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
Study of the safety and immunogenicity of 20vPnC and a booster dose of BNT162b2 administered at the same visit or each vaccine given alone
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Coadministration Group | Experimental | Participants receive an injection of pneumococcal vaccine (20vPnC) and of COVID-19 vaccine (BNT162b2) at the same visit. |
|
| 20vPnC-only Group | Active Comparator | Participants receive an injection of pneumococcal vaccine (20vPnC) and of saline at the same visit. |
|
| BNT162b2-only Group | Active Comparator | Participants receive an injection of COVID-19 vaccine (BNT162b2) and of saline at the same visit. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| 20-valent pneumococcal conjugate vaccine (20vPnC) | Biological | 20-valent pneumococcal conjugate vaccine (20vPnC) |
|
| Measure | Description | Time Frame |
|---|---|---|
| Percentage of Participants With Local Reactions at Each Injection Site Within 10 Days After Vaccination | Local reactions included pain at injection site, redness and swelling and were 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) and 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 daily activity, moderate: interfered with daily activity and severe: prevented daily activity. Percentage of participants with local reactions at each injection site within 10 days after vaccination and the associated 2-sided 95% confidence interval (CI) based on the Clopper and Pearson method was presented. | Within 10 days after vaccination |
| Percentage of Participants With Systemic Events Within 7 Days After Vaccination | Systemic events including fever, fatigue, headache, chills, muscle pain and joint pain were recorded by participants using an e-diary. Fever was defined as temperature >=38.0 degree Celsius (C) and categorized as >=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, chills, 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. Percentage of participants with systemic events within 7 days after vaccination and the associated 2-sided 95% CI based on the Clopper and Pearson method was presented. | Within 7 days after vaccination |
| Percentage of Participants With Adverse Events (AEs) Within 1 Month After Vaccination | An AE was defined as any untoward medical occurrence in a clinical study participant, temporally associated with the use of study intervention, whether or not considered related to the study intervention. Percentage of participants with AEs and the associated 2-sided 95% CI based on the Clopper and Pearson method was presented. Only AEs collected by non-systematic assessment (i.e. excluding local reactions and systemic events) were reported in this outcome measure. |
| Measure | Description | Time Frame |
|---|---|---|
| Geometric Mean Titers (GMTs) of Pneumococcal Serotype-Specific Opsonophagocytic Activity (OPA) at 1 Month After Vaccination With 20vPnC | OPA titers were measured from serum samples for 20vPnC serotypes: 1, 3, 4, 5, 6A, 6B, 7F,8, 9V, 10A, 11A, 12F, 14, 15B, 18C, 19A, 19F, 22F, 23F, and 33F. GMTs and 2-sided CIs were calculated by exponentiating the mean logarithm of the OPA titers and the corresponding CIs and based on the Student t distribution. Data for this outcome measure was planned to be analyzed for coadministration group (20vPnC + BNT162b2) and 20vPnC only group (20vPnC + saline) as specified in protocol. |
Not provided
Inclusion Criteria:
Exclusion Criteria:
Not provided
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 | ||
| Diablo Clinical Research, Inc. |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 37244809 | Derived | Fitz-Patrick D, Young M, Yacisin K, McElwee K, Belanger T, Belanger K, Peng Y, Lee DY, Gruber WC, Scott DA, Watson W. Randomized trial to evaluate the safety, tolerability, and immunogenicity of a booster (third dose) of BNT162b2 COVID-19 vaccine coadministered with 20-valent pneumococcal conjugate vaccine in adults >/=65 years old. Vaccine. 2023 Jun 23;41(28):4190-4198. doi: 10.1016/j.vaccine.2023.05.002. Epub 2023 May 8. |
| 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
A total of 570 participants were enrolled in the study and randomized to a study treatment.
Eligible participants who received 2 doses of ribonucleic acid (RNA)-based COVID-19 vaccine (BNT162b2) at least 6 months previously in study C4591001 (NCT04368728) were stratified by prior pneumococcal vaccine status (no previous pneumococcal vaccine [naïve] or receipt of at least 1 dose of a pneumococcal vaccine [experienced]) and randomized to 1 of the 3 vaccine groups in this study.
