Poliomyelitis Clinical Trial
Official title:
Sero-conversion Study for a Two-dose Schedule of Sabin Strain Inactivated Poliovirus Vaccine in China
This study aims to obtain the direct domestic IPV vaccine monitoring data for the CNBG
products, and provide scientific evidence for the National Immunization Program and long-term
polio vaccine immunization policy.
The overall objective of this research is to determine the seroconversion rates of two
reduced Sabin IPV schedules in Chinese children - a 2-dose schedule and a 3-dose schedule.
In April 2017, WHO/SAGE recommended that a two-dose, IPV-only schedule can be used after
polio eradication, with a schedule seroconversion target of at least 90%. The recommendation
was based in part on a study conducted in Cuba using Salk-IPV at 4 months and 8 months of
age. However, for domestic Sabin IPVs, there are no such data to support a 2-dose schedule
among Chinese infants.Two Sabin IPV products that are available to China's National
Immunization Program - produced by Kunming Bio institute and China National Biotec Group
(CNBG).The monitoring study on sIPV produced by Kunming Bio institute has already applied for
approval.This study aims to obtain the direct domestic IPV vaccine monitoring data for the
CNBG products, and provide scientific evidence for the National Immunization Program and
long-term polio vaccine immunization policy.
The overall objective of this research is to determine the seroconversion rates of two
reduced Sabin IPV schedules in Chinese children - a 2-dose schedule and a 3-dose schedule.
The specific objectives of the study are to:
1. Determine whether the seroconversion rate is above 90% with a 2-dose Sabin IPV schedule,
with the first dose given at 4 months and the second dose given ≥4 months after the
first dose.
2. Measure neutralizing antibody titers against poliovirus type I, II and III among
two-dose Sabin IPV alone schedule, compared with three-dose Sabin IPV alone schedule.
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