- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT04224519
Consistency Study for Three Commercial Lots of Inactivated Poliomyelitis Vaccine Made From Sabin Strain
Study Overview
Status
Conditions
Intervention / Treatment
Detailed Description
This randomized and blind clinical study includes three test groups with 400 infants for each group. Sample estimation for this study has been conducted using statistical methods.
A total of 1,200 2-month old healthy subjects were enrolled for inoculation of vaccine from 3 different lots with 1 month interval. All subjects received blood collection for immunogenicity test before and after primary immunization for evaluation of immunogenicity consistency, while safety observation was conducted within 30 days after each vaccination (30min via close safety monitoring, 0-7 days via participant diary card and 8-30 days via contact card for collection of adverse events) for safety evaluation of sIPV of 3 commercial lots.
Study Type
Enrollment (Actual)
Phase
- Phase 4
Contacts and Locations
Study Locations
-
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Yunnan
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Kunming, Yunnan, China, 650022
- Disease prevention and control center of Yunnan province
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Description
Inclusion Criteria:
- Healthy infants of 2 months of age
- The legal identity certificate (birth/household register) and vaccination certificate of the participants can be provided, and the legal guardian can provide the legal identity certificate (identity card).
- Guardians are able to understand the experimental vaccine, volunteer to participate in the study and sign informed consent for participation.
- Guardians are capable of using thermometer, graduated scale, filling diary card and contact card.
- Participants are not vaccinated with polio vaccine and immunoglobulin (except for Hepatitis b specific immunoglobulin) after birth, no vaccination of live vaccine within 28 days before enrollment and no vaccination of inactivated vaccine within 14 days before enrollment.
- Participants or guardians are able to obey and follow all study instructions, complete all the monitoring, and cooperate to complete collection of blood sample.
- Axillary temperature ≤37℃
Exclusion Criteria:
- Allergic to any active substance, inactive substance or materials used during production such as kanamycin.
- Patients with fever or acute disease.
- Have thrombocytopenia or hemorrhagic diseases
- Patients undergoing immunosuppressive therapy or immunodeficiency
- Have uncontrolled epilepsy or other progressive neurological disorders
- Other situations that the investigator consider as non-eligible
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Prevention
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Quadruple
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: Batch 1 of sIPV
The first commercial batch of sIPV
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Type I 30 DU, Type II 32 DU, Type III 45 DU
|
Experimental: Batch 2 of sIPV
The second commercial batch of sIPV
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Type I 30 DU, Type II 32 DU, Type III 45 DU
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Experimental: Batch 3 of sIPV
The third commercial batch of sIPV
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Type I 30 DU, Type II 32 DU, Type III 45 DU
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Seroconversion rate of neutralizing antibody
Time Frame: 1 month after primary immunization
|
Blood samples were collected before and after immunization.
Seroconversion rate of serum neutralizing antibody was determined.
Intergroup differences analysis of the post-immunization positive conversion and ≥4-fold increase rate of antibody was performed.
|
1 month after primary immunization
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Local and systemic adverse reactions
Time Frame: Within 1 month after primary immunization
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Safety monitoring for local and systemic adverse reaction within 30 days after 3-dose primary immunization via close monitoring or diary card.
|
Within 1 month after primary immunization
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
GMT of neutralizing antibody
Time Frame: 1 month after primary immunization
|
Blood samples were taken before and after immunization for the determination of antibody level of serum neutralizing antibody.
Intergroup differences analysis of antibody level was conducted.
|
1 month after primary immunization
|
Collaborators and Investigators
Collaborators
Investigators
- Principal Investigator: Xiaoqiang Liu, Disease prevention and control center of Yunnan province
Publications and helpful links
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- 20171217
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
IPD Plan Description
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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