20-valent Pneumococcal Conjugate Vaccine Safety and Immunogenicity Study of a 3-Dose Series in Healthy Infants
NCT ID: NCT04546425
Last Updated: 2024-01-08
Study Results
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View full resultsBasic Information
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COMPLETED
PHASE3
1258 participants
INTERVENTIONAL
2020-09-09
2023-02-18
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
PREVENTION
QUADRUPLE
Study Groups
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20-valent pneumococcal conjugate vaccine
Pneumococcal conjugate vaccine
20-valent pneumococcal conjugate vaccine
20-valent pneumococcal conjugate vaccine
13-valent pneumococcal conjugate vaccine
Pneumococcal conjugate vaccine
13-valent pneumococcal conjugate vaccine
13-valent pneumococcal conjugate vaccine
Interventions
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20-valent pneumococcal conjugate vaccine
20-valent pneumococcal conjugate vaccine
13-valent pneumococcal conjugate vaccine
13-valent pneumococcal conjugate vaccine
Eligibility Criteria
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Inclusion Criteria
* Healthy infants determined by clinical assessment, including medical history and clinical judgment, to be eligible for the study.
Exclusion Criteria
* Major known congenital malformation or serious chronic disorder.
* Other acute or chronic medical or psychiatric condition or laboratory abnormality that may increase the risk associated with study participation or investigational product administration or may interfere with the interpretation of study results and, in the judgment of the investigator, would make the participant inappropriate for entry into this study.
* Previous vaccination with any licensed or investigational pneumococcal vaccine, or planned receipt through study participation.
42 Days
112 Days
ALL
Yes
Sponsors
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Pfizer
INDUSTRY
Responsible Party
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Principal Investigators
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Pfizer CT.gov Call Center
Role: STUDY_DIRECTOR
Pfizer
Locations
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Perth Children's Hospital
Nedlands, Western Australia, Australia
Telethon Kids Institute, Vaccine Trials Group, Perth Children's Hospital
Nedlands, Western Australia, Australia
Cliniques Universitaires Saint-Luc
Brussels, , Belgium
University Hospital Antwerp
Edegem, , Belgium
DD ordinace s.r.o.
Jindřichův Hradec, , Czechia
Ordinace praktického lékaře pro děti a dorost
Jindřichův Hradec, , Czechia
Samostatna ordinace praktickeho lekare pro deti a dorost
Jindřichův Hradec, , Czechia
Zdravotnicke stredisko Dubina, verejna obchodni spolecnost
Pardubice, , Czechia
MUDr. Jitka Fabianova
Prague, , Czechia
MEDICENTRUM 6 s.r.o. - Ordinace praktickeho lekare pro deti a dorost
Prague, , Czechia
Medicentrum 6 s.r.o.
Prague, , Czechia
Hvidovre Hospital
Hvidovre, , Denmark
Kadrina Tervisekeskus OU
Kadrina, , Estonia
Merekivi Perearstid.
Tallinn, , Estonia
Merelahe Family Doctors Centre
Tallinn, , Estonia
OU Al Mare Perearstikeskus
Tallinn, , Estonia
Sinu Arst Health Center
Tallinn, , Estonia
Clinical Research Centre
Tartu, , Estonia
Espoo Vaccine Research Clinic
Espoo, , Finland
Helsinki South Vaccine Research Clinic
Helsinki, , Finland
Helsinki East Vaccine Research Clinic
Helsinki, , Finland
Jarvenpaa Vaccine Research Clinic
Järvenpää, , Finland
Kokkola Vaccine Research Clinic
Kokkola, , Finland
FVR, Oulun rokotetutkimusklinikka
Oulu, , Finland
Tampereen yliopisto Oulun Rokotetutkimusklinikka
Oulu, , Finland
Pori Vaccine Research Clinic
Pori, , Finland
