The purpose of this research is to evaluate the reactogenicity, safety and the humoral immune responses of investigational Flu Seasonal/SARS-CoV-2 mRNA vaccine in comparison to co-administered licensed seasonal Flu and mRNA COVID-19 vaccines and individual investigational Flu Seasonal mRNA and mRNA COVID-19 vaccines.
The main purpose of the study, called NAVIGATE (CD388.SQ.2.05), is to see if CD388 is well tolerated and safe in a large number of individuals. The study will also look for the dose of CD388 that may be most effective in preventing influenza infection that causes symptoms.
You are invited to take part in this clinical trial because currently, there is no approved vaccine for the prevention of acute gastroenteritis (AGE) caused by norovirus. Acute gastroenteritis, commonly known as the stomach flu or stomach bug, is characterized by symptoms such as nausea, vomiting, diarrhea, abdominal cramps, and sometimes fever. The purpose of this clinical trial is to evaluate an investigational vaccine to prevent AGE caused by a norovirus infection.
RSV is a germ that can cause cold-like symptoms. In severe cases, RSV can cause cough, runny nose, sore throat and breathing problems. RSV affects people of all ages but can be more serious in infants, older adults, and people whose bodies cannot easily fight the germs.
The ultimate plan for this study vaccine is to prevent disease caused by RSV in infants and toddlers. However, prior to testing in children, this study vaccine has to be tested in healthy adults. Results from this study will help determine whether this experimental vaccine is safe and well tolerated in healthy adults prior to testing in children.
The purpose of the study is to collect blood from individuals who receive a licensed pneumococcal conjugate vaccine (PCV20, for Part 1 of the study and PCV21 for Part 2 of the study), also known as Prevnar 20 and Capvaxive, respectively, for protection against invasive pneumococcal disease caused by a bacteria called Streptococcus pneumoniae (or S. pneumoniae). Receiving either PCV20 or PCV21 vaccine can help the body fight the infection by making defenses (called antibodies) against S. pneumoniae.
We are doing this research trial to find out more about an investigational vaccine called mRNA-1189 that is being tested to see if it gives protection from a virus called Epstein-Bar Virus, or EBV for short. EBV is a very common virus that is spread from person to person by close contact beginning in childhood. By age 24, about 90% of people will have already had an EBV infection, however most people show no symptoms. EBV is also the main cause of an illness called infectious mononucleosis (IM), or “mono” for short.
