Evaluation of Safety and Immunogenicity of Combined Immunization of sIPV, DTaP and HepA

A Randomized, Controlled, Multicenter Phase 4 Clinic Trial to Evaluate the Safety and Immunogenicity of Combined Immunization of Sabin-strain Inactivated Polio Vaccine (sIPV), Diphtheria, Tetanus, Pertussis (DTaP) Vaccine and Live Attenuated Hepatitis A Vaccine (HepA)

Eligible,healthy infants who have finished the 3-dose-schedule of sIPV+DTaP combined vaccination clinical trial (NCT04053010) will be recruited and divided into 4 groups, and will receive vaccination at the age of 18-month-old as follows:

1. Group 1: sIPV + DTaP + HepA,
2. Group 2: sIPV only,
3. Group 3: DTaP only,
4. Group 4: HepA only.

The immunogenicity and safety of the 4 groups will be compared and analyzed before and 30-40 days after vaccination.

Study Overview

• Status: Unknown
• Conditions: Vaccination
• Intervention / Treatment: Biological: sIPV+DTaP+HepA; Biological: sIPV; Biological: DTaP; Biological: HepA

Detailed Description

Following the clinical trial of "Combined Immunization of sIPV and DTaP" in 2019, this study recruits 600 18-month-old subjects who have received 3 doses of sIPV + DTaP, and gives them a 4th dose of vaccination (booster immunization). They are divided into 4 different groups, with 150 subjects in each group, and are innoculated with different vaccines.

To be specific, group 1 receives sIPV (0.5ml)+ DTaP (0.5ml)+ HepA(0.5ml); group 2 receives sIPV (0.5ml); group 3 receives DTaP (0.5ml); group 4 receives HepA (0.5ml).

Blood samples will be collected before vaccination and 30-40 days after this booster immunization. Neutralization antibody will 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): 600
• Phase: Phase 4

Contacts and Locations

Study Locations

• China
  • Hebei
    • Shijia Zhuang, Hebei, China, 050024
      • Recruiting
      • Hebei Provincial Center for Disease Control and Prevention
      • Contact: Zhenguo Zhang; Phone Number: +86-311-86573434; Email: hbepi@hotmail.com
  • Shaanxi
    • Xi'an, Shaanxi, China, 710054
      • Recruiting
      • Shaanxi Provincial Center for Disease Control and Prevention
      • Contact: Shaobai Zhang; Phone Number: +86-29-82211350; Email: maolyzhang@163.com
  • Shanxi
    • Taiyuan, Shanxi, China, 030012
      • Recruiting
      • Shanxi Provincial Center for Disease Control and Prevention
      • Contact: Shaoying Chang; Phone Number: +86-351-7553136; Email: chshy007@163.com

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 must have participated the clinical trial titled "Clinic Trial to Evaluate the Safety and Immunogenicity of Combined Immunization of sIPV and DTaP" (NCT04053010) in 2019, and have finished 3 doses of combined immunization of sIPV and DTaP;
• Subjects aged 18-19 months old at the date of recruitment;
• With informed consent form (ICF) signed by parent(s) or guardian(s);
• Parent(s) or guardian(s) are able to attend all planned clinical appointments and obey/follow all study instructions;
• Subjects have not been vaccinated with sIPV/DTaP/HepA at the age of 18-month-old yet;
• No less than 14 days since the last dose of vaccination;
• Axillary temperature ≤37.0℃.

