UMEM Research Studies

This study is a prospective TND aimed at determining VE of the 20vPnC in older adults in the US, with expansion to ex-US sites, including but not limited to Europe (e.g. Spain) and Israel, pending 20vPnC recommendations. This study is being conducted as a postmarketing requirement according to the FDA accelerated approval regulations. Upon expansion to Europe (e.g. Spain), this study will include data collection needed to fill the EMA PAM. Adults ≥65 years of age admitted for hospitalization at a study hospital with signs, symptoms, and radiologic evidence of CAP will be screened for enrollment eligibility.

 

Informed consent will be obtained from all eligible participants, their LAR, or next of kin as permitted by local laws and institutional regulations before any study data collection or procedures are performed. All participants will have a non-invasive urine specimen collected for pneumococcal detection by BinaxNOW® S. pneumoniae and vaccine serotype determination by serotype-specific UAD assays. All other clinical and medical data collection will be done through direct participant interview and review of medical records. Determining VE for 20vPnC will require access to documented vaccination history on all participants. Participants will be asked to provide vaccination history information as well as contact information for primary care physician(s), pharmacies where vaccination was provided, and health insurance providers so that site staff may obtain documented vaccination history data. State registries, if available, will also be explored as an additional source for documented vaccination history. Participants are expected to actively participate for up to 2 days if the interview and urine collection cannot be completed at a single visit on Day 1. Additional data will be collected at Day 30 including hospitalization details, inhospital death, final diagnosis at hospital discharge, and the accumulated vaccine history data. It is expected that the visit window for the Day 30 visit (i.e. up to Day 45) should be sufficient for sites to review the various sources providing vaccine history information. 

 

Approximately 12,500 adults ≥65 years of age will be enrolled at approximately 30 sites in the US, 10 sites in Europe (e.g. Spain), and 10 sites in Israel. Ex-US sites will be added to facilitate reaching enrollment targets more rapidly than can be achieved in the US alone.Sites will be evaluated for participation based on past experience with CAP studies, geographic location, and access to vaccination history data.