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A Study to Evaluate the Immunogenicity and Safety of Sequential Vaccination Among Infants With Poliomyelitis Vaccine (Vero Cells), Inactivated, Sabin Strains (Hereinafter as "sIPV") From Different Manufacturers.
To evaluate the immunogenicity and safety of sequential vaccination with Sinovac sIPV among infants who have received two doses of Biological Products Co., Ltd. sIPV.
In this study, two hundred infants ≤ 12 months of age vaccinated with two doses of sIPV produced by Beijing Institute of Biological Products Co., Ltd., will be enrolled with a balanced male-to-female ratio. After enrollment with informed consent from the guardians of the participants, they will be divided into two groups, i.e., the study group and the control group, according to the 1:1 ratio. They will be vaccinated with one dose of the sIPV produced by Sinovac or the sIPV produced by Beijing Institute, respectively. The 30-minute observation will be conducted after the vaccination. Immediate reactions will be observed and solicited adverse events within 0-7 days, while unsolicited adverse events within 0-30 days will be collected to evaluate vaccine safety. About 2.5-3.0 ml of venous blood will be collected from all participants before and 30 days after vaccination, and anti-poliovirus type 1, type 2, and type 3 neutralizing antibody tests will be performed to evaluate immunogenicity.
Age
0 - 1 years
Sex
ALL
Healthy Volunteers
Yes
Disease Control and Prevention Center, Xiaonan District, Xiaogan City
Xiaogan, China
Start Date
May 20, 2024
Primary Completion Date
September 6, 2024
Completion Date
December 6, 2024
Last Updated
March 14, 2025
200
ACTUAL participants
sIPV
BIOLOGICAL
Lead Sponsor
Sinovac Biotech Co., Ltd
NCT05644184
NCT06947499
Data Source & Attribution
This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.
Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.
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View ClinicalTrials.gov Terms and ConditionsNCT06137664