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 |
|---|---|---|---|---|---|---|---|---|---|---|---|
| NCT05065177 | Safety and Immunogenicity Study of Live Attenuated Mumps Vaccines in Healthy Infants | PHASE3 | COMPLETED | 1,140 | — | — | Jan 1, 2016 | Apr 1, 2016 | Oct 1, 2021 | 1 | China |
Subjects whose pre-immune HI antibody level \< 1:2 are considered susceptible; among these subjects, those with post-immune HI antibody level ≥ 1:2 are considered seroconverted.
| Arm | Type | Description |
|---|---|---|
| Experimental Group | EXPERIMENTAL | * Single intramuscular injection of the investigational vaccine (0.5 ml) on Day 0; * Intervention: investigational live attenuated mumps vaccine; |
| Control Group | ACTIVE_COMPARATOR | * Single intramuscular injection of the control vaccine (0.5 ml) on Day 0; * Intervention: control live attenuated mumps vaccine; |
| Name | Type | Description |
|---|---|---|
| Investigational live attenuated mumps vaccine | BIOLOGICAL | The investigational vaccine was manufactured by Sinovac (Dalian) Vaccine Technology Co., Ltd. |
| control live attenuated mumps vaccine | BIOLOGICAL | The control vaccine was manufactured by Zhejiang VACN bio-pharmaceutical Co. Ltd. |
Inclusion Criteria: * Healthy volunteer between 8 - 18 months old; * Proven legal identity; * Guardian(s) of the volunteer should be capable of understanding the written consent form, and such form should be signed before the infant being included into this study; * Complying with the requirement o...