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Rotavirus Vaccine (ROTARIX)
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 | Rotavirus Vaccine (ROTARIX) |
|---|---|
| Also known as | ROTARIX |
| Sponsor | International Centre for Diarrhoeal Disease Research, Bangladesh |
| Drug class | Live attenuated vaccine |
| Modality | Biologic |
| Therapeutic area | Immunology / Infectious Disease |
| Phase | FDA-approved |
Mechanism of action
The vaccine contains a weakened strain of rotavirus that replicates in the intestinal tract, triggering both humoral (antibody) and cell-mediated immune responses without causing disease. This primes the immune system to recognize and neutralize wild-type rotavirus upon natural exposure, preventing severe rotavirus gastroenteritis.
Approved indications
- Prevention of rotavirus gastroenteritis in infants and young children
Common side effects
- Diarrhea
- Vomiting
- Fever
- Irritability
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)
- Effectiveness of Monovalent Rotavirus Vaccine (RV1)
- Safety and Immunogenicity of an Investigational Pentavalent Meningococcal ABCYW Vaccine Against Meningococcal Disease in Children, Toddlers, and Infants (PHASE1, PHASE2)
- 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)
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 |
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