Seinäjoki Vaccine Research Clinic
Seinäjoki, , Finland
Tampere Vaccine Research Center
Tampere, , Finland
Turku Vaccine Research Clinic
Turku, , Finland
Fondazione IRCCS Ca' Granda Ospedale Maggiore Policlinico U.O.S.D. Pediatria Alta lntensita di Cura
Milan, Milan, Italy
Azienda Ospedaliero Universitaria Meyer
Florence, , Italy
Azienda Ospedaliera Universitaria
Foggia, , Italy
Ospedale Policlinico San Martino
Genova, , Italy
Stichting Apotheek der Haarlemse Ziekenhuizen
Haarlem, , Netherlands
Spaarne Gasthuis (Kennemer Gasthuis)
Hoofddorp, , Netherlands
Akershus University Hospital
Lorenskog, , Norway
Oslo University Hospital, Ulleval
Oslo, , Norway
Stavanger University Hospital
Stavanger, , Norway
Akershus University Hospital - Sykehusapoteket Ahus
Viken, , Norway
IN-VIVO Sp z o.o. IN-VIVO Bydgoszcz
Bydgoszcz, , Poland
Szpital Uniwersytecki nr 2 im. dr Jana Biziela w Bydgoszczy
Bydgoszcz, , Poland
Prywatny Gabinet Lekarski dr n. med. Jerzy Brzostek
Dębica, , Poland
Centrum Badan Klinicznych JCI
Krakow, , Poland
Krakowski Szpital Specjalistyczny im. Jana Pawla II Oddzial Pediatrii i Neurologii Dzieciecej
Krakow, , Poland
GRAVITA. Diagnostyka i Leczenie nieplodnosci
Lodz, , Poland
Rodzinne Centrum Medyczne LUBMED
Luboń, , Poland
Specjalistyczny Zespół Opieki Zdrowotnej nad Matką i Dzieckiem w Poznaniu
Poznan, , Poland
Niepubliczny Zaklad Lecznictwa Ambulatoryjnego Michalkowice Jarosz i Partnerzy Spolka Lekarska
Siemianowice Śląskie, , Poland
Nasz Lekarz Przychodnie Medyczne Slawomir Jeka
Torun, , Poland
Szpital im. Sw. Jadwigi Slaskiej w Trzebnicy
Trzebnica, , Poland
Szpital Bielanski im. ks. J. Popieluszki SPZOZ
Warsaw, , Poland
Provita 001
Warsaw, , Poland
Uniwersytecki Szpital Kliniczny im. J. Mikulicza-Radeckiego we Wroclawiu
Wroclaw, , Poland
Centrum Medyczne AD-MED Sp. z o. o. Przychodnia Dla Rodziny
Wroclaw, , Poland
Niepubliczny Zaklad Opieki Zdrowotnej "SALMED"
Łęczna, , Poland
Federal State Budget Institution of Healthcare Central clinical hospital of Russian
Moscow, , Russia
State Budget Institution of Healthcare of Perm Region "City Children's Clinical Polyclinic #5"
Perm, , Russia
LLC PiterClinica
Saint Petersburg, , Russia
State autonomous institution of healthcare of Sverdlovsk region
Yekaterinburg, , Russia
PEDIAMED s.r.o.
Bratislava, , Slovakia
NASA DOKTORKA s.r.o.
Bratislava, , Slovakia
Rozvojova agentura Banskobystrickeho samospravneho kraja, n.o.
Detva, , Slovakia
MUDr. Martin Zavrel Vseobecna ambulancia pre deti a dorast
Horné Srnie, , Slovakia
Všeobecná ambulancia pre deti a dorast
Humenné, , Slovakia
PEDAMB s.r.o.
Košice, , Slovakia
MUDr. Drusková s.r.o.
Liptovská Osada, , Slovakia
Countries
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References
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Korbal P, Wysocki J, Jackowska T, Kline M, Tamimi N, Drozd J, Lei L, Peng Y, Giardina PC, Gruber W, Scott D, Watson W. Phase 3 Safety and Immunogenicity Study of a Three-dose Series of Twenty-valent Pneumococcal Conjugate Vaccine in Healthy Infants and Toddlers. Pediatr Infect Dis J. 2024 Jun 1;43(6):587-595. doi: 10.1097/INF.0000000000004300. Epub 2024 Mar 8.
Provided Documents
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Document Type: Study Protocol
Document Type: Statistical Analysis Plan
Related Links
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To obtain contact information for a study center near you, click here.
Other Identifiers
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2019-003306-27
Identifier Type: EUDRACT_NUMBER
Identifier Source: secondary_id
B7471012
Identifier Type: -
Identifier Source: org_study_id
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