Overview
Rotavirus commonly infects children and infants causing severe diarrhea and vomiting leading to potentially fatal dehydration. Two rotavirus vaccines are available for the prevention of rotavirus gastroenteritis, Rotateq and Rotarix. Rotateq is a live vaccine consisting of 5 reassorted human-bovine viral strains. Rotarix is a live attenuated vaccine containing the 89-12 human strain. Rotavirus vaccines are 90% effective in protecting against severe rotavirus infection.
Background
Rotavirus commonly infects children and infants causing severe diarrhea and vomiting leading to potentially fatal dehydration. Two rotavirus vaccines are available for the prevention of rotavirus gastroenteritis, Rotateq and Rotarix. Rotateq is a live vaccine consisting of 5 reassorted human-bovine viral strains. Rotarix is a live attenuated vaccine containing the 89-12 human strain. Rotavirus vaccines are 90% effective in protecting against severe rotavirus infection.
Indication
Rotarix is indicated for prevention of rotavirus gastroenteritis caused by G1, G3, G4, and G9 types in infants aged 6-24 weeks . Rotateq is indicated for the prevention of rotavirus gastroenteritis caused by G1, G2, G3, G4, and G9 types in infants aged 6-32 weeks .
Associated Conditions
- Rotavirus Gastroenteritis caused by rotavirus G1
- Rotavirus Gastroenteritis caused by rotavirus G2
- Rotavirus Gastroenteritis caused by rotavirus G3
- Rotavirus Gastroenteritis caused by rotavirus G4
- Rotavirus Gastroenteritis caused by rotavirus G9
Clinical Trials
Title | Posted | Study ID | Phase | Status | Sponsor |
|---|---|---|---|---|---|
2025/02/13 | Phase 3 | Recruiting | |||
2025/02/13 | Phase 3 | Recruiting | |||
2024/12/16 | Phase 3 | Recruiting | |||
2024/10/17 | Phase 1 | Recruiting | |||
2024/05/03 | Phase 3 | Active, not recruiting | |||
2023/04/03 | Phase 3 | Active, not recruiting | |||
2020/12/09 | Phase 2 | Completed | Centre for Infectious Disease Research in Zambia | ||
2018/08/08 | Phase 3 | Completed | |||
2016/10/21 | Phase 4 | Active, not recruiting | |||
2014/06/25 | Phase 3 | UNKNOWN | Anna Taddio |
FDA Drug Approvals
Approved Product | Manufacturer | NDC Code | Route | Strength | Effective Date |
|---|---|---|---|---|---|
| No FDA approvals found for this drug. | |||||
EMA Drug Approvals
Approved Product | Authorization Holder | Status | Issued Date |
|---|---|---|---|
| No EMA approvals found for this drug. | |||
HSA Drug Approvals
Approved Product | Manufacturer | Approval Number | Dosage Form | Strength | Approval Date |
|---|---|---|---|---|---|
| RotaTeq | SIN13303P | SOLUTION | 2.0 X exponential 6 infectious units | 6/22/2007 | |
| Rotarix Oral Suspension (Tube) | SIN13813P | SUSPENSION | Not less than 10⁶ CCID₅₀/dose (1.5 ml) | 6/1/2010 | |
| RotaTeq | SIN13303P | SOLUTION | 2.3 X exponential 6 infectious units | 6/22/2007 | |
| Rotarix Oral Suspension (Oral Applicator) | SIN13743P | SUSPENSION | Not less than 10⁶ CCID₅₀/dose (1.5 ml) | 12/4/2009 | |
| RotaTeq | SIN13303P | SOLUTION | 2.2 X exponential 6 infectious units | 6/22/2007 | |
| RotaTeq | SIN13303P | SOLUTION | 2.8 X exponential 6 infectious units | 6/22/2007 | |
| RotaTeq | SIN13303P | SOLUTION | 2.2 X exponential 6 infectious units | 6/22/2007 |
NMPA Drug Approvals
Approved Product | Company | Approval Number | Drug Type | Dosage Form | Approval Date |
|---|---|---|---|---|---|
| No NMPA approvals found for this drug. | |||||
PPB Drug Approvals
Approved Product | Registration No. | Company | Licence No. | Strength | Registration Date |
|---|---|---|---|---|---|
| ROTARIX VACCINE ORAL SUSPENSION | N/A | glaxosmithkline limited | N/A | N/A | 7/25/2006 |
| ROTARIX VACCINE ORAL SUSPENSION IN SQUEEZABLE TUBE | N/A | glaxosmithkline limited | N/A | N/A | 10/3/2024 |
TGA Drug Approvals
Approved Product | ARTG ID | Sponsor | Registration Type | Status | Registration Date |
|---|---|---|---|---|---|
| ROTATEQ rotavirus vaccine live oral pentavalent pre-filled dosing tube | 120245 | Medicine | A | 5/11/2006 | |
| ROTATEQ rotavirus vaccine live oral pentavalent pre-filled dosing tube | 120245 | Medicine | A | 5/11/2006 | |
| ROTATEQ rotavirus vaccine live oral pentavalent pre-filled dosing tube | 120245 | Medicine | A | 5/11/2006 | |
| ROTATEQ rotavirus vaccine live oral pentavalent pre-filled dosing tube | 120245 | Medicine | A | 5/11/2006 | |
| ROTATEQ rotavirus vaccine live oral pentavalent pre-filled dosing tube | 120245 | Medicine | A | 5/11/2006 | |
| ROTARIX human rotavirus (live attenuated oral vaccine) oral liquid tube | 326141 | Medicine | A | 2/19/2020 | |
| ROTARIX human rotavirus (live attenuated oral vaccine) oral liquid | 146776 | Medicine | A | 8/27/2008 |