Vaccine Effectiveness of a 20-Valent Pneumococcal Conjugate Vaccine Against Vaccine-Type CAP Using a Testing-Negative Design
Study Details
Study Description
Brief Summary
This is a Phase 4, multicenter real-world effectiveness study conducted at investigator hospital sites in the United States. This study is a post-approval evaluation of the effectiveness of 20-valent pneumococcal conjugate vaccine (20vPnC) against vaccine-type (VT) radiologically-confirmed community-acquired pneumonia (RAD+CAP). The primary objective of the study is to determine vaccine effectiveness (VE) of 20vPnC against RAD+CAP caused by the 7 additional serotypes contained in 20vPnC beyond licensed 13-valent pneumococcal conjugate vaccine (13vPnC; serotypes 8, 10A, 11A, 12F, 15B, 22F, and 33F) plus 15C among adults ≥65 years of age.
| Condition or Disease | Intervention/Treatment | Phase |
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Detailed 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.
Study Design
Arms and Interventions
| Arm | Intervention/Treatment |
|---|---|
| Case Cases will be defined as participants hospitalized for RAD+CAP in whom the 7 additional serotypes in 20vPnC beyond 13vPnC plus 15C. |
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| 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. |
Outcome Measures
Primary Outcome Measures
- Vaccine effectiveness 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 Outcome Measures
- Vaccine effectiveness calculated as 1 minus the odds ratio for 20vPnC vaccination among cases and controls multiplied by 100 adjusted for potentially confounding variables. [55 months]
- The proportion of participants with RAD+CAP who are positive for any of the 7 additional serotypes contained in 20vPnC beyond 13vPnC plus 15C as detected by UAD-2 or culture. [55 months]
- The proportion of participants with RAD+CAP who are positive for any of the serotypes contained in 20vPnC plus 6C and 15C as detected by UAD-1, UAD-2, or culture [55 months]
- The proportion of participants with RAD+CAP who are positive for any of the serotypes contained in 13vPnC plus 6C as detected by either UAD-1 or culture. [55 months]
- Among those positive for a serotype detected by serotype-specific UAD, the proportion of participants with RAD+CAP who are positive for any of the UAD serotypes as detected by UAD-1, UAD-2, or culture. [55 months]
- The proportion of participants with RAD+CAP who have S. pneumoniae identified by culture, BinaxNOW®, or serotype-specific UADs. [55 months]
- Clinical characteristics of disease and hospitalization among those with any RAD+CAP due to all 13vPnC and/or 20vPnC serotypes plus 6C and 15C individually and aggregately. [55 months]
Eligibility Criteria
Criteria
Inclusion Criteria:
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Male or female participants ≥65 years of age.
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Hospitalized participant with physician clinical suspicion of CAP with the presence of ≥2 of the following 10 clinical signs or symptoms:
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fever (oral temperature >38.0°C/100.4°F or tympanic temperature >38.5°C/101.2°F),
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hypothermia (<35.5°C/95.9°F measured by a healthcare provider)
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chills or rigors,
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pleuritic chest pain,
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new or worsening cough,
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sputum production,
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dyspnea (shortness of breath),
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tachypnea (respiratory rate >20/min),
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malaise, or
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abnormal auscultatory findings suggestive of pneumonia (rales or evidence of pulmonary consolidation including dullness on percussion, bronchial breath sounds, or egophony).
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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).
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Capable of giving signed informed consent
Exclusion Criteria:
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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).
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Received any pneumococcal vaccine ≤30 days prior to enrollment.
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Unable to provide urine specimen (e.g. anuric).
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Previous enrollment in the study within the past 30 days.
Contacts and Locations
Locations
No locations specified.Sponsors and Collaborators
- Pfizer
Investigators
- Study Director: Pfizer CT.gov Call Center, Pfizer
Study Documents (Full-Text)
None provided.More Information
Additional Information:
Publications
None provided.- B7471015