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The purpose of this study is to observe the occurrence of adverse reaction and antibody positive rate, the elevated level of antibody,Geometric mean titer (GMT) between groups of live attenuated varicella vaccine without gelatin.
Observational Objectives:
To describe the safety of evaluated vaccine, in children aged ≥ 1th birthday and ≤ 12th birthday.
To describe the immunogenicity of evaluated vaccine, in children aged ≥ 1th birthday and ≤ 12th birthday.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| vaccine without gelatin | Experimental | use the upper arm flank deltoid muscle adheres to stick cohere place the skin after 75% ethyl alcohol disinfection the hypodermic injection |
|
| vaccine with gelatin | Active Comparator | use the upper arm flank deltoid muscle adheres to stick cohere place the skin after 75% ethyl alcohol disinfection the hypodermic injection |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| vaccine without gelatin | Biological | use the upper arm flank deltoid muscle adheres to stick cohere place the skin after 75% ethyl alcohol disinfection the hypodermic injection |
| Measure | Description | Time Frame |
|---|---|---|
| To evaluate the immunogenicity of evaluated vaccine | The immunologic equivalence of 4weeks after vaccination of influenza virus vaccine was measured in terms of the level of antibody. | 8 months |
| Measure | Description | Time Frame |
|---|---|---|
| To evaluate the safety of live attenuated varicella vaccine | The incidence of adverse events was analyzed statistically. | 4 months |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Nianmin Shi | Beijing Chaoyang District Center for Disease Control and Prevention | Study Chair |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Chaoyang District Center for Disease Control and Prevention | Beijing | Beijing Municipality | China | |||
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| ID | Term |
|---|---|
| D002644 | Chickenpox |
| D006562 | Herpes Zoster |
| ID | Term |
|---|---|
| D000073618 | Varicella Zoster Virus Infection |
| D006566 | Herpesviridae Infections |
| D004266 | DNA Virus Infections |
| D014777 | Virus Diseases |
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| ID | Term |
|---|---|
| D014612 | Vaccines |
| D005780 | Gelatin |
| ID | Term |
|---|---|
| D001688 | Biological Products |
| D045424 | Complex Mixtures |
| D012596 | Scleroproteins |
| D011506 | Proteins |
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| vaccine with gelatin | Biological | use the upper arm flank deltoid muscle adheres to stick cohere place the skin after 75% ethyl alcohol disinfection the hypodermic injection |
|
| Sanhe Center for Disease Control and Prevention |
| Langfang |
| Hebei |
| China |
| Jiuyuan Center for Disease Control and Prevention | Baotou | Inner Mongolia | China |
| D007239 | Infections |
| D000602 |
| Amino Acids, Peptides, and Proteins |