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

NCT04054882 | Completed Phase 4 DMC

• 1 other identifier: sIPV/DTaP-2019-01
• Study Type: interventional
• Target: 702
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Vaccination

Outcome Measures

Primary Outcomes (3)

• 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

• 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

• numbers of participants who experience adverse events

  analyse the numbers and rates of participants who have adverse events following immunization

  6 months

Study Arms (3)

Sabin-IPV and DTaP

EXPERIMENTAL

234 subjects are simultaneously administrated with Sabin-IPV and DTaP at the age of 3/4/5 months old, 0.5 ml each dose, respectively

Biological: Sabin-IPV and DTaP

Sabin-IPV only

ACTIVE COMPARATOR

234 subjects are administrated with Sabin-IPV only at the age of 3/4/5 months old, 0.5 ml each dose, respectively

Biological: Sabin-IPV

DTaP only

ACTIVE COMPARATOR

234 subjects are administrated with DTaP only at the age of 3/4/5 months old, 0.5 ml each dose, respectively

Biological: DTaP

Interventions

Sabin-IPV and DTaP BIOLOGICAL

simultaneously administration of Sabin-IPV and DTaP

Sabin-IPV and DTaP

Sabin-IPV BIOLOGICAL

administration of Sabin-IPV only

Sabin-IPV only

DTaP BIOLOGICAL

administration of DTaP only

DTaP only

Eligibility Criteria

• Age: 3 Months - 3 Months
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17)

You may qualify if:

• 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;

You may not qualify if:

• 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.

Sponsors & Collaborators

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

Study Sites (1)

Jiangsu Provincial Center for Disease Control and Prevention

Nanjing, Jiangsu, 210009, China

Location

Related Publications (1)

• Sun X, Xu Y, Tang F, Xiao Y, Wang Z, Wang B, Zhu X, Yang X, Chen H. Immunogenicity and safety of concomitant administration of the chinese inactivated poliovirus vaccine with the diphtheria-tetanus-acellular pertussis (DTaP) vaccine in children: A multicenter, randomized, non-inferiority, controlled trial. Front Immunol. 2022 Jul 26;13:905634. doi: 10.3389/fimmu.2022.905634. eCollection 2022.

  PMID: 35958596 DERIVED

Study Officials

• Fenyang Tang

  Jiangsu Provincial Center for Disease Control and Prevention

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 9, 2019
• First Posted: August 13, 2019
• Study Start: August 16, 2019
• Primary Completion: March 30, 2020
• Study Completion: September 9, 2021
• Last Updated: July 7, 2022

Record last verified: 2019-08

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)