Last reviewed · How we verify
ROTAVAC®
ROTAVAC is a live attenuated oral vaccine that protects against rotavirus infection.
ROTAVAC is a live attenuated oral vaccine that protects against rotavirus infection. Used for Prevention of severe rotavirus diarrhea and dehydration in infants and young children.
At a glance
| Generic name | ROTAVAC® |
|---|---|
| Sponsor | Centre for Infectious Disease Research in Zambia |
| Modality | Biologic |
| Therapeutic area | Infectious Diseases |
| Phase | Phase 3 |
Mechanism of action
ROTAVAC contains a weakened form of the rotavirus that causes the disease in humans. This weakened virus stimulates the body's immune system to produce antibodies that can fight off future infections. The vaccine is administered orally and provides protection against severe rotavirus diarrhea and dehydration.
Approved indications
- Prevention of severe rotavirus diarrhea and dehydration in infants and young children
Common side effects
- Gastrointestinal symptoms
Key clinical trials
- To Determine the Safety and Efficacy of Liquid ROTAVAC 5C Vaccine Against Childhood Diarrhea Caused by Rotavirus (PHASE3)
- Study of BBIL's ROTAVAC® and ROTAVAC 5CM Vaccines in Zambia (PHASE2, PHASE3)
- Evaluate Immunogenicity, Safety, and Reactogenicity of Rotavac in Healthy Infants in Vietnam (PHASE3)
- Evaluate Immunogenicity, Safety, and Reactogenicity of Rotavac® in Healthy Infants Aged Between 6-8 Weeks in Vietnam (PHASE3)
Primary sources
Every claim on this page is sourced from regulatory or scientific primary sources. See our editorial policy for full methodology.
| Source | Used for |
|---|---|
| ClinicalTrials.gov | Trial enrolment, design, endpoints, results |
Competitive intelligence
For the full competitive landscape — auto-detected comparators, recent regulatory actions across the set, upcoming PDUFA, patent timeline, sponsor landscape:
- ROTAVAC® CI brief — competitive landscape report
- ROTAVAC® updates RSS · CI watch RSS
- Centre for Infectious Disease Research in Zambia portfolio CI