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A Study to Describe the Safety and Immunogenicity of 20vPnC in Infants in India and Taiwan

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: NCT05512819
Recruitment Status : Active, not recruiting
First Posted : August 23, 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 infants and toddlers.

This study is enrolling participants who are:

  • Born after at least 36 weeks of pregnancy and about 2 months of age at the time of entering the study
  • Have a bodyweight of at least 3 kg

Participants will receive either the study vaccine (20vPnC) or a licensed vaccine (13vPnC) as a 4-dose schedule as a shot in the muscle. Participants will receive Dose 1 on study day 1. Dose 2 will be given 28-70 days after Dose 1, and Dose 3 will be given 28-70 days after Dose 2. Dose 4 will be given at 365-455 days (approximately 12-15 months) of age.

Participation in the study will take approximately 15 months, during which participants will come to the study clinic for 6 times. The study team will ask questions about the participant's health and take some blood samples during the visit.


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 : 190 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Prevention
Official Title: A PHASE 3, RANDOMIZED, DOUBLE-BLIND TRIAL TO EVALUATE THE SAFETY AND IMMUNOGENICITY OF A 20-VALENT PNEUMOCOCCAL CONJUGATE VACCINE GIVEN IN A SERIES OF 3 INFANT DOSES AND 1 TODDLER DOSE IN INFANTS IN INDIA AND TAIWAN
Actual Study Start Date : September 16, 2022
Estimated Primary Completion Date : February 17, 2024
Estimated Study Completion Date : February 17, 2024

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Vaccines

Arms and Interventions
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Arm Intervention/treatment
Experimental: 20-valent pneumococcal conjugate vaccine
Pneumococcal conjugate vaccine (20vPnC)
 Biological: 20-valent pneumococcal conjugate vaccine
20-valent pneumococcal conjugate vaccine
Active Comparator: 13-valent pneumococcal conjugate vaccine
Pneumococcal conjugate vaccine (13vPnC)
 Biological: 13-valent pneumococcal conjugate vaccine
13-valent pneumococcal conjugate vaccine


Outcome Measures
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Primary Outcome Measures :
  1. Percentage of participants with local reactions (redness, swelling, and pain at the injection site) [ Time Frame: Day 7 ]
    Prompted local reactions after each dose

  2. Percentage of participants with systemic events (fever, decreased appetite, drowsiness/increased sleep, and irritability) [ Time Frame: Day 7 ]
    Prompted systemic reactions after each dose

  3. Percentage of participants with adverse events (AEs) from Dose 1 through 1 month after Dose 3 in each group [ Time Frame: Dose 1 to 1 month after Dose 3 ]
    Adverse events occurring from Dose 1 to 1 month after Dose 3 in each group

  4. Percentage of participants with AEs from Dose 4 through 1 month after Dose 4 in each group [ Time Frame: Dose 4 to 1 month after Dose 4 ]
    Adverse events occurring from Dose 4 to 1 month after Dose 4 in each group

  5. Percentage of participants with SAEs from Dose 1 through 1 month after Dose 4 in each group [ Time Frame: Dose 1 to 1 month after Dose 4 ]
    SAEs occurring up to 1 month after Dose 4 in each group


Secondary Outcome Measures :
  1. Geometric mean concentrations (GMCs) of serotype-specific IgG concentrations 1 month after Dose 3 in each vaccine group [ Time Frame: 1 month after Dose 3 ]
    IgG GMCs for the 20vPnC serotypes 1 month after Dose 3

  2. Percentages of participants with predefined serotype-specific IgG concentration for the 20vPnC serotypes at approximately 1 month after Dose 3 in each vaccine group [ Time Frame: 1 month after Dose 3 ]
    IgG concentrations for 20vPnC serotypes 1 month after Dose 3

  3. GMCs of serotype-specific IgG concentrations 1 month after Dose 4 in each vaccine group [ Time Frame: 1 month after Dose 4 ]
    IgG GMCs for the 20vPnC serotypes 1 month after Dose 4

  4. Percentages of participants with predefined serotype-specific IgG concentrations for the 20vPnC serotypes at approximately 1 month after Dose 4 in each vaccine group [ Time Frame: 1 month after Dose 4 ]
    IgG concentrations for 20vPnC serotypes 1 month after Dose 4


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:   42 Days to 84 Days   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • Male or female infants born at ≥36 weeks of gestation and approximately 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
  • Weight of 3.0 kg or greater at the time of randomization

Exclusion Criteria:

  • History of severe adverse reaction associated with a vaccine and/or severe allergic reaction (eg, anaphylaxis) to any component of 13vPnC, 20vPnC, or any other diphtheria toxoid-containing vaccine.
  • 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 study intervention 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.
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): NCT05512819


Locations
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Taiwan
Mackay Memorial Hospital-Hsinchu
Hsinchu City, Hsinchu, Taiwan, 30071
Taichung Veterans General Hospital
Taichung, Taiwan, 407219
National Taiwan University Hospital
Taipei, Taiwan, 100
Mackay Memorial Hospital
Taipei, Taiwan, 10449
Chang Gung Medical Foundation-Linkou Branch
Taoyuan, Taiwan, 333
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: NCT05512819    
Other Study ID Numbers: B7471024
First Posted: August 23, 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