Immunogenicity and Safety of Sabin-IPV Replacement Vaccination

NCT04051736 | Completed Phase 4 DMC

• 1 other identifier: ChinaNBG
• Study Type: interventional
• Target: 360
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Vaccination

Outcome Measures

Primary Outcomes (1)

• Seroconversion rate

  determine the seroconversion rate of both groups

  4 months

Secondary Outcomes (1)

• Neutralizing antibody titers

  4 months

Other Outcomes (1)

• number of participants who experience adverse events

  6 months

Study Arms (2)

group 1

EXPERIMENTAL

180 2-month-old subjects will be enrolled with vaccination schedule as follows: 1st: Salk-IPV; 2nd: Sabin-IPV; 3rd: Sabin-IPV

Biological: Inactivated Polio Vaccine

group 2

ACTIVE COMPARATOR

180 2-month-old subjects will be enrolled with vaccination schedule as follows: 1st: Salk-IPV; 2nd: Salk-IPV; 3rd: Salk-IPV

Biological: Inactivated Polio Vaccine

Interventions

Inactivated Polio Vaccine BIOLOGICAL

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

group 1; group 2

Eligibility Criteria

• Age: 60 Days - 89 Days
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17)

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 vaccines 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;

Sponsors & Collaborators

• China National Biotec Group Company Limited: lead
• Beijing Institute of Biological Products Co Ltd.: collaborator
• Beijing Center for Disease Control and Prevention: collaborator
• Peking University: collaborator

Study Sites (1)

Beijing Center for Disease Control and Prevention

Beijing, Beijing Municipality, 100013, China

Location

Related Publications (1)

• Chen H, Gao Z, Bai S, Liu X, Han S, Xiao Y, Liu F, Yu Y, Sun H, Yang X. Immunogenicity and safety of sabin-strain based inactivated poliovirus vaccine replacing salk-strain based inactivated poliovirus vaccine: An innovative application of different strain-IPVs replacement. Vaccine. 2021 Apr 22;39(17):2467-2474. doi: 10.1016/j.vaccine.2021.02.073. Epub 2021 Mar 31.

  PMID: 33810904 DERIVED

MeSH Terms

Interventions

Poliovirus Vaccine, Inactivated

Intervention Hierarchy (Ancestors)

Vaccines, Inactivated; Vaccines; Biological Products; Complex Mixtures; Poliovirus Vaccines; Viral Vaccines

Study Officials

• Jiang WU

  Beijing Center for Disease Control and Prevention

  STUDY DIRECTOR

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 8, 2019
• First Posted: August 9, 2019
• Study Start: March 1, 2018
• Primary Completion: December 28, 2018
• Study Completion: August 31, 2020
• Last Updated: September 9, 2020

Record last verified: 2020-09

Locations

CN (1)