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ORV 116E
ORV 116E is an oral rotavirus vaccine candidate designed to provide immunization against rotavirus infection.
ORV 116E is an oral rotavirus vaccine candidate designed to provide immunization against rotavirus infection. Used for Prevention of rotavirus gastroenteritis in infants and children.
At a glance
| Generic name | ORV 116E |
|---|---|
| Also known as | ROTAVAC |
| Sponsor | Bharat Biotech International Limited |
| Drug class | Live attenuated vaccine |
| Modality | Biologic |
| Therapeutic area | Immunology / Infectious Disease |
| Phase | Phase 3 |
Mechanism of action
ORV 116E is a live attenuated rotavirus vaccine developed by Bharat Biotech for oral administration. It aims to induce mucosal and systemic immune responses to protect against rotavirus gastroenteritis, particularly in infants and young children in resource-limited settings.
Approved indications
- Prevention of rotavirus gastroenteritis in infants and children
Common side effects
- Mild diarrhea
- Fever
- Irritability
Key clinical trials
Primary sources
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| Source | Used for |
|---|---|
| ClinicalTrials.gov | Trial enrolment, design, endpoints, results |