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Safety and Immunogenicity Study of 20vPnC When Coadministered With a Booster Dose of BNT162b2

Primary Purpose

Pneumococcal Disease, COVID-19, SARS-CoV-2 Infection

Status
Completed
Phase
Phase 3
Locations
United States
Study Type
Interventional
Intervention
20-valent pneumococcal conjugate vaccine (20vPnC)
BNT162b2
Saline
Sponsored by
Pfizer
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Pneumococcal Disease

Eligibility Criteria

65 Years - undefined (Older Adult)All SexesAccepts Healthy Volunteers

Inclusion Criteria:

  • 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

Exclusion Criteria:

  • 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

Sites / Locations

  • Anaheim Clinical Trials, LLC
  • Diablo Clinical Research, Inc.
  • Alliance for Multispecialty Research, LLC
  • Indago Research & Health Center, Inc
  • Research Centers of America ( Hollywood )
  • Acevedo Clinical Research Associates
  • Clinical Neuroscience Solutions
  • Clinical Research Atlanta
  • East-West Medical Research Institute
  • Solaris Clinical Research
  • Alliance for Multispecialty Research, LLC
  • Clinical Research Professionals
  • Sundance Clinical Research
  • Meridian Clinical Research, LLC
  • Meridian Clinical Research, LLC
  • Accellacare - Wilmington
  • Aventiv Research Inc
  • Alliance for Multispecialty Research, LLC
  • Clinical Neuroscience Solutions, Inc. dba CNS Healthcare
  • Benchmark Research
  • IMA Clinical Research San Antonio
  • DM Clinical Research
  • Martin Diagnostic Clinic
  • Martins Diagnostic Clinic
  • J. Lewis Research, Inc. / Foothill Family Clinic
  • J. Lewis Research, Inc. / Foothill Family Clinic South
  • Wenatchee Valley Hospital

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Experimental

Active Comparator

Active Comparator

Arm Label

Coadministration Group

20vPnC-only Group

BNT162b2-only Group

Arm Description

Participants receive an injection of pneumococcal vaccine (20vPnC) and of COVID-19 vaccine (BNT162b2) at the same visit.

Participants receive an injection of pneumococcal vaccine (20vPnC) and of saline at the same visit.

Participants receive an injection of COVID-19 vaccine (BNT162b2) and of saline at the same visit.

Outcomes

Primary Outcome Measures

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.
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.
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.
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.

Secondary Outcome Measures

Geometric Mean Titers (GMTs) of Pneumococcal Serotype-Specific Opsonophagocytic Activity (OPA) at 1 Month After Vaccination With 20vPnC
OPA titers were measured from serum samples for 20vPnC serotypes: 1, 3, 4, 5, 6A, 6B, 7F,8, 9V, 10A, 11A, 12F, 14, 15B, 18C, 19A, 19F, 22F, 23F, and 33F. GMTs and 2-sided CIs were calculated by exponentiating the mean logarithm of the OPA titers and the corresponding CIs and based on the Student t distribution. Data for this outcome measure was planned to be analyzed for coadministration group (20vPnC + BNT162b2) and 20vPnC only group (20vPnC + saline) as specified in protocol.
Geometric Mean Concentration (GMC) of Full-Length S-Binding Immunoglobulin G (IgG) Levels at 1 Month After Vaccination With BNT162b2
IgG levels were measured in serum samples using severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) full-length S-binding assay. GMCs and 2-sided CIs were calculated by exponentiating the mean logarithm of the concentrations and the corresponding CIs and based on the Student t distribution. Data for this outcome measure was planned to be analyzed for coadministration group (20vPnC + BNT162b2) and BNT162b2 only group (BNT162b2 + saline) as specified in protocol.
Geometric Mean Fold Rise (GMFR) of Full-Length S-Binding IgG Levels From Before Vaccination to 1 Month After Vaccination With BNT162b2
The GMFR for each vaccine group was defined as the geometric mean of the fold rises in the assay results from before to approximately 1 month after vaccination. GMFRs and the corresponding 2-sided 95% CIs were calculated by exponentiating the mean logarithm of fold rises and the corresponding CIs and based on the Student t distribution. Data for this outcome measure was planned to be analyzed for coadministration group (20vPnC + BNT162b2) and BNT162b2 only group (BNT162b2 + saline) as specified in the protocol.

