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The study will evaluate the safety and immunogenicity of a haemophilus influenzae type b conjugate vaccine (Hib) in Healthy Children 2 Months to 5 Years of Age who have not been previously immunized with a Hib vaccine. Children 2 to 5 months of age will receive 3 doses of Hib vaccine, Children 6 to 11 months of age will receive 2 doses of Hib vaccine, Children 1 to 5 years of age will receive 1 dose of Hib vaccine, with each dose given approximately 1 month apart.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Minhai-HIB | Experimental | Participants at age 1 to 5 years of enrollment will receive one dose on Hib vaccine. Participants at age 6 to 11 months of enrollment will receive 2 doses on Hib vaccine at one months apart. Participants at age 2 to 5 months of enrollment will receive 3 doses on Hib vaccine at one months apart. |
|
| Act-HIBĀ® | Active Comparator | Participants at age 1 to 5 years of enrollment will receive one dose on Hib vaccine. Participants at age 6 to 11 months of enrollment will receive 2 doses on Hib vaccine at one months apart. Participants at age 2 to 5 months of enrollment will receive 3 doses on Hib vaccine at one months apart. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Minhai-HIB | Biological | 0.5ml, intramuscular |
| |
| Act-HIBĀ® |
| Measure | Description | Time Frame |
|---|---|---|
| Number of Subjects With Anti-polyribosylribitol Phosphate (Anti-PRP) Antibody Concentrations Greater Than or Equal to (ā„) 0.15 Microgram Per Milliliter (µg/mL) and ā„ 1.0 µg/mL | 28 days after last dose of primary vaccination |
| Measure | Description | Time Frame |
|---|---|---|
| Number of Subjects With Any Solicited Local and General Symptoms | Within 7 days after any vaccination | |
| Number of Subjects With Any Unsolicited Adverse Events (AEs) | Within 28 days after any vaccination |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Guifan Li | Contact | 86-10-59613591 | guifan@sohu.com |
| Name | Affiliation | Role |
|---|---|---|
| shengli xia | Henan Provincial Center for Disease Control and Prevention | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Henan Provincial Center for Disease Control and Prevention | Recruiting | Zhengzhou | Henan | China |
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| ID | Term |
|---|---|
| D006192 | Haemophilus Infections |
| ID | Term |
|---|---|
| D016871 | Pasteurellaceae Infections |
| D016905 | Gram-Negative Bacterial Infections |
| D001424 | Bacterial Infections |
| D001423 | Bacterial Infections and Mycoses |
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| ID | Term |
|---|---|
| C514867 | Hiberix |
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| Biological |
0.5ml, intramuscular |
|
| Anti-polyribosylribitol Phosphate (Anti-PRP) Antibody Concentrations | 28 days after last dose of primary vaccination |
| D007239 | Infections |