This study is a randomized, double-blinded, placebo-controlled, Phase 1, dose-escalation study to evaluate the safety, reactogenicity and immunogenicity of Inactivated Rotavirus Vaccine (IRV) performed in healthy adult (aged 18-49 years), adolescent (aged 6-17 years) and infant subjects (aged 2-71 months). Primary objectives of the clinical trial include assessing the safety and tolerability of IRV given at two and three dose levels and comparing the safety and tolerability of IRV after each vaccination, between dosage groups, and by pre-vaccination rotavirus immune status. Secondary objective of the clinical trial is immunogenicity evaluation after each vaccination, between dosage groups, and by pre-vaccination rotavirus immune status.
Age range
2 Months – 49 Years
Sex
ALL
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AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
Safety index-incidence of adverse reactions/events
Timeframe: 0-30 minutes after the first dose vaccination
Safety index-incidence of adverse reactions/events
Timeframe: 0-30 minutes after the second dose vaccination
Safety index-incidence of adverse reactions/events
Timeframe: 0-30 minutes after the third dose vaccination
Safety index-incidence of abnormal blood biochemistry assessment
Timeframe: Day 4 after the first dose vaccination
Safety index-incidence of abnormal blood routine assessment
Timeframe: Day 4 after the first dose vaccination
Safety index-incidence of abnormal urine routine assessment
Timeframe: Day 4 after the first dose vaccination
Safety index-incidence of abnormal blood biochemistry assessment
Timeframe: Day 4 after the second dose vaccination
Safety index-incidence of abnormal blood routine assessment
Timeframe: Day 4 after the second dose vaccination
Safety index-incidence of abnormal urine routine assessment
Timeframe: Day 4 after the second dose vaccination
Safety index-incidence of abnormal blood biochemistry assessment
Timeframe: Day 4 after the third dose vaccination
Safety index-incidence of abnormal blood routine assessment
Timeframe: Day 4 after the third dose vaccination
Safety index-incidence of abnormal urine routine assessment
Timeframe: Day 4 after the third dose vaccination
Safety index-incidence of adverse reactions/events
Timeframe: Day 0 to7 after the first dose vaccination
Safety index-incidence of adverse reactions/events
Timeframe: Day 8 to30 after the first dose vaccination
Safety index-incidence of adverse reactions/events
Timeframe: Day 0 to7 after the second dose vaccination
Safety index-incidence of adverse reactions/events
Timeframe: Day 8 to30 after the second dose vaccination
Safety index-incidence of adverse reactions/events
Timeframe: Day 0 to7 after the third dose vaccination
Safety index-incidence of adverse reactions/events
Timeframe: Day 8 to30 after the third dose vaccination
Safety index-incidence of serious adverse events
Timeframe: From the beginning of the vaccination to 6 months after the last vaccination completed