Last reviewed · How we verify
Rotarix (RV1)
Rotarix is a live attenuated rotavirus vaccine that stimulates the immune system to produce antibodies and cellular immunity against rotavirus infection.
Rotarix is a live attenuated rotavirus vaccine that stimulates the immune system to produce antibodies and cellular immunity against rotavirus infection. Used for Prevention of rotavirus gastroenteritis in infants and young children.
At a glance
| Generic name | Rotarix (RV1) |
|---|---|
| Also known as | ROTARIX™ |
| Sponsor | Telethon Kids Institute |
| Drug class | Live attenuated vaccine |
| Target | Rotavirus VP4 and VP7 surface proteins |
| Modality | Small molecule |
| Therapeutic area | Immunology / Infectious Disease |
| Phase | FDA-approved |
Mechanism of action
Rotarix contains a single strain of live attenuated human rotavirus (RV1) that replicates in the intestinal tract, triggering both humoral and mucosal immune responses. This vaccination prevents severe rotavirus gastroenteritis by inducing protective antibodies and T-cell mediated immunity against the virus. The vaccine provides cross-protection against multiple rotavirus genotypes through immune memory.
Approved indications
- Prevention of rotavirus gastroenteritis in infants and young children
Common side effects
- Diarrhea
- Vomiting
- Fever
- Irritability
- Intussusception (rare)
Key clinical trials
- Effectiveness of Monovalent Rotavirus Vaccine (RV1)
- Optimising Rotavirus Vaccine in Aboriginal Children (PHASE4)
- Randomized, Controlled Single-blind Clinical Study to Assess Vaccine Interchangeability Between RV5 and RV1 Using Seven Combined Anti-rotavirus Prevention Programs (PHASE3)
- Potential Mechanisms for Intussusception After Rotavirus Vaccine-Pilot Study (PHASE4)
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:
- Rotarix (RV1) CI brief — competitive landscape report
- Rotarix (RV1) updates RSS · CI watch RSS
- Telethon Kids Institute portfolio CI