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RotaTeq™ (V260)
RotaTeq is a live attenuated rotavirus vaccine that stimulates the immune system to produce antibodies and cellular immunity against rotavirus.
RotaTeq is a live attenuated rotavirus vaccine that stimulates the immune system to produce antibodies and cellular immunity against rotavirus. Used for Prevention of rotavirus gastroenteritis in infants and children.
At a glance
| Generic name | RotaTeq™ (V260) |
|---|---|
| Also known as | RotaTeq™, RotaTeq, V260 |
| Sponsor | Merck Sharp & Dohme LLC |
| Drug class | Live attenuated vaccine |
| Modality | Biologic |
| Therapeutic area | Immunology / Infectious Disease |
| Phase | FDA-approved |
Mechanism of action
RotaTeq contains five live reassortant rotavirus strains (derived from human and bovine rotavirus parents) that replicate in the intestinal tract and induce both humoral and mucosal immune responses. The vaccine prevents rotavirus gastroenteritis by generating neutralizing antibodies and T-cell mediated immunity against the major rotavirus serotypes. Protection is achieved through intestinal mucosal immunity and systemic antibody responses.
Approved indications
- Prevention of rotavirus gastroenteritis in infants and children
Common side effects
- Diarrhea
- Vomiting
- Fever
- Irritability
Key clinical trials
- Lot-to-lot Consistency Study of a 21-valent Pneumococcal Conjugate Vaccine in Healthy Infants From 2 Months of Age (PHASE3)
- Study of a Quadrivalent Meningococcal Conjugate Vaccine (MenACYW Conjugate Vaccine) Given With Routine Pediatric Vaccines in Healthy Infants and Toddlers in India and the Republic of South Africa (PHASE3)
- A Study to Evaluate the Interchangeability of V114 and Prevnar 13™ in Healthy Infants (V114-027/PNEU-DIRECTION) (PHASE3)
- Safety and Immune Response of a Rotavirus Vaccine in HIV-infected and Uninfected Children Born to HIV-infected Mothers (PHASE2)
- Safety, Tolerability, and Immunogenicity of V419 in Healthy Infants When Given at 2, 4, and 11 to 12 Months (V419-008) (PHASE3)
- Efficacy, Safety, and Immunogenicity of V260 in Healthy Chinese Infants (V260-024) (PHASE3)
- Safety, Tolerability, and Immunogenicity of V419 Given Concomitantly With Prevnar 13™ and RotaTeq™ (V419-005) (PHASE3)
- Immunogenicity and Safety of Concomitant Administration of RotaTeq™ (V260) and the Diphtheria, Tetanus, Pertussis and Inactivated Poliovirus Vaccine (DTP-IPV) in Healthy Japanese Infants (V260-060) (PHASE4)
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 |