A Study to Evaluate the Safety, Tolerability, and Immunogenicity of a Modified RNA Vaccine Against Influenza

NCT05052697 | Completed Phase 1 Results FDA Drug

• 1 other identifier: C4781001
• Study Type: interventional
• Target: 1,158
• Locations: 1 country
• Sites: 100

Brief Summary

This study will be divided into two substudies - Substudy A (SSA) and Substudy B (SSB) Substudy A This is a Phase 1 randomized substudy to evaluate the safety and immunogenicity of monovalent influenza modRNA vaccine (mIRV) and bivalent influenza modRNA vaccine (bIRV) at various dose levels, and quadrivalent influenza modRNA vaccine (qIRV), in participants 65 to 85 years of age. Participants will receive at Vaccination 1 either:

• 1 of 4 dose levels of mIRV (either A or B Strain),
• 1 of 4 dose levels of bIRV (containing both A and B strains),
• qIRV (at 1 dose level), or
• A licensed quadrivalent influenza vaccine (QIV). At approximately 8 weeks following Vaccination 1, participants will be unblinded and QIV (Vaccination 2) administered to participants not having previously received this at Vaccination 1. Additionally, participants who previously received QIV at Vaccination 1 will receive one of the following for Vaccination 2:
• mIRV encoding A strain at dose level 4, or
• mIRV encoding B strain at dose level 4. Substudy B This is a randomized substudy to evaluate the safety and immunogenicity of the following vaccination schedules in participants 65 to 85 years of age: 2-Visit Schedules
• 2 doses of qIRV (at a dose level 1), administered 21 days apart.
• 2 doses of licensed QIV, administered 21 days apart (as a control group)
• A dose of licensed QIV following by a dose of bIRV encoding 2 A strains at dose level combination 1 or 2, administered 21 days apart. 1-Visit Schedules
• A dose of licensed QIV administered concurrently in the opposite arm with bIRV encoding 2 A strains at dose level combination 1 or 2.
• A dose of bIRV encoding 2 A strains administered concurrently in the opposite arm with a dose of bIRV encoding 2 B strains.at dose level 1.
• A dose of qIRV encoding 2 A strains and 2 B strains at dose level 2 (at one of two possible dose level combinations).
• A dose of qIRV encoding 2 A strains and 2 B strains at dose level 3.
• 1 dose of licensed QIV (as a control group). Substudy B In participants 18 to 64 years of age:
• A dose of qIRV encoding 2 A strains and 2 B strains at a dose level combination 1 or 2.

Conditions

Influenza, Human

Keywords

Grippe; Flu; Influenza; Vaccine; RNA vaccine

Outcome Measures

Primary Outcomes (35)

• Percentage of Participants Reporting Local Reactions After Vaccination 1: Substudy A

  Local reactions included pain at the injection site, redness and swelling and were recorded by participants in an electronic diary. Redness and swelling were measured and recorded in measuring device units, where 1 measuring device unit=0.5 centimeter (cm). Redness and swelling were graded as mild (Grade 1): greater than (\>) 2.0 cm to 5.0 cm; moderate (Grade 2): \>5.0 cm to 10.0 cm; severe (Grade 3): \>10 cm; potentially life-threatening (Grade 4): necrosis or exfoliative dermatitis (redness) and necrosis (swelling). Pain at injection site was graded as mild (Grade 1): did not interfere with activity; moderate (Grade 2): interfered with activity; severe (Grade 3): prevented daily activity and potentially life-threatening (Grade 4): emergency room visit or hospitalization for severe pain. Grade 4 reactions were classified by the investigator or medically qualified person. Exact 2-sided confidence interval was based on the Clopper and Pearson method.

  From Day 1 to Day 7 after Vaccination 1

• Percentage of Participants Reporting Local Reactions After Vaccination 2: Substudy A

  Local reactions included pain at the injection site, redness and swelling and were recorded by participants in an electronic diary. Redness and swelling were measured and recorded in measuring device units, where 1 measuring device unit=0.5 cm. Redness and swelling were graded as mild (Grade 1): \>2.0 cm to 5.0 cm; moderate (Grade 2): \>5.0 cm to 10.0 cm; severe (Grade 3): \>10 cm; potentially life-threatening (Grade 4): necrosis or exfoliative dermatitis. Pain at injection site was graded as mild (Grade 1): did not interfere with activity; moderate (Grade 2): interfered with activity; severe (Grade 3): prevented daily activity and potentially life-threatening (Grade 4): emergency room visit or hospitalization for severe pain. Grade 4 reactions were classified by the investigator or medically qualified person. Exact 2-sided confidence interval was based on the Clopper and Pearson method.

  From Day 1 to Day 7 after Vaccination 2

• Percentage of Participants Reporting Systemic Events After Vaccination 1: Substudy A

  Systemic events included fever, vomiting, diarrhea, headache,fatigue,chills,new/worsened muscle pain \& new/worsened joint pain \& recorded by participants in an electronic diary.Fever defined as oral temperature greater than equal to(\>=)38.0 degrees Celsius(deg C) \& categorized as\>=38.0 to 38.4 deg C, \>38.4 to 38.9 deg C,\>38.9 to 40.0 deg C \& \>40.0 deg C. Vomiting graded as:Grade(G)1:1-2 times in 24 hours(h);G2:\>2 times in 24h;G3:required Intravenous (IV) hydration.Diarrhea graded as: G1:2-3 loose stools in 24h;G2: 4-5 loose stools in 24h;G3: 6 or more loose stools in 24h.Headache,fatigue,chills, new/worsened muscle pain \& new/worsened joint pain:G1:didn't interfere with activity;G2: some interference with activity;G3:prevented daily routine activity.For all systemic events except fever, Grade 4=emergency room visit or hospitalization. Grade 4 events were classified by the investigator or medically qualified person.Exact 2-sided confidence interval based on Clopper and Pearson method.

