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| ID | Type | Description | Link |
|---|---|---|---|
| 2018-004278-91 | EudraCT Number |
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This Phase 3 will describe the safety and immunogenicity of a 20-valent pneumococcal conjugate vaccine formulation in adults 65 years of age or older with prior pneumococcal vaccination
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 13vPnC | Active Comparator | Pneumococcal conjugate vaccine |
|
| PPSV23 | Active Comparator | Pneumococcal polysaccharide vaccine |
|
| 20vPnC | Experimental | Pneumococcal conjugate vaccine |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| 13vPnC | Biological | Pneumococcal conjugate vaccine |
| |
| PPSV23 |
| Measure | Description | Time Frame |
|---|---|---|
| Percentage of Participants With Local Reactions Within 10 Days After Vaccination | Local reactions were recorded using an electronic diary (e-diary). Local reactions included redness, swelling and pain at the injection site. 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 cm), moderate (>5.0 to 10.0 cm) and severe (>10.0 cm). Pain at injection site was graded as mild (did not interfere with activity), moderate (interfered with activity), and severe (prevented daily activity). | Within 10 days after vaccination |
| Percentage of Participants With Systemic Events Within 7 Days After Vaccination | Systemic events fever, fatigue, headache, muscle pain and joint pain were recorded by using an e-diary. Fever was defined as temperature >=38.0 degree Celsius (C) and categorized to >=38.0 to 38.4 degree C, >38.4 to 38.9 degree C, >38.9 to 40.0 degree C and >40.0 degree C. Fatigue, headache, muscle pain and joint pain were graded as mild (did not interfere with activity), moderate (some interference with activity) and severe (prevented daily routine activity). | Within 7 days after vaccination |
| Percentage of Participants With Adverse Events (AEs) Within 1 Month After Vaccination | An AE was any untoward medical occurrence in study participants who received study vaccine without regard to possibility of causal relationship with the treatment. | Within 1 month after vaccination |
| Percentage of Participants With Serious Adverse Events (SAEs) Within 6 Months After Vaccination | An SAE was any untoward medical occurrence at any dose that results in death; is life-threatening (immediate risk of death); requires inpatient hospitalization or prolongation of existing hospitalization; results in persistent or significant disability/incapacity (substantial disruption of the ability to conduct normal life functions); results in congenital anomaly/birth defect or that is considered to be an important medical event. |
| Measure | Description | Time Frame |
|---|---|---|
| Pneumococcal OPA Geometric Mean Fold Rise (GMFR) From Before Vaccination to 1 Month After Vaccination | OPA GMFR is the ratio of OPA GMTs, 1 month after vaccination to before vaccination. OPA GMFRs from before to 1 month after vaccination were calculated for pneumococcal serotypes 1, 3, 4, 5, 6A, 6B, 7F, 9V, 14, 18C, 19A, 19F, 23F, 8, 10A, 11A, 12F, 15B, 22F and 33F. | From before vaccination to 1 month after vaccination |
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Inclusion Criteria
Male or female adults 65 years of age or greater.
Adults determined by clinical assessment, including medical history and clinical judgment, to be eligible for the study, including adults with preexisting stable disease, defined as disease not requiring significant change in therapy in the previous 6 weeks or hospitalization for worsening disease within 12 weeks before receipt of investigational product.
Female subject of nonchildbearing potential; male subject not able to father children or who is able to father children and willing to use a highly effective method of contraception.
