Rotavirus, live
Highest phase reached
Approved
Drug type
Vaccine component
First approval year
2006
- First approval year
- 2006
- Listing at source
- Listed
- Highest phase reached
- Approved
- Drug type
- Vaccine component
- Drug name
- Rotavirus, live
- rotateq
- Rotateq
- RotaTeq
- RotaTeq (V260)
- rotateq v260
- RotaTeq®
- RotaTeq®,
- Rotateq™
- RotaTeq™
- RotaTeq™ (V260)
- rotavirus live
- Rotavirus, live
- ChEMBL ID
- CHEMBL6068358
- First in class
- No
- Orphan designation
- No
- Drug name stem
- -vir-
- Condition
- Rotavirus Infections
- Highest recorded phase
- 4
- Condition identifier
- EFO:0002622
- Subject identifier
- D012400
- Condition
- Vaccination
- Highest recorded phase
- 4
- Condition identifier
- EFO:0004292
- Subject identifier
- D014611
- Condition identifier
- EFO_0002622
- Condition identifier
- MONDO_0005148
- Highest recorded phase
- 1
- Condition identifier
- MONDO_0005194
- Highest recorded phase
- 1
- Condition identifier
- MONDO_0006517
- Highest recorded phase
- 3
- Event
- adverse event following immunisation
- Reports
- 1
- Reporting signal score
- 8.7865
- Event
- apnoea
- Reports
- 2
- Reporting signal score
- 6.53555
- Event
- autoimmune enteropathy
- Reports
- 1
- Reporting signal score
- 7.58266
- Event
- autoimmune neutropenia
- Reports
- 2
- Reporting signal score
- 12.6536
- Event
- bronchiolitis
- Reports
- 2
- Reporting signal score
- 8.0755
- Event
- cholestasis
- Reports
- 7
- Reporting signal score
- 24.1474
- Event
- cortical visual impairment
- Reports
- 1
- Reporting signal score
- 8.49884
- Event
- crying
- Reports
- 4
- Reporting signal score
- 12.4998
- Event
- diarrhoea
- Reports
- 9
- Reporting signal score
- 8.43932
- Event
- exposure via breast milk
- Reports
- 2
- Reporting signal score
- 8.84506
- Event
- gastroenteritis
- Reports
- 3
- Reporting signal score
- 8.99837
- Event
- haematochezia
- Reports
- 6
- Reporting signal score
- 17.2892
- Event
- heterophoria
- Reports
- 1
- Reporting signal score
- 6.53568
- Event
- hypotonic-hyporesponsive episode
- Reports
- 1
- Reporting signal score
- 7.02318
- Event
- hypovitaminosis
- Reports
- 7
- Reporting signal score
- 47.9566
- Event
- immune thrombocytopenic purpura
- Reports
- 2
- Reporting signal score
- 7.59475
- Event
- intussusception
- Reports
- 2
- Reporting signal score
- 10.9033
- Event
- kinematic imbalances due to suboccipital strain
- Reports
- 1
- Reporting signal score
- 7.93928
- Event
- liver injury
- Reports
- 7
- Reporting signal score
- 26.6012
- Event
- mucous stools
- Reports
- 2
- Reporting signal score
- 8.83261
- Event
- nasal flaring
- Reports
- 1
- Reporting signal score
- 6.94097
- Event
- pallor
- Reports
- 4
- Reporting signal score
- 11.6336
- Event
- papule
- Reports
- 2
- Reporting signal score
- 7.20507
- Event
- pyrexia
- Reports
- 8
- Reporting signal score
- 9.64921
- Event
- rash macular
- Reports
- 3
- Reporting signal score
- 8.81561
And 8 more, listed on the interactive page.
- Dose
- Not specified (liquid dose in each tube)
- Route
- Oral
- How often
- Starting at 6 to 12 weeks of age, with subsequent doses at 4 to 10 week intervals, for 3 doses total
- Do not mix with other vaccines or solutions
- Do not reconstitute or dilute
- Prodrug
- No
- Chirality
- Single enantiomer
- Inorganic
- No
- Natural product
- No
Related records
Trials (26)
- A Study of the Immunogenicity, Tolerability, and Safety of a New Formulation of RotaTeq™ in Infants (V260-035)
- A Study of V419 Given Concomitantly With Prevnar 13™ and RotaTeq™ (V419-006)
- A Study to Evaluate the Interchangeability of V114 and Prevnar 13™ in Healthy Infants (V114-027/PNEU-DIRECTION)
- Concomitant Administration of a New Hexavalent Vaccine With a Meningococcal Serogroup C Conjugate Vaccine in Healthy Infants During Primary Series Immunisation Followed by Booster Vaccination
- Dose Confirmation Efficacy Study (V260-007)
- Efficacy, Safety, and Immunogenicity of V260 in Healthy Chinese Infants (V260-024)
- Fractional Inactivated Poliovirus Vaccine Booster and Rotavirus Study
- 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)
- Immunogenicity and Safety of Concomitant and Non-Concomitant Administration of RotaTeq® (V260) and Inactivated Poliomyelitis Vaccine in Healthy Chinese Infants (V260-074)
- Impact of Systematic Infants Vaccination Against Rotavirus on Gastroenteritis Hospitalization: a Prospective Study in Brest District, France.
- Phase III Placebo-controlled Study of V260 (RotaTeq™) in Japanese Healthy Infants (V260-029)(COMPLETED)
- Potential Mechanisms for Intussusception After Rotavirus Vaccine-Pilot Study
- Randomized, Controlled Single-blind Clinical Study to Assess Vaccine Interchangeability Between RV5 and RV1 Using Seven Combined Anti-rotavirus Prevention Programs
- RotaTeq® and Meningococcus C Vaccine in Healthy Infants (V260-016)
- Rotavirus Efficacy and Safety Trial (REST)(V260-006)
- Safety and Immune Response of a Rotavirus Vaccine in HIV-infected and Uninfected Children Born to HIV-infected Mothers
- Safety and Immunogenicity of Rotavirus Vaccine (RotaTeq(R)) in Infants With Short Bowel Syndrome
- Safety and Immunogenicity of Sequential Rotavirus Vaccine Schedules
- Safety, Reactogenicity and Immunogenicity of Heat-stable Rotavirus Vaccine (HSRV) in Adults and Infants
- Safety, Tolerability, and Immunogenicity of V114 in Healthy Infants (V114-029)