Community-Acquired Pneumonia (CAP)NCT07251465
A Study to Learn How Effective is PCV20 to Help Stop Adults Who Have a Higher Chance of Getting Pneumonia
An observational study of Community-Acquired Pneumonia (CAP), run by Pfizer at 1 site in United States.
Trial summary
The purpose of this study is to learn how well PCV20 stops adults from getting community-acquired pneumonia. Pneumonia is an infection of the lungs that can be caused by germs like bacteria, virus, or fungi. This study uses existing healthcare information. No participants will be actively enrolled. Read more about this study
- Who is it for?
- Ages 19 years and older
- Conditions the study is for
- Community-Acquired Pneumonia (CAP)
- What is being tested?
- Receipt of PCV20
- Type of treatment
- Vaccines
- How many people
- 846,279 participants
- Where
- 1 siteUnited States
- Study dates
- 21 Jan 2026to 30 Sep 2026
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
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 19 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: The study will include a cohort of adults 19-64 years of age with at least one medical or behavioral risk factor associated with an increased risk of pneumococcal disease and a cohort of adults ≥65 years of age. Individuals who meet the eligibility criteria as of 01 July 2022 or who become eligible during the cohort identification period (01 July 2022 through 31 May 2025) will be included in the study. Individuals could contribute to both the 19-64 and ≥65 years of age cohorts if the individual met the inclusion and exclusion criteria for each respective cohort. Follow-up time will be classified by PCV20 exposure status. Within each cohort (19-64, ≥65 years), individuals can contribute one PCV20-unvaccinated time-segment, one PCV20-vaccinated time-segment, or both.
Who may be able to join
- 19-64 years of age cohort 1. Aged ≥19 at some point between July 1, 2022 and May 31, 2025 with 1-year continuous membership prior to July 1, 2022 2. At least 1 year of continuous enrollment as a KPSC member prior to the index date, allowing for 45-day administrative gaps 3. Age 19-64 years of age on the index date with ≥1 medical condition or risk factor identified during the 1-year continuous enrollment period prior to the index date 4. At least one outpatient visit prior to the index date
- 65 years cohort
- Aged ≥19 at some point between July 1, 2022 and May 31, 2025 with 1-year continuous membership prior to July 1, 2022
- ≥1 year of continuous enrollment as a KPSC member prior to the index date, allowing for 45-day administrative gaps
- Age ≥65 years on the index date
- At least one outpatient visit prior to the index date
Who cannot join
- 19-64 years of age cohort
- <!-- -->
- Received PCV20 prior to June 1, 2022, turning age 19 years, or meeting the medical condition or behavioral risk factor inclusion criteria
- Vaccinated index date is >30 days after the first PCV20 vaccination date or >1 dose of PCV20 is received <30 days prior to the index date
- Received PCV15 or PCV21 prior to the index date
- Received PPSV23 ≤2 years prior to the index date
Show all 15Show fewer
- Received PCV13 ≤5 years prior to the index date
- Outcome-related diagnosis code in the EHR <30 days prior to the index date
- 65 years cohort
- Received PCV20 prior to June 1, 2022 or prior to turning ≥65 years of age
- Vaccinated index date is >30 days after the first PCV20 vaccination date or >1 dose of PCV20 is received <30 days prior to the index date
- Received PCV15 or PCV21 prior to the index date
- Received PPSV23 ≤2 years prior to the index date
- Received PCV13 ≤5 years prior to the index date
- Outcome-related diagnosis code in the EHR <30 days prior to the index date
Trial locations and contacts
1 site in 1 country.
About this study
Official title: EFFECTIVENESS OF PNEUMOCOCCAL VACCINATION (PCV20) TO PREVENT ALL-CAUSE PNEUMONIA AND LOWER RESPIRATORY TRACT INFECTIONS AMONG ADULTS ≥19 YEARS OF AGE WITH AN INCREASED RISK OF PNEUMOCOCCAL DISEASE AT KAISER PERMANENTE SOUTHERN CALIFORNIA
The purpose of this study is to learn how well PCV20 stops adults from getting community-acquired pneumonia. Pneumonia is an infection of the lungs that can be caused by germs like bacteria, virus, or fungi. This study uses existing healthcare information. No participants will be actively enrolled. The information of participants will be taken from Kaiser Permanente Southern California's (KPSC) electronic health records (EHR).
We will look at the EHR information for adults who meet the following points:
Read more
- 19 years of age or older and a KPSC member between 01 July 2022 and 31 May 2025.
- have higher risk of pneumococcal disease due to older age or a chronic medical condition
- have been a KPSC member for the year before joining the study and for at least one year before 01 July 2022.
- have not received PCV15, PCV21, PPSV23 (2 years before), or PCV13 (5 years before) joining the study.
- have not received PCV20 before 01 June 2022.
- have not received PCV20 before turning 65 or before having a chronic medical condition which has higher risk of pneumococcal disease.
- have had at least one outpatient visit.
- have not had pneumonia or lower respiratory tract infection within 30 days of joining the study.
