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
| |