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

Vaccination Clinical Trial

Official title:

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)

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04636827
• Other study ID #: sIPV-DTaP-HepA-2020
• Status: Recruiting
• Phase: Phase 4
• Start date: November 11, 2020
• Est. completion date: December 2021

Study information

• Verified date: November 2020
• Source: China National Biotec Group Company Limited
• Contact: Shaobai Zhang
• Phone: +86-29-82231502
• Email: maolyzhang[@]163.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 600
• Est. completion date: December 2021
• Est. primary completion date: August 2021
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Months to 19 Months

Eligibility

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.

Related Conditions & MeSH terms

• Vaccination

Intervention

Biological:
• sIPV+DTaP+HepA
sIPV+DTaP+HepA at the age of 18 month old
• sIPV
sIPV at the age of 18 month old
• DTaP
DTaP at the age of 18 month old
• HepA
HepA at the age of 18 month old

Locations

Country	Name	City	State
China	Hebei Provincial Center for Disease Control and Prevention	Shijia Zhuang	Hebei
China	Shanxi Provincial Center for Disease Control and Prevention	Taiyuan	Shanxi
China	Shaanxi Provincial Center for Disease Control and Prevention	Xi'an	Shaanxi

Sponsors (5)

Lead Sponsor	Collaborator
China National Biotec Group Company Limited	Beijing Institute of Biological Products Co., Ltd, Hubei Provincial Center for Disease Control and Prevention, Shaanxi Provincial Center for Disease Control and Prevention, Shanxi Provincial Center for Disease Control and Prevention

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Seroconversion rate (sIPV)	determine the rate of positive seroconversion against poliovirus type I, II and III of the subjects	Baseline (before vaccination) results
Primary	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
Primary	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
Primary	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
Primary	Seroconversion rate (HepA)	determine the rate of positive seroconversion rate of anti-hepatitis A virus antibody of the subjects	Baseline (before vaccination) results
Primary	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
Primary	Geometric Mean Concentration (GMC) (sIPV)	GMCs of poliovirus type I, II and III of the subjects	Baseline (before vaccination) results
Primary	Geometric Mean Concentration (GMC) (sIPV)	GMCs of poliovirus type I, II and III of the subjects	Results obtained 30-40 days after vaccination
Primary	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
Primary	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
Primary	Geometric Mean Concentration (GMC) (HepA)	GMCs of anti-hepatitis A virus antibody of the subjects	Baseline (before vaccination) results
Primary	Geometric Mean Concentration (GMC) (HepA)	GMCs of anti-hepatitis A virus antibody of the subjects	Results obtained 30-40 days after vaccination
Secondary	Adverse Events Following Immunization (AEFI)	analyse the incidence of adverse events following immunization, both solicited and unsolicited	0-6 months