Male or female adults who meet 1 of the following:
Exclusion Criteria
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| Name | Affiliation | Role |
|---|---|---|
| Pfizer CT.gov Call Center | Pfizer | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Coastal Clinical Research, Inc. | Mobile | Alabama | 36608 | United States | ||
| East Valley Gastroenterology and Hepatology Associates |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 34839993 | Derived | Cannon K, Elder C, Young M, Scott DA, Scully IL, Baugher G, Peng Y, Jansen KU, Gruber WC, Watson W. A trial to evaluate the safety and immunogenicity of a 20-valent pneumococcal conjugate vaccine in populations of adults >/=65 years of age with different prior pneumococcal vaccination. Vaccine. 2021 Dec 17;39(51):7494-7502. doi: 10.1016/j.vaccine.2021.10.032. Epub 2021 Nov 25. |
| 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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| ID | Title | Description |
|---|---|---|
| FG000 | Cohort A: 20vPnC | Participants with receipt of 23-valent pneumococcal polysaccharide vaccine (PPSV23) greater than or equal to (>=) 1 to less than or equal to (<=) 5 years, and no 13-valent pneumococcal conjugate vaccine (13vPnC), prior to study vaccination, and randomized to receive a single dose of 0.5 milliliter (mL) intramuscular injection of 20-valent pneumococcal conjugate vaccine (20vPnC) on Day 1. |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| SAP | No | Yes | No | Statistical Analysis Plan | Mar 23, 2020 | Feb 2, 2021 |
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| Biological |
Pneumococcal polysaccharide vaccine |
|
| 20vPnC | Biological | Pneumococcal conjugate vaccine |
|
| Within 6 months after vaccination |
| Percentage of Participants With Newly Diagnosed Chronic Medical Conditions (NDCMCs) Within 6 Months After Vaccination | An NDCMC was defined as a disease or medical condition, not previously identified, that was expected to be persistent or was otherwise long-lasting in its effects. | Within 6 months after vaccination |
| Pneumococcal Opsonophagocytic Activity (OPA) Geometric Mean Titers (GMTs) at 1 Month After Vaccination | OPA GMTs were determined for serotypes: 1, 3, 4, 5, 6A, 6B, 7F, 9V, 14, 18C, 19A, 19F, 23F, 8, 10A, 11A, 12F, 15B, 22F and 33F. OPA titer was expressed as reciprocal of the highest serum dilution. | 1 month after vaccination |
| Percentage of Participants With >=4-Fold Rise in Pneumococcal OPA Titers From Before Vaccination to 1 Month After Vaccination | Percentage of participants with a >=4-fold rise in pneumococcal OPA titers from before vaccination to 1 month after vaccination were calculated for pneumococcal serotypes 1, 3, 4, 5, 6A, 6B, 7F, 9V, 14, 18C, 19A, 19F, 23F, 8, 10A, 11A, 12F, 15B, 22F and 33F. | From before vaccination to 1 month after vaccination |
| Percentage of Participants With Pneumococcal OPA Titers >=Lower Limit of Quantitation (LLOQ) at 1 Month After Vaccination | The percentage of participants with OPA titers >=LLOQ at 1 month after vaccination were calculated for pneumococcal serotypes 1, 3, 4, 5, 6A, 6B, 7F, 9V, 14, 18C, 19A, 19F, 23F, 8, 10A, 11A, 12F, 15B, 22F and 33F. | 1 month after vaccination |
| Chandler |
| Arizona |
| 85224 |
| United States |
| The Pain Center of Arizona | Peoria | Arizona | 85381 | United States |
| HOPE Research Institute | Phoenix | Arizona | 85018 | United States |
| The Pain Center of Arizona | Phoenix | Arizona | 85018 | United States |
| Anaheim Clinical Trials, LLC | Anaheim | California | 92801 | United States |
| Diablo Clinical Research, Inc. | Walnut Creek | California | 94598 | United States |
| Clinical Research Consulting, LLC | Milford | Connecticut | 06460 | United States |
| Optimal Research, LLC | Melbourne | Florida | 32934 | United States |
| Synexus Clinical Research US, Inc | The Villages | Florida | 32162 | United States |
| Meridian Clinical Research, LLC | Savannah | Georgia | 31406 | 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 | 67205 | United States |
| Heartland Research Associates, LLC | Wichita | Kansas | 67207 | United States |
| MedPharmics, LLC | Metairie | Louisiana | 70006 | United States |
| Meridian Clinical Research, LLC | Rockville | Maryland | 20854 | United States |
| Meridian Clinical Research, LLC | Norfolk | Nebraska | 68701 | United States |
| MedPharmics, LLC | Albuquerque | New Mexico | 87102 | United States |
| Carolina Institute for Clinical Research | Fayetteville | North Carolina | 28304 | United States |
| PMG Research of Wilmington, LLC | Wilmington | North Carolina | 28401 | United States |
| CTI Clinical Research Center | Cincinnati | Ohio | 45212 | United States |
| Sterling Research Group, Ltd. | Cincinnati | Ohio | 45246 | United States |
| Prestige Clinical Research | Franklin | Ohio | 45005 | United States |
| Lynn Health Science Institute | Oklahoma City | Oklahoma | 73112 | United States |
| Kaiser Permanente Center For Health Research | Portland | Oregon | 97227 | United States |
| Columbia Research Group, Inc. | Portland | Oregon | 97239 | United States |
| Medical Research South, LLC | Goose Creek | South Carolina | 29445 | United States |
| Ventavia Research Group | Keller | Texas | 76248 | United States |
| J. Lewis Research Inc. / Foothill Family Clinic Draper | Draper | Utah | 84020 | United States |
| J. Lewis Research, Inc. - Foothill Family Clinic | Salt Lake City | Utah | 84109 | United States |
| J. Lewis Research, Inc. / Foothill Family Clinic South | Salt Lake City | Utah | 84121 | United States |
| J. Lewis Research, Inc. / Jordan River Family Medicine | South Jordan | Utah | 84095 | United States |
| Kaiser Permanente Washington Health Research Institute | Seattle | Washington | 98101 | United States |
| PharmaSite | Malmö | Skåne County | 21152 | Sweden |
| Ladulaas Kliniska Studier | Borås | 50630 | Sweden |
| Infektionskliniken | Eskilstuna | 63188 | Sweden |
| CTC Gothia Forum | Gothenburg | 413 45 | Sweden |
| ProbarE i Lund | Lund | 22222 | Sweden |
| Avdelningen for Kliniska Provningar | Örebro | 703 62 | Sweden |
| Karolinska Trial Alliance, KTA Prim | Stockholm | 11361 | Sweden |
| Akardo Med Site | Stockholm | 11446 | Sweden |
| FG001 | Cohort A: 13vPnC | Participants with receipt of PPSV23, >=1 to <=5 years, and no 13vPnC, prior to study vaccination, and randomized to receive a single dose of 0.5 mL intramuscular injection of 13vPnC on Day 1. |
| FG002 | Cohort B: 20vPnC | Participants with receipt of 13vPnC, >=6 months, and no PPSV23, prior to study vaccination, and randomized to receive a single dose of 0.5 mL intramuscular injection of 20vPnC on Day 1. |
| FG003 | Cohort B: PPSV23 | Participants with receipt of 13vPnC, >=6 months, and no PPSV23, prior to study vaccination, and randomized to receive a single dose of 0.5 mL intramuscular injection of PPSV23 on Day 1. |
| FG004 | Cohort C: 20vPnC | Participants with receipt of 13vPnC followed by PPSV23 (PPSV23 dose >=1 year) prior to study vaccination, received a single dose of 0.5 mL intramuscular injection of 20vPnC on Day 1. |
| Vaccinated |
|
| Safety Population |
|
| Evaluable Immunogenicity Population (for 20vPnC Cohorts) |
|
| COMPLETED |
|
| NOT COMPLETED |
|
|
All randomized population.
Not provided
| ID | Title | Description |
|---|---|---|
| BG000 | Cohort A: 20vPnC | Participants with receipt of 23-valent pneumococcal polysaccharide vaccine (PPSV23) greater than or equal to (>=) 1 to less than or equal to (<=) 5 years, and no 13-valent pneumococcal conjugate vaccine (13vPnC), prior to study vaccination, and randomized to receive a single dose of 0.5 milliliter (mL) intramuscular injection of 20-valent pneumococcal conjugate vaccine (20vPnC) on Day 1. |
| BG001 | Cohort A: 13vPnC | Participants with receipt of PPSV23, >=1 to <=5 years, and no 13vPnC, prior to study vaccination, and randomized to receive a single dose of 0.5 mL intramuscular injection of 13vPnC on Day 1. |
| BG002 | Cohort B: 20vPnC | Participants with receipt of 13vPnC, >=6 months, and no PPSV23, prior to study vaccination, and randomized to receive a single dose of 0.5 mL intramuscular injection of 20vPnC on Day 1. |
| BG003 | Cohort B: PPSV23 | Participants with receipt of 13vPnC, >=6 months, and no PPSV23, prior to study vaccination, and randomized to receive a single dose of 0.5 mL intramuscular injection of PPSV23 on Day 1. |
| BG004 | Cohort C: 20vPnC | Participants with receipt of 13vPnC followed by PPSV23 (PPSV23 dose >=1 year) prior to study vaccination, received a single dose of 0.5 mL intramuscular injection of 20vPnC on Day 1. |
| BG005 | 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 | Local reactions were recorded using an electronic diary (e-diary). Local reactions included redness, swelling and pain at the injection site. 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 cm), moderate (>5.0 to 10.0 cm) and severe (>10.0 cm). Pain at injection site was graded as mild (did not interfere with activity), moderate (interfered with activity), and severe (prevented daily activity). | The safety population included participants who received 1 dose of 20vPnC, PPSV23, or 13vPnC and had safety follow-up after vaccination. Here, "Overall Number of Participants Analyzed" refers to number of participants with any e-diary data reported after vaccination in the safety population. | Posted | Number | 95% Confidence Interval | percentage of participants | Within 10 days after vaccination |
|
|
| |||||||||||||||||||||||||||||||||||||
| Primary | Percentage of Participants With Systemic Events Within 7 Days After Vaccination | Systemic events fever, fatigue, headache, muscle pain and joint pain were recorded by using an e-diary. Fever was defined as temperature >=38.0 degree Celsius (C) and categorized to >=38.0 to 38.4 degree C, >38.4 to 38.9 degree C, >38.9 to 40.0 degree C and >40.0 degree C. Fatigue, headache, muscle pain and joint pain were graded as mild (did not interfere with activity), moderate (some interference with activity) and severe (prevented daily routine activity). | The safety population included participants who received 1 dose of 20vPnC, PPSV23, or 13vPnC and had safety follow-up after vaccination. Here, "Overall Number of Participants Analyzed" refers to number of participants with any e-diary data reported after vaccination in the safety population. | Posted | Number | 95% Confidence Interval | percentage of participants | Within 7 days after vaccination |
| |||||||||||||||||||||||||||||||||||||||
| Primary | Percentage of Participants With Adverse Events (AEs) Within 1 Month After Vaccination | An AE was any untoward medical occurrence in study participants who received study vaccine without regard to possibility of causal relationship with the treatment. | The safety population included participants who received 1 dose of 20vPnC, PPSV23, or 13vPnC and had safety follow-up after vaccination. | Posted | Number | 95% Confidence Interval | percentage of participants | Within 1 month after vaccination |
| |||||||||||||||||||||||||||||||||||||||
| Primary | Percentage of Participants With Serious Adverse Events (SAEs) Within 6 Months After Vaccination | An SAE was any untoward medical occurrence at any dose that results in death; is life-threatening (immediate risk of death); requires inpatient hospitalization or prolongation of existing hospitalization; results in persistent or significant disability/incapacity (substantial disruption of the ability to conduct normal life functions); results in congenital anomaly/birth defect or that is considered to be an important medical event. | The safety population included participants who received 1 dose of 20vPnC, PPSV23, or 13vPnC and had safety follow-up after vaccination. | Posted | Number | 95% Confidence Interval | percentage of participants | Within 6 months after vaccination |
| |||||||||||||||||||||||||||||||||||||||
| Primary | Percentage of Participants With Newly Diagnosed Chronic Medical Conditions (NDCMCs) Within 6 Months After Vaccination | An NDCMC was defined as a disease or medical condition, not previously identified, that was expected to be persistent or was otherwise long-lasting in its effects. | The safety population included participants who received 1 dose of 20vPnC, PPSV23, or 13vPnC and had safety follow-up after vaccination. | Posted | Number | 95% Confidence Interval | percentage of participants | Within 6 months after vaccination |
| |||||||||||||||||||||||||||||||||||||||
