Safety and Immunogenicity of 20vPnC in Toddlers With 2 Prior Doses of Prevenar 13
NCT ID: NCT05408429
Last Updated: 2024-09-19
Study Results
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View full resultsBasic Information
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COMPLETED
PHASE3
356 participants
INTERVENTIONAL
2022-06-24
2023-06-01
Brief Summary
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This study is being conducted in children who:
* are between 12 to 23 months of age;
* are healthy as determined by the study doctors;
* have received 2 doses of Prevnar 13 during the first year in life.
Participants in this study will receive either 1 dose or 2 doses of the study vaccine or 1 dose of Prevnar 13 as a shot in the muscle. During the study, participants will have to come to the study clinic to receive the vaccines and have blood sample collected. The study team will work with participants' parents or legal guardians to monitor any unwanted reactions to the vaccines. Participants are expected to take part in this study for about 1 or 3 months, for 1 dose or 2 dose schedules, respectively.
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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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2-Dose 20vPnC Group
Pneumococcal conjugate vaccine (2 doses approximately 2 months apart)
20-valent pneumococcal conjugate vaccine
20-valent pneumococcal conjugate vaccine
1-Dose 20vPnC Group
Pneumococcal conjugate vaccine
20-valent pneumococcal conjugate vaccine
20-valent pneumococcal conjugate vaccine
13vPnC Group
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 toddlers determined by clinical assessment, including medical history and clinical judgment, to be eligible for the study
* 2 infant doses of Prevenar 13 prior to 12 months of age
Exclusion Criteria
* Major known congenital malformation or serious chronic disorder
* Other chronic medical or laboratory abnormality that may increase the risk associated with study participation or, in the investigator's judgment, make the participant inappropriate for the study.
* Previous vaccination with any investigational pneumococcal vaccine, or planned receipt through study participation
12 Months
23 Months
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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Gyerkőc- Med Szolgáltató és Kereskedelmi Betéti Társaság
Budapest, , Hungary
Lurko-Med Kft Hazi Gyermekorvosi Rendelo
Budapest, , Hungary
Elitance Duo Kft.
Budapest, , Hungary
Private practice - Dr. Várhelyiné Dr. Torday Judit
Debrecen, , Hungary
Zsebibaba 2004 Bt. 8. Sz Gyermekkorzet
Eger, , Hungary
Mimiped Betéti Társaság
Győr, , Hungary
Futurenest Klinikai Kutató Kft.
Miskolc, , Hungary
Papp és Társa Egészségügyi és Szolgaltató Betéti Társaság
Szigetvár, , Hungary
Rodzinne Centrum Medyczne LUBMED
Luboń, Greater Poland Voivodeship, Poland
MICS Centrum Medyczne Toruń
Torun, Kuyavian-Pomeranian Voivodeship, Poland
Przylądek Zdrowia
Krakow, Lesser Poland Voivodeship, Poland
SZPZOZ im. Dzieci Warszawy w Dziekanowie Lesnym
Łomianki, Masovian Voivodeship, Poland
IN-VIVO Bydgoszcz
Bydgoszcz, , Poland
SZPZOZ im. Dzieci Warszawy w Dziekanowie Lesnym
Dziekanów Leśny, , Poland
Pro Familia Altera Sp. z o.o.
Katowice, , Poland
NZOZ Vita Longa Sp. z o.o.
Katowice, , Poland
Przylądek Zdrowia
Krakow, , Poland
Krakowski Szpital Specjalistyczny im. Jana Pawła II
Krakow, , Poland
Specjalistyczny Zespol Opieki Zdrowotnej nad Matka i Dzieckiem w Poznaniu
Poznan, , Poland
Specjalistyczny Zespół Opieki Zdrowotnej nad Matką i Dzieckiem w Poznaniu
Poznan, , Poland
Centrum Medyczne Pratia Poznan
Skorzewo, , Poland
MICS Centrum Medyczne Toruń
Torun, , Poland
Szpital Bielanski im. Ks. Jerzego Popieluszki SPZOZ w Warszawie
Warsaw, , Poland
Uniwersytecki Szpital Kliniczny im. J. Mikulicza-Radeckiego we Wroclawiu
Wroclaw, , Poland
CHUS - Hospital Clinico Universitario
Santiago de Compostela, A Coruña [LA Coruña], Spain
Hospital Germans Trias i Pujol
Badalona, Barcelona [barcelona], Spain
Hospital Sant Joan de Déu
Esplugues de Llobregat, Barcelona [barcelona], Spain
Hospital Sant Joan de Déu
Esplugues de Llobregat, Barcelona, Spain
Hospital Universitari General de Catalunya
Sant Cugat del Vallès, Barcelona, Spain
EAP Osona Sud - Alt Congost S.L.P
Centelles, Catalunya [cataluña], Spain
Hospital Clinico Universitario Santiago de Compostela
Santiago de Compostela, LA Coruña, Spain
CHUS - Hospital Clinico Universitario
Santiago de Compostela, LA Coruña, Spain
Hospital Universitario HM Monteprincipe
Boadilla del Monte, Madrid, Spain
Hospital Universitario HM Puerta del Sur
Madrid, Madrid, Comunidad de, Spain
Grupo Pediatrico Uncibay
Málaga, Málaga, Spain
Hospital de Nens de Barcelona
Barcelona, , Spain
Hospital General Universitario Gregorio Maranon
Madrid, , Spain
Hospital General Universitario Gregorio Marañón
Madrid, , Spain
Hospital Universitario 12 de Octubre
Madrid, , Spain
Hospital Universitario HM Sanchinarro
Madrid, , Spain
Grupo Pediatrico Uncibay
Málaga, , Spain
Instituto Hispalense de Pediatria
Seville, , Spain
Instituto Hispalense de Pediatria
Seville, , Spain
Countries
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References
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Martinon-Torres F, Martinez SN, Kline MJ, Drozd J, Trammel J, Peng Y, Giardina PC, Gruber WC, Watson W, Bickham K, Tamimi N. A phase 3 study of 20-valent pneumococcal conjugate vaccine in healthy toddlers previously vaccinated in infancy with 13-valent pneumococcal conjugate vaccine. Vaccine. 2025 Apr 19;53:126931. doi: 10.1016/j.vaccine.2025.126931. Epub 2025 Mar 12.
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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2021-006624-41
Identifier Type: EUDRACT_NUMBER
Identifier Source: secondary_id
B7471027
Identifier Type: -
Identifier Source: org_study_id
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