Exclusion Criteria:

• With 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;
• With a clearly diagnosed history of thrombocytopenia or other coagulopathy, may cause contraindications for subcutaneous injection;
• With any serious chronic illness, acute infectious diseases, or respiratory diseases;
• With severe cardiovascular disease, liver and kidney diseases or diabetes mellitus with complications;
• With any kind of infectious, purulent, or allergic skin diseases;
• With 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

4

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: group 1 (sIPV+DTaP+HepA); 150 subjects; simultaneously administration of sIPV+DTaP+HepA as booster immunization at the age of 18 months old, 0.5 ml each, respectively	Biological: sIPV+DTaP+HepA; sIPV+DTaP+HepA at the age of 18 month old
Active Comparator: group 2 (sIPV); 150 subjects; vaccination of 0.5 ml sIPV as booster immunization at the age of 18 months old	Biological: sIPV; sIPV at the age of 18 month old
Active Comparator: group 3 (DTaP); 150 subjects; vaccination of 0.5 ml DTaP as booster immunization at the age of 18 months old	Biological: DTaP; DTaP at the age of 18 month old
Active Comparator: group 4 (HepA); 150 subjects; vaccination of 0.5 ml HepA as booster immunization at the age of 18 months old	Biological: HepA; HepA at the age of 18 month old

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Seroconversion rate (sIPV)	determine the rate of positive seroconversion against poliovirus type I, II and III of the subjects	Baseline (before vaccination) results
Seroconversion rate (sIPV)	determine the rate of positive seroconversion against poliovirus type I, II and III of the subjects	Results obtained 30-40 days after vaccination
Seroconversion rate (DTaP)	determine the positive seroconversion rate of anti-pertussis toxoid , anti- filamentous hemagglutinin, anti-diphtheria toxoid and anti-tetanic antibody of the subjects	Baseline (before vaccination) results
Seroconversion rate (DTaP)	determine the positive seroconversion rate of anti-pertussis toxoid , anti- filamentous hemagglutinin, anti-diphtheria toxoid and anti-tetanic antibody of the subjects	Results obtained 30-40 days after vaccination
Seroconversion rate (HepA)	determine the rate of positive seroconversion rate of anti-hepatitis A virus antibody of the subjects	Baseline (before vaccination) results
Seroconversion rate (HepA)	determine the rate of positive seroconversion rate of anti-hepatitis A virus antibody of the subjects	Results obtained 30-40 days after vaccination
Geometric Mean Concentration (GMC) (sIPV)	GMCs of poliovirus type I, II and III of the subjects	Baseline (before vaccination) results
Geometric Mean Concentration (GMC) (sIPV)	GMCs of poliovirus type I, II and III of the subjects	Results obtained 30-40 days after vaccination
Geometric Mean Concentration (GMC) (DTaP)	GMCs of anti-pertussis toxoid , anti- filamentous hemagglutinin, anti-diphtheria toxoid and anti-tetanic antibody of the subjects	Baseline (before vaccination) results
Geometric Mean Concentration (GMC) (DTaP)	GMCs of anti-pertussis toxoid , anti- filamentous hemagglutinin, anti-diphtheria toxoid and anti-tetanic antibody of the subjects	Results obtained 30-40 days after vaccination
Geometric Mean Concentration (GMC) (HepA)	GMCs of anti-hepatitis A virus antibody of the subjects	Baseline (before vaccination) results
Geometric Mean Concentration (GMC) (HepA)	GMCs of anti-hepatitis A virus antibody of the subjects	Results obtained 30-40 days after vaccination

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Adverse Events Following Immunization (AEFI)	analyse the incidence of adverse events following immunization, both solicited and unsolicited	0-6 months

Collaborators and Investigators

• Sponsor: China National Biotec Group Company Limited
• Collaborators: Beijing 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 Shaobai, Shaanxi Provincial Center for Disease Control and Prevention

Study record dates

Study Major Dates

• Study Start (Actual): November 11, 2020
• Primary Completion (Anticipated): August 1, 2021
• Study Completion (Anticipated): December 1, 2021

Study Registration Dates

• First Submitted: November 16, 2020
• First Submitted That Met QC Criteria: November 16, 2020
• First Posted (Actual): November 19, 2020

Study Record Updates

• Last Update Posted (Actual): November 19, 2020
• Last Update Submitted That Met QC Criteria: November 16, 2020
• Last Verified: November 1, 2020

More Information

Terms related to this study

• Other Study ID Numbers: sIPV-DTaP-HepA-2020

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