  From Day 1 to Day 7 After Vaccination 1

• Percentage of Participants Reporting Systemic Events After Vaccination 2: Substudy A

  Systemic events included fever, vomiting, diarrhea, headache, fatigue, chills, new/worsened muscle pain \& new /worsened joint pain \& recorded by participants in electronic diary. Fever defined as oral temperature \>=38.0 deg C \& categorized as \>=38.0 to 38.4 deg C, \>38.4 to 38.9 deg C, \>38.9 to 40.0 deg C \& \>40.0 deg C. Vomiting graded as: Grade(G) 1: 1-2 times in 24 h; G2: \>2 times in 24 h; G3: required IV hydration. Diarrhea graded as: G1: 2-3 loose stools in 24 h; G2: 4-5 loose stools in 24 h; G3: 6 or more loose stools in 24 h. Headache, fatigue, chills, new/worsened muscle pain \& new/worsened joint pain: G1: didn't interfere with activity; G2: some interference with activity; G3: prevented daily routine activity. For all systemic events except fever, Grade 4= emergency room visit or hospitalization. Grade 4 events were classified by the investigator or medically qualified person. Exact 2-sided confidence interval based on Clopper and Pearson method.

  From Day 1 to Day 7 after Vaccination 2

• Percentage of Participants Reporting Adverse Events After Vaccination 1: Substudy A

  An adverse event (AE) was defined as any untoward medical occurrence in a participant temporally associated with the use of study intervention, whether or not considered related to the study intervention. Exact 2-sided 95% CI was based on the Clopper and Pearson method. Only AEs collected by non-systematic assessment (i.e, excluding local reactions and systematic events) were reported in this outcome measure.

  From Day 1 up to 4 weeks After Vaccination 1

• Percentage of Participants Reporting Adverse Events After Vaccination 2: Substudy A

  An AE was defined as any untoward medical occurrence in a participant temporally associated with the use of study intervention, whether or not considered related to the study intervention. Exact 2-sided 95% CI was based on the Clopper and Pearson method. Only AEs collected by non-systematic assessment (i.e. excluding local reactions and systemic events) were reported in this outcome measure.

  From Day 1 up to 4 weeks After vaccination 2

• Percentage of Participants Reporting Serious Adverse Events (SAE) From First Vaccination to 6 Months After Last Vaccination: Substudy A

  An SAE was defined as any untoward medical occurrence that, at any dose, met one or more of the following criteria - resulted in death, was life-threatening, required inpatient hospitalization or prolongation of existing hospitalization, resulted in persistent or significant disability/incapacity, was a congenital anomaly/birth defect and was a suspected transmission via a Pfizer product of an infectious agent, pathogenic or non-pathogenic and other important medical event.

  From vaccination 1 on day 1 up to 6 months after vaccination 2

• Percentage of Participants With Abnormal Hematology Values at 2 Days After Vaccination 1: Substudy A

  Hematology parameters included erythrocytes, lymphocytes, neutrophils, eosinophils/leukocytes, erythrocyte (ery) mean corpuscular volume, ery. mean corpuscular hemoglobin and ery. mean corpuscular hemoglobin concentration. The primary criteria were as follows erythrocytes, lymphocytes, neutrophils: \<0.8\*lower limit of normal (LLN); Lymphocytes/Leukocytes, Eosinophils/Leukocytes, Monocytes/Leukocytes: \>1.2\*upper limit of normal (ULN); Ery. Mean Corpuscular Volume:\>1.1\*ULN; Ery. Mean Corpuscular Hemoglobin and Ery.Mean Corpuscular hemoglobin Concentration: \< 0.9\*LLN. Also add 95% CI was based on Clopper and Pearson method.

  2 days after vaccination 1

• Percentage of Participants With Abnormal Hematology Values at 1 Week After Vaccination 1: Substudy A

  Hematology parameters included erythrocytes, neutrophils, eosinophils/leukocytes, monocytes/leukocytes, ery mean corpuscular hemoglobin. The primary criteria were as follows erythrocytes and neutrophils: \<0.8\* LLN; Eosinophils/Leukocytes and Monocytes/Leukocytes: \>1.2\* ULN; Ery. Mean Corpuscular Hemoglobin:\>1.1\*ULN. 95% CI was based on Clopper and Pearson method.

  1 week after vaccination 1

• Percentage of Participants With Abnormal Chemistry Values at 2 Days After Vaccination 1: Substudy A

  Chemistry parameters included blood urea nitrogen and C-reactive protein. The primary criteria were as follows Blood Urea Nitrogen: \> 1.3\*ULN; C Reactive Protein: \> 1.1\*ULN. 95% CI was based on Clopper and Pearson method.

  2 days after vaccination 1

• Percentage of Participants With Abnormal Chemistry Values at 1 Week After Vaccination 1: Substudy A

  Chemistry parameters included blood urea nitrogen and C-reactive protein. The primary criteria were as follows Blood Urea Nitrogen: \> 1.3\*ULN; C Reactive Protein: \> 1.1\*ULN. Also add 95% CI was based on Clopper and Pearson method.

  1 week after vaccination 1

• Percentage of Participants With Grade Shifts in Hematology Values at 2 Days After Vaccination 1: Substudy A

  Hematology parameters included hemoglobin, lymphocytes, neutrophils decrease, platelets decrease, white blood cells (WBC) decrease and WBC increase. Laboratory abnormalities were graded by Food and Drug Administration (FDA) toxicity grading scale for healthy adult volunteers enrolled in preventive vaccine clinical trials as grade 1=mild; grade 2=moderate; grade 3=severe and grade 4=potentially life-threatening. Percentage of participants with shift in hematology values were reported in this outcome measure. Categories with at least 1 non-zero data values showing any shift in Grade from baseline to 2 days after vaccination 1 were reported. Participants whose grade category was unchanged (e.g. normal to normal) were not reported.

  From Baseline (prior to vaccination 1) to 2 days after vaccination 1

• Percentage of Participants With Grade Shifts in Hematology Values at 1 Week After Vaccination 1: Substudy A

  Hematology parameters included hemoglobin, lymphocytes, neutrophils decrease, WBC decrease and WBC increase. Laboratory abnormalities were graded by FDA toxicity grading scale for healthy adult volunteers enrolled in preventive vaccine clinical trials as grade 1=mild; grade 2=moderate; grade 3=severe and grade 4=potentially life-threatening. Percentage of participants with shift in hematology values were reported in this outcome measure. Categories with at least 1 non-zero data values showing any shift in Grade from baseline to 1 week after vaccination 1 were reported. Participants whose grade category was unchanged (e.g. normal to normal) were not reported.

  From Baseline (prior to vaccination 1) to 1 week after vaccination 1

• Percentage of Participants With Grade Shifts in Chemistry Laboratory Values at 2 Days After Vaccination 1: Substudy A

  Chemistry abnormalities were graded by toxicity grading scale for healthy adult volunteers enrolled in preventive vaccine clinical trials as grade 1=mild; grade 2=moderate; grade 3=severe and grade 4=potentially life-threatening. Percentage of participants with shift in chemistry values were reported in this outcome measure. Categories with at least 1 non-zero data values showing any shift in Grade from baseline to 2 days after vaccination 1 (post-baseline) were reported. Participants whose grade category was unchanged (e.g. normal to normal) were not reported. The parameters reported were - Alanine Aminotransferase Increased (ALP), Alkaline Phosphatase Increased (ALP), Aspartate Aminotransferase Increased (AST), Creatinine Increased and Urea Nitrogen.

  From Baseline (prior to vaccination 1) to 2 days after vaccination 1

• Percentage of Participants With Grade Shifts in Chemistry Laboratory Values at 1 Week After Vaccination 1: Substudy A

  Chemistry abnormalities were graded by toxicity grading scale for healthy adult volunteers enrolled in preventive vaccine clinical trials as grade 1=mild; grade 2=moderate; grade 3=severe and grade 4=potentially life-threatening. Percentage of participants with shift in chemistry values were reported in this outcome measure. Categories with at least 1 non-zero data values showing any shift in Grade from baseline to 1 week after vaccination 1 (post-baseline) were reported. Participants whose grade category was unchanged (e.g. normal to normal) were not reported. The parameters reported were - Alanine Aminotransferase Increased, Alkaline Phosphatase Increased, Aspartate Aminotransferase Increased, Creatinine Increased and Urea Nitrogen.

  From Baseline (prior to vaccination 1) to 1 week after vaccination 1

• Percentage of Participants With New Electrocardiogram (ECG) Abnormalities at 2 Days After Vaccination 1: Substudy A

  An ECG abnormality was defined as any new abnormality that, as judged by a cardiologist, was consistent with probable or possible myocarditis or pericarditis, including: Sustained atrial or ventricular arrhythmias, Second-degree Mobitz Type II or worse atrioventricular block, new bundle branch block and Diffuse ST-segment elevation or PR-segment inversion, compatible with pericarditis.

  2 days after vaccination 1

• Percentage of Participants With New Electrocardiogram (ECG) Abnormalities at 1 Week After Vaccination 1: Substudy A

  An ECG abnormality was defined as any new abnormality that, as judged by a cardiologist, was consistent with probable or possible myocarditis or pericarditis, including: Sustained atrial or ventricular arrhythmias, Second-degree Mobitz Type II or worse atrioventricular block, new bundle branch block and Diffuse ST-segment elevation or PR-segment inversion, compatible with pericarditis.

  1 week after vaccination 1

• Percentage of Participants Reporting Local Reactions After Vaccination for 1-Visit Schedule (Initial Enrollment): Substudy B

  Local reactions included pain at the injection site, redness and swelling and were recorded by participants in an electronic diary. Redness and swelling were measured and recorded in measuring device units, where 1 measuring device unit=0.5 cm. Redness and swelling were graded as mild (Grade 1): \>2.0 cm to 5.0 cm; moderate (Grade 2): \>5.0 cm to 10.0 cm; severe (Grade 3): \>10 cm; potentially life-threatening (Grade 4): necrosis or exfoliative dermatitis. Pain at injection site was graded as mild (Grade 1): did not interfere with activity; moderate (Grade 2): interfered with activity; severe (Grade 3): prevented daily activity and potentially life-threatening (Grade 4): emergency room visit or hospitalization for severe pain. Exact 2-sided confidence interval was based on the Clopper and Pearson method.

  From Day 1 to Day 7 after vaccination

• Percentage of Participants Reporting Local Reactions After Vaccination 1 for 2- Visit Schedule (Initial Enrollment): Substudy B

  Local reactions included pain at the injection site, redness and swelling and were recorded by participants in an electronic diary. Redness and swelling were measured and recorded in measuring device units, where 1 measuring device unit=0.5 cm. Redness and swelling were graded as mild (Grade 1): \>2.0 cm to 5.0 cm; moderate (Grade 2): \>5.0 cm to 10.0 cm; severe (Grade 3): \>10 cm; potentially life-threatening (Grade 4): necrosis or exfoliative dermatitis. Pain at injection site was graded as mild (Grade 1): did not interfere with activity; moderate (Grade 2): interfered with activity; severe (Grade 3): prevented daily activity and potentially life-threatening (Grade 4): emergency room visit or hospitalization for severe pain. Exact 2-sided confidence interval was based on the Clopper and Pearson method.

  From Day 1 to Day 7 after vaccination 1

• Percentage of Participants Reporting Local Reactions After Vaccination 2 for 2- Visit Schedule (Initial Enrollment): Substudy B

  Local reactions included pain at the injection site, redness and swelling and were recorded by participants in an electronic diary. Redness and swelling were measured and recorded in measuring device units, where 1 measuring device unit=0.5 cm. Redness and swelling were graded as mild (Grade 1): \>2.0 cm to 5.0 cm; moderate (Grade 2): \>5.0 cm to 10.0 cm; severe (Grade 3): \>10 cm; potentially life-threatening (Grade 4): necrosis or exfoliative dermatitis. Pain at injection site was graded as mild (Grade 1): did not interfere with activity; moderate (Grade 2): interfered with activity; severe (Grade 3): prevented daily activity and potentially life-threatening (Grade 4): emergency room visit or hospitalization for severe pain. Exact 2-sided confidence interval was based on the Clopper and Pearson method.

  From Day 1 to Day 7 after vaccination 2

• Percentage of Participants Reporting Local Reactions After Vaccination for Expanded Enrollment: Substudy B

  Local reactions included pain at the injection site, redness and swelling and were recorded by participants in an electronic diary. Redness and swelling were measured and recorded in measuring device units, where 1 measuring device unit=0.5 cm. Redness and swelling were graded as mild (Grade 1): \>2.0 cm to 5.0 cm; moderate (Grade 2): \>5.0 cm to 10.0 cm; severe (Grade 3): \>10 cm; potentially life-threatening (Grade 4): necrosis or exfoliative dermatitis. Pain at injection site was graded as mild (Grade 1): did not interfere with activity; moderate (Grade 2): interfered with activity; severe (Grade 3): prevented daily activity and potentially life-threatening (Grade 4): emergency room visit or hospitalization for severe pain. Exact 2-sided confidence interval was based on the Clopper and Pearson method.

