Clinical trial NCT04546425: 20-valent Pneumococcal Conjugate Vaccine Safety and Immunogenicity Study of a 3-Dose Series in Healthy Infants
Official title: A PHASE 3, RANDOMIZED, DOUBLE-BLIND TRIAL TO EVALUATE THE SAFETY AND IMMUNOGENICITY OF A 20-VALENT PNEUMOCOCCAL CONJUGATE VACCINE GIVEN AS A SERIES OF 2 INFANT DOSES AND 1 TODDLER DOSE IN HEALTHY INFANTS
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Pneumococcal Disease
Lead sponsor: Pfizer
Sponsor class: INDUSTRY
First posted: 2020-09-14
Enrollment: 1258
Sex: ALL
Minimum age (years): 42
Maximum age (years): 112
Standard ages: CHILD
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief summary: 20-valent Pneumococcal Conjugate Vaccine Safety and Immunogenicity Study of a 3-Dose Series in Healthy Infants


Eligibility criteria: Inclusion Criteria:

* Male or female infants born at \>36 weeks of gestation and 2 months of age at the time of consent.
* Healthy infants determined by clinical assessment, including medical history and clinical judgment, to be eligible for the study.

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 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.

Primary outcomes:
measure: Percentage of Participants With Local Reactions Within 7 Days After Dose 1: Primary Study Population
timeFrame: Within 7 days after Dose 1
measure: Percentage of Participants With Local Reactions Within 7 Days After Dose 2: Primary Study Population
timeFrame: Within 7 days after Dose 2
measure: Percentage of Participants With Local Reactions Within 7 Days After Dose 3: Primary Study Population
timeFrame: Within 7 days after Dose 3
measure: Percentage of Participants With Systemic Events Within 7 Days After Dose 1: Primary Study Population
timeFrame: Within 7 Days after Dose 1
measure: Percentage of Participants With Systemic Events Within 7 Days After Dose 2: Primary Study Population
timeFrame: Within 7 Days after Dose 2
measure: Percentage of Participants With Systemic Events Within 7 Days After Dose 3: Primary Study Population
timeFrame: Within 7 Days after Dose 3
measure: Percentage of Participants With Adverse Events (AEs) From Dose 1 to 1 Month After Dose 2: Primary Study Population
timeFrame: From Dose 1 to 1 month after Dose 2
measure: Percentage of Participants With Adverse Events (AEs) From Dose 3 to 1 Month After Dose 3: Primary Study Population
timeFrame: From Dose 3 to 1 month after Dose 3
measure: Percentage of Participants With Serious Adverse Events (SAEs) From Dose 1 to 1 Month After Dose 3: Primary Study Population
timeFrame: From Dose 1 to 1 month after Dose 3
measure: Percentage of Participants With Newly Diagnosed Chronic Medical Condition (NDCMC) From Dose 1 to 1 Month After Dose 3: Primary Study Population
timeFrame: From Dose 1 to 1 month after Dose 3
measure: Percentage of Participants With Predefined Pneumococcal Immunoglobulin G (IgG) Antibody 1 Month After Dose 2: Primary Study Population
timeFrame: 1 month after Dose 2
measure: Geometric Mean Concentration (GMC) of Serotype-specific Pneumococcal IgG Antibody 1 Month After Dose 2: Primary Study Population
timeFrame: 1 month after Dose 2
measure: GMC of Serotype-specific Pneumococcal IgG Antibody 1 Month After Dose 3: Primary Study Population
timeFrame: 1 month after Dose 3
measure: Percentage of Participants With Predefined Antibody Levels for Concomitant Vaccine Antigens 1 Month After Dose 3: Primary Study Population
timeFrame: 1 month after Dose 3
measure: GMC of Measles Virus Antibody 1 Month After Dose 3: Primary Study Population
timeFrame: 1 month after Dose 3
measure: GMC of Mumps Virus Antibody 1 Month After Dose 3: Primary Study Population
timeFrame: 1 month after Dose 3
measure: GMC of Rubella Virus Antibody 1 Month After Dose 3: Primary Study Population
timeFrame: 1 month after Dose 3
measure: GMC of Varicella Virus Antibody 1 Month After Dose 3: Primary Study Population
timeFrame: 1 month after Dose 3
measure: Percentage of Participants With Local Reactions Within 7 Days After Dose 1: Russian Cohort
timeFrame: Within 7 days after Dose 1
