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Trial details imported from ClinicalTrials.gov
For full trial details, please see the original record at
https://clinicaltrials.gov/study/NCT05310084
Registration number
NCT05310084
Ethics application status
Date submitted
25/03/2022
Date registered
4/04/2022
Titles & IDs
Public title
Safety and Immunogenicity of BNT162b2 Coadministered With SIIV in Adults 18 Through 64 Years of Age
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Scientific title
A PHASE 3, RANDOMIZED, OBSERVER-BLIND TRIAL TO EVALUATE THE SAFETY AND IMMUNOGENICITY OF BNT162b2 WHEN COADMINISTERED WITH SEASONAL INACTIVATED INFLUENZA VACCINE (SIIV) IN ADULTS 18 THROUGH 64 YEARS OF AGE
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Secondary ID [1]
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C4591030
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Universal Trial Number (UTN)
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Trial acronym
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Linked study record
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Health condition
Health condition(s) or problem(s) studied:
SARS-CoV-2 Infection
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0
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COVID-19
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Condition category
Condition code
Infection
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Other infectious diseases
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Respiratory
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0
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Other respiratory disorders / diseases
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Intervention/exposure
Study type
Interventional
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Description of intervention(s) / exposure
Treatment: Other - BNT162b2
Other interventions - Placebo
Treatment: Other - Seasonal Inactivated Influenza Vaccine
Experimental: Coadministration Group - BNT162b2 and SIIV followed by placebo a month later
Experimental: Separate Administration Group - Placebo and SIIV followed by BNT162b2 a month later
Treatment: Other: BNT162b2
Intramuscular injection
Other interventions: Placebo
Saline intramuscular injection
Treatment: Other: Seasonal Inactivated Influenza Vaccine
SIIV intramuscular injection
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Intervention code [1]
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Treatment: Other
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Intervention code [2]
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Other interventions
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Comparator / control treatment
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Control group
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Outcomes
Primary outcome [1]
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Percentage of Participants With Local Reactions Within 7 Days After Vaccination 1
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Assessment method [1]
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Local reactions included redness, swelling, and pain at the injection site occurring at the BNT162b2 or placebo injection site. Local reactions were recorded by participants in an electronic diary (e-diary). Redness and swelling were measured and recorded in measuring device units. 1 measuring device unit =0.5 centimeter (cm) and graded as mild: greater than (\>) 2.0 to 5.0 cm, moderate: \>5.0 to 10.0 cm, severe: \>10.0 cm, and potentially life threatening (Grade 4): necrosis or exfoliative dermatitis. Pain at injection site was graded as mild: did not interfere with daily activity, moderate: interfered with daily activity, severe: prevented daily activity, and potentially life threatening (Grade 4): emergency room visit or hospitalization for severe pain. Exact 2-sided confidence interval (CI), based on the Clopper and Pearson method was used.
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Timepoint [1]
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Within 7 Days After Vaccination 1
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Primary outcome [2]
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Percentage of Participants With Local Reactions Within 7 Days After Vaccination 2
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Assessment method [2]
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Local reactions included redness, swelling, and pain at the injection site occurring at the BNT162b2 or placebo injection site. Local reactions were recorded by participants in an e-diary. Redness and swelling were measured and recorded in measuring device units. 1 measuring device unit =0.5 cm and graded as mild: greater than \>2.0 to 5.0 cm, moderate: \>5.0 to 10.0 cm, severe: \>10.0 cm, and potentially life threatening (Grade 4): necrosis or exfoliative dermatitis. Pain at injection site was graded as mild: did not interfere with daily activity, moderate: interfered with daily activity, severe: prevented daily activity, and potentially life threatening (Grade 4): emergency room visit or hospitalization for severe pain. Exact 2-sided CI, based on the Clopper and Pearson method was used.
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Timepoint [2]
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Within 7 Days After Vaccination 2
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Primary outcome [3]
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Percentage of Participants With Systemic Events Within 7 Days After Vaccination 1
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Assessment method [3]
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Systemic events included fever, fatigue, headache, chills, vomiting, diarrhea, new or worsened muscle pain, and new or worsened joint pain recorded by participants in an e-diary. Fever was defined as temperature: \>=38.0 degrees (deg) Celsius (C), and categorized as: \>=38.0 to 38.4 deg C, \>38.4 to 38.9 deg C, \>38.9 to 40.0 deg C, and \>40.0 deg C. Fatigue, headache, chills, new or worsened muscle pain, and new or worsened joint pain were graded as mild: did not interfere with activity, moderate: some interference with activity, and severe: prevented daily routine activity. Vomiting graded as mild: 1 to 2 times in 24 hours(h), moderate: \>2 times in 24h, severe: required intravenous hydration, and grade 4: emergency room (ER) visit or hospitalization for hypotensive shock. Diarrhea graded as mild: 2 to 3 loose stools in 24h, moderate: 4 to 5 loose stools in 24h, severe: 6 or more loose stools in 24h, and grade 4: ER visit or hospitalization for severe diarrhea.
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Timepoint [3]
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Within 7 Days After Vaccination 1
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Primary outcome [4]
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Percentage of Participants With Systemic Events Within 7 Days After Vaccination 2
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Assessment method [4]
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Systemic events included fever, fatigue, headache, chills, vomiting, diarrhea, new or worsened muscle pain, and new or worsened joint pain recorded by participants in an e-diary. Fever was defined as temperature: \>=38.0 deg C, and categorized as: \>=38.0 to 38.4 deg C, \>38.4 to 38.9 deg C, \>38.9 to 40.0 deg C, and \>40.0 deg C. Fatigue, headache, chills, new or worsened muscle pain, and new or worsened joint pain were graded as mild: did not interfere with activity, moderate: some interference with activity, and severe: prevented daily routine activity. Vomiting graded as mild: 1 to 2 times in 24h, moderate: \>2 times in 24h, severe: required intravenous hydration, and grade 4: ER visit or hospitalization for hypotensive shock. Diarrhea graded as mild: 2 to 3 loose stools in 24h, moderate: 4 to 5 loose stools in 24h, severe: 6 or more loose stools in 24h, and grade 4: ER visit or hospitalization for severe diarrhea. Exact 2-sided CI, based on Clopper and Pearson method used.
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Timepoint [4]
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Within 7 Days After Vaccination 2
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Primary outcome [5]
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Percentage of Participants With Adverse Events Within 1 Month After Vaccination 1
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Assessment method [5]
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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. Exact 2-sided CI was calculated using 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.
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Timepoint [5]
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Within 1 month after Vaccination 1
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Primary outcome [6]
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Percentage of Participants With Adverse Events Within 1 Month After Vaccination 2
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Assessment method [6]
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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. Exact 2-sided CI was calculated using 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.
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Timepoint [6]
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Within 1 month after Vaccination 2
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Primary outcome [7]
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Percentage of Participants With Serious Adverse Events Within 1 Month After Vaccination 1
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Assessment method [7]
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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. Exact 2-sided CI was calculated using the Clopper and Pearson method. SAE was an AE resulting in any of the following outcomes or deemed significant for any other reason: death; initial/prolonged inpatient hospitalization; life-threatening experience (immediate risk of dying); persistent or significant disability/incapacity; congenital anomaly; or that was considered to be an important medical event.
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Timepoint [7]
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Within 1 Month After Vaccination 1
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Primary outcome [8]
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Percentage of Participants With Serious Adverse Events Within 1 Month After Vaccination 2
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Assessment method [8]
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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. Exact 2-sided CI was calculated using the Clopper and Pearson method. SAE was an AE resulting in any of the following outcomes or deemed significant for any other reason: death; initial/prolonged inpatient hospitalization; life-threatening experience (immediate risk of dying); persistent or significant disability/incapacity; congenital anomaly; or that was considered to be an important medical event.
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Timepoint [8]
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Within 1 Month After Vaccination 2
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Primary outcome [9]
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Geometric Mean Ratio (GMR) Based on Geometric Mean Concentration (GMC) of Full-Length S-binding Immunoglobulin G (IgG) at 1 Month After BNT162b2 Vaccination
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Assessment method [9]
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GMCs of full-length S-binding IgG level for the coadministration group and separate administration group were reported in this outcome measure in descriptive data section. GMC and the 2-sided 95% CI were calculated by exponentiating the LSMeans of the concentrations and the corresponding CIs based on analysis of logarithmically transformed assay results using a linear regression model with terms of vaccine group, age group, and the corresponding baseline assay results (log scale). Assay results below the LLOQ were set to 0.5\*LLOQ. Geometric mean ratio (GMR) was reported in the statistical analysis section and was calculated as ratio of GMCs in the coadministration group to the separate administration group. Here, "Number of participants analyzed" signifies number of participants evaluable for this outcome measure.
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Timepoint [9]
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1 Month After BNT162b2 vaccination
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Primary outcome [10]
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Geometric Mean Ratio (GMR) Based on Geometric Mean Titer (GMT) of Strain-Specific Hemagglutination Inhibition (HAI) at 1 Month After SIIV Vaccination
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Assessment method [10]
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GMTs of strain-specific HAI titers for the coadministration group and separate administration group were reported in this outcome measure in descriptive data section. GMTs and the 2-sided 95% CIs were calculated by exponentiating the LSMeans of the titers and the corresponding CIs based on analysis of logarithmically transformed assay results using a linear regression model with terms of vaccine group, age group, and the corresponding baseline assay results (log scale). Assay results below the LLOQ were set to 0.5\*LLOQ, and results above the ULOQ were set to ULOQ+1. Geometric mean ratio (GMR) was reported in the statistical analysis section and was calculated as ratio of GMT in the coadministration group to the separate administration group.
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Timepoint [10]
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1 Month After SIIV vaccination
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Secondary outcome [1]
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Geometric Mean Concentration (GMC) of Full-Length S-binding IgG Levels Before Vaccination and 1 Month After BNT162b2 Vaccination
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Assessment method [1]
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GMCs were calculated by exponentiating the mean logarithm of the concentrations and the corresponding CIs (based on the Student's t-distribution). Assay results below the lower limit of quantitation (LLOQ) were set to 0.5\*LLOQ. Here, "Number of participants analyzed" signifies number of participants evaluable for this outcome measure''.
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Timepoint [1]
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Before BNT162b2 vaccination, and 1 month After BNT162b2 vaccination
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Secondary outcome [2]
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Geometric Mean Fold Rise (GMFR) of Full-Length S-binding IgG Levels From Before Vaccination to 1 Month After BNT162b2 Vaccination
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Assessment method [2]
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GMFR was defined as the geometric mean of the ratios of IgG concentrations at 1 month after BNT162b2 vaccination to that before BNT162b2 vaccination. GMFRs were calculated by exponentiating the mean logarithm of fold rises and the corresponding CIs (based on the Student's t-distribution). Assay results below the LLOQ were set to 0.5\*LLOQ. Here, "Number of participants analyzed" signifies number of participants evaluable for this outcome measure''.
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Timepoint [2]
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From before BNT162b2 vaccination to 1 month After BNT162b2 vaccination
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Secondary outcome [3]
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Geometric Mean Titer (GMT) of SARS-CoV-2 Neutralizing Titers Before Vaccination and 1 Month After BNT162b2 Vaccination
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Assessment method [3]
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GMTs were calculated by exponentiating the mean logarithm of the titers and the corresponding CIs (based on the Student's t-distribution). Assay results below LLOQ were set to 0.5\*LLOQ. Here, "Number of participants analyzed" signifies number of participants evaluable for this outcome measure''. Analysis was performed in a subset of 100 participants from each group.
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Timepoint [3]
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Before BNT162b2 vaccination, and 1 month after BNT162b2 vaccination
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Secondary outcome [4]
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Geometric Mean Fold Rise (GMFR) of SARS-CoV-2 Neutralizing Titers From Before Vaccination to 1 Month After BNT162b2 Vaccination
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Assessment method [4]
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GMFR was defined as the geometric mean of the ratios of SARS-CoV-2 neutralizing titers at 1 month after BNT162b2 vaccination to that before BNT162b2 vaccination. GMFRs were calculated by exponentiating the mean logarithm of fold rises and the corresponding CIs (based on the Student's t-distribution). Assay results below the LLOQ were set to 0.5\*LLOQ. Here, "Number of participants analyzed" signifies number of participants evaluable for this outcome measure''. Analysis was performed in a subset of 100 participants from each group.
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Timepoint [4]
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From before BNT162b2 vaccination to 1 month after BNT162b2 vaccination
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Secondary outcome [5]
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Geometric Mean Titer (GMT) of Strain-Specific HAI Titers Before Vaccination and 1 Month After SIIV Vaccination
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Assessment method [5]
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GMTs were calculated by exponentiating the mean logarithm of the titers and the corresponding CIs (based on the Student's t-distribution). Assay results below the LLOQ were set to 0.5\*LLOQ, and results above the ULOQ were set to ULOQ+1. The analysis was performed on the influenza strains: H1N1 A/Victoria, H3N2 A/Darwin, B/Austria, and B/Phuket.
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Timepoint [5]
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Before SIIV vaccination, and 1 month after SIIV vaccination
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Secondary outcome [6]
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Geometric Mean Fold Rise (GMFR) of Strain-Specific HAI Titers From Before Vaccination to 1 Month After SIIV Vaccination
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Assessment method [6]
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GMFR was defined as ratio of the geometric mean of strain-specific HAI titers at 1 month after SIIV vaccination to the geometric mean of strain-specific HAI titers before SIIV vaccination. GMFRs were calculated by exponentiating the mean logarithm of fold rises and the corresponding CIs (based on the Student's t-distribution). Assay results below the LLOQ were set to 0.5\*LLOQ, and results above the ULOQ were set to ULOQ+1. The analysis was performed on the influenza strains: H1N1 A/Victoria, H3N2 A/Darwin, B/Austria, and B/Phuket.
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Timepoint [6]
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From before vaccination to 1 month after SIIV vaccination
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Eligibility
Key inclusion criteria
1. Participants 18 through 64 years of age, inclusive, at the time of consent.
2. Are willing and able to comply with all scheduled visits, treatment plan, laboratory tests, lifestyle considerations, and other study procedures.
3. Adults determined by clinical assessment, including medical history and clinical judgment, to be eligible for the study, including adults with preexisting stable disease, defined as disease not requiring significant change in therapy in the previous 6 weeks or hospitalization for worsening disease within 12 weeks before receipt of study intervention.
4. Have received 3 prior doses of 30 µg BNT162b2, with the third dose being at least 90 days before Visit 1 (Day 1). Documented confirmation of prior BNT162b2 receipt must be obtained prior to randomization.
5. Capable of giving personal signed informed consent, which includes compliance with the requirements and restrictions listed in the ICD and in this protocol.
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Minimum age
18
Years
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Maximum age
64
Years
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Sex
Both males and females
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Can healthy volunteers participate?
Yes
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Key exclusion criteria
1. 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.
2. Allergy to egg proteins (egg or egg products) or chicken proteins.
3. History of Guillain-Barré syndrome.
4. History of severe adverse reaction associated with a vaccine and/or severe allergic reaction (eg, anaphylaxis) to any component of the study intervention(s).
5. A positive SARS-CoV-2 test result (either by NAAT or rapid antigen test) within 28 days of Visit 1 (Day 1).
6. Immunocompromised individuals with known or suspected immunodeficiency, as determined by history and/or laboratory/physical examination.
7. Bleeding diathesis or condition associated with prolonged bleeding that would, in the opinion of the investigator, contraindicate intramuscular injection.
8. Women who are pregnant or breastfeeding.
9. Vaccination with any influenza vaccine <6 months before study intervention administration, or planned receipt of any licensed or investigational nonstudy influenza vaccine during study participation.
10. Individuals who receive treatment with radiotherapy or immunosuppressive therapy, including cytotoxic agents or systemic corticosteroids (if systemic corticosteroids are administered for =14 days at a dose of =20 mg/day of prednisone or equivalent), eg, for COPD, or planned receipt throughout the study. Inhaled/nebulized, intra-articular, intrabursal, or topical (skin or eyes) corticosteroids are permitted.
11. Receipt of blood/plasma products or immunoglobulin, from 60 days before study intervention administration or planned receipt throughout the study.
12. Receipt of any passive antibody therapy specific to COVID-19 from 90 days before study intervention administration or planned receipt throughout the study.
13. Prior receipt of any COVID-19 vaccine other than BNT162b2 or receipt of more than 3 prior doses of BNT162b2.
14. Participation in other studies involving study intervention within 28 days prior to study entry and/or during study participation.
15. Investigator site staff or Pfizer/BioNTech employees directly involved in the conduct of the study, site staff otherwise supervised by the investigator, and their respective family members.
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Study design
Purpose of the study
Prevention
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Allocation to intervention
Randomised controlled trial
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Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
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Methods used to generate the sequence in which subjects will be randomised (sequence generation)
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Masking / blinding
Blinded (masking used)
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Who is / are masked / blinded?
The people receiving the treatment/s
The people administering the treatment/s
The people assessing the outcomes
The people analysing the results/data
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Intervention assignment
Parallel
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Other design features
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Phase
Phase 3
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Type of endpoint/s
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Statistical methods / analysis
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Recruitment
Recruitment status
Completed
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Data analysis
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Reason for early stopping/withdrawal
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Other reasons
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Date of first participant enrolment
Anticipated
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Actual
20/04/2022
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Date of last participant enrolment
Anticipated
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Actual
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Date of last data collection
Anticipated
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Actual
5/10/2022
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Sample size
Target
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Accrual to date
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Final
1134
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Recruitment in Australia
Recruitment state(s)
NSW,QLD,VIC
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Recruitment hospital [1]
0
0
Northern Beaches Clinical Research - Brookvale
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Recruitment hospital [2]
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Australian Clinical Research Network - Sydney
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Recruitment hospital [3]
0
0
Westmead Hospital - Westmead
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Recruitment hospital [4]
0
0
Paratus Clinical Research Brisbane - Albion
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Recruitment hospital [5]
0
0
AusTrials - Wellers Hill - Wellers Hill
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Recruitment hospital [6]
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Emeritus Research - Camberwell
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Recruitment hospital [7]
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0
Barwon Health - Geelong
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Recruitment postcode(s) [1]
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2100 - Brookvale
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Recruitment postcode(s) [2]
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0
NSW 2035 - Sydney
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Recruitment postcode(s) [3]
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0
2145 - Westmead
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Recruitment postcode(s) [4]
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0
4010 - Albion
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Recruitment postcode(s) [5]
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4121 - Wellers Hill
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Recruitment postcode(s) [6]
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0
3124 - Camberwell
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Recruitment postcode(s) [7]
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0
3220 - Geelong
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Recruitment outside Australia
Country [1]
0
0
New Zealand
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State/province [1]
0
0
Auckland
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Country [2]
0
0
New Zealand
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State/province [2]
0
0
BAY OF Plenty
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Country [3]
0
0
New Zealand
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State/province [3]
0
0
Canterbury
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Country [4]
0
0
New Zealand
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State/province [4]
0
0
Hawke's BAY
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Country [5]
0
0
New Zealand
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State/province [5]
0
0
Manawatu-wanganui
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Country [6]
0
0
New Zealand
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State/province [6]
0
0
Waikato
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Country [7]
0
0
New Zealand
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State/province [7]
0
0
Wellington
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Country [8]
0
0
New Zealand
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State/province [8]
0
0
Nelson
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Funding & Sponsors
Primary sponsor type
Commercial sector/industry
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Name
BioNTech SE
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Address
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Country
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Other collaborator category [1]
0
0
Commercial sector/industry
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Name [1]
0
0
Pfizer
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Address [1]
0
0
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Country [1]
0
0
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Ethics approval
Ethics application status
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Summary
Brief summary
This study will assess the safety and immunogenicity of a fourth dose (booster) of BNT162b2 when coadministered with SIIV compared to separate administration of the vaccines when given 1 month apart (SIIV followed by BNT162b2), in participants who have received 3 prior doses of 30 µg BNT162b2, with the third dose being at least 90 days before Visit 1 (Day 1). * Healthy adults 18 through 64 years of age will be randomized 1:1 to either the co-administration group, or the separate administration group * The duration of the study for each participant will be approximately 2 months * There are 3 scheduled study visits each about 1 month apart * The study will be conducted in New Zealand and Australia.
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Trial website
https://clinicaltrials.gov/study/NCT05310084
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Trial related presentations / publications
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Public notes
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Contacts
Principal investigator
Name
0
0
Pfizer CT.gov Call Center
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Address
0
0
Pfizer
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Country
0
0
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Phone
0
0
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Fax
0
0
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Email
0
0
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Contact person for public queries
Name
0
0
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Address
0
0
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Country
0
0
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Phone
0
0
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Fax
0
0
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Email
0
0
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Contact person for scientific queries
Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
No
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No/undecided IPD sharing reason/comment
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What supporting documents are/will be available?
No Supporting Document Provided
Type
Other Details
Attachment
Study protocol
https://cdn.clinicaltrials.gov/large-docs/84/NCT05310084/Prot_000.pdf
Statistical analysis plan
https://cdn.clinicaltrials.gov/large-docs/84/NCT05310084/SAP_001.pdf
Results publications and other study-related documents
No documents have been uploaded by study researchers.
Results are available at
https://clinicaltrials.gov/study/NCT05310084