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

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

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.

Study Overview

• Status: Completed
• Conditions: Pneumococcal Disease
• Intervention / Treatment: Biological: 20-valent pneumococcal conjugate vaccine; Biological: 13-valent pneumococcal conjugate vaccine

• Study Type: Interventional
• Enrollment (Actual): 356
• Phase: Phase 3

Contacts and Locations

Study Locations

• Hungary
  • Budapest, Hungary, 1042
    • Gyerkőc- Med Szolgáltató és Kereskedelmi Betéti Társaság
  • Budapest, Hungary, 1048
    • Lurko-Med Kft Hazi Gyermekorvosi Rendelo
  • Budapest, Hungary, 1188
    • Elitance Duo Kft.
  • Debrecen, Hungary, 4025
    • Private practice - Dr. Várhelyiné Dr. Torday Judit
  • Eger, Hungary, 3300
    • Zsebibaba 2004 Bt. 8. Sz Gyermekkorzet
  • Győr, Hungary, 9024
    • Mimiped Betéti Társaság
  • Miskolc, Hungary, 3527
    • Futurenest Klinikai Kutató Kft.
  • Szigetvár, Hungary, 7900
    • Papp és Társa Egészségügyi és Szolgaltató Betéti Társaság
• Poland
  • Bydgoszcz, Poland, 85-048
    • IN-VIVO Bydgoszcz
  • Dziekanów Leśny, Poland, 05-092
    • SZPZOZ im. Dzieci Warszawy w Dziekanowie Lesnym
  • Katowice, Poland, 40-648
    • Pro Familia Altera Sp. z o.o.
  • Katowice, Poland, 40-748
    • NZOZ Vita Longa Sp. z o.o.
  • Krakow, Poland, 30-644
    • Przylądek Zdrowia
  • Krakow, Poland, 31-202
    • Krakowski Szpital Specjalistyczny im. Jana Pawła II
  • Poznan, Poland, 60-663
    • Specjalistyczny Zespol Opieki Zdrowotnej nad Matka i Dzieckiem w Poznaniu
  • Poznań, Poland, 60-663
    • Specjalistyczny Zespół Opieki Zdrowotnej nad Matką i Dzieckiem w Poznaniu
  • Skorzewo, Poland, 60-185
    • Centrum Medyczne Pratia Poznań
  • Torun, Poland, 87-100
    • MICS Centrum Medyczne Torun
  • Warszawa, Poland, 01-809
    • Szpital Bielanski im. Ks. Jerzego Popieluszki SPZOZ w Warszawie
  • Wroclaw, Poland, 50-368
    • Uniwersytecki Szpital Kliniczny im. J. Mikulicza-Radeckiego we Wroclawiu
  • Kujawsko-pomorskie
    • Torun, Kujawsko-pomorskie, Poland, 87-100
      • MICS Centrum Medyczne Torun
  • Mazowieckie
    • Lomianki, Mazowieckie, Poland, 05-092
      • SZPZOZ im. Dzieci Warszawy w Dziekanowie Lesnym
  • Małopolskie
    • Krakow, Małopolskie, Poland, 30-644
      • Przylądek Zdrowia
  • Wielkopolskie
    • Lubon, Wielkopolskie, Poland, 62-030
      • Rodzinne Centrum Medyczne LUBMED
• Spain
  • Barcelona, Spain, 08009
    • Hospital de Nens de Barcelona
  • Madrid, Spain, 28041
    • Hospital Universitario 12 de Octubre
  • Madrid, Spain, 28009
    • Hospital General Universitario Gregorio Marañon
  • Madrid, Spain, 28050
    • Hospital Universitario HM Sanchinarro
  • Malaga, Spain, 29015
    • Grupo Pediatrico Uncibay
  • Sevilla, Spain, 41014
    • Instituto Hispalense de Pediatria
  • Sevilla, Spain, 41012
    • Instituto Hispalense de Pediatria
  • A Coruña [LA Coruña]
    • Santiago de Compostela, A Coruña [LA Coruña], Spain, 15706
      • CHUS - Hospital Clinico Universitario
  • Barcelona
    • Esplugues de Llobregat, Barcelona, Spain, 08950
      • Hospital Sant Joan de Déu
    • Sant Cugat del Vallès, Barcelona, Spain, 08195
      • Hospital Universitari General de Catalunya
  • Barcelona [barcelona]
    • Badalona, Barcelona [barcelona], Spain, 08916
      • Hospital Germans Trias i Pujol
    • Esplugues de Llobregat, Barcelona [barcelona], Spain, 08950
      • Hospital Sant Joan de Déu
  • Catalunya [cataluña]
    • Centelles, Catalunya [cataluña], Spain, 08500
      • EAP Osona Sud - Alt Congost S.L.P
  • LA Coruña
    • Santiago de Compostela, LA Coruña, Spain, 15760
      • CHUS - Hospital Clinico Universitario
    • Santiago de Compostela, LA Coruña, Spain, 15706
      • Hospital Clinico Universitario Santiago de Compostela
  • Madrid
    • Boadilla del Monte, Madrid, Spain, 28660
      • Hospital Universitario HM Monteprincipe
  • Madrid, Comunidad DE
    • Madrid, Madrid, Comunidad DE, Spain, 28938
      • Hospital Universitario Hm Puerta Del Sur
  • Málaga
    • Malaga, Málaga, Spain, 29015
      • Grupo Pediatrico Uncibay

