Pneumococcal DiseasePhase 3NCT04887948

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

A Phase 3 study testing 20-valent pneumococcal conjugate vaccine (20vPnC), BNT162b2 and Saline in people with Pneumococcal Disease and COVID-19, run by Pfizer at 27 sites in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

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Trial 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 Read more about this study

Who is it for?: Ages 65 years and olderHealthy volunteers can take part
Conditions the study is for: Pneumococcal Disease, COVID-19, SARS-CoV-2 Infection
What is being tested?: 20-valent pneumococcal conjugate vaccine (20vPnC), BNT162b2 and Saline
Type of treatment: Vaccines, Injection or infusion
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 570 participants
Where: 27 sitesUnited States
Study dates: 20 May 2021to 8 Dec 2021
Phase: Phase 3
Are there results?: Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages 65 years and older
All sexes
Healthy volunteers accepted
Older adult

Who may be able to join

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

Who cannot join

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

Trial locations and contacts

27 sites in 1 country.

City, postcode or hospital

27 sites in 1 country

United States27 sites

Anaheim Clinical Trials, LLC
Anaheim, California, 92801
Benchmark Research
Austin, Texas, 78705
Clinical Research Professionals
Chesterfield, Missouri, 63005
Aventiv Research Inc
Columbus, Ohio, 43213
Alliance for Multispecialty Research, LLC
Coral Gables, Florida, 33134
Meridian Clinical Research, LLC
Endwell, New York, 13760
Indago Research & Health Center, Inc
Hialeah, Florida, 33012
Research Centers of America ( Hollywood )
Hollywood, Florida, 33024
East-West Medical Research Institute
Honolulu, Hawaii, 96814
Alliance for Multispecialty Research, LLC
Knoxville, Tennessee, 37909
Clinical Neuroscience Solutions, Inc. dba CNS Healthcare
Memphis, Tennessee, 38119
Solaris Clinical Research
Meridian, Idaho, 83646
Acevedo Clinical Research Associates
Miami, Florida, 33142
Alliance for Multispecialty Research, LLC
Newton, Kansas, 67114
Meridian Clinical Research, LLC
Omaha, Nebraska, 68134
Clinical Neuroscience Solutions
Orlando, Florida, 32801
J. Lewis Research, Inc. / Foothill Family Clinic
Salt Lake City, Utah, 84109
J. Lewis Research, Inc. / Foothill Family Clinic South
Salt Lake City, Utah, 84121
IMA Clinical Research San Antonio
San Antonio, Texas, 78229
Sundance Clinical Research
St Louis, Missouri, 63141
Clinical Research Atlanta
Stockbridge, Georgia, 30281
DM Clinical Research
Tomball, Texas, 77375
Martin Diagnostic Clinic
Tomball, Texas, 77375
Martins Diagnostic Clinic
Tomball, Texas, 77375
Diablo Clinical Research, Inc.
Walnut Creek, California, 94598
Wenatchee Valley Hospital
Wenatchee, Washington, 98801
Accellacare - Wilmington
Wilmington, North Carolina, 28401

Other trials in United States

About this study

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 of the safety and immunogenicity of 20vPnC and a booster dose of BNT162b2 administered at the same visit or each vaccine given alone

Conditions: Pneumococcal Disease, COVID-19, SARS-CoV-2 Infection
Being tested: 20-valent pneumococcal conjugate vaccine (20vPnC), BNT162b2, Saline
Medical subject headings: Pneumococcal Infections, COVID-19

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

20-valent pneumococcal conjugate vaccine (20vPnC)Biological
20-valent pneumococcal conjugate vaccine (20vPnC)
BNT162b2Biological
RNA-based SARS-CoV-2 vaccine (BNT162b2)
SalineOther
Normal saline for injection

Study groups in NCT04887948
Study group	Role	What they receive
Coadministration Group	Experimental	Participants receive an injection of pneumococcal vaccine (20vPnC) and of COVID-19 vaccine (BNT162b2) at the same visit. Receives: Biological: 20-valent pneumococcal conjugate vaccine (20vPnC); Biological: BNT162b2
20vPnC-only Group	Active comparator	Participants receive an injection of pneumococcal vaccine (20vPnC) and of saline at the same visit. Receives: Biological: 20-valent pneumococcal conjugate vaccine (20vPnC); Other: Saline
BNT162b2-only Group	Active comparator	Participants receive an injection of COVID-19 vaccine (BNT162b2) and of saline at the same visit. Receives: Biological: BNT162b2; Other: Saline

What is being measured

The primary outcome is the main question the study is designed to answer.

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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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
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.
Measured: 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
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.
Measured: 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
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.
Measured: Before vaccination to 1 month after vaccination with BNT162b2

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

20 May 20218 Dec 2021

First posted14 May 2021
Study start20 May 2021
Primary completion8 Dec 2021
Study completion8 Dec 2021

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
Publications (1)Papers the sponsor has linked to this study.
Other trials for Pneumococcal DiseaseStudies of the same condition, open and under way.
More trials run by PfizerThe sponsor's other registered studies.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Interventional
Phase: Phase 3
Primary purpose: Prevention
Allocation: Randomised
Intervention model: Parallel groups
Masking: Triple blind
Who is masked: Participant, Investigator, Outcomes assessor
Enrolment: 570 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT04887948
Sponsor's protocol ID: B7471026
Status last verified: Nov 2022
First submitted: 10 May 2021
Last updated: 14 Dec 2022
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: Yes
FDA-regulated drug: Yes
FDA-regulated device: No
Individual data sharing: Yes: 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.

Publications

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.
PubMed 37244809

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

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Study at a glance

From the registry record, last updated by the sponsor on 14 Dec 2022. Recruitment status is as the sponsor reported it: confirm with the study team.

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
ClinicalTrials.gov ID: NCT04887948
Acronym / sponsor ID: B7471026
Conditions: Pneumococcal Disease, COVID-19, SARS-CoV-2 Infection
Phase: Phase 3
Study type: Interventional
Recruitment status: Completed
Enrolment: 570 participants (actual)
Lead sponsor: PfizerIndustry (pharma, biotech, devices)
Study start: 20 May 2021 (actual)
Primary completion: 8 Dec 2021 (actual)
Study completion: 8 Dec 2021 (actual)
First posted: 14 May 2021 (actual)
Results: Posted 14 Dec 2022

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

Study of the safety and immunogenicity of 20vPnC and a booster dose of BNT162b2 administered at the same visit or each vaccine given alone

Study design

Primary purpose: Prevention
Allocation: Randomised
Intervention model: Parallel groups
Masking: Triple blind (participant, investigator, outcomes assessor)
Number of arms: 3

Arm	Type	Receives
Coadministration Group	Experimental	Biological: 20-valent pneumococcal conjugate vaccine (20vPnC), Biological: BNT162b2Participants receive an injection of pneumococcal vaccine (20vPnC) and of COVID-19 vaccine (BNT162b2) at the same visit.
20vPnC-only Group	Active comparator	Biological: 20-valent pneumococcal conjugate vaccine (20vPnC), Other: SalineParticipants receive an injection of pneumococcal vaccine (20vPnC) and of saline at the same visit.
BNT162b2-only Group	Active comparator	Biological: BNT162b2, Other: SalineParticipants receive an injection of COVID-19 vaccine (BNT162b2) and of saline at the same visit.

Who may qualify

Ages: 65 years and older
Sex: All
Healthy volunteers: Accepted
Age groups: Older adult

Key inclusion criteria (4 listed)

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

Key exclusion criteria (6 listed)

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

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
20-valent pneumococcal conjugate vaccine (20vPnC)20-valent pneumococcal conjugate vaccine (20vPnC)	Biological	20vPnC-only Group, Coadministration Group
BNT162b2RNA-based SARS-CoV-2 vaccine (BNT162b2)	Biological	BNT162b2-only Group, Coadministration Group
SalineNormal saline for injection	Other	20vPnC-only Group, BNT162b2-only Group

Primary outcome

Percentage of Participants With Local Reactions at Each Injection Site Within 10 Days After Vaccination
Time frame: 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
Time frame: 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
Time frame: From day of vaccination (Day 1) up to 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
Time frame: From day of vaccination (Day 1) up to 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.

3 secondary outcomes

Geometric Mean Titers (GMTs) of Pneumococcal Serotype-Specific Opsonophagocytic Activity (OPA) at 1 Month After Vaccination With 20vPnC
Time frame: 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
Time frame: 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
Time frame: Before vaccination to 1 month after vaccination with BNT162b2

Results and safety

Results posted to the registry on 14 Dec 2022, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
Coadministration Group: 20vPnC+BNT162b2	190	184
20vPnC Only Group: 20vPnC+Saline	191	177
BNT162b2 Only Group: BNT162b2+Saline	189	182

Primary outcome: Percentage of Participants With Local Reactions at Each Injection Site Within 10 Days After Vaccination

Time frame: Within 10 days after vaccination. Number (95% Confidence Interval). Unit: Percentage of participants

Measure	Coadministration Group (20vPnC+BNT162b2): 20vPnC Vaccination Site n = 185	Coadministration Group (20vPnC+BNT162b2): BNT162b2 Vaccination Site n = 185	20vPnC Only Group (20vPnC+Saline): 20vPnC Vaccination Site n = 186	20vPnC Only Group (20vPnC+Saline): Saline Vaccination Site n = 186	BNT162b2 Only Group (BNT162b2+Saline): BNT162b2 Vaccination Site n = 185	BNT162b2 Only Group (BNT162b2+Saline): Saline Vaccination Site n = 185
Redness: Any	8.6 (5.0 to 13.7)	9.7 (5.9 to 14.9)	8.1 (4.6 to 13.0)	0.0 (0.0 to 2.0)	9.7 (5.9 to 14.9)	2.7 (0.9 to 6.2)
Redness: Mild	5.9 (3.0 to 10.4)	5.9 (3.0 to 10.4)	4.3 (1.9 to 8.3)	0.0 (0.0 to 2.0)	6.5 (3.4 to 11.1)	2.2 (0.6 to 5.4)
Redness: Moderate	2.7 (0.9 to 6.2)	3.2 (1.2 to 6.9)	3.2 (1.2 to 6.9)	0.0 (0.0 to 2.0)	2.7 (0.9 to 6.2)	0.5 (0.0 to 3.0)
Redness: Severe	0.0 (0.0 to 2.0)	0.5 (0.0 to 3.0)	0.5 (0.0 to 3.0)	0.0 (0.0 to 2.0)	0.5 (0.0 to 3.0)	0.0 (0.0 to 2.0)
Swelling: Any	8.1 (4.6 to 13.0)	9.7 (5.9 to 14.9)	8.6 (5.0 to 13.6)	0.0 (0.0 to 2.0)	11.4 (7.2 to 16.8)	1.1 (0.1 to 3.9)
Swelling: Mild	5.4 (2.6 to 9.7)	5.9 (3.0 to 10.4)	5.4 (2.6 to 9.7)	0.0 (0.0 to 2.0)	6.5 (3.4 to 11.1)	0.0 (0.0 to 2.0)
Swelling: Moderate	2.7 (0.9 to 6.2)	3.8 (1.5 to 7.6)	3.2 (1.2 to 6.9)	0.0 (0.0 to 2.0)	4.9 (2.2 to 9.0)	1.1 (0.1 to 3.9)
Swelling: Severe	0.0 (0.0 to 2.0)	0.0 (0.0 to 2.0)	0.0 (0.0 to 2.0)	0.0 (0.0 to 2.0)	0.0 (0.0 to 2.0)	0.0 (0.0 to 2.0)

Population analysed: Safety population included all participants who received at least 1 dose of the study intervention and had safety follow-up after vaccination. Here, "Overall Number of Participants Analyzed" signifies number of participants with any e-diary data reported after vaccination.

Primary outcome: Percentage of Participants With Systemic Events Within 7 Days After Vaccination

Time frame: Within 7 days after vaccination. Number (95% Confidence Interval). Unit: Percentage of participants