The study will begin on 01 July 2022 and end on 30 June 2025. At the end of the follow-up period, the study will compare the number of community-acquired pneumonia cases among people who did and did not receive PCV20.
- Conditions
- Community-Acquired Pneumonia (CAP)
- Being tested
- Receipt of PCV20
- Keywords
- Respiratory tract infections, Vaccines
- Medical subject headings
- Community-Acquired Pneumonia, Respiratory Tract Infections
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Receipt of PCV20Biological
The main exposure of interest will be receipt of PCV20.
| Study group | Role | What they receive |
|---|---|---|
| Adults ≥19-64 years old with medical conditions and behavioral risk factors | For the 19-64 years of age cohort, the unvaccinated index date is the earliest day during the cohort identification period when the individual is 19-64 years of age, has ≥1 year of prior continuous enrollment, and has a medical or behavioral risk factor during the prior 1-year continuous enrollment period. The vaccinated index is the day during the cohort identification period that is 30 days after PCV20 vaccination received when the individual has ≥1 year of prior continuous enrollment, is 19-64 years of age, and has a risk factor identified during the prior 1-year continuous enrollment period. Receives: Biological: Receipt of PCV20 | |
| Adults ≥65 years old | For the ≥65 years of age cohort, the unvaccinated index date is the earliest day between 01 July 2022 and 31 May 2025 (cohort identification period) when the individual is ≥65 years of age and has ≥1 year of prior continuous enrollment. The vaccinated index date is the date during the cohort identification period that is 30 days after PCV20 vaccination received when the individual is ≥65 years of age and has ≥1 year of prior continuous enrollment. Receives: Biological: Receipt of PCV20 |
What is being measured
The primary outcome is the main question the study is designed to answer.
PCV20 vaccine effectiveness (VE) against all-cause pneumonia (ACP) separately among both adults 19-64 years of age with medical conditions and behavioral risk factors and among adults ≥65 years of age
PCV20 VE against ACP calculated as (1-aHR) × 100% separately among adults aged 19-64 years with medical conditions or behavioral risk factors and among adults ≥65 years of age
Measured: 3 years
Secondary outcomes (2)
Incidence rates calculated separately among adults 19-64 years of age with medical conditions or behavioral risk factors and among adults ≥65 years of age
Unweighted and unadjusted incidence rates will be calculated as the number of ACP episodes per 100,000 person-years overall and separately for PCV20-vaccinated and unvaccinated time-segments. Incidence rates will be calculated separately among adults 19-64 years of age with medical conditions or behavioral risk factors and among adults ≥65 years of age
Measured: 3 years
Absolute rate reduction of ACP associated with PCV20 vaccination calculated separately among adults 19-64 years of age with medical conditions or behavioral risk factors and among adults ≥65 years of age
Absolute rate reduction of ACP associated with PCV20 vaccination will be calculated using the weighted VE estimate from the Cox proportional hazards model along with the non-model based unadjusted incidence rate (IR) during PCV20-vaccinated follow-up time. Absolute rate reduction will be calculated separately among adults 19-64 years of age with medical conditions or behavioral risk factors and among adults ≥65 years of age.
Measured: 3 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Nov 2025
- Study start21 Jan 2026
- Primary completion30 Sep 2026 (estimated)
- Study completion30 Sep 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Community-Acquired Pneumonia (CAP)Studies 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
- Observational
- Observational model
- Cohort
- Time perspective
- Retrospective
- Enrolment
- 846,279 participants (actual)
Sponsor and investigators
- Lead sponsor
- Pfizer
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Kaiser Permanente
- Responsible party
- Sponsor
- Investigators
- Pfizer CT.gov Call Center, Study director, Pfizer
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07251465
- Sponsor's protocol ID
- B7471041
- Status last verified
- Aug 2026
- First submitted
- 20 Aug 2025
- Last updated
- 25 Aug 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 25 Aug 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- EFFECTIVENESS OF PNEUMOCOCCAL VACCINATION (PCV20) TO PREVENT ALL-CAUSE PNEUMONIA AND LOWER RESPIRATORY TRACT INFECTIONS AMONG ADULTS ≥19 YEARS OF AGE WITH AN INCREASED RISK OF PNEUMOCOCCAL DISEASE AT KAISER PERMANENTE SOUTHERN CALIFORNIA
- ClinicalTrials.gov ID
- NCT07251465
- Acronym / sponsor ID
- B7471041
- Conditions
- Community-Acquired Pneumonia (CAP)
- Keywords
- Respiratory tract infections, Vaccines
- Study type
- Observational
- Recruitment status
- Active, not recruiting
- Enrolment
- 846,279 participants (actual)
- Lead sponsor
- PfizerIndustry (pharma, biotech, devices)
- Collaborators
- Kaiser Permanente
- Study start
- 21 Jan 2026 (actual)
- Primary completion
- 30 Sep 2026 (estimated)
- Study completion
- 30 Sep 2026 (estimated)
- First posted
- 26 Nov 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The purpose of this study is to learn how well PCV20 stops adults from getting community-acquired pneumonia. Pneumonia is an infection of the lungs that can be caused by germs like bacteria, virus, or fungi. This study uses existing healthcare information. No participants will be actively enrolled. The information of participants will be taken from Kaiser Permanente Southern California's (KPSC) electronic health records (EHR).
