Evaluation of Immunogenicity and Safety of Combined Immunization of sIPV, DTaP and MMR
A Randomized, Controlled, Multicenter Phase 4 Clinic Trial to Evaluate the Immunogenicity and Safety of Combined Immunization of Sabin-strain Inactivated Polio Vaccine (sIPV), Diphtheria, Tetanus, Pertussis Vaccine (DTaP) and Measles, Moms and Rubella Vaccine (MMR)
1 other identifier
interventional
600
1 country
3
Brief Summary
Eligible,healthy infants who have finished the 3-dose-schedule of sIPV+DTaP combined vaccination clinical trial (NCT04054882) will be recruited and divided into 4 groups, and will receive vaccination at the age of 18-month-old as follows: Group 1: sIPV + DTaP + MMR, Group 2: sIPV only, Group 3: DTaP only, Group 4: MMR only. The immunogenicity and safety of the 4 groups will be compared and analyzed before and 30 days after vaccination.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for phase_4
Started Nov 2020
Shorter than P25 for phase_4
3 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
Study Start
First participant enrolled
November 13, 2020
CompletedFirst Submitted
Initial submission to the registry
November 17, 2020
CompletedFirst Posted
Study publicly available on registry
November 20, 2020
CompletedPrimary Completion
Last participant's last visit for primary outcome
September 1, 2021
CompletedStudy Completion
Last participant's last visit for all outcomes
December 1, 2021
CompletedDecember 10, 2020
December 1, 2020
10 months
November 17, 2020
December 9, 2020
Conditions
Outcome Measures
Primary Outcomes (12)
Seroconversion rate (sIPV)
determine the rate of positive seroconversion against poliovirus type I, II and III of the subjectsdetermine the rate of positive seroconversion against poliovirus type I, II and III of the subjects
Baseline (before vaccination) results
Seroconversion rate (sIPV)
determine the rate of positive seroconversion against poliovirus type I, II and III of the subjectsdetermine the rate of positive seroconversion against poliovirus type I, II and III of the subjects
Results obtained 30 days after vaccination
Seroconversion rate (DTaP)
determine the positive seroconversion rate of anti-pertussis toxoid , anti- filamentous hemagglutinin, anti-diphtheria toxoid and anti-tetanic antibody of the subjects
Baseline (before vaccination) results
Seroconversion rate (DTaP)
determine the positive seroconversion rate of anti-pertussis toxoid , anti- filamentous hemagglutinin, anti-diphtheria toxoid and anti-tetanic antibody of the subjects
Results obtained 30 days after vaccination
Seroconversion rate (MMR)
determine the positive seroconversion rate of measles, mumps, rubella antibodies of the subjects
Baseline (before vaccination) results
Seroconversion rate (MMR)
determine the positive seroconversion rate of measles, mumps, rubella antibodies of the subjects
Results obtained 30 days after vaccination
Geometric Mean Concentration (GMC) (sIPV)
GMCs of poliovirus type I, II and III of the subjects
Baseline (before vaccination) results
Geometric Mean Concentration (GMC) (sIPV)
GMCs of poliovirus type I, II and III of the subjects
Results obtained 30 days after vaccination
Geometric Mean Concentration (GMC) (DTaP)
GMCs of anti-pertussis toxoid , anti- filamentous hemagglutinin, anti-diphtheria toxoid and anti-tetanic antibody of the subjects
Baseline (before vaccination) results
Geometric Mean Concentration (GMC) (DTaP)
GMCs of anti-pertussis toxoid , anti- filamentous hemagglutinin, anti-diphtheria toxoid and anti-tetanic antibody of the subjects
Results obtained 30 days after vaccination
Geometric Mean Concentration (GMC) (MMR)
GMCs of measles, mumps, rubella antibodies of the subjects
Baseline (before vaccination) results
Geometric Mean Concentration (GMC) (MMR)
GMCs of measles, mumps, rubella antibodies of the subjects
Results obtained 30 days after vaccination
Secondary Outcomes (1)
Adverse Events Following Immunization (AEFI)
0-6 months
Study Arms (4)
group 1 (sIPV+DTaP+MMR)
EXPERIMENTAL150 subjects; simultaneously administration of sIPV+DTaP+MMR as booster immunization at the age of 18 months old, 0.5 ml each, respectively
group 2 (sIPV)
ACTIVE COMPARATOR150 subjects; vaccination of 0.5 ml sIPV as booster immunization at the age of 18 months old
group 3 (DTaP)
ACTIVE COMPARATOR150 subjects; vaccination of 0.5 ml DTaP as booster immunization at the age of 18 months old
group 4 (MMR)
ACTIVE COMPARATOR150 subjects; vaccination of 0.5 ml MMR as booster immunization at the age of 18 months old
Interventions
Eligibility Criteria
You may qualify if:
- Subjects must have participated the clinical trial titled "Clinic Trial to Evaluate the Safety and Immunogenicity of Combined Immunization of sIPV and DTaP" (NCT04054882) in 2019, and have finished 3 doses of combined immunization of sIPV and DTaP;
- Subjects aged 18 months old at the date of recruitment;
- With informed consent form (ICF) signed by parent(s) or guardian(s);
- Parent(s) or guardian(s) are able to attend all planned clinical appointments and obey/follow all study instructions;
- Subjects have been vaccinated with a first dose of MMR, but have not been vaccinated with the 2nd dose of MMR and the booster (4th) dose of sIPV and DTaP;
- No less than 14 days since the last dose of vaccination;
- Axillary temperature ≤37.0℃.
You may not qualify if:
- With a medical history with hypersensitiveness, eclampsia, epilepsy, cerebropathia and neurological illness;
- Allergic to any ingredient of vaccine or with allergy history to any vaccine;
- 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);
- Administration of immunoglobulins within 30 days prior to this study;
- Acute febrile disease(temperature ≥ 37.0°C) or infectious disease;
- With a clearly diagnosed history of thrombocytopenia or other coagulopathy, may cause contraindications for subcutaneous injection;
- With any serious chronic illness, acute infectious diseases, or respiratory diseases;
- With severe cardiovascular disease, liver and kidney diseases or diabetes mellitus with complications;
- With any kind of infectious, purulent, or allergic skin diseases;
- With any other factor that makes the investigator determines the subject is unsuitable for this study.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- China National Biotec Group Company Limitedlead
- Jiangsu Province Centers for Disease Control and Preventioncollaborator
- Anhui Provincial Center for Disease Control and Preventioncollaborator
- Sichuan Center for Disease Control and Preventioncollaborator
- Beijing Institute of Biological Products Co Ltd.collaborator
- Chengdu Institute of Biological Products Co.,Ltd.collaborator
- Peking Universitycollaborator
- National Institutes for Food and Drug Control, Chinacollaborator
Study Sites (3)
Anhui Provincial Center for Disease Control and Prevention
Hefei, Anhui, 230601, China
Jiangsu Province Centers for Disease Control and Prevention
Nanjing, Jiangsu, 210009, China
Sichuan Center for Disease Control and Prevention
Chengdu, Sichuan, 610041, China
Study Officials
- PRINCIPAL INVESTIGATOR
Fenyang Tang
Jiangsu Province Centers for Disease Control and Prevention
Central Study Contacts
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
November 17, 2020
First Posted
November 20, 2020
Study Start
November 13, 2020
Primary Completion
September 1, 2021
Study Completion
December 1, 2021
Last Updated
December 10, 2020
Record last verified: 2020-12
Data Sharing
- IPD Sharing
- Will not share