Evaluation of the Safety and Immunogenicity of Simultaneously Administration of sIPV and DTaP

A Randomized, Controlled, Multicenter Phase 4 Clinic Trial to Evaluate the Safety and Immunogenicity of Simultaneously Administration of sIPV and DTaP

Subjects will be recruited and divided into 3 groups:(1)combined immunization of Sabin-IPV and DTaP, (2) Sabin-IPV only and (3) DTaP only.

After finishing the two basic vaccine EPI procedures, the immunogenicity and safety of both combined immunization group and individual vaccination groups will be compared and the data will be analyzed.

Study Overview

• Status: Completed
• 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 implemented soon and the immunogenicity and safety studies should be conducted. In China according to the current vaccination schedule, the arrangement of Sabin-IPV and DTaP falls on the same date -- at infants' 3rd and 4th months of age. In order to avoid the vaccination time conflict and explore the feasibility of simultaneous immunization, we design this phase 4 clinical trial of simultaneous vaccination of the two vaccines.

To be specific, the subjects were divided into 3 groups. Group 1 : Sabin-IPV (1st, 2nd, and 3rd doses) and DTaP (1st, 2nd, and 3rd doses) are simultaneously administrated at 3,4,5 months old ; Group 2 : subjects receive 1 dose of sIPV only at 3,4,5 months old ; Group 3 : subjects receive 1 dose of DTaP only at 3,4,5 months old .

Blood samples would be collected both before vaccination and 28-40 days after the 3rd dose of vaccination. Neutralization antibody will be detected to evaluate the seroprotection rates and antibody geometric mean concentrations. The safety of both immunization schedules will be monitored too.

• Study Type: Interventional
• Enrollment (Actual): 702
• Phase: Phase 4

Contacts and Locations

Study Locations

• China
  • Jiangsu
    • Nanjing, Jiangsu, China, 210009
      • Jiangsu Provincial Center for Disease Control and Prevention

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 1 year to 1 year (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, cerebropathy and neurological illness;
• allergic to any ingredient of vaccine or with allergy history to any vaccine;
• subjects with immunodeficiency 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: Sabin-IPV and DTaP; 234 subjects are simultaneously administrated with Sabin-IPV and DTaP at the age of 3/4/5 months old, 0.5 ml each dose, respectively	Biological: Sabin-IPV and DTaP; simultaneously administration of Sabin-IPV and DTaP
Active Comparator: Sabin-IPV only; 234 subjects are administrated with Sabin-IPV only at the age of 3/4/5 months old, 0.5 ml each dose, respectively	Biological: Sabin-IPV; administration of Sabin-IPV only
Active Comparator: DTaP only; 234 subjects are administrated with DTaP only at the age of 3/4/5 months old, 0.5 ml each dose, respectively	Biological: DTaP; administration of DTaP only

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Seroconversion rates at both baseline and 30 days after the 3rd vaccination	Determine the seroconversion rates of diphtheria, tetanus, pertussis, poliovirus (types I,II,III). Diphtheria titers are determined by toxin neutralization assay; tetanus titers are determined by enzyme-linked immunosorbent assay (ELISA)	4 months
Neutralizing antibody titers at both baseline and 30 days after the 3rd vaccination	Measure neutralizing antibody titers against: (1) poliovirus type I, II and III，(2) anti-pertussis toxoid ,(3) anti- FHA,(4) anti-diphtheria toxoid and (5) anti-tetanic antibodies	4 months
numbers of participants who experience adverse events	analyse the numbers and rates of participants who have adverse events following immunization	6 months

Collaborators and Investigators

• Sponsor: China National Biotec Group Company Limited
• Collaborators: Peking University; Beijing Institute of Biological Products Co Ltd.; Sichuan Center for Disease Control and Prevention; National Institutes for Food and Drug Control, China; Chengdu Institute of Biological Products Co.,Ltd.; Jiangsu Province Center for Disease Control and Prevention; Anhui Provincial Center for Disease Control and Prevention
• Investigators: Study Director: Fenyang Tang, Jiangsu Provincial Center for Disease Control and Prevention

Publications and helpful links

General Publications

• Sun X, Xu Y, Tang F, Xiao Y, Wang Z, Wang B, Zhu X, Yang X, Chen H. Immunogenicity and safety of concomitant administration of the chinese inactivated poliovirus vaccine with the diphtheria-tetanus-acellular pertussis (DTaP) vaccine in children: A multicenter, randomized, non-inferiority, controlled trial. Front Immunol. 2022 Jul 26;13:905634. doi: 10.3389/fimmu.2022.905634. eCollection 2022.

Study record dates

Study Major Dates

• Study Start (Actual): August 16, 2019
• Primary Completion (Actual): March 30, 2020
• Study Completion (Actual): September 9, 2021

Study Registration Dates

• First Submitted: August 9, 2019
• First Submitted That Met QC Criteria: August 10, 2019
• First Posted (Actual): August 13, 2019

Study Record Updates

• Last Update Posted (Actual): July 7, 2022
• Last Update Submitted That Met QC Criteria: July 5, 2022
• Last Verified: August 1, 2019

More Information

Terms related to this study

• Other Study ID Numbers: sIPV/DTaP-2019-01

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No

Drug and device information, study documents

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