Imus

Researchers are evaluating the safety and immune response of a chikungunya virus virus-like particle (CHIKV VLP) vaccine in children aged 1 to under 12 years. This phase 3, global, randomized, double-blind, placebo-controlled study aims to compare the vaccine with a placebo to understand its effects in this young population. The study focuses on measuring the vaccine's ability to produce antibodies and monitoring safety events over an extended follow-up period. Participants will receive either the CHIKV VLP vaccine, which contains virus-like particles adsorbed on aluminum hydroxide adjuvant, or a placebo consisting of formulation buffer. The vaccination occurs on Day 1, followed by monitoring for adverse events up to Day 29 and immune response assessment on Day 22. The study is planned to continue safety monitoring through Day 732 for those who complete the trial. During the study, children will undergo medical history reviews, physical examinations, and regular safety assessments including recording of any adverse events. Researchers will collect blood samples to measure antibody responses on Day 22 and monitor for any serious or medically significant events throughout the trial. Participants are expected to attend all scheduled visits and comply with study procedures over the course of the study period.

Researchers are evaluating the immune response and safety of Sabin strain and wild strain inactivated poliovirus vaccines (sIPV and wIPV) given in different sequences and injection methods. This Phase IV clinical trial includes healthy infants aged 56 to 84 days and compares four vaccination regimens using either subcutaneous or intramuscular injections. The goal is to determine which method and sequence provide better immune protection against poliomyelitis. A total of 480 infants will be randomly assigned to one of four groups, each receiving three doses of vaccine spaced 28 days apart, with a 14-day window. The groups differ in the combination and order of wIPV and sIPV doses. In each group, two-thirds of infants receive injections into the muscle, while one-third get subcutaneous injections. Mothers will also provide blood samples to test for infections to help identify any perinatal transmission risks. During the study, infants will be observed for immediate reactions after each vaccination. Parents will keep diary cards to record any adverse events for 28 days following each dose. Blood samples will be collected from infants before the first vaccine and about 28 days after the last dose to measure antibody levels against poliovirus types. Serious adverse events will be monitored throughout. The study aims to assess both vaccine safety and immune response over the vaccination period.