Efficacy, Safety, and Immunogenicity of the MATISSE (Maternal Immunization Study for Safety and Efficacy) Maternal Respiratory Syncytial Virus Prefusion F Protein Vaccine Trial.

Objective: To evaluate descriptive efficacy data, exploratory immunogenicity data, and safety follow-up through study completion from the global, phase 3 MATISSE (Maternal Immunization Study for Safety and Efficacy) maternal vaccination trial of bivalent respiratory syncytial virus (RSV) prefusion F protein vaccine (RSVpreF).

Methods: MATISSE was a phase 3, randomized, double-blinded, placebo-controlled trial. Healthy pregnant participants aged 49 years or younger at 24-36 weeks of gestation were randomized (1:1) to receive a single RSVpreF 120 micrograms or placebo dose.

Preterm Birth Frequency and Associated Outcomes From the MATISSE (Maternal Immunization Study for Safety and Efficacy) Maternal Trial of the Bivalent Respiratory Syncytial Virus Prefusion F Protein Vaccine.

Objective: To describe preterm birth frequency and newborn and infant outcomes overall and among preterm children in the MATISSE (Maternal Immunization Study for Safety and Efficacy) trial of maternal vaccination with bivalent respiratory syncytial virus (RSV) prefusion F protein-based vaccine (RSVpreF) to protect infants against severe RSV-associated illness.

Methods: MATISSE was a global, phase 3, randomized, double-blind trial. Pregnant individuals received single injections of RSVpreF or placebo.

Developing and Evaluating SEE-Diabetes: A Patient-Centered Educational Decision Support System for Diabetes Care.

Objectives: This feasibility study evaluated the effectiveness of Support-Engage-Empower-Diabetes (SEE-Diabetes), a patient-centered educational tool designed to promote shared decision-making of diabetes management in older adults. We aimed to assess SEE-Diabetes's ability to facilitate patient engagement and collaborative goal setting, as measured by the Observational Patient Involvement (OPTION) scale and Shared Decision-Making Questionnaire (SDM-Q-Doc). We hypothesized that these instruments would effectively differentiate between healthcare providers who actively leveraged SEE-Diabetes to guide patient-centric conversations and set goals compared to those who did not.

Ear disease, hearing loss, and cognitive outcomes in high school children who were previous participants in a randomized placebo controlled trial of an 11 valent conjugate pneumococcal vaccine administered in infancy.

Background: The WHO estimates that close to 1.7 billion people worldwide have hearing loss; 34 million of whom are children, with 90% residing in low- and middle-income countries. While the effects of ear disease and hearing loss on language, academic, and behavioral development are established, there is remarkably little data on intellectual and other cognitive differences.