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Rotarix TM
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 TM |
|---|---|
| Sponsor | GlaxoSmithKline |
| Drug class | Live attenuated vaccine |
| Target | Rotavirus (RIX4414 strain) |
| Modality | Biologic |
| Therapeutic area | Immunology / Infectious Disease |
| Phase | FDA-approved |
Mechanism of action
Rotarix contains a single strain of live attenuated human rotavirus (RIX4414) 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
Key clinical trials
- Effectiveness Study of GSK Biologicals' Rotarix TM Vaccine in Hospitalized Children
- Immunogenicity and Safety Study of Rotarix TM in Taiwanese Infants Who Received Hepatitis B Immunoglobulin After Birth. (PHASE4)
- Primary Vaccination Study With a Pneumococcal Conjugate Vaccine in Healthy Children 6-12wks of Age (PHASE3)
- The Influence of the Microbiome on Rotavirus Vaccine Immunogenic Response in Infants in Karachi, Pakistan
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 TM CI brief — competitive landscape report
- Rotarix TM updates RSS · CI watch RSS
- GlaxoSmithKline portfolio CI