Of Patras
Department Name
Pediatric Department
Contact Person Name
Despoina Gkentzi
Contact Person Email
gkentzid@gmail.com
Site Name
University General Hospital Of Ioannina
Department Name
Department of Pediatric Infectious Diseases
Contact Person Name
Fani Ladomenou
Contact Person Email
fladomenou@gmail.com
Site Name
University General Hospital Attikon
Department Name
Third Department of Pediatrics
Contact Person Name
Vassiliki Papaevangelou
Contact Person Email
vpapaev@med.uoa.gr
Site Name
Athens General Children's Hospital Panagioti And Aglaia Kyriakou
Department Name
2nd Department of Pediatrics
Contact Person Name
Maria Tsolia
Contact Person Email
maria.n.tsolia@gmail.com
Site Name
University General Hospital Of Heraklion
Department Name
Pediatric Department
Contact Person Name
Eleni Vergadi
Contact Person Email
eleni.vergadi@uoc.gr
Site Name
Hippokration Hospital
Department Name
3rd Department of Pediatrics
Contact Person Name
Ilias Iosifidis
Contact Person Email
iosifidish@gmail.com
Site Name
Nosokomeio Paidon I Agia Sofia
Department Name
1st Department of Pediatrics, NKUA
Contact Person Name
Athanasios Michos
Contact Person Email
amichos@med.uoa.gr
Site Name
Third Department site (Athens)
Department Name
Third Department of Pediatrics
Contact Person Name
Vassiliki Papaevangelou
Contact Person Email
vpapaev@med.uoa.gr

Czechia

Earliest CTIS Part Ii Submission Date
27-02-2025
Latest Decision Or Authorization Date
09-03-2026
Processing Time Days
375
Number Of Sites
4
Number Of Participants
53

Sites

Site Name
MUDr. Daniela Verdánová, MBA
Department Name
Private Praxis
Contact Person Name
Daniela Verdánová
Contact Person Email
daniela.verdanova@seznam.cz
Site Name
MUDr. Leopold Sedlacek s.r.o.
Department Name
Private Praxis
Contact Person Name
Radovan Sedláček
Contact Person Email
studie.sedlacek@gmail.com
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
Pediatrie Slunicko s.r.o.
Department Name
Private Praxis
Contact Person Name
Martina Farolfi
Contact Person Email
Martina.farolfi@seznam.cz

Germany

Earliest CTIS Part Ii Submission Date
03-03-2025
Latest Decision Or Authorization Date
13-03-2026
Processing Time Days
375
Number Of Sites
11
Number Of Participants
140

Sites

Site Name
Kinder- und Jugendärzte Hürth-Park, Dr. med. Ludwig Stapenhorst
Department Name
Pediatric clinic
Contact Person Name
Ludwig Stapenhorst
Site Name
Universitaet Leipzig
Department Name
Pediatric clinic
Contact Person Name
Ulrich Thome
Site Name
Clinical Research & Healthcare GmbH
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
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
Praxis kleinundGROSS
Department Name
Pediatric clinic
Contact Person Name
Ralph Köllges
Contact Person Email
r.koellges@t-online.de
Site Name
Evangelisches Krankenhaus Duesseldorf
Department Name
Pediatric clinic
Contact Person Name
Monika Gappa
Contact Person Email
monika.gappa@evkduesseldorf.de
Site Name
Praxis Donner & Luechtrath
Department Name
Pediatric clinic
Contact Person Name
Matthias Donner
Contact Person Email
donner@praxis-mitkoepfchen.de
Site Name
Kinderarztpraxis Leyental
Department Name
Pediatric clinic
Contact Person Name
Sebastian Wirth
Contact Person Email
info@kinderarzt-wirth.de
Site Name
GPR Gesundheits und Pflegezentrum Ruesselsheim gGmbH
Department Name
Pediatric clinic
Contact Person Name
Christiane Wiethoff
Contact Person Email
Wiethoff@gpruesselsheim.de
Site Name
Facharztpraxis für Kinder- und Jugendmedizin
Department Name
Pediatric clinic
Contact Person Name
Karsten Jünger
Contact Person Email
dr.karsten.juenger@gmx.de

Belgium

Earliest CTIS Part Ii Submission Date
03-12-2024
Latest Decision Or Authorization Date
11-03-2026
Processing Time Days
463
Number Of Sites
6
Number Of Participants
86

