Immunogenicity and Safety of Sabin-IPV Replacement Vaccination

Vaccination Clinical Trial

Official title:

a Randomized, Controlled Clinical Trial of Immunogenicity and Safety of Sabin-based Inactivated Polio Vaccine Replacing Salk-based Inactivated Polio Vaccine

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04051736
• Other study ID #: ChinaNBG
• Status: Completed
• Phase: Phase 4
• Start date: March 1, 2018
• Est. completion date: August 31, 2020

Study information

• Verified date: September 2020
• Source: China National Biotec Group Company Limited
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

This study replaced the 2nd and 3rd dose of Salk-IPV (produced by Sanofi) with Sabin-IPV (produced by CNBG) and then reviewed the safety and immunogenicity of the vaccination, aiming to acquire scientific evidence for the feasibility of immunization involving different viral strains replacement.

Description:

It is required by China Food and Drug Administration (CFDA) that considering in the real situation IPV receivers may be immuned by different viral strains of this vaccine, a phase 4 clinical trial aiming to demonstrate the safety and immunogenicity of the immunization schedule should be carried out. To be specific, the subjects were divided into 2 groups.

Group 1 received Salk-IPV+Sabin-IPV+Sabin-IPV respectively at the age of 2,3,4 months old.

Group 2 received Salk-IPV+Salk-IPV+Salk-IPV respectively at the age of 2,3,4 months old.

Blood sample was collected before vaccination and 30 days after the third dose of vaccination. Neutralization antibody against type I, Type II and Type III poliomyelitis virus were detected to evaluate the seroprotection rates and antibody geometric mean concentrations. The safety of both immunization schedule will also been monitored.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 360
• Est. completion date: August 31, 2020
• Est. primary completion date: December 28, 2018
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 60 Days to 89 Days

Eligibility

Inclusion Criteria:

• 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 vaccines within 14 days;

• axillary temperature =37.0?

Exclusion Criteria:

• 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;

Related Conditions & MeSH terms

• Vaccination

Intervention

Biological:
• Inactivated Polio Vaccine
Inactivated Polio Vaccine at age of 2,3,4 months old, respectively

Locations

Country	Name	City	State
China	Beijing Center for Disease Control and Prevention	Beijing	Beijing

Sponsors (4)

Lead Sponsor	Collaborator
China National Biotec Group Company Limited	Beijing Center for Disease Control and Prevention, Beijing Institute of Biological Products Co., Ltd, Peking University

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	number of participants who experience adverse events	analyse the number and rate of vaccine participants who have adverse events following immunization	6 months
Primary	Seroconversion rate	determine the seroconversion rate of both groups	4 months
Secondary	Neutralizing antibody titers	Measure neutralizing antibody titers against poliovirus type I, II and III	4 months