We will look at the EHR information for adults who meet the following points:
- 19 years of age or older and a KPSC member between 01 July 2022 and 31 May 2025.
- have higher risk of pneumococcal disease due to older age or a chronic medical condition
- have been a KPSC member for the year before joining the study and for at least one year before 01 July 2022.
- have not received PCV15, PCV21, PPSV23 (2 years before), or PCV13 (5 years before) joining the study.
- have not received PCV20 before 01 June 2022.
- have not received PCV20 before turning 65 or before having a chronic medical condition which has higher risk of pneumococcal disease.
- have had at least one outpatient visit.
- have not had pneumonia or lower respiratory tract infection within 30 days of joining the study.
The study will begin on 01 July 2022 and end on 30 June 2025. At the end of the follow-up period, the study will compare the number of community-acquired pneumonia cases among people who did and did not receive PCV20.
Study design
- Observational model
- Cohort
- Time perspective
- Retrospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Adults ≥19-64 years old with medical conditions and behavioral risk factors | – | Biological: Receipt of PCV20For the 19-64 years of age cohort, the unvaccinated index date is the earliest day during the cohort identification period when the individual is 19-64 years of age, has ≥1 year of prior continuous enrollment, and has a medical or behavioral risk factor during the prior 1-year continuous enrollment period. The vaccinated index is the day during the cohort identification period that is 30 days after PCV20 vaccination received when the individual has ≥1 year of prior continuous enrollment, is 19-64 years of age, and has a risk factor identified during the prior 1-year continuous enrollment period. |
| Adults ≥65 years old | – | Biological: Receipt of PCV20For the ≥65 years of age cohort, the unvaccinated index date is the earliest day between 01 July 2022 and 31 May 2025 (cohort identification period) when the individual is ≥65 years of age and has ≥1 year of prior continuous enrollment. The vaccinated index date is the date during the cohort identification period that is 30 days after PCV20 vaccination received when the individual is ≥65 years of age and has ≥1 year of prior continuous enrollment. |
Who may qualify
- Ages
- 19 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- The study will include a cohort of adults 19-64 years of age with at least one medical or behavioral risk factor associated with an increased risk of pneumococcal disease and a cohort of adults ≥65 years of age. Individuals who meet the eligibility criteria as of 01 July 2022 or who become eligible during the cohort identification period (01 July 2022 through 31 May 2025) will be included in the study. Individuals could contribute to both the 19-64 and ≥65 years of age cohorts if the individual met the inclusion and exclusion criteria for each respective cohort. Follow-up time will be classified by PCV20 exposure status. Within each cohort (19-64, ≥65 years), individuals can contribute one PCV20-unvaccinated time-segment, one PCV20-vaccinated time-segment, or both.
Key inclusion criteria (6 listed)
- 19-64 years of age cohort 1. Aged ≥19 at some point between July 1, 2022 and May 31, 2025 with 1-year continuous membership prior to July 1, 2022 2. At least 1 year of continuous enrollment as a KPSC member prior to the index date, allowing for 45-day administrative gaps 3. Age 19-64 years of age on the index date with ≥1 medical condition or risk factor identified during the 1-year continuous enrollment period prior to the index date 4. At least one outpatient visit prior to the index date
- 65 years cohort
Key exclusion criteria (15 listed)
- 19-64 years of age cohort
- <!-- -->
- 65 years cohort
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 |
|---|---|---|
| Receipt of PCV20The main exposure of interest will be receipt of PCV20. | Biological | Adults ≥19-64 years old with medical conditions and behavioral risk factors, Adults ≥65 years old |
Primary outcome
PCV20 vaccine effectiveness (VE) against all-cause pneumonia (ACP) separately among both adults 19-64 years of age with medical conditions and behavioral risk factors and among adults ≥65 years of age
Time frame: 3 years
PCV20 VE against ACP calculated as (1-aHR) × 100% separately among adults aged 19-64 years with medical conditions or behavioral risk factors and among adults ≥65 years of age
2 secondary outcomes
Incidence rates calculated separately among adults 19-64 years of age with medical conditions or behavioral risk factors and among adults ≥65 years of age
Time frame: 3 years
Absolute rate reduction of ACP associated with PCV20 vaccination calculated separately among adults 19-64 years of age with medical conditions or behavioral risk factors and among adults ≥65 years of age
Time frame: 3 years
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 25 Aug 2026.
- To obtain contact information for a study center near you, click here.Link provided by the sponsor.
- Individual participant dataSharing planned: No
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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
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Community-Acquired Pneumonia (CAP), run by Pfizer at 1 site 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 6 inclusion and 15 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: under way, not looking for participants, as of the sponsor's last update on 25 Aug 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site 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.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
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?
PCV20 vaccine effectiveness (VE) against all-cause pneumonia (ACP) separately among both adults 19-64 years of age with medical conditions and behavioral risk factors and among adults ≥65 years of age (time frame: 3 years). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 25 Aug 2026.