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Human Rotavirus, live attenuated
A live attenuated rotavirus vaccine that replicates in the intestinal tract to stimulate immune responses against rotavirus without causing severe disease.
A live attenuated rotavirus vaccine that replicates in the intestinal tract to stimulate immune responses against rotavirus without causing severe disease. Used for Prevention of rotavirus gastroenteritis in infants and young children.
At a glance
| Generic name | Human Rotavirus, live attenuated |
|---|---|
| Also known as | Rotarix™ |
| Sponsor | Sanofi Pasteur, a Sanofi Company |
| Drug class | Live attenuated vaccine |
| Modality | Biologic |
| Therapeutic area | Immunology / Infectious Disease |
| Phase | Phase 3 |
Mechanism of action
The vaccine contains weakened (attenuated) rotavirus strains that can replicate in the intestinal epithelium but have reduced virulence. This replication triggers both mucosal and systemic immune responses, including the production of neutralizing antibodies and cellular immunity against rotavirus antigens. The attenuated virus provides protection against wild-type rotavirus infection while minimizing the risk of vaccine-strain disease.
Approved indications
- Prevention of rotavirus gastroenteritis in infants and young children
Common side effects
- Diarrhea
- Vomiting
- Fever
- Irritability
- Loss of appetite
Key clinical trials
- A Study on the Immune Response and Safety of Inactivated Poliovirus Vaccine (IPV) When Co-administered With Human Rotavirus (HRV) Porcine Circovirus (PCV)-Free Vaccine in Healthy Chinese Infants (PHASE3)
- Study of DTwP-HepB-Hib-IPV (SHAN6™) Vaccine Administered Concomitantly With Routine Pediatric Vaccines to Healthy Infants and Toddlers in Thailand (PHASE3)
- Infant Malaria Vaccine Schedule Optimization (PHASE2)
- Human Challenge With Live-attenuated Rotavirus to Assess Next-generation Rotavirus Vaccines in Africa (PHASE2)
- Immunogenicity, Reactogenicity and Safety of GlaxoSmithKline (GSK) Biologicals' Rotarix Porcine Circovirus (PCV)-Free Liquid Compared to Rotarix Liquid Given in 2-doses in Healthy Chinese Infants Starting at Age 6-16 Weeks (PHASE3)
- Optimising Rotavirus Vaccine in Aboriginal Children (PHASE4)
- Efficacy and Safety of a Pentavalent Rotavirus Vaccine (BRV-PV) Against Severe Rotavirus Gastroenteritis in Niger (PHASE3)
- Safety Study of 2 Formulations of GSK's Human Rotavirus (HRV) Vaccine (444563), in Healthy Infants Starting at Age 6-12 Weeks (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:
- Human Rotavirus, live attenuated CI brief — competitive landscape report
- Human Rotavirus, live attenuated updates RSS · CI watch RSS
- Sanofi Pasteur, a Sanofi Company portfolio CI