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 influenza vaccine administered at the same visit or separately
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Coadministration Group | Active Comparator | Participants receive injections of pneumococcal vaccine (20vPnC) and influenza vaccine at the same visit, and then receive an injection of saline 1 month later. |
|
| Separate Administration Group | Active Comparator | Participants receive injections of saline and influenza vaccine at the same visit, and then receive an injection of 20vPnC 1 month later. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Experimental 20-valent pneumococcal conjugate vaccine (20vPnC) | Biological | Experimental 20-valent pneumococcal conjugate vaccine (20vPnC) |
|
| Measure | Description | Time Frame |
|---|---|---|
| Percentage of Participants With Local Reactions Within 10 Days After Vaccination With 20vPnC | Local reactions were collected at the 20vPnC injection sites after Vaccination 1 and Vaccination 2 and were recorded by the participants 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). Percentage of participants with local reactions at the 20vPnC injection site in the Coadministration group and the Separate administration group and the associated 2-sided 95% confidence interval (CI) based on the Clopper and Pearson method was presented. | Within 10 days after Vaccination 1 for Coadministration group and within 10 days after Vaccination 2 for Separate Administration group |
| Percentage of Participants With Systemic Events Within 7 Days After Each Vaccination By Each Vaccine | Systemic events including fever, fatigue, headache, 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, 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 each vaccination and the associated 2-sided 95% CI based on the Clopper and Pearson method was presented. | Within 7 days after each vaccination |
| Percentage of Participants With Adverse Events (AEs) Within 1 Month After Each Vaccination by Each Vaccine | 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. |
| Measure | Description | Time Frame |
|---|---|---|
| Percentage of Participants With Greater Than or Equal to (≥4) Fold Rise in Serotype-Specific Opsonophagocytic Activity (OPA) Titers From Before Vaccination to 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, 33F. Percentage of participants with >=4 fold rise in serotype-specific OPA titers from before vaccination to 1 month after vaccination with 20vPnC and the associated 2-sided 95% CI based on the Clopper and Pearson method was presented. |
Not provided
Inclusion Criteria:
Exclusion Criteria:
History of severe adverse reaction associated with a vaccine and/or severe allergic reaction (eg, anaphylaxis)
Previous vaccination with any investigational pneumococcal vaccine, or planned receipt of any licensed or investigational pneumococcal vaccine through study participation.
Vaccination with any influenza or pneumococcal vaccine <6 months before investigational product administration, or planned receipt of any licensed or investigational non-study influenza vaccine during study participation.
-- Serious chronic disorder, that in the investigator's opinion would make the participant inappropriate for entry into the study
Other acute or chronic medical or psychiatric condition or laboratory abnormality that may increase the risk associated with study participation or investigational product administration or may interfere with the interpretation of study results
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 |
|---|---|---|---|---|---|---|
| Alliance for Multispecialty Research, LLC | Mobile | Alabama | 36608 | United States | ||
| East Valley Gastroenterology and Hepatology Associates |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 36828719 | Derived | Cannon K, Cardona JF, Yacisin K, Thompson A, Belanger TJ, Lee DY, Peng Y, Moyer L, Ginis J, Gruber WC, Scott DA, Watson W. Safety and immunogenicity of a 20-valent pneumococcal conjugate vaccine coadministered with quadrivalent influenza vaccine: A phase 3 randomized trial. Vaccine. 2023 Mar 24;41(13):2137-2146. doi: 10.1016/j.vaccine.2022.11.046. Epub 2023 Feb 23. |
| 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 1796 participants were enrolled in the study and assigned to a study treatment.
Not provided
Not provided
| ID | Title | Description |
|---|---|---|
| FG000 | (SIIV+20vPnC)/Saline: Coadministration | On Day 1, participants received a single dose of seasonal inactivated influenza vaccine (SIIV) intramuscularly into the right deltoid along with 0.5 milliliter (mL) 20-valent pneumococcal conjugate vaccine (20vPnC) intramuscularly into the left deltoid (Vaccination 1). After one month, participants received 0.5 mL of saline intramuscularly into the left deltoid (Vaccination 2). Participants were followed up for 6 months after Vaccination 2. |
| 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 | Jun 15, 2020 | Jun 15, 2022 |
Not provided
Not provided
Not provided
Not provided
Not provided
| Saline | Other | Normal saline for injection |
|
| Influenza vaccine | Biological | Seasonal inactivated influenza vaccine (SIIV) |
|
| Within 1 month after each vaccination |
| Percentage of Participants With Serious Adverse Events (SAEs) From the First Vaccination up to 6 Months After Last Vaccination | An SAE was defined as any untoward medical occurrence that, 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 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. Percentage of participants with SAEs and the associated 2-sided 95% CI based on the Clopper and Pearson method was presented. | From Day 1 up to 6 months after last Vaccination (i.e. up to 7 months) |
| Percentage of Participants With Newly Diagnosed Chronic Medical Condition (NDCMC) up to 6 Months After Last Vaccination | An NDCMC was defined as a significant 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 NDCMC and the associated 2-sided 95% CI based on the Clopper and Pearson method was presented. | Up to 6 months after last Vaccination (i.e. up to 7 months) |
| Model-Based Pneumococcal Opsonophagocytic Activity (OPA) Geometric Mean Titers (GMTs) 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, 33F. GMTs and 2-sided CIs were calculated by exponentiating the LS means and the corresponding CIs based on analysis of log-transformed OPA titers using a regression model | 1 month after the 20vPnC administration in each group (1 month after Vaccination 1 in the Coadministration group and 1 month after Vaccination 2 in the Separate Administration group). |
| Model-Based Hemagglutination Inhibition (HAI) Strain Specific Geometric Mean Titers (GMT) at 1 Month After Vaccination With SIIV | HAI titers to the influenza strains (A/H1N1, A/H3N2, B/Victoria, and B/Phuket) in the SIIV administered sera samples was collected and reported in this outcome measure at 1 month after Vaccination 1. GMTs and 2-sided CIs were calculated by exponentiating the LS means and the corresponding CIs based on analysis of log-transformed HAI titers using a regression model. | At 1 month after Vaccination 1 with SIIV |
| Before Vaccination 1 to 1 month after 20vPnC vaccination in both groups (i.e., 1 month after Vaccination 1 in Coadministration group and 1 month after Vaccination 2 in Separate Administration group) |
| Pneumococcal Opsonophagocytic Activity (OPA) Geometric Mean Fold Rise (GMFR) From Before Vaccination to 1 Month After Vaccination With 20vPnC | OPA titers were measured from serum samples for serotypes: 1, 3, 4, 5, 6A, 6B, 7F,8, 9V, 10A, 11A, 12F, 14, 15B, 18C, 19A, 19F, 22F, 23F, 33F. GMFR was calculated as geometric mean of fold rise from before vaccination on Day 1 to 1 month after vaccination with 20vPnC. GMFRs and the corresponding 2-sided CIs were calculated by exponentiating the mean logarithm of the OPA titers or fold rises and the corresponding CIs. | Before Vaccination 1 to 1 month after 20vPnC vaccination in both groups (i.e., 1 month after Vaccination 1 in Coadministration group and 1 month after Vaccination 2 in Separate Administration group) |
| Hemagglutination Inhibition (HAI) Strain Specific Geometric Mean Fold Rise (GMFR) Before Vaccination to 1 Month After Vaccination With SIIV | HAI titers were measured from serum samples for serotypes A/H1N1, A/H3N2, B/Victoria, B/Phuket. GMFR was calculated as geometric mean of fold rise from before vaccination on Day 1 to 1 month after vaccination with SIIV. GMFRs were calculated for participants with non-missing values both before and after vaccination. | Before Vaccination 1 to 1 month after Vaccination 1 with SIIV |
| Chandler |
| Arizona |
| 85224 |
| United States |
| Hope Research Institute | Phoenix | Arizona | 85018 | United States |
| Paradigm Clinical Research Center | Redding | California | 96001 | United States |
| Artemis Institute for Clinical Research | San Diego | California | 92103 | United States |
| California Research Foundation | San Diego | California | 92123-1881 | United States |
| Diablo Clinical Research, Inc. | Walnut Creek | California | 94598 | United States |
