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This is a Phase 3, randomized, double-blind study to evaluate the safety and immunogenicity of VAX-31 and seasonal influenza vaccine in pneumococcal-naïve adults ≥ 50 years when the two vaccines are administered at the same visit or separately.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| VAX-31 + SIV | Experimental | Participants will receive a single dose of VAX-31 administered as an intramuscular injection at Day 1, concomitantly administered with SIV, followed by placebo at Month 1. |
|
| Placebo + SIV | Experimental | Participants will receive placebo administered via intramuscular injection at Day 1, concomitantly administered with SIV, followed by VAX-31 at Month 1. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| 31-valent pneumococcal conjugate vaccine | Biological | 0.5 mL of VAX-31 will be administered into the deltoid muscle |
|
| Measure | Description | Time Frame |
|---|---|---|
| For each of the 32 serotypes (the 31 serotypes included in VAX-31, and serotype 20B), the ratio (co-administration group to sequential administration group) of opsonophagocytic activity (OPA) geometric mean titers (GMT) in evaluable participants | 1 Month after VAX-31 vaccination | |
| For each of the strains in SIV, the ratio (co-administration group to sequential administration group) of hemagglutination inhibition (HAI) GMT in evaluable participants | 1 Month after SIV administration | |
| Percentage of participants reporting solicited local adverse events (AE) within 7 days after Day 1 and Month 1 vaccination (redness, swelling, and pain at injection site) in each group | 7 days after each vaccination | |
| Percentage of participants reporting solicited systemic AE within 7 days after Day 1 and Month 1 vaccination (fever, headache, fatigue, muscle pain, and joint pain) in each group | 7 days after each vaccination | |
| Percentage of participants reporting unsolicited AE within 1 month after Day 1 and Month 1 vaccination in each group | 7 days after each vaccination | |
| Percentage of participants reporting NOCI, MAAE, and SAE within 6 months after last vaccination in each group | 6 Months after last vaccination |
| Measure | Description | Time Frame |
|---|---|---|
| For each of the 32 serotypes (the 31 serotypes included in VAX-31, and serotype 20B), the ratio (co-administration group to sequential administration group) of IgG geometric mean concentrations (GMC) in evaluable participants | 1 month after VAX-31 administration |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Hope Research Institute | Phoenix | Arizona | 85032 | United States | ||
| Tekton Research at Fort Collins |
Vaxcyte is committed to providing access to anonymized data from the company's clinical trials for the purpose of legitimate scientific research. Requests for data may be addressed to datasharing@vaxcyte.com. Requests must be accompanied by a detailed analysis plan and will be reviewed for scientific validity. Data will be made available after initial product approval. Sharing of data may require execution of a data-sharing agreement.
Individual participant data will be shared after deidentification and made available starting 6 months after initial product approval.
Criteria will depend on the specific proposal received and may include qualification of the scientific researchers, potential contribution to the research field, scientific rigor of statistical and analytical methods, and other criteria appropriate for the proposal.
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| Seasonal Influenza Vaccine (SIV) (Flublok) | Biological | 0.5 mL of SIV into the deltoid muscle |
|
| Placebo | Biological | 0.5mL of placebo (normal saline) into the deltoid muscle |
|
| Fort Collins |
| Colorado |
| 80525 |
| United States |
| University Clinical Research - Deland | DeLand | Florida | 32720-0834 | United States |
| CenExel Research Centers of America | Hollywood | Florida | 33024 | United States |
| Health Awareness | Jupiter | Florida | 33458 | United States |
| Accel Research Sites - Lakeland | Lakeland | Florida | 33803 | United States |
| Accel Research Sites - Largo | Largo | Florida | 33777 | United States |
| Precision Clinical Research | Sunrise | Florida | 33351 | United States |
| Velocity Valparaiso | Valparaiso | Indiana | 46383 | United States |
| Johnson County ClinTrials | Lenexa | Kansas | 66219 | United States |
| AMR Lexington | Lexington | Kentucky | 40509 | United States |
| DM Clinical Research - Detroit | Detroit | Michigan | 48076 | United States |
| Velocity Omaha | Omaha | Nebraska | 68134 | United States |
| Rochester Clinical Research | Rochester | New York | 14609 | United States |
| CTI Clinical Research Center | Cincinnati | Ohio | 45212 | United States |
| Coastal Carolina Research Center | North Charleston | South Carolina | 29405 | United States |
| DelRicht Research - Hendersonville | Hendersonville | Tennessee | 37075 | United States |
| AMR Knxoville | Knoxville | Tennessee | 37909 | United States |
| Tekton Research at Austin | Austin | Texas | 78745 | United States |
| REX Clinical Trials | Beaumont | Texas | 77701 | United States |
| Epic Medical Research | DeSoto | Texas | 75115 | United States |
| CenExel JBR Clinical Research | Salt Lake City | Utah | 84107 | United States |
| Charlottesville Medical Research Center | Charlottesville | Virginia | 22911 | United States |
| Health Research of Hampton Roads, Inc. | Newport News | Virginia | 23606 | United States |
| Clinical Research Partners, LLC. | Richmond | Virginia | 23226 | United States |
| ID | Term |
|---|---|
| D011014 | Pneumonia |
| D011008 | Pneumococcal Infections |
| ID | Term |
|---|---|
| D012141 | Respiratory Tract Infections |
| D007239 | Infections |
| D008171 | Lung Diseases |
| D012140 | Respiratory Tract Diseases |
| D013290 | Streptococcal Infections |
| D016908 | Gram-Positive Bacterial Infections |
| D001424 | Bacterial Infections |
| D001423 | Bacterial Infections and Mycoses |
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| ID | Term |
|---|---|
| C528512 | FluBlok |
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