Clinical Trials Logo

Clinical Trial Summary

Eligible,healthy infants will be recruited and divided into 3 groups:(1)combined immunization of sIPV and DTaP group, (2) sIPV group and (3) DTaP group. After completing the two basic vaccine EPI procedures, the immunogenicity and safety of the combined immunization group and the individual vaccination groups will be compared and analyzed.


Clinical Trial Description

It is recommended by China Food and Drug Administration (CFDA) that studies on simultaneous immunization of Sabin-IPV and DTaP be carried out as soon as possible, and the immunogenicity and safety studies should also be conducted. Currently in China the vaccination schedules of sIPV and DTaP overlap at infants' 3rd and 4th months of age. In order to avoid the vaccination time conflict and explore the possibility of simultaneous vaccination, we design this clinical study of simultaneous vaccination of the two vaccines.

To be specific, the subjects were divided into 3 groups. Group 1 : sIPV (1st, 2nd, and 3rd doses) and DTaP (1st, 2nd, and 3rd doses) were simultaneously inoculated at 3,4,5 months old ; Group 2 : received 1 dose of sIPV at 3,4,5 months old ; Group 3 : received 1 dose of DTaP at 3,4,5 months old . Blood sample would be collected both before vaccination and 28-40 days after the 3rd dose of vaccination. Neutralization antibody would also be detected to evaluate the seroprotection rates and antibody geometric mean concentrations. The safety of both immunization schedule will be monitored as well. ;


Study Design


Related Conditions & MeSH terms


NCT number NCT04053010
Study type Interventional
Source China National Biotec Group Company Limited
Contact Shaobai ZHANG
Phone +86-29-82231502
Email maolyzhang@163.com
Status Recruiting
Phase Phase 4
Start date August 10, 2019
Completion date May 30, 2020

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