Not provided
| ID | Title | Description |
|---|---|---|
| FG000 | Coadministration Group: 20vPnC+BNT162b2 | On Day 1, participants were randomized to receive a single dose of 0.5 milliliter (mL) 20-valent pneumococcal conjugate vaccine (20vPnC) intramuscularly into the right deltoid and a single dose of 0.3 mL booster dose of BNT162b2 intramuscularly into the left deltoid. Participants were followed up for 6 months after vaccination. |
| 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 | Apr 8, 2021 | Oct 7, 2022 |
Not provided
Not provided
Not provided
Not provided
Not provided
Triple
| BNT162b2 | Biological | RNA-based SARS-CoV-2 vaccine (BNT162b2) |
|
| Saline | Other | Normal saline for injection |
|
| From day of vaccination (Day 1) up to 1 month after vaccination |
| Percentage of Participants With Serious Adverse Events (SAEs) Within 6 Months After Vaccination | A SAE was defined as any untoward medical occurrence that, at any dose, resulted in death; was life-threatening (immediate risk of death); required inpatient hospitalization or prolongation of existing hospitalization; resulted in persistent or significant disability/incapacity (substantial disruption of the ability to conduct normal life functions); resulted in congenital anomaly/birth defect; was a suspected transmission via a Pfizer product of an infectious agent, pathogenic or non-pathogenic or that was considered to be an important medical event. Percentage of participants with SAEs and the associated 2-sided 95% CI based on the Clopper and Pearson method was presented. | From day of vaccination (Day 1) up to 6 months after vaccination |
| 1 month after vaccination with 20vPnC |
| Geometric Mean Concentration (GMC) of Full-Length S-Binding Immunoglobulin G (IgG) Levels at 1 Month After Vaccination With BNT162b2 | IgG levels were measured in serum samples using severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) full-length S-binding assay. GMCs and 2-sided CIs were calculated by exponentiating the mean logarithm of the concentrations and the corresponding CIs and based on the Student t distribution. Data for this outcome measure was planned to be analyzed for coadministration group (20vPnC + BNT162b2) and BNT162b2 only group (BNT162b2 + saline) as specified in protocol. | 1 month after vaccination with BNT162b2 |
| Geometric Mean Fold Rise (GMFR) of Full-Length S-Binding IgG Levels From Before Vaccination to 1 Month After Vaccination With BNT162b2 | The GMFR for each vaccine group was defined as the geometric mean of the fold rises in the assay results from before to approximately 1 month after vaccination. GMFRs and the corresponding 2-sided 95% CIs were calculated by exponentiating the mean logarithm of fold rises and the corresponding CIs and based on the Student t distribution. Data for this outcome measure was planned to be analyzed for coadministration group (20vPnC + BNT162b2) and BNT162b2 only group (BNT162b2 + saline) as specified in the protocol. | Before vaccination to 1 month after vaccination with BNT162b2 |
| Walnut Creek |
| California |
| 94598 |
| United States |
| Alliance for Multispecialty Research, LLC | Coral Gables | Florida | 33134 | United States |
| Indago Research & Health Center, Inc | Hialeah | Florida | 33012 | United States |
| Research Centers of America ( Hollywood ) | Hollywood | Florida | 33024 | United States |
| Acevedo Clinical Research Associates | Miami | Florida | 33142 | United States |
| Clinical Neuroscience Solutions | Orlando | Florida | 32801 | United States |
| Clinical Research Atlanta | Stockbridge | Georgia | 30281 | United States |
| East-West Medical Research Institute | Honolulu | Hawaii | 96814 | United States |
| Solaris Clinical Research | Meridian | Idaho | 83646 | United States |
| Alliance for Multispecialty Research, LLC | Newton | Kansas | 67114 | United States |
| Clinical Research Professionals | Chesterfield | Missouri | 63005 | United States |
| Sundance Clinical Research | St Louis | Missouri | 63141 | United States |
| Meridian Clinical Research, LLC | Omaha | Nebraska | 68134 | United States |
| Meridian Clinical Research, LLC | Endwell | New York | 13760 | United States |
| Accellacare - Wilmington | Wilmington | North Carolina | 28401 | United States |
| Aventiv Research Inc | Columbus | Ohio | 43213 | United States |
| Alliance for Multispecialty Research, LLC | Knoxville | Tennessee | 37909 | United States |
| Clinical Neuroscience Solutions, Inc. dba CNS Healthcare | Memphis | Tennessee | 38119 | United States |
| Benchmark Research | Austin | Texas | 78705 | United States |
| IMA Clinical Research San Antonio | San Antonio | Texas | 78229 | United States |
| DM Clinical Research | Tomball | Texas | 77375 | United States |
| Martin Diagnostic Clinic | Tomball | Texas | 77375 | United States |
| Martins Diagnostic Clinic | Tomball | Texas | 77375 | 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 |
| Wenatchee Valley Hospital | Wenatchee | Washington | 98801 | United States |
| FG001 |
| 20vPnC Only Group: 20vPnC+Saline |
On Day 1, participants were randomized to receive a single dose of 0.5 mL 20vPnC intramuscularly into the right deltoid and a single dose of 0.3 mL saline intramuscularly into the left deltoid. Participants were followed up for 6 months after vaccination. |
| FG002 | BNT162b2 Only Group: BNT162b2+Saline | On Day 1, participants were randomized to receive a single dose of 0.5 mL saline intramuscularly into the right deltoid and a single dose of 0.3 mL booster dose of BNT162b2 intramuscularly into the left deltoid. Participants were followed up for 6 months after vaccination. |
| Vaccinated |
|
| COMPLETED |
|
| NOT COMPLETED |
|
|
Safety population included all participants who received at least 1 dose of the study intervention and had safety follow-up after vaccination.
Not provided
| ID | Title | Description |
|---|---|---|
| BG000 | Coadministration Group: 20vPnC+BNT162b2 | On Day 1, participants were randomized to receive a single dose of 0.5 mL 20vPnC intramuscularly into the right deltoid and a single dose of 0.3 mL booster dose of BNT162b2 intramuscularly into the left deltoid. Participants were followed up for 6 months after vaccination. |
| BG001 | 20vPnC Only Group: 20vPnC+Saline | On Day 1, participants were randomized to receive a single dose of 0.5 mL 20vPnC intramuscularly into the right deltoid and a single dose of 0.3 mL saline intramuscularly into the left deltoid. Participants were followed up for 6 months after vaccination. |
| BG002 | BNT162b2 Only Group: BNT162b2+Saline | On Day 1, participants were randomized to receive a single dose of 0.5 mL saline intramuscularly into the right deltoid and a single dose of 0.3 mL booster dose of BNT162b2 intramuscularly into the left deltoid. Participants were followed up for 6 months after vaccination. |
| BG003 | 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 at Each Injection Site Within 10 Days After Vaccination | Local reactions included pain at injection site, redness and swelling and were 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) and 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 daily activity, moderate: interfered with daily activity and severe: prevented daily activity. Percentage of participants with local reactions at each injection site within 10 days after vaccination and the associated 2-sided 95% confidence interval (CI) based on the Clopper and Pearson method was presented. | Safety population included all participants who received at least 1 dose of the study intervention and had safety follow-up after vaccination. Here, "Overall Number of Participants Analyzed" signifies number of participants with any e-diary data reported after vaccination. | 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 including fever, fatigue, headache, chills, muscle pain and joint pain were recorded by participants using an e-diary. Fever was defined as temperature >=38.0 degree Celsius (C) and categorized as >=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, chills, 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. Percentage of participants with systemic events within 7 days after vaccination and the associated 2-sided 95% CI based on the Clopper and Pearson method was presented. | Safety population included all participants who received at least 1 dose of the study intervention and had safety follow-up after vaccination. Here, "Overall Number of Participants Analyzed" (N) signifies number of participants with any e-diary data reported after vaccination. | 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 defined as any untoward medical occurrence in a clinical study participant, temporally associated with the use of study intervention, whether or not considered related to the study intervention. Percentage of participants with AEs and the associated 2-sided 95% CI based on the Clopper and Pearson method was presented. Only AEs collected by non-systematic assessment (i.e. excluding local reactions and systemic events) were reported in this outcome measure. | Safety population included all participants who received at least 1 dose of the study intervention and had safety follow-up after vaccination. | Posted | Number | 95% Confidence Interval | Percentage of participants | From day of vaccination (Day 1) up to 1 month after vaccination |
| ||||||||||||||||||||||||||||||||||||||||||
| Primary | Percentage of Participants With Serious Adverse Events (SAEs) Within 6 Months After Vaccination | A SAE was defined as any untoward medical occurrence that, at any dose, resulted in death; was life-threatening (immediate risk of death); required inpatient hospitalization or prolongation of existing hospitalization; resulted in persistent or significant disability/incapacity (substantial disruption of the ability to conduct normal life functions); resulted in congenital anomaly/birth defect; was a suspected transmission via a Pfizer product of an infectious agent, pathogenic or non-pathogenic or that was considered to be an important medical event. Percentage of participants with SAEs and the associated 2-sided 95% CI based on the Clopper and Pearson method was presented. | Safety population included all participants who received at least 1 dose of the study intervention and had safety follow-up after vaccination. | Posted | Number | 95% Confidence Interval | Percentage of participants | From day of vaccination (Day 1) up to 6 months after vaccination |
| ||||||||||||||||||||||||||||||||||||||||||
| Secondary | Geometric Mean Titers (GMTs) of Pneumococcal Serotype-Specific Opsonophagocytic Activity (OPA) at 1 Month After Vaccination With 20vPnC | OPA titers were measured from serum samples for 20vPnC serotypes: 1, 3, 4, 5, 6A, 6B, 7F,8, 9V, 10A, 11A, 12F, 14, 15B, 18C, 19A, 19F, 22F, 23F, and 33F. GMTs and 2-sided CIs were calculated by exponentiating the mean logarithm of the OPA titers and the corresponding CIs and based on the Student t distribution. Data for this outcome measure was planned to be analyzed for coadministration group (20vPnC + BNT162b2) and 20vPnC only group (20vPnC + saline) as specified in protocol. | Evaluable immunogenicity population (EIP): all randomized participants who received assigned vaccination; had at least 1 valid immunogenicity result from the blood sample collected within 20 to 49 days after vaccination at Day 1; had no other major protocol deviations as determined by clinician. Here, "Number Analyzed" signifies participants with valid OPA titers for the specified serotype. | Posted | Geometric Mean | 95% Confidence Interval | Titer | 1 month after vaccination with 20vPnC |
| ||||||||||||||||||||||||||||||||||||||||||
| Secondary | Geometric Mean Concentration (GMC) of Full-Length S-Binding Immunoglobulin G (IgG) Levels at 1 Month After Vaccination With BNT162b2 | IgG levels were measured in serum samples using severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) full-length S-binding assay. GMCs and 2-sided CIs were calculated by exponentiating the mean logarithm of the concentrations and the corresponding CIs and based on the Student t distribution. Data for this outcome measure was planned to be analyzed for coadministration group (20vPnC + BNT162b2) and BNT162b2 only group (BNT162b2 + saline) as specified in protocol. | EIP: all randomized participants who received assigned vaccination; had at least 1 valid immunogenicity result from blood sample collected within 20 to 49 days after vaccination at Day 1; had no other major protocol deviations as determined by clinician. Participants with SARS-CoV-2 infection up to 1 month after vaccination (including subclinical infection, ie positive for N-binding antibody) were excluded from analysis. N=participants with valid assay results at specified sampling time point. | Posted | Geometric Mean | 95% Confidence Interval | Units per milliliter | 1 month after vaccination with BNT162b2 |
| ||||||||||||||||||||||||||||||||||||||||||
| Secondary | Geometric Mean Fold Rise (GMFR) of Full-Length S-Binding IgG Levels From Before Vaccination to 1 Month After Vaccination With BNT162b2 | The GMFR for each vaccine group was defined as the geometric mean of the fold rises in the assay results from before to approximately 1 month after vaccination. GMFRs and the corresponding 2-sided 95% CIs were calculated by exponentiating the mean logarithm of fold rises and the corresponding CIs and based on the Student t distribution. Data for this outcome measure was planned to be analyzed for coadministration group (20vPnC + BNT162b2) and BNT162b2 only group (BNT162b2 + saline) as specified in the protocol. | EIP: participants received assigned vaccination; at least 1 valid immunogenicity result from sample collected within 20 to 49 days after Day1 vaccination; no other major protocol deviations determined by clinician. Participants with SARS-CoV-2 infection upto 1 month after vaccination (including subclinical infection, ie positive for N-binding antibody)excluded from analysis. N=participants with valid full-length S-binding IgG from before and 1 month after BNT162b2 booster dose sample collection. | Posted | Geometric Mean | 95% Confidence Interval | Fold rise | Before vaccination to 1 month after vaccination with BNT162b2 |
|
Systematic assessment: local reactions recorded within 10 days after vaccination, and systemic events recorded within 7 days after vaccination; Non-systematic assessment: SAEs recorded from day of vaccination (Day 1) up to 6 months after vaccination and other AEs recorded from Day 1 up to 1 month after vaccination
Same event may appear as AE and SAE but 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.
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 | Coadministration Group: 20vPnC+BNT162b2 | On Day 1, participants were randomized to receive a single dose of 0.5 mL 20vPnC intramuscularly into the right deltoid and a single dose of 0.3 mL booster dose of BNT162b2 intramuscularly into the left deltoid. Participants were followed up for 6 months after vaccination. | 1 | 187 | 1 | 187 | 157 | 187 |
| EG001 | 20vPnC Only Group: 20vPnC+Saline | On Day 1, participants were randomized to receive a single dose of 0.5 mL 20vPnC intramuscularly into the right deltoid and a single dose of 0.3 mL saline intramuscularly into the left deltoid. Participants were followed up for 6 months after vaccination. | 0 | 187 | 2 | 187 | 137 | 187 |
| EG002 | BNT162b2 Only Group: BNT162b2+Saline | On Day 1, participants were randomized to receive a single dose of 0.5 mL saline intramuscularly into the right deltoid and a single dose of 0.3 mL booster dose of BNT162b2 intramuscularly into the left deltoid. Participants were followed up for 6 months after vaccination. | 0 | 185 | 5 | 185 | 149 | 185 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Angina unstable | Cardiac disorders | MedDRA v24.1 | Non-systematic Assessment |
| |
| Duodenal perforation | Gastrointestinal disorders | MedDRA v24.1 | Non-systematic Assessment |
| |
| Femur fracture | Injury, poisoning and procedural complications | MedDRA v24.1 | Non-systematic Assessment |
| |
| Breast cancer stage I | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA v24.1 | Non-systematic Assessment |
| |
| Glioblastoma | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA v24.1 | Non-systematic Assessment |
| |
| Lung adenocarcinoma | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA v24.1 | Non-systematic Assessment |
| |
| Metastases to liver | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA v24.1 | Non-systematic Assessment |
| |
| Small intestine carcinoma | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA v24.1 | Non-systematic Assessment |
| |
| Acute kidney injury | Renal and urinary disorders | MedDRA v24.1 | Non-systematic Assessment |
|
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Chills (CHILLS) | General disorders | MedDRA v24.1 | Systematic Assessment |
| |
| Fatigue (FATIGUE) | General disorders | MedDRA v24.1 | Systematic Assessment |
| |
| Injection site erythema (REDNESS) | General disorders | MedDRA v24.1 | Systematic Assessment |
| |
| Injection site pain (PAIN) | General disorders | MedDRA v24.1 | Systematic Assessment |
| |
| Injection site swelling (SWELLING) | General disorders | MedDRA v24.1 | Systematic Assessment |
| |
| Pyrexia (FEVER) | General disorders | MedDRA v24.1 | Systematic Assessment |
| |
| Urinary tract infection | Infections and infestations | MedDRA v24.1 | Non-systematic Assessment |
| |
| Arthralgia (JOINT PAIN) | Musculoskeletal and connective tissue disorders | MedDRA v24.1 | Systematic Assessment |
| |
| Myalgia (MUSCLE PAIN) | Musculoskeletal and connective tissue disorders | MedDRA v24.1 | Systematic Assessment |
| |
| Dizziness | Nervous system disorders | MedDRA v24.1 | Non-systematic Assessment |
| |
| Headache (HEADACHE) | Nervous system disorders | MedDRA v24.1 | 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. | 1-800-718-1021 | ClinicalTrials.gov_Inquiries@pfizer.com |
| Prot_000.pdf |
| SAP | No | Yes | No | Statistical Analysis Plan | Jun 30, 2021 | Oct 7, 2022 | SAP_001.pdf |
Not provided
| ID | Term |
|---|---|
| D011008 | Pneumococcal Infections |
| D000086382 | COVID-19 |
| ID | Term |
|---|---|