Sites

Site Name
Anima
Contact Person Name
Erik Buntinx
Contact Person Email
erik.buntinx@anima-alken.be
Site Name
UZ Leuven
Department Name
Pediatrics Department
Contact Person Name
Marijke Proesmans
Contact Person Email
marijke.proesmans@uzleuven.be
Site Name
Algemeen Ziekenhuis Delta
Contact Person Name
Inge Matthijs
Contact Person Email
Inge.Matthijs@azdelta.be
Site Name
Universitair Ziekenhuis Antwerpen
Contact Person Name
Stijn Verhulst
Contact Person Email
Stijn.Verhulst@uza.be
Site Name
Medif
Contact Person Name
Marc Demeulemeester
Contact Person Email
demeumed@gmail.com
Site Name
Az St-Jan Brugge-Oostende A.V.
Contact Person Name
Kate Sauer
Contact Person Email
kate.sauer@azsintjan.be

Finland

Earliest CTIS Part Ii Submission Date
25-02-2025
Latest Decision Or Authorization Date
09-03-2026
Processing Time Days
377
Number Of Sites
9
Number Of Participants
155

Sites

Site Name
FVR Suomen rokotetutkimus Oy (Jarvenpaa)
Department Name
NAP
Contact Person Name
Miia Virta
Site Name
FVR Suomen rokotetutkimus Oy (Oulu)
Department Name
NAP
Contact Person Name
Satu Kokko
Contact Person Email
rokotetutkimus.oulu@fvr.fi
Site Name
FVR Suomen rokotetutkimus Oy (Turku)
Department Name
NAP
Contact Person Name
Ulpu Elonsalo
Contact Person Email
rokotetutkimus.turku@fvr.fi
Site Name
FVR Suomen rokotetutkimus Oy (Helsinki)
Department Name
NAP
Contact Person Name
Ulpu Elonsalo
Site Name
FVR Suomen rokotetutkimus Oy (Kokkola)
Department Name
NAP
Contact Person Name
Pauliina Paavola
Contact Person Email
rokotetutkimus.kokkola@fvr.fi
Site Name
FVR Suomen rokotetutkimus Oy (Seinajoki)
Department Name
NAP
Contact Person Name
Hilkka Liitsola
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 (Tampere)
Department Name
NAP
Contact Person Name
Oskari Pitkänen
Contact Person Email
rokotetutkimus.tampere@fvr.fi

Poland

Earliest CTIS Part Ii Submission Date
24-02-2025
Latest Decision Or Authorization Date
13-03-2026
Processing Time Days
382
Number Of Sites
9
Number Of Participants
300

Sites

Site Name
Szpital Bielanski Im.Ks.Jerzego Popieluszki Samodzielny Publiczny Zaklad Opieki Zdrowotnej
Department Name
Kliniczny Oddział Pediatryczny
Contact Person Name
Teresa Jackowska
Contact Person Email
tjackowska@gmail.com
Site Name
Szpital Im. Sw. Jadwigi Slaskiej W Trzebnicy Samodzielny Publiczny Zaklad Opieki Zdrowotnej
Department Name
Oddział Pediatryczny z Pododdziałem Niemowlęcym Szpitala im. Św. Jadwigi Śląskiej w Trzebnicy
Contact Person Name
Henryk Szymański
Contact Person Email
henryktomasz@poczta.onet.pl
Site Name
Samodzielny Zespol Publicznych Zakladow Opieki Zdrowotnej Im. Dzieci Warszawy W Dziekanowie Lesnym
Department Name
Kliniczny Oddział Pediatrii z Pododdziałem Alergologii, Endokrynologii, Neurologii
Contact Person Name
Piotr Hartmann
Site Name
Medicover Integrated Clinical Services Sp. z o.o.
Department Name
N/D
Contact Person Name
Elżbieta Kopińska
Site Name
Jagiellońskie Centrum Innowacji Sp. z o.o.
Department Name
N/D
Contact Person Name
Hanna Czajka
Contact Person Email
cbk@jci.pl
Site Name
Niepubliczny Zaklad Lecznictwa Ambulatoryjnego Michalkowice Rybarczyk I Partnerzy Spolka Lekarska sp.p.
Department Name
N/D
Contact Person Name
Barbara Pajek
Contact Person Email
barbarapajek@interia.pl
Site Name
In Vivo Sp. z o.o.
Department Name
N/D
Contact Person Name
Piotr Korbal
Contact Person Email
kontakt@in-vivo.pl
Site Name
Uniwersytecki Szpital Kliniczny Im. Jana Mikulicza-Radeckiego We Wroclawiu
Department Name
Klinika Pediatrii i Chorób Infekcyjnych USK im. Jana Mikulicza-Radeckiego we Wrocławiu
Contact Person Name
Leszek Szenborn
Contact Person Email
leszek.szenborn@umw.edu.pl
Site Name
Provita Poliklinika Sp. z o.o.
Department Name
N/D
Contact Person Name
Ernest Kuchar
Contact Person Email
ernest.kuchar@gmail.com

