The purpose of this study is to evaluate the safety of sIPVs of different dosages in adults, children and infants in a phase I open-label study, and then assess its immunogenicity and safety in healthy infants between 60 and 90 days old in a phase II blind, randomized, and controlled study.
This study is a combination of phases I and II. Phase I study is open-label, and only collect safety information of the investigational sIPVs in adults, children and infants. Phase II study is double-blind, randomized, controlled study of the immunogenicity and safety of the investigational vaccines and two other commercialized inactivated poliovirus vaccines in healthy infants.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
SINGLE
Enrollment
708
The investigational vaccines were manufactured by Sinovac Biotech Co., Ltd..
The investigational vaccines were manufactured by Sinovac Biotech Co., Ltd..
The investigational vaccines were manufactured by Sinovac Biotech Co., Ltd..
Pizhou City Center for Disease Control and Prevention
Xuzhou, Jiangsu, China
The seroconversion rates (SCRs) of each group of the phase II trial after three-dose regimen
Subjects whose pre-immune antibody level \< 1:8 and post-immune antibody level ≥ 1:8, or those whose pre-immune antibody level ≥ 1:8 and the increase of post-immune antibody level ≥ 4 folds are considered seroconverted.
Time frame: 90 days
The post-immune geometric mean titer (GMT) of each group of the phase II trial after three-dose regimen
GMT of each group of the phase II trial 30 days after three-dose regimen which lasts 60 days.
Time frame: 90 days
The geometric mean fold increase (GMI) of each group after three-dose regimen
The GMI is the increase of post-immune GMT from pre-immune GMT.
Time frame: 90 days
The incidences of solicited adverse events (AEs) of each group in both phase I and II trials
Solicited AEs occurred within 7 days after each injection will be collected.
Time frame: 7 days
The incidences of unsolicited adverse events (AEs) of each group in both phase I and II trials
Unsolicited AEs occurred within 30 days after each injection will be collected.
Time frame: 30 days
The incidences of serious adverse events (SAEs) of each group in both phase I and II trials
SAEs occurred within 30 days after each injection will be collected.
Time frame: 30 days
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The investigational vaccines were manufactured by Sinovac Biotech Co., Ltd..
The investigational vaccines were manufactured by Sinovac Biotech Co., Ltd..
The control vaccine was manufactured by Chinese Academy of Medical Sciences.
The control vaccine was manufactured by Sanofi Pasteur S.A (IMOVAX POLIO).