Safety and Immunogenicity Study of 20vPnC When Coadministered With a Booster Dose of BNT162b2
NCT ID: NCT04887948
Last Updated: 2022-12-14
Study Results
Outcome measurements, participant flow, baseline characteristics, and adverse events have been published for this study.
View full resultsBasic Information
Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.
COMPLETED
PHASE3
570 participants
INTERVENTIONAL
2021-05-20
2021-12-08
Brief Summary
Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.
Detailed Description
Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.
Conditions
See the medical conditions and disease areas that this research is targeting or investigating.
Study Design
Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.
RANDOMIZED
PARALLEL
PREVENTION
TRIPLE
Study Groups
Review each arm or cohort in the study, along with the interventions and objectives associated with them.
Coadministration Group
Participants receive an injection of pneumococcal vaccine (20vPnC) and of COVID-19 vaccine (BNT162b2) at the same visit.
20-valent pneumococcal conjugate vaccine (20vPnC)
20-valent pneumococcal conjugate vaccine (20vPnC)
BNT162b2
RNA-based SARS-CoV-2 vaccine (BNT162b2)
20vPnC-only Group
Participants receive an injection of pneumococcal vaccine (20vPnC) and of saline at the same visit.
20-valent pneumococcal conjugate vaccine (20vPnC)
20-valent pneumococcal conjugate vaccine (20vPnC)
Saline
Normal saline for injection
BNT162b2-only Group
Participants receive an injection of COVID-19 vaccine (BNT162b2) and of saline at the same visit.
BNT162b2
RNA-based SARS-CoV-2 vaccine (BNT162b2)
Saline
Normal saline for injection
Interventions
Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.
20-valent pneumococcal conjugate vaccine (20vPnC)
20-valent pneumococcal conjugate vaccine (20vPnC)
BNT162b2
RNA-based SARS-CoV-2 vaccine (BNT162b2)
Saline
Normal saline for injection
Eligibility Criteria
Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.
Inclusion Criteria
* Participating or participated in Study C4591001, received 2 doses of 30 µg BNT162b2 with the second dose given ≥6 months prior to the first vaccination in this study, and have not received a third dose of BNT162b2
* Adults determined by clinical assessment, including medical history and clinical judgement, to be eligible for the study, including adults with preexisting stable disease
* Adults who have no history of ever receiving a pneumococcal vaccine, or received a licensed pneumococcal vaccination ≥12 months prior to the first vaccination in this study
Exclusion Criteria
* Serious chronic disorder that in the investigator's opinion would make the participant inappropriate for entry into the study
* Previous clinical or microbiological diagnosis of COVID-19
* Previous vaccination with any investigational pneumococcal vaccine, or planned receipt of any licensed or investigational pneumococcal vaccine through study participation
* Previous vaccination with any coronavirus vaccine, other than those received in Study C4591001
* Other medical or psychiatric condition including recent (within the past year) or active suicidal ideation/behavior or laboratory abnormality that may increase the risk of study participation or, in the investigator's judgment, make the participant inappropriate for the study
65 Years
ALL
Yes
Sponsors
Meet the organizations funding or collaborating on the study and learn about their roles.
Pfizer
INDUSTRY
Responsible Party
Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.
Principal Investigators
Learn about the lead researchers overseeing the trial and their institutional affiliations.
Pfizer CT.gov Call Center
Role: STUDY_DIRECTOR
Pfizer
Locations
Explore where the study is taking place and check the recruitment status at each participating site.
Anaheim Clinical Trials, LLC
Anaheim, California, United States
Diablo Clinical Research, Inc.
Walnut Creek, California, United States
Alliance for Multispecialty Research, LLC
Coral Gables, Florida, United States
Indago Research & Health Center, Inc
Hialeah, Florida, United States
Research Centers of America ( Hollywood )
Hollywood, Florida, United States
Acevedo Clinical Research Associates
Miami, Florida, United States
Clinical Neuroscience Solutions
Orlando, Florida, United States
Clinical Research Atlanta
Stockbridge, Georgia, United States
East-West Medical Research Institute
Honolulu, Hawaii, United States
Solaris Clinical Research
Meridian, Idaho, United States
Alliance for Multispecialty Research, LLC
Newton, Kansas, United States
Clinical Research Professionals
Chesterfield, Missouri, United States
Sundance Clinical Research
St Louis, Missouri, United States
Meridian Clinical Research, LLC
Omaha, Nebraska, United States
Meridian Clinical Research, LLC
Endwell, New York, United States
Accellacare - Wilmington
Wilmington, North Carolina, United States
Aventiv Research Inc
Columbus, Ohio, United States
Alliance for Multispecialty Research, LLC
Knoxville, Tennessee, United States
Clinical Neuroscience Solutions, Inc. dba CNS Healthcare
Memphis, Tennessee, United States
Benchmark Research
Austin, Texas, United States
IMA Clinical Research San Antonio
San Antonio, Texas, United States
DM Clinical Research
Tomball, Texas, United States
Martin Diagnostic Clinic
Tomball, Texas, United States
Martins Diagnostic Clinic
Tomball, Texas, United States
J. Lewis Research, Inc. / Foothill Family Clinic
Salt Lake City, Utah, United States
J. Lewis Research, Inc. / Foothill Family Clinic South
Salt Lake City, Utah, United States
Wenatchee Valley Hospital
Wenatchee, Washington, United States
Countries
Review the countries where the study has at least one active or historical site.
References
Explore related publications, articles, or registry entries linked to this study.
Fitz-Patrick D, Young M, Yacisin K, McElwee K, Belanger T, Belanger K, Peng Y, Lee DY, Gruber WC, Scott DA, Watson W. Randomized trial to evaluate the safety, tolerability, and immunogenicity of a booster (third dose) of BNT162b2 COVID-19 vaccine coadministered with 20-valent pneumococcal conjugate vaccine in adults >/=65 years old. Vaccine. 2023 Jun 23;41(28):4190-4198. doi: 10.1016/j.vaccine.2023.05.002. Epub 2023 May 8.
Provided Documents
Download supplemental materials such as informed consent forms, study protocols, or participant manuals.
Document Type: Study Protocol
Document Type: Statistical Analysis Plan
Related Links
Access external resources that provide additional context or updates about the study.
To obtain contact information for a study center near you, click here.
Other Identifiers
Review additional registry numbers or institutional identifiers associated with this trial.
B7471026
Identifier Type: -
Identifier Source: org_study_id