Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
This is a Phase 2, randomized, double-blinded study with a 2-arm parallel design. Healthy adults aged 60 through 64 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 followed 1 month later with a dose of saline or Prevnar 13 followed 1 month later with a dose of PPSV23 (control group).
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Multivalent | Experimental | Pneumococcal conjugate vaccine |
|
| Control | Active Comparator | Prevnar 13 and PPSV23 |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Multivalent | Biological | Pneumococcal conjugate vaccine |
| |
| Measure | Description | Time Frame |
|---|---|---|
| Percentage of Participants With Local Reactions Within 10 Days After Vaccination 1 | Local reactions included pain at injection site, swelling and redness recorded by participants in an electronic diary (e-diary). Redness and swelling were measured and recorded in measuring device units. 1 measuring device unit=0.5 centimeter (cm). Redness and swelling were graded as mild: greater than (>) 2.0 to 5.0 centimeter (cm), moderate: 5.5 to 10.0 cm and severe: greater than or equal to (>=) 10.5 cm. Pain was graded as mild: did not interfere with activity, moderate: interfered with activity and severe: prevented daily activity. | within 10 days after Vaccination 1 |
| Percentage of Participants With Systemic Events Within 7 Days After Vaccination 1 | Systemic events included fever, fatigue, headache, muscle pain and joint pain, recorded by participants in an e-diary. Fever was categorized as: >=38.0 degrees Celsius (C), >=38.0 to 38.4 degrees C, >38.4 to 38.9 degrees C, >38.9 to 40.0 degrees C and >40.0 degrees C. Fatigue, headache, muscle pain and joint pain were graded as mild: no interference with activity, moderate: some interference with activity and severe: prevents daily routine activity. | within 7 days after Vaccination 1 |
| Percentage of Participants With Adverse Events (AEs) Within 1 Month After Vaccination 1 | An AE was any untoward medical occurrence in a participant who received investigational product without regard to possibility of causal relationship. AEs included both serious and non-serious adverse events. Serious adverse event (SAE) was an AE resulting in any of the following outcomes or deemed significant for any other reason: death; initial or prolonged inpatient hospitalization; life-threatening experience (immediate risk of dying); persistent or significant disability/incapacity; congenital anomaly. | within 1 month after Vaccination 1 (up to 35 days) |
| Percentage of Participants With Serious Adverse Events (SAEs) or Newly Diagnosed Chronic Medical Conditions (NDCMCs) Within 6 Months After Vaccination 1 |
| Measure | Description | Time Frame |
|---|---|---|
| Serotype-Specific Pneumococcal Opsonophagocytic Activity (OPA) Geometric Mean Titres (GMTs) 1 Month After Vaccination 1: 13 Common Serotypes in 13vPnC | Antibody-mediated serum OPA against the 13 common pneumococcal serotypes specific to 13vPnC (serotypes 1, 3, 4, 5, 6A, 6B, 7F, 9V, 14, 18C, 19A, 19F and 23F) were measured using a pneumococcal OPA assay. Results were expressed as OPA GMTs. Assay results below the lower limit of quantitation (LLOQ) were set to 0.5*LLOQ in the analysis. |
Not provided
Inclusion Criteria:
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Affiliation | Role |
|---|---|---|
| Pfizer CT.gov Call Center | Pfizer | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Anaheim Clinical Trials, LLC | Anaheim | California | 92801 | United States | ||
| Clinical Research of South Florida |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 32716500 | Derived | Hurley D, Griffin C, Young M, Scott DA, Pride MW, Scully IL, Ginis J, Severs J, Jansen KU, Gruber WC, Watson W. Safety, Tolerability, and Immunogenicity of a 20-Valent Pneumococcal Conjugate Vaccine (PCV20) in Adults 60 to 64 Years of Age. Clin Infect Dis. 2021 Oct 5;73(7):e1489-e1497. doi: 10.1093/cid/ciaa1045. |
| Label | URL |
|---|---|
| To obtain contact information for a study center near you, click here. | View source |
Not provided
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.
