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Rotarix, dose 1
Rotarix, dose 1 is a Biologic drug developed by University of Vermont. It is currently FDA-approved. Also known as: Rotavirus vaccine.
Rotarix is a live attenuated vaccine component that induces an immune response. It is used to prevent rotavirus infections, gastroenteritis, and rotavirus gastroenteritis in infants.
At a glance
| Generic name | Rotarix, dose 1 |
|---|---|
| Also known as | Rotavirus vaccine |
| Sponsor | University of Vermont |
| Modality | Biologic |
| Phase | FDA-approved |
Approved indications
Common side effects
Key clinical trials
- Study of the Safety of a 21-valent Pneumococcal Conjugate Vaccine in Healthy Infants From Approximately 2 Months of Age (PHASE3)
- Lot-to-lot Consistency Study of a 21-valent Pneumococcal Conjugate Vaccine in Healthy Infants From 2 Months of Age (PHASE3)
- Study of Mixed Vaccination Schedules With a 21-valent Pneumococcal Conjugate Vaccine and a 20-valent Pneumococcal Conjugate Vaccine in Healthy Infants From Approximately 2 Months of Age (PHASE3)
- Safety and Immunogenicity of GSK Meningococcal Group B Vaccine and 13-valent Pneumococcal Vaccine Administered Concomitantly With Routine Infant Vaccines to Healthy Infants (PHASE3)
- 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)
- 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)
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, dose 1 CI brief — competitive landscape report
- Rotarix, dose 1 updates RSS · CI watch RSS
- University of Vermont portfolio CI
Frequently asked questions about Rotarix, dose 1
What is Rotarix, dose 1?
Who makes Rotarix, dose 1?
Is Rotarix, dose 1 also known as anything else?
What development phase is Rotarix, dose 1 in?
Related
- Manufacturer: University of Vermont — full pipeline
- Also known as: Rotavirus vaccine
Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing