Clinical trial NCT04636827: Evaluation of Safety and Immunogenicity of Combined Immunization of sIPV, DTaP and HepA
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)
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE4
Conditions: Vaccination
Lead sponsor: China National Biotec Group Company Limited
Sponsor class: INDUSTRY
Collaborators: name: Shaanxi Provincial Center for Disease Control and Prevention
name: Hubei Provincial Center for Disease Control and Prevention
name: Beijing Institute of Biological Products Co Ltd.
First posted: 2020-11-19
Enrollment: 600
Sex: ALL
Minimum age (years): 18
Maximum age (years): 19
Standard ages: CHILD
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief 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.

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.

Eligibility criteria: 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.

Primary outcomes:
measure: Seroconversion rate (sIPV)
timeFrame: Baseline (before vaccination) results
measure: Seroconversion rate (sIPV)
timeFrame: Results obtained 30-40 days after vaccination
measure: Seroconversion rate (DTaP)
timeFrame: Baseline (before vaccination) results
measure: Seroconversion rate (DTaP)
timeFrame: Results obtained 30-40 days after vaccination
measure: Seroconversion rate (HepA)
timeFrame: Baseline (before vaccination) results
measure: Seroconversion rate (HepA)
timeFrame: Results obtained 30-40 days after vaccination
measure: Geometric Mean Concentration (GMC) (sIPV)
timeFrame: Baseline (before vaccination) results
measure: Geometric Mean Concentration (GMC) (sIPV)
timeFrame: Results obtained 30-40 days after vaccination
measure: Geometric Mean Concentration (GMC) (DTaP)
timeFrame: Baseline (before vaccination) results
measure: Geometric Mean Concentration (GMC) (DTaP)
timeFrame: Results obtained 30-40 days after vaccination
measure: Geometric Mean Concentration (GMC) (HepA)
timeFrame: Baseline (before vaccination) results
measure: Geometric Mean Concentration (GMC) (HepA)
timeFrame: Results obtained 30-40 days after vaccination
Secondary outcomes:
measure: Adverse Events Following Immunization (AEFI)
timeFrame: 0-6 months
Other outcomes:
Locations:
city: Shijia Zhuang
country: China
facility: Hebei Provincial Center for Disease Control and Prevention
state: Hebei
city: Xi'an
country: China
facility: Shaanxi Provincial Center for Disease Control and Prevention
state: Shaanxi
city: Taiyuan
country: China
facility: Shanxi Provincial Center for Disease Control and Prevention
state: Shanxi
Study officials:
affiliation: Shaanxi Provincial Center for Disease Control and Prevention
name: Shaobai Shaobai
role: PRINCIPAL_INVESTIGATOR
References: