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

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

Status
Active, not recruiting
Phases
Phase 4
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR2000040818
Enrollment
Unknown
Registered
2020-12-11
Start date
2018-05-01
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

Interventions

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 immuni
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.

Sponsors

Inner Mongolia Autonomous Region Center for Diseases Prevention and Control
Lead Sponsor

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 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

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.

Design outcomes

Primary

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

Secondary

MeasureTime frame
the occurrence of adverse events;

Countries

China

Contacts

Public ContactShaohong Yan
yshid2005@163.com+86-471-5984929

Outcome results

None listed

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