Clinical trial NCT05408429: Safety and Immunogenicity of 20vPnC in Toddlers With 2 Prior Doses of Prevenar 13
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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Pneumococcal Disease
Lead sponsor: Pfizer
Sponsor class: INDUSTRY
First posted: 2022-06-07
Enrollment: 356
Sex: ALL
Minimum age (years): 12
Maximum age (years): 23
Standard ages: CHILD
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief 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.


Eligibility criteria: 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

Primary outcomes:
measure: Percentage of Participants With Local Reactions Within 7 Days After Last Vaccination
timeFrame: Within 7 days after last vaccination (for reporting arm 2-Dose 20vPnC last vaccination was Dose 2 and for 1-dose 20vPnC and 13vPnC Control it was Dose 1)
measure: Percentage of Participants With Systemic Events Within 7 Days After Last Vaccination
timeFrame: Within 7 days after last vaccination (for reporting arm 2-Dose 20vPnC last vaccination was Dose 2 and for 1-dose 20vPnC and 13vPnC Control it was Dose 1)
measure: Percentage of Participants With Adverse Events (AEs) From Last Vaccination to 1 Month After Last Vaccination
timeFrame: From last vaccination to 1 Month after last vaccination (for reporting arm 2-Dose 20vPnC last vaccination was Dose 2 and for 1-dose 20vPnC and 13vPnC Control it was Dose 1)
measure: Percentage of Participants With Serious Adverse Events (SAEs) From Last Vaccination to 1 Month After Last Vaccination
timeFrame: From last vaccination to 1 Month after last vaccination (for reporting arm 2-Dose 20vPnC last vaccination was Dose 2 and for 1-dose 20vPnC and 13vPnC Control it was Dose 1)
measure: Percentage of Participants With Predefined Serotype-Specific Immunoglobulin G (IgG) Concentrations for the 7 Additional Serotypes 1 Month After Last Vaccination
timeFrame: 1 Month after last vaccination (for reporting arm 2-Dose 20vPnC last vaccination was Dose 2 and for 1-dose 20vPnC and 13vPnC Control it was Dose 1)
Secondary outcomes:
measure: Serotype-specific IgG Geometric Mean Concentrations (GMC) 1 Month After Last Vaccination
timeFrame: 1 Month after last vaccination (for reporting arm 2-Dose 20vPnC last vaccination was Dose 2 and for 1-dose 20vPnC and 13vPnC Control it was Dose 1)
measure: Percentage of Participants With Predefined IgG Concentrations for the 13 Matched Serotypes 1 Month After Last Vaccination
timeFrame: 1 Month after last vaccination (for reporting arm 2-Dose 20vPnC last vaccination was Dose 2 and for 1-dose 20vPnC and 13vPnC Control it was Dose 1)
measure: Serotype-Specific Opsonophagocytic Activity (OPA) Geometric Mean Titers (GMTs) 1 Month After Last Vaccination
timeFrame: 1 Month after last vaccination (for reporting arm 2-Dose 20vPnC last vaccination was Dose 2 and for 1-dose 20vPnC and 13vPnC Control it was Dose 1)
Other outcomes:
Locations:
city: Budapest
country: Hungary
facility: Gyerkőc- Med Szolgáltató és Kereskedelmi Betéti Társaság
city: Budapest
country: Hungary
facility: Lurko-Med Kft Hazi Gyermekorvosi Rendelo
city: Budapest
country: Hungary
facility: Elitance Duo Kft.
city: Debrecen
country: Hungary
facility: Private practice - Dr. Várhelyiné Dr. Torday Judit
city: Eger
country: Hungary
facility: Zsebibaba 2004 Bt. 8. Sz Gyermekkorzet
city: Győr
country: Hungary
facility: Mimiped Betéti Társaság
city: Miskolc
country: Hungary
facility: Futurenest Klinikai Kutató Kft.
