NCT05452941|RecruitingFDA Drug

A Study to Learn About How 20-Valent Pneumococcal Conjugate Vaccine Works in a Real-world Setting

A Phase 4 Study Using a Test-Negative Design to Evaluate the Effectiveness of a 20-valent Pneumococcal Conjugate Vaccine Against Vaccine-type Radiologically-confirmed Community-acquired Pneumonia in Adults >/= 65 Years of Age

Pfizer ClinicalTrials.gov

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2 other identifiers

B74710152023-507293-40-00

Study Type

observational

Target

12,500

Locations

3 countries

Sites

Timeline

RegisteredJul 2022

StartedOct 2022

CompletionJun 2027

Brief Summary

The purpose of this study is to learn about how well the 20-valent pneumococcal conjugate vaccine (20vPnC) works against radiologically-confirmed community-acquired pneumonia (RAD+CAP) due to the 7 new serotypes (types of a bacteria called Streptococcus pneumoniae that cause pneumonia) included in 20vPnC vaccine. This study is seeking participants who:

are male or female ≥65 years of age.
are hospitalized with physician suspicion of community acquired pneumonia (CAP).
have pneumonia confirmed with imaging like a chest x-ray Participants will be asked to provide demographic and medical history information, and to provide a urine sample that will be used to test for pneumonia caused by specific strains of a bacteria called Streptococcus pneumoniae. We will compare the proportion of participants who have pneumonia caused by specific strains of the bacteria Streptococcus pneumoniae and were previously vaccinated with 20vPnC with the proportion of participants who have pneumonia caused by something other than vaccine type Streptococcus pneumoniae and have been vaccinated with 20vPnC. Participants will actively take part in the study for about 1-2 days. Information on participant's illness and hospitalization details will be collected through day 30 of their hospitalization through medical chart review.

Trial Health

On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment

12,500

participants targeted

Target at P75+ for all trials

Timeline

13mo left

Started Oct 2022

Longer than P75 for all trials

Geographic Reach

3 countries

93 active sites

Status

recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

4.6 years study duration

Study Progress77%

Oct 2022Jun 2027

First Submitted

Initial submission to the registry

July 6, 2022

Completed

6 days until next milestone

First Posted

Study publicly available on registry

July 12, 2022

Completed

4 months until next milestone

Study Start

First participant enrolled

October 27, 2022

Completed

4.6 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 4, 2027

Expected

Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

June 4, 2027

Last Updated

April 17, 2026

Status Verified

April 1, 2026

Enrollment Period

4.6 years

First QC Date

July 6, 2022

Last Update Submit

April 14, 2026

Conditions

Pneumonia

Outcome Measures

Primary Outcomes (1)

Effectiveness of 20vPnC against all (invasive + non-invasive) RAD+CAP due to the 7 additional serotypes in 20vPnC beyond 13vPnC plus 15C
Vaccine effectiveness as calculated as 1 minus the odds ratio for 20vPnC vaccination among cases vs. controls multiplied by 100 adjusted for potentially confounding variables
55 months

Secondary Outcomes (18)

Effectiveness of 20vPnC against non-invasive RAD+CAP due to the 7 additional serotypes in 20vPnC beyond 13vPnC plus 15C
55 months
Effectiveness of 20vPnC against all RAD+CAP due to any 20vPnC serotype plus 6C and 15C
55 months
Effectiveness of 20vPnC against non-invasive RAD+CAP due to any 20vPnC serotype plus 6C and 15C
55 months
Proportion of participants with RAD+CAP due to the 7 additional serotypes in 20vPnC beyond 13vPnC plus 15C, individually and aggregately
55 months
The proportion of all RAD+CAP due to any 20vPnC serotype plus 6C and 15C, individually and aggregately
55 months
+13 more secondary outcomes

Study Arms (2)

Case

Cases will be defined as participants hospitalized for RAD+CAP in whom the 7 additional serotypes in 20vPnC beyond 13vPnC plus 15C are identified.

Diagnostic Test: Diagnostic test on urine samples

Control

All other participants who meet study inclusion criteria but for whom 20vPnC serotypes are not identified from any source and all other RAD+CAP of non-pneumococcal etiologies will serve as test-negative controls.

Diagnostic Test: Diagnostic test on urine samples

Interventions

Diagnostic test on urine samplesDIAGNOSTIC_TEST

Testing by BinaxNOW® S. pneumoniae and serotype-specific urine antigen detection (UAD) assays (UAD-1 and UAD-2).

