Clinic Trial to Evaluate the Safety and Immunogenicity of Combined Immunization of sIPV and DTaP

A Randomized, Controlled, Multicenter Vaccine Clinical Trial to Evaluate The Safety and Immunogenicity of Combined Immunization With Inactivated Poliomyelitis Vaccine Made From Sabin Strains (Vero cell) and Diphtheria, Tetanus and Acellular Pertussis Combined Vaccine, Adsorbed

Status

Recruiting

Phases

Phase 4

Study type

Interventional

Source

ChiCTR

Registry ID

ChiCTR2100042116

Enrollment

Unknown

Registered

2021-01-14

Start date

2019-07-22

Completion date

Unknown

Last updated

2021-04-12

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Polio, Pertussis, Diphtheria, Tetanus

Interventions

Combined immunization of sIPV and DTaP group:For 2 months old, collect pre-immunization blood, vaccinate single dose of the first sIPV, 0.5ml per dose

for 3 months old vaccinate the second dose of sIPV and the first dose of DTaP simultaneously, 0.5ml per dose, and for 4 months old vaccinate the third dose of sIPV and the second dose o

sIPV group:For 2 months old, collect pre-immunization blood, vaccinate single dose of sIPV on 2 months old, 3 months old, 4 months old respectively, 0.5ml per dose. There is a one-month interval betwe

DTaP group:For 2 months old, collect pre-immunization blood, vaccinate single dose of sIPV on 2 months old, 0.5ml per dose

then vaccinate single dose of DTaP on 3 months old, 4 months old, 5 months old respectively, 0.5ml per dose. There is a one-month interval between each vaccination. After completing immune

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: 1)Subjects aged 2 months old at the date of recruitment; 2)with informed consent signed by parent(s) or guardians; 3)parent(s) or guardians are able to attend all planned clinical appointments and obey and follow all study instructions; 4)subjects have not been vaccinated with IPV vaccine, OPV vaccine, DTP vaccine and related vaccines; 5)The interval between the last vaccination of the subjects >= 14 days; 6)Before entering this study, the body temperature was confirmed to be <= 37.0 degrees C by medical history and clinical examination.

Exclusion criteria

Exclusion criteria: 1)Subject who has a medical history with Hypersensitiveness, eclampsia, epilepsy, cerebropathia and neurological illness; 2)Allergic to any ingredient of vaccine or with allergy history to any vaccine; 3)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); 4)Administration of immunoglobulins within 30 days prior to this study; 5)Acute febrile disease(temperature >= 37.0 degrees C) or infectious disease; 6)Have a clearly diagnosed history of thrombocytopenia or other coagulopathy, may cause contraindications for subcutaneous injection; 7)Any serious chronic illness, acute infectious diseases, or respiratory diseases; 8)Severe cardiovascular disease, liver and kidney diseases or diabetes with complications; 9)Various infectious, suppurative and allergic skin diseases; 10)Any situation that the researchers believe may affect the evaluation of the trial.

Design outcomes

Primary

Measure	Time frame
Antibody positive rate ;Seroconversion rate;Geometric Mean Titres (GMT);Geometric Mean Titres (GMT);Geometric Mean Concentration (GMC);Geometric Mean Concentration (GMC);	—

Secondary

Measure	Time frame
Adverse Events Following Immunization (AEFI);	—

Countries

China

Contacts

Public ContactFenyang Tang

Jiangsu Province Centers for Disease Control and Prevention

tfyepi@163.com+86 25-83759419

Outcome results

None listed

Source: ChiCTR (via WHO ICTRP) · Data processed: Feb 4, 2026