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This study will evaluate the safety and efficacy of two doses of two commercially available vaccines used to prevent Haemophilus influenzae type b infections in children 6-12 months of age.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Arm 1 | Active Comparator |
| |
| Arm 2 | Active Comparator |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Haemophilus influenzae type b (Hib) vaccine | Biological | Comparator study of two commercially available Haemophilus influenzae type b (Hib) vaccines - a monovalent glycoprotein-conjugated (diptheria toxin - CRM197) vaccine and a tetanus toxoid-conjugated vaccine. |
| Measure | Description | Time Frame |
|---|---|---|
| Anti-PRP antibody levels at day 31 post last vaccination | 30 days after last vaccination |
| Measure | Description | Time Frame |
|---|---|---|
| Solicited local and systemic reactions, AEs, and SAEs | 30 days post last vaccination |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Hebei Province | China |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 23964690 | Derived | Jun L, Yuguo C, Zhiguo W, Jinfeng L, Huawei M, Xiuhua L, Yonggui Z, Yanhua X, Kong Y, Hongtao L, Yuliang Z. Assessment of immunogenicity and safety following primary and booster immunisation with a CRM197 -conjugated Haemophilus influenzae type B vaccine in healthy Chinese infants. Int J Clin Pract. 2013 Oct;67(10):971-8. doi: 10.1111/ijcp.12267. Epub 2013 Aug 22. |
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| ID | Term |
|---|---|
| D006192 | Haemophilus Infections |
| D007239 | 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 |
|---|---|
| D014612 | Vaccines |
| ID | Term |
|---|---|
| D001688 | Biological Products |
| D045424 | Complex Mixtures |
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