CaseControl

Eligibility Criteria

Age65 Years+

Sexall

Healthy VolunteersNo

Age GroupsOlder Adult (65+)

Sampling MethodNon-Probability Sample

Study Population

Males and females ages 65 and older hospitalized for suspected community acquired pneumonia.

You may qualify if:

Male or female participants ≥65 years of age.
Hospitalized participant with physician clinical suspicion of CAP with the presence of ≥2 of the following 10 clinical signs or symptoms:
fever (oral temperature \>38.0°C/100.4°F or tympanic temperature \>38.5°C/101.2°F),
hypothermia (\<35.5°C/95.9°F measured by a healthcare provider)
chills or rigors,
pleuritic chest pain,
new or worsening cough,
sputum production,
dyspnea (shortness of breath),
tachypnea (respiratory rate \>20/min),
malaise, or
abnormal auscultatory findings suggestive of pneumonia (rales or evidence of pulmonary consolidation including dullness on percussion, bronchial breath sounds, or egophony).
Has a radiographic finding that is consistent with pneumonia (e.g., pleural effusion, increased pulmonary density due to infection, the presence of alveolar infiltrates \[multi-lobar, lobar, or segmental\] containing air bronchograms).
Capable of giving signed informed consent

You may not qualify if:

Any participant who develops signs and symptoms of pneumonia after being hospitalized for ≥48 hours (either at the study site, another transferring hospital, or a combination of these).
Received any pneumococcal vaccine ≤30 days prior to enrollment.
Unable to provide urine specimen (e.g. anuric).
Previous enrollment in the study within the past 30 days.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Pfizerlead

Study Sites (93)

Kaiser Permanete Baldwin Park

Baldwin Park, California, 91706, United States

RECRUITING

Kaiser Permanete Downey

Downey, California, 90241, United States

RECRUITING

El Centro Regional Medical Center

El Centro, California, 92243, United States

RECRUITING

Kaiser Permanente Fontana Medical Center

Fontana, California, 92335, United States

RECRUITING

University of California San Francisco - Fresno

Fresno, California, 93701, United States

RECRUITING

Kaiser Permanente

Los Angeles, California, 90027, United States

RECRUITING

Southern California Permanente Medical Group

Los Angeles, California, 90027, United States

RECRUITING

Kaiser Permanente West Los Angeles Medical Center

Los Angeles, California, 90034, United States

RECRUITING

Kaiser Permanente Vaccine Study Center

Oakland, California, 94612, United States

RECRUITING

Kaiser Permanente Oakland Medical Center

Oakland, California, 96411, United States

RECRUITING

Kaiser Permanente Ontario Medical Center

Ontario, California, 91761, United States

RECRUITING

Southern California Permanente Medical Group (SCPMG)

Pasadena, California, 91101, United States

RECRUITING

Kaiser Permanente Riverside Medical Center

Riverside, California, 92505, United States

RECRUITING

Kaiser Permanente Roseville Medical Center

Roseville, California, 95661, United States

RECRUITING

Kaiser Permanente South Sacramento Medical Center

Sacramento, California, 95823, United States

RECRUITING

Kaiser Permanente Sacramento Medical Center

Sacramento, California, 95825, United States

RECRUITING

Kaiser Permanente Zion Medical Center

San Diego, California, 92120, United States

RECRUITING

Kaiser Permanente San Diego Medical Center

San Diego, California, 92123, United States

RECRUITING

The Regents of the University of California

San Francisco, California, 94143, United States

RECRUITING

Kaiser Permanente San Jose Medical Center

San Jose, California, 95119, United States

RECRUITING

Kaiser Permanente Santa Clara Medical Center

Santa Clara, California, 95051, United States

RECRUITING

Kaiser Permanente South San Francisco Medical Center

South San Francisco, California, 94080, United States

RECRUITING

Kaiser Permanente Walnut Creek Medical Center

Walnut Creek, California, 94596, United States

RECRUITING

Hartford Hospital

Hartford, Connecticut, 06106, United States

ACTIVE NOT RECRUITING

Starling Physicians

Hartford, Connecticut, 06106, United States

ACTIVE NOT RECRUITING

MedStar Washington Hospital Center

Washington D.C., District of Columbia, 20010, United States

RECRUITING

Emory University Hospital Midtown

Atlanta, Georgia, 30308, United States

RECRUITING

Emory Children's Center - Vaccine Research Clinic (ECC-VRC)

Atlanta, Georgia, 30322, United States

RECRUITING

Emory University Hospital

Atlanta, Georgia, 30322, United States

RECRUITING

Norton Clark Hospital

Jeffersonville, Indiana, 47130, United States

RECRUITING

Norton Hospital