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HRV Lyophilized
HRV Lyophilized is a live attenuated human rotavirus vaccine that stimulates immune responses against rotavirus infection.
HRV Lyophilized is a live attenuated human rotavirus vaccine that stimulates immune responses against rotavirus infection. Used for Prevention of rotavirus gastroenteritis in infants and young children.
At a glance
| Generic name | HRV Lyophilized |
|---|---|
| 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 form of human rotavirus that replicates in the intestinal tract, triggering both humoral and mucosal immune responses. This primes the immune system to recognize and neutralize wild-type rotavirus upon natural exposure, preventing severe 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
- Safety Study of 2 Formulations of GSK's Human Rotavirus (HRV) Vaccine (444563), in Healthy Infants Starting at Age 6-12 Weeks (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)
- Immunogenicity, Reactogenicity and Safety Study of Two Different Formulations of GSK Biologicals' Human Rotavirus Vaccine, Rotarix, in Healthy Infants (PHASE3)
- To Assess Immunogenicity, Reactogenicity & Safety of 2 Formulations of GSK's HRV Vaccine as 2-dose Vaccination (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:
- HRV Lyophilized CI brief — competitive landscape report
- HRV Lyophilized updates RSS · CI watch RSS
- GlaxoSmithKline portfolio CI