- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT03133923
Phase II of Live Attenuated Mumps (F-genotype) Vaccine (Human Diploid Cell, KMB-17) in Chinese Infants
Safety and Efficacy of Attenuated Mumps Vaccine (Human Diploid Cell)
Study Overview
Status
Conditions
Intervention / Treatment
- Biological: ≥3.0 lgCCID50/mlbut <3.5lgCCID50/ml Live Attenuated Mumps Vaccine (Human Diploid Cell) in infants(8-24 months old)
- Biological: ≥4.5 lgCCID50/ml Live Attenuated Mumps Vaccine (Human Diploid Cell) in infants(8-24 months old)
- Biological: Measles and Mumps Combined Vaccine,Live(SIBP)( positive control)
Detailed Description
In order to evaluation the safety and immunogenicity of different doses Live Attenuated Mumps Vaccine (Human diploid cell).The study will Determine the optimal dose of vaccine and provide the clinical trail basis for the phase Ⅲ trail design.
Primary objective:
After single dose immunization of low dose(≥3.0but<3.5lgCCID50)、high dose (≥4.5lgCCID50)Live Attenuated Mumps Vaccine (Human Diploid Cell) in Chinese healthy Infants volunteer aged from 8 to 24 months old.the study will evaluate the standardized positive rate of neutralizing antibody and the GMT of the hemagglutination inhibition antibody and neutralizing antibody,proposing the immune reference dose for phase III clinical trials.
Secondary objective: Evaluate the safety of low dose(≥3.0but<3.5lgCCID50)、high dose (≥4.5lgCCID50)Live Attenuated Mumps Vaccine (Human Diploid Cell) in Chinese healthy Infants volunteer aged from 8 to 24 months old.
Study Type
Enrollment (Estimated)
Phase
- Phase 2
Contacts and Locations
Study Locations
-
-
Hubei
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Wuhan, Hubei, China, 430079
- Hubei Provincial Center for Disease Control and Prevention
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Description
Inclusion Criteria:
- Healthy males and females (from 8 months to 24 months old) as determined by medical history, physical examination, laboratory examination and clinical judgment of the investigator.
- Provided legal identification for the sake of recruitment.
- Without the routine corticosteroids of vaccination .
- Never has gone down with mumps or taken a vaccine contain mumps.
- parent(s)/legal guardian(s) are able to understand and sign informed consents and be able to read a thermometer and dividing ruler .At the same time,the parent(s)/legal guardian(s)should have the ability and objective to comply with the requirements of the protocol.
- Participants or guardians are able to attend all planned clinical appointment and obey and follow all study instructions; can persist for a 1-month visit and receive blood sample and throat swab collection according to program requirements.
- Axillary temperature ≤37℃.
Exclusion Criteria:
- Subject who has a medical history of Mumps or taken a vaccine contain mumps.
- Subject that has a medical history of any of the following: allergic history, or allergic to any ingredient of vaccine
- Convulsant,encephalopathy,psychosis or family histoty of epileptics.
- Clinical diagnosis of coagulopathy (such as clotting factor deficiency, coagulation disorders, platelet abnormalities), significant bruising or blood clotting disorder,it will couse the contraindication of subcutaneous injection
- Any prior administration of attenuated live vaccine in last 15 days;Any prior administration of subunit or inactivated vaccines in last 7 days
- Any prior administration of other research medicines in last 30 days.
- Any prior administration of blood products(immunoglobulin etc.) in last 1 month;Any prior administration of immunodepressant ,cytotoxic drugs or corticosteroids in last 6 months(except the corticosteroids spray can treat irritability rhinitis orcorticosteroids to cure noncomplication acute dermatitis ).
- Any confirmed or suspected autoimmune disease or immune deficiency diseases(like favism or other diseases etc. ), including human immunodeficiency virus (HIV) infection.
- Suffering from congenital deformity or serious chronic disease(congenital heart disease,Down's syndrome,diabetes,sickle cell anemia,nervous illness,cardiocardiopathy,hypertension,bronchitis,pneumonia,asthma,infectious skin diseases)
- Acute or chronic infectious disease,active infectious;Laboratory test show Routine blood abnormal or hepatorenal dysfunction.
