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This Phase 1b will describe the safety and immunogenicity of 2 multivalent pneumococcal conjugate vaccine formulations in healthy Japanese adults in the United States.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Prevnar 13 | Active Comparator | 13 valent Pneumococcal Conjugate |
|
| multivalent pneumococcal conjugate formulation 1 | Experimental | multivalent pneumococcal conjugate formulation 1 |
|
| multivalent pneumococcal conjugate formulation 2 | Experimental | multivalent pneumococcal conjugate formulation 2 |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Prevnar 13 | Biological | 13 valent Pneumococcal Conjugate |
| |
| Measure | Description | Time Frame |
|---|---|---|
| Subjects reporting prompted local reactions within 14 days after vaccination (redness, swelling, and pain at the injection site). | Subjects reporting prompted local reactions within 14 days after vaccination (redness, swelling, and pain at the injection site). | 14 days after vaccination |
| Subjects reporting prompted systemic events within 14 days after vaccination (fever, headache, fatigue, muscle pain, and joint pain). | Subjects reporting prompted systemic events within 14 days after vaccination (fever, headache, fatigue, muscle pain, and joint pain). | 14 days after vaccination |
| Subjects reporting adverse events (AEs) within 1 month after vaccination. | Subjects reporting adverse events (AEs) within 1 month after vaccination. | 1 month after vaccination |
| Subjects reporting serious adverse events (SAEs) within 6 months after vaccination. | Subjects reporting serious adverse events (SAEs) within 6 months after vaccination. | 6 months after vaccination |
| Subjects reporting newly diagnosed chronic medical conditions (NDCMCs) within 6 months after vaccination. | Subjects reporting newly diagnosed chronic medical conditions (NDCMCs) within 6 months after vaccination. | 6 months after vaccination |
| Measure | Description | Time Frame |
|---|---|---|
| Immunogenicity | Pneumococcal serotype-specific OPA titers 1 month after vaccination. | 1 month after vaccination |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Pfizer CT.gov Call Center | Pfizer | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Collaborative Neuroscience Network, LLC. | Garden Grove | California | 92845 | United States | ||
| Collaborative Neuroscience Network, LLC. |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 33545022 | Derived | Fitz-Patrick D, Young M Jr, Scott DA, Scully IL, Baugher G, Peng Y, Jansen KU, Gruber W, Watson W. A randomized phase 1 study of the safety and immunogenicity of 2 novel pneumococcal conjugate vaccines in healthy Japanese adults in the United States. Hum Vaccin Immunother. 2021 Jul 3;17(7):2249-2256. doi: 10.1080/21645515.2020.1863177. Epub 2021 Feb 5. |
| Label | URL |
|---|---|
| To obtain contact information for a study center near you, click here. | View source |
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Pfizer will provide access to individual de-identified participant data and related study documents (e.g. protocol, Statistical Analysis Plan (SAP), Clinical Study Report (CSR)) upon request from qualified researchers, and subject to certain criteria, conditions, and exceptions. Further details on Pfizer's data sharing criteria and process for requesting access can be found at: https://www.pfizer.com/science/clinical\_trials/trial\_data\_and\_results/data\_requests.
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| multivalent pneumococcal conjugate formulation 1 |
| Biological |
multivalent pneumococcal conjugate formulation 1 |
|
| multivalent pneumococcal conjugate formulation 2 | Biological | multivalent pneumococcal conjugate formulation 2 |
|
| Long Beach |
| California |
| 90806 |
| United States |
| East-West Medical Research Institute | Honolulu | Hawaii | 96814 | United States |
| Clinilabs Drug Development Corporation | Eatontown | New Jersey | 07724 | United States |
| ID | Term |
|---|---|
| D011008 | Pneumococcal Infections |
| ID | Term |
|---|---|
| D013290 | Streptococcal Infections |
| D016908 | Gram-Positive Bacterial Infections |
| D001424 | Bacterial Infections |
| D001423 | Bacterial Infections and Mycoses |
| D007239 | Infections |
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| ID | Term |
|---|---|
| C538862 | 13-valent pneumococcal vaccine |
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