- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT01712906
A Phase I, Safety Study of Live Attenuated Mumps (F-genotype) Vaccine (Human Diploid Cell, KMB-17) in Chinese Children
A Phase II Clinical Trial for Live Attenuated Mumps (F-genotype) Vaccine (Human Diploid Cell, KMB-17) in Chinese Children
Study Overview
Status
Conditions
Study Type
Enrollment (Actual)
Phase
- Phase 1
Contacts and Locations
Study Locations
-
-
Hebei
-
Shijiazhuang, Hebei, China, 050021
- Hebei Provincial Center for Diseases Control and Prevention
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Description
Inclusion Criteria:
- Healthy subjects (8 months-59 years old) as established by medical history and clinical examination
- The subjects oneself or their legal guardian must be aware of this vaccines
- Voluntarily participate in the study and signed Informed Consent Form
- Subjects with temperature ≤ 37.0℃
- With the ability and objective to comply with the requirements of the protocol
- Persist for a 1-month visit and receive blood tests according to program requirements
Exclusion Criteria:
- Subject who has a clinical diagnosis Mumps
- Subject who vaccinated Mumps vaccine in last 6 months
- ≤37 weeks gestation
- weight ≤ 2500 g when it was born
- Allergy or serious side-effects to a vaccine or any ingredient of vaccine
- Epilepsy, seizures, convulsions, neurological illness
- Congenital or hereditary immunodeficiency
- Autoimmune disease
- Severe malnutrition or dysgenopathy
- Asthma, thyroidectomy, angioneurotic edema, diabetes or cancer
- Asplenia, functional asplenia, and any circumstances leading to the asplenia or splenectomy
- Clinical diagnosis of coagulopathy (such as clotting factor deficiency, coagulation disorders, platelet abnormalities), significant bruising or blood clotting disorder
- Acute illness or acute exacerbation of chronic disease in last 7 days
- Any prior administration of immunodepressant or corticosteroids in last 6 months
- Any prior administration of blood products in last 3 months
- Any prior administration of live-attenuated vaccine in last 28 days or 1 months
- Any prior administration of subunit or inactivated vaccines in last 14 days
- Under the anti-TB prevention or therapy
- Fever before vaccination, axillary temperature ﹥37.0℃
- The laboratory test abnormalities before vaccination, including blood tests (hemoglobin, total white blood cells, WBC, platelets), blood biochemistry tests (ALT, total bilirubin, direct bilirubin, Cr, BUN) and urine tests (urine protein, urine sugar, blood cells), etc.
- Hypertension or hypotension. Systolic blood pressure ﹥140mmHg and/or diastolic blood pressure ﹥90mmHg; systolic blood pressure ﹤90mmHg and/or diastolic blood pressure ﹤60mmHg
- Breast-feeding, pregnant, planning a pregnancy within 60 days or positive pregnancy test women
- 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: 3.50±0.25logCCID50/ml in adults
Attenuated Mumps vaccine (KMB-17) of 3.50±0.25logCCID50/ml
in 16 adults aged 16-59 years old on day 0.
|
Attenuated Mumps vaccine (KMB-17) of 3.50±0.25logCCID50/ml
in adults (16-59 years old),children (5-15 years old or 2-4 years old) and infants (8-23 months old) on day 0.
|
Experimental: 4.25±0.25 logCCID50/ml in adults
Attenuated Mumps vaccine (KMB-17) of 4.25±0.25 logCCID50/ml in 16 adults aged 16-59 years old on day 0.
|
Attenuated Mumps vaccine (KMB-17) of 4.25±0.25 logCCID50/ml in adults (16-59 years old),children (5-15 years old or 2-4 years old) and infants (8-23 months old) on day 0.
|
Experimental: 5.00±0.25 logCCID50/ml in adults
Attenuated Mumps vaccine (KMB-17) of 4.25±0.25 logCCID50/ml in 16 adults aged 16-59 years old on day 0.
|
Attenuated Mumps vaccine (KMB-17) of 5.00±0.25 logCCID50/ml in adults (16-59 years old),children (5-15 years old or 2-4 years old) and infants (8-23 months old) on day 0.
|
Placebo Comparator: 0 logCCID50/ml in adults
0 logCCID50/ml in 18 adults aged 16-59 years old on day 0.
