Pneumococcal DiseasePhase 3NCT03835975

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 study testing 13vPnC, PPSV23 and 20vPnC in people with Pneumococcal Disease, run by Pfizer at 42 sites in 2 countries.

Completed

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

Official record

Search all trials

Trial 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 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
What is being tested?: 13vPnC, PPSV23 and 20vPnC
Type of treatment: Vaccines
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 875 participants
Where: 42 sitesin 2 countries
Study dates: 12 Feb 2019to 12 Feb 2020
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 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).

Who cannot join

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.

Trial locations and contacts

42 sites in 2 countries.

Country

City, postcode or hospital

42 sites in 2 countries

United States34 sites

MedPharmics, LLC
Albuquerque, New Mexico, 87102
Anaheim Clinical Trials, LLC
Anaheim, California, 92801
East Valley Gastroenterology and Hepatology Associates
Chandler, Arizona, 85224
CTI Clinical Research Center
Cincinnati, Ohio, 45212
Sterling Research Group, Ltd.
Cincinnati, Ohio, 45246
J. Lewis Research Inc. / Foothill Family Clinic Draper
Draper, Utah, 84020
Carolina Institute for Clinical Research
Fayetteville, North Carolina, 28304
Prestige Clinical Research
Franklin, Ohio, 45005
Medical Research South, LLC
Goose Creek, South Carolina, 29445
East-West Medical Research Institute
Honolulu, Hawaii, 96814
Ventavia Research Group
Keller, Texas, 76248
Optimal Research, LLC
Melbourne, Florida, 32934
MedPharmics, LLC
Metairie, Louisiana, 70006
Clinical Research Consulting, LLC
Milford, Connecticut, 06460
Coastal Clinical Research, Inc.
Mobile, Alabama, 36608
Meridian Clinical Research, LLC
Norfolk, Nebraska, 68701
Lynn Health Science Institute
Oklahoma City, Oklahoma, 73112
The Pain Center of Arizona
Peoria, Arizona, 85381
HOPE Research Institute
Phoenix, Arizona, 85018
The Pain Center of Arizona
Phoenix, Arizona, 85018
Kaiser Permanente Center For Health Research
Portland, Oregon, 97227
Columbia Research Group, Inc.
Portland, Oregon, 97239
Meridian Clinical Research, LLC
Rockville, Maryland, 20854
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
Meridian Clinical Research, LLC
Savannah, Georgia, 31406
Kaiser Permanente Washington Health Research Institute
Seattle, Washington, 98101
J. Lewis Research, Inc. / Jordan River Family Medicine
South Jordan, Utah, 84095
Clinical Research Atlanta
Stockbridge, Georgia, 30281
Synexus Clinical Research US, Inc
The Villages, Florida, 32162
Diablo Clinical Research, Inc.
Walnut Creek, California, 94598
Heartland Research Associates, LLC
Wichita, Kansas, 67205
Heartland Research Associates, LLC
Wichita, Kansas, 67207
PMG Research of Wilmington, LLC
Wilmington, North Carolina, 28401

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Sweden8 sites

Ladulaas Kliniska Studier
Borås, 50630
Infektionskliniken
Eskilstuna, 63188
CTC Gothia Forum
Gothenburg, 413 45
ProbarE i Lund
Lund, 22222
PharmaSite
Malmö, Skåne County, 21152
Avdelningen for Kliniska Provningar
Örebro, 703 62
Karolinska Trial Alliance, KTA Prim
Stockholm, 11361
Akardo Med Site
Stockholm, 11446

Other trials in Sweden

About this study

Official title: 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

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

Conditions: Pneumococcal Disease
Being tested: 13vPnC, PPSV23, 20vPnC
Medical subject headings: Pneumococcal Infections

What participants receive

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

13vPnCBiological
Pneumococcal conjugate vaccine
PPSV23Biological
Pneumococcal polysaccharide vaccine
20vPnCBiological
Pneumococcal conjugate vaccine

Study groups in NCT03835975
Study group	Role	What they receive
13vPnC	Active comparator	Pneumococcal conjugate vaccine Receives: Biological: 13vPnC
PPSV23	Active comparator	Pneumococcal polysaccharide vaccine Receives: Biological: PPSV23
20vPnC	Experimental	Pneumococcal conjugate vaccine Receives: Biological: 20vPnC