city: Szigetvár
country: Hungary
facility: Papp és Társa Egészségügyi és Szolgaltató Betéti Társaság
city: Torun
country: Poland
facility: MICS Centrum Medyczne Toruń
state: Kujawsko-pomorskie
city: Lomianki
country: Poland
facility: SZPZOZ im. Dzieci Warszawy w Dziekanowie Lesnym
state: Mazowieckie
city: Krakow
country: Poland
facility: Przylądek Zdrowia
state: Małopolskie
city: Lubon
country: Poland
facility: Rodzinne Centrum Medyczne LUBMED
state: Wielkopolskie
city: Bydgoszcz
country: Poland
facility: IN-VIVO Bydgoszcz
city: Dziekanów Leśny
country: Poland
facility: SZPZOZ im. Dzieci Warszawy w Dziekanowie Lesnym
city: Katowice
country: Poland
facility: Pro Familia Altera Sp. z o.o.
city: Katowice
country: Poland
facility: NZOZ Vita Longa Sp. z o.o.
city: Krakow
country: Poland
facility: Przylądek Zdrowia
city: Krakow
country: Poland
facility: Krakowski Szpital Specjalistyczny im. Jana Pawła II
city: Poznan
country: Poland
facility: Specjalistyczny Zespol Opieki Zdrowotnej nad Matka i Dzieckiem w Poznaniu
city: Poznań
country: Poland
facility: Specjalistyczny Zespół Opieki Zdrowotnej nad Matką i Dzieckiem w Poznaniu
city: Skorzewo
country: Poland
facility: Centrum Medyczne Pratia Poznan
city: Torun
country: Poland
facility: MICS Centrum Medyczne Toruń
city: Warszawa
country: Poland
facility: Szpital Bielanski im. Ks. Jerzego Popieluszki SPZOZ w Warszawie
city: Wroclaw
country: Poland
facility: Uniwersytecki Szpital Kliniczny im. J. Mikulicza-Radeckiego we Wroclawiu
city: Santiago de Compostela
country: Spain
facility: CHUS - Hospital Clinico Universitario
state: A Coruña [LA Coruña]
city: Badalona
country: Spain
facility: Hospital Germans Trias i Pujol
state: Barcelona [barcelona]
city: Esplugues de Llobregat
country: Spain
facility: Hospital Sant Joan de Déu
state: Barcelona [barcelona]
city: Esplugues de Llobregat
country: Spain
facility: Hospital Sant Joan de Déu
state: Barcelona
city: Sant Cugat del Vallès
country: Spain
facility: Hospital Universitari General de Catalunya
state: Barcelona
city: Centelles
country: Spain
facility: EAP Osona Sud - Alt Congost S.L.P
state: Catalunya [cataluña]
city: Santiago de Compostela
country: Spain
facility: Hospital Clinico Universitario Santiago de Compostela
state: LA Coruña
city: Santiago de Compostela
country: Spain
facility: CHUS - Hospital Clinico Universitario
state: LA Coruña
city: Madrid
country: Spain
facility: Hospital Universitario HM Puerta del Sur
state: Madrid, Comunidad DE
city: Boadilla del Monte
country: Spain
facility: Hospital Universitario HM Monteprincipe
state: Madrid
city: Malaga
country: Spain
facility: Grupo Pediatrico Uncibay
state: Málaga
city: Barcelona
country: Spain
facility: Hospital de Nens de Barcelona
city: Madrid
country: Spain
facility: Hospital General Universitario Gregorio Maranon
city: Madrid
country: Spain
facility: Hospital General Universitario Gregorio Marañón
city: Madrid
country: Spain
facility: Hospital Universitario 12 de Octubre
city: Madrid
country: Spain
facility: Hospital Universitario HM Sanchinarro
city: Malaga
country: Spain
facility: Grupo Pediatrico Uncibay
city: Sevilla
country: Spain
facility: Instituto Hispalense de Pediatria
city: Sevilla
country: Spain
facility: Instituto Hispalense de Pediatria
Study officials:
affiliation: Pfizer
name: Pfizer CT.gov Call Center
role: STUDY_DIRECTOR
References: