A Randomized, Controlled, Multi-center Clinical Trial to Evaluate the Sequential Procedures of Inactivated Poliomyelitis Vaccine Made From Sabin Strains (Vero cell)

• Register: ChiCTR
• Last refreshed on: 12 April 2021
• Main ID: ChiCTR2000040818
• Date of registration: 2020-12-11
• Prospective Registration: No
• Primary sponsor: Inner Mongolia Autonomous Region Center for Diseases Prevention and Control
• Public title: A Randomized, Controlled, Multi-center Clinical Trial to Evaluate the Sequential Procedures of Inactivated Poliomyelitis Vaccine Made From Sabin Strains (Vero cell)
• Scientific title: A Randomized, Controlled, Multi-center Clinical Trial to Evaluate the Sequential Procedures of Inactivated Poliomyelitis Vaccine Made From Sabin Strains (Vero cell)
• Date of first enrolment: 2018-05-01
• Target sample size: Group1 (sIPV+bOPV+bOPV):207;Group2 (sIPV+sIPV+bOPV):207;Group3 (sIPV+sIPV+sIPV):207;
• Recruitment status: Completed
• URL: http://www.chictr.org.cn/showproj.aspx?proj=64836
• Study type: Interventional study
• Study design: Parallel
• Phase: 4

Countries of recruitment

China

Contacts

• Name: Shaohong Yan

• Name: Haiping Chen
• Affiliation: China National Biotec Group Company Limited

Key inclusion & exclusion 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 never been vaccinated with rotavirus or DPT vaccine;
5.subjects did not receive any vaccination within 14 days;
6.axillary temperature <= 37.0 degrees C.
Exclusion criteria: 1.With 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.With a clearly diagnosed history of thrombocytopenia or other coagulopathy, may cause contraindications for subcutaneous injection;
7.With any serious chronic illness, acute infectious diseases, or respiratory diseases;
8.Suffering from severe cardiovascular disease (pulmonary heart disease, pulmonary edema, high blood pressure can not be controlled to the normal range by drugs), liver and kidney disease, diabetes with complications;
9.With any kind of infectious, purulent, or allergic skin diseases;
10.With any other factor that makes the investigator determines the subject is unsuitable for this study.

Age minimum:
Age maximum:
Gender: Both

Health Condition(s) or Problem(s) studied

Polio

Intervention(s)

Group1 (sIPV+bOPV+bOPV):Subjects were vaccinated with 1 dose of Sabin-IPV and 2 doses of bOPV at their age of 2/3/4 months old, respectively.One month interval between each dose, complete basic immunization.;Group2 (sIPV+sIPV+bOPV):Subjects were vaccinated with 2 doses of Sabin-IPV and 1 dose of bOPV at their age of 2/3/4 months old, respectively.Complete basic immunization.;Group3 (sIPV+sIPV+sIPV):Subjects were vaccinated with 3 doses of Sabin-IPV at their age of 2/3/4 months old, respectively.Complete basic immunization.;

Primary Outcome(s)

Antibody positive rate;Seroconversion rate;Geometric Mean Titres (GMT);Geometric Mean Titres (GMT);

Secondary Outcome(s)

the occurrence of adverse events;

Source(s) of Monetary Support

Beijing Biological Products Institute Co., Ltd.

Ethics review

Status: Approved
Approval date: 05/07/2018
Contact:

Jingyuan Yang