What is being measured

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

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).
Measured: 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).
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 1 month after vaccination

Secondary outcomes (3)

Pneumococcal OPA Geometric Mean Fold Rise (GMFR) From Before Vaccination to 1 Month After Vaccination
OPA GMFR is the ratio of OPA GMTs, 1 month after vaccination to before vaccination. OPA GMFRs from before to 1 month after vaccination were calculated for pneumococcal serotypes 1, 3, 4, 5, 6A, 6B, 7F, 9V, 14, 18C, 19A, 19F, 23F, 8, 10A, 11A, 12F, 15B, 22F and 33F.
Measured: 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
Percentage of participants with a >=4-fold rise in pneumococcal OPA titers from before vaccination to 1 month after vaccination were calculated for pneumococcal serotypes 1, 3, 4, 5, 6A, 6B, 7F, 9V, 14, 18C, 19A, 19F, 23F, 8, 10A, 11A, 12F, 15B, 22F and 33F.
Measured: 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
The percentage of participants with OPA titers >=LLOQ at 1 month after vaccination were calculated for pneumococcal serotypes 1, 3, 4, 5, 6A, 6B, 7F, 9V, 14, 18C, 19A, 19F, 23F, 8, 10A, 11A, 12F, 15B, 22F and 33F.
Measured: 1 month after vaccination

Timeline

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

12 Feb 201912 Feb 2020

First posted11 Feb 2019
Study start12 Feb 2019
Primary completion12 Feb 2020
Study completion12 Feb 2020

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: None (open label)
Enrolment: 875 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT03835975
Sponsor's protocol ID: B7471006
Other IDs: 2018-004278-91, 2018
Status last verified: Feb 2021
First submitted: 7 Feb 2019
Last updated: 21 Feb 2021
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

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.
PubMed 34839993

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 21 Feb 2021. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: 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
ClinicalTrials.gov ID: NCT03835975
Acronym / sponsor ID: B7471006
Conditions: Pneumococcal Disease
Phase: Phase 3
Study type: Interventional
Recruitment status: Completed
Enrolment: 875 participants (actual)
Lead sponsor: PfizerIndustry (pharma, biotech, devices)
Study start: 12 Feb 2019 (actual)
Primary completion: 12 Feb 2020 (actual)
Study completion: 12 Feb 2020 (actual)
First posted: 11 Feb 2019 (actual)
Results: Posted 21 Feb 2021

Clinical summary

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

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

Study design

Primary purpose: Prevention
Allocation: Randomised
Intervention model: Parallel groups
Masking: None (open label)
Number of arms: 3

Arm	Type	Receives
13vPnC	Active comparator	Biological: 13vPnCPneumococcal conjugate vaccine
PPSV23	Active comparator	Biological: PPSV23Pneumococcal polysaccharide vaccine
20vPnC	Experimental	Biological: 20vPnCPneumococcal conjugate vaccine

Who may qualify

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

Key inclusion criteria (7 listed)

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:

Key exclusion criteria (2 listed)

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.

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
13vPnCPneumococcal conjugate vaccine	Biological	13vPnC
PPSV23Pneumococcal polysaccharide vaccine	Biological	PPSV23
20vPnCPneumococcal conjugate vaccine	Biological	20vPnC

Primary outcome

Percentage of Participants With Local Reactions Within 10 Days After Vaccination
Time frame: 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).
Percentage of Participants With Systemic Events Within 7 Days After Vaccination
Time frame: 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).
Percentage of Participants With Adverse Events (AEs) Within 1 Month After Vaccination
Time frame: 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.
Percentage of Participants With Serious Adverse Events (SAEs) Within 6 Months After Vaccination
Time frame: 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.
Percentage of Participants With Newly Diagnosed Chronic Medical Conditions (NDCMCs) Within 6 Months After Vaccination
Time frame: 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.
Pneumococcal Opsonophagocytic Activity (OPA) Geometric Mean Titers (GMTs) at 1 Month After Vaccination
Time frame: 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.

