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| Name | Class |
|---|---|
| China National Biotec Group Company Limited | INDUSTRY |
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Nowadays these are some vaccines being vaccinated simultaneously, and a doubt is aroused if the safety and immunogenicity are same between inoculating several vaccines simultaneously and inoculating individually. So we carry out this study.
The purpose of this study is to evaluate the difference of safety and immunogenicity on vaccinating rotavirus vaccine simultaneously with measles-rubella vaccine(MR) or measles-mumps-rubella vaccine(MMR) compared to vaccinating rotavirus vaccine, MR or MMR individually.
Quality control plan:
Statistical plan
safety evaluation method
At the time of vaccination, vaccinees were instructed to report any adverse event to physicians or vaccination providers. Adverse events that were fatal or that resulted in disability and clusters of events (i.e., notably high numbers of similar adverse events related to a certain vaccine) were required to be reported within 2 hours after their occurrence. The following adverse events were required to be reported within 2 days after their occurrence: anaphylaxis or other allergic reactions occurring within 24 hours after vaccination; fever (axillary temperature, >38.5°C), angioedema, or a local injection-site reaction (diameter, >2.5 cm) occurring within 5 days after vaccination; purpura, an Arthus reaction, febrile convulsion, seizure, or polyneuritis occurring within 15 days after vaccination. Other reactions that were common and minor (e.g., mild pain and fatigue) were not required to be reported.
Immunogenicity evaluation
Enzyme-linked immunosorbent assay (abbreviated as ELSIA) is used to quantitatively test immunoglobulin G (IgG) of measles, rubella, mumps, test kit is provided by Virion\Serion company. Rotavirus Immunoglobulin A (RV-IgA) is used to test the antibody of rotavirus.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| rotavirus | Placebo Comparator | vaccinate one dose rotavirus vaccine for each of 700 participants aged 8~9months |
|
| measles-rubella | Placebo Comparator | vaccinate one dose measles-rubella vaccine for each of 350 participants aged 8~9 months. |
|
| measles-mumps-rubella | Placebo Comparator | vaccinate one dose measles-mumps-rubella vaccine for each of 350 participants aged 8~9 months. |
|
| rotavirus, measles-rubella | Experimental | simultaneously vaccinate one dose rotavirus vaccine and one dose measles-rubella vaccine for each of 700 participants aged 8~9 months. |
|
| rotavirus, measles-mumps-rubella | Experimental | simultaneously vaccinate one dose rotavirus vaccine and one dose measles-mumps-rubella vaccine for each of 700 participants aged 8~9 months. |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| rotavirus vaccine | Biological | 3ml/dose, oral |
|
| Measure | Description | Time Frame |
|---|---|---|
| the occurrence rate of general reaction of different vaccination groups | general reaction includes fever (axillary temperature> 3.85℃), local injection-site reaction (diameter> 2.5 cm) etc. | 1 months after vaccination |
| Measure | Description | Time Frame |
|---|---|---|
| the occurrence rate of severe adverse event of different vaccination groups | severe reaction include: anaphylaxis, angioedema, purpura, an Arthus reaction, febrile convulsion, seizure, polyneuritis, other adverse events cause fatal, result in disability or clusters of events (i.e., notably high numbers of similar adverse events related to a certain vaccine) | 1 month after vaccination |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| rui ao, Master | Sichuan Provincial Center for Disease Control and Prevention | Study Director |
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| ID | Term |
|---|---|
| D022243 | Rotavirus Vaccines |
| D022542 | Measles-Mumps-Rubella Vaccine |
| ID | Term |
|---|---|
| D014765 | Viral Vaccines |
| D014612 | Vaccines |
| D001688 | Biological Products |
| D045424 | Complex Mixtures |
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| measles-rubella vaccine | Biological | 0.5ml per dose, subcutaneous injection |
|
|
| measles-mumps-rubella vaccine | Biological | 0.5ml per dose, subcutaneous injection |
|
|
| The variation of antibody Geometric Mean Titer compared between before and after vaccination | this measure is used to assess the immunogenicity of different groups | 1 month after vaccination |
| D017778 |
| Vaccines, Combined |
| D008458 | Measles Vaccine |
| D009108 | Mumps Vaccine |
| D012411 | Rubella Vaccine |