Bacoor

Researchers are evaluating molnupiravir, a study medicine designed to stop the COVID-19 virus from multiplying, to see if it can prevent severe illness from COVID-19 more effectively than a placebo. This Phase 3 randomized, placebo-controlled, double-blind study focuses on non-hospitalized adults at high risk of severe disease progression due to COVID-19. The study addresses the need for alternative treatments for people who cannot take certain COVID-19 medications due to availability or potential drug interactions. Participants will receive either molnupiravir or a placebo, both given orally as two 400 mg film-coated tablets every 12 hours for 5 days, totaling 10 doses. Some participants may also receive remdesivir as part of standard care if clinically appropriate and available. The study compares the effects of molnupiravir with placebo in preventing severe illness outcomes. Throughout the study, participants will be monitored for outcomes such as hospitalization, death, or medically attended visits related to COVID-19 up to 29 days. Safety is assessed by tracking adverse events for up to about 5 months and discontinuation of study treatment due to adverse events for about 5 days. The study involves laboratory tests, symptom assessments, and safety evaluations to understand molnupiravir's impact on disease progression and participant health.

Researchers are evaluating the safety, immune response, and effectiveness of the V181 dengue vaccine in healthy children aged 2 to 17 years. The study aims to show that V181 is safe, well tolerated, and reduces the frequency of dengue infections caused by any of the four dengue virus types, regardless of whether the child had previous exposure to dengue before vaccination. This is a phase 3, randomized, double-blind, placebo-controlled trial involving healthy participants within this age range. Participants will be randomly assigned to receive either a single 0.5 mL subcutaneous dose of the V181 vaccine or a placebo on Day 1. A subset of about 3,600 participants will be closely followed for immune response and safety for 28 days after vaccination. From this group, around 620 participants will be randomly selected to have their long-term immune response evaluated at selected times for up to 5 years after vaccination. Throughout the study, children will undergo medical history reviews and physical exams to confirm health status. Safety will be monitored by recording adverse events, including those requiring medical attention up to 6 months post-vaccination and serious events up to 5 years. The study also tracks injection site reactions and systemic side effects shortly after vaccination, and measures vaccine effectiveness by monitoring dengue infection rates up to 3 years after vaccination. Immune response tests will be done at planned intervals to assess how well the vaccine works over time.