Working…
COVID-19 is an emerging, rapidly evolving situation.
Get the latest public health information from CDC: https://www.coronavirus.gov.

Get the latest research information from NIH: https://www.nih.gov/coronavirus.
ClinicalTrials.gov
ClinicalTrials.gov Menu
Trial record 1 of 1 for:    NCT04382326
Previous Study | Return to List | Next Study

20-valent Pneumococcal Conjugate Vaccine Safety and Immunogenicity Study of a 4-Dose Series in Healthy Infants

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. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04382326
Recruitment Status : Recruiting
First Posted : May 11, 2020
Last Update Posted : November 13, 2020
Sponsor:
Information provided by (Responsible Party):
Pfizer

Brief Summary:
20-valent Pneumococcal Conjugate Vaccine Safety and Immunogenicity Study of a 4-Dose Series in Healthy Infants

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

Layout table for study information
Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 2000 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 IN HEALTHY INFANTS
Actual Study Start Date : May 20, 2020
Estimated Primary Completion Date : May 7, 2022
Estimated Study Completion Date : May 7, 2022

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: 20-valent pneumococcal conjugate vaccine
Pneumococcal conjugate vaccine
Biological: 20-valent pneumococcal conjugate vaccine
20-valent pneumococcal conjugate vaccine

Active Comparator: 13-valent pneumococcal conjugate vaccine
Pneumococcal conjugate vaccine
Biological: 13-valent pneumococcal conjugate vaccine
13-valent pneumococcal conjugate vaccine




Primary Outcome Measures :
  1. The percentages of participants reporting prompted local reactions within 7 days after each vaccination in each group [ Time Frame: Day 7 ]
    Prompted local reactions after each dose in each group

  2. The percentages of participants reporting prompted systemic events within 7 days after each vaccination in each group [ Time Frame: Day 7 ]
    Prompted systemic reactions after each dose in each group

  3. The percentages of participants reporting AEs from Dose 1 to 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. The percentages of participants reporting AEs from Dose 4 to 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. The percentages of participants reporting SAEs up to 6 months after Dose 4 in each group [ Time Frame: Dose 1 to 6 months after Dose 4 ]
    SAEs occurring up to 6 months after Dose 4 in each group

  6. The percentages of participants reporting Newly Diagnosed Chronic Medical Conditions (NDCMCs) up to 6 months after Dose 4 in each group [ Time Frame: Dose 1 to 6 months after Dose 4 ]
    NDCMCs occurring up to 6 months after Dose 4 in each group

  7. The percentages of participants with pre-defined pneumococcal IgG concentrations at 1 month after Dose 3 [ Time Frame: 1 month after Dose 3 ]
    IgG concentrations 1 month after Dose 3

  8. IgG GMCs 1 month after Dose 4 [ Time Frame: 1 month after Dose 4 ]
    IgG GMCs 1 month after Dose 4

  9. The percentages of participants with prespecified antibody levels to specific concomitant vaccine antigens 1 month after Dose 3 [ Time Frame: 1 month after Dose 3 ]
    Antibody levels 1 month after Dose 3


Secondary Outcome Measures :
  1. IgG GMCs 1 month after Dose 3 [ Time Frame: 1 month after Dose 3 ]
    IgG GMC concentrations 1 month after Dose 3

  2. The percentages of participants with predefined pneumococcal IgG concentrations at 1 month after Dose 4 [ Time Frame: 1 month after Dose 4 ]
    IgG concentrations 1 month after Dose 4

  3. OPA GMTs at 1 month after Dose 3 in each group [ Time Frame: 1 month after Dose 3 ]
    OPA GMTs 1 month after Dose 3

  4. OPA GMTs at 1 month after Dose 4 in each group [ Time Frame: 1 month after Dose 4 ]
    OPA GMTs 1 month after Dose 4

  5. IgG GMFRs from 1 month after Dose 3 to before Dose 4 [ Time Frame: From 1 month after Dose 3 to before Dose 4 ]
    IgG GMFRs from 1 month after Dose 3 to before Dose 4

  6. IgG GMFRs from 1 month before to 1 month after Dose 4 [ Time Frame: From 1 month before to 1 month after Dose 4 ]
    IgG GMFRs from 1 month before to 1 month after Dose 4

  7. IgG GMFRs from 1 month after Dose 3 to 1 month after Dose 4 [ Time Frame: From 1 month after Dose 3 to 1 month after Dose 4 ]
    IgG GMFRs from 1 month after Dose 3 to 1 month after Dose 4

  8. Percentages of participants with pre-specified antibody levels to specific concomitant vaccine antigen 1 month after Dose 3 [ Time Frame: 1 month after Dose 3 ]
    Antibody levels 1 month after Dose 3

  9. Ratios of antibody levels for specific concomitant vaccine antigens 1 month after Dose 4 [ Time Frame: 1 month after Dose 4 ]
    Antibody levels 1 month after Dose 4



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.


Layout table for eligibility information
Ages Eligible for Study:   42 Days to 98 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 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
  • Previous receipt of >1 dose of hepatitis B vaccine; or receipt of a single hepatitis B vaccine dose administered at >30 days old, or previous receipt of any licensed or investigational pneumococcal vaccine, or planned receipt through study participation

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): NCT04382326


Contacts
Layout table for location contacts
Contact: Pfizer CT.gov Call Center 1-800-718-1021 ClinicalTrials.gov_Inquiries@pfizer.com

Locations
Show Show 111 study locations
Sponsors and Collaborators
Pfizer
Investigators
Layout table for investigator information
Study Director: Pfizer CT.gov Call Center Pfizer
Additional Information:
Layout table for additonal information
Responsible Party: Pfizer
ClinicalTrials.gov Identifier: NCT04382326    
Other Study ID Numbers: B7471011
2019-003305-10 ( EudraCT Number )
First Posted: May 11, 2020    Key Record Dates
Last Update Posted: November 13, 2020
Last Verified: November 2020
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

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