Clinic Trial to Evaluate the Safety and Immunogenicity of Combined Immunization of sIPV and DTaP

A Randomized, Controlled, Multicenter Vaccine Clinical Trial to Evaluate The Safety and Immunogenicity of Combined Immunization With sIPV and DTaP

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.

Study Overview

• Status: Unknown
• Conditions: Vaccination
• Intervention / Treatment: Biological: Sabin-IPV and DTaP; Biological: Sabin-IPV; Biological: DTaP

Detailed 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 Type: Interventional
• Enrollment (Anticipated): 702
• Phase: Phase 4

Contacts and Locations

Study Locations

• China
  • Shaanxi
    • Xi'an, Shaanxi, China, 710054
      • Recruiting
      • Shaanxi Provincial Center for Disease Control and Prevention
      • Contact: Shaobai ZHANG; Phone Number: +86-29-82231502; Email: maolyzhang@163.com

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 3 months to 3 months (Child)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria:

• subjects aged 3 months 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 have not been vaccinated with IPV vaccine, OPV vaccine, DTP vaccine and related vaccines;

Exclusion Criteria:

• subject who has a medical history with Hypersensitiveness, eclampsia, epilepsy, cerebropathia and neurological illness;
• allergic to any ingredient of vaccine or with allergy history to any vaccine;
• subjects with immunodeficency or suspected impairment of immunologic function (e.g. caused by HIV), or subjects are in the process of immunosuppressor therapy(Taking orally injecting of steroid hormone);
• administration of immunoglobulins within 30 days prior to this study;
• acute febrile disease(temperature ≥ 37.0°C) or infectious disease;
• have a clearly diagnosed history of thrombocytopenia or other coagulopathy, may cause contraindications for subcutaneous injection;
• any serious chronic illness, acute infectious diseases, or respiratory diseases;
• severe cardiovascular disease, liver and kidney diseases or diabetes mellitus with complications;
• any kind of infectious, purulent, or allergic skin diseases;
• any other factor that makes the investigator determines the subject is unsuitable for this study.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: group 1; 234 subjects; simultaneously administration of Sabin-IPV and DTaP at the age of 3/4/5 months old, 0.5 ml each dose, respectively	Biological: Sabin-IPV and DTaP; Sabin-IPV +DTaP at the age of 3/4/5 months old respectively
Active Comparator: group 2; 234 subjects; Sabin-IPV only at the age of 3/4/5 months old, 0.5 ml each dose, respectively	Biological: Sabin-IPV; Sabin-IPV only at the age of 3/4/5 months old respectively
Active Comparator: group 3; 234 subjects; DTaP only at the age of 3/4/5 months old, 0.5 ml each dose, respectively	Biological: DTaP; DTaP only at the age of 3/4/5 months old respectively

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Seroconversion rate I	determine the rate of positive seroconversion against poliovirus type I, II and III of the 3 groups	1 month after the 3rd dose
Seroconversion rate II	determine the positive seroconversion rate of anti-pertussis toxoid , anti- filamentous hemagglutinin, anti-diphtheria toxoid and anti-tetanic antibody of the 3 groups	1 month after the 3rd dose
Neutralizing antibody titers I	Measure neutralizing antibody titers against poliovirus type I, II and III	1 month after the 3rd dose
Neutralizing antibody titers II	Measure neutralizing antibody titers against diphtheria, pertussis toxoid, pertussis filamentous hemagglutinin, and tetanic of the 3 groups	1 month after the 3rd dose

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
safety outcomes	Adverse event following vaccinations	6 months

Collaborators and Investigators

• Sponsor: China National Biotec Group Company Limited
• Collaborators: Beijing Institute of Biological Products Co Ltd.; Wuhan Institute of Biological Products Co., Ltd; Hubei Provincial Center for Disease Control and Prevention; Shaanxi Provincial Center for Disease Control and Prevention
• Investigators: Principal Investigator: Shaobai Zhang, Shaanxi Provincial Center for Disease Control and Prevention

Study record dates

Study Major Dates

• Study Start (Actual): August 10, 2019
• Primary Completion (Anticipated): December 31, 2019
• Study Completion (Anticipated): May 30, 2020

Study Registration Dates

• First Submitted: August 9, 2019
• First Submitted That Met QC Criteria: August 9, 2019
• First Posted (Actual): August 12, 2019

Study Record Updates

• Last Update Posted (Actual): August 12, 2019
• Last Update Submitted That Met QC Criteria: August 9, 2019
• Last Verified: August 1, 2019

More Information

Terms related to this study

• Other Study ID Numbers: sIPV/DTaP-2019-02

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No