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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 | Clinical Trials | Clareo Health

COMPLETEDPHASE3

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

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

NCT03835975•Pfizer

View on ClinicalTrials.gov

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

Eligibility

Age

65 - No limit years

Sex

ALL

Healthy Volunteers

Yes

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.

Locations (42)

Coastal Clinical Research, Inc.

Mobile, Alabama, United States

East Valley Gastroenterology and Hepatology Associates

Chandler, Arizona, United States

The Pain Center of Arizona

Peoria, Arizona, United States

HOPE Research Institute

Phoenix, Arizona, United States

The Pain Center of Arizona

Phoenix, Arizona, United States

Anaheim Clinical Trials, LLC

Anaheim, California, United States

Diablo Clinical Research, Inc.

Walnut Creek, California, United States

Clinical Research Consulting, LLC

Milford, Connecticut, United States

Optimal Research, LLC

Melbourne, Florida, United States

Synexus Clinical Research US, Inc

The Villages, Florida, United States

Key Dates

Start Date

February 12, 2019

Primary Completion Date

February 12, 2020

Completion Date

February 12, 2020

Last Updated

February 21, 2021

Enrollment

875

ACTUAL participants

Conditions

Pneumococcal Disease

Interventions

13vPnC

BIOLOGICAL

PPSV23

BIOLOGICAL

20vPnC

BIOLOGICAL

Carriage to Assess Protection of New Pneumococcal Vaccines - PCV15

NCT06731374

Pneumococcal DiseasePneumococcal Carriage

View study

RECRUITINGPHASE3

A Clinical Trial to Evaluate the Immunogenicity and Safety of the 23-valent Pneumococcal Polysaccharide Vaccine in Healthy People

NCT06044077

Pneumococcal Disease

View study

ACTIVE_NOT_RECRUITING

Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: February 21, 2021Data synced to Clareo: March 29, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.

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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

Inclusion Criteria

Exclusion Criteria

Carriage to Assess Protection of New Pneumococcal Vaccines - PCV15

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20-valent Pneumococcal Conjugate Vaccine Safety and Immunogenicity Study in Pneumococcal Vaccine-Naïve Adults 60 Years of Age and Older in Japan, Korea, and Taiwan