Clinical trial NCT03835975: 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
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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Pneumococcal Disease
Lead sponsor: Pfizer
Sponsor class: INDUSTRY
First posted: 2019-02-11
Enrollment: 875
Sex: ALL
Minimum age (years): 65
Standard ages: OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

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


Eligibility 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.

Primary outcomes:
measure: Percentage of Participants With Local Reactions Within 10 Days After Vaccination
timeFrame: Within 10 days after vaccination
measure: Percentage of Participants With Systemic Events Within 7 Days After Vaccination
timeFrame: Within 7 days after vaccination
measure: Percentage of Participants With Adverse Events (AEs) Within 1 Month After Vaccination
timeFrame: Within 1 month after vaccination
measure: Percentage of Participants With Serious Adverse Events (SAEs) Within 6 Months After Vaccination
timeFrame: Within 6 months after vaccination
measure: Percentage of Participants With Newly Diagnosed Chronic Medical Conditions (NDCMCs) Within 6 Months After Vaccination
timeFrame: Within 6 months after vaccination
measure: Pneumococcal Opsonophagocytic Activity (OPA) Geometric Mean Titers (GMTs) at 1 Month After Vaccination
timeFrame: 1 month after vaccination
Secondary outcomes:
measure: Pneumococcal OPA Geometric Mean Fold Rise (GMFR) From Before Vaccination to 1 Month After Vaccination
timeFrame: From before vaccination to 1 month after vaccination
measure: Percentage of Participants With >=4-Fold Rise in Pneumococcal OPA Titers From Before Vaccination to 1 Month After Vaccination
timeFrame: From before vaccination to 1 month after vaccination
measure: Percentage of Participants With Pneumococcal OPA Titers >=Lower Limit of Quantitation (LLOQ) at 1 Month After Vaccination
timeFrame: 1 month after vaccination
Other outcomes:
Locations:
city: Mobile
country: United States
facility: Coastal Clinical Research, Inc.
state: Alabama
city: Chandler
country: United States
facility: East Valley Gastroenterology and Hepatology Associates
state: Arizona
city: Peoria
country: United States
facility: The Pain Center of Arizona
state: Arizona
city: Phoenix
country: United States
facility: HOPE Research Institute
state: Arizona
city: Phoenix
country: United States
facility: The Pain Center of Arizona
state: Arizona
city: Anaheim
country: United States
facility: Anaheim Clinical Trials, LLC
state: California
city: Walnut Creek
country: United States
facility: Diablo Clinical Research, Inc.
state: California
city: Milford
country: United States
facility: Clinical Research Consulting, LLC
state: Connecticut
city: Melbourne
country: United States
facility: Optimal Research, LLC
state: Florida
city: The Villages
country: United States
facility: Synexus Clinical Research US, Inc
state: Florida
city: Savannah
country: United States
facility: Meridian Clinical Research, LLC
state: Georgia
city: Stockbridge
country: United States
facility: Clinical Research Atlanta
state: Georgia
city: Honolulu
country: United States
facility: East-West Medical Research Institute
state: Hawaii
city: Wichita
country: United States
facility: Heartland Research Associates, LLC
state: Kansas
city: Wichita
country: United States
facility: Heartland Research Associates, LLC
state: Kansas
city: Metairie
country: United States
facility: MedPharmics, LLC
state: Louisiana
city: Rockville
country: United States
facility: Meridian Clinical Research, LLC
state: Maryland
city: Norfolk
country: United States
facility: Meridian Clinical Research, LLC
state: Nebraska
city: Albuquerque
country: United States
facility: MedPharmics, LLC
state: New Mexico
city: Fayetteville
country: United States
facility: Carolina Institute for Clinical Research
state: North Carolina
city: Wilmington
country: United States
facility: PMG Research of Wilmington, LLC
state: North Carolina
city: Cincinnati
country: United States
facility: CTI Clinical Research Center
state: Ohio
city: Cincinnati
country: United States
facility: Sterling Research Group, Ltd.
state: Ohio
city: Franklin
country: United States
facility: Prestige Clinical Research
state: Ohio
city: Oklahoma City
country: United States
facility: Lynn Health Science Institute
state: Oklahoma
city: Portland
country: United States
facility: Kaiser Permanente Center For Health Research
state: Oregon
city: Portland
country: United States
facility: Columbia Research Group, Inc.
state: Oregon
city: Goose Creek
country: United States
facility: Medical Research South, LLC
state: South Carolina
city: Keller
country: United States
facility: Ventavia Research Group
state: Texas
city: Draper
country: United States
facility: J. Lewis Research Inc. / Foothill Family Clinic Draper
state: Utah
city: Salt Lake City
country: United States
facility: J. Lewis Research, Inc. - Foothill Family Clinic
state: Utah
city: Salt Lake City
country: United States
facility: J. Lewis Research, Inc. / Foothill Family Clinic South
state: Utah
city: South Jordan
country: United States
facility: J. Lewis Research, Inc. / Jordan River Family Medicine
state: Utah
city: Seattle
country: United States
facility: Kaiser Permanente Washington Health Research Institute
state: Washington
city: Malmo
country: Sweden
facility: PharmaSite
state: Skane
city: Boras
country: Sweden
facility: Ladulaas Kliniska Studier
city: Eskilstuna
country: Sweden
facility: Infektionskliniken
city: Goteborg
country: Sweden
facility: CTC Gothia Forum
city: Lund
country: Sweden
facility: ProbarE i Lund
city: Orebro
country: Sweden
facility: Avdelningen for Kliniska Provningar
city: Stockholm
country: Sweden
facility: Karolinska Trial Alliance, KTA Prim
city: Stockholm
country: Sweden
facility: Akardo Med Site
Study officials:
affiliation: Pfizer
name: Pfizer CT.gov Call Center
role: STUDY_DIRECTOR
References:
citation: Cannon K, Elder C, Young M, Scott DA, Scully IL, Baugher G, Peng Y, Jansen KU, Gruber WC, Watson W. A trial to evaluate the safety and immunogenicity of a 20-valent pneumococcal conjugate vaccine in populations of adults >/=65 years of age with different prior pneumococcal vaccination. Vaccine. 2021 Dec 17;39(51):7494-7502. doi: 10.1016/j.vaccine.2021.10.032. Epub 2021 Nov 25.