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

Vaccination Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04054882
• Other study ID #: sIPV/DTaP-2019-01
• Status: Completed
• Phase: Phase 4
• Start date: August 16, 2019
• Est. completion date: September 9, 2021

Study information

• Verified date: August 2019
• Source: China National Biotec Group Company Limited
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 702
• Est. completion date: September 9, 2021
• Est. primary completion date: March 30, 2020
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 3 Months to 3 Months

Eligibility

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.

Related Conditions & MeSH terms

• Vaccination

Intervention

Biological:
• Sabin-IPV and DTaP
simultaneously administration of Sabin-IPV and DTaP
• Sabin-IPV
administration of Sabin-IPV only
• DTaP
administration of DTaP only

Locations

Country	Name	City	State
China	Jiangsu Provincial Center for Disease Control and Prevention	Nanjing	Jiangsu

Sponsors (8)

Lead Sponsor	Collaborator
China National Biotec Group Company Limited	Anhui Provincial Center for Disease Control and Prevention, Beijing Institute of Biological Products Co Ltd., Chengdu Institute of Biological Products Co.,Ltd., Jiangsu Province Center for Disease Control and Prevention, National Institutes for Food and Drug Control, China, Peking University, Sichuan Center for Disease Control and Prevention

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	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
Primary	numbers of participants who experience adverse events	analyse the numbers and rates of participants who have adverse events following immunization	6 months