COVID-19, SARS-CoV-2 Infection
Conditions
Keywords
COVID-19, Coronavirus, Vaccine, SARS-CoV-2, RNA Vaccine
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.
Interventions
BIOLOGICALSeasonal Inactivated Influenza Vaccine
SIIV intramuscular injection
OTHERPlacebo
Saline intramuscular injection
BIOLOGICALBNT162b2
Intramuscular injection
Sponsors
Pfizer
BioNTech SE
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Masking description
This is an Observer-Blind Study. The vaccines and placebo will be administered by an unblinded third-party site staff member.
Eligibility
Sex/Gender
ALL
Age
18 Years to 64 Years
Healthy volunteers
Yes
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.
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Geometric Mean Ratio (GMR) Based on Geometric Mean Titer (GMT) of Strain-Specific Hemagglutination Inhibition (HAI) at 1 Month After SIIV Vaccination | 1 Month After SIIV vaccination | 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. |
| Percentage of Participants With Systemic Events Within 7 Days After Vaccination 2 | Within 7 Days After Vaccination 2 | 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. |
| Percentage of Participants With Adverse Events Within 1 Month After Vaccination 1 | Within 1 month after Vaccination 1 | 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. |
| Percentage of Participants With Adverse Events Within 1 Month After Vaccination 2 | Within 1 month after Vaccination 2 | 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. |
| Percentage of Participants With Serious Adverse Events Within 1 Month After Vaccination 1 | Within 1 Month After Vaccination 1 | 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. |
| Percentage of Participants With Serious Adverse Events Within 1 Month After Vaccination 2 | Within 1 Month After Vaccination 2 | 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. |
| Geometric Mean Ratio (GMR) Based on Geometric Mean Concentration (GMC) of Full-Length S-binding Immunoglobulin G (IgG) at 1 Month After BNT162b2 Vaccination | 1 Month After BNT162b2 vaccination | 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. |
| Percentage of Participants With Local Reactions Within 7 Days After Vaccination 1 | Within 7 Days After Vaccination 1 | 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. |
| Percentage of Participants With Local Reactions Within 7 Days After Vaccination 2 | Within 7 Days After Vaccination 2 | 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. |
| Percentage of Participants With Systemic Events Within 7 Days After Vaccination 1 | Within 7 Days After Vaccination 1 | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Geometric Mean Fold Rise (GMFR) of Full-Length S-binding IgG Levels From Before Vaccination to 1 Month After BNT162b2 Vaccination | From before BNT162b2 vaccination to 1 month After BNT162b2 vaccination | 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''. |
| Geometric Mean Titer (GMT) of SARS-CoV-2 Neutralizing Titers Before Vaccination and 1 Month After BNT162b2 Vaccination | Before BNT162b2 vaccination, and 1 month after BNT162b2 vaccination | 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. |
| Geometric Mean Fold Rise (GMFR) of SARS-CoV-2 Neutralizing Titers From Before Vaccination to 1 Month After BNT162b2 Vaccination | From before BNT162b2 vaccination to 1 month after BNT162b2 vaccination | 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. |
| Geometric Mean Titer (GMT) of Strain-Specific HAI Titers Before Vaccination and 1 Month After SIIV Vaccination | Before SIIV vaccination, and 1 month after SIIV vaccination | 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. |
| Geometric Mean Fold Rise (GMFR) of Strain-Specific HAI Titers From Before Vaccination to 1 Month After SIIV Vaccination | From before vaccination to 1 month after SIIV vaccination | 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. |
| Geometric Mean Concentration (GMC) of Full-Length S-binding IgG Levels Before Vaccination and 1 Month After BNT162b2 Vaccination | Before BNT162b2 vaccination, and 1 month After BNT162b2 vaccination | 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''. |
Countries
Australia, New Zealand
Participant flow
Recruitment details
A total of 1165 participants were screened, out of which 31 were screen failures and 1134 were randomized into the study.
Participants by arm
| Arm | Count |
|---|---|
| Coadministration Group Participants were randomized to receive 30 mcg IM injection of BNT162b2 vaccine along with IM injection of SIIV on Day 1 (Visit 1), and IM injection of Placebo 1 month later (Visit 2). | 564 |
| Separate Administration Group Participants were randomized to receive an IM injection of Placebo along with IM injection of SIIV on Day 1 (Visit 1), and 30 mcg IM injection of BNT162b2 vaccine 1 month later (Visit 2). | 564 |
| Total | 1,128 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 |
|---|---|---|---|
| Overall Study | Adverse Event | 1 | 1 |
| Overall Study | Lost to Follow-up | 1 | 1 |
| Overall Study | Participant availability | 0 | 4 |
| Overall Study | Randomized but not vaccinated | 4 | 2 |
| Overall Study | Withdrawal by Subject | 2 | 3 |
Baseline characteristics
| Characteristic | Separate Administration Group | Total | Coadministration Group |
|---|---|---|---|
| Age, Continuous | 39.8 Years STANDARD_DEVIATION 13.52 | 39.7 Years STANDARD_DEVIATION 13.35 | 39.7 Years STANDARD_DEVIATION 13.2 |
| Ethnicity (NIH/OMB) Hispanic or Latino | 9 Participants | 14 Participants | 5 Participants |
| Ethnicity (NIH/OMB) Not Hispanic or Latino | 537 Participants | 1076 Participants | 539 Participants |
| Ethnicity (NIH/OMB) Unknown or Not Reported | 18 Participants | 38 Participants | 20 Participants |
| Race (NIH/OMB) American Indian or Alaska Native | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Asian | 66 Participants | 139 Participants | 73 Participants |
| Race (NIH/OMB) Black or African American | 2 Participants | 3 Participants | 1 Participants |
| Race (NIH/OMB) More than one race | 10 Participants | 11 Participants | 1 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 36 Participants | 62 Participants | 26 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 11 Participants | 28 Participants | 17 Participants |
| Race (NIH/OMB) White | 439 Participants | 885 Participants | 446 Participants |
| Sex: Female, Male Female | 361 Participants | 717 Participants | 356 Participants |
| Sex: Female, Male Male | 203 Participants | 411 Participants | 208 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk | EG002 affected / at risk | EG003 affected / at risk |
|---|---|---|---|---|
| deaths Total, all-cause mortality | 0 / 564 | 0 / 562 | 0 / 564 | 0 / 557 |
| other Total, other adverse events | 532 / 564 | 261 / 562 | 364 / 564 | 502 / 557 |
| serious Total, serious adverse events | 2 / 564 | 3 / 562 | 1 / 564 | 4 / 557 |
Outcome results
Primary
Geometric Mean Ratio (GMR) Based on Geometric Mean Concentration (GMC) of Full-Length S-binding Immunoglobulin G (IgG) at 1 Month After BNT162b2 Vaccination
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.
Time frame: 1 Month After BNT162b2 vaccination
Population: Evaluable BNT162b2 immunogenicity population: Eligible participants who received all vaccinations(Vax) at Visit1(V1) (coadministration group) or all Vax at V1 and V2 (separate administration group) as randomized, had at least 1 valid full-length S-binding IgG result from blood sample collected 28 to 42 days after BNT162b2 vax, had no reported COVID-19/new SARS-CoV-2 infection after V1 through 1 month after BNT162b2 vax, and had no other important protocol deviations as determined by clinician.
| Arm | Measure | Value (GEOMETRIC_MEAN) |
|---|---|---|
| Coadministration Group | Geometric Mean Ratio (GMR) Based on Geometric Mean Concentration (GMC) of Full-Length S-binding Immunoglobulin G (IgG) at 1 Month After BNT162b2 Vaccination | 13767.8 Units per millilitre (U/mL) |
| Separate Administration Group | Geometric Mean Ratio (GMR) Based on Geometric Mean Concentration (GMC) of Full-Length S-binding Immunoglobulin G (IgG) at 1 Month After BNT162b2 Vaccination | 16644.5 Units per millilitre (U/mL) |
95% CI: [0.77, 0.89]
Primary
Geometric Mean Ratio (GMR) Based on Geometric Mean Titer (GMT) of Strain-Specific Hemagglutination Inhibition (HAI) at 1 Month After SIIV Vaccination
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.
Time frame: 1 Month After SIIV vaccination
Population: Evaluable SIIV immunogenicity population: participants who received all vaccinations at Visit 1 as randomized, had at least 1 valid and determinate HAI titer result from the blood sample collected 28 to 42 days after SIIV, and had no other important protocol deviations as determined by the clinician. Here, Number of participants analyzed signifies number of participants evaluable and Number Analyzed (n) signifies number of participants evaluable for specified rows for this outcome measure.
