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The objective of the study is to evaluate the safety and tolerability of a single injection of VAX-24 at 3 dose levels compared to Prevnar 20â„¢ (PCV20) in adults 18 to 49 years of age in Phase 1. The Phase 2 will evaluate the safety, tolerability, and immunogenicity of a single injection of VAX-24 at 3 dose levels compared to PCV20 in adults aged 50 to 64 years of age in Phase 2.
The objective of the study is to evaluate the safety and tolerability of a single injection of VAX-24 at 3 dose levels (Low: 1.1 mcg; Mid: 2.2 mcg; or Mixed: 2.2/4.4 mcg) compared to Prevnar 20â„¢ (PCV20) in adults 18 to 49 years of age in Phase 1. The Phase 2 will evaluate the safety, tolerability, and immunogenicity of a single injection of VAX-24 at 3 dose levels (Low: 1.1 mcg; Mid: 2.2 mcg; or Mixed: 2.2/4.4 mcg) compared to PCV20 in adults aged 50 to 64 years of age.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| VAX-24 Low Dose | Experimental | Participants will receive a single dose of VAX-24 1.1 mcg administered as an intramuscular injection on Day 1. |
|
| VAX-24 Mid Dose | Experimental | Participants will receive a single dose of VAX-24 2.2 mcg administered as an intramuscular injection on Day 1. |
|
| VAX-24 Mixed Dose | Experimental | Participants will receive a single dose of VAX-24 2.2 mcg/4.4 mcg administered as an intramuscular injection on Day 1. |
|
| PCV20 | Active Comparator | Participants will receive a single intramuscular injection of the standard dose of PCV20 on Day 1. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| 24 valent pneumococcal conjugate vaccine | Biological | 0.5 ml dose of VAX-24 will be administered into the deltoid muscle at Day 1 |
|
| Measure | Description | Time Frame |
|---|---|---|
| Percentage of Participants Reporting Solicited Local Reactions Within 7 Days After Vaccination in Each Age Group | Solicited local reactions include redness/erythema, swelling/induration, and pain at injection site within 7 days after vaccination in each age group | 7 days after vaccination |
| Percentage of Participants Reporting Solicited Systemic Events Within 7 Days After Vaccination in Each Age Group | Solicited systemic reactions include fever, headache, fatigue, muscle pain, and joint pain | 7 days after vaccination |
| Percentage of Participants Reporting Unsolicited Adverse Events (AE) in Each Age Group | Percentage of participants in each age group with adverse events (AEs) whose date of onset occurs after the study vaccine and within the 28 days after vaccination. | 1 month after vaccination |
| Percentage of Participants Reporting SAEs and New Onset of Chronic Illnesses (NOCI) | Percentage of participants with SAEs and NOCIs | 6 months after vaccination |
| Measure | Description | Time Frame |
|---|---|---|
| Percentage of Participants With Laboratory Value Abnormalities and/or Potentially Clinically Significant Laboratory Values | Shifts from Normal at Baseline to Abnormal on Day 29 in Clinical Chemistry Parameters Occurring in >5% of Subjects Aged 50 to 64 Years | 1 month after vaccination |
| VAX-24 Pneumococcal Serotype-specific Opsonophagocytic Assay (OPA) Geometric Mean Titer (GMTs) |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Clinical Development | Vaxcyte, Inc. | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| CenExel RCA | Hollywood | Florida | 33024 | United States | ||
| Precision Clinical Research |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 38061367 | Result | Wassil J, Sisti M, Fairman J, Davis M, Fierro C, Bennett S, Johnson D, Migone TS, Nguyen K, Sauer P, Currie M, Iki S, Simon JK. Evaluating the safety, tolerability, and immunogenicity of a 24-valent pneumococcal conjugate vaccine (VAX-24) in healthy adults aged 18 to 64 years: a phase 1/2, double-masked, dose-finding, active-controlled, randomised clinical trial. Lancet Infect Dis. 2024 Mar;24(3):308-318. doi: 10.1016/S1473-3099(23)00572-8. Epub 2023 Dec 4. |
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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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In Phase 1, 95 participants were screened; 21 did not meet inclusion/exclusion criteria, 4 withdrew consent, and 6 discontinued for other reason. Five of Phase 1 screen failures were rescreened and enrolled in Phase 2. An additional 1001 participants were screened (for a total of 1006); of these, 235 failed screening: 173 did not meet inclusion/exclusion criteria, 12 withdrew consent, and 50 failed for other reasons.
First subject was enrolled 22-Feb-2022 and last subject randomized/vaccinated was 01-Jul-22. Study sites were medical clinics.
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| ID | Title | Description |
|---|---|---|
| FG000 | VAX-24 Low Dose | Participants will receive a single dose of VAX-24 administered as an intramuscular injection on Day 1 at the 1.1 mcg dose levels. 24 valent pneumococcal conjugate vaccine: 0.5 ml dose of VAX-24 will be administered into the deltoid muscle at Day 1 |
| FG001 | VAX-24 Mid Dose |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Phase 1, Adults 18-49 Years of Age |
|
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot | Yes | No | No | Study Protocol | May 31, 2022 | Feb 1, 2024 |
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Triple (Participant, Investigator, Outcomes Assessor)
| 20 valent pneumococcal conjugate vaccine | Biological | 0.5 ml dose of PCV20 will be administered into the deltoid muscle at Day 1 |
|
Antibody geometric mean titers as measured by OPA for the 24 pneumococcal serotypes in VAX-24 |
| 1 month after vaccination |
| VAX-24 Pneumococcal Serotype-specific Immunoglobulin G (IgG) Geometric Mean Concentration (GMCs) | Antibody geometric mean concentrations as measured by IgG for the 24 pneumococcal serotypes in VAX-24 | 1 month after vaccination |
| Sunrise |
| Florida |
| 33351 |
| United States |
| Meridian Clinical Research | Savannah | Georgia | 31406 | United States |
| Velocity Clinical Research | Valparaiso | Indiana | 46383 | United States |
| Johnson County Clin-Trials | Lenexa | Kansas | 66219 | United States |
| Benchmark Research | Metairie | Louisiana | 70006 | United States |
| Alliance for Multispecialty Research | Kansas City | Missouri | 64114 | United States |
| Rochester Clinical Research | Rochester | New York | 14609 | United States |
| Acellacare of Wilmington | Wilmington | North Carolina | 28401 | United States |
| Velocity Clinical Research | Warwick | Rhode Island | 02886 | United States |
| Coastal Carolina Research | North Charleston | South Carolina | 29405 | United States |
| Benchmark Research | San Angelo | Texas | 76904 | United States |
| JBR Clinical Research | Salt Lake City | Utah | 84107 | United States |
Participants will receive a single dose of VAX-24 administered as an intramuscular injection on Day 1 at 2.2 mcg dose level. 24 valent pneumococcal conjugate vaccine: 0.5 ml dose of VAX-24 will be administered into the deltoid muscle at Day 1 |
| FG002 | VAX-24 Mixed Dose | Participants will receive a single dose of VAX-24 administered as an intramuscular injection on Day 1 at 2.2/4.4 mcg dose levels. 24 valent pneumococcal conjugate vaccine: 0.5 ml dose of VAX-24 will be administered into the deltoid muscle at Day 1 |
| FG003 | PCV20 | Participants will receive a single intramuscular injection of the standard dose of PCV20 on Day 1. 20 valent pneumococcal conjugate vaccine: 0.5 ml dose of PCV20 will be administered into the deltoid muscle at Day 1 |
| COMPLETED |
|
| NOT COMPLETED |
|
|
| Phase 2, Adults 50-64 Years |
|
|
Baseline demographics include all randomized subjects from Phase 1 and Phase 2 by age group. The prespecified immunogenicity analysis and Laboratory Value Abnormalities and/or Potentially Clinically Significant Laboratory Values included only subjects 50-64 years old.
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| ID | Title | Description |
|---|---|---|
| BG000 | VAX-24 Low Dose 18-49 Yrs | Participants will receive a single dose of VAX-24 administered as an intramuscular injection on Day 1 at 1.1 mcg dose level. 24 valent pneumococcal conjugate vaccine: 0.5 ml dose of VAX-24 will be administered into the deltoid muscle at Day 1 |
| BG001 | VAX-24 Mid Dose 18-49 Yrs | Participants will receive a single dose of VAX-24 administered as an intramuscular injection on Day 1 at 2.2 mcg dose level. 24 valent pneumococcal conjugate vaccine: 0.5 ml dose of VAX-24 will be administered into the deltoid muscle at Day 1 |
| BG002 | VAX-24 Mixed Dose 18-49 Yrs | Participants will receive a single dose of VAX-24 administered as an intramuscular injection on Day 1 at 2.2 mcg/4.4 mcg dose levels. 24 valent pneumococcal conjugate vaccine: 0.5 ml dose of VAX-24 will be administered into the deltoid muscle at Day 1 |
| BG003 | PCV20 18-49 Yrs | Participants will receive a single intramuscular injection of the standard dose of PCV20 on Day 1. 20 valent pneumococcal conjugate vaccine: 0.5 ml dose of PCV20 will be administered into the deltoid muscle at Day 1 |
| BG004 | VAX-24 Low Dose 50-64 Yrs | Participants will receive a single dose of VAX-24 administered as an intramuscular injection on Day 1 at 1.1 mcg dose level. 24 valent pneumococcal conjugate vaccine: 0.5 ml dose of VAX-24 will be administered into the deltoid muscle at Day 1 |
| BG005 | VAX-24 Mid Dose 50-64 Yrs | Participants will receive a single dose of VAX-24 administered as an intramuscular injection on Day 1 at 2.2 mcg dose level. 24 valent pneumococcal conjugate vaccine: 0.5 ml dose of VAX-24 will be administered into the deltoid muscle at Day 1 |
| BG006 | VAX-24 Mixed Dose 50-64 Yrs | Participants will receive a single dose of VAX-24 administered as an intramuscular injection on Day 1 at 2.2 mcg/4.4 mcg dose levels. 24 valent pneumococcal conjugate vaccine: 0.5 ml dose of VAX-24 will be administered into the deltoid muscle at Day 1 |
| BG007 | PCV20 50-64 Yrs | Participants will receive a single intramuscular injection of the standard dose of PCV20 on Day 1. 20 valent pneumococcal conjugate vaccine: 0.5 ml dose of PCV20 will be administered into the deltoid muscle at Day 1 |
| BG008 | Total | Total of all reporting groups |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes | ||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Median | Inter-Quartile Range | Years |
| |||||||||||||||
| Sex: Female, Male | Count of Participants | Participants |
| ||||||||||||||||
| Ethnicity (NIH/OMB) | Count of Participants | Participants |
| ||||||||||||||||
| Race (NIH/OMB) | Count of Participants | Participants |
| ||||||||||||||||
| Region of Enrollment | Number | participants |
| ||||||||||||||||
| Height (cm) | Median | Inter-Quartile Range | cm |
| |||||||||||||||
| Weight (kg) | Median | Inter-Quartile Range | kg |
| |||||||||||||||
| Body Mass Index (kg/m^2) Median, Q1 - Q3 | Median | Inter-Quartile Range | kg/m^2 |
|
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||||||||||||||||||||||||||||||||||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Percentage of Participants Reporting Solicited Local Reactions Within 7 Days After Vaccination in Each Age Group | Solicited local reactions include redness/erythema, swelling/induration, and pain at injection site within 7 days after vaccination in each age group | Safety population, defined as all patients exposed to study vaccine. Subject safety data were analyzed according to the vaccine regimen they received: 1 subject was randomized to VAX-24 2.2/4.4 mcg but received VAX-24 2.2 mcg, and 2 subjects were randomized to VAX-24 2.2 mcg but received PCV20. | Posted | Number | percentage of participants | 7 days after vaccination |
|
|
| |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Primary | Percentage of Participants Reporting Solicited Systemic Events Within 7 Days After Vaccination in Each Age Group | Solicited systemic reactions include fever, headache, fatigue, muscle pain, and joint pain | Safety population, which included all subjects in the Exposed Population who provided safety assessment data. Subject safety data were analyzed according to the vaccine regimen they received: 1 subject was randomized to VAX-24 2.2/4.4 mcg but received VAX-24 2.2 mcg, and 2 subjects were randomized to VAX-24 2.2 mcg but received PCV20. | Posted | Number | Percentage of participants | 7 days after vaccination |
| |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Primary | Percentage of Participants Reporting Unsolicited Adverse Events (AE) in Each Age Group | Percentage of participants in each age group with adverse events (AEs) whose date of onset occurs after the study vaccine and within the 28 days after vaccination. | Safety population, including all subjects in the Exposed Population who provided safety assessment data. Subject safety data were analyzed according to the vaccine regimen they received: 1 subject was randomized to VAX-24 2.2/4.4 mcg but received VAX-24 2.2 mcg, and 2 subjects were randomized to VAX-24 2.2 mcg but received PCV20. | Posted | Number | Percentage of participants | 1 month after vaccination |
| |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Primary | Percentage of Participants Reporting SAEs and New Onset of Chronic Illnesses (NOCI) | Percentage of participants with SAEs and NOCIs | Safety population, including all subjects in the exposed population who provided safety assessment data. Subject safety data were analyzed according to the vaccine regimen they received: 1 subject was randomized to VAX-24 2.2/4.4 mcg but received VAX-24 2.2 mcg, and 2 subjects were randomized to VAX-24 2.2 mcg but received PCV20. | Posted | Number | percentage of participants | 6 months after vaccination |
| |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | Percentage of Participants With Laboratory Value Abnormalities and/or Potentially Clinically Significant Laboratory Values | Shifts from Normal at Baseline to Abnormal on Day 29 in Clinical Chemistry Parameters Occurring in >5% of Subjects Aged 50 to 64 Years | Prespecified analysis population included all subjects age 50-64 in the Exposed Population who provided safety assessment data. Subject safety data were analyzed according to the vaccine regimen they received: 1 subject was randomized to VAX-24 2.2/4.4 mcg but received VAX-24 2.2 mcg, and 2 subjects were randomized to VAX-24 2.2 mcg but received PCV20. | Posted | Number | percentage of participants | 1 month after vaccination |
| |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | VAX-24 Pneumococcal Serotype-specific Opsonophagocytic Assay (OPA) Geometric Mean Titer (GMTs) | Antibody geometric mean titers as measured by OPA for the 24 pneumococcal serotypes in VAX-24 | Prespecified Immunogenicity Evaluable Population included all subjects 50 to 64 years in the Exposed Population with no major protocol deviation impacting immunogenicity assessment, no prohibited medication or vaccine, and provided evaluable serum sample results for baseline and Day 29 within required time frames. Data were analyzed according to vaccine received: 1 subject randomized to VAX-24 2.2/4.4 mcg received VAX-24 2.2 mcg; 2 subjects randomized to VAX-24 2.2 mcg received PCV20. | Posted | Geometric Mean | 95% Confidence Interval | Titer | 1 month after vaccination |
| ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | VAX-24 Pneumococcal Serotype-specific Immunoglobulin G (IgG) Geometric Mean Concentration (GMCs) | Antibody geometric mean concentrations as measured by IgG for the 24 pneumococcal serotypes in VAX-24 | Prespecified Immunogenicity Evaluable Population included all subjects 50 to 64 years in the Exposed Population with no major protocol deviation impacting immunogenicity assessment, no prohibited medication or vaccine, and provided evaluable serum sample results for baseline and Day 29 within required time frames. Data were analyzed according to vaccine received: 1 subject randomized to VAX-24 2.2/4.4 mcg received VAX-24 2.2 mcg; 2 subjects randomized to VAX-24 2.2 mcg received PCV20. | Posted | Geometric Mean | 95% Confidence Interval | mcg/mL | 1 month after vaccination |
|
6 months
All subjects had safety labs analyzed at Baseline and Day 29. Solicited AEs were collected for 7 days and unsolicited AEs for 28 days post-vaccination. SAEs, new onset of chronic illness and medically attended adverse events were collected for 6 months post-vaccination. Subject safety data were analyzed according to the vaccine regimen received: 1 subject was randomized to VAX-24 2.2/4.4 mcg but received VAX-24 2.2 mcg, and 2 subjects were randomized to VAX-24 2.2 mcg but received PCV20.
Not provided
| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | VAX-24 Low Dose 18-49 Yrs | Participants will receive a single dose of VAX-24 administered as an intramuscular injection on Day 1 at one of three dose levels. 24 valent pneumococcal conjugate vaccine: 0.5 ml dose of VAX-24 will be administered into the deltoid muscle at Day 1 | 0 | 16 | 0 | 16 | 9 | 16 |
| EG001 | VAX-24 Mid Dose 18-49 Yrs | Participants will receive a single dose of VAX-24 administered as an intramuscular injection on Day 1 at one of three dose levels. 24 valent pneumococcal conjugate vaccine: 0.5 ml dose of VAX-24 will be administered into the deltoid muscle at Day 1 | 0 | 16 | 0 | 16 | 13 | 16 |
| EG002 | VAX-24 Mixed Dose 18-49 Yrs | Participants will receive a single dose of VAX-24 administered as an intramuscular injection on Day 1 at one of three dose levels. 24 valent pneumococcal conjugate vaccine: 0.5 ml dose of VAX-24 will be administered into the deltoid muscle at Day 1 | 0 | 16 | 0 | 16 | 14 | 16 |
| EG003 | PCV20 18-49 Yrs | Participants will receive a single intramuscular injection of the standard dose of PCV20 on Day 1. 20 valent pneumococcal conjugate vaccine: 0.5 ml dose of PCV20 will be administered into the deltoid muscle at Day 1 | 0 | 16 | 0 | 16 | 16 | 16 |
| EG004 | VAX-24 Low Dose 50-64 Yrs | Participants will receive a single dose of VAX-24 administered as an intramuscular injection on Day 1 at one of three dose levels. 24 valent pneumococcal conjugate vaccine: 0.5 ml dose of VAX-24 will be administered into the deltoid muscle at Day 1 | 0 | 193 | 2 | 193 | 161 | 193 |
| EG005 | VAX-24 Mid Dose 50-64 Yrs | Participants will receive a single dose of VAX-24 administered as an intramuscular injection on Day 1 at one of three dose levels. 24 valent pneumococcal conjugate vaccine: 0.5 ml dose of VAX-24 will be administered into the deltoid muscle at Day 1 | 0 | 191 | 3 | 191 | 155 | 191 |
| EG006 | VAX-24 Mixed Dose 50-64 Yrs | Participants will receive a single dose of VAX-24 administered as an intramuscular injection on Day 1 at one of three dose levels. 24 valent pneumococcal conjugate vaccine: 0.5 ml dose of VAX-24 will be administered into the deltoid muscle at Day 1 | 0 | 191 | 1 | 191 | 164 | 191 |
| EG007 | PCV20 50-64 Yrs | Participants will receive a single intramuscular injection of the standard dose of PCV20 on Day 1. 20 valent pneumococcal conjugate vaccine: 0.5 ml dose of PCV20 will be administered into the deltoid muscle at Day 1 | 0 | 196 | 4 | 196 | 163 | 196 |
| EG008 | VAX-24 Low Dose 18-64 Yrs | Participants will receive a single dose of VAX-24 administered as an intramuscular injection on Day 1 at one of three dose levels. 24 valent pneumococcal conjugate vaccine: 0.5 ml dose of VAX-24 will be administered into the deltoid muscle at Day 1 | 0 | 209 | 2 | 209 | 170 | 209 |
| EG009 | VAX-24 Mid Dose 18-64 Yrs | Participants will receive a single dose of VAX-24 administered as an intramuscular injection on Day 1 at one of three dose levels. 24 valent pneumococcal conjugate vaccine: 0.5 ml dose of VAX-24 will be administered into the deltoid muscle at Day 1 | 0 | 207 | 3 | 207 | 168 | 207 |
| EG010 | VAX-24 Mixed Dose 18-64 Yrs | Participants will receive a single dose of VAX-24 administered as an intramuscular injection on Day 1 at one of three dose levels. 24 valent pneumococcal conjugate vaccine: 0.5 ml dose of VAX-24 will be administered into the deltoid muscle at Day 1 | 0 | 207 | 1 | 207 | 178 | 207 |
| EG011 | PCV20 18-64 Yrs | Participants will receive a single intramuscular injection of the standard dose of PCV20 on Day 1. 20 valent pneumococcal conjugate vaccine: 0.5 ml dose of PCV20 will be administered into the deltoid muscle at Day 1 | 0 | 212 | 4 | 212 | 179 | 212 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Acetabulum fracture | Injury, poisoning and procedural complications | MedDRA 25.0 | Non-systematic Assessment |
| |
| Bladder Injury | Injury, poisoning and procedural complications | MedDRA 25.0 | Non-systematic Assessment |
| |
| Forearm Fracture | Injury, poisoning and procedural complications | MedDRA 25.0 | Non-systematic Assessment |
| |
| Lower limb fracture | Injury, poisoning and procedural complications | MedDRA 25.0 | Non-systematic Assessment |
| |
| Pulmonary embolism | Respiratory, thoracic and mediastinal disorders | MedDRA 25.0 | Non-systematic Assessment |
| |
| Breast Cancer | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 25.0 | Non-systematic Assessment |
| |
| Invasive ductal breast carcinoma | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 25.0 | Non-systematic Assessment |
| |
| Deep vein thrombosis | Vascular disorders | MedDRA 25.0 | Non-systematic Assessment |
| |
| Colitis ulcerative | Gastrointestinal disorders | MedDRA 25.0 | Non-systematic Assessment |
| |
| Gastric ulcer haemorrhage | Gastrointestinal disorders | MedDRA 25.0 | Non-systematic Assessment |
| |
| Pancreatitis | Gastrointestinal disorders | MedDRA 25.0 | Non-systematic Assessment |
| |
| Toxic encephalopathy | Nervous system disorders | MedDRA 25.0 | Non-systematic Assessment |
| |
| Depression | Psychiatric disorders | MedDRA 25.0 | Non-systematic Assessment |
| |
| Acute kidney injury | Renal and urinary disorders | MedDRA 25.0 | Non-systematic Assessment |
| |
| Pelvic Fracture | Injury, poisoning and procedural complications | MedDRA 25.0 | Non-systematic Assessment |
|
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Oropharyngeal pain | Respiratory, thoracic and mediastinal disorders | MedDRA 25.0 | Non-systematic Assessment |
| |
| Nasal congestion | Respiratory, thoracic and mediastinal disorders | MedDRA 25.0 | Non-systematic Assessment |
| |
| Rhinorrhea | Respiratory, thoracic and mediastinal disorders | MedDRA 25.0 | Non-systematic Assessment |
| |
| Throat irritation | Respiratory, thoracic and mediastinal disorders | MedDRA 25.0 | Non-systematic Assessment |
| |
| Injection site bruising | General disorders | MedDRA 25.0 | Non-systematic Assessment |
| |
| Injection site pain | Skin and subcutaneous tissue disorders | MedDRA 25.0 | Systematic Assessment |
| |
| Bronchitis | Infections and infestations | MedDRA 25.0 | Non-systematic Assessment |
| |
| Subcutaneous abscess | Infections and infestations | MedDRA 25.0 | Non-systematic Assessment |
| |
| Upper respiratory tract infection | Infections and infestations | MedDRA 25.0 | Non-systematic Assessment |
| |
| Arthralgia | Musculoskeletal and connective tissue disorders | MedDRA 25.0 | Non-systematic Assessment |
| |
| Erythema | Skin and subcutaneous tissue disorders | MedDRA 25.0 | Systematic Assessment |
| |
| Edema | Skin and subcutaneous tissue disorders | MedDRA 25.0 | Systematic Assessment |
| |
| Fatigue | General disorders | MedDRA 25.0 | Systematic Assessment |
| |
| Headache | General disorders | MedDRA 25.0 | Systematic Assessment |
| |
| Muscle pain | Musculoskeletal and connective tissue disorders | MedDRA 25.0 | Non-systematic Assessment |
| |
| Joint pain | Musculoskeletal and connective tissue disorders | MedDRA 25.0 | Non-systematic Assessment |
| |
| Fever | General disorders | MedDRA 25.0 | Systematic Assessment |
|
Some limitations of this clinical study include the lack of a group, such as 3·3 µg or 4·4 µg, for all serotypes, aimed at understanding whether the dose response of polysaccharide can overcome carrier suppression. The relatively low ethnic diversity of participants is also a limitation, which will be addressed in larger phase 3 clinical trials.
Sponsor shall review within the ninety (90) day period. Upon receiving any notification from Sponsor requesting deletion of Confidential Information, correction of inaccuracies, or a delay in publication to allow the filing of patent application, Institution or Investigator shall take the requested action of Sponsor.
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Vice President of Clinical Development | Vaxcyte | (650) 585-0029 | clinicaltrialsgov@vaxcyte.com |
| Prot_002.pdf |
| SAP | No | Yes | No | Statistical Analysis Plan | Dec 29, 2022 | Feb 1, 2024 | SAP_003.pdf |
Not provided
| Withdrawal by Subject |
|
| Unavailable for follow up |
|
| Male |
|
| Not Hispanic or Latino |
|
| Unknown or Not Reported |
|
| Asian |
|
| Native Hawaiian or Other Pacific Islander |
|
| Black or African American |
|
| White |
|
| More than one race |
|
| Unknown or Not Reported |
|
| Pain at injection site; Overall, Any Grade |
|
| Erythema (redness) at injection site; Overall, Any Grade |
|
| Edema (swelling) at injection site; Overall, Any Grade |
|
Participants will receive a single dose of VAX-24 administered as an intramuscular injection on Day 1 at 2.2 mcg/4.4 mcg dose levels.
24 valent pneumococcal conjugate vaccine: 0.5 ml dose of VAX-24 will be administered into the deltoid muscle at Day 1
| OG003 | PCV20 18-49 Yrs | Participants will receive a single intramuscular injection of the standard dose of PCV20 on Day 1. 20 valent pneumococcal conjugate vaccine: 0.5 ml dose of PCV20 will be administered into the deltoid muscle at Day 1 |
| OG004 | VAX-24 Low Dose 50-64 Yrs | Participants will receive a single dose of VAX-24 administered as an intramuscular injection on Day 1 at 1.1 mcg dose level. 24 valent pneumococcal conjugate vaccine: 0.5 ml dose of VAX-24 will be administered into the deltoid muscle at Day 1 |
| OG005 | VAX-24 Mid Dose 50-64 Yrs | Participants will receive a single dose of VAX-24 administered as an intramuscular injection on Day 1 at 2.2 mcg dose level. 24 valent pneumococcal conjugate vaccine: 0.5 ml dose of VAX-24 will be administered into the deltoid muscle at Day 1 |
| OG006 | VAX-24 Mixed Dose 50-64 Yrs | Participants will receive a single dose of VAX-24 administered as an intramuscular injection on Day 1 at 2.2 mcg/4.4 mcg dose levels. 24 valent pneumococcal conjugate vaccine: 0.5 ml dose of VAX-24 will be administered into the deltoid muscle at Day 1 |
| OG007 | PCV20 50-64 Yrs | Participants will receive a single intramuscular injection of the standard dose of PCV20 on Day 1. 20 valent pneumococcal conjugate vaccine: 0.5 ml dose of PCV20 will be administered into the deltoid muscle at Day 1 |
| OG008 | VAX-24 Low Dose 18-64 Yrs | Participants will receive a single dose of VAX-24 administered as an intramuscular injection on Day 1 at 1.1 mcg dose level. 24 valent pneumococcal conjugate vaccine: 0.5 ml dose of VAX-24 will be administered into the deltoid muscle at Day 1 |
| OG009 | VAX-24 Mid Dose 18-64 Yrs | Participants will receive a single dose of VAX-24 administered as an intramuscular injection on Day 1 at 2.2 mcg dose level. 24 valent pneumococcal conjugate vaccine: 0.5 ml dose of VAX-24 will be administered into the deltoid muscle at Day 1 |
| OG010 | VAX-24 Mixed Dose 18-64 Yrs | Participants will receive a single dose of VAX-24 administered as an intramuscular injection on Day 1 at 2.2 mcg/4.4 mcg dose levels. 24 valent pneumococcal conjugate vaccine: 0.5 ml dose of VAX-24 will be administered into the deltoid muscle at Day 1 |
| OG011 | PCV20 18-64 Yrs | Participants will receive a single intramuscular injection of the standard dose of PCV20 on Day 1. 20 valent pneumococcal conjugate vaccine: 0.5 ml dose of PCV20 will be administered into the deltoid muscle at Day 1 |
|
|
Participants will receive a single dose of VAX-24 administered as an intramuscular injection on Day 1 at 2.2/4.4 mcg dose levels. 24 valent pneumococcal conjugate vaccine: 0.5 ml dose of VAX-24 will be administered into the deltoid muscle at Day 1 |
| OG003 | PCV20 18-49 Yrs | Participants will receive a single intramuscular injection of the standard dose of PCV20 on Day 1. 20 valent pneumococcal conjugate vaccine: 0.5 ml dose of PCV20 will be administered into the deltoid muscle at Day 1 |
| OG004 | VAX-24 Low Dose 50-64 Yrs | Participants will receive a single dose of VAX-24 administered as an intramuscular injection on Day 1 at 1.1 mcg dose levels. 24 valent pneumococcal conjugate vaccine: 0.5 ml dose of VAX-24 will be administered into the deltoid muscle at Day 1 |
| OG005 | VAX-24 Mid Dose 50-64 Yrs | Participants will receive a single dose of VAX-24 administered as an intramuscular injection on Day 1 at 2.2 mcg dose levels. 24 valent pneumococcal conjugate vaccine: 0.5 ml dose of VAX-24 will be administered into the deltoid muscle at Day 1 |
| OG006 | VAX-24 Mixed Dose 50-64 Yrs | Participants will receive a single dose of VAX-24 administered as an intramuscular injection on Day 1 at 2.2 mcg/4.4 mcg dose levels. 24 valent pneumococcal conjugate vaccine: 0.5 ml dose of VAX-24 will be administered into the deltoid muscle at Day 1 |
| OG007 | PCV20 50-64 | Participants will receive a single intramuscular injection of the standard dose of PCV20 on Day 1. 20 valent pneumococcal conjugate vaccine: 0.5 ml dose of PCV20 will be administered into the deltoid muscle at Day 1 |
| OG008 | VAX-24 Low Dose 18-64 | Participants will receive a single dose of VAX-24 administered as an intramuscular injection on Day 1 at 1.1 mcg dose levels. 24 valent pneumococcal conjugate vaccine: 0.5 ml dose of VAX-24 will be administered into the deltoid muscle at Day 1 |
| OG009 | VAX-24 Mid Dose 18-64 Yrs | Participants will receive a single dose of VAX-24 administered as an intramuscular injection on Day 1 at 2.2 mcg dose level. 24 valent pneumococcal conjugate vaccine: 0.5 ml dose of VAX-24 will be administered into the deltoid muscle at Day 1 |
| OG010 | VAX-24 Mixed Dose 18-64 Yrs | Participants will receive a single dose of VAX-24 administered as an intramuscular injection on Day 1 at 2.2/4.4 mcg dose levels. 24 valent pneumococcal conjugate vaccine: 0.5 ml dose of VAX-24 will be administered into the deltoid muscle at Day 1 |
| OG011 | PCV20 18-64 Yrs | Participants will receive a single intramuscular injection of the standard dose of PCV20 on Day 1. 20 valent pneumococcal conjugate vaccine: 0.5 ml dose of PCV20 will be administered into the deltoid muscle at Day 1 |
|
|
| OG003 | PCV20 18-49 Yrs | Participants will receive a single intramuscular injection of the standard dose of PCV20 on Day 1. 20 valent pneumococcal conjugate vaccine: 0.5 ml dose of PCV20 will be administered into the deltoid muscle at Day 1 |
| OG004 | VAX-24 Low Dose 50-64 Yrs | Participants will receive a single dose of VAX-24 administered as an intramuscular injection on Day 1 at 1.1 mcg dose level. 24 valent pneumococcal conjugate vaccine: 0.5 ml dose of VAX-24 will be administered into the deltoid muscle at Day 1 |
| OG005 | VAX-24 Mid Dose 50-64 Yrs | Participants will receive a single dose of VAX-24 administered as an intramuscular injection on Day 1 at 2.2 mcg dose level. 24 valent pneumococcal conjugate vaccine: 0.5 ml dose of VAX-24 will be administered into the deltoid muscle at Day 1 |
| OG006 | VAX-24 Mixed Dose | Participants will receive a single dose of VAX-24 administered as an intramuscular injection on Day 1 at 2.2 mcg/4.4 mcg dose levels. 24 valent pneumococcal conjugate vaccine: 0.5 ml dose of VAX-24 will be administered into the deltoid muscle at Day 1 |
| OG007 | PCV20 50-64 Yrs | Participants will receive a single intramuscular injection of the standard dose of PCV20 on Day 1. 20 valent pneumococcal conjugate vaccine: 0.5 ml dose of PCV20 will be administered into the deltoid muscle at Day 1 |
| OG008 | VAX-24 Low Dose 18-64 Yrs | Participants will receive a single dose of VAX-24 administered as an intramuscular injection on Day 1 at 1.1 mcg dose level. 24 valent pneumococcal conjugate vaccine: 0.5 ml dose of VAX-24 will be administered into the deltoid muscle at Day 1 |
| OG009 | VAX-24 Mid Dose 18-64 Yrs | Participants will receive a single dose of VAX-24 administered as an intramuscular injection on Day 1 at 2.2 mcg dose level. 24 valent pneumococcal conjugate vaccine: 0.5 ml dose of VAX-24 will be administered into the deltoid muscle at Day 1 |
| OG010 | VAX-24 Mixed Dose 18-64 Yrs | Participants will receive a single dose of VAX-24 administered as an intramuscular injection on Day 1 at 2.2 mcg/4.4 mcg dose levels. 24 valent pneumococcal conjugate vaccine: 0.5 ml dose of VAX-24 will be administered into the deltoid muscle at Day 1 |
| OG011 | PCV20 18-64 Yrs | Participants will receive a single intramuscular injection of the standard dose of PCV20 on Day 1. 20 valent pneumococcal conjugate vaccine: 0.5 ml dose of PCV20 will be administered into the deltoid muscle at Day 1 |
|
|
Participants will receive a single dose of VAX-24 administered as an intramuscular injection on Day 1 at 2.2 mcg/4.4 mcg dose levels. 24 valent pneumococcal conjugate vaccine: 0.5 ml dose of VAX-24 will be administered into the deltoid muscle at Day 1 |
| OG003 | PCV20 | Participants will receive a single intramuscular injection of the standard dose of PCV20 on Day 1. 20 valent pneumococcal conjugate vaccine: 0.5 ml dose of PCV20 will be administered into the deltoid muscle at Day 1 |
|
|
| VAX-24 Mixed Dose |
Participants will receive a single dose of VAX-24 administered as an intramuscular injection on Day 1 at 2.2 mcg/4.4 mcg dose levels. 24 valent pneumococcal conjugate vaccine: 0.5 ml dose of VAX-24 will be administered into the deltoid muscle at Day 1 |
| OG003 | PCV20 | Participants will receive a single intramuscular injection of the standard dose of PCV20 on Day 1. 20 valent pneumococcal conjugate vaccine: 0.5 ml dose of PCV20 will be administered into the deltoid muscle at Day 1 |
|
|
| VAX-24 Mixed Dose |
Participants will receive a single dose of VAX-24 administered as an intramuscular injection on Day 1 at 2.2 mcg/4.4 mcg dose levels. 24 valent pneumococcal conjugate vaccine: 0.5 ml dose of VAX-24 will be administered into the deltoid muscle at Day 1 |
| OG003 | PCV20 | Participants will receive a single intramuscular injection of the standard dose of PCV20 on Day 1. 20 valent pneumococcal conjugate vaccine: 0.5 ml dose of PCV20 will be administered into the deltoid muscle at Day 1 |
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