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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT05408429
Recruitment Status : Active, not recruiting
First Posted : June 7, 2022
Last Update Posted : March 20, 2023
Sponsor:
Information provided by (Responsible Party):
Pfizer

Study Description
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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.


Condition or disease Intervention/treatment Phase
Pneumococcal Disease Biological: 20-valent pneumococcal conjugate vaccine Biological: 13-valent pneumococcal conjugate vaccine Phase 3

Study Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 357 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Masking Description: The study is partially masked. Participants randomized to receive 2 doses of 20vPnC will not have treatment masking. Participants randomized to receive 1 dose of 20vPnC or 13vPnC will have treatment masking.
Primary Purpose: Prevention
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
Actual Study Start Date : June 24, 2022
Estimated Primary Completion Date : June 8, 2023
Estimated Study Completion Date : June 8, 2023

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Vaccines

Arms and Interventions
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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


Outcome Measures
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Primary Outcome Measures :
  1. Percentage of participants reporting prompted local reactions within 7 days after the last assigned vaccination in each group [ Time Frame: Day 7 ]
    Prompted local reactions after the last assigned vaccination in each group

  2. Percentage of participants reporting prompted systemic events within 7 days after the last assigned vaccination in each group [ Time Frame: Day 7 ]
    Prompted systemic events after the last assigned vaccination in each group

  3. Percentage of participants reporting adverse events (AEs) within 1 month after the last assigned vaccination in each group [ Time Frame: 1 month after the last vaccination ]
    AEs occurring from last vaccination to 1 month after the last vaccination in each group

  4. Percentage of participants reporting serious adverse events (SAEs) within month after the last assigned vaccination in each group [ Time Frame: 1 month after the last vaccination ]
    SAEs occurring from last vaccination to 1 month after the last vaccination in each group

  5. Percentages of participants with predefined serotype-specific IgG concentrations for the 7 additional serotypes 1 month after the last assigned vaccination in each group [ Time Frame: 1 month after the last vaccination ]
    IgG concentrations 1 month after the last assigned vaccination


Secondary Outcome Measures :
  1. Geometric mean concentrations (GMCs) of serotype-specific IgG concentrations 1 month after the last assigned vaccination in each group [ Time Frame: 1 month after the last vaccination ]
    IgG GMCs 1 month after the last assigned vaccination

  2. Percentages of participants with predefined serotype-specific IgG concentrations for the 13 matched serotypes 1 month after the last assigned vaccination in each group [ Time Frame: 1 month after the last vaccination ]
    IgG concentrations 1 month after the last assigned vaccination

  3. Opsonophagocytic activity (OPA) GMTs 1 month after the last assigned vaccination in each in group [ Time Frame: 1 month after the last vaccination ]
    OPA GMTs 1 month after the last assigned vaccination


Eligibility Criteria
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Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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Ages Eligible for Study:   12 Months to 23 Months   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
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
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT05408429


Locations
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Sponsors and Collaborators
Pfizer
Investigators
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Study Director: Pfizer CT.gov Call Center Pfizer
More Information
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Additional Information:

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Responsible Party: Pfizer
ClinicalTrials.gov Identifier: NCT05408429    
Other Study ID Numbers: B7471027
2021-006624-41 ( EudraCT Number )
First Posted: June 7, 2022    Key Record Dates
Last Update Posted: March 20, 2023
Last Verified: March 2023
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Yes
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.
URL: https://www.pfizer.com/science/clinical_trials/trial_data_and_results/data_requests

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Pneumococcal Infections
Streptococcal Infections
Gram-Positive Bacterial Infections
Bacterial Infections
Bacterial Infections and Mycoses
 Infections
Vaccines
Heptavalent Pneumococcal Conjugate Vaccine
Immunologic Factors
Physiological Effects of Drugs