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NCT05408429 Clinical Trial

Safety and Immunogenicity of 20vPnC in Toddlers With 2 Prior Doses of Prevenar 13

Pneumococcal Disease Clinical Trial

Official title:
A PHASE 3, RANDOMIZED, PARTIALLY DOUBLE-BLIND TRIAL TO EVALUATE THE SAFETY AND IMMUNOGENICITY OF 20-VALENT PNEUMOCOCCAL CONJUGATE VACCINE IN HEALTHY TODDLERS 12 THROUGH 23 MONTHS OF AGE WITH 2 PRIOR INFANT DOSES OF PREVENAR 13

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT05408429
Other study ID # B7471027
Secondary ID 2021-006624-41
Status Completed
Phase Phase 3
First received
Last updated
Start date June 24, 2022
Est. completion date June 1, 2023

Study information
Verified date November 2023
Source Pfizer
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

The purpose of this study is to understand the safety and effects of a study vaccine (20vPnC) in toddlers who had 2 prior doses of Prevnar 13. 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.

Recruitment information / eligibility
Status Completed
Enrollment 356
Est. completion date June 1, 2023
Est. primary completion date June 1, 2023
Accepts healthy volunteers Accepts Healthy Volunteers
Gender All
Age group 12 Months to 23 Months
Eligibility Inclusion Criteria: - Male or female toddlers =12 to <24 months of age at the time of consent - 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: - History of severe adverse reaction associated with a vaccine and/or severe allergic reaction (eg, anaphylaxis) - 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

Study Design

Related Conditions & MeSH terms

Intervention

Biological:
• 20-valent pneumococcal conjugate vaccine
20-valent pneumococcal conjugate vaccine
• 13-valent pneumococcal conjugate vaccine
13-valent pneumococcal conjugate vaccine

Locations
Country Name City State
Hungary Elitance Duo Kft. Budapest
Hungary Gyerkoc- Med Szolgáltató és Kereskedelmi Betéti Társaság Budapest
Hungary Lurko-Med Kft Hazi Gyermekorvosi Rendelo Budapest
Hungary Private practice - Dr. Várhelyiné Dr. Torday Judit Debrecen
Hungary Zsebibaba 2004 Bt. 8. Sz Gyermekkorzet Eger
Hungary Mimiped Betéti Társaság Gyor
Hungary Futurenest Klinikai Kutató Kft. Miskolc
Hungary Papp és Társa Egészségügyi és Szolgaltató Betéti Társaság Szigetvár
Poland IN-VIVO Bydgoszcz Bydgoszcz
Poland SZPZOZ im. Dzieci Warszawy w Dziekanowie Lesnym Dziekanów Lesny
Poland NZOZ Vita Longa Sp. z o.o. Katowice
Poland Pro Familia Altera Sp. z o.o. Katowice
Poland Krakowski Szpital Specjalistyczny im. Jana Pawla II Krakow
Poland Przyladek Zdrowia Krakow Malopolskie
Poland Przyladek Zdrowia Krakow
Poland SZPZOZ im. Dzieci Warszawy w Dziekanowie Lesnym Lomianki Mazowieckie
Poland Rodzinne Centrum Medyczne LUBMED Lubon Wielkopolskie
Poland Specjalistyczny Zespol Opieki Zdrowotnej nad Matka i Dzieckiem w Poznaniu Poznan
Poland Specjalistyczny Zespól Opieki Zdrowotnej nad Matka i Dzieckiem w Poznaniu Poznan
Poland Centrum Medyczne Pratia Poznan Skorzewo
Poland MICS Centrum Medyczne Torun Torun
Poland MICS Centrum Medyczne Torun Torun Kujawsko-pomorskie
Poland Szpital Bielanski im. Ks. Jerzego Popieluszki SPZOZ w Warszawie Warszawa
Poland Uniwersytecki Szpital Kliniczny im. J. Mikulicza-Radeckiego we Wroclawiu Wroclaw
Spain Hospital Germans Trias i Pujol Badalona Barcelona [barcelona]
Spain Hospital de Nens de Barcelona Barcelona
Spain Hospital Universitario HM Monteprincipe Boadilla del Monte Madrid
Spain EAP Osona Sud - Alt Congost S.L.P Centelles Catalunya [cataluña]
Spain Hospital Sant Joan de Déu Esplugues de Llobregat Barcelona [barcelona]
Spain Hospital Sant Joan de Déu Esplugues de Llobregat 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 Puerta del Sur Madrid Madrid, Comunidad DE
Spain Hospital Universitario HM Sanchinarro Madrid
Spain Grupo Pediatrico Uncibay Malaga
Spain Grupo Pediatrico Uncibay Malaga Málaga
Spain Hospital Universitari General de Catalunya Sant Cugat del Vallès Barcelona
Spain CHUS - Hospital Clinico Universitario Santiago de Compostela A Coruña [LA Coruña]
Spain CHUS - Hospital Clinico Universitario Santiago de Compostela LA Coruña
Spain Hospital Clinico Universitario Santiago de Compostela Santiago de Compostela LA Coruña
Spain Instituto Hispalense de Pediatria Sevilla
Spain Instituto Hispalense de Pediatria Sevilla

