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This is a Phase 1 first-in-human, randomized, controlled, observer-blinded study with a 2-arm parallel design. Healthy adults aged 18 to 49 years of age with no history of pneumococcal vaccination will be randomized equally to receive either a single intramuscular dose of multivalent pneumococcal conjugate vaccine or a licensed tetanus, diphtheria, acellular pertussis combination vaccine (Tdap) (control group).
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Multivalent | Experimental | Pneumococcal conjugate vaccine |
|
| Tdap | Active Comparator | Tetanus, diphtheria, and pertussis vaccine |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Multivalent | Biological | Pneumococcal conjugate vaccine |
| |
| Measure | Description | Time Frame |
|---|---|---|
| Percentage of subjects reproting prompted local reactions within 14 days after vaccination (redness, swelling. limitation of arm movement, and pain at injection site). | Day 15 | |
| Percentage of subjects reporting prompted systemic events within 14 days after vaccination (fever, headache, fatigue, chills, rash, decreased appetite, nausea/vomiting, new muscle pain, aggravated muscle pain, new joint pain, and aggravated joint pain). | Day 15 | |
| Percentage of subjects reporting adverse events (AEs) within 1 month after vaccination. | 1 month after vaccination | |
| Percentage of subjects with clinical laboratory abnormalities after vaccination. | Day 6 | |
| Percentage of subjects reporting serious adverse events (SAEs) and newly diagnosed chronic medical conditions (NDCMCs) within 6 months after vaccination. | 6 months after vaccination |
| Measure | Description | Time Frame |
|---|---|---|
| Pneumococcal serotype-specific opsonophagocytic activity (OPA) geometric mean titers (GMTs) measured 1 month after vaccination. | 1 month after vaccination | |
| Pneumococcal serotype-specific OPA geometric mean fold rises (GMFRs) measured from before vaccination to 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 |
|---|---|---|---|---|---|---|
| New Haven Clinical Research Unit | New Haven | Connecticut | 06511 | United States |
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| Label | URL |
|---|---|
| To obtain contact information for a study center near you, click here. | View source |
| To obtain contact information for a study center near you, click here. | View source |
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| Tdap |
| Biological |
Tetanus, diphtheria, and pertussis vaccine |
|
| 1 month after vaccination |
| 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 |
|---|---|
| D017778 | Vaccines, Combined |
| ID | Term |
|---|---|
| D014612 | Vaccines |
| D001688 | Biological Products |
| D045424 | Complex Mixtures |
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