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

Pfizer

Status: Enrolling

Conditions: Pneumonia

Treatments: Diagnostic Test: Diagnostic test on urine samples

Study type: Observational

Funder types: Industry

Identifiers

NCT05452941

B7471015

2023-507293-40-00 (Registry Identifier)

Details and patient eligibility

About

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.

Full description

This is an observational test-negative design study in which all study participants are adults ≥65 years of age hospitalized with RAD+CAP at one of the study sites. The only protocol-specified study procedure is a non-invasive urine specimen collection for pneumococcal detection using BinaxNOW® S. pneumoniae and the serotype-specific urinary antigen detection (UAD) assays. Cases and controls will be differentiated by the presence of vaccine serotypes that are identified by any method, including Quellung reaction of pneumococcal isolates obtained from standard of care (SOC) cultures from blood or high-quality respiratory tract specimens, or serotype specific UAD assays performed on urine specimens. The serotype-specific UAD assays, termed UAD-1 and UAD-2, detect the 13 serotypes in 13vPnC (1, 3, 4, 5, 6A/C, 6B/D, 7F/A, 9V/A, 14, 18C/A/ B/ F, 19A, 19F, 23F) (UAD-1) and 11 additional serotypes (2, 8, 9N, 10A/39, 11A/D/F, 12F, 15B/C, 17F/A, 20A/B, 22F/A, 33F/A) (UAD-2). For the primary objective, cases will be defined as participants hospitalized for RAD+CAP in whom the 7 additional serotypes in 20vPnC beyond 13vPnC plus 15C are identified. 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.

Enrollment: 12,500 estimated patients

Sex: All

Ages: 65+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

1. Male or female participants ≥65 years of age.

2. 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).

3. 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).

4. Capable of giving signed informed consent

Exclusion criteria

1. 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).
2. Received any pneumococcal vaccine ≤30 days prior to enrollment.
3. Unable to provide urine specimen (e.g. anuric).
4. Previous enrollment in the study within the past 30 days.

Trial design

12,500 participants in 2 patient groups

Case

Description:

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

Treatment:

Diagnostic Test: Diagnostic test on urine samples

Control

Description:

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.

Treatment:

Diagnostic Test: Diagnostic test on urine samples