Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
investigational 23-valent PPV · 1 trial · 1 indication
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...
The investigational 23-valent PPV is a pneumococcal polysaccharide vaccine used for the prevention of pneumococcal infections. It is being developed by Sinovac Biotech, Ltd (SVA) and is currently in Phase 3 clinical development. The vaccine is designed to protect against infections caused by Streptococcus pneumoniae.
The investigational 23-valent PPV is being developed by Sinovac Biotech, Ltd, a biopharmaceutical company listed on the NASDAQ under the ticker SVA. The company is conducting clinical trials to evaluate the vaccine's safety and immunogenicity in healthy children, adults, and elderly individuals.
The investigational 23-valent PPV is in Phase 3 clinical development. It is not yet approved by regulatory authorities and remains an investigational vaccine. A Phase 3 clinical trial has been completed to assess its safety and immunogenicity in healthy participants aged 2 years and older.
The investigational 23-valent PPV has been studied in one Phase 3 clinical trial, identified as NCT02451969. This completed trial, titled 'Safety and Immunogenicity Study of 23-valent Pneumococcal Polysaccharide Vaccine in Healthy Children, Adults and Elderly,' enrolled 1,760 participants in China and was randomized, double-blind, and active-controlled.
The investigational 23-valent PPV is a 23-valent pneumococcal polysaccharide vaccine, which targets 23 serotypes of Streptococcus pneumoniae. It is being developed by Sinovac Biotech, Ltd as a potential vaccine for pneumococcal infections. The vaccine is currently in Phase 3 clinical development and is not yet approved.