Clinical Trials Logo
  1. Home
  2. Vaccination
  3. NCT04051736

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 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.

Clinical Trial 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. ;

Study Design

Related Conditions & MeSH terms

Clinical Trial Details
NCT number NCT04051736
Study type Interventional
Source China National Biotec Group Company Limited
Contact
Status Completed
Phase Phase 4
Start date March 1, 2018
Completion date August 31, 2020
View Details
See also
  Status Clinical Trial Phase
Completed NCT05009251 - Using Explainable AI Risk Predictions to Nudge Influenza Vaccine Uptake N/A
Completed NCT03284515 - Vaccination In Pregnancy Gene Signature: VIP Signature Study
Completed NCT05012163 - Lottery Incentive Nudges to Increase Influenza Vaccinations N/A
Recruiting NCT05996549 - Cost-effectiveness of the Influenza Vaccination Phase 4
Completed NCT04323137 - Encouraging Flu Vaccination Among High-Risk Patients Identified by ML N/A
Completed NCT01224301 - School Influenza Vaccine vs Standard of Care With Nested Trial of 2 Parent Notification Intensities N/A
Completed NCT00169858 - Long Term Immunogenicity Study of Engerix-B Vaccine in 10 Year Old Children and the Effect of Booster Injections Phase 4
Completed NCT05509283 - Nudging Flu Vaccination in Patients at Moderately High Risk for Flu and Flu-related Complications N/A
Completed NCT02907580 - Influenza Vaccine Attitudes, Intent, and Receipt: Pediatric N/A
Recruiting NCT06160999 - Improving Uptake of Pediatric Vaccines Through Religious Conferences and Vaccines-in-a-van in Aceh, Indonesia N/A
Recruiting NCT03875703 - Post-Vaccination Biological Collection
Completed NCT03287830 - Flu2Text: Text Message Reminders for 2nd Dose of Influenza Vaccine N/A
Completed NCT02907645 - Influenza Vaccine Randomized Educational Trial: Adult N/A
Completed NCT03220555 - Efficacy of the Buzzy® Device on the Prevention of Health Care Induced Pediatric Pain in a Vaccination Center N/A
Withdrawn NCT05023512 - Understanding Public Attitudes Towards the COVID-19 Vaccination N/A
Recruiting NCT02937428 - To Look or Not to Look at the Needle During Vaccination Phase 3
Completed NCT00813319 - Girls OnGuard: HPV Vaccination Uptake Among African American Adolescent Females Phase 3
Completed NCT03104790 - Assessment of Viral Shedding in Children Previously in Receipt of Multiple Doses of Live Attenuated Influenza Vaccine (LAIV) Compared to Influenza Vaccine-naïve Controls Phase 4
Completed NCT04780867 - Psychological and Lifestyle Factors on Health Outcomes N/A
Completed NCT03239795 - Promoting Influenza Vaccination In General Practice Waiting Rooms N/A