| D013290 | Streptococcal Infections |
| D016908 | Gram-Positive Bacterial Infections |
| D001424 | Bacterial Infections |
| D001423 | Bacterial Infections and Mycoses |
| D007239 | Infections |
| D011024 | Pneumonia, Viral |
| D011014 | Pneumonia |
| D012141 | Respiratory Tract Infections |
| D014777 | Virus Diseases |
| D018352 | Coronavirus Infections |
| D003333 | Coronaviridae Infections |
| D030341 | Nidovirales Infections |
| D012327 | RNA Virus Infections |
| D008171 | Lung Diseases |
| D012140 | Respiratory Tract Diseases |
Not provided
Not provided
| ID | Term |
|---|---|
| D000090982 | BNT162 Vaccine |
| D012965 | Sodium Chloride |
| ID | Term |
|---|---|
| D000087503 | mRNA Vaccines |
| D000087504 | Nucleic Acid-Based Vaccines |
| D014614 | Vaccines, Synthetic |
| D011994 | Recombinant Proteins |
| D011506 | Proteins |
| D000602 | Amino Acids, Peptides, and Proteins |
| D014612 | Vaccines |
| D001688 | Biological Products |
| D045424 | Complex Mixtures |
| D000086663 | COVID-19 Vaccines |
| D014765 | Viral Vaccines |
| D000941 | Antigens |
| D001685 | Biological Factors |
| 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: Mild |
|
| Redness: Moderate |
|
| Redness: Severe |
|
| Swelling: Any |
|
| Swelling: Mild |
|
| Swelling: Moderate |
|
| Swelling: Severe |
|
| Pain at injection site: Any |
|
| Pain at injection site: Mild |
|
| Pain at injection site: Moderate |
|
| Pain at injection site: Severe |
|
On Day 1, participants were randomized to receive a single dose of 0.5 mL 20vPnC intramuscularly into the right deltoid and a single dose of 0.3 mL saline intramuscularly into the left deltoid. Participants were followed up for 6 months after vaccination. |
| OG002 | BNT162b2 Only Group: BNT162b2+Saline | On Day 1, participants were randomized to receive a single dose of 0.5 mL saline intramuscularly into the right deltoid and a single dose of 0.3 mL booster dose of BNT162b2 intramuscularly into the left deltoid. Participants were followed up for 6 months after vaccination. |
|
|
| OG002 | BNT162b2 Only Group: BNT162b2+Saline | On Day 1, participants were randomized to receive a single dose of 0.5 mL saline intramuscularly into the right deltoid and a single dose of 0.3 mL booster dose of BNT162b2 intramuscularly into the left deltoid. Participants were followed up for 6 months after vaccination. |
|
|
| OG002 | BNT162b2 Only Group: BNT162b2+Saline | On Day 1, participants were randomized to receive a single dose of 0.5 mL saline intramuscularly into the right deltoid and a single dose of 0.3 mL booster dose of BNT162b2 intramuscularly into the left deltoid. Participants were followed up for 6 months after vaccination. |
|
|
On Day 1, participants were randomized to receive a single dose of 0.5 mL 20vPnC intramuscularly into the right deltoid and a single dose of 0.3 mL saline intramuscularly into the left deltoid. Participants were followed up for 6 months after vaccination.
|
|
| BNT162b2 Only Group: BNT162b2+Saline |
On Day 1, participants were randomized to receive a single dose of 0.5 mL saline intramuscularly into the right deltoid and a single dose of 0.3 mL booster dose of BNT162b2 intramuscularly into the left deltoid. Participants were followed up for 6 months after vaccination. |
|
|
| OG001 |
| BNT162b2 Only Group: BNT162b2+Saline |
On Day 1, participants were randomized to receive a single dose of 0.5 mL saline intramuscularly into the right deltoid and a single dose of 0.3 mL booster dose of BNT162b2 intramuscularly into the left deltoid. Participants were followed up for 6 months after vaccination. |
|
|