Licensure |
Several countries, 2006 |
Several countries, 2006 |
India, 2014 |
India, 2017 |
Vietnam, 2012 |
China, 2000 |
Clinical trial phase IIb |
Prequalification |
Yes |
Yes |
Yes |
Yes |
No |
No |
No |
Strains |
Monovalent, human derived G1P[8] |
Pentavalent, WC3 G6P[5] bovine reassortant G1–4,P8 |
Monovalent, human neonatal derived G9P[11] |
Pentavalent, UK Bovine G6P[5], reassortant G1–4, G9 |
Monovalent, human G1P[8] |
Monovalent, Lamb G10P[12] |
Monovalent, human neonatal G3P[6] |
Number of doses |
2 |
3 |
3 |
3 |
2 |
3 |
3 |
Age, first dose |
6 weeks |
6 weeks |
6 weeks |
6 weeks |
6 weeks |
2 months |
New born: 0–5 days Infant: 8 weeks |
Age, last dose |
10 weeks |
14 weeks |
14 weeks |
14 weeks |
14 weeks |
36 months |
New born: 14 week Infant: 18 weeks |
Dosage |
106 median CCID50 of live attenuated human G1P[8] RV |
2.0–2.8 × 106 infectious units per reassortant |
105 fluorescent focus unit (FFU) of live rotavirus |
105.6 infectious units per reassortant |
106.3 FFU/dose of live attenuated human G1P[8] particles |
> 5.5 log CCID50
|
8.3–8.7 × 106 FCFU/ml |
UNICEF price per course for GAVI-supported countries, 2020 [122] |
$4.58 |
$9.60 (RotaTeq is no longer an option available to GAVI-supported countries) |
$2.55 |
$4.65 (1-dose vial) $2.85 (2-dose vial) |
$17.60 |
$72 for the three-dose series |
|