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Trial to Evaluate the Safety and Immunogenicity of a 20-Valent Pneumococcal Vaccine in Adults 65 Years of Age or Older With Prior Pneumococcal Vaccination

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: NCT03835975
Recruitment Status : Completed
First Posted : February 11, 2019
Last Update Posted : February 21, 2020
Sponsor:
Information provided by (Responsible Party):
Pfizer

Brief Summary:
This Phase 3 will describe the safety and immunogenicity of a 20-valent pneumococcal conjugate vaccine formulation in adults 65 years of age or older with prior pneumococcal vaccination

Condition or disease Intervention/treatment Phase
Pneumococcal Disease Biological: 13vPnC Biological: PPSV23 Biological: 20vPnC Phase 3

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 875 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Prevention
Official Title: A PHASE 3, RANDOMIZED, OPEN-LABEL TRIAL TO EVALUATE THE SAFETY AND IMMUNOGENICITY OF A 20-VALENT PNEUMOCOCCAL CONJUGATE VACCINE IN ADULTS ≥65 YEARS OF AGE WITH PRIOR PNEUMOCOCCAL VACCINATION
Actual Study Start Date : February 12, 2019
Actual Primary Completion Date : February 12, 2020
Actual Study Completion Date : February 12, 2020

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Active Comparator: 13vPnC
Pneumococcal conjugate vaccine
Biological: 13vPnC
Pneumococcal conjugate vaccine

Active Comparator: PPSV23
Pneumococcal polysaccharide vaccine
Biological: PPSV23
Pneumococcal polysaccharide vaccine

Experimental: 20vPnC
Pneumococcal conjugate vaccine
Biological: 20vPnC
Pneumococcal conjugate vaccine




Primary Outcome Measures :
  1. Percentage of subjects reporting prompted local reactions (redness, swelling, and pain at the injection site) within 10 days after vaccination [ Time Frame: Day 10 ]
    Prompted local reactions after vaccination.

  2. Percentage of subjects reporting prompted systemic events (fever, headache, fatigue, muscle pain, and joint pain) within 7 days after vaccination [ Time Frame: Day 7 ]
    Prompted systemic events after vaccination.

  3. Percentage of subjects reporting adverse events (AEs) within 1 month after vaccination [ Time Frame: 1 month after vaccination ]
    Adverse events occurring within 1 month after vaccination.

  4. Percentage of subjects reporting serious adverse events (SAEs) and newly diagnosed chronic medical conditions (NDCMCs) within 6 months after vaccination [ Time Frame: 6 months after vaccination ]
    SAEs and NDCMCs occurring within 6 months after vaccination.

  5. Pneumococcal serotype-specific OPA titers 1 month after vaccination [ Time Frame: 1 month after vaccination ]
    OPA titers 1 month after vaccination.


Secondary Outcome Measures :
  1. Fold rise in serotype-specific OPA titers from before to 1 month after vaccination [ Time Frame: 1 month after vaccination ]
    Fold rise in OPA titers 1 month after vaccination.

  2. ≥4-Fold rise in serotype-specific OPA titers from before to 1 month after vaccination [ Time Frame: 1 month after vaccination ]
    Subjects with ≥4-fold rise in OPA titers 1 month after vaccination.

  3. Serotype-specific OPA titers greater than or equal to the lower limit of quantitation (≥ LLOQ) 1 month after vaccination [ Time Frame: 1 month after vaccination ]
    Subjects with OPA titers ≥ LLOQ 1 month after vaccination.



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Ages Eligible for Study:   65 Years and older   (Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria

  1. Male or female adults 65 years of age or greater.
  2. Adults determined by clinical assessment, including medical history and clinical judgment, to be eligible for the study, including adults with preexisting stable disease, defined as disease not requiring significant change in therapy in the previous 6 weeks or hospitalization for worsening disease within 12 weeks before receipt of investigational product.
  3. Female subject of nonchildbearing potential; male subject not able to father children or who is able to father children and willing to use a highly effective method of contraception.
  4. Male or female adults who meet 1 of the following:

    1. Vaccination with PPSV23 greater than or equal to 1 year and less than or equal to 5 years prior to vaccination in the study, and no prior 13vPnC vaccination (Cohort A).
    2. Vaccination with 13vPnC greater than or equal to 6 months prior to vaccination in the study, and no prior PPSV23 vaccination (Cohort B).
    3. Vaccination with 13vPnC followed by PPSV23 (PPSV23 vaccination greater than or equal to 1 year prior to vaccination in the study) (Cohort C).

Exclusion Criteria

  1. Serious chronic disorder including metastatic malignancy, severe chronic obstructive pulmonary disease (COPD) requiring supplemental oxygen, end-stage renal disease with or without dialysis, clinically unstable cardiac disease, or any other disorder that, in the investigator's opinion, excludes the subject from participating in the study.
  2. History of microbiologically proven invasive disease caused by S pneumoniae.

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): NCT03835975


Locations
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Sponsors and Collaborators
Pfizer
Investigators
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Study Director: Pfizer CT.gov Call Center Pfizer
Additional Information:
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Responsible Party: Pfizer
ClinicalTrials.gov Identifier: NCT03835975    
Other Study ID Numbers: B7471006
2018-004278-91 ( EudraCT Number )
First Posted: February 11, 2019    Key Record Dates
Last Update Posted: February 21, 2020
Last Verified: February 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

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Studies a U.S. FDA-regulated Drug Product: Yes
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
Heptavalent Pneumococcal Conjugate Vaccine
Immunologic Factors
Physiological Effects of Drugs