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Rotavirus Vaccine, Live, Pentavalent
Rotavirus Vaccine, Live, Pentavalent is a Live attenuated vaccine Biologic drug developed by Sanofi Pasteur, a Sanofi Company. It is currently FDA-approved for Prevention of rotavirus gastroenteritis in infants and young children. Also known as: RotaTeq®.
A live attenuated pentavalent rotavirus vaccine that stimulates immune responses against the five most common rotavirus serotypes to prevent rotavirus gastroenteritis.
A live attenuated pentavalent rotavirus vaccine that stimulates immune responses against the five most common rotavirus serotypes to prevent rotavirus gastroenteritis. Used for Prevention of rotavirus gastroenteritis in infants and young children.
At a glance
| Generic name | Rotavirus Vaccine, Live, Pentavalent |
|---|---|
| Also known as | RotaTeq® |
| Sponsor | Sanofi Pasteur, a Sanofi Company |
| Drug class | Live attenuated vaccine |
| Modality | Biologic |
| Therapeutic area | Immunology / Infectious Disease |
| Phase | FDA-approved |
Mechanism of action
The vaccine contains live, weakened strains of rotavirus (serotypes G1, G2, G3, G4, and P1A) that replicate in the intestinal tract and induce both humoral and mucosal immune responses. This generates protective antibodies and cellular immunity against rotavirus infection, reducing the incidence and severity of rotavirus-caused diarrhea in infants and young children.
Approved indications
- Prevention of rotavirus gastroenteritis in infants and young children
Common side effects
- Diarrhea
- Vomiting
- Fever
- Irritability
- Intussusception
Key clinical trials
- Study of DTwP-HepB-Hib-IPV (SHAN6™) Vaccine Administered Concomitantly With Routine Pediatric Vaccines to Healthy Infants and Toddlers in Thailand (PHASE3)
- Study of a Pneumococcal Conjugate Vaccine When Administered Concomitantly With Routine Pediatric Vaccines in Healthy Toddlers and Infants (PHASE2)
- PhaseⅡClinical Trial of Oral Hexavalent Reassortant Rotavirus Attenuated Live Vaccine (Vero Cells) (PHASE2)
- Immunogenicity and Safety of Concomitant and Non-Concomitant Administration of RotaTeq® (V260) and Inactivated Poliomyelitis Vaccine in Healthy Chinese Infants (V260-074) (PHASE3)
- Immunogenicity and Safety Study of a Quadrivalent Meningococcal Conjugate Vaccine Administered Concomitantly With Routine Pediatric Vaccines in Healthy Infants and Toddlers (PHASE3)
- Safety and Immunogenicity of a Quadrivalent Meningococcal Conjugate Vaccine When Administered Concomitantly With Routine Pediatric Vaccines in Healthy Infants and Toddlers in the Russian Federation and Mexico (PHASE3)
- Efficacy and Safety of a Pentavalent Rotavirus Vaccine (BRV-PV) Against Severe Rotavirus Gastroenteritis in Niger (PHASE3)
- A Study to Evaluate the Interchangeability of V114 and Prevnar 13™ in Healthy Infants (V114-027/PNEU-DIRECTION) (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, Live, Pentavalent CI brief — competitive landscape report
- Rotavirus Vaccine, Live, Pentavalent updates RSS · CI watch RSS
- Sanofi Pasteur, a Sanofi Company portfolio CI
Frequently asked questions about Rotavirus Vaccine, Live, Pentavalent
What is Rotavirus Vaccine, Live, Pentavalent?
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What is Rotavirus Vaccine, Live, Pentavalent used for?
Who makes Rotavirus Vaccine, Live, Pentavalent?
Is Rotavirus Vaccine, Live, Pentavalent also known as anything else?
What drug class is Rotavirus Vaccine, Live, Pentavalent in?
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Related
- Drug class: All Live attenuated vaccine drugs
- Manufacturer: Sanofi Pasteur, a Sanofi Company — full pipeline
- Therapeutic area: All drugs in Immunology / Infectious Disease
- Indication: Drugs for Prevention of rotavirus gastroenteritis in infants and young children
- Also known as: RotaTeq®
- Compare: Rotavirus Vaccine, Live, Pentavalent vs similar drugs
- Pricing: Rotavirus Vaccine, Live, Pentavalent cost, discount & access