CDC-9 Inactivated Rotavirus Vaccine (IRV) Intramuscular (IM) Phase 1 Clinical Trial in Healthy Adults

Exclusion criteria

• . Subject has an acute illness with fever (temperature \>100.4 °F) within 72 hours prior to enrollment or \>3 looser-than-normal stools or any vomiting within 7 days prior to enrollment.
• . Positive pregnancy test either at screening or just prior to each vaccine administration.
• . Female subject who is breastfeeding or plans to breastfeed from the time of the first vaccination through 60 days after the last vaccination.
• . Has any medical disease or condition that, in the opinion of the site PI or appropriate sub-investigator, precludes study participation.⁶
• . Presence of self-reported or medically documented significant medical or psychiatric condition(s) as determined by the investigator.
• . Has a positive test result for hepatitis B surface antigen, hepatitis C virus antibody, or HIV types 1 or 2 antibodies at screening.
• . Currently enrolled in or plans to participate in another clinical trial with an investigational agent⁷ that will be received during the study-reporting period.
• . Has a history of hypersensitivity or severe allergic reaction (e.g., anaphylaxis, generalized urticaria, angioedema, other significant reaction) to any vaccine component or any previous licensed or unlicensed vaccines.