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| ID | Title | Description |
|---|---|---|
| FG000 | 20vPnC Followed by Saline | Participants received a single 0.5 milliliter [mL] intramuscular injection of 20-valent pneumococcal conjugate vaccine (20vPnC) (Vaccination 1) on Day 1 followed by 0.5 mL of saline 1 month after Vaccination 1 (Vaccination 2). Participants were followed up to 12 months after Vaccination 1. |
| FG001 |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Overall Study |
|
Not provided
Not provided
| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot | Yes | No | No | Study Protocol | Jul 20, 2017 | Dec 10, 2019 |
Not provided
Not provided
Not provided
Not provided
Not provided
| Prevnar 13 |
| Biological |
Pneumococcal conjugate vaccine |
|
| PPSV23 | Biological | Pneumococcal polysaccharide vaccine |
|
|
| Saline | Other | Placebo |
|
An AE was any untoward medical occurrence in a participant who received study drug without regard to possibility of causal relationship. SAE was an AE resulting in any of the following outcomes or deemed significant for any other reason: death; initial or prolonged inpatient hospitalization; life-threatening experience (immediate risk of dying); persistent or significant disability/incapacity; congenital anomaly. An NDCMC was defined as a disease or medical condition, not previously identified, that is expected to be persistent or is otherwise long-lasting in its effects. Percentage of participants with either SAE or NDCMCs during the specified duration are reported.
| within 6 months after Vaccination 1 (up to 196 days) |
| Percentage of Participants With Serious Adverse Events (SAEs) or Newly Diagnosed Chronic Medical Conditions (NDCMCs) Within 12 Months After Vaccination 1 | An AE was any untoward medical occurrence in a participant who received study drug without regard to possibility of causal relationship. SAE was an AE resulting in any of the following outcomes or deemed significant for any other reason: death; initial or prolonged inpatient hospitalization; life-threatening experience (immediate risk of dying); persistent or significant disability/incapacity; congenital anomaly. An NDCMC was defined as a disease or medical condition, not previously identified, that is expected to be persistent or is otherwise long-lasting in its effects. Percentage of participants with either SAE or NDCMCs during the specified duration are reported. | within 12 months after Vaccination 1 (up to 378 days) |
| 1 month after Vaccination 1 |
| Serotype-Specific Pneumococcal Opsonophagocytic Activity (OPA) Geometric Mean Titres (GMTs) 1 Month After Any Vaccination: 7 Additional Serotypes in 20vPnC | Antibody-mediated serum OPA against the 7 additional pneumococcal serotypes (8, 10A, 11A, 12F, 15B, 22F, 33F) were measured using a pneumococcal OPA assay. Results were expressed as OPA GMTs. Assay results below the LLOQ were set to 0.5*LLOQ in the analysis. | 1 month after Vaccination 1 for 20vPnC followed by saline reporting group; 1 month after Vaccination 2 for 13vPnC followed by PPSV23 reporting group |
| Serotype-specific Pneumococcal Opsonophagocytic Activity (OPA) Geometric Mean Fold Rise (GMFR) From Pre-Vaccination 1 to 1 Month Post-Vaccination 1: 13 Common Serotypes in 13vPnC | GMFR for the 13 pneumococcal serotypes (1, 3, 4, 5, 6A, 6B, 7F, 9V, 14, 18C, 19A, 19F, and 23F) from before Vaccination 1 to one month after Vaccination 1 were calculated as the mean of the difference of logarithmically transformed OPA results (after vaccination - before vaccination) and transform back to the original scale. GMFRs were calculated using data from participants with non-missing OPA results at both time points. Assay results below the LLOQ were set to 0.5*LLOQ in the analysis. | before Vaccination 1 to one month after Vaccination 1 |
| Serotype-specific Pneumococcal Opsonophagocytic Activity (OPA) Geometric Mean Fold Rise (GMFR) From Pre-Vaccination 1 to 1 Month Post Any Vaccination: 7 Additional Serotypes in 20vPnC | GMFR for 7 additional pneumococcal serotypes (8, 10A, 11A, 12F, 15B, 22F, 33F) from before Vaccination 1 to one month after either Vaccination 1 (20vPnC) or Vaccination 2 (PPSV23) were calculated as the mean of the difference of logarithmically transformed OPA results (after vaccination - before vaccination) and transform back to the original scale. GMFRs were calculated using data from participants with non-missing OPA results at both time points. Assay results below the LLOQ were set to 0.5*LLOQ in the analysis. | before Vaccination 1 to 1 month after Vaccination 1 for 20vPnC followed by saline reporting group; before Vaccination 1 to 1 month after Vaccination 2 for 13vPnC followed by PPSV23 reporting group |
| Coral Gables |
| Florida |
| 33134 |
| United States |
| Avail Clinical Research, LLC | DeLand | Florida | 32720 | United States |
| Qps-Mra, Llc | South Miami | Florida | 33143 | United States |
| Clinical Research Atlanta | Stockbridge | Georgia | 30281 | United States |
| East-West Medical Research Institute | Honolulu | Hawaii | 96814 | United States |
| Heartland Research Associates, LLC | Wichita | Kansas | 67207 | United States |
| Lynn Health Science Institute | Oklahoma City | Oklahoma | 73112 | United States |
| Medical Research South, LLC | Charleston | South Carolina | 29414 | United States |
| Benchmark Research | Austin | Texas | 78705 | United States |
| Clinical Trials of Texas, Inc. | San Antonio | Texas | 78229 | United States |
| Martin Diagnostic Clinic | Tomball | Texas | 77375 | United States |
| J. Lewis Research Inc. / Foothill Family Clinic Draper | Draper | Utah | 84020 | United States |
| J. Lewis Research, Inc. - Jordan River Family Medicine | South Jordan | Utah | 84095 | United States |
| 13vPnC Followed by PPSV23 |
Participants received a single 0.5 mL intramuscular injection of 13-valent pneumococcal conjugate vaccine (13vPnC) (Vaccination 1) on Day 1 followed by 0.5 mL of 23-valent pneumococcal polysaccharide vaccine (PPSV23) 1 month after Vaccination 1 (Vaccination 2). Participants were followed up to 12 months after Vaccination 1. |
| Safety Population |
|
| Evaluable Immunogenicity Population(EIP) |
|
| COMPLETED |
|
| NOT COMPLETED |
|
|
Safety analysis set included all participants who had received 1 dose of 20vPnC or 13vPnC.
Not provided
| ID | Title | Description |
|---|---|---|
| BG000 | 20vPnC Followed by Saline | Participants received a single 0.5 milliliter [mL] intramuscular injection of 20-valent pneumococcal conjugate vaccine (20vPnC) (Vaccination 1) on Day 1 followed by 0.5 mL of saline 1 month after Vaccination 1 (Vaccination 2). Participants were followed up to 12 months after Vaccination 1. |
| BG001 | 13vPnC Followed by PPSV23 | Participants received a single 0.5 mL intramuscular injection of 13-valent pneumococcal conjugate vaccine (13vPnC) (Vaccination 1) on Day 1 followed by 0.5 mL of 23-valent pneumococcal polysaccharide vaccine (PPSV23) 1 month after Vaccination 1 (Vaccination 2). Participants were followed up to 12 months after Vaccination 1. |
| BG002 | 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 | Mean | Standard Deviation | years |
| |||||||||||||||
| Sex: Female, Male | Count of Participants | Participants |
| ||||||||||||||||
| Ethnicity (NIH/OMB) | Count of Participants | Participants |
| ||||||||||||||||
| Race (NIH/OMB) | Count of Participants | Participants |
|
| 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 With Local Reactions Within 10 Days After Vaccination 1 | Local reactions included pain at injection site, swelling and redness recorded by participants in an electronic diary (e-diary). Redness and swelling were measured and recorded in measuring device units. 1 measuring device unit=0.5 centimeter (cm). Redness and swelling were graded as mild: greater than (>) 2.0 to 5.0 centimeter (cm), moderate: 5.5 to 10.0 cm and severe: greater than or equal to (>=) 10.5 cm. Pain was graded as mild: did not interfere with activity, moderate: interfered with activity and severe: prevented daily activity. | Safety analysis set included all participants who had received 1 dose of 20vPnC or 13vPnC. Here "Overall number of participants analyzed" signifies participants who were evaluable for this outcome measure. | Posted | Number | 95% Confidence Interval | percentage of participants | within 10 days after Vaccination 1 |
|
|
| |||||||||||||||||||||||||||||||||||
| Primary | Percentage of Participants With Systemic Events Within 7 Days After Vaccination 1 | Systemic events included fever, fatigue, headache, muscle pain and joint pain, recorded by participants in an e-diary. Fever was categorized as: >=38.0 degrees Celsius (C), >=38.0 to 38.4 degrees C, >38.4 to 38.9 degrees C, >38.9 to 40.0 degrees C and >40.0 degrees C. Fatigue, headache, muscle pain and joint pain were graded as mild: no interference with activity, moderate: some interference with activity and severe: prevents daily routine activity. | Safety analysis set included all participants who had received 1 dose of 20vPnC or 13vPnC. Here "Overall number of participants analyzed" signifies participants who were evaluable for this outcome measure. | Posted | Number | 95% Confidence Interval | percentage of participants | within 7 days after Vaccination 1 |
| |||||||||||||||||||||||||||||||||||||
| Primary | Percentage of Participants With Adverse Events (AEs) Within 1 Month After Vaccination 1 | An AE was any untoward medical occurrence in a participant who received investigational product without regard to possibility of causal relationship. AEs included both serious and non-serious adverse events. Serious adverse event (SAE) was an AE resulting in any of the following outcomes or deemed significant for any other reason: death; initial or prolonged inpatient hospitalization; life-threatening experience (immediate risk of dying); persistent or significant disability/incapacity; congenital anomaly. | Safety analysis set included all participants who had received 1 dose of 20vPnC or 13vPnC. | Posted | Number | 95% Confidence Interval | percentage of participants | within 1 month after Vaccination 1 (up to 35 days) |
| |||||||||||||||||||||||||||||||||||||
| Primary | Percentage of Participants With Serious Adverse Events (SAEs) or Newly Diagnosed Chronic Medical Conditions (NDCMCs) Within 6 Months After Vaccination 1 | An AE was any untoward medical occurrence in a participant who received study drug without regard to possibility of causal relationship. SAE was an AE resulting in any of the following outcomes or deemed significant for any other reason: death; initial or prolonged inpatient hospitalization; life-threatening experience (immediate risk of dying); persistent or significant disability/incapacity; congenital anomaly. An NDCMC was defined as a disease or medical condition, not previously identified, that is expected to be persistent or is otherwise long-lasting in its effects. Percentage of participants with either SAE or NDCMCs during the specified duration are reported. | Safety analysis set included all participants who had received 1 dose of 20vPnC or 13vPnC. | Posted | Number | 95% Confidence Interval | percentage of participants | within 6 months after Vaccination 1 (up to 196 days) |
| |||||||||||||||||||||||||||||||||||||
| Primary | Percentage of Participants With Serious Adverse Events (SAEs) or Newly Diagnosed Chronic Medical Conditions (NDCMCs) Within 12 Months After Vaccination 1 | An AE was any untoward medical occurrence in a participant who received study drug without regard to possibility of causal relationship. SAE was an AE resulting in any of the following outcomes or deemed significant for any other reason: death; initial or prolonged inpatient hospitalization; life-threatening experience (immediate risk of dying); persistent or significant disability/incapacity; congenital anomaly. An NDCMC was defined as a disease or medical condition, not previously identified, that is expected to be persistent or is otherwise long-lasting in its effects. Percentage of participants with either SAE or NDCMCs during the specified duration are reported. | Safety analysis set included all participants who had received 1 dose of 20vPnC or 13vPnC. | Posted | Number | 95% Confidence Interval | percentage of participants | within 12 months after Vaccination 1 (up to 378 days) |
| |||||||||||||||||||||||||||||||||||||
| Secondary | Serotype-Specific Pneumococcal Opsonophagocytic Activity (OPA) Geometric Mean Titres (GMTs) 1 Month After Vaccination 1: 13 Common Serotypes in 13vPnC | Antibody-mediated serum OPA against the 13 common pneumococcal serotypes specific to 13vPnC (serotypes 1, 3, 4, 5, 6A, 6B, 7F, 9V, 14, 18C, 19A, 19F and 23F) were measured using a pneumococcal OPA assay. Results were expressed as OPA GMTs. Assay results below the lower limit of quantitation (LLOQ) were set to 0.5*LLOQ in the analysis. | EIP: participants with no major protocol deviations, received assigned vaccine, blood drawn within 27 to 49 days after Vaccination 1 or 2, had OPA titres for at least 1 serotype either 1 month after Vaccination 1 or 2. 'Number analyzed' = Participants evaluable for this outcome measure at specified rows. | Posted | Geometric Mean | 95% Confidence Interval | Titer (1/dilution) | 1 month after Vaccination 1 |
| |||||||||||||||||||||||||||||||||||||
| Secondary | Serotype-Specific Pneumococcal Opsonophagocytic Activity (OPA) Geometric Mean Titres (GMTs) 1 Month After Any Vaccination: 7 Additional Serotypes in 20vPnC | Antibody-mediated serum OPA against the 7 additional pneumococcal serotypes (8, 10A, 11A, 12F, 15B, 22F, 33F) were measured using a pneumococcal OPA assay. Results were expressed as OPA GMTs. Assay results below the LLOQ were set to 0.5*LLOQ in the analysis. | EIP: participants with no major protocol deviations, received assigned vaccine, blood drawn within 27 to 49 days after Vaccination 1 or 2, had OPA titres for at least 1 serotype either 1 month after Vaccination 1 or 2. 'Number analyzed' = Participants evaluable for this outcome measure at specified rows. | Posted | Geometric Mean | 95% Confidence Interval | Titer (1/dilution) | 1 month after Vaccination 1 for 20vPnC followed by saline reporting group; 1 month after Vaccination 2 for 13vPnC followed by PPSV23 reporting group |
| |||||||||||||||||||||||||||||||||||||
| Secondary | Serotype-specific Pneumococcal Opsonophagocytic Activity (OPA) Geometric Mean Fold Rise (GMFR) From Pre-Vaccination 1 to 1 Month Post-Vaccination 1: 13 Common Serotypes in 13vPnC | GMFR for the 13 pneumococcal serotypes (1, 3, 4, 5, 6A, 6B, 7F, 9V, 14, 18C, 19A, 19F, and 23F) from before Vaccination 1 to one month after Vaccination 1 were calculated as the mean of the difference of logarithmically transformed OPA results (after vaccination - before vaccination) and transform back to the original scale. GMFRs were calculated using data from participants with non-missing OPA results at both time points. Assay results below the LLOQ were set to 0.5*LLOQ in the analysis. | EIP: participants with no major protocol deviations, received assigned vaccine, blood drawn within 27 to 49 days after Vaccination 1 or 2, had OPA titres for at least 1 serotype either 1 month after Vaccination 1 or 2. 'Number analyzed' = Number of participants with non-missing OPA results at both time points at specified rows. | Posted | Geometric Mean | 95% Confidence Interval | fold rise | before Vaccination 1 to one month after Vaccination 1 |
| |||||||||||||||||||||||||||||||||||||
| Secondary | Serotype-specific Pneumococcal Opsonophagocytic Activity (OPA) Geometric Mean Fold Rise (GMFR) From Pre-Vaccination 1 to 1 Month Post Any Vaccination: 7 Additional Serotypes in 20vPnC | GMFR for 7 additional pneumococcal serotypes (8, 10A, 11A, 12F, 15B, 22F, 33F) from before Vaccination 1 to one month after either Vaccination 1 (20vPnC) or Vaccination 2 (PPSV23) were calculated as the mean of the difference of logarithmically transformed OPA results (after vaccination - before vaccination) and transform back to the original scale. GMFRs were calculated using data from participants with non-missing OPA results at both time points. Assay results below the LLOQ were set to 0.5*LLOQ in the analysis. | EIP: participants with no protocol deviations, received assigned vaccine, blood drawn within 27 to 49 days after Vaccination 1 or 2, had OPA titres for at least 1 serotype either 1 month after Vaccination 1 or 2. 'Number analyzed' = Number of Participants with non-missing OPA results at both time points at specified row. | Posted | Geometric Mean | 95% Confidence Interval | fold rise | before Vaccination 1 to 1 month after Vaccination 1 for 20vPnC followed by saline reporting group; before Vaccination 1 to 1 month after Vaccination 2 for 13vPnC followed by PPSV23 reporting group |
|
Local reactions: within 10 days after vaccination (systematic assessment), Systemic events: within 7 days after vaccination (systematic assessment), Non serious AEs: Baseline up to 1 month after Vaccination 1 (up to 35 days), SAEs: Baseline up to 12 months after Vaccination 1 (up to 378 days)
Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Safety population was analyzed.
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 | 20vPnC Followed by Saline | Participants received a single 0.5 milliliter [mL] intramuscular injection of 20-valent pneumococcal conjugate vaccine (20vPnC) (Vaccination 1) on Day 1 followed by 0.5 mL of saline 1 month after Vaccination 1 (Vaccination 2). Participants were followed up to 12 months after Vaccination 1. | 0 | 221 | 9 | 221 | 162 | 221 |
| EG001 | 13vPnC Followed by PPSV23 | Participants received a single 0.5 mL intramuscular injection of 13-valent pneumococcal conjugate vaccine (13vPnC) (Vaccination 1) on Day 1 followed by 0.5 mL of 23-valent pneumococcal polysaccharide vaccine (PPSV23) 1 month after Vaccination 1 (Vaccination 2). Participants were followed up to 12 months after Vaccination 1. | 0 | 222 | 11 | 222 | 164 | 222 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Anaemia | Blood and lymphatic system disorders | MedDRA Version 21.1 | Non-systematic Assessment |
| |
| Cardiomyopathy | Cardiac disorders | MedDRA Version 21.1 | Non-systematic Assessment |
| |
| Chest pain | General disorders | MedDRA Version 21.1 | Non-systematic Assessment |
| |
| Jaundice cholestatic | Hepatobiliary disorders | MedDRA Version 21.1 | Non-systematic Assessment |
| |
| Cellulitis | Infections and infestations | MedDRA Version 21.1 | Non-systematic Assessment |
| |
| Cellulitis staphylococcal | Infections and infestations | MedDRA Version 21.1 | Non-systematic Assessment |
| |
| Meningitis pneumococcal | Infections and infestations | MedDRA Version 21.1 | Non-systematic Assessment |
| |
| Septic shock | Infections and infestations | MedDRA Version 21.1 | Non-systematic Assessment |
| |
| Head injury | Injury, poisoning and procedural complications | MedDRA Version 21.1 | Non-systematic Assessment |
| |
| Lower limb fracture | Injury, poisoning and procedural complications | MedDRA Version 21.1 | Non-systematic Assessment |
| |
| Road traffic accident | Injury, poisoning and procedural complications | MedDRA Version 21.1 | Non-systematic Assessment |
| |
| Osteoarthritis | Musculoskeletal and connective tissue disorders | MedDRA Version 21.1 | Non-systematic Assessment |
| |
| Adenocarcinoma | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA Version 21.1 | Non-systematic Assessment |
| |
| Lung neoplasm malignant | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA Version 21.1 | Non-systematic Assessment |
| |
| Prostate cancer | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA Version 21.1 | Non-systematic Assessment |
| |
| Spindle cell sarcoma | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA Version 21.1 | Non-systematic Assessment |
| |
| Uterine cancer | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA Version 21.1 | Non-systematic Assessment |
| |
| Cerebrovascular accident | Nervous system disorders | MedDRA Version 21.1 | Non-systematic Assessment |
| |
| Lacunar infarction | Nervous system disorders | MedDRA Version 21.1 | Non-systematic Assessment |
| |
| Seizure | Nervous system disorders | MedDRA Version 21.1 | Non-systematic Assessment |
| |
| Transient ischaemic attack | Nervous system disorders | MedDRA Version 21.1 | Non-systematic Assessment |
| |
| Nephrolithiasis | Renal and urinary disorders | MedDRA Version 21.1 | Non-systematic Assessment |
| |
| Respiratory distress | Respiratory, thoracic and mediastinal disorders | MedDRA Version 21.1 | Non-systematic Assessment |
|
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Injection site pruritus | General disorders | MedDRA Version 21.1 | Non-systematic Assessment |
| |
| Acute sinusitis | Infections and infestations | MedDRA Version 21.1 | Non-systematic Assessment |
| |
| Bronchitis | Infections and infestations | MedDRA Version 21.1 | Non-systematic Assessment |
| |
| Gastroenteritis | Infections and infestations | MedDRA Version 21.1 | Non-systematic Assessment |
| |
| Sinusitis | Infections and infestations | MedDRA Version 21.1 | Non-systematic Assessment |
| |
| Tooth infection | Infections and infestations | MedDRA Version 21.1 | Non-systematic Assessment |
| |
| Upper respiratory tract infection | Infections and infestations | MedDRA Version 21.1 | Non-systematic Assessment |
| |
| Fall | Injury, poisoning and procedural complications | MedDRA Version 21.1 | Non-systematic Assessment |
| |
| Myalgia | Musculoskeletal and connective tissue disorders | MedDRA Version 21.1 | Non-systematic Assessment |
| |
| Osteoarthritis | Musculoskeletal and connective tissue disorders | MedDRA Version 21.1 | Non-systematic Assessment |
| |
| Dizziness | Nervous system disorders | MedDRA Version 21.1 | Non-systematic Assessment |
| |
| Cough | Respiratory, thoracic and mediastinal disorders | MedDRA Version 21.1 | Non-systematic Assessment |
| |
| Dyspnoea | Respiratory, thoracic and mediastinal disorders | MedDRA Version 21.1 | Non-systematic Assessment |
| |
| Lymphadenopathy | Blood and lymphatic system disorders | MedDRA Version 21.1 | Non-systematic Assessment |
| |
| Deafness unilateral | Ear and labyrinth disorders | MedDRA Version 21.1 | Non-systematic Assessment |
| |
| Hypothyroidism | Endocrine disorders | MedDRA Version 21.1 | Non-systematic Assessment |
| |
| Dental caries | Gastrointestinal disorders | MedDRA Version 21.1 | Non-systematic Assessment |
| |
| Diarrhoea | Gastrointestinal disorders | MedDRA Version 21.1 | Non-systematic Assessment |
| |
| Chest pain | General disorders | MedDRA Version 21.1 | Non-systematic Assessment |
| |
| Fatigue | General disorders | MedDRA Version 21.1 | Systematic Assessment |
| |
| Injection site hypersensitivity | General disorders | MedDRA Version 21.1 | Non-systematic Assessment |
| |
| Injection site pain | General disorders | MedDRA Version 21.1 | Non-systematic Assessment |
| |
| Injection site pain | General disorders | MedDRA Version 21.1 | Systematic Assessment |
| |
| Pyrexia | General disorders | MedDRA Version 21.1 | Systematic Assessment |
| |
| Swelling | General disorders | MedDRA Version 21.1 | Systematic Assessment |
| |
| Gastroenteritis viral | Infections and infestations | MedDRA Version 21.1 | Non-systematic Assessment |
| |
| Gingivitis | Infections and infestations | MedDRA Version 21.1 | Non-systematic Assessment |
| |
| Laryngitis viral | Infections and infestations | MedDRA Version 21.1 | Non-systematic Assessment |
| |
| Nasopharyngitis | Infections and infestations | MedDRA Version 21.1 | Non-systematic Assessment |
| |
| Urinary tract infection | Infections and infestations | MedDRA Version 21.1 | Non-systematic Assessment |
| |
| Vaginal infection | Infections and infestations | MedDRA Version 21.1 | Non-systematic Assessment |
| |
| Viral upper respiratory tract infection | Infections and infestations | MedDRA Version 21.1 | Non-systematic Assessment |
| |
| Contusion | Injury, poisoning and procedural complications | MedDRA Version 21.1 | Non-systematic Assessment |
| |
| Muscle strain | Injury, poisoning and procedural complications | MedDRA Version 21.1 | Non-systematic Assessment |
| |
| Skin laceration | Injury, poisoning and procedural complications | MedDRA Version 21.1 | Non-systematic Assessment |
| |
| Gout | Metabolism and nutrition disorders | MedDRA Version 21.1 | Non-systematic Assessment |
| |
| Hyperglycaemia | Metabolism and nutrition disorders | MedDRA Version 21.1 | Non-systematic Assessment |
| |
| Arthralgia | Musculoskeletal and connective tissue disorders | MedDRA Version 21.1 | Systematic Assessment |
| |
| Back pain | Musculoskeletal and connective tissue disorders | MedDRA Version 21.1 | Non-systematic Assessment |
| |
| Myalgia | Musculoskeletal and connective tissue disorders | MedDRA Version 21.1 | Systematic Assessment |
| |
| Headache | Nervous system disorders | MedDRA Version 21.1 | Non-systematic Assessment |
| |
| Headache | Nervous system disorders | MedDRA Version 21.1 | Systematic Assessment |
| |
| Lumbar radiculopathy | Nervous system disorders | MedDRA Version 21.1 | Non-systematic Assessment |
| |
| Presyncope | Nervous system disorders | MedDRA Version 21.1 | Non-systematic Assessment |
| |
| Haematuria | Renal and urinary disorders | MedDRA Version 21.1 | Non-systematic Assessment |
| |
| Asthma | Respiratory, thoracic and mediastinal disorders | MedDRA Version 21.1 | Non-systematic Assessment |
| |
| Nasal congestion | Respiratory, thoracic and mediastinal disorders | MedDRA Version 21.1 | Non-systematic Assessment |
| |
| Respiratory tract congestion | Respiratory, thoracic and mediastinal disorders | MedDRA Version 21.1 | Non-systematic Assessment |
| |
| Rhinitis allergic | Respiratory, thoracic and mediastinal disorders | MedDRA Version 21.1 | Non-systematic Assessment |
| |
| Sinus congestion | Respiratory, thoracic and mediastinal disorders | MedDRA Version 21.1 | Non-systematic Assessment |
| |
| Upper respiratory tract congestion | Respiratory, thoracic and mediastinal disorders | MedDRA Version 21.1 | Non-systematic Assessment |
| |
| Erythema | General disorders | MedDRA Version 21.1 | Systematic Assessment |
|
Pfizer has the right to review disclosures, requesting a delay of less than 60 days. Investigator will postpone single center publications until after disclosure of pooled data (all sites), less than 12 months from study completion/termination at all participating sites. Investigator may not disclose previously undisclosed confidential information other than study results.
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Pfizer ClinicalTrials.gov Call Center | Pfizer Inc. | 8007181021 | ClinicalTrials.gov_Inquiries@pfizer.com |
| Prot_000.pdf |
| SAP | No | Yes | No | Statistical Analysis Plan | Jan 31, 2018 | Dec 10, 2019 | SAP_001.pdf |
| 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 |
Not provided
Not provided
| ID | Term |
|---|---|
| D017778 | Vaccines, Combined |
| C538862 | 13-valent pneumococcal vaccine |
| C414006 | 23-valent pneumococcal capsular polysaccharide vaccine |
| D012965 | Sodium Chloride |
| ID | Term |
|---|---|
| D014612 | Vaccines |
| D001688 | Biological Products |
| D045424 | Complex Mixtures |
| D002712 | Chlorides |
| D006851 | Hydrochloric Acid |
| D017606 | Chlorine Compounds |
| D007287 | Inorganic Chemicals |
| D017670 | Sodium Compounds |
Not provided
Not provided
| 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 |
|
| Redness: Severe |
|
| Swelling: Mild |
|
| Swelling: Moderate |
|
| Swelling: Severe |
|
| Pain at injection site: Mild |
|
| Pain at injection site: Moderate |
|
| Pain at injection site: Severe |
|
|
|
|
|
|
|
|
|
|
|
|
|
Participants received a single 0.5 mL intramuscular injection of 13-valent pneumococcal conjugate vaccine (13vPnC) (Vaccination 1) on Day 1 followed by 0.5 mL of 23-valent pneumococcal polysaccharide vaccine (PPSV23) 1 month after Vaccination 1 (Vaccination 2). Participants were followed up to 12 months after Vaccination 1.
|
|
| OG001 |
| 13vPnC Followed by PPSV23 |
Participants received a single 0.5 mL intramuscular injection of 13-valent pneumococcal conjugate vaccine (13vPnC) (Vaccination 1) on Day 1 followed by 0.5 mL of 23-valent pneumococcal polysaccharide vaccine (PPSV23) 1 month after Vaccination 1 (Vaccination 2). Participants were followed up to 12 months after Vaccination 1. |
|
|