This study was intended to explore the safety and immunogenicity of the test vaccine compared to the control vaccine. The trial consisted of two phases. Phase I used an open-ended design. Phase II used a randomized, blinded, parallel-controlled non-inferiority design with the same type of active vaccine, in which the control vaccine 5-dose group and the test vaccine 5 group were kept blinded throughout, the test vaccine 4-dose B group was kept blinded from the other three groups until visit 4 (D14), and the test vaccine 4-dose A group was kept blinded from the control vaccine 5-dose group and the test vaccine 5-dose group until visit 5 (D28).
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Antibody SCR in 5-dose groups of test vaccine and 5-dose groups of control vaccine
Timeframe: Day 14
Antibody GMC in 5-dose groups of test vaccine and 5-dose groups of control vaccine
Timeframe: Day 14
Antibody SCR in 4-dose groups of test vaccine and 5-dose groups of control vaccine
Timeframe: Day 14
Antibody GMC in 4-dose groups of test vaccine and 5-dose groups of control vaccine
Timeframe: Day 14
Antibody SCR in 5-dose groups of test vaccine and 5-dose groups of control vaccine
Timeframe: Day 42
Antibody SCR in 4-dose groups of test vaccine and 5-dose groups of control vaccine
Timeframe: Day 42