Safety and Immunogenicity Study of 20vPnC When Coadministered With a Booster Dose of BNT162b2
A PHASE 3, RANDOMIZED, DOUBLE BLIND TRIAL TO DESCRIBE THE SAFETY AND IMMUNOGENICITY OF 20 VALENT PNEUMOCOCCAL CONJUGATE VACCINE WHEN COADMINISTERED WITH A BOOSTER DOSE OF BNT162b2 IN ADULTS 65 YEARS OF AGE AND OLDER
1 other identifier
interventional
570
1 country
27
Brief Summary
Study of the safety and immunogenicity of 20vPnC and a booster dose of BNT162b2 administered at the same visit or each vaccine given alone
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for phase_3
Started May 2021
Shorter than P25 for phase_3
27 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
May 10, 2021
CompletedFirst Posted
Study publicly available on registry
May 14, 2021
CompletedStudy Start
First participant enrolled
May 20, 2021
CompletedPrimary Completion
Last participant's last visit for primary outcome
December 8, 2021
CompletedStudy Completion
Last participant's last visit for all outcomes
December 8, 2021
CompletedResults Posted
Study results publicly available
December 14, 2022
CompletedDecember 14, 2022
November 1, 2022
7 months
May 10, 2021
October 7, 2022
November 17, 2022
Conditions
Outcome Measures
Primary Outcomes (4)
Percentage of Participants With Local Reactions at Each Injection Site Within 10 Days After Vaccination
Local reactions included pain at injection site, redness and swelling and were recorded by participants in an electronic diary (e-diary). Redness and swelling were measured and recorded in measuring device units. 1 measuring device unit =0.5 centimeter (cm) and 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 daily activity, moderate: interfered with daily activity and severe: prevented daily activity. Percentage of participants with local reactions at each injection site within 10 days after vaccination and the associated 2-sided 95% confidence interval (CI) based on the Clopper and Pearson method was presented.
Within 10 days after vaccination
Percentage of Participants With Systemic Events Within 7 Days After Vaccination
Systemic events including fever, fatigue, headache, chills, muscle pain and joint pain were recorded by participants using an e-diary. Fever was defined as temperature \>=38.0 degree Celsius (C) and categorized as \>=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, chills, 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. Percentage of participants with systemic events within 7 days after vaccination and the associated 2-sided 95% CI based on the Clopper and Pearson method was presented.
Within 7 days after vaccination
Percentage of Participants With Adverse Events (AEs) Within 1 Month After Vaccination
An AE was defined as any untoward medical occurrence in a clinical study participant, temporally associated with the use of study intervention, whether or not considered related to the study intervention. Percentage of participants with AEs and the associated 2-sided 95% CI based on the Clopper and Pearson method was presented. Only AEs collected by non-systematic assessment (i.e. excluding local reactions and systemic events) were reported in this outcome measure.
From day of vaccination (Day 1) up to 1 month after vaccination
Percentage of Participants With Serious Adverse Events (SAEs) Within 6 Months After Vaccination
A SAE was defined as any untoward medical occurrence that, at any dose, resulted in death; was life-threatening (immediate risk of death); required inpatient hospitalization or prolongation of existing hospitalization; resulted in persistent or significant disability/incapacity (substantial disruption of the ability to conduct normal life functions); resulted in congenital anomaly/birth defect; was a suspected transmission via a Pfizer product of an infectious agent, pathogenic or non-pathogenic or that was considered to be an important medical event. Percentage of participants with SAEs and the associated 2-sided 95% CI based on the Clopper and Pearson method was presented.
From day of vaccination (Day 1) up to 6 months after vaccination
Secondary Outcomes (3)
Geometric Mean Titers (GMTs) of Pneumococcal Serotype-Specific Opsonophagocytic Activity (OPA) at 1 Month After Vaccination With 20vPnC
1 month after vaccination with 20vPnC
Geometric Mean Concentration (GMC) of Full-Length S-Binding Immunoglobulin G (IgG) Levels at 1 Month After Vaccination With BNT162b2
1 month after vaccination with BNT162b2
Geometric Mean Fold Rise (GMFR) of Full-Length S-Binding IgG Levels From Before Vaccination to 1 Month After Vaccination With BNT162b2
Before vaccination to 1 month after vaccination with BNT162b2
Study Arms (3)
Coadministration Group
EXPERIMENTALParticipants receive an injection of pneumococcal vaccine (20vPnC) and of COVID-19 vaccine (BNT162b2) at the same visit.
20vPnC-only Group
ACTIVE COMPARATORParticipants receive an injection of pneumococcal vaccine (20vPnC) and of saline at the same visit.
BNT162b2-only Group
ACTIVE COMPARATORParticipants receive an injection of COVID-19 vaccine (BNT162b2) and of saline at the same visit.
Interventions
20-valent pneumococcal conjugate vaccine (20vPnC)
Eligibility Criteria
You may qualify if:
- Male or female participants ≥65 years of age at the time of consent
- 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
You may not qualify if:
- History of severe adverse reaction associated with a vaccine and/or severe allergic reaction (eg, anaphylaxis)
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Pfizerlead
Study Sites (27)
Anaheim Clinical Trials, LLC
Anaheim, California, 92801, United States
Diablo Clinical Research, Inc.
Walnut Creek, California, 94598, United States
Alliance for Multispecialty Research, LLC
Coral Gables, Florida, 33134, United States
Indago Research & Health Center, Inc
Hialeah, Florida, 33012, United States
Research Centers of America ( Hollywood )
Hollywood, Florida, 33024, United States
Acevedo Clinical Research Associates
Miami, Florida, 33142, United States
Clinical Neuroscience Solutions
Orlando, Florida, 32801, United States
Clinical Research Atlanta
Stockbridge, Georgia, 30281, United States
East-West Medical Research Institute
Honolulu, Hawaii, 96814, United States
Solaris Clinical Research
Meridian, Idaho, 83646, United States
Alliance for Multispecialty Research, LLC
Newton, Kansas, 67114, United States
Clinical Research Professionals
Chesterfield, Missouri, 63005, United States
Sundance Clinical Research
St Louis, Missouri, 63141, United States
Meridian Clinical Research, LLC
Omaha, Nebraska, 68134, United States
Meridian Clinical Research, LLC
Endwell, New York, 13760, United States
Accellacare - Wilmington
Wilmington, North Carolina, 28401, United States
Aventiv Research Inc
Columbus, Ohio, 43213, United States
Alliance for Multispecialty Research, LLC
Knoxville, Tennessee, 37909, United States
Clinical Neuroscience Solutions, Inc. dba CNS Healthcare
Memphis, Tennessee, 38119, United States
Benchmark Research
Austin, Texas, 78705, United States
IMA Clinical Research San Antonio
San Antonio, Texas, 78229, United States
DM Clinical Research
Tomball, Texas, 77375, United States
Martin Diagnostic Clinic
Tomball, Texas, 77375, United States
Martins Diagnostic Clinic
Tomball, Texas, 77375, 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
Wenatchee Valley Hospital
Wenatchee, Washington, 98801, United States
Related Publications (1)
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.
PMID: 37244809DERIVED
Related Links
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention 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
- TRIPLE
- Who Masked
- PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
- Masking Details
- Triple
- Purpose
- PREVENTION
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
May 10, 2021
First Posted
May 14, 2021
Study Start
May 20, 2021
Primary Completion
December 8, 2021
Study Completion
December 8, 2021
Last Updated
December 14, 2022
Results First Posted
December 14, 2022
Record last verified: 2022-11
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.