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 |
|---|---|---|---|---|---|---|---|---|---|---|---|
| NCT01421121 | Safety and Immunogenicity of an Inactivated EV71 Vaccine in Infants | PHASE2 | COMPLETED | 540 | — | — | Jun 1, 2011 | Dec 1, 2011 | Nov 27, 2012 | 1 | China |
Primary immunogenicity end point were geometric mean titer of neutralization antibody againt EV71 virus \>= 1:8
| Arm | Type | Description |
|---|---|---|
| 100U EV71 vaccine with adjuvant | EXPERIMENTAL | 120 infants received 2 doses of 100U EV71 vaccine with aluminium hydroxide adjuvant 28 days apart |
| 200 U EV71 vaccine with adjuvant | EXPERIMENTAL | 120 infants received 2 doses of 200U EV71 vaccine with aluminium hydroxide adjuvant 28 days apart |
| 400U EV71 vaccine with adjuvant | EXPERIMENTAL | 120 infants received 2 doses of 400U EV71 vaccine with aluminium hydroxide adjuvant 28 days apart |
| 200U EV71 vaccine without adjuvant | EXPERIMENTAL | 60 infants received 2 doses of 200U EV71 vaccine without adjuvant 28 days apart |
| Placebo | PLACEBO_COMPARATOR | 120 infants received 2 doses of placebo 28 days apart. |
| Name | Type | Description |
|---|---|---|
| 100U EV71 vaccine with adjuvant | BIOLOGICAL | inactivated vaccine (vero cell) against EV71 of 100U /0.5ml, two doses, 28 days interval |
| 200 U EV71 vaccine with adjuvant | BIOLOGICAL | inactivated vaccine (vero cell) against EV71 of 200U /0.5ml, two doses, 28 days interval |
| 400U EV71 vaccine with adjuvant | BIOLOGICAL | inactivated vaccine (vero cell) against EV71 of 400U /0.5ml, two doses, 28 days interval |
| 200U EV71 vaccine without adjuvant | BIOLOGICAL | inactivated vaccine (vero cell) against EV71 without adjuvant of 200U /0.5ml, two doses, 28 days interval |
| Placebo | BIOLOGICAL | 0.5ml placebo, two doses, 28 days interval |
Inclusion Criteria: 1. Healthy males and females, aged from 6 months to 11 years old Health is determined by medical history, physical examination, laboratory examination and clinical judgment of the investigator 2. Provided legal identification for the sake of recruitment. 3. Subjects and/or paren...