| Primary | Pneumococcal Opsonophagocytic Activity (OPA) Geometric Mean Titers (GMTs) at 1 Month After Vaccination | OPA GMTs were determined for serotypes: 1, 3, 4, 5, 6A, 6B, 7F, 9V, 14, 18C, 19A, 19F, 23F, 8, 10A, 11A, 12F, 15B, 22F and 33F. OPA titer was expressed as reciprocal of the highest serum dilution. | Evaluable immunogenicity population: All participants who received 20vPnC as randomized, enrolled in appropriate cohort based on prior vaccination history, had Visit 2 blood collection within 27 to 49 days after vaccination, had at least 1 valid and determinate OPA titer for any serotype for Visit 2, had no major protocol deviations. Data for this outcome measure were planned to be analyzed for 20vPnC groups of each cohort. Number Analyzed =number of participants evaluable for each serotypes. | Posted | Geometric Mean | 95% Confidence Interval | titer | 1 month after vaccination |
| |||||||||||||||||||||||||||||||||||||||
| Secondary | Pneumococcal OPA Geometric Mean Fold Rise (GMFR) From Before Vaccination to 1 Month After Vaccination | OPA GMFR is the ratio of OPA GMTs, 1 month after vaccination to before vaccination. OPA GMFRs from before to 1 month after vaccination were calculated for pneumococcal serotypes 1, 3, 4, 5, 6A, 6B, 7F, 9V, 14, 18C, 19A, 19F, 23F, 8, 10A, 11A, 12F, 15B, 22F and 33F. | Evaluable immunogenicity population was analyzed. Data for this outcome measure were planned to be analyzed for 20vPnC groups of each cohort. Number analyzed= number of participants evaluable with OPA titers available at both time points for each serotype. | Posted | Geometric Mean | 95% Confidence Interval | fold rise | From before vaccination to 1 month after vaccination |
| |||||||||||||||||||||||||||||||||||||||
| Secondary | Percentage of Participants With >=4-Fold Rise in Pneumococcal OPA Titers From Before Vaccination to 1 Month After Vaccination | Percentage of participants with a >=4-fold rise in pneumococcal OPA titers from before vaccination to 1 month after vaccination were calculated for pneumococcal serotypes 1, 3, 4, 5, 6A, 6B, 7F, 9V, 14, 18C, 19A, 19F, 23F, 8, 10A, 11A, 12F, 15B, 22F and 33F. | Evaluable immunogenicity population: All participants who received 20vPnC as randomized, enrolled in appropriate cohort based on prior vaccination history, had Visit 2 blood collection within 27 to 49 days after vaccination, had at least 1 valid and determinate OPA titer for any serotype for Visit 2, had no major protocol deviations. Data for this outcome measure were planned to be analyzed for 20vPnC groups of each cohort. Number Analyzed =number of participants evaluable for each serotype. | Posted | Number | 95% Confidence Interval | percentage of participants | From before vaccination to 1 month after vaccination |
| |||||||||||||||||||||||||||||||||||||||
| Secondary | Percentage of Participants With Pneumococcal OPA Titers >=Lower Limit of Quantitation (LLOQ) at 1 Month After Vaccination | The percentage of participants with OPA titers >=LLOQ at 1 month after vaccination were calculated for pneumococcal serotypes 1, 3, 4, 5, 6A, 6B, 7F, 9V, 14, 18C, 19A, 19F, 23F, 8, 10A, 11A, 12F, 15B, 22F and 33F. | Evaluable immunogenicity population: All participants who received 20vPnC as randomized, enrolled in appropriate cohort based on prior vaccination history, had Visit 2 blood collection within 27 to 49 days after vaccination, had at least 1 valid and determinate OPA titer for any serotype for Visit 2, had no major protocol deviations. Data for this outcome measure were planned to be analyzed for 20vPnC groups of each cohort. Number Analyzed =number of participants evaluable for each serotype. | Posted | Number | 95% Confidence Interval | percentage of participants | 1 month after vaccination |
|
Other AEs: local reactions within 10 days after vaccination, systemic events: within 7 days after vaccination (systematic assessment), non serious AEs up to 1 month after Vaccination; SAEs: up to 6 months after vaccination
Same event may appear as AE and SAE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. 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 | Cohort A: 20vPnC | Participants with receipt of 23-valent pneumococcal polysaccharide vaccine (PPSV23) greater than or equal to (>=) 1 to less than or equal to (<=) 5 years, and no 13-valent pneumococcal conjugate vaccine (13vPnC), prior to study vaccination, and randomized to receive a single dose of 0.5 milliliter (mL) intramuscular injection of 20-valent pneumococcal conjugate vaccine (20vPnC) on Day 1. | 0 | 253 | 2 | 253 | 173 | 253 |
