To Evaluate the Immunogenicity and Safety of Sequential Immunization Schedules of Sabin IPV and bOPV
A Randomized, Multi-center, Controlled Clinical Trial for Evaluating the Immunogenicity and Safety of Sequential Immunization Schedules of Sabin IPV and bOPV
1 other identifier
interventional
604
1 country
1
Brief Summary
The purpose of this study is to evaluate the immunogenicity and safety of sequential immunization schedules of Sabin IPV and bOPV.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for phase_4
Started Mar 2018
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
Study Start
First participant enrolled
March 1, 2018
CompletedPrimary Completion
Last participant's last visit for primary outcome
January 25, 2019
CompletedStudy Completion
Last participant's last visit for all outcomes
June 12, 2019
CompletedFirst Submitted
Initial submission to the registry
August 9, 2019
CompletedFirst Posted
Study publicly available on registry
August 13, 2019
CompletedAugust 13, 2019
August 1, 2019
11 months
August 9, 2019
August 11, 2019
Conditions
Outcome Measures
Primary Outcomes (1)
Seroconversion rates at both baseline and 30 days after the 3rd vaccination
Determine the seroconversion rates of poliovirus (types I,II,III）at both baseline and 30 days after the 3rd vaccination
4 months
Secondary Outcomes (1)
Neutralizing antibody titers at both baseline and 30 days after the 3rd vaccination
4 months
Other Outcomes (1)
the occurrence of adverse events
6 months
Study Arms (3)
sIPV+bOPV+bOPV
EXPERIMENTAL202 subjects were vaccinated with 1 dose of Sabin-IPV and 2 doses of bOPV at their age of 2/3/4 months old, respectively
sIPV+sIPV+bOPV
ACTIVE COMPARATOR197 subjects were vaccinated with 2 doses of Sabin-IPV and 1 dose of bOPV at their age of 2/3/4 months old, respectively
sIPV+sIPV+sIPV
ACTIVE COMPARATOR205 subjects were vaccinated with 3 doses of Sabin-IPV at their age of 2/3/4 months old, respectively
Interventions
202 subjects were vaccinated with 1 dose of Sabin-IPV and 2 doses of bOPV at their age of 2/3/4 months old, respectively
197 subjects were vaccinated with 2 doses of Sabin-IPV and 1 dose of bOPV at their age of 2/3/4 months old, respectively
205 subjects were vaccinated with 3 doses of Sabin-IPV at their age of 2/3/4 months old, respectively
Eligibility Criteria
You may qualify if:
- subjects aged from 60 days to 89 days old at the date of recruitment;
- with informed consent signed by parent(s) or guardians;
- parent(s) or guardians are able to attend all planned clinical appointments and obey and follow all study instructions;
- subjects did not receive any vaccination within 14 days;
- axillary temperature ≤37.0℃
You may not qualify if:
- allergic to any ingredient of vaccine or with allergy history to any vaccine;
- acute febrile disease or infectious disease;
- serious chronic diseases;
- any other factor that makes the investigator determines the subject is unsuitable for this study;
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- China National Biotec Group Company Limitedlead
- Inner Mongolia Autonomous Region Center for Diseases Prevention and Controlcollaborator
- Shaanxi Provincial Center for Disease Control and Preventioncollaborator
- Hubei Provincial Center for Disease Control and Preventioncollaborator
- Peking Universitycollaborator
Study Sites (1)
Inner Mongolia Autonomous Region Center for Diseases Prevention and Control
Hohhot, Inner Mongolia, 010031, China
Related Publications (1)
Yan S, Chen H, Zhang Z, Chang S, Xiao Y, Luo L, Zhang Z, Sun L, Chen X, Yang Y, Shi X, Guo Y, Sun Y, Li H, Li N, Han S, Ma M, Yang X. Immunogenicity and safety of different sequential schedules of Sabin strain-based inactivated poliovirus vaccination: A randomized, controlled, open-label, phase IV clinical trial in China. Vaccine. 2020 Sep 11;38(40):6274-6279. doi: 10.1016/j.vaccine.2020.07.042. Epub 2020 Jul 31.
PMID: 32747216DERIVED
Study Officials
- PRINCIPAL INVESTIGATOR
Shaohong Yan
Inner Mongolia Autonomous Region Center for Diseases Prevention and Control
Study Design
- Study Type
- interventional
- Phase
- phase 4
- Allocation
- RANDOMIZED
- Masking
- SINGLE
- Who Masked
- OUTCOMES ASSESSOR
- Purpose
- PREVENTION
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
August 9, 2019
First Posted
August 13, 2019
Study Start
March 1, 2018
Primary Completion
January 25, 2019
Study Completion
June 12, 2019
Last Updated
August 13, 2019
Record last verified: 2019-08
Data Sharing
- IPD Sharing
- Will not share