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 1 year to 1 year (Child)
• Accepts Healthy Volunteers: Yes

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Quadruple

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: 2-Dose 20vPnC Group; Pneumococcal conjugate vaccine (2 doses approximately 2 months apart)	Biological: 20-valent pneumococcal conjugate vaccine; 20-valent pneumococcal conjugate vaccine
Experimental: 1-Dose 20vPnC Group; Pneumococcal conjugate vaccine	Biological: 20-valent pneumococcal conjugate vaccine; 20-valent pneumococcal conjugate vaccine
Active Comparator: 13vPnC Group; Pneumococcal conjugate vaccine	Biological: 13-valent pneumococcal conjugate vaccine; 13-valent pneumococcal conjugate vaccine

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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
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
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
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
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
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
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
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

Collaborators and Investigators

• Sponsor: Pfizer
• Investigators: Study Director: Pfizer CT.gov Call Center, Pfizer

Publications and helpful links

Helpful Links

• To obtain contact information for a study center near you, click here.

Study record dates

Study Major Dates

• Study Start (Actual): June 24, 2022
• Primary Completion (Actual): June 1, 2023
• Study Completion (Actual): June 1, 2023

Study Registration Dates

• First Submitted: June 1, 2022
• First Submitted That Met QC Criteria: June 1, 2022
• First Posted (Actual): June 7, 2022

Study Record Updates

• Last Update Posted (Estimated): November 3, 2023
• Last Update Submitted That Met QC Criteria: November 1, 2023
• Last Verified: November 1, 2023

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Infections; Bacterial Infections; Bacterial Infections and Mycoses; Streptococcal Infections; Gram-Positive Bacterial Infections; Pneumococcal Infections; Physiological Effects of Drugs; Immunologic Factors; Vaccines; Heptavalent Pneumococcal Conjugate Vaccine
• Other Study ID Numbers: B7471027; 2021-006624-41 (EudraCT Number)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES
• IPD Plan Description: Pfizer will provide access to individual de-identified participant data and related study documents (e.g. protocol, Statistical Analysis Plan (SAP), Clinical Study Report (CSR)) upon request from qualified researchers, and subject to certain criteria, conditions, and exceptions. Further details on Pfizer's data sharing criteria and process for requesting access can be found at: https://www.pfizer.com/science/clinical_trials/trial_data_and_results/data_requests.

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No