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Live attenuated human rotavirus vaccine
Live attenuated human rotavirus vaccine is a Live attenuated vaccine Biologic drug developed by GlaxoSmithKline. It is currently in Phase 3 development for Prevention of rotavirus gastroenteritis in infants and young children.
A live attenuated rotavirus vaccine stimulates the immune system to produce antibodies and cellular immunity against rotavirus by introducing a weakened form of the virus.
A live attenuated rotavirus vaccine stimulates the immune system to produce antibodies and cellular immunity against rotavirus by introducing a weakened form of the virus. Used for Prevention of rotavirus gastroenteritis in infants and young children.
At a glance
| Generic name | Live attenuated human rotavirus vaccine |
|---|---|
| Sponsor | GlaxoSmithKline |
| Drug class | Live attenuated vaccine |
| Modality | Biologic |
| Therapeutic area | Immunology / Infectious Disease |
| Phase | Phase 3 |
Mechanism of action
The vaccine contains a live but weakened (attenuated) rotavirus strain that replicates in the intestinal tract without causing severe disease. This triggers both humoral (antibody) and cell-mediated immune responses, priming the immune system to recognize and neutralize wild-type rotavirus upon natural exposure. The attenuated virus is designed to be immunogenic while maintaining a safety profile suitable for infants.
Approved indications
- Prevention of rotavirus gastroenteritis in infants and young children
Common side effects
- Diarrhea
- Vomiting
- Fever
- Irritability
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:
- Live attenuated human rotavirus vaccine CI brief — competitive landscape report
- Live attenuated human rotavirus vaccine updates RSS · CI watch RSS
- GlaxoSmithKline portfolio CI
Frequently asked questions about Live attenuated human rotavirus vaccine
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Related
- Drug class: All Live attenuated vaccine drugs
- Manufacturer: GlaxoSmithKline — full pipeline
- Therapeutic area: All drugs in Immunology / Infectious Disease
- Indication: Drugs for Prevention of rotavirus gastroenteritis in infants and young children
- Compare: Live attenuated human rotavirus vaccine vs similar drugs
- Pricing: Live attenuated human rotavirus vaccine cost, discount & access