Full Information

First Posted
May 10, 2021
Last Updated
November 17, 2022
Sponsor
Pfizer
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1. Study Identification

Unique Protocol Identification Number
NCT04887948
Brief Title
Safety and Immunogenicity Study of 20vPnC When Coadministered With a Booster Dose of BNT162b2
Official Title
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
Study Type
Interventional

2. Study Status

Record Verification Date
November 2022
Overall Recruitment Status
Completed
Study Start Date
May 20, 2021 (Actual)
Primary Completion Date
December 8, 2021 (Actual)
Study Completion Date
December 8, 2021 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Pfizer

4. Oversight

Studies a U.S. FDA-regulated Drug Product
Yes
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. Study Description

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

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Pneumococcal Disease, COVID-19, SARS-CoV-2 Infection

7. Study Design

Primary Purpose
Prevention
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigatorOutcomes Assessor
Masking Description
Triple
Allocation
Randomized
Enrollment
570 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Coadministration Group
Arm Type
Experimental
Arm Description
Participants receive an injection of pneumococcal vaccine (20vPnC) and of COVID-19 vaccine (BNT162b2) at the same visit.
Arm Title
20vPnC-only Group
Arm Type
Active Comparator
Arm Description
Participants receive an injection of pneumococcal vaccine (20vPnC) and of saline at the same visit.
Arm Title
BNT162b2-only Group
Arm Type
Active Comparator
Arm Description
Participants receive an injection of COVID-19 vaccine (BNT162b2) and of saline at the same visit.
Intervention Type
Biological
Intervention Name(s)
20-valent pneumococcal conjugate vaccine (20vPnC)
Intervention Description
20-valent pneumococcal conjugate vaccine (20vPnC)
Intervention Type
Biological
Intervention Name(s)
BNT162b2
Intervention Description
RNA-based SARS-CoV-2 vaccine (BNT162b2)
Intervention Type
Other
Intervention Name(s)
Saline
Intervention Description
Normal saline for injection
Primary Outcome Measure Information:
Title
Percentage of Participants With Local Reactions at Each Injection Site Within 10 Days After Vaccination
Description
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.
Time Frame
Within 10 days after vaccination
Title
Percentage of Participants With Systemic Events Within 7 Days After Vaccination
Description
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.
Time Frame
Within 7 days after vaccination
Title
Percentage of Participants With Adverse Events (AEs) Within 1 Month After Vaccination
Description
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.
Time Frame
From day of vaccination (Day 1) up to 1 month after vaccination
Title
Percentage of Participants With Serious Adverse Events (SAEs) Within 6 Months After Vaccination
Description
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.
Time Frame
From day of vaccination (Day 1) up to 6 months after vaccination
Secondary Outcome Measure Information:
Title
Geometric Mean Titers (GMTs) of Pneumococcal Serotype-Specific Opsonophagocytic Activity (OPA) at 1 Month After Vaccination With 20vPnC
Description
OPA titers were measured from serum samples for 20vPnC serotypes: 1, 3, 4, 5, 6A, 6B, 7F,8, 9V, 10A, 11A, 12F, 14, 15B, 18C, 19A, 19F, 22F, 23F, and 33F. GMTs and 2-sided CIs were calculated by exponentiating the mean logarithm of the OPA titers and the corresponding CIs and based on the Student t distribution. Data for this outcome measure was planned to be analyzed for coadministration group (20vPnC + BNT162b2) and 20vPnC only group (20vPnC + saline) as specified in protocol.
Time Frame
1 month after vaccination with 20vPnC
Title
Geometric Mean Concentration (GMC) of Full-Length S-Binding Immunoglobulin G (IgG) Levels at 1 Month After Vaccination With BNT162b2
Description
IgG levels were measured in serum samples using severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) full-length S-binding assay. GMCs and 2-sided CIs were calculated by exponentiating the mean logarithm of the concentrations and the corresponding CIs and based on the Student t distribution. Data for this outcome measure was planned to be analyzed for coadministration group (20vPnC + BNT162b2) and BNT162b2 only group (BNT162b2 + saline) as specified in protocol.
Time Frame
1 month after vaccination with BNT162b2
Title
Geometric Mean Fold Rise (GMFR) of Full-Length S-Binding IgG Levels From Before Vaccination to 1 Month After Vaccination With BNT162b2
Description
The GMFR for each vaccine group was defined as the geometric mean of the fold rises in the assay results from before to approximately 1 month after vaccination. GMFRs and the corresponding 2-sided 95% CIs were calculated by exponentiating the mean logarithm of fold rises and the corresponding CIs and based on the Student t distribution. Data for this outcome measure was planned to be analyzed for coadministration group (20vPnC + BNT162b2) and BNT162b2 only group (BNT162b2 + saline) as specified in the protocol.
Time Frame
Before vaccination to 1 month after vaccination with BNT162b2

