Last reviewed · How we verify
Human rotavirus liquid vaccine
This live attenuated rotavirus vaccine stimulates the immune system to produce antibodies and cellular immunity against rotavirus, preventing infection and severe gastroenteritis.
This live attenuated 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 | Human rotavirus liquid 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 weakened live rotavirus that replicates in the intestinal tract, triggering both humoral (antibody) and mucosal immune responses without causing disease. This primes the immune system to recognize and neutralize wild-type rotavirus upon natural exposure, preventing or reducing the severity of rotavirus gastroenteritis 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
- 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)
- 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)
- Mixed Schedule Study of Live Oral Rotavirus Vaccines and Trivalent P2-VP8 Subunit Rotavirus Vaccine (PHASE2)
- Safety Study of 2 Formulations of GSK's Human Rotavirus (HRV) Vaccine (444563), in Healthy Infants Starting at Age 6-12 Weeks (PHASE3)
- Phase III Study of Liquid Formulation of ROTAVIN (PHASE3)
- This Study Will Evaluate the Immunogenicity, Reactogenicity and Safety of the Routine Infant Vaccines Pediarix®, Hiberix® and Prevenar 13® When Co-administered With GlaxoSmithKline (GSK) Biologicals' Liquid Human Rotavirus Vaccine (HRV) as Compared to GSK's Licensed Lyophilized Vaccine (PHASE3)
- Study of BBIL's ROTAVAC® and ROTAVAC 5CM Vaccines in Zambia (PHASE2, 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:
- Human rotavirus liquid vaccine CI brief — competitive landscape report
- Human rotavirus liquid vaccine updates RSS · CI watch RSS
- GlaxoSmithKline portfolio CI