| EG001 | Cohort A: 13vPnC | Participants with receipt of PPSV23, >=1 to <=5 years, and no 13vPnC, prior to study vaccination, and randomized to receive a single dose of 0.5 mL intramuscular injection of 13vPnC on Day 1. | 0 | 122 | 2 | 122 | 69 | 122 |
| EG002 | Cohort B: 20vPnC | Participants with receipt of 13vPnC, >=6 months, and no PPSV23, prior to study vaccination, and randomized to receive a single dose of 0.5 mL intramuscular injection of 20vPnC on Day 1. | 0 | 246 | 6 | 246 | 178 | 246 |
| EG003 | Cohort B: PPSV23 | Participants with receipt of 13vPnC, >=6 months, and no PPSV23, prior to study vaccination, and randomized to receive a single dose of 0.5 mL intramuscular injection of PPSV23 on Day 1. | 0 | 127 | 2 | 127 | 96 | 127 |
| EG004 | Cohort C: 20vPnC | Participants with receipt of 13vPnC followed by PPSV23 (PPSV23 dose >=1 year) prior to study vaccination, received a single dose of 0.5 mL intramuscular injection of 20vPnC on Day 1. | 0 | 125 | 2 | 125 | 86 | 125 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Acute myocardial infarction | Cardiac disorders | MedDRA v22.1 | Non-systematic Assessment |
| |
| Cardiac failure congestive | Cardiac disorders | MedDRA v22.1 | Non-systematic Assessment |
| |
| Dysphagia | Gastrointestinal disorders | MedDRA v22.1 | Non-systematic Assessment |
| |
| Gastrointestinal haemorrhage | Gastrointestinal disorders | MedDRA v22.1 | Non-systematic Assessment |
| |
| Cholecystitis | Hepatobiliary disorders | MedDRA v22.1 | Non-systematic Assessment |
| |
| Appendicitis | Infections and infestations | MedDRA v22.1 | Non-systematic Assessment |
| |
| Clostridium difficile colitis | Infections and infestations | MedDRA v22.1 | Non-systematic Assessment |
| |
| Pneumonia | Infections and infestations | MedDRA v22.1 | Non-systematic Assessment |
| |
| Blood pressure decreased | Investigations | MedDRA v22.1 | Non-systematic Assessment |
| |
| Dehydration | Metabolism and nutrition disorders | MedDRA v22.1 | Non-systematic Assessment |
| |
| Osteoarthritis | Musculoskeletal and connective tissue disorders | MedDRA v22.1 | Non-systematic Assessment |
| |
| Prostate cancer | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA v22.1 | Non-systematic Assessment |
| |
| Carotid artery stenosis | Nervous system disorders | MedDRA v22.1 | Non-systematic Assessment |
| |
| Syncope | Nervous system disorders | MedDRA v22.1 | Non-systematic Assessment |
| |
| Cardiac pacemaker replacement | Surgical and medical procedures | MedDRA v22.1 | Non-systematic Assessment |
|
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Fatigue (FATIGUE) | General disorders | MedDRA v22.1 | Systematic Assessment |
| |
| Injection site erythema (REDNESS) | General disorders | MedDRA v22.1 | Systematic Assessment |
| |
| Injection site pain (PAIN) | General disorders | MedDRA v22.1 | Systematic Assessment |
| |
| Injection site swelling (SWELLING) | General disorders | MedDRA v22.1 | Systematic Assessment |
| |
| Nasopharyngitis | Infections and infestations | MedDRA v22.1 | Non-systematic Assessment |
| |
| Urinary tract infection | Infections and infestations | MedDRA v22.1 | Non-systematic Assessment |
| |
| Arthralgia (JOINT PAIN) | Musculoskeletal and connective tissue disorders | MedDRA v22.1 | Systematic Assessment |
| |
| Myalgia (MUSCLE PAIN) | Musculoskeletal and connective tissue disorders | MedDRA v22.1 | Systematic Assessment |
| |
| Pyrexia (FEVER) | General disorders | MedDRA v22.1 | Systematic Assessment |
| |
| Dizziness | Nervous system disorders | MedDRA v22.1 | Non-systematic Assessment |
| |
| Headache (HEADACHE) | Nervous system disorders | MedDRA v22.1 | Non-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. | 1-800-718-1021 | ClinicalTrials.gov_Inquiries@pfizer.com |
| SAP_000.pdf |
| Prot | Yes | No | No | Study Protocol | Feb 11, 2019 | Feb 2, 2021 | Prot_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 |
|---|---|
| C414006 | 23-valent pneumococcal capsular polysaccharide vaccine |
Not provided