measure: Percentage of Participants With Local Reactions Within 7 Days After Dose 2: Russian Cohort
timeFrame: Within 7 days after Dose 2
measure: Percentage of Participants With Local Reactions Within 7 Days After Dose 3: Russian Cohort
timeFrame: Within 7 days after Dose 3
measure: Percentage of Participants With Systemic Events Within 7 Days After Dose 1: Russian Cohort
timeFrame: Within 7 Days after Dose 1
measure: Percentage of Participants With Systemic Events Within 7 Days After Dose 2: Russian Cohort
timeFrame: Within 7 Days after Dose 2
measure: Percentage of Participants With Systemic Events Within 7 Days After Dose 3: Russian Cohort
timeFrame: Within 7 Days after Dose 3
measure: Percentage of Participants With AEs From Dose 1 to 1 Month After Dose 2: Russian Cohort
timeFrame: From Dose 1 to 1 month after Dose 2
measure: Percentage of Participants With AEs From Dose 3 to 1 Month After Dose 3: Russian Cohort
timeFrame: From Dose 3 to 1 month after Dose 3
measure: Percentage of Participants With SAEs From Dose 1 to 1 Month After Dose 3: Russian Cohort
timeFrame: From Dose 1 to 1 month after Dose 3
measure: Percentage of Participants With NDCMC From Dose 1 to 1 Month After Dose 3: Russian Cohort
timeFrame: From Dose 1 to 1 month after Dose 3
measure: Percentage of Participants With Predefined Pneumococcal IgG Antibody 1 Month After Dose 2: Russian Cohort
timeFrame: 1 month after Dose 2
measure: GMC of Serotype-specific Pneumococcal IgG Antibody 1 Month After Dose 2: Russian Cohort
timeFrame: 1 month after Dose 2
measure: GMC of Serotype-specific Pneumococcal IgG Antibody 1 Month After Dose 3: Russian Cohort
timeFrame: 1 month after Dose 3
Secondary outcomes:
measure: Percentage of Participants With Predefined Pneumococcal IgG Antibody 1 Month After Dose 3: Primary Study Population
timeFrame: 1 Month after Dose 3
measure: Geometric Mean Titers (GMTs) of Serotype-specific Opsonophagocytic Activity (OPA) 1 Month After Dose 2: Primary Study Population
timeFrame: 1 month after Dose 2
measure: Geometric Mean Titers (GMTs) of Serotype-specific Opsonophagocytic Activity (OPA) 1 Month After Dose 3: Primary Study Population
timeFrame: 1 Month after Dose 3
measure: Geometric Mean Fold Rise (GMFRs) of IgG Concentrations From Before Dose 3 to 1 Month After Dose 3: Primary Study Population
timeFrame: Before Dose 3 to 1 month after Dose 3
measure: Percentage of Participants With Predefined Antibody Levels for Concomitant Vaccine Antigens 1 Month After Dose 2: Primary Study Population
timeFrame: 1 month after Dose 2
measure: Percentage of Participants With Predefined Pneumococcal IgG Antibody 1 Month After Dose 3: Russian Cohort
timeFrame: 1 Month after Dose 3
measure: GMTs of Serotype-specific OPA at 1 Month After Dose 2: Russian Cohort
timeFrame: 1 month after Dose 2
measure: GMTs of Serotype-specific OPA at 1 Month After Dose 3: Russian Cohort
timeFrame: 1 Month after Dose 3
Other outcomes:
Locations:
city: Nedlands
country: Australia
facility: Perth Children's Hospital
state: Western Australia
city: Nedlands
country: Australia
facility: Telethon Kids Institute, Vaccine Trials Group, Perth Children's Hospital
state: Western Australia
city: Brussels
country: Belgium
facility: Cliniques Universitaires Saint-Luc
city: Edegem
country: Belgium
facility: University Hospital Antwerp
city: Jindrichuv Hradec
country: Czechia
facility: DD ordinace s.r.o.
city: Jindrichuv Hradec
country: Czechia
facility: Ordinace praktického lékaře pro děti a dorost
city: Jindrichuv Hradec
country: Czechia
facility: Samostatna ordinace praktickeho lekare pro deti a dorost
city: Pardubice
country: Czechia
facility: Zdravotnicke stredisko Dubina, verejna obchodni spolecnost
city: Praha 3
country: Czechia
facility: MUDr. Jitka Fabianova
city: Praha 6
country: Czechia
facility: MEDICENTRUM 6 s.r.o. - Ordinace praktickeho lekare pro deti a dorost
city: Praha 6
country: Czechia
facility: Medicentrum 6 s.r.o.
city: Hvidovre
country: Denmark
facility: Hvidovre Hospital
city: Kadrina
country: Estonia
facility: Kadrina Tervisekeskus OU
city: Tallinn
country: Estonia
facility: Merekivi Perearstid.
city: Tallinn
country: Estonia
facility: Merelahe Family Doctors Centre
city: Tallinn
country: Estonia
facility: OU Al Mare Perearstikeskus
city: Tallinn
country: Estonia
facility: Sinu Arst Health Center
city: Tartu
country: Estonia
facility: Clinical Research Centre
city: Espoo
country: Finland
facility: Espoo Vaccine Research Clinic
city: Helsinki
country: Finland
facility: Helsinki South Vaccine Research Clinic
city: Helsinki
country: Finland
facility: Helsinki East Vaccine Research Clinic
city: Jarvenpaa
country: Finland
facility: Jarvenpaa Vaccine Research Clinic
city: Kokkola
country: Finland
facility: Kokkola Vaccine Research Clinic
city: Oulu
country: Finland
facility: FVR, Oulun rokotetutkimusklinikka
city: Oulu
country: Finland
facility: Tampereen yliopisto Oulun Rokotetutkimusklinikka
city: Pori
country: Finland
facility: Pori Vaccine Research Clinic
city: Seinajoki
country: Finland
facility: Seinäjoki Vaccine Research Clinic
city: Tampere
country: Finland
facility: Tampere Vaccine Research Center
city: Turku
country: Finland
facility: Turku Vaccine Research Clinic
city: Milano
country: Italy
facility: Fondazione IRCCS Ca' Granda Ospedale Maggiore Policlinico U.O.S.D. Pediatria Alta lntensita di Cura
state: Milan
city: Firenze
country: Italy
facility: Azienda Ospedaliero Universitaria Meyer
city: Foggia
country: Italy
facility: Azienda Ospedaliera Universitaria
city: Genova
country: Italy
facility: Ospedale Policlinico San Martino
city: Haarlem
country: Netherlands
facility: Stichting Apotheek der Haarlemse Ziekenhuizen
city: Hoofddorp
country: Netherlands
facility: Spaarne Gasthuis (Kennemer Gasthuis)
city: Lorenskog
country: Norway
facility: Akershus University Hospital
city: Oslo
country: Norway
facility: Oslo University Hospital, Ulleval
city: Stavanger
country: Norway
facility: Stavanger University Hospital
city: Viken
country: Norway
facility: Akershus University Hospital - Sykehusapoteket Ahus
city: Bydgoszcz
country: Poland
facility: IN-VIVO Sp z o.o. IN-VIVO Bydgoszcz
city: Bydgoszcz
country: Poland
facility: Szpital Uniwersytecki nr 2 im. dr Jana Biziela w Bydgoszczy
city: Debica
country: Poland
facility: Prywatny Gabinet Lekarski dr n. med. Jerzy Brzostek
city: Krakow
country: Poland
facility: Centrum Badan Klinicznych JCI
city: Krakow
country: Poland
facility: Krakowski Szpital Specjalistyczny im. Jana Pawla II Oddzial Pediatrii i Neurologii Dzieciecej
city: Leczna
country: Poland
facility: Niepubliczny Zaklad Opieki Zdrowotnej "SALMED"
city: Lodz
country: Poland
facility: GRAVITA. Diagnostyka i Leczenie nieplodnosci
city: Lubon
country: Poland
facility: Rodzinne Centrum Medyczne LUBMED
city: Poznan
country: Poland
facility: Specjalistyczny Zespół Opieki Zdrowotnej nad Matką i Dzieckiem w Poznaniu
city: Siemianowice Slaskie
country: Poland
facility: Niepubliczny Zaklad Lecznictwa Ambulatoryjnego Michalkowice Jarosz i Partnerzy Spolka Lekarska
city: Torun
country: Poland
facility: Nasz Lekarz Przychodnie Medyczne Slawomir Jeka
city: Trzebnica
country: Poland
facility: Szpital im. Sw. Jadwigi Slaskiej w Trzebnicy
city: Warszawa
country: Poland
facility: Szpital Bielanski im. ks. J. Popieluszki SPZOZ
city: Warszawa
country: Poland
facility: Provita 001
city: Wroclaw
country: Poland
facility: Uniwersytecki Szpital Kliniczny im. J. Mikulicza-Radeckiego we Wroclawiu
city: Wroclaw
country: Poland
facility: Centrum Medyczne AD-MED Sp. z o. o. Przychodnia Dla Rodziny
city: Ekaterinburg
country: Russian Federation
facility: State autonomous institution of healthcare of Sverdlovsk region
city: Moscow
country: Russian Federation
facility: Federal State Budget Institution of Healthcare Central clinical hospital of Russian
city: Perm
country: Russian Federation
facility: State Budget Institution of Healthcare of Perm Region "City Children's Clinical Polyclinic #5"
city: Saint Petersburg
country: Russian Federation
facility: LLC PiterClinica
city: Bratislava
country: Slovakia
facility: PEDIAMED s.r.o.
city: Bratislava
country: Slovakia
facility: NASA DOKTORKA s.r.o.
city: Detva
country: Slovakia
facility: Rozvojova agentura Banskobystrickeho samospravneho kraja, n.o.
city: Horne Srnie
country: Slovakia
facility: MUDr. Martin Zavrel Vseobecna ambulancia pre deti a dorast
city: Humenne
country: Slovakia
facility: Všeobecná ambulancia pre deti a dorast
city: Kosice
country: Slovakia
facility: PEDAMB s.r.o.
city: Liptovská Osada
country: Slovakia
facility: MUDr. Drusková s.r.o.
Study officials:
affiliation: Pfizer
name: Pfizer CT.gov Call Center
role: STUDY_DIRECTOR
References: