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
2 other identifiers
interventional
875
2 countries
42
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
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for phase_3
Started Feb 2019
Shorter than P25 for phase_3
42 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
February 7, 2019
CompletedFirst Posted
Study publicly available on registry
February 11, 2019
CompletedStudy Start
First participant enrolled
February 12, 2019
CompletedPrimary Completion
Last participant's last visit for primary outcome
February 12, 2020
CompletedStudy Completion
Last participant's last visit for all outcomes
February 12, 2020
CompletedResults Posted
Study results publicly available
February 21, 2021
CompletedFebruary 21, 2021
February 1, 2021
1 year
February 7, 2019
February 2, 2021
February 2, 2021
Conditions
Outcome Measures
Primary Outcomes (6)
Percentage of Participants With Local Reactions Within 10 Days After Vaccination
Local reactions were recorded using an electronic diary (e-diary). Local reactions included redness, swelling and pain at the injection site. Redness and swelling were measured and recorded in measuring device units. 1 measuring device unit =0.5 centimeter (cm). Redness and swelling were graded as mild (greater than \[\>\] 2.0 to 5.0 cm), moderate (\>5.0 to 10.0 cm) and severe (\>10.0 cm). Pain at injection site was graded as mild (did not interfere with activity), moderate (interfered with activity), and severe (prevented daily activity).
Within 10 days after vaccination
Percentage of Participants With Systemic Events Within 7 Days After Vaccination
Systemic events fever, fatigue, headache, muscle pain and joint pain were recorded by using an e-diary. Fever was defined as temperature \>=38.0 degree Celsius (C) and categorized to \>=38.0 to 38.4 degree C, \>38.4 to 38.9 degree C, \>38.9 to 40.0 degree C and \>40.0 degree C. Fatigue, headache, muscle pain and joint pain were graded as mild (did not interfere with activity), moderate (some interference with activity) and severe (prevented daily routine activity).
Within 7 days after vaccination
Percentage of Participants With Adverse Events (AEs) Within 1 Month After Vaccination
An AE was any untoward medical occurrence in study participants who received study vaccine without regard to possibility of causal relationship with the treatment.
Within 1 month after vaccination
Percentage of Participants With Serious Adverse Events (SAEs) Within 6 Months After Vaccination
An SAE was any untoward medical occurrence at any dose that results in death; is life-threatening (immediate risk of death); requires inpatient hospitalization or prolongation of existing hospitalization; results in persistent or significant disability/incapacity (substantial disruption of the ability to conduct normal life functions); results in congenital anomaly/birth defect or that is considered to be an important medical event.
Within 6 months after vaccination
Percentage of Participants With Newly Diagnosed Chronic Medical Conditions (NDCMCs) Within 6 Months After Vaccination
An NDCMC was defined as a disease or medical condition, not previously identified, that was expected to be persistent or was otherwise long-lasting in its effects.
Within 6 months after vaccination
Pneumococcal Opsonophagocytic Activity (OPA) Geometric Mean Titers (GMTs) at 1 Month After Vaccination
OPA GMTs were determined for serotypes: 1, 3, 4, 5, 6A, 6B, 7F, 9V, 14, 18C, 19A, 19F, 23F, 8, 10A, 11A, 12F, 15B, 22F and 33F. OPA titer was expressed as reciprocal of the highest serum dilution.
1 month after vaccination
Secondary Outcomes (3)
Pneumococcal OPA Geometric Mean Fold Rise (GMFR) From Before Vaccination to 1 Month After Vaccination
From before vaccination to 1 month after vaccination
Percentage of Participants With >=4-Fold Rise in Pneumococcal OPA Titers From Before Vaccination to 1 Month After Vaccination
From before vaccination to 1 month after vaccination
Percentage of Participants With Pneumococcal OPA Titers >=Lower Limit of Quantitation (LLOQ) at 1 Month After Vaccination
1 month after vaccination
Study Arms (3)
13vPnC
ACTIVE COMPARATORPneumococcal conjugate vaccine
PPSV23
ACTIVE COMPARATORPneumococcal polysaccharide vaccine
20vPnC
EXPERIMENTALPneumococcal conjugate vaccine
Interventions
Eligibility Criteria
You may qualify if:
- Male or female adults 65 years of age or greater.
- 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.
- 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.
- Male or female adults who meet 1 of the following:
- 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).
- Vaccination with 13vPnC greater than or equal to 6 months prior to vaccination in the study, and no prior PPSV23 vaccination (Cohort B).
- Vaccination with 13vPnC followed by PPSV23 (PPSV23 vaccination greater than or equal to 1 year prior to vaccination in the study) (Cohort C).
You may not qualify if:
- 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.
- History of microbiologically proven invasive disease caused by S pneumoniae.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Pfizerlead
Study Sites (42)
Coastal Clinical Research, Inc.
Mobile, Alabama, 36608, United States
East Valley Gastroenterology and Hepatology Associates
Chandler, Arizona, 85224, United States
The Pain Center of Arizona
Peoria, Arizona, 85381, United States
HOPE Research Institute
Phoenix, Arizona, 85018, United States
The Pain Center of Arizona
Phoenix, Arizona, 85018, United States
Anaheim Clinical Trials, LLC
Anaheim, California, 92801, United States
Diablo Clinical Research, Inc.
Walnut Creek, California, 94598, United States
Clinical Research Consulting, LLC
Milford, Connecticut, 06460, United States
Optimal Research, LLC
Melbourne, Florida, 32934, United States
Synexus Clinical Research US, Inc
The Villages, Florida, 32162, United States
Meridian Clinical Research, LLC
Savannah, Georgia, 31406, United States
Clinical Research Atlanta
Stockbridge, Georgia, 30281, United States
East-West Medical Research Institute
Honolulu, Hawaii, 96814, United States
Heartland Research Associates, LLC
Wichita, Kansas, 67205, United States
Heartland Research Associates, LLC
Wichita, Kansas, 67207, United States
MedPharmics, LLC
Metairie, Louisiana, 70006, United States
Meridian Clinical Research, LLC
Rockville, Maryland, 20854, United States
Meridian Clinical Research, LLC
Norfolk, Nebraska, 68701, United States
MedPharmics, LLC
Albuquerque, New Mexico, 87102, United States
Carolina Institute for Clinical Research
Fayetteville, North Carolina, 28304, United States
PMG Research of Wilmington, LLC
Wilmington, North Carolina, 28401, United States
CTI Clinical Research Center
Cincinnati, Ohio, 45212, United States
Sterling Research Group, Ltd.
Cincinnati, Ohio, 45246, United States
Prestige Clinical Research
Franklin, Ohio, 45005, United States
Lynn Health Science Institute
Oklahoma City, Oklahoma, 73112, United States
Kaiser Permanente Center For Health Research
Portland, Oregon, 97227, United States
Columbia Research Group, Inc.
Portland, Oregon, 97239, United States
Medical Research South, LLC
Goose Creek, South Carolina, 29445, United States
Ventavia Research Group
Keller, Texas, 76248, United States
J. Lewis Research Inc. / Foothill Family Clinic Draper
Draper, Utah, 84020, United States
J. Lewis Research, Inc. - Foothill Family Clinic
Salt Lake City, Utah, 84109, United States
J. Lewis Research, Inc. / Foothill Family Clinic South
Salt Lake City, Utah, 84121, United States
J. Lewis Research, Inc. / Jordan River Family Medicine
South Jordan, Utah, 84095, United States
Kaiser Permanente Washington Health Research Institute
Seattle, Washington, 98101, United States
PharmaSite
Malmo, Skåne County, 21152, Sweden
Ladulaas Kliniska Studier
Borås, 50630, Sweden
Infektionskliniken
Eskilstuna, 63188, Sweden
CTC Gothia Forum
Gothenburg, 413 45, Sweden
ProbarE i Lund
Lund, 22222, Sweden
Avdelningen for Kliniska Provningar
Örebro, 703 62, Sweden
Karolinska Trial Alliance, KTA Prim
Stockholm, 11361, Sweden
Akardo Med Site
Stockholm, 11446, Sweden
Related Publications (1)
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.
PMID: 34839993DERIVED
Related Links
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Results Point of Contact
- Title
- Pfizer ClinicalTrials.gov Call Center
- Organization
- Pfizer Inc.
Study Officials
- STUDY DIRECTOR
Pfizer CT.gov Call Center
Pfizer
Publication Agreements
- PI is Sponsor Employee
- No
- Restriction Type
- OTHER
- Restrictive Agreement
- Yes
Study Design
- Study Type
- interventional
- Phase
- phase 3
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- PREVENTION
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
February 7, 2019
First Posted
February 11, 2019
Study Start
February 12, 2019
Primary Completion
February 12, 2020
Study Completion
February 12, 2020
Last Updated
February 21, 2021
Results First Posted
February 21, 2021
Record last verified: 2021-02
Data Sharing
- IPD Sharing
- Will share
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.