10. Eligibility

Sex
All
Minimum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria: 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 Exclusion Criteria: 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Pfizer CT.gov Call Center
Organizational Affiliation
Pfizer
Official's Role
Study Director
Facility Information:
Facility Name
Anaheim Clinical Trials, LLC
City
Anaheim
State/Province
California
ZIP/Postal Code
92801
Country
United States
Facility Name
Diablo Clinical Research, Inc.
City
Walnut Creek
State/Province
California
ZIP/Postal Code
94598
Country
United States
Facility Name
Alliance for Multispecialty Research, LLC
City
Coral Gables
State/Province
Florida
ZIP/Postal Code
33134
Country
United States
Facility Name
Indago Research & Health Center, Inc
City
Hialeah
State/Province
Florida
ZIP/Postal Code
33012
Country
United States
Facility Name
Research Centers of America ( Hollywood )
City
Hollywood
State/Province
Florida
ZIP/Postal Code
33024
Country
United States
Facility Name
Acevedo Clinical Research Associates
City
Miami
State/Province
Florida
ZIP/Postal Code
33142
Country
United States
Facility Name
Clinical Neuroscience Solutions
City
Orlando
State/Province
Florida
ZIP/Postal Code
32801
Country
United States
Facility Name
Clinical Research Atlanta
City
Stockbridge
State/Province
Georgia
ZIP/Postal Code
30281
Country
United States
Facility Name
East-West Medical Research Institute
City
Honolulu
State/Province
Hawaii
ZIP/Postal Code
96814
Country
United States
Facility Name
Solaris Clinical Research
City
Meridian
State/Province
Idaho
ZIP/Postal Code
83646
Country
United States
Facility Name
Alliance for Multispecialty Research, LLC
City
Newton
State/Province
Kansas
ZIP/Postal Code
67114
Country
United States
Facility Name
Clinical Research Professionals
City
Chesterfield
State/Province
Missouri
ZIP/Postal Code
63005
Country
United States
Facility Name
Sundance Clinical Research
City
Saint Louis
State/Province
Missouri
ZIP/Postal Code
63141
Country
United States
Facility Name
Meridian Clinical Research, LLC
City
Omaha
State/Province
Nebraska
ZIP/Postal Code
68134
Country
United States
Facility Name
Meridian Clinical Research, LLC
City
Endwell
State/Province
New York
ZIP/Postal Code
13760
Country
United States
Facility Name
Accellacare - Wilmington
City
Wilmington
State/Province
North Carolina
ZIP/Postal Code
28401
Country
United States
Facility Name
Aventiv Research Inc
City
Columbus
State/Province
Ohio
ZIP/Postal Code
43213
Country
United States
Facility Name
Alliance for Multispecialty Research, LLC
City
Knoxville
State/Province
Tennessee
ZIP/Postal Code
37909
Country
United States
Facility Name
Clinical Neuroscience Solutions, Inc. dba CNS Healthcare
City
Memphis
State/Province
Tennessee
ZIP/Postal Code
38119
Country
United States
Facility Name
Benchmark Research
City
Austin
State/Province
Texas
ZIP/Postal Code
78705
Country
United States
Facility Name
IMA Clinical Research San Antonio
City
San Antonio
State/Province
Texas
ZIP/Postal Code
78229
Country
United States
Facility Name
DM Clinical Research
City
Tomball
State/Province
Texas
ZIP/Postal Code
77375
Country
United States
Facility Name
Martin Diagnostic Clinic
City
Tomball
State/Province
Texas
ZIP/Postal Code
77375
Country
United States
Facility Name
Martins Diagnostic Clinic
City
Tomball
State/Province
Texas
ZIP/Postal Code
77375
Country
United States
Facility Name
J. Lewis Research, Inc. / Foothill Family Clinic
City
Salt Lake City
State/Province
Utah
ZIP/Postal Code
84109
Country
United States
Facility Name
J. Lewis Research, Inc. / Foothill Family Clinic South
City
Salt Lake City
State/Province
Utah
ZIP/Postal Code
84121
Country
United States
Facility Name
Wenatchee Valley Hospital
City
Wenatchee
State/Province
Washington
ZIP/Postal Code
98801
Country
United States

12. IPD Sharing Statement

Plan to Share IPD
Yes
IPD Sharing Plan Description
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.
IPD Sharing URL
https://www.pfizer.com/science/clinical_trials/trial_data_and_results/data_requests
Links:
URL
https://pmiform.com/clinical-trial-info-request?StudyID=B7471026
Description
To obtain contact information for a study center near you, click here.

Learn more about this trial

Safety and Immunogenicity Study of 20vPnC When Coadministered With a Booster Dose of BNT162b2

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