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Human rotavirus RIX4414 strain vaccine
Human rotavirus RIX4414 strain vaccine is a Live attenuated vaccine Biologic drug developed by Sanofi Pasteur, a Sanofi Company. It is currently in Phase 3 development for Prevention of rotavirus gastroenteritis in infants and young children. Also known as: Rotarix®.
This live attenuated rotavirus vaccine stimulates the immune system to produce antibodies and cellular immunity against rotavirus, preventing infection and severe gastroenteritis.
This live attenuated rotavirus vaccine stimulates the immune system to produce antibodies and cellular immunity against rotavirus, preventing infection and severe gastroenteritis. Used for Prevention of rotavirus gastroenteritis in infants and young children.
At a glance
| Generic name | Human rotavirus RIX4414 strain vaccine |
|---|---|
| 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
RIX4414 is an oral live attenuated vaccine containing a reassortant rotavirus derived from bovine and human rotavirus strains. Upon oral administration, the vaccine replicates in the intestinal epithelium, triggering both humoral (antibody) and cell-mediated immune responses. This generates protective immunity against wild-type rotavirus infection, particularly severe rotavirus gastroenteritis in infants and young children.
Approved indications
- Prevention of rotavirus gastroenteritis in infants and young children
Common side effects
- Diarrhea
- Vomiting
- Fever
- Irritability
Key clinical trials
- Human Challenge With Live-attenuated Rotavirus to Assess Next-generation Rotavirus Vaccines in Africa (PHASE2)
- Optimising Rotavirus Vaccine in Aboriginal Children (PHASE4)
- Immunogenicity and Safety of a Quadrivalent Meningococcal Conjugate Vaccine in Infants and Toddlers When Administered Concomitantly With Routine Pediatric Vaccines in the United Kingdom (PHASE3)
- Mixed Schedule Study of Live Oral Rotavirus Vaccines and Trivalent P2-VP8 Subunit Rotavirus Vaccine (PHASE2)
- Study of BBIL's ROTAVAC® and ROTAVAC 5CM Vaccines in Zambia (PHASE2, 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 RIX4414 strain vaccine CI brief — competitive landscape report
- Human rotavirus RIX4414 strain vaccine updates RSS · CI watch RSS
- Sanofi Pasteur, a Sanofi Company portfolio CI
Frequently asked questions about Human rotavirus RIX4414 strain vaccine
What is Human rotavirus RIX4414 strain vaccine?
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What is Human rotavirus RIX4414 strain vaccine used for?
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Is Human rotavirus RIX4414 strain vaccine also known as anything else?
What drug class is Human rotavirus RIX4414 strain vaccine in?
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Related
- Drug class: All Live attenuated vaccine drugs
- Manufacturer: Sanofi Pasteur, a Sanofi Company — full pipeline
- Therapeutic area: All drugs in Immunology / Infectious Disease
- Indication: Drugs for Prevention of rotavirus gastroenteritis in infants and young children
- Also known as: Rotarix®