Rotavirus, live attenuated
Highest phase reached
Approved
Drug type
Vaccine component
First approval year
1999
- First approval year
- 1999
- Listing at source
- Listed
- Highest phase reached
- Approved
- Drug type
- Vaccine component
- Drug name
- Rotavirus, live attenuated
- rotarix
- Rotarix
- rotashield
- Rotashield
- oral rotarix
- Oral Rotarix®
- Rotarix
- Rotarix (primary vaccination study)
- Rotarix (RV1)
- Rotarix ™
- Rotarix®
- Rotarix®,
- Rotarix™
- rotavirus live attenuated
- Rotavirus Vaccine (ROTARIX)
- Rotavirus, live attenuated
- ChEMBL ID
- CHEMBL6068351
- 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
- EFO_0004197
- Highest recorded phase
- 3
- Condition identifier
- MONDO_0005148
- Highest recorded phase
- 1
- Condition identifier
- MONDO_0005194
- Highest recorded phase
- 4
- 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
- contraindication to vaccination
- Reports
- 1
- Reporting signal score
- 6.17225
- 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
And 9 more, listed on the interactive page.
- Prodrug
- No
- Chirality
- Single enantiomer
- Inorganic
- No
- Natural product
- No
Related records
Trials (106)
- A Dose-escalating Study to Evaluate the Immunogenicity and Safety of Rotavin-M1 Vaccine in Healthy Infants
- A Phase 1 Dose Escalation Study to Examine the Safety of the P2-VP8 Rotavirus Vaccine
- A Study of a Quadrivalent Meningococcal Tetanus Protein Conjugate Vaccine in Infants and Toddlers
- A Study of Safety, Reactogenicity and Immunogenicity of HRV Vaccine in HIV Infected Infants in South Africa
- A Study of the Immunogenicity and Safety of Whole-Cell Pertussis Containing Vaccine Administered Concomitantly With RotaTeq™ (V260) or Rotarix™ (V260-036)(WITHDRAWN)
- A Study of the Interaction Between BCG And MenC Immunisation: BAM
- A Study of V260 in Healthy Chinese Adults, Children and Infants (V260-028)(COMPLETED)
- A Study to Evaluate Immune Response and Safety of Two Doses of GSK Biologicals' HRV Liquid Vaccine in Healthy Infants.
- A Study to Explore the Existence of Horizontal Transmission of the RIX4414 Vaccine Strain Between Twins Within a Family.
- A Surveillance Study on Timing and Coverage Of Rotavirus and MenB Vaccine Co-administration in Campania Region, Italy
- A Trial to Assess the Safety, Immunogenicity and Efficacy of a Trivalent Rotavirus P2-VP8 Subunit Vaccine in Prevention of Severe Rotavirus Gastroenteritis in Healthy Infants in Africa and India
- An Alternate Dosing Schedule for Pentavalent Rotavirus Vaccine (RotaTeq)
- Antibody Persistence at Age 3.5 and 4.5 Years After Primary and Booster DTaP-IPV-Hep B-PRP~T or Infanrix Hexa Vaccination
- Assess Efficacy, Immune Response & Safety of 2 Doses of Oral Live Attenuated HRV Vaccine at Different Viral Concentrations in Healthy Infants
- Assess Efficacy, Immune Response & Safety of 2 Doses of Oral Live Attenuated HRV Vaccine in Healthy Infants
- Assessment of Clinical Consistency of Three Production Lots of GSK Biologicals' HRV Vaccine
- Baby Vaccine Study (Sched3)
- CDC-9 Inactivated Rotavirus Vaccine (IRV) Intramuscular (IM) Phase 1 Clinical Trial in Healthy Adults
- CDC-9 Inactivated Rotavirus Vaccine (IRV) Microneedle Patch (MNP) in Healthy Adults
- Co-administration Study of an Investigational Live-Attenuated Respiratory Syncytial Virus Vaccine in Infants and Toddlers
Approved for (1)
In development for (1)
- Hepatitis B virus infection Phase 3