  From Day 1 to Day 7 after vaccination 1 for all arms; From Day 1 to Day 7 after vaccination 2 for 2 doses of qIRV (dose level 1), 2-visit schedule arm

• Percentage of Participants Reporting Systemic Events After Vaccination for 1-Visit Schedule (Initial Enrollment): Substudy B

  Systemic events included fever, vomiting, diarrhea, headache, fatigue, chills, new/worsened muscle pain \& new /worsened joint pain \& recorded by participants in electronic diary. Fever defined as oral temperature \>=38.0 deg C \& categorized as \>=38.0 to 38.4 deg C, \>38.4 to 38.9 deg C, \>38.9 to 40.0 deg C \& \>40.0 deg C. Vomiting graded as: G 1: 1-2 times in 24 hrs; G 2: \>2 times in 24 hrs; G 3: required IV hydration; G 4: emergency room visit/ hospitalization for hypotensive shock. Diarrhea graded as: G 1: 2-3 loose stools in 24 hrs; G 2: 4-5 loose stools in 24 hrs; G 3: 6 or more loose stools in 24 hrs \& G 4: emergency room visit/ hospitalization. Headache, fatigue, chills, new/worsened muscle pain \& new/worsened joint pain: G 1: didn't interfere with activity; G 2: some interference with activity; G 3: prevented daily routine activity \& G 4: emergency room visit/ hospitalization. Exact 2-sided confidence interval based on Clopper and Pearson method.

  From Day 1 to Day 7 after vaccination

• Percentage of Participants Reporting Systemic Events After Vaccination 1 for 2- Visit Schedule (Initial Enrollment): Substudy B

  Systemic events included fever, vomiting, diarrhea, headache, fatigue, chills, new/worsened muscle pain \& new /worsened joint pain \& recorded by participants in electronic diary. Fever defined as oral temperature \>=38.0 deg C \& categorized as \>=38.0 to 38.4 deg C, \>38.4 to 38.9 deg C, \>38.9 to 40.0 deg C \& \>40.0 deg C. Vomiting graded as: G 1: 1-2 times in 24 hrs; G 2: \>2 times in 24 hrs; G 3: required IV hydration; G 4: emergency room visit/ hospitalization for hypotensive shock. Diarrhea graded as: G 1: 2-3 loose stools in 24 hrs; G 2: 4-5 loose stools in 24 hrs; G 3: 6 or more loose stools in 24 hrs \& G 4: emergency room visit/ hospitalization. Headache, fatigue, chills, new/worsened muscle pain \& new/worsened joint pain: G 1: didn't interfere with activity; G 2: some interference with activity; G 3: prevented daily routine activity \& G 4: emergency room visit/ hospitalization. Exact 2-sided confidence interval based on Clopper and Pearson method.

  From Day 1 to Day 7 after vaccination 1

• Percentage of Participants Reporting Systemic Events After Vaccination 2 for 2-Visit Schedule (Initial Enrollment) : Substudy B

  Systemic events included fever, vomiting, diarrhea, headache, fatigue, chills, new/worsened muscle pain \& new /worsened joint pain \& recorded by participants in electronic diary. Fever defined as oral temperature \>=38.0 deg C \& categorized as \>=38.0 to 38.4 deg C, \>38.4 to 38.9 deg C, \>38.9 to 40.0 deg C \& \>40.0 deg C. Vomiting graded as: G 1: 1-2 times in 24 hrs; G 2: \>2 times in 24 hrs; G 3: required IV hydration; G 4: emergency room visit/ hospitalization for hypotensive shock. Diarrhea graded as: G: 1: 2-3 loose stools in 24 hrs; G 2: 4-5 loose stools in 24 hrs; G 3: 6 or more loose stools in 24 hrs \& G 4: emergency room visit/ hospitalization. Headache, fatigue, chills, new/worsened muscle pain \& new/worsened joint pain: G 1: didn't interfere with activity; G 2: some interference with activity; G 3: prevented daily routine activity \& G 4: emergency room visit/ hospitalization. Exact 2-sided confidence interval based on Clopper and Pearson method.

  From day 1 to day 7 of vaccination 2

• Percentage of Participants Reporting Systemic Events After Vaccination for Expanded Enrollment: Substudy B

  Systemic events included fever, vomiting, diarrhea, headache, fatigue, chills, new/worsened muscle pain \& new /worsened joint pain \& recorded by participants in electronic diary. Fever defined as oral temperature \>=38.0 deg C \& categorized as \>=38.0 to 38.4 deg C, \>38.4 to 38.9 deg C, \>38.9 to 40.0 deg C \& \>40.0 deg C. Vomiting graded as: G 1: 1-2 times in 24 hrs; G 2: \>2 times in 24 hrs; G 3: required IV hydration; G 4: emergency room visit/ hospitalization for hypotensive shock. Diarrhea graded as: G 1: 2-3 loose stools in 24 hrs; G 2: 4-5 loose stools in 24 hrs; G 3: 6 or more loose stools in 24 hrs \& G 4: emergency room visit/ hospitalization. Headache, fatigue, chills, new/worsened muscle pain \& new/worsened joint pain: G 1: didn't interfere with activity; G 2: some interference with activity; G 3: prevented daily routine activity \& G 4: emergency room visit/ hospitalization. Exact 2-sided confidence interval based on Clopper and Pearson method.

  From Day 1 to Day 7 after vaccination 1 for all arms; From Day 1 to Day 7 after vaccination 2 for 2 doses of qIRV (dose level 1), 2-visit schedule arm

• Percentage of Participants Reporting Adverse Events From First Vaccination Until 4 Weeks After Last Vaccination: Substudy B

  An AE was defined as any untoward medical occurrence in a participant temporally associated with the use of study intervention, whether or not considered related to the study intervention. Only AEs collected by non-systematic assessment (i.e, excluding local reactions and systematic events) were reported in this outcome measure.

  From first vaccination to 4 weeks after last vaccination (i.e., Vaccination 1 for 1-visit schedule arms and Vaccination 2 for 2-visit schedule arms)

• Percentage of Participants Reporting Serious Adverse Events From First Vaccination Until 6 Months After Last Vaccination: Substudy B

  An SAE was defined as any untoward medical occurrence that, at any dose, met one or more of the following criteria - resulted in death, was life-threatening, required inpatient hospitalization or prolongation of existing hospitalization, resulted in persistent or significant disability/incapacity, was a congenital anomaly/birth defect and was a suspected transmission via a Pfizer product of an infectious agent, pathogenic or non-pathogenic and other important medical event.

  From first vaccination to 6 month after last vaccination (i.e., Vaccination 1 for 1-visit schedule arms and Vaccination 2 for 2-visit schedule arms)

• Percentage of Participants Reporting Abnormal Troponin I Laboratory Values 2 Days After Vaccination 1 for 2-Visit Schedule (Initial Enrollment): Substudy B

  Percentage of participants reporting abnormal troponin I laboratory values 2 days after vaccination 1 were reported in this outcome measure.

  2 days after vaccination 1

• Percentage of Participants Reporting Abnormal Troponin I Laboratory Values 2 Days After Vaccination 2 for 2-Visit Schedule (Initial Enrollment): Substudy B

  Percentage of participants reporting abnormal troponin I laboratory values 2 days after vaccination 2 were reported in this outcome measure.

  2 days after vaccination 2

• Percentage of Participants Reporting Abnormal Troponin I Laboratory Values 2 Days After Vaccination for 1-Visit Schedule (Initial Enrollment): Substudy B

  Percentage of participants reporting abnormal troponin I laboratory values 2 days after vaccination were reported in this outcome measure.

  2 days after vaccination

• Percentage of Participants Reporting Abnormal Troponin I Laboratory Values 2 Days After Vaccination for Expanded Enrollment: Substudy B

  Percentage of participants reporting abnormal troponin I laboratory values 2 days after vaccination were reported in this outcome measure.

  2 days after last vaccination (i.e., Vaccination 1 for 1-visit schedule arms and Vaccination 2 for 2-visit schedule arms)

• Percentage of Participants Reporting New ECG Abnormalities 2 Days After Vaccination 1 for 2-Visit Schedule (Initial Enrollment): Substudy B

  Twelve lead ECGs were performed after the participant had rested quietly for at least 10 minutes in a supine position. An ECG abnormality was defined as any new abnormality that, as judged by a cardiologist, was consistent with probable or possible myocarditis or pericarditis, including: Sustained atrial or ventricular arrhythmias, Second-degree Mobitz Type II or worse atrioventricular block, new bundle branch block and Diffuse ST-segment elevation or PR-segment inversion, compatible with pericarditis.

  2 days after vaccination 1

• Percentage of Participants Reporting New ECG Abnormalities 2 Days After Vaccination 2 for 2-Visit Schedule (Initial Enrollment): Substudy B

  Twelve lead ECGs were performed after the participant had rested quietly for at least 10 minutes in a supine position. An ECG abnormality was defined as any new abnormality that, as judged by a cardiologist, was consistent with probable or possible myocarditis or pericarditis, including: Sustained atrial or ventricular arrhythmias, Second-degree Mobitz Type II or worse atrioventricular block, new bundle branch block and Diffuse ST-segment elevation or PR-segment inversion, compatible with pericarditis.

  2 days after vaccination 2

• Percentage of Participants Reporting New ECG Abnormalities 2 Days After Vaccination 1 for 1-Visit Schedule (Initial Enrollment): Substudy B

  Twelve lead ECGs were performed after the participant had rested quietly for at least 10 minutes in a supine position. An ECG abnormality was defined as any new abnormality that, as judged by a cardiologist, was consistent with probable or possible myocarditis or pericarditis, including: Sustained atrial or ventricular arrhythmias, Second-degree Mobitz Type II or worse atrioventricular block, new bundle branch block and Diffuse ST-segment elevation or PR-segment inversion, compatible with pericarditis.

  2 days after vaccination 1

• Percentage of Participants Reporting New ECG Abnormalities 2 Days After Vaccination for Expanded Enrollment: Substudy B

  Twelve lead ECGs were performed after the participant had rested quietly for at least 10 minutes in a supine position. An ECG abnormality was defined as any new abnormality that, as judged by a cardiologist, was consistent with probable or possible myocarditis or pericarditis, including: Sustained atrial or ventricular arrhythmias, Second-degree Mobitz Type II or worse atrioventricular block, new bundle branch block and Diffuse ST-segment elevation or PR-segment inversion, compatible with pericarditis.

  2 days after last vaccination (i.e., Vaccination 1 for 1-visit schedule arms and Vaccination 2 for 2-visit schedule arms)

Secondary Outcomes (26)

• Geometric Mean Titers (GMTs) of Hemagglutination Inhibition (HAI) Titers at Weeks 1, 4 and 8 After Vaccination 1: Substudy A

  Weeks 1, 4 and 8 after vaccination 1

• Geometric Mean Fold Rise (GMFR) in HAI Titers From Before Vaccination to 1, 4, and 8 Weeks After Vaccination 1: Substudy A

  Before vaccination to 1, 4 and 8 weeks after vaccination 1

• Percentage of Participants Achieving HAI Seroconversion for Each Strain At 1, 4, and 8 Weeks After Vaccination 1: Substudy A

  At 1, 4 and 8 Weeks after vaccination 1

• Percentage of Participants With HAI Titer >=1:40 for Each Strain Before Vaccination 1 and at 1, 4, and 8 Weeks After Vaccination 1: Substudy A

  Before vaccination 1 on day 1 and 1, 4 and 8 weeks after vaccination 1

• Percentage of Participants Who Achieved HAI Seroconversion for All Strains at 1, 4, and 8 Weeks After Vaccination 1: qIRV Versus Licensed QIV, Substudy A

  At 1, 4, and 8 weeks After vaccination 1

Study Arms (28)

SSA: mIRV A (dose level 1) + QIV

EXPERIMENTAL

Biological: mIRV; Biological: QIV

SSA: mIRV A (dose level 2) + QIV

EXPERIMENTAL

Biological: mIRV; Biological: QIV

SSA: mIRV A (dose level 3) + QIV

EXPERIMENTAL

Biological: mIRV; Biological: QIV

SSA: mIRV A (dose level 4) + QIV

EXPERIMENTAL

Biological: mIRV; Biological: QIV

SSA: mIRV B (dose level 1) + QIV

EXPERIMENTAL

Biological: mIRV; Biological: QIV

SSA: mIRV B (dose level 2) + QIV

EXPERIMENTAL

Biological: mIRV; Biological: QIV

SSA: mIRV B (dose level 3) + QIV

EXPERIMENTAL

Biological: mIRV; Biological: QIV

SSA: mIRV B (dose level 4) + QIV

EXPERIMENTAL

Biological: mIRV; Biological: QIV

SSA: bIRV AB (dose level combination 1) + QIV

EXPERIMENTAL

Biological: bIRV AB; Biological: QIV

SSA: bIRV AB (dose level combination 2) + QIV

EXPERIMENTAL

Biological: bIRV AB; Biological: QIV

SSA: bIRV AB (dose level combination 3) + QIV

EXPERIMENTAL

Biological: bIRV AB; Biological: QIV

SSA: bIRV AB (dose level combination 4) + QIV

EXPERIMENTAL

Biological: bIRV AB; Biological: QIV

SSA: QIV + mIRV A strain (dose level 4)

EXPERIMENTAL

Biological: mIRV; Biological: QIV

SSA: qIRV (dose level 1) + QIV

EXPERIMENTAL

Biological: qIRV; Biological: QIV

SSA: QIV + mIRV B strain (dose level 4)

EXPERIMENTAL

Biological: mIRV; Biological: QIV

SSB: 2 doses of qIRV (dose level 1), 2-visit schedule

EXPERIMENTAL

Biological: qIRV

SSB: 2 doses of QIV, 2-visit schedule

EXPERIMENTAL

Biological: QIV

SSB: QIV + bIRV AA (dose level combination 1), 2-visit schedule

EXPERIMENTAL

Biological: QIV; Biological: bIRV AA

SSB: QIV + bIRV AA (dose level combination 2), 2-visit schedule

EXPERIMENTAL

Biological: QIV; Biological: bIRV AA

SSB: QIV + bIRV AA (dose level combination 1), 1-visit schedule

EXPERIMENTAL

Biological: QIV; Biological: bIRV AA

SSB: QIV + bIRV AA (dose level combination 2), 1-visit schedule

EXPERIMENTAL

Biological: QIV; Biological: bIRV AA

SSB: qIRV (dose level 2, dose combination 1), 1-visit schedule

EXPERIMENTAL

NOTE: Arm Description has not been entered.

Biological: qIRV

SSB: qIRV (dose level 2, dose combination 2), 1-visit schedule

EXPERIMENTAL

NOTE: Arm Description has not been entered

Biological: qIRV

SSB: qIRV (dose level 3), 1-visit schedule

EXPERIMENTAL

NOTE: Arm Description has not been entered

Biological: qIRV

SSB: bIRV AA + bIRV BB (both dose level combination 1), 1-visit schedule

EXPERIMENTAL

NOTE: Arm Description has not been entered

Biological: bIRV AA; Biological: bIRV BB

SSB: 1 dose of QIV, 1-visit schedule

EXPERIMENTAL

NOTE: Arm Description has not been entered

Biological: QIV

SSB: qIRV (dose level 1), 1-visit schedule

EXPERIMENTAL

NOTE: Arm Description has not been entered.

Biological: qIRV

SSB: qIRV (dose level 2), 1-visit schedule

EXPERIMENTAL

NOTE: Arm Description has not been entered.

Biological: qIRV

Interventions

mIRV BIOLOGICAL

Intramuscular injection

SSA: QIV + mIRV A strain (dose level 4); SSA: QIV + mIRV B strain (dose level 4); SSA: mIRV A (dose level 1) + QIV; SSA: mIRV A (dose level 2) + QIV; SSA: mIRV A (dose level 3) + QIV; SSA: mIRV A (dose level 4) + QIV; SSA: mIRV B (dose level 1) + QIV; SSA: mIRV B (dose level 2) + QIV; SSA: mIRV B (dose level 3) + QIV; SSA: mIRV B (dose level 4) + QIV

bIRV AB BIOLOGICAL

Intramuscular injection

SSA: bIRV AB (dose level combination 1) + QIV; SSA: bIRV AB (dose level combination 2) + QIV; SSA: bIRV AB (dose level combination 3) + QIV; SSA: bIRV AB (dose level combination 4) + QIV

qIRV BIOLOGICAL

Intramuscular injection

SSA: qIRV (dose level 1) + QIV; SSB: 2 doses of qIRV (dose level 1), 2-visit schedule; SSB: qIRV (dose level 1), 1-visit schedule; SSB: qIRV (dose level 2), 1-visit schedule; SSB: qIRV (dose level 2, dose combination 1), 1-visit schedule; SSB: qIRV (dose level 2, dose combination 2), 1-visit schedule; SSB: qIRV (dose level 3), 1-visit schedule

QIV BIOLOGICAL

Intramuscular injection

SSA: QIV + mIRV A strain (dose level 4); SSA: QIV + mIRV B strain (dose level 4); SSA: bIRV AB (dose level combination 1) + QIV; SSA: bIRV AB (dose level combination 2) + QIV; SSA: bIRV AB (dose level combination 3) + QIV; SSA: bIRV AB (dose level combination 4) + QIV; SSA: mIRV A (dose level 1) + QIV; SSA: mIRV A (dose level 2) + QIV; SSA: mIRV A (dose level 3) + QIV; SSA: mIRV A (dose level 4) + QIV; SSA: mIRV B (dose level 1) + QIV; SSA: mIRV B (dose level 2) + QIV; SSA: mIRV B (dose level 3) + QIV; SSA: mIRV B (dose level 4) + QIV; SSA: qIRV (dose level 1) + QIV; SSB: 1 dose of QIV, 1-visit schedule; SSB: 2 doses of QIV, 2-visit schedule; SSB: QIV + bIRV AA (dose level combination 1), 1-visit schedule; SSB: QIV + bIRV AA (dose level combination 1), 2-visit schedule; SSB: QIV + bIRV AA (dose level combination 2), 1-visit schedule; SSB: QIV + bIRV AA (dose level combination 2), 2-visit schedule

bIRV AA BIOLOGICAL

Intramuscular injection

SSB: QIV + bIRV AA (dose level combination 1), 1-visit schedule; SSB: QIV + bIRV AA (dose level combination 1), 2-visit schedule; SSB: QIV + bIRV AA (dose level combination 2), 1-visit schedule; SSB: QIV + bIRV AA (dose level combination 2), 2-visit schedule; SSB: bIRV AA + bIRV BB (both dose level combination 1), 1-visit schedule

bIRV BB BIOLOGICAL

Intramuscular injection

SSB: bIRV AA + bIRV BB (both dose level combination 1), 1-visit schedule

Eligibility Criteria

• Age: 18 Years - 85 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Male or female participants 65 to 85 years of age.
• Participants who are willing and able to comply with all scheduled visits, treatment plan, laboratory tests, lifestyle considerations, and other study procedures.
• Male participant who is able to father children and willing to use an acceptable method of contraception; or female participant not of childbearing potential; or male participant not able to father children.
• Capable of giving signed informed consent.

You may not qualify if:

• Other medical or psychiatric condition including recent (within the past year) or active suicidal ideation/behavior or laboratory abnormality that may increase the risk of study participation or, in the investigator's judgment, make the participant inappropriate for the study.
• History of severe adverse reaction associated with a vaccine and/or severe allergic reaction (eg, anaphylaxis) to any component of the study intervention.
• Immunocompromised individuals with known or suspected immunodeficiency, as determined by history and/or laboratory/physical examination.
• Bleeding diathesis or condition associated with prolonged bleeding that would, in the opinion of the investigator, contraindicate intramuscular injection.
• Women who are pregnant or breastfeeding.
• Allergy to egg proteins (egg or egg products) or chicken proteins.
• Participant who has had significant exposure to laboratory-confirmed SARS-CoV-2 infection, COVID-19, or influenza in the past 14 days known prior to Visit 1
• Any participant who has a SARS-CoV-2 RT-PCR or antigen test in the past 10 days prior to Visit 1 that has not been confirmed as negative.
• Individuals who receive treatment with radiotherapy or immunosuppressive therapy, including cytotoxic agents or systemic corticosteroids, eg, for cancer or an autoimmune disease, or planned receipt throughout the study.
• Receipt of blood/plasma products, immunoglobulin, or monoclonal antibodies, from 60 days before study intervention administration, or planned receipt throughout the study.
• Vaccination with any influenza vaccine within 6 months (175 days) before study intervention administration.
• Any participant who has received or plans to receive a modRNA-platform SARS-CoV-2 vaccine within 60 days of Visit 1
• Participation in other studies involving study intervention within 28 days prior to study entry and/or during study participation.
• Screening hematology/blood chemistry lab \>=Grade 1 abnormality. Except Bilirubin, other stable Grade1 abnormalities may be considered eligible by Investigator.
• Screening ECG that is consistent with probable or possible myocarditis or pericarditis, or demonstrates clinically relevant abnormalities that may affect participant safety or study results.

Sponsors & Collaborators

• Pfizer: lead

Study Sites (100)

North Alabama Research Center

Athens, Alabama, 35611, United States

Location

The Heart Center

Athens, Alabama, 35611, United States

Location

Arizona Heart Rhythm Center

Phoenix, Arizona, 85016, United States

Location

HOPE Research Institute

Phoenix, Arizona, 85018, United States

Location

The Pain Center of Arizona

Phoenix, Arizona, 85018, United States

Location

Noble Clinical Research

Tucson, Arizona, 85704, United States

Location

Pima Heart and Vascular

Tucson, Arizona, 85704, United States

Location

Inland Valley Cardiovascular Center

Murrieta, California, 92563, United States

Location

Orange County Heart Institute

Orange, California, 92868, United States

Location

Artemis Institute for Clinical Research

Riverside, California, 92503, United States

Location

Orange County Research Center

Tustin, California, 92780, United States

Location

Pediatrics-Infectious Diseases - Clinical Trials Center at University of Colorado Anschutz Medical C

Aurora, Colorado, 80045, United States

Location

UCHealth Heart and Vascular Center - Anschutz Medical Campus

Aurora, Colorado, 80045, United States

Location

Yale University School of Medicine

New Haven, Connecticut, 06510, United States

Location

Yale Cardiology

New Haven, Connecticut, 06519, United States

Location

Yale University School of Medicine

New Haven, Connecticut, 06519, United States

Location

Alliance for Multispecialty Research, LLC

Coral Gables, Florida, 33134, United States

Location

Halifax Health Medical Center

Daytona Beach, Florida, 32114, United States

Location

NYU Langone Cardiology Associates

Delray Beach, Florida, 33484, United States

Location

First Coast Heart & Vascular Center

Fleming Island, Florida, 32003, United States

Location

Fleming Island Center for Clinical Research

Fleming Island, Florida, 32003, United States

Location

Proactive Clinical Research,LLC

Fort Lauderdale, Florida, 33308, United States

Location

Alliance for Multispecialty Research, LLC

Fort Myers, Florida, 33912, United States

Location

Millennium Physician Group

Fort Myers, Florida, 33912, United States

Location

Robert B. Pritt, DO

Fort Myers, Florida, 33912, United States

Location

Direct Helpers Research Center.

Hialeah, Florida, 33012, United States

Location

Best Quality Research,Inc.

Hialeah, Florida, 33016, United States

Location

Elixia Infectious Disease, LLC

Hollywood, Florida, 33024, United States

Location

First Coast Heart & Vascular Center

Jacksonville, Florida, 32216, United States

Location

Clinical Neuroscience Solutions, Inc. dba CNS Healthcare

Jacksonville, Florida, 32256, United States

Location

First Coast Cardiovascular Institute

Jacksonville, Florida, 32256, United States

Location

Premier Cardiology and Vascular Associates

Maitland, Florida, 32751, United States

Location

LMG Research

Miami, Florida, 33125, United States

Location

Millennium Clinical Research

Miami, Florida, 33125, United States

Location

Optimus U Corporation

Miami, Florida, 33125, United States

Location

Suncoast Research Group

Miami, Florida, 33135, United States

Location

Schiff Center for Liver Diseases/University of Miami

Miami, Florida, 33136, United States

Location

University of Miami Hospital

Miami, Florida, 33136, United States

Location

Dr Gerardo A. Polanco, MD

Miami, Florida, 33156, United States

Location

Research Institute of South Florida

Miami, Florida, 33173, United States

Location

Entrust Clinical Research

Miami, Florida, 33176, United States

Location

Jackson Medical Group Cardiac Care

Miami, Florida, 33176, United States

Location

Miami Dade Medical Research Institute, LLC

Miami, Florida, 33176, United States

Location

Clinical Neuroscience Solutions, Inc.

Orlando, Florida, 32801, United States

Location

Central Florida Cardiology Group

Orlando, Florida, 32803, United States

Location

Innovation Medical Research Center

Palmetto Bay, Florida, 33157, United States

Location

DBC Research USA

Pembroke Pines, Florida, 33029, United States

Location

Progressive Medical Research

Port Orange, Florida, 32127, United States

Location

My Cardiologist

South Miami, Florida, 33143, United States

Location

Precision Clinical Research

Sunrise, Florida, 33351, United States

Location

Genesis Clinical Research, LLC

Tampa, Florida, 33603, United States

Location

Conquest Research

Winter Park, Florida, 32789, United States

Location

Centricity Research Columbus Georgia Multispecialty

Columbus, Georgia, 31904, United States

Location

IACT Health

Columbus, Georgia, 31904, United States

Location

IACT Health

Rincon, Georgia, 31326, United States

Location

East-West Medical Research Institute

Honolulu, Hawaii, 96814, United States

Location

University of Iowa

Iowa City, Iowa, 52242, United States

Location

Alliance for Multispecialty Research, LLC

Wichita, Kansas, 67205, United States

Location

Alliance for Multispecialty Research, LLC

Wichita, Kansas, 67207, United States

Location

Heartland Cardiology, LLC

Wichita, Kansas, 67226, United States

Location

Centennial Medical Group

Elkridge, Maryland, 21075, United States

Location

Associates of Cardiology

Silver Spring, Maryland, 20910, United States

Location

Henry Ford Hospital

Detroit, Michigan, 48202, United States

Location

Pioneer Heart Institute

Lincoln, Nebraska, 68506, United States

Location

Velocity Clinical Research, Norfolk

Norfolk, Nebraska, 68701, United States

Location

Meridian Clinical Research - 3345 North 107th Street

Omaha, Nebraska, 68134, United States

Location

Velocity Clinical Research, Omaha

Omaha, Nebraska, 68134, United States

Location

Sanjay Vohra, MD, F.A.C.C.

Henderson, Nevada, 89074, United States

Location

Wr-Crcn, Llc.

Las Vegas, Nevada, 89106, United States

Location

Excel Clinical Research, LLC

Las Vegas, Nevada, 89109, United States

Location

Las Vegas Clinical Trials

North Las Vegas, Nevada, 89030, United States

Location

Hassman Research Institute

Berlin, New Jersey, 08009, United States

Location

Penn Medicine

Somers Point, New Jersey, 08244, United States

Location

South Jersey Infectious Disease

Somers Point, New Jersey, 08244, United States

Location

NYU Langone - Center for the Prevention of Cardiovascular Disease

New York, New York, 10016, United States

Location

NYU Langone Health

New York, New York, 10016, United States

Location

Rochester General Hospital Infectious Disease

Rochester, New York, 14621, United States

Location

Rochester General Hospital

Rochester, New York, 14621, United States

Location

University of Rochester Medical Center

Rochester, New York, 14642, United States

Location

Upstate Health Care Center-University Cardiovascular Group of Syracuse

Syracuse, New York, 13202, United States

Location

SUNY Upstate Medical University Global Health Research Unit

Syracuse, New York, 13215, United States

Location

M3-Emerging Medical Research, LLC

Durham, North Carolina, 27704, United States

Location

Carolina Institute for Clinical Research

Fayetteville, North Carolina, 28303, United States

Location

Monroe Biomedical Research

Monroe, North Carolina, 28112, United States

Location

University Hospitals Cleveland Medical Center

Cleveland, Ohio, 44106, United States

Location

Aventiv Research Inc.

Columbus, Ohio, 43213, United States

Location

Centricity Research Columbus Ohio Multispecialty

Columbus, Ohio, 43213, United States

Location

Columbus Cardiovascular Associates, Inc

Columbus, Ohio, 43213, United States

Location

Pennsylvania Heart and Vascular Group

Jenkintown, Pennsylvania, 19046, United States

Location

Main Street Physician's Care

Little River, South Carolina, 29566, United States

Location

Prolato Clinical Research Center

Houston, Texas, 77054, United States

Location

DM Clinical Research

Houston, Texas, 77065, United States

Location

DM Clinical Research

Humble, Texas, 77338, United States

Location

Cedar Health Research

Irving, Texas, 75062, United States

Location

Harmony Heart Group

Plano, Texas, 75093, United States

Location

Mt Olympus Medical Research

Sugar Land, Texas, 77479, United States

Location

DM Clinical Research

Tomball, Texas, 77375, United States

Location

Northwest Heart Center

Tomball, Texas, 77375, United States

Location

Centricity Research Suffolk Primary Care

Suffolk, Virginia, 23435, United States

Location

Sentara BelleHarbour

Suffolk, Virginia, 23435, United States

Location

Related Publications (1)

• Branche A, Mulligan MJ, Maniar A, Puente O, Oladipupo I, Crowther G, Zareba AM, Yi Z, Scully I, Gomme E, Koury K, Kitchin N, Allen PS, Anderson AS, Gurtman A, Lindert K. A Phase 1/2 Randomized Study to Evaluate the Safety, Tolerability, and Immunogenicity of Nucleoside-Modified Messenger RNA Influenza Vaccines in Healthy Adults. Vaccines (Basel). 2025 Apr 3;13(4):383. doi: 10.3390/vaccines13040383.

  PMID: 40333267 DERIVED

Related Links

• To obtain contact information for a study center near you, click here.

MeSH Terms

Conditions

Influenza, Human

Condition Hierarchy (Ancestors)

Respiratory Tract Infections; Infections; Orthomyxoviridae Infections; RNA Virus Infections; Virus Diseases; Respiratory Tract Diseases

Results Point of Contact

• Title: Pfizer ClinicalTrials.gov Call Center
• Organization: Pfizer Inc.

ClinicalTrials.gov_Inquiries@pfizer.com

1-800-718-1021

Study Officials

• Pfizer CT.gov Call Center

  Pfizer

  STUDY DIRECTOR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: OTHER
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Masking Details: SSA: observer-blinded, sponsor unblind SSB: single-blind, sponsor unblind
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 28, 2021
• First Posted: September 22, 2021
• Study Start: September 13, 2021
• Primary Completion: January 27, 2023
• Study Completion: January 27, 2023
• Last Updated: March 12, 2024
• Results First Posted: March 12, 2024

Record last verified: 2024-03

Data Sharing

• IPD Sharing: Will share

Locations

US (100)