This is a study of CDC-9 inactivated rotavirus vaccine (IRV) for intramuscular administration (IM) in healthy adults aged 18 to 45 years at two dose levels in a 3-dose series. The purpose is to determine if it is safe and if the recipient's immune system responds to the vaccine.
Who can participate
Age range18 Years ā 45 Years
SexALL
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Inclusion criteria
ā. Provides written informed consent prior to any study procedures being performed.
ā. Be able to understand and agrees to comply with planned study procedures and be available for all study visits.
ā. Subject is between the ages of 18 - 45 years, inclusive, on the day of signing informed consent.
ā. Agrees to collection of venous blood per protocol.
ā. Body Mass Index 18.0 - 35.9 kg/mĀ² at the time of screening.
ā. Subject is in good health as determined by vital signs, medical history, and targeted physical examination, and the judgment of the investigator.
ā. Clinical screening laboratory evaluations (White blood cell (WBCs), hemoglobin (Hgb), platelets (plts), absolute neutrophil count (ANC), alanine transaminase (ALT), aspartate transaminase (AST), Alkaline Phosphatase (ALP), Total Bilirubin (T. Bili), and creatinine (Cr) are within acceptable normal reference ranges.
ā. Women of childbearing potentialĀ¹ must agree to use or have practiced true abstinenceĀ² or use at least one acceptable primary form of contraception.Ā³,ā“
Exclusion criteria
ā. Subject has an acute illness with fever (temperature \>100.4 Ā°F) within 72 hours prior to enrollment or \>3 looser-than-normal stools or any vomiting within 7 days prior to enrollment.
ā. Positive pregnancy test either at screening or just prior to each vaccine administration.
What they're measuring
1
Any unsolicited adverse events
Timeframe: Up to Day 29 following each vaccination or placebo
2
Any serious adverse events
Timeframe: Up to end of the study (Day 237)
3
Any solicited site reactions from vaccination
Timeframe: Up to Day 8 following vaccination or placebo
4
Any solicited systemic reactions from vaccination
Timeframe: Up to Day 8 following vaccination or placebo
5
Any new-onset medical conditions (NOMC)
Timeframe: Day 1 vaccination or placebo through end of the study (Day 237)
6
Any medically attended adverse events (MAAEs) from first vaccination until end of the study
Timeframe: From Day 1 vaccination or placebo through the end of the study (Day 237)
. Female subject who is breastfeeding or plans to breastfeed from the time of the first vaccination through 60 days after the last vaccination.
ā. Has any medical disease or condition that, in the opinion of the site PI or appropriate sub-investigator, precludes study participation.ā¶
ā. Presence of self-reported or medically documented significant medical or psychiatric condition(s) as determined by the investigator.
ā. Has a positive test result for hepatitis B surface antigen, hepatitis C virus antibody, or HIV types 1 or 2 antibodies at screening.
ā. Currently enrolled in or plans to participate in another clinical trial with an investigational agentā· that will be received during the study-reporting period.
ā. 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.