Measure	Coadministration Group: 20vPnC+BNT162b2 n = 185	20vPnC Only Group: 20vPnC+Saline n = 186	BNT162b2 Only Group: BNT162b2+Saline n = 185
Fever: >=38.0 degree C	13.0 (8.5 to 18.7)	1.1 (0.1 to 3.8)	8.6 (5.0 to 13.7)
Fever: >=38.0 degree C to 38.4 degree C	7.0 (3.8 to 11.7)	0.5 (0.0 to 3.0)	2.7 (0.9 to 6.2)
Fever: >38.4 degree C to 38.9 degree C	5.4 (2.6 to 9.7)	0.5 (0.0 to 3.0)	4.9 (2.2 to 9.0)
Fever: >38.9 degree C to 40.0 degree C	0.5 (0.0 to 3.0)	0.0 (0.0 to 2.0)	1.1 (0.1 to 3.9)
Fever: >40.0 degree C	0.0 (0.0 to 2.0)	0.0 (0.0 to 2.0)	0.0 (0.0 to 2.0)
Fatigue: Any	54.1 (46.6 to 61.4)	36.0 (29.1 to 43.4)	54.6 (47.1 to 61.9)
Fatigue: Mild	17.8 (12.6 to 24.1)	23.7 (17.7 to 30.4)	27.0 (20.8 to 34.0)
Fatigue: Moderate	33.0 (26.3 to 40.3)	12.4 (8.0 to 18.0)	24.9 (18.8 to 31.7)

Population analysed: Safety population included all participants who received at least 1 dose of the study intervention and had safety follow-up after vaccination. Here, "Overall Number of Participants Analyzed" (N) signifies number of participants with any e-diary data reported after vaccination.

Primary outcome: Percentage of Participants With Adverse Events (AEs) Within 1 Month After Vaccination

Time frame: From day of vaccination (Day 1) up to 1 month after vaccination. Number (95% Confidence Interval). Unit: Percentage of participants

Measure	Coadministration Group: 20vPnC+BNT162b2 n = 187	20vPnC Only Group: 20vPnC+Saline n = 187	BNT162b2 Only Group: BNT162b2+Saline n = 185
Value	5.3 (2.6 to 9.6)	4.3 (1.9 to 8.3)	6.5 (3.4 to 11.1)

Population analysed: Safety population included all participants who received at least 1 dose of the study intervention and had safety follow-up after vaccination.

Primary outcome: Percentage of Participants With Serious Adverse Events (SAEs) Within 6 Months After Vaccination

Time frame: From day of vaccination (Day 1) up to 6 months after vaccination. Number (95% Confidence Interval). Unit: Percentage of participants

Measure	Coadministration Group: 20vPnC+BNT162b2 n = 187	20vPnC Only Group: 20vPnC+Saline n = 187	BNT162b2 Only Group: BNT162b2+Saline n = 185
Value	0.5 (0.0 to 2.9)	1.1 (0.1 to 3.8)	2.7 (0.9 to 6.2)

Population analysed: Safety population included all participants who received at least 1 dose of the study intervention and had safety follow-up after vaccination.

3 secondary outcomes are reported in the full results.

Adverse events

Time frame: Systematic assessment: local reactions recorded within 10 days after vaccination, and systemic events recorded within 7 days after vaccination; Non-systematic assessment: SAEs recorded from day of vaccination (Day 1) up to 6 months after vaccination and other AEs recorded from Day 1 up to 1 month after vaccination. Other adverse events reported at 1% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
Coadministration Group: 20vPnC+BNT162b2	1 of 187 (0.5%)	157 of 187 (84%)	1 of 187
20vPnC Only Group: 20vPnC+Saline	2 of 187 (1.1%)	137 of 187 (73.3%)	0 of 187
BNT162b2 Only Group: BNT162b2+Saline	5 of 185 (2.7%)	149 of 185 (80.5%)	0 of 185

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Research links

Official record on ClinicalTrials.govLast updated by the sponsor 14 Dec 2022.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Derived from this study: PubMed 37244809Fitz-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.
To obtain contact information for a study center near you, click here.Link provided by the sponsor.
Individual participant dataSharing planned: Yes. 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.

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Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

Pfizer CT.gov Call Center study director

Pfizer

27 sites in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing 20-valent pneumococcal conjugate vaccine (20vPnC), BNT162b2 and Saline in people with Pneumococcal Disease and COVID-19, run by Pfizer at 27 sites in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 4 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 14 Dec 2022. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 27 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Yes. Results are posted in the registry (first posted 14 Dec 2022). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Percentage of Participants With Local Reactions at Each Injection Site Within 10 Days After Vaccination (time frame: Within 10 days after vaccination). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT04887948, which also lists 1 linked publication.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 14 Dec 2022.