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 Kutato 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 With Local Reactions Within 7 Days After Last Vaccination	Local reactions included redness, swelling, and pain at the injection site, recorded by parents/legal guardians of participants in an electronic diary (e-diary). Redness and swelling were measured and recorded in measuring device (caliper) units. 1 measuring device unit = 0.5 centimeter (cm). Redness and swelling were graded as mild (greater than [>] 0 to 2.0 cm), moderate (>2.0 to 7.0 cm) and severe (>7.0 cm). Pain at injection site was graded as mild (hurt if gently touched example, whimpered, winced, protested, or withdrew), moderate (hurt if gently touched, with crying), and severe (caused limitation of limb movement). 95 percent (%) confidence interval (CI) was based on Clopper and Pearson method.	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)
Percentage of Participants With Systemic Events Within 7 Days After Last Vaccination	Systemic events included fever, decreased appetite, drowsiness/increased sleep and irritability, recorded by parents/legal guardians of participants using an e-diary. Fever: temperature >=38.0 degree Celsius (C) and categorized as >=38.0 to 38.4 degree C,>38.4 to 38.9 degree C,>38.9 to 40.0 degree C and >40.0 degree C. Decreased appetite was graded as mild (decreased interest in eating), moderate (decreased oral intake) and severe (refusal to feed). Drowsiness was graded as mild (increased/prolonged sleeping bouts), moderate (slightly subdued, interfered with daily activity) and severe (disabling, not interested in usual daily activity). Irritability was graded as mild (easily consolable), moderate (required increased attention) and severe (inconsolable, crying could not be comforted). 95% CI was based on Clopper & Pearson method.	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)
Percentage of Participants With Adverse Events (AEs) From Last Vaccination to 1 Month After Last Vaccination	An AE was any untoward medical occurrence in a participant, temporally associated with the use of study intervention, whether or not considered related to the study intervention. 95% CI was based on the Clopper and Pearson method. AEs reported in this endpoint excluded local reactions and systemic events collected from an e-diary.	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)
Percentage of Participants With Serious Adverse Events (SAEs) From Last Vaccination to 1 Month After Last Vaccination	A SAE was any untoward medical occurrence that: resulted in death; required inpatient hospitalization or prolongation of existing hospitalization; resulted in persistent or significant disability/ incapacity; was a congenital anomaly/birth defect; was a suspected transmission via a Pfizer product of an infectious agent, pathogenic or non-pathogenic, was considered serious and other important medical events. 95% CI was based on the Clopper and Pearson method.	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)
Percentage of Participants With Predefined Serotype-Specific Immunoglobulin G (IgG) Concentrations for the 7 Additional Serotypes 1 Month After Last Vaccination	Pneumococcal serotype-specific IgG concentrations were measured for serum samples for 7 additional serotypes: 8, 10A, 11A, 12F, 15B, 22F, 33F. The predefined level was 0.35 microgram per milliliter (mcg/mL) for all 7 additional serotypes. 95% CI was based on the Clopper and Pearson method.	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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
Serotype-specific IgG Geometric Mean Concentrations (GMC) 1 Month After Last Vaccination	Pneumococcal serotype-specific IgG concentrations were measured for serum samples for 13vPnC serotypes: 1, 3, 4, 5, 6A, 6B, 7F, 9V, 14, 18C, 19A, 19F, and 23F and 7 additional serotypes: 8, 10A, 11A, 12F, 15B, 22F, 33F. Assay results below the lower limit of quantitation (LLOQ) were set to 0.5*LLOQ. GMC and corresponding 2-sided 95% CIs were calculated by exponentiating mean logarithm of concentration, corresponding 2-sided 95% CIs (based on Student's t distribution).	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)
Percentage of Participants With Predefined IgG Concentrations for the 13 Matched Serotypes 1 Month After Last Vaccination	Pneumococcal serotype-specific IgG concentrations were measured for serum samples for 13vPnC serotypes:1, 3, 4, 5, 6A, 6B, 7F, 9V, 14, 18C,19A,19F, 23F. Predefined level was 0.35 mcg/mL for all 13vPnC serotypes except serotypes 5, 6B, and 19A, which had predefined levels of 0.23, 0.10, and 0.12 mcg/mL, respectively. 95% CI was based on the Clopper and Pearson method.	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)
Serotype-Specific Opsonophagocytic Activity (OPA) Geometric Mean Titers (GMTs) 1 Month After Last Vaccination	OPA titers for the 20 pneumococcal serotypes (1, 3, 4, 5, 6A, 6B, 7F, 9V, 14, 18C, 19A, 19F, 23F, 8, 10A, 11A, 12F, 15B, 22F, and 33F) were determined in randomly selected subsets of participants at 1 month after last vaccination received. OPA titers below the LLOQ were set to 0.5*LLOQ. GMTs and 2-sided CIs were calculated by exponentiating the mean logarithm of the titers and the corresponding CIs based on the Student's t distribution.	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)

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 (Actual): September 19, 2024
• Last Update Submitted That Met QC Criteria: May 14, 2024
• Last Verified: May 1, 2024

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