|
0 logCCID50/ml in adults (16-59 years old),children (5-15 years old or 2-4 years old) and infants (8-23 months old) on day 0.
|
Experimental: 3.50±0.25logCCID50/ml in children (5-15 years old)
Attenuated Mumps vaccine (KMB-17) of 3.50±0.25logCCID50/ml
in 16 children aged 5-15 years old on day 0.
|
Attenuated Mumps vaccine (KMB-17) of 3.50±0.25logCCID50/ml
in adults (16-59 years old),children (5-15 years old or 2-4 years old) and infants (8-23 months old) on day 0.
|
Experimental: 4.25±0.25 logCCID50/ml in children (5-15 years old)
Attenuated Mumps vaccine (KMB-17) of 4.25±0.25 logCCID50/ml in 16 children aged 5-15 years old on day 0.
|
Attenuated Mumps vaccine (KMB-17) of 4.25±0.25 logCCID50/ml in adults (16-59 years old),children (5-15 years old or 2-4 years old) and infants (8-23 months old) on day 0.
|
Experimental: 5.00±0.25 logCCID50/ml in children (5-15 years old)
Attenuated Mumps vaccine (KMB-17) of 5.00±0.25 logCCID50/ml in 16 children aged 5-15 years old on day 0.
|
Attenuated Mumps vaccine (KMB-17) of 5.00±0.25 logCCID50/ml in adults (16-59 years old),children (5-15 years old or 2-4 years old) and infants (8-23 months old) on day 0.
|
Placebo Comparator: 0 logCCID50/ml in children (5-15 years old)
0 logCCID50/ml in 18 children aged 5-15 years old on day 0.
|
0 logCCID50/ml in adults (16-59 years old),children (5-15 years old or 2-4 years old) and infants (8-23 months old) on day 0.
|
Experimental: 3.50±0.25logCCID50/ml in children (2-4 years old)
Attenuated Mumps vaccine (KMB-17) of 3.50±0.25logCCID50/ml
in 16 children aged 2-4 years old on day 0.
|
Attenuated Mumps vaccine (KMB-17) of 3.50±0.25logCCID50/ml
in adults (16-59 years old),children (5-15 years old or 2-4 years old) and infants (8-23 months old) on day 0.
|
Experimental: 4.25±0.25 logCCID50/ml in children (2-4 years old)
Attenuated Mumps vaccine (KMB-17) of 4.25±0.25 logCCID50/ml in 16 children aged 2-4 years old on day 0.
|
Attenuated Mumps vaccine (KMB-17) of 4.25±0.25 logCCID50/ml in adults (16-59 years old),children (5-15 years old or 2-4 years old) and infants (8-23 months old) on day 0.
|
Experimental: 5.00±0.25 logCCID50/ml in children (2-4 years old)
Attenuated Mumps vaccine (KMB-17) of 5.00±0.25 logCCID50/ml in 16 children aged 2-4 years old on day 0.
|
Attenuated Mumps vaccine (KMB-17) of 5.00±0.25 logCCID50/ml in adults (16-59 years old),children (5-15 years old or 2-4 years old) and infants (8-23 months old) on day 0.
|
Placebo Comparator: 0 logCCID50/ml in children (2-4 years old)
0 logCCID50/ml in 18 children aged 2-4 years old on day 0.
|
0 logCCID50/ml in adults (16-59 years old),children (5-15 years old or 2-4 years old) and infants (8-23 months old) on day 0.
|
Active Comparator: Attenuated Mumps vaccine in children (2-4 years old)
Attenuated Mumps vaccine (Zhe Jiang Vacn Bio-pharmaceutical Co., LTD.; NO.20110528-1) in 18 children aged 2-4 years old on day 0.
|
Attenuated Mumps vaccine (Zhe Jiang Vacn Bio-pharmaceutical Co., LTD.; NO.20110528-1) in children (2-4 years old) and infants (8-23 months old) on day 0.
|
Experimental: 3.50±0.25logCCID50/ml in infants
Attenuated Mumps vaccine (KMB-17) of 3.50±0.25logCCID50/ml
in 16 infants aged 8-23 months old on day 0.
|
Attenuated Mumps vaccine (KMB-17) of 3.50±0.25logCCID50/ml
in adults (16-59 years old),children (5-15 years old or 2-4 years old) and infants (8-23 months old) on day 0.
|
Experimental: 4.25±0.25 logCCID50/ml in infants
Attenuated Mumps vaccine (KMB-17) of 4.25±0.25 logCCID50/ml in 16 infants aged 8-23 months old on day 0.
|
Attenuated Mumps vaccine (KMB-17) of 4.25±0.25 logCCID50/ml in adults (16-59 years old),children (5-15 years old or 2-4 years old) and infants (8-23 months old) on day 0.
|
Experimental: 5.00±0.25 logCCID50/ml in infants
Attenuated Mumps vaccine (KMB-17) of 5.00±0.25 logCCID50/ml in 16 infants aged 8-23 months old on day 0.
|
Attenuated Mumps vaccine (KMB-17) of 5.00±0.25 logCCID50/ml in adults (16-59 years old),children (5-15 years old or 2-4 years old) and infants (8-23 months old) on day 0.
|
Placebo Comparator: 0 logCCID50/ml in infants
0 logCCID50/ml in 18 infants aged 8-23 months old on day 0.
|
0 logCCID50/ml in adults (16-59 years old),children (5-15 years old or 2-4 years old) and infants (8-23 months old) on day 0.
|
Active Comparator: Attenuated Mumps vaccine in infants
Attenuated Mumps vaccine (Zhe Jiang Vacn Bio-pharmaceutical Co., LTD.; NO.20110528-1) in 18 infants aged 8-23 months old on day 0.
|
Attenuated Mumps vaccine (Zhe Jiang Vacn Bio-pharmaceutical Co., LTD.; NO.20110528-1) in children (2-4 years old) and infants (8-23 months old) on day 0.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Evaluate the Safety of Attenuated Mumps Vaccine (Human Diploid Cell, KMB-17) in Chinese Adults.
Time Frame: within the first 28 days after the vaccination
|
Adverse reactions associated with vaccine were observed in Chinese Adults (from 16 to 59 years old) after the vaccination
|
within the first 28 days after the vaccination
|
Evaluate the Safety of Attenuated Mumps Vaccine (Human Diploid Cell, KMB-17) in Chinese Children.
Time Frame: within the first 28 days after the vaccination
|
Adverse reactions associated with vaccine were observed in Chinese Children (from 5 to 15 years old) after the vaccination.
|
within the first 28 days after the vaccination
|
Evaluate the safety of Attenuated Mumps Vaccine (Human Diploid Cell, KMB-17) in Chinese Children.
Time Frame: within the first 28 days after the vaccination
|
Adverse reactions associated with vaccine were observed in Chinese Children (from 2 to 4 years old) after the vaccination.
|
within the first 28 days after the vaccination
|
Evaluate the safety of Attenuated Mumps Vaccine (Human Diploid Cell, KMB-17) in Chinese Infants.
Time Frame: within the first 28 days after the vaccination
|
Adverse reactions associated with vaccine were observed in Chinese Infants (from 8 to 23 months old) after the vaccination.
|
within the first 28 days after the vaccination
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Evaluate the seroconversion rate of anti-Mumps antibodies in serum of adults, children and infants, after vaccination.
Time Frame: within the first 28 days after the vaccination
|
The seroconversion rate of anti-MuV antibodies was evaluated in serum of adults at the 0 and 28 days after vaccination. The seroconversion rate of anti-MuV antibodies was evaluated in serum of children at the 0 and 28 days after vaccination. The seroconversion rate of anti-MuV antibodies was evaluated in serum of infants at the 0 and 28 days after vaccination. |
within the first 28 days after the vaccination
|
Evaluate the abnormity change of live and kidney function indexes in serum of adults, children and infants, after vaccination
Time Frame: within the first 4 days after the vaccination
|
The abnormity change of live and kidney function indexes were evaluated in serum of adults at 0, 4 days after vaccination. The abnormity change of live and kidney function indexes were evaluated in serum of children at 0, 4 days after vaccination. The abnormity change of live and kidney function indexes were evaluated in serum of infants at 0, 4 days after vaccination. |
within the first 4 days after the vaccination
|
Collaborators and Investigators
Investigators
- Principal Investigator: Yuliang Zhao, Master, Hebei Provincial Center for Diseases Control and Prevention
Publications and helpful links
Study record dates
Study Major Dates
Study Start
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimated)
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
- FMumps-KMB17-I-IMB-CAMS
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