| Arm | Measure | Group | Value (GEOMETRIC_MEAN) |
|---|---|---|---|
| Coadministration Group | Geometric Mean Ratio (GMR) Based on Geometric Mean Titer (GMT) of Strain-Specific Hemagglutination Inhibition (HAI) at 1 Month After SIIV Vaccination | B/Austria | 80.1 Titer |
| Coadministration Group | Geometric Mean Ratio (GMR) Based on Geometric Mean Titer (GMT) of Strain-Specific Hemagglutination Inhibition (HAI) at 1 Month After SIIV Vaccination | B/Phuket | 81.3 Titer |
| Coadministration Group | Geometric Mean Ratio (GMR) Based on Geometric Mean Titer (GMT) of Strain-Specific Hemagglutination Inhibition (HAI) at 1 Month After SIIV Vaccination | H1N1 A/Victoria | 301.7 Titer |
| Coadministration Group | Geometric Mean Ratio (GMR) Based on Geometric Mean Titer (GMT) of Strain-Specific Hemagglutination Inhibition (HAI) at 1 Month After SIIV Vaccination | H3N2 A/Darwin | 226.8 Titer |
| Separate Administration Group | Geometric Mean Ratio (GMR) Based on Geometric Mean Titer (GMT) of Strain-Specific Hemagglutination Inhibition (HAI) at 1 Month After SIIV Vaccination | H3N2 A/Darwin | 235.6 Titer |
| Separate Administration Group | Geometric Mean Ratio (GMR) Based on Geometric Mean Titer (GMT) of Strain-Specific Hemagglutination Inhibition (HAI) at 1 Month After SIIV Vaccination | B/Austria | 89.7 Titer |
| Separate Administration Group | Geometric Mean Ratio (GMR) Based on Geometric Mean Titer (GMT) of Strain-Specific Hemagglutination Inhibition (HAI) at 1 Month After SIIV Vaccination | H1N1 A/Victoria | 316.5 Titer |
| Separate Administration Group | Geometric Mean Ratio (GMR) Based on Geometric Mean Titer (GMT) of Strain-Specific Hemagglutination Inhibition (HAI) at 1 Month After SIIV Vaccination | B/Phuket | 81.3 Titer |
Comparison: B/Austria95% CI: [0.77, 1.04]
Comparison: B/Phuket95% CI: [0.89, 1.13]
Comparison: H1N1 A/Victoria95% CI: [0.83, 1.09]
Comparison: H3N2 A/Darwin95% CI: [0.85, 1.09]
Primary
Percentage of Participants With Adverse Events Within 1 Month After Vaccination 1
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.
Time frame: Within 1 month after Vaccination 1
Population: Safety population included all participants who received any of the study intervention.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Coadministration Group | Percentage of Participants With Adverse Events Within 1 Month After Vaccination 1 | 31.6 Percentage of participants |
| Separate Administration Group | Percentage of Participants With Adverse Events Within 1 Month After Vaccination 1 | 30.5 Percentage of participants |
Primary
Percentage of Participants With Adverse Events Within 1 Month After Vaccination 2
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.
Time frame: Within 1 month after Vaccination 2
Population: Safety population included all participants who received any of the study intervention. Here, Number of participants analyzed signifies number of participants evaluable for this outcome measure''.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Coadministration Group | Percentage of Participants With Adverse Events Within 1 Month After Vaccination 2 | 29.0 Percentage of participants |
| Separate Administration Group | Percentage of Participants With Adverse Events Within 1 Month After Vaccination 2 | 25.1 Percentage of participants |
Primary
Percentage of Participants With Local Reactions Within 7 Days After Vaccination 1
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.
Time frame: Within 7 Days After Vaccination 1
Population: Safety population included all participants who received any of the study intervention. Here, ''Number of participants analyzed'' (N) signifies number of participants evaluable and Number Analyzed (n) signifies number of participants evaluable for specified rows for this outcome measure.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Coadministration Group | Percentage of Participants With Local Reactions Within 7 Days After Vaccination 1 | Redness: Grade 4 | 0 Percentage of participants |
| Coadministration Group | Percentage of Participants With Local Reactions Within 7 Days After Vaccination 1 | Swelling: Severe | 0 Percentage of participants |
| Coadministration Group | Percentage of Participants With Local Reactions Within 7 Days After Vaccination 1 | Redness: Mild | 6.2 Percentage of participants |
| Coadministration Group | Percentage of Participants With Local Reactions Within 7 Days After Vaccination 1 | Swelling: Grade 4 | 0 Percentage of participants |
| Coadministration Group | Percentage of Participants With Local Reactions Within 7 Days After Vaccination 1 | Swelling: Any | 9.2 Percentage of participants |
| Coadministration Group | Percentage of Participants With Local Reactions Within 7 Days After Vaccination 1 | Pain at the injection site: Any | 86.2 Percentage of participants |
| Coadministration Group | Percentage of Participants With Local Reactions Within 7 Days After Vaccination 1 | Redness: Severe | 0.2 Percentage of participants |
| Coadministration Group | Percentage of Participants With Local Reactions Within 7 Days After Vaccination 1 | Pain at the injection site: Mild | 66.3 Percentage of participants |
| Coadministration Group | Percentage of Participants With Local Reactions Within 7 Days After Vaccination 1 | Swelling: