> Trialight public data. Index of pages: https://trialight.com/llms.txt
> Web page: https://trialight.com/data/asset/rotavirus-live-attenuated-ae261f7b-dfa4-479d-b08c-b30770d2b48e
> Record changed: 2026-10-13

# Rotavirus, live attenuated

Highest phase reached

Approved

Source: [www.ebi.ac.uk](https://www.ebi.ac.uk/chembl/explore/compound/CHEMBL6068351)

Drug type

Vaccine component

Source: [www.ebi.ac.uk](https://www.ebi.ac.uk/chembl/explore/compound/CHEMBL6068351)

First approval year

1999

Source: [www.ebi.ac.uk](https://www.ebi.ac.uk/chembl/explore/compound/CHEMBL6068351)

## Development status

**First approval year**

1999

Source: [www.ebi.ac.uk](https://www.ebi.ac.uk/chembl/explore/compound/CHEMBL6068351)

**Listing at source**

Listed

**Highest phase reached**

Approved

Source: [www.ebi.ac.uk](https://www.ebi.ac.uk/chembl/explore/compound/CHEMBL6068351)

## Names and chemistry

**Drug type**

Vaccine component

Source: [www.ebi.ac.uk](https://www.ebi.ac.uk/chembl/explore/compound/CHEMBL6068351)

**Drug name**

Rotavirus, live attenuated

Source: [www.ebi.ac.uk](https://www.ebi.ac.uk/chembl/explore/compound/CHEMBL6068351)

### Brand names (4)

- rotarix
- Rotarix
- rotashield
- Rotashield

### Other names (12)

- oral rotarix
- Oral Rotarix®
- Rotarix
- Rotarix (primary vaccination study)
- Rotarix (RV1)
- Rotarix ™
- Rotarix®
- Rotarix®,
- Rotarix™
- rotavirus live attenuated
- Rotavirus Vaccine (ROTARIX)
- Rotavirus, live attenuated

## Identifiers

**ChEMBL ID**

CHEMBL6068351

Source: [www.ebi.ac.uk](https://www.ebi.ac.uk/chembl/explore/compound/CHEMBL6068351)

## Regulatory information

### Other regulatory facts

**First in class**

No

**Orphan designation**

No

## Pharmacology

### Drug classification

**Drug name stem**

\-vir-

### Investigated indications (2)

- **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

### Open Targets indications (5)

- **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

### Reported adverse events (34)

- **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.

## Chemical properties

**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](https://trialight.com/data/trial/co-administration-study-of-an-investigational-live-7909bc3c-d5cb-4ef7-9416-19caf2e95f7f.md)

### Approved for (1)

- [Rotavirus infection](https://trialight.com/data/condition/rotavirus-infection-7e79da16-09e8-58fb-861e-f85f158082a6.md)

### In development for (1)

- [Hepatitis B virus infection](https://trialight.com/data/condition/hepatitis-b-virus-infection-63cb6d13-50c4-5e97-86fd-ce5481d9d1c6.md) Phase 3

---

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