> Trialight public data. Index of pages: https://trialight.com/llms.txt
> Web page: https://trialight.com/data/asset/rotavirus-live-8b7b385a-1a1e-4351-ba68-1a88e0118ad4
> Record changed: 2026-10-13

# Rotavirus, live

Highest phase reached

Approved

Source: [www.ebi.ac.uk](https://www.ebi.ac.uk/chembl/explore/compound/CHEMBL6068358)

Drug type

Vaccine component

Source: [www.ebi.ac.uk](https://www.ebi.ac.uk/chembl/explore/compound/CHEMBL6068358)

First approval year

2006

Source: [www.ebi.ac.uk](https://www.ebi.ac.uk/chembl/explore/compound/CHEMBL6068358)

## Development status

**First approval year**

2006

Source: [www.ebi.ac.uk](https://www.ebi.ac.uk/chembl/explore/compound/CHEMBL6068358)

**Listing at source**

Listed

**Highest phase reached**

Approved

Source: [www.ebi.ac.uk](https://www.ebi.ac.uk/chembl/explore/compound/CHEMBL6068358)

## Names and chemistry

**Drug type**

Vaccine component

Source: [www.ebi.ac.uk](https://www.ebi.ac.uk/chembl/explore/compound/CHEMBL6068358)

**Drug name**

Rotavirus, live

Source: [www.ebi.ac.uk](https://www.ebi.ac.uk/chembl/explore/compound/CHEMBL6068358)

### Brand names (2)

- rotateq
- Rotateq

### Other names (10)

- RotaTeq
- RotaTeq (V260)
- rotateq v260
- RotaTeq®
- RotaTeq®,
- Rotateq™
- RotaTeq™
- RotaTeq™ (V260)
- rotavirus live
- Rotavirus, live

## Identifiers

**ChEMBL ID**

CHEMBL6068358

Source: [www.ebi.ac.uk](https://www.ebi.ac.uk/chembl/explore/compound/CHEMBL6068358)

## 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 (4)

- **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

### Reported adverse events (33)

- **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.

## Dosing

**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

### Conditions of use (2)

- Do not mix with other vaccines or solutions
- Do not reconstitute or dilute

## Chemical properties

**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)

### Approved for (1)

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

---

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