Approval Probability 71%
TA Base Rate26%
Adjusted LOA41%
ML RiskLOW_RISK
| NCT ID | Title | Phase | Status | Enrollment | Velocity | Design | Start | Completion | Last Updated | Sites | Countries |
|---|---|---|---|---|---|---|---|---|---|---|---|
| NCT02062385 | Efficacy, Safety, and Immunogenicity of V260 in Healthy Chinese Infants (V260-024) | PHASE3 | COMPLETED | 4,040 | — | — | May 30, 2014 | Jun 11, 2015 | Nov 27, 2018 | - | — |
The number of participants with rotavirus gastroenteritis (RVGE) caused by naturally-occurring wild-type rotavirus (regardless of serotype or disease severity) was assessed. The case definition of RVGE included 1) 3 or more watery or looser-than-normal stools within a 24-hour period and/or forceful vomiting, and 2) naturally-occurring wild-type rotavirus must be detected in a stool specimen taken within 7 days after the onset of symptoms.
| Arm | Type | Description |
|---|---|---|
| V260 with staggered EPI | EXPERIMENTAL | V260 administered as a 2 mL oral solution at age \~2, 3, and 4 months, and staggered China Expanded Program on Immunizations (EPI) as follows: Oral poliovirus vaccine (OPV) administered as a 1 g oral solution at age \~2.5, 3.5, and 4.5 months, and diphtheria, tetanus, acellular pertussis vaccine (DTaP) administered as a 0.5 mL intramuscular injection at age \~3.5, 4.5, and 5.5 months |
| Placebo with staggered EPI | PLACEBO_COMPARATOR | Placebo administered as a 2 mL oral solution at age \~2, 3, and 4 months, and staggered EPI as follows: OPV administered as a 1 g oral solution at age \~2.5, 3.5, and 4.5 months, and DTaP administered as a 0.5 mL intramuscular injection at age \~3.5, 4.5, and 5.5 months |
| V260 with concomitant EPI | EXPERIMENTAL | V260 administered as a 2 mL oral solution at age \~2, 3, and 4 months, and concomitant EPI as follows: OPV administered as a 1 g oral solution at age \~2, 3, and 4 months and DTaP administered as a 0.5 mL intramuscular injection at age \~3, 4, and 5 months |
| Placebo with concomitant EPI | PLACEBO_COMPARATOR | Placebo administered as a 2 mL oral solution at age \~2, 3, and 4 months, and concomitant EPI as follows: OPV administered as a 1 g oral solution at age \~2, 3, and 4 months and DTaP administered as a 0.5 mL intramuscular injection at age \~3, 4, and 5 months |
| Name | Type | Description |
|---|---|---|
| V260 | BIOLOGICAL | V260 (RotaTeq™; live, oral, pentavalent rotavirus vaccine) |
| Placebo to V260 | BIOLOGICAL | Placebo control |
| OPV | BIOLOGICAL | Oral poliovirus vaccine administered according to the standard of care |
| DTaP | BIOLOGICAL | Diphtheria, Tetanus, Acellular Pertussis vaccine administered according to the standard of care |
Inclusion Criteria: * Healthy infants at least 6 weeks (42 days) and up to 12 weeks (84 days) of age at the time of the first study vaccination * Parent/legal guardian agrees to participate by giving written informed consent and is willing and able to comply with study requirements Exclusion Crite...