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 |
|---|---|---|---|---|---|---|---|---|---|---|---|
| NCT02451969 | Safety and Immunogenicity Study of 23-valent Pneumococcal Polysaccharide Vaccine in Healthy Children, Adults and Elderly | PHASE3 | COMPLETED | 1,760 | — | — | Apr 1, 2015 | Feb 1, 2017 | May 3, 2017 | 1 | China |
For each serotype, the SCR is the percentage of participants with the increase of relative antibody concentration ≥ 2 folds after vaccination. The relative antibody concentrations were measured using Enzyme Linked Immunosorbent Assay (ELISA).
| Arm | Type | Description |
|---|---|---|
| Experimental Group | EXPERIMENTAL | * Single intramuscular injection of the investigational vaccine (0.5 ml) on Day 0 * Intervention: investigational 23-valent PPV |
| Control Group | ACTIVE_COMPARATOR | * Single intramuscular injection of the control vaccine (0.5 ml) on Day 0 * Intervention: control 23-valent PPV |
| Name | Type | Description |
|---|---|---|
| investigational 23-valent PPV | BIOLOGICAL | The investigational vaccine was manufactured by Sinovac Biotech Co., Ltd. |
| control 23-valent PPV | BIOLOGICAL | The control vaccine was manufactured by Chengdu Institute of Biological products Co., Ltd. |
Inclusion Criteria: * Healthy volunteer ≥ 2 years old; * Proven legal identity; * Written consent of the guardian of participants \< 18 years old, and written consent of the participant ≥ 12 years old; * Complying with the requirement of the study protocol; Exclusion Criteria: * Prior vaccination...