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The objective of this study was to evaluate the safety and immunogenicity of Haemophilus influenzae type b vaccine in different injection site.
A randomized trial was conducted in 680 healthy infants with Hib vaccine of two brands. The different sub-groups were selected randomly based on the plan to inoculate vaccines in the upper arm deltoid or vastus lateralis muscle. The safety and immunogenicity were assessed after three or two doses.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Inoculation in upper arm deltoid | Active Comparator | Inoculation of Hib vaccine of two brands in upper arm deltoid |
|
| Inoculation in vastus lateralis muscle | Experimental | Inoculation of Hib vaccine of two brands in vastus lateralis muscle |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Inoculation in upper arm deltoid | Biological | Inoculation of Hib vaccine of two brands in upper arm deltoid |
|
| Measure | Description | Time Frame |
|---|---|---|
| Incidence rate of adverse events of Haemophilus influenzae type b vaccine in different injection site | one year |
| Measure | Description | Time Frame |
|---|---|---|
| Antibody titre of Haemophilus influenzae type b vaccine in different injection site | one year |
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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 | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Beijing Huaxin Hospital | Beijing | Beijing Municipality | China | |||
| Beijing Chaoyang Women's and Children's Hospital |
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| ID | Term |
|---|---|
| D014611 | Vaccination |
| ID | Term |
|---|---|
| D016233 | Immunotherapy, Active |
| D007114 | Immunization |
| D007167 | Immunotherapy |
| D056747 | Immunomodulation |
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| Inoculation in vastus lateralis muscle | Biological | Inoculation of Hib vaccine of two brands in vastus lateralis muscle |
|
| Beijing |
| China |
| Beijing Dongba Hospital | Beijing | China |
| Cuigezhuang community health service centers | Beijing | China |
| Xiaohongmen community health service centers | Beijing | China |
| D001691 |
| Biological Therapy |
| D013812 | Therapeutics |
| D007158 | Immunologic Techniques |
| D008919 | Investigative Techniques |
| D011322 | Primary Prevention |
| D011314 | Preventive Health Services |
| D006296 | Health Services |
| D005159 | Health Care Facilities Workforce and Services |
| D003140 | Communicable Disease Control |
| D015980 | Public Health Practice |
| D011634 | Public Health |
| D004778 | Environment and Public Health |