3 secondary outcomes

Pneumococcal OPA Geometric Mean Fold Rise (GMFR) From Before Vaccination to 1 Month After Vaccination
Time frame: 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
Time frame: 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
Time frame: 1 month after vaccination

Results and safety

Results posted to the registry on 21 Feb 2021, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
Cohort A: 20vPnC	253	250
Cohort A: 13vPnC	122	119
Cohort B: 20vPnC	248	245
Cohort B: PPSV23	127	126
Cohort C: 20vPnC	125	125

Primary outcome: Percentage of Participants With Local Reactions Within 10 Days After Vaccination

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

Measure	Cohort A: 20vPnC n = 253	Cohort A: 13vPnC n = 121	Cohort B: 20vPnC n = 245	Cohort B: PPSV23 n = 126	Cohort C: 20vPnC n = 125
Redness: Any	7.9 (4.9 to 11.9)	2.5 (0.5 to 7.1)	8.6 (5.4 to 12.8)	12.7 (7.4 to 19.8)	4.8 (1.8 to 10.2)
Redness: Mild	3.6 (1.6 to 6.6)	1.7 (0.2 to 5.8)	2.9 (1.2 to 5.8)	4.8 (1.8 to 10.1)	1.6 (0.2 to 5.7)
Redness: Moderate	3.2 (1.4 to 6.1)	0.8 (0.0 to 4.5)	5.3 (2.9 to 8.9)	7.1 (3.3 to 13.1)	3.2 (0.9 to 8.0)
Redness: Severe	1.2 (0.2 to 3.4)	0 (0.0 to 3.0)	0.4 (0.0 to 2.3)	0.8 (0.0 to 4.3)	0 (0.0 to 2.9)
Swelling: Any	9.9 (6.5 to 14.2)	6.6 (2.9 to 12.6)	9.4 (6.0 to 13.8)	14.3 (8.7 to 21.6)	4.0 (1.3 to 9.1)
Swelling: Mild	5.1 (2.8 to 8.6)	6.6 (2.9 to 12.6)	5.7 (3.2 to 9.4)	6.3 (2.8 to 12.1)	1.6 (0.2 to 5.7)
Swelling: Moderate	3.6 (1.6 to 6.6)	0 (0.0 to 3.0)	3.7 (1.7 to 6.9)	7.1 (3.3 to 13.1)	2.4 (0.5 to 6.9)
Swelling: Severe	1.2 (0.2 to 3.4)	0 (0.0 to 3.0)	0 (0.0 to 1.5)	0.8 (0.0 to 4.3)	0 (0.0 to 2.9)

Population analysed: The safety population included participants who received 1 dose of 20vPnC, PPSV23, or 13vPnC and had safety follow-up after vaccination. Here, "Overall Number of Participants Analyzed" refers to number of participants with any e-diary data reported after vaccination in the safety population.

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	Cohort A: 20vPnC n = 253	Cohort A: 13vPnC n = 121	Cohort B: 20vPnC n = 245	Cohort B: PPSV23 n = 126	Cohort C: 20vPnC n = 125
Fever: >=38.0 degree C	0.8 (0.1 to 2.8)	0 (0.0 to 3.0)	0 (0.0 to 1.5)	1.6 (0.2 to 5.6)	0 (0.0 to 2.9)
Fever: >=38.0 degree C to 38.4 degree C	0.8 (0.1 to 2.8)	0 (0.0 to 3.0)	0 (0.0 to 1.5)	0.8 (0.0 to 4.3)	0 (0.0 to 2.9)
Fever: >38.4 degree C to 38.9 degree C	0 (0.0 to 1.4)	0 (0.0 to 3.0)	0 (0.0 to 1.5)	0.8 (0.0 to 4.3)	0 (0.0 to 2.9)
Fever: >38.9 degree C to 40.0 degree C	0 (0.0 to 1.4)	0 (0.0 to 3.0)	0 (0.0 to 1.5)	0 (0.0 to 2.9)	0 (0.0 to 2.9)
Fever: >40.0 degree C	0 (0.0 to 1.4)	0 (0.0 to 3.0)	0 (0.0 to 1.5)	0 (0.0 to 2.9)	0 (0.0 to 2.9)
Fatigue: Any	28.9 (23.4 to 34.9)	22.3 (15.2 to 30.8)	31.0 (25.3 to 37.2)	33.3 (25.2 to 42.3)	32.8 (24.7 to 41.8)
Fatigue: Mild	17.8 (13.3 to 23.1)	9.9 (5.2 to 16.7)	19.6 (14.8 to 25.1)	19.8 (13.3 to 27.9)	19.2 (12.7 to 27.2)
Fatigue: Moderate	11.1 (7.5 to 15.6)	9.9 (5.2 to 16.7)	10.2 (6.7 to 14.7)	13.5 (8.1 to 20.7)	12.0 (6.9 to 19.0)