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: Mild |
|
| Redness: Moderate |
|
| Redness: Severe |
|
| Swelling: Any |
|
| Swelling: Mild |
|
| Swelling: Moderate |
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| Swelling: Severe |
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| Pain at the injection site: Any |
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| Pain at the injection site: Mild |
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| Pain at the injection site: Moderate |
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| Pain at the injection site: Severe |
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| OG002 | Cohort B: 20vPnC | Participants with receipt of 13vPnC, >=6 months, and no PPSV23, prior to study vaccination, and randomized to receive a single dose of 0.5 mL intramuscular injection of 20vPnC on Day 1. |
| OG003 | Cohort B: PPSV23 | Participants with receipt of 13vPnC, >=6 months, and no PPSV23, prior to study vaccination, and randomized to receive a single dose of 0.5 mL intramuscular injection of PPSV23 on Day 1. |
| OG004 | Cohort C: 20vPnC | Participants with receipt of 13vPnC followed by PPSV23 (PPSV23 dose >=1 year) prior to study vaccination, received a single dose of 0.5 mL intramuscular injection of 20vPnC on Day 1. |
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|
| OG003 | Cohort B: PPSV23 | Participants with receipt of 13vPnC, >=6 months, and no PPSV23, prior to study vaccination, and randomized to receive a single dose of 0.5 mL intramuscular injection of PPSV23 on Day 1. |
| OG004 | Cohort C: 20vPnC | Participants with receipt of 13vPnC followed by PPSV23 (PPSV23 dose >=1 year) prior to study vaccination, received a single dose of 0.5 mL intramuscular injection of 20vPnC on Day 1. |
|
|
| OG002 | Cohort B: 20vPnC | Participants with receipt of 13vPnC, >=6 months, and no PPSV23, prior to study vaccination, and randomized to receive a single dose of 0.5 mL intramuscular injection of 20vPnC on Day 1. |
| OG003 | Cohort B: PPSV23 | Participants with receipt of 13vPnC, >=6 months, and no PPSV23, prior to study vaccination, and randomized to receive a single dose of 0.5 mL intramuscular injection of PPSV23 on Day 1. |
| OG004 | Cohort C: 20vPnC | Participants with receipt of 13vPnC followed by PPSV23 (PPSV23 dose >=1 year) prior to study vaccination, received a single dose of 0.5 mL intramuscular injection of 20vPnC on Day 1. |
|
|
Participants with receipt of 13vPnC, >=6 months, and no PPSV23, prior to study vaccination, and randomized to receive a single dose of 0.5 mL intramuscular injection of 20vPnC on Day 1.
| OG003 | Cohort B: PPSV23 | Participants with receipt of 13vPnC, >=6 months, and no PPSV23, prior to study vaccination, and randomized to receive a single dose of 0.5 mL intramuscular injection of PPSV23 on Day 1. |
| OG004 | Cohort C: 20vPnC | Participants with receipt of 13vPnC followed by PPSV23 (PPSV23 dose >=1 year) prior to study vaccination, received a single dose of 0.5 mL intramuscular injection of 20vPnC on Day 1. |
|
|
| OG002 | Cohort C: 20vPnC | Participants with receipt of 13vPnC followed by PPSV23 (PPSV23 dose >=1 year) prior to study vaccination, received a single dose of 0.5 mL intramuscular injection of 20vPnC on Day 1. |
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| OG002 |
| Cohort C: 20vPnC |
Participants with receipt of 13vPnC followed by PPSV23 (PPSV23 dose >=1 year) prior to study vaccination, received a single dose of 0.5 mL intramuscular injection of 20vPnC on Day 1. |
|
|
Participants with receipt of 13vPnC, >=6 months, and no PPSV23, prior to study vaccination, and randomized to receive a single dose of 0.5 mL intramuscular injection of 20vPnC on Day 1.
| OG002 | Cohort C: 20vPnC | Participants with receipt of 13vPnC followed by PPSV23 (PPSV23 dose >=1 year) prior to study vaccination, received a single dose of 0.5 mL intramuscular injection of 20vPnC on Day 1. |
|
|
| OG002 | Cohort C: 20vPnC | Participants with receipt of 13vPnC followed by PPSV23 (PPSV23 dose >=1 year) prior to study vaccination, received a single dose of 0.5 mL intramuscular injection of 20vPnC on Day 1. |
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