- Malignant disease(like cancer),heredopathia or other disease that will cuase eccyliosis.The spleen or other important organ has been removed for any reason.
- Any condition that in the opinion of the investigator, may interfere with the evaluation of study objectives.
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Prevention
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Triple
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: Attenuated Mumps vaccine (KMB-17), low
Biological/Vaccine: ≥3.0logCCID50/ml but <3.5 logCCID50/ml Attenuated Mumps vaccine (KMB-17)[ ≥3.0logCCID50/ml but <3.5 logCCID50/ml] in 360 infants (8-24 months old) on 0 day
|
≥3.0 lgCCID50/ml but <3.5lgCCID50/ml;Live Attenuated Mumps (F-genotype) Vaccine (Human Diploid Cell, KMB-17) in 360 infants(aged 8-24 months ) on 0 day
|
Experimental: Attenuated Mumps vaccine (KMB-17), high
Biological/Vaccine: ≥4.5logCCID50/ml Attenuated Mumps vaccine (KMB-17)[≥4.5 logCCID50/ml] in 360 infants (8-24 months old) on 0 day
|
≥4.5CCID50/ml;Live Attenuated Mumps (F-genotype) Vaccine (Human Diploid Cell, KMB-17) in 360 infants(aged 8-24 months ) on 0 day
|
Active Comparator: Measles and Mumps Combined Vaccine,Live
manufacturer:Shanghai Institute of Biological Products Co., Ltd.
(SIBP ) Measles and Mumps Combined Vaccine,Live in 360 infants in 360 infants (8-24 months old) on 0 day
|
Measles and Mumps Combined Vaccine,Live(SIBP) in 360 infants(aged 8-24 months ) on 0 day
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Positive conversion rate of Muv hemagglutination inhibition antibody of different single dose of Muv Vaccine
Time Frame: the 0 days(before vaccination) and 28 day after the vaccination
|
To compared the positive conversion rate of Muv hemagglutination inhibition antibody after vaccinate 3 diffirent group (low dose:≥3.0logCCID50/ml
but <3.5logCCID50/ml,high dose:≥4.5logCCID50/ml,active
comparator :shanghai institute of Biological Products Co,Ltd's measles and Mumps Combined Vaccine.live)
|
the 0 days(before vaccination) and 28 day after the vaccination
|
Positive conversion rate of Muv neutralization antibody of different single dose of Muv Vaccine
Time Frame: the 0 days(before vaccination) and 28 day after the vaccination
|
To compared the positive conversion rate of Muv neutralization antibody after vaccinate 3 diffirent group (low dose:≥3.0logCCID50/ml
but <3.5logCCID50/ml,high dose:≥4.5logCCID50/ml,active
comparator :shanghai institute of Biological Products Co,Ltd's measles and Mumps Combined Vaccine.live)
|
the 0 days(before vaccination) and 28 day after the vaccination
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
The GMT of the hemagglutination inhibition antibody and neutralizing antibody
Time Frame: the 0 days(before vaccination) and the 28 day after the vaccination
|
evaluate the GMT of the hemagglutination inhibition antibody and neutralizing antibody in serum after the subjects get injected different dose of vaccine
|
the 0 days(before vaccination) and the 28 day after the vaccination
|
The GMT of the neutralizing antibody
Time Frame: the 0 days(before vaccination) and the 28 day after the vaccination
|
evaluate the GMT of the neutralizing antibody in serum after the subjects get injected different dose of vaccine
|
the 0 days(before vaccination) and the 28 day after the vaccination
|
The incidence rate of ADR after vaccination
Time Frame: within the first 28 days after the vaccination
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Study the incidence rate of ADR after vaccination
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within the first 28 days after the vaccination
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viral shedding after the vaccination
Time Frame: the 0(before vaccination),4,10 days after the vaccination
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Using the method of PCR to detection the viral shedding of Muv after the vaccination.
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the 0(before vaccination),4,10 days after the vaccination
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Collaborators and Investigators
Investigators
- Principal Investigator: Beifang Yang, PhD, Hubei Provincial Center for Disease Control and Prevention
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Estimated)
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
- 2015L00195
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
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