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

Time frame: Within 1 month after vaccination. Number (95% Confidence Interval). Unit: percentage of participants

Measure	Cohort A: 20vPnC n = 253	Cohort A: 13vPnC n = 122	Cohort B: 20vPnC n = 246	Cohort B: PPSV23 n = 127	Cohort C: 20vPnC n = 125
Value	7.5 (4.6 to 11.5)	9.0 (4.6 to 15.6)	4.9 (2.5 to 8.4)	11.0 (6.2 to 17.8)	10.4 (5.7 to 17.1)

Population analysed: The safety population included participants who received 1 dose of 20vPnC, PPSV23, or 13vPnC and had safety follow-up after vaccination.

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

Time frame: Within 6 months after vaccination. Number (95% Confidence Interval). Unit: percentage of participants

Measure	Cohort A: 20vPnC n = 253	Cohort A: 13vPnC n = 122	Cohort B: 20vPnC n = 246	Cohort B: PPSV23 n = 127	Cohort C: 20vPnC n = 125
Value	0.8 (0.1 to 2.8)	1.6 (0.2 to 5.8)	2.4 (0.9 to 5.2)	1.6 (0.2 to 5.6)	1.6 (0.2 to 5.7)

Population analysed: The safety population included participants who received 1 dose of 20vPnC, PPSV23, or 13vPnC and had safety follow-up after vaccination.

3 secondary outcomes are reported in the full results.

Adverse events

Time frame: Other AEs: local reactions within 10 days after vaccination, systemic events: within 7 days after vaccination (systematic assessment), non serious AEs up to 1 month after Vaccination; SAEs: up to 6 months after vaccination. Other adverse events reported at 1% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
Cohort A: 20vPnC	2 of 253 (0.8%)	173 of 253 (68.4%)	0 of 253
Cohort A: 13vPnC	2 of 122 (1.6%)	69 of 122 (56.6%)	0 of 122
Cohort B: 20vPnC	6 of 246 (2.4%)	178 of 246 (72.4%)	0 of 246
Cohort B: PPSV23	2 of 127 (1.6%)	96 of 127 (75.6%)	0 of 127
Cohort C: 20vPnC	2 of 125 (1.6%)	86 of 125 (68.8%)	0 of 125

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 21 Feb 2021.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Derived from this study: PubMed 34839993Cannon 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.
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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RecruitingPhase 3
A Study to Learn About the Safety of an Expanded Pneumococcal Vaccine in Healthy Infants
Pneumococcal Disease
Active, not recruitingObservational study
A Study to Learn About the Safety of PREVENAR 20 Vaccine in Infants Aged Between Two to Six Months
Pneumococcal Disease
Active, not recruitingPhase 3
A Clinical Study to Evaluate the Safety, Tolerability, and Immunogenicity of VAX-31 With Influenza Vaccine in Adults ≥ 50 Years of Age
Pneumococcal Disease
Not yet recruiting
Impact of Multidisciplinary Care, Structured and Targeted on the COPD Patient's Clinical Pathway.
Chronic Obstructive Pulmonary Disease, Lung Diseases, Obstructive

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

42 sites in 2 countries: see every site and its status.

Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing 13vPnC, PPSV23 and 20vPnC in people with Pneumococcal Disease, run by Pfizer at 42 sites in 2 countries.

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 7 inclusion and 2 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 21 Feb 2021. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 42 sites in United States, Sweden. 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 21 Feb 2021). 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 Within 10 Days After Vaccination (time frame: Within 10 days after vaccination). The study lists 6 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 NCT03835975, 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 21 Feb 2021.