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Evaluate the safety and tolerability of a single booster dose of NU300, co-administered with Prevnar 13® over a 28 day period following the injection compared to a single booster of ACTHIB co-administered with Prevnar 13® over a 28 day period following the injection.
Evaluate the immunogenicity, as determined by anti-PRP polysaccharide response, of a single booster dose of NU300 co-administered with Prevnar 13® compared to a single booster dose of ActHIB® co-administered with Prevnar 13®.
Evaluate the individual IgG antibody quantitative response to the 13 antigens in Prevnar 13® following NU300 co-administration with Prevnar 13® compared to the IgG antibody response to the pneumococcal polysaccharides following ActHIB® co-administration with Prevnar 13® 28 days following injection.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| NU300 and Prevnar 13 | Experimental | NU300 at a single dose of 0.5 mL IM |
|
| ActHIB and Prevnar 13 | Active Comparator | ActHIB at a dose of 0.5 ml IM |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| NU300 | Biological |
| ||
| ActHIB |
| Measure | Description | Time Frame |
|---|---|---|
| safety and efficacy | Evaluate the safety and tolerability of a single booster dose of NU300, co-administered with Prevnar 13® compared to a single booster dose of ActHIB® co-administered with Prevnar 13®, over a 28 day period following injection Evaluate the immunogenicity, as determined by anti-PRP polysaccharide response, of a single booster dose of NU300 co-administered with Prevnar 13® compared to a single booster dose of ActHIB® co-administered with Prevnar 13®. | one month |
| Measure | Description | Time Frame |
|---|---|---|
| Evaluate the individual IgG antibody quantitative response to the 13 antigens in Prevnar 13® | Evaluate the individual IgG antibody quantitative response to the 13 antigens in Prevnar 13® following NU300 co-administration with Prevnar 13® compared to the IgG antibody response to the pneumococcal polysaccharides following ActHIB® co-administration with Prevnar 13® 28 days following injection | one month |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Oakland | California | 94611 | United States | |||
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| ID | Term |
|---|---|
| D003141 | Communicable Diseases |
| ID | Term |
|---|---|
| D007239 | Infections |
| D020969 | Disease Attributes |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
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| ID | Term |
|---|---|
| C055753 | Haemophilus influenza type b polysaccharide vaccine-tetanus toxin conjugate |
| C538862 | 13-valent pneumococcal vaccine |
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|
| Prevnar 13 | Biological |
|
| Bardstown |
| Kentucky |
| 40004 |
| United States |