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Rotavirus vaccine
Rotavirus vaccine stimulates the immune system to produce antibodies and cellular immunity against rotavirus, preventing infection and severe gastroenteritis.
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 | Rotavirus vaccine |
|---|---|
| Also known as | Rotarix, brazilian rotavirus vaccine, RotaTeq® Rotarix®, Rotarix™ or RotaTeq™, RotaTeq/ROTARIX |
| Sponsor | PATH |
| Drug class | Live attenuated vaccine |
| Modality | Biologic |
| Therapeutic area | Immunology / Infectious Disease |
| Phase | FDA-approved |
Mechanism of action
The vaccine contains live attenuated rotavirus strains that replicate in the intestinal tract, triggering both humoral (antibody) and cell-mediated immune responses. This primes the immune system to recognize and neutralize wild-type rotavirus upon natural exposure, preventing or reducing the severity of rotavirus-induced diarrhea and dehydration 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
- The Oral Hexavalent Reassortant Rotavirus Attenuated Live Vaccine (Vero Cells) (PHASE1)
- CDC-9 Inactivated Rotavirus Vaccine (IRV) Intramuscular (IM) Phase 1 Clinical Trial in Healthy Adults (PHASE1)
- CDC-9 Inactivated Rotavirus Vaccine (IRV) Microneedle Patch (MNP) in Healthy Adults (PHASE1)
- 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 a 4-Dose Regimen of a 21-valent Pneumococcal Conjugate Vaccine in Healthy Infants From Approximately 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)
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:
- Rotavirus vaccine CI brief — competitive landscape report
- Rotavirus vaccine updates RSS · CI watch RSS
- PATH portfolio CI