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

Last updated: November 16, 2020
Sponsor: China National Biotec Group Company Limited
Overall Status: Active - Recruiting

Phase

4

Condition

N/A

Treatment

N/A

Clinical Study ID

NCT04636827
sIPV-DTaP-HepA-2020
  • Ages 18-19
  • All Genders
  • Accepts Healthy Volunteers

Study 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.

Eligibility Criteria

Inclusion

Inclusion Criteria:

  • Subjects must have participated the clinical trial titled "Clinic Trial to Evaluatethe 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 andobey/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

Exclusion Criteria:

  • With a medical history with hypersensitiveness, eclampsia, epilepsy, cerebropathia andneurological 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(Takingorally 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 causecontraindications for subcutaneous injection;
  • With any serious chronic illness, acute infectious diseases, or respiratory diseases;
  • With severe cardiovascular disease, liver and kidney diseases or diabetes mellituswith complications;
  • With any kind of infectious, purulent, or allergic skin diseases;
  • With any other factor that makes the investigator determines the subject is unsuitablefor this study.

Study Design

Total Participants: 600
Study Start date:
November 11, 2020
Estimated Completion Date:
December 31, 2021

Study 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.

Connect with a study center

  • Hebei Provincial Center for Disease Control and Prevention

    Shijia Zhuang, Hebei 050024
    China

    Active - Recruiting

  • Shaanxi Provincial Center for Disease Control and Prevention

    Xi'an, Shaanxi 710054
    China

    Active - Recruiting

  • Shanxi Provincial Center for Disease Control and Prevention

    Taiyuan, Shanxi 030012
    China

    Active - Recruiting

Not the study for you?

Let us help you find the best match. Sign up as a volunteer and receive email notifications when clinical trials are posted in the medical category of interest to you.