Sponsors (1)
Lead Sponsor Collaborator
Pfizer

Countries where clinical trial is conducted

Hungary,  Poland,  Spain, 

Outcome
Type Measure Description Time frame Safety issue
Primary Percentage of participants reporting prompted local reactions within 7 days after the last assigned vaccination in each group Prompted local reactions after the last assigned vaccination in each group Day 7
Primary Percentage of participants reporting prompted systemic events within 7 days after the last assigned vaccination in each group Prompted systemic events after the last assigned vaccination in each group Day 7
Primary Percentage of participants reporting adverse events (AEs) within 1 month after the last assigned vaccination in each group AEs occurring from last vaccination to 1 month after the last vaccination in each group 1 month after the last vaccination
Primary Percentage of participants reporting serious adverse events (SAEs) within month after the last assigned vaccination in each group SAEs occurring from last vaccination to 1 month after the last vaccination in each group 1 month after the last vaccination
Primary Percentages of participants with predefined serotype-specific IgG concentrations for the 7 additional serotypes 1 month after the last assigned vaccination in each group IgG concentrations 1 month after the last assigned vaccination 1 month after the last vaccination
Secondary Geometric mean concentrations (GMCs) of serotype-specific IgG concentrations 1 month after the last assigned vaccination in each group IgG GMCs 1 month after the last assigned vaccination 1 month after the last vaccination
Secondary Percentages of participants with predefined serotype-specific IgG concentrations for the 13 matched serotypes 1 month after the last assigned vaccination in each group IgG concentrations 1 month after the last assigned vaccination 1 month after the last vaccination
Secondary Opsonophagocytic activity (OPA) GMTs 1 month after the last assigned vaccination in each in group OPA GMTs 1 month after the last assigned vaccination 1 month after the last vaccination
See also
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Completed NCT02146365 - Nasopharyngeal Carriage Study in Healthy Kenyan Toddlers
Completed NCT04525599 - A Study to Assess the Safety, Tolerability and Immunogenicity of ASP3772, a Pneumococcal Vaccine, in Toddlers 12 to 15 Months of Age in Comparison to an Active Comparator Phase 1
Active, not recruiting NCT05512819 - A Study to Describe the Safety and Immunogenicity of 20vPnC in Infants in India and Taiwan Phase 3
Completed NCT04530838 - 20-valent Pneumococcal Conjugate Vaccine Safety and Immunogenicity Study in Healthy Japanese Infants Phase 3
Active, not recruiting NCT06026748 - A Phase I Study of XJ103 in Chinese Healthy Subjects Phase 1
Completed NCT04526574 - Safety and Immunogenicity of 20vPnC Coadministered With SIIV in Adults ≥65 Years of Age Phase 3
Completed NCT05329259 - A Study to Describe the Safety of a Vaccine (Called 13vPnC) in Healthy People 18 to 49 Years of Age in India Phase 4
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Completed NCT01298544 - A Study to Assess the Antibody Response of Healthy Chinese Children Who Have Been Vaccinated Previously With 4-doses of Prevenar (a Pneumococcal Vaccine) as Babies and Toddlers Phase 4
Completed NCT04830358 - Safety and Immunogenicity of the 'EuPCV15' in Healthy Korean Adults Phase 1
Completed NCT04379713 - 20-valent Pneumococcal Conjugate Vaccine Safety Study in Healthy Infants Phase 3
Completed NCT04887948 - Safety and Immunogenicity Study of 20vPnC When Coadministered With a Booster Dose of BNT162b2 Phase 3
Completed NCT04382326 - 20-valent Pneumococcal Conjugate Vaccine Safety and Immunogenicity Study of a 4-Dose Series in Healthy Infants Phase 3
Not yet recruiting NCT00843895 - Multicenter Prospective Evaluation of the Incidence and Serotyes of Invasive Pneumoccocal Disease (IPD) Among Children Below 5 Years N/A
Completed NCT01734239 - A Phase III Clinical Trial to Study the Safety and Immunogenicity of Pneumovax™ 23 (V110) in Participants From the Russian Population (V110-018) Phase 3

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