Estonia

Earliest CTIS Part Ii Submission Date
26-02-2025
Latest Decision Or Authorization Date
12-03-2026
Processing Time Days
379
Number Of Sites
3
Number Of Participants
80

Sites

Site Name
Kliiniliste Uuringute Keskus OÜ
Department Name
Kliiniliste Uuringute Keskus OÜ
Contact Person Name
Airi Poder
Contact Person Email
airi.poder@std.ee
Site Name
Vee Perearstikeskus OÜ
Department Name
Vee Perearstikes kus OÜ
Contact Person Name
Kulli Ulst
Contact Person Email
kylli.ulst@veeperearst.eu
Site Name
Al Mare Perearstikeskus OU
Department Name
Al Mare Perearstikes kus OÜ (Al Mare Family Doctors Centre)
Contact Person Name
Kaia Kiiroja
Contact Person Email
kaia@almarearstid.ee

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
Name
PRA Hellas CRO A.E.
Responsibilities
For Greece: Fee payments - Site monitoring - Submissions to EC - Negotiate, Sign and Execute clinical trial agreements - Payment executions - Safety reporting - Assistance in IMP/clinical supplies import, in biological samples/clinical supplies/IMP export
Name
PPD Global Central Labs
Responsibilities
Logistics sample management : collection of samples and distribution to labs
Name
Endpoint Clinical Inc.
Name
Pharmaceutical Product Development LLC

Third parties

  • {"country":"Ireland","full_name":"Icon Clinical Research Limited","duties_or_roles":"Centralized 24-Hour Emergency System: eSMS","organisation_type":"Pharmaceutical company"}
  • {"country":"Belgium","full_name":"PPD Global Central Labs","duties_or_roles":"Logistics sample management : collection of samples and distribution to labs","organisation_type":"Pharmaceutical company"}
  • {"country":"Greece","full_name":"PRA Hellas CRO A.E.","duties_or_roles":"For Greece: Fee payments - Site monitoring - Submissions to EC - Negotiate, Sign and Execute clinical trial agreements - Payment executions - Safety reporting - Assistance in IMP/clinical supplies import, in biological samples/clinical supplies/IMP export","organisation_type":"Pharmaceutical company"}
  • {"country":"United States","full_name":"Endpoint Clinical Inc.","duties_or_roles":"","organisation_type":"Pharmaceutical company"}
  • {"country":"United States","full_name":"Pharmaceutical Product Development LLC","duties_or_roles":"","organisation_type":"Pharmaceutical company"}
  • {"country":"Finland","full_name":"Oriola Finland Oy","duties_or_roles":"","organisation_type":"Pharmaceutical company"}
  • {"country":"United States","full_name":"Medidata Solutions Inc.","duties_or_roles":"","organisation_type":"Non-Pharmaceutical company"}

Investigational products

Investigational Product Name
Pneumococcal Conjugate Vaccine (PCV)
Active Substance
Pneumococcal polysaccharide conjugate (multiple serotypes)
Modality
Vaccine
Routes Of Administration
INTRAMUSCULAR INJECTION
Route
Intramuscular injection
Authorisation Status
PRD10933654 (sponsor product entry; no marketing authorisation number provided in listing)
Starting Dose
0.5 ml
Dose Levels
0.5 ml
Maximum Dose
2 ml
Investigational Product Name
Vaxneuvance suspension for injection in pre-filled syringe Pneumococcal polysaccharide conjugate vaccine (15-valent, adsorbed)
Active Substance
Pneumococcal polysaccharide conjugate (multiple serotypes)
Modality
Vaccine
Routes Of Administration
INTRAMUSCULAR INJECTION
Route
Intramuscular injection
Authorisation Status
Marketing authorisation: EU/1/21/1591/003
Starting Dose
0.5 ml
Dose Levels
0.5 ml
Maximum Dose
2 ml
Combination Treatment
Yes

Related trials

Other published trials that may interest you.