| Alliance for Multispecialty Research, LLC - Miami | Coral Gables | Florida | 33134 | United States |
| Nature Coast Clinical Research | Crystal River | Florida | 34429 | United States |
| Indago Research and Health Center, Inc. | Hialeah | Florida | 33012 | United States |
| Jacksonville Center for Clinical Research | Jacksonville | Florida | 32216 | United States |
| Suncoast Research Group, LLC | Miami | Florida | 33135 | United States |
| Alpha Science Research, LLC | Miami | Florida | 33186 | United States |
| Lakes Research | Miami Lakes | Florida | 33014 | United States |
| Clinical Neuroscience Solutions, Inc | Orlando | Florida | 32801 | United States |
| Meridian Clinical Research, LLC | Savannah | Georgia | 31406 | United States |
| Clinical Research Atlanta | Stockbridge | Georgia | 30281 | United States |
| Advanced Clinical Research | Meridian | Idaho | 83642 | United States |
| Alliance for Multispecialty Research, LLC | El Dorado | Kansas | 67042 | United States |
| Alliance for Multispecialty Research, LLC | Wichita | Kansas | 67205 | United States |
| Alliance for Multispecialty Research, LLC | Wichita | Kansas | 67207 | United States |
| Alliance for Multispecialty Research, LLC | New Orleans | Louisiana | 70119 | United States |
| Centennial Medical Group | Elkridge | Maryland | 21075 | United States |
| Meridian Clinical Research, LLC | Rockville | Maryland | 20854 | United States |
| Sundance Clinical Research, LLC | St Louis | Missouri | 63141 | United States |
| Meridian Clinical Research | Norfolk | Nebraska | 68701 | United States |
| Meridian Clinical Research, LLC | Omaha | Nebraska | 68134 | United States |
| Meridian Clinical Research, LLC | Binghamton | New York | 13901 | United States |
| Meridian Clinical Research, LLC | Endwell | New York | 13760 | United States |
| PMG Research of Charlotte, LLC | Charlotte | North Carolina | 28209 | United States |
| PharmQuest | Greensboro | North Carolina | 27408 | United States |
| PMG Research of Hickory, LLC | Hickory | North Carolina | 28601 | United States |
| Accellacare - Raleigh | Raleigh | North Carolina | 27609 | United States |
| M3 Wake Research, Inc. | Raleigh | North Carolina | 27612 | United States |
| PMG Research of Rocky Mount, LLC | Rocky Mount | North Carolina | 27804 | United States |
| PMG Research of Wilmington, LLC | Wilmington | North Carolina | 28401 | United States |
| Lillestol Research LLC | Fargo | North Dakota | 58104 | United States |
| CTI Clinical Research Center | Cincinnati | Ohio | 45212 | United States |
| Meridian Clinical Research | Cincinnati | Ohio | 45219 | United States |
| Velocity Clinical Research, Inc. | Cleveland | Ohio | 44122 | United States |
| Prestige Clinical Research | Franklin | Ohio | 45005 | United States |
| Lynn Health Science Institute | Oklahoma City | Oklahoma | 73112 | United States |
| Omega Medical Research | Warwick | Rhode Island | 02886 | United States |
| Main Street Physician's Care | Little River | South Carolina | 29566 | United States |
| Coastal Carolina Research Center | North Charleston | South Carolina | 29405 | United States |
| Internal Medicine and Pediatric Associates of Bristol, PC | Bristol | Tennessee | 37620 | United States |
| Clinical Research Associates, Inc. | Nashville | Tennessee | 37203 | United States |
| Benchmark Research | Austin | Texas | 78705 | United States |
| Velocity Clinical Research, Austin | Cedar Park | Texas | 78613 | United States |
| Benchmark Research | Fort Worth | Texas | 76135 | United States |
| Texas Health Resource | Fort Worth | Texas | 76135 | United States |
| Texas Center for Drug Development, Inc. | Houston | Texas | 77081 | United States |
| Wellness Clinical Research | McKinney | Texas | 75071 | United States |
| LinQ Research, LLC | Pearland | Texas | 77584 | United States |
| Diagnostics Research Group | 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. / 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 |
| Alliance for Multispecialty Research - Norfolk | Norfolk | Virginia | 23502 | United States |
| National Clinical Research, Inc | Richmond | Virginia | 23294 | United States |
| Allegiance Research Specialists, LLC | Wauwatosa | Wisconsin | 53226 | United States |
| FG001 | (SIIV+Saline)/20vPnC: Separate Administration | On Day 1, participants received a single dose of SIIV intramuscularly into the right deltoid and 0.5 mL of saline intramuscularly into the left deltoid (Vaccination 1). After one month, participants received 0.5 mL of 20vPnC intramuscularly into the left deltoid. (Vaccination 2). Participants were followed up for 6 months after Vaccination 2. |
| Vaccination 1 |
|
| Vaccination 2 |
|
| COMPLETED |
|
| NOT COMPLETED |
|
|
Safety population included all randomized participants who received 1 dose of 20vPnC or SIIV or saline and had safety follow-up after any dose.
Not provided
| ID | Title | Description |
|---|---|---|
| BG000 | (SIIV+20vPnC)/Saline: Coadministration | On Day 1, participants received a single dose of SIIV intramuscularly into the right deltoid along with 0.5 mL 20vPnC intramuscularly into the left deltoid (Vaccination 1). After one month, participants received 0.5 mL of saline intramuscularly into the left deltoid (Vaccination 2). Participants were followed up for 6 months after Vaccination 2. |
| BG001 | (SIIV+Saline)/20vPnC: Separate Administration | On Day 1, participants received a single dose of SIIV intramuscularly into the right deltoid and 0.5 mL of saline intramuscularly into the left deltoid (Vaccination 1). After one month, participants received 0.5 mL of 20vPnC intramuscularly into the left deltoid. (Vaccination 2). Participants were followed up for 6 months after Vaccination 2. |
| 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 With 20vPnC | Local reactions were collected at the 20vPnC injection sites after Vaccination 1 and Vaccination 2 and were recorded by the participants 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). Percentage of participants with local reactions at the 20vPnC injection site in the Coadministration group and the Separate administration group and the associated 2-sided 95% confidence interval (CI) based on the Clopper and Pearson method was presented. | Safety population included all randomized participants who received 1 dose of 20vPnC or SIIV or saline and had safety follow-up after any dose. Here, "Overall Number of Participants Analyzed" (N) signifies number of participants with any e-diary data reported after vaccination with 20vPnC. | Posted | Number | 95% Confidence Interval | Percentage of participants | Within 10 days after Vaccination 1 for Coadministration group and within 10 days after Vaccination 2 for Separate Administration group |
|
|
| |||||||||||||||||||||||||||||||||||
| Primary | Percentage of Participants With Systemic Events Within 7 Days After Each Vaccination By Each Vaccine | Systemic events including fever, fatigue, headache, 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, 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 each vaccination and the associated 2-sided 95% CI based on the Clopper and Pearson method was presented. | Safety population included all randomized participants who received 1 dose of 20vPnC or SIIV or saline and had safety follow-up after any dose. Here, 'N' signifies number of participants with any e-diary data reported after the vaccination at the specified visit. | Posted | Number | 95% Confidence Interval | Percentage of participants | Within 7 days after each vaccination |
| |||||||||||||||||||||||||||||||||||||
| Primary | Percentage of Participants With Adverse Events (AEs) Within 1 Month After Each Vaccination by Each Vaccine | 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. | Safety population included all randomized participants who received 1 dose of 20vPnC or SIIV or saline and had safety follow-up after any dose. Here, 'Overall number of participants analyzed' (N) is the number of participants included in the safety population who received the specified vaccination. | Posted | Number | 95% Confidence Interval | Percentage of participants | Within 1 month after each vaccination |
| |||||||||||||||||||||||||||||||||||||
| Primary | Percentage of Participants With Serious Adverse Events (SAEs) From the First Vaccination up to 6 Months After Last Vaccination | An SAE was defined as any untoward medical occurrence that, 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 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. 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 randomized participants who received 1 dose of 20vPnC or SIIV or saline and had safety follow-up after any dose. | Posted | Number | 95% Confidence Interval | Percentage of participants | From Day 1 up to 6 months after last Vaccination (i.e. up to 7 months) |
| |||||||||||||||||||||||||||||||||||||
| Primary | Percentage of Participants With Newly Diagnosed Chronic Medical Condition (NDCMC) up to 6 Months After Last Vaccination | An NDCMC was defined as a significant 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 NDCMC and the associated 2-sided 95% CI based on the Clopper and Pearson method was presented. | Safety population included all randomized participants who received 1 dose of 20vPnC or SIIV or saline and had safety follow-up after any dose. | Posted | Number | 95% Confidence Interval | Percentage of participants | Up to 6 months after last Vaccination (i.e. up to 7 months) |
| |||||||||||||||||||||||||||||||||||||
| Primary | Model-Based Pneumococcal Opsonophagocytic Activity (OPA) Geometric Mean Titers (GMTs) 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, 33F. GMTs and 2-sided CIs were calculated by exponentiating the LS means and the corresponding CIs based on analysis of log-transformed OPA titers using a regression model | Evaluable pneumococcal immunogenicity(EPI) population: all randomized participants who received assigned vaccinations; blood collected within 27 to 49 days after 20vPnC; with least 1 valid OPA result from sample collected 1 month after 20vPnC vaccination; had no other major protocol deviations as determined by clinician. Here,'N':number of participants in evaluable immunogenicity population and 'number analyzed': number of evaluable participants with a valid OPA titer for the specified serotype. | Posted | Geometric Mean | 95% Confidence Interval | Titer | 1 month after the 20vPnC administration in each group (1 month after Vaccination 1 in the Coadministration group and 1 month after Vaccination 2 in the Separate Administration group). |
| |||||||||||||||||||||||||||||||||||||
| Primary | Model-Based Hemagglutination Inhibition (HAI) Strain Specific Geometric Mean Titers (GMT) at 1 Month After Vaccination With SIIV | HAI titers to the influenza strains (A/H1N1, A/H3N2, B/Victoria, and B/Phuket) in the SIIV administered sera samples was collected and reported in this outcome measure at 1 month after Vaccination 1. GMTs and 2-sided CIs were calculated by exponentiating the LS means and the corresponding CIs based on analysis of log-transformed HAI titers using a regression model. | Evaluable HAI immunogenicity population: all randomized participants who received assigned vaccinations; had blood collected within 27 to 49 days after SIIV; had at least 1 valid HAI result from blood sample collected 1 month after SIIV vaccination; had no other major protocol deviations as determined by clinician. Here, 'N': number of participants in evaluable HAI immunogenicity population, 'number analyzed': number of evaluable HAI participants with a valid result for the specified HAI strain. | Posted | Geometric Mean | 95% Confidence Interval | Titer | At 1 month after Vaccination 1 with SIIV |
| |||||||||||||||||||||||||||||||||||||
| Secondary | Percentage of Participants With Greater Than or Equal to (≥4) Fold Rise in Serotype-Specific Opsonophagocytic Activity (OPA) Titers From Before Vaccination to 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, 33F. Percentage of participants with >=4 fold rise in serotype-specific OPA titers from before vaccination to 1 month after vaccination with 20vPnC and the associated 2-sided 95% CI based on the Clopper and Pearson method was presented. | EPI population: all randomized participants who received assigned vaccinations; blood collected within 27 to 49 days after 20vPnC with at least 1 valid OPA result from sample collected 1 month after 20vPnC vaccination; no other major protocol deviations as determined by clinician. Here, 'N': number of participants with valid results for both timepoints (before Vaccination 1 and 1 month after 20vPnC), 'number analyzed': participants evaluable for specific serotypes. | Posted | Number | 95% Confidence Interval | Percentage of participants | Before Vaccination 1 to 1 month after 20vPnC vaccination in both groups (i.e., 1 month after Vaccination 1 in Coadministration group and 1 month after Vaccination 2 in Separate Administration group) |
| |||||||||||||||||||||||||||||||||||||
| Secondary | Pneumococcal Opsonophagocytic Activity (OPA) Geometric Mean Fold Rise (GMFR) From Before Vaccination to 1 Month After Vaccination With 20vPnC | OPA titers were measured from serum samples for serotypes: 1, 3, 4, 5, 6A, 6B, 7F,8, 9V, 10A, 11A, 12F, 14, 15B, 18C, 19A, 19F, 22F, 23F, 33F. GMFR was calculated as geometric mean of fold rise from before vaccination on Day 1 to 1 month after vaccination with 20vPnC. GMFRs and the corresponding 2-sided CIs were calculated by exponentiating the mean logarithm of the OPA titers or fold rises and the corresponding CIs. | EPI population: all randomized participants who received assigned vaccinations; blood collected within 27 to 49 days after 20vPnC with at least 1 valid OPA result from sample collected 1 month after 20vPnC vaccination; no other major protocol deviations as determined by clinician. Here, 'N': number of participants in the EPI, 'number analyzed': participants with valid OPA titers both before vaccination at Visit 1 and 1 month after 20vPnC blood sample collections. | Posted | Geometric Mean | 95% Confidence Interval | Fold rise | Before Vaccination 1 to 1 month after 20vPnC vaccination in both groups (i.e., 1 month after Vaccination 1 in Coadministration group and 1 month after Vaccination 2 in Separate Administration group) |
| |||||||||||||||||||||||||||||||||||||
| Secondary | Hemagglutination Inhibition (HAI) Strain Specific Geometric Mean Fold Rise (GMFR) Before Vaccination to 1 Month After Vaccination With SIIV | HAI titers were measured from serum samples for serotypes A/H1N1, A/H3N2, B/Victoria, B/Phuket. GMFR was calculated as geometric mean of fold rise from before vaccination on Day 1 to 1 month after vaccination with SIIV. GMFRs were calculated for participants with non-missing values both before and after vaccination. | Evaluable HAI immunogenicity population:randomized participants who received assigned vaccinations; blood collected within 27 to 49 days after SIIV;had at least 1 valid HAI result from blood sample collected 1 month after SIIV vaccination; no other major protocol deviations as determined by clinician. 'N': participants analyzed in HAI immunogenicity population, 'number analyzed':participants with valid HAI titers both before vaccination at Visit 1 and 1 month after SIIV blood sample collections. | Posted | Geometric Mean | 95% Confidence Interval | Fold rise | Before Vaccination 1 to 1 month after Vaccination 1 with SIIV |
|
Local reactions(systematic assessment): within 10 days after Vaccination 1 for Coadministration group and within 10 days after Vaccination 2 for Separate Administration group, Systemic events(systematic assessment): within 7 days after Vaccination 1 for Coadministration group and within 7 days after Vaccination 2 for Separate Administration group, SAEs: from Day 1 up to 6 months after last vaccination(i.e., up to 7 months) and other AEs: up to 1 month after each 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.
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 | (SIIV+20vPnC)/Saline: Coadministration | On Day 1, participants received a single dose of seasonal inactivated influenza vaccine (SIIV) intramuscularly into the right deltoid along with 0.5 milliliter (mL) 20-valent pneumococcal conjugate vaccine (20vPnC) intramuscularly into the left deltoid (Vaccination 1). After one month, participants received 0.5 mL of saline intramuscularly into the left deltoid (Vaccination 2). Participants were followed up for 6 months after Vaccination 2. | 2 | 895 | 33 | 895 | 629 | 895 |
| EG001 | (SIIV+Saline)/20vPnC: Separate Administration | On Day 1, participants received a single dose of SIIV intramuscularly into the right deltoid and 0.5 mL of saline intramuscularly into the left deltoid (Vaccination 1). After one month, participants received 0.5 mL of 20vPnC intramuscularly into the left deltoid. (Vaccination 2). Participants were followed up for 6 months after Vaccination 2. | 3 | 896 | 33 | 896 | 644 | 896 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Anaemia | Blood and lymphatic system disorders | MedDRA v24.0 | Non-systematic Assessment |
| |
| Acute left ventricular failure | Cardiac disorders | MedDRA v24.0 | Non-systematic Assessment |
| |
| Acute myocardial infarction | Cardiac disorders | MedDRA v24.0 | Non-systematic Assessment |
| |
| Atrial fibrillation | Cardiac disorders | MedDRA v24.0 | Non-systematic Assessment |
| |
| Atrioventricular block complete | Cardiac disorders | MedDRA v24.0 | Non-systematic Assessment |
| |
| Cardiac failure | Cardiac disorders | MedDRA v24.0 | Non-systematic Assessment |
| |
| Cardiac failure congestive | Cardiac disorders | MedDRA v24.0 | Non-systematic Assessment |
| |
| Cardiogenic shock | Cardiac disorders | MedDRA v24.0 | Non-systematic Assessment |
| |
| Coronary artery disease | Cardiac disorders | MedDRA v24.0 | Non-systematic Assessment |
| |
| Left ventricular failure | Cardiac disorders | MedDRA v24.0 | Non-systematic Assessment |
| |
| Myocardial infarction | Cardiac disorders | MedDRA v24.0 | Non-systematic Assessment |
| |
| Retinal detachment | Eye disorders | MedDRA v24.0 | Non-systematic Assessment |
| |
| Gastrointestinal haemorrhage | Gastrointestinal disorders | MedDRA v24.0 | Non-systematic Assessment |
| |
| Intestinal obstruction | Gastrointestinal disorders | MedDRA v24.0 | Non-systematic Assessment |
| |
| Pancreatitis | Gastrointestinal disorders | MedDRA v24.0 | Non-systematic Assessment |
| |
| Pancreatitis chronic | Gastrointestinal disorders | MedDRA v24.0 | Non-systematic Assessment |
| |
| Small intestinal obstruction | Gastrointestinal disorders | MedDRA v24.0 | Non-systematic Assessment |
| |
| Upper gastrointestinal haemorrhage | Gastrointestinal disorders | MedDRA v24.0 | Non-systematic Assessment |
| |
| Chest pain | General disorders | MedDRA v24.0 | Non-systematic Assessment |
| |
| Vascular stent stenosis | General disorders | MedDRA v24.0 | Non-systematic Assessment |
| |
| Cholecystitis acute | Hepatobiliary disorders | MedDRA v24.0 | Non-systematic Assessment |
| |
| Cholelithiasis | Hepatobiliary disorders | MedDRA v24.0 | Non-systematic Assessment |
| |
| Cholestasis | Hepatobiliary disorders | MedDRA v24.0 | Non-systematic Assessment |
| |
| COVID-19 | Infections and infestations | MedDRA v24.0 | Non-systematic Assessment |
| |
| COVID-19 pneumonia | Infections and infestations | MedDRA v24.0 | Non-systematic Assessment |
| |
| Cellulitis | Infections and infestations | MedDRA v24.0 | Non-systematic Assessment |
| |
| Liver abscess | Infections and infestations | MedDRA v24.0 | Non-systematic Assessment |
| |
| Osteomyelitis | Infections and infestations | MedDRA v24.0 | Non-systematic Assessment |
| |
| Sepsis | Infections and infestations | MedDRA v24.0 | Non-systematic Assessment |
| |
| Femur fracture | Injury, poisoning and procedural complications | MedDRA v24.0 | Non-systematic Assessment |
| |
| Hip fracture | Injury, poisoning and procedural complications | MedDRA v24.0 | Non-systematic Assessment |
| |
| Humerus fracture | Injury, poisoning and procedural complications | MedDRA v24.0 | Non-systematic Assessment |
| |
| Pelvic fracture | Injury, poisoning and procedural complications | MedDRA v24.0 | Non-systematic Assessment |
| |
| Procedural pain | Injury, poisoning and procedural complications | MedDRA v24.0 | Non-systematic Assessment |
| |
| Subdural haematoma | Injury, poisoning and procedural complications | MedDRA v24.0 | Non-systematic Assessment |
| |
| Hypoglycaemia | Metabolism and nutrition disorders | MedDRA v24.0 | Non-systematic Assessment |
| |
| Haematoma muscle | Musculoskeletal and connective tissue disorders | MedDRA v24.0 | Non-systematic Assessment |
| |
| Osteoarthritis | Musculoskeletal and connective tissue disorders | MedDRA v24.0 | Non-systematic Assessment |
| |
| Colon cancer stage IV | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA v24.0 | Non-systematic Assessment |
| |
| Endometrial adenocarcinoma | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA v24.0 | Non-systematic Assessment |
| |
| Lung adenocarcinoma | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA v24.0 | Non-systematic Assessment |
| |
| Lung neoplasm malignant | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA v24.0 | Non-systematic Assessment |
| |
| Malignant melanoma in situ | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA v24.0 | Non-systematic Assessment |
| |
| Prostate cancer | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA v24.0 | Non-systematic Assessment |
| |
| Prostate cancer metastatic | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA v24.0 | Non-systematic Assessment |
| |
| Renal cancer | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA v24.0 | Non-systematic Assessment |
| |
| Carotid artery stenosis | Nervous system disorders | MedDRA v24.0 | Non-systematic Assessment |
| |
| Syncope | Nervous system disorders | MedDRA v24.0 | Non-systematic Assessment |
| |
| Acute kidney injury | Renal and urinary disorders | MedDRA v24.0 | Non-systematic Assessment |
| |
| Nephrolithiasis | Renal and urinary disorders | MedDRA v24.0 | Non-systematic Assessment |
| |
| Benign prostatic hyperplasia | Reproductive system and breast disorders | MedDRA v24.0 | Non-systematic Assessment |
| |
| Acute respiratory failure | Respiratory, thoracic and mediastinal disorders | MedDRA v24.0 | Non-systematic Assessment |
| |
| Pulmonary embolism | Respiratory, thoracic and mediastinal disorders | MedDRA v24.0 | Non-systematic Assessment |
| |
| Pulmonary hypertension | Respiratory, thoracic and mediastinal disorders | MedDRA v24.0 | Non-systematic Assessment |
| |
| Pulmonary oedema | Respiratory, thoracic and mediastinal disorders | MedDRA v24.0 | Non-systematic Assessment |
| |
| Respiratory failure | Respiratory, thoracic and mediastinal disorders | MedDRA v24.0 | Non-systematic Assessment |
| |
| Aortic stenosis | Vascular disorders | MedDRA v24.0 | Non-systematic Assessment |
| |
| Intermittent claudication | Vascular disorders | MedDRA v24.0 | Non-systematic Assessment |
| |
| Peripheral artery aneurysm | Vascular disorders | MedDRA v24.0 | Non-systematic Assessment |
| |
| Thrombosis | Vascular disorders | MedDRA v24.0 | Non-systematic Assessment |
| |
| Neoplasm | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA v24.0 | Non-systematic Assessment |
|
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Fatigue (FATIGUE) | General disorders | MedDRA v24.0 | Systematic Assessment |
| |
| Injection site erythema (REDNESS) | General disorders | MedDRA v24.0 | Systematic Assessment |
| |
| Injection site pain (PAIN) | General disorders | MedDRA v24.0 | Systematic Assessment |
| |
| Injection site swelling (SWELLING) | General disorders | MedDRA v24.0 | Systematic Assessment |
| |
| Pyrexia (FEVER) | General disorders | MedDRA v24.0 | Systematic Assessment |
| |
| COVID-19 | Infections and infestations | MedDRA v24.0 | Non-systematic Assessment |
| |
| Arthralgia (JOINT PAIN) | Musculoskeletal and connective tissue disorders | MedDRA v24.0 | Systematic Assessment |
| |
| Myalgia (MUSCLE PAIN) | Musculoskeletal and connective tissue disorders | MedDRA v24.0 | Systematic Assessment |
| |
| Headache (HEADACHE) | Nervous system disorders | MedDRA v24.0 | Systematic Assessment |
| |
| Fall | Injury, poisoning and procedural complications | MedDRA v24.0 | Non-systematic Assessment |
| |
| SARS-CoV-2 test positive | Investigations | MedDRA v24.0 | 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 |
| Prot_000.pdf |
| SAP | No | Yes | No | Statistical Analysis Plan | Oct 27, 2020 | Jun 15, 2022 | 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 |
|---|---|
| D012965 | Sodium Chloride |
| D007252 | Influenza Vaccines |
| ID | Term |
|---|---|
| D002712 | Chlorides |
| D006851 | Hydrochloric Acid |
| D017606 | Chlorine Compounds |
| D007287 | Inorganic Chemicals |
| D017670 | Sodium Compounds |
| D014765 | Viral Vaccines |
| D014612 | Vaccines |
| D001688 | Biological Products |
| D045424 | Complex Mixtures |
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: Moderate |
|
| Redness: Severe |
|
| Swelling: Any |
|
| Swelling: Mild |
|
| Swelling: Moderate |
|
| Swelling: Severe |
|
| Pain at the injection site: Any |
|
| Pain at the injection site: Mild |
|
| Pain at the injection site: Moderate |
|
| Pain at the injection site: Severe |
|
| OG002 | Saline Only | Participants in the (SIIV+20vPnC)/Saline: Coadministration group received 0.5 mL of saline intramuscularly into the left deltoid (Vaccination 2), one month after Vaccination 1. |
| OG003 | Separate 20vPnC | Participants in the (SIIV+Saline)/20vPnC group received single dose of 0.5 ml of 20vPnC injected intramuscularly into the left deltoid (Vaccination 2), one month after Vaccination 1. |
|
|
| OG003 | Separate 20vPnC | Participants in the (SIIV+Saline)/20vPnC group received single dose of 0.5 ml of 20vPnC injected intramuscularly into the left deltoid (Vaccination 2), one month after Vaccination 1. |
|
|
|
|
|
|
| (SIIV+Saline)/20vPnC: Separate Administration |
On Day 1, participants received a single dose of SIIV intramuscularly into the right deltoid and 0.5 mL of saline intramuscularly into the left deltoid (Vaccination 1). After one month, participants received 0.5 mL of 20vPnC intramuscularly into the left deltoid. (Vaccination 2). Participants were followed up for 6 months after Vaccination 2. |
|
|
|
On Day 1, participants received a single dose of SIIV intramuscularly into the right deltoid and 0.5 mL of saline intramuscularly into the left deltoid (Vaccination 1). After one month, participants received 0.5 mL of 20vPnC intramuscularly into the left deltoid. (Vaccination 2). Participants were followed up for 6 months after Vaccination 2. |
|
|
|
| OG001 | (SIIV+Saline)/20vPnC: Separate Administration | On Day 1, participants received a single dose of SIIV intramuscularly into the right deltoid and 0.5 mL of saline intramuscularly into the left deltoid (Vaccination 1). After one month, participants received 0.5 mL of 20vPnC intramuscularly into the left deltoid. (Vaccination 2). Participants were followed up for 6 months after Vaccination 2. |
|
|
| OG001 | (SIIV+Saline)/20vPnC: Separate Administration | On Day 1, participants received a single dose of SIIV intramuscularly into the right deltoid and 0.5 mL of saline intramuscularly into the left deltoid (Vaccination 1). After one month, participants received 0.5 mL of 20vPnC intramuscularly into the left deltoid. (Vaccination 2). Participants were followed up for 6 months after Vaccination 2. |
|
|
On Day 1, participants received a single dose of SIIV intramuscularly into the right deltoid and 0.5 mL of saline intramuscularly into the left deltoid (Vaccination 1). After one month, participants received 0.5 mL of 20vPnC intramuscularly into the left deltoid. (Vaccination 2). Participants were followed up for 6 months after Vaccination 2. |
|
|