PNEUMOCOCCAL POLYSACCHARIDE CONJUGATES (multiple serotypes conjugated to CRM197) (see product record for full list of serotypes) for Community-acquired pneumonia

Inclusion criteria

• {"criterion_text":"- Male or female participants ≥65 years of age.\n- 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).\n- 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).\n- Capable of giving signed informed consent as described in Appendix 1 of the Protocol, which includes compliance with the requirements and restrictions listed in the ICD and in this protocol."}

Exclusion criteria

• {"criterion_text":"- 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).\n- Received any pneumococcal vaccine ≤30 days prior to enrollment.\n- Unable to provide urine specimen (e.g. anuric).\n- Previous enrollment in the study within the past 30 days."}

Primary endpoints

• {"endpoint_text":"- VE calculated as 1 minus the OR for 20vPnC vaccination among cases and controls multiplied by 100 adjusted for potentially confounding variables.","definition_or_measurement_approach":"VE calculated as 1 minus the odds ratio (OR) for 20vPnC vaccination among cases and controls, multiplied by 100, adjusted for potentially confounding variables."}

Secondary endpoints

• {"endpoint_text":"- VE calculated as 1 minus the OR for 20vPnC vaccination among cases versus controls* multiplied by 100 adjusted for potentially confounding variables.\n- VE calculated as 1 minus the OR of 20vPnC vaccination among cases and controls multiplied by 100 adjusted for potentially confounding variables, using data from European/Israeli participants\n- Among participants with RAD+CAP: • VE by age group (i.e., 65–74 years, 75–84 years, and ≥85 years) • VE by sex (i.e., male vs female) • VE by ACIP-defined risk group and by age group\n- VE by prior influenza vaccination in past 12 months (ie, vaccinated vs. non-vaccinated); VE by co-administration of influenza vaccination\n- VE against 13vPnC serotypes, the 7 additional serotypes in 20vPnC beyond 13vPnC plus 15C and 20vPnC serotypes by previous vaccination with 13vPnC\n- VE against individual serotypes\n- VE against the 13 shared serotypes contained in 20vPnC and 13vPnC","definition_or_measurement_approach":"All secondary endpoints are vaccine effectiveness (VE) estimates calculated as 1 minus the OR for 20vPnC vaccination among cases vs controls multiplied by 100, adjusted for potentially confounding variables; some endpoints are subgroup analyses (European/Israeli participants, age groups, sex, ACIP risk groups, prior influenza vaccination, serotype-specific analyses)."}

Methods

• Screening of adults ≥65 years admitted for hospitalization at participating study hospitals with signs, symptoms, and radiologic evidence of community-acquired pneumonia (as described in the protocol).
• Use of recruitment materials and digital patient-facing resources (documents listed in CTIS: recruitment materials including landing page, video storyboard, participant brochure, and eConsent materials) and eConsent services.

Spain

Earliest CTIS Part Ii Submission Date

02-02-2024

Latest Decision Or Authorization Date

08-05-2026

Processing Time Days

826

Number Of Sites

15

Number Of Participants

4600

Primary sponsor

Full Name

Pfizer Inc.

Organisation Type

Pharmaceutical company

Country Of Registered Address

United States

Contract research organisations

Name

Iqvia Biotech LLC

Responsibilities

eConsent services

Name

Premier Research Group S.L.

Responsibilities

Dictionary coding

Name

Icon Public Limited Company

Responsibilities

Medical Imaging – Central Reader/Reading Services.

Name

Syneos Health Inc.

Responsibilities

Regulatory processing document; PCRO

Third parties

• {"country":"United States","full_name":"Thermo Fisher Scientific Inc.","duties_or_roles":"Clinical supplies","organisation_type":"Pharmaceutical company"}
• {"country":"Spain","full_name":"Premier Research Group S.L.","duties_or_roles":"Dictionary coding","organisation_type":"Pharmaceutical company"}
• {"country":"United States","full_name":"Baylor College Of Medicine","duties_or_roles":"Biospecimen testing","organisation_type":"Educational Institution"}
• {"country":"United States","full_name":"Iqvia Biotech LLC","duties_or_roles":"eConsent services","organisation_type":"Pharmaceutical company"}
• {"country":"Ireland","full_name":"Icon Public Limited Company","duties_or_roles":"Medical Imaging – Central Reader/Reading Services.","organisation_type":"Pharmaceutical company"}
• {"country":"United States","full_name":"Syneos Health Inc.","duties_or_roles":"Regulatory processing document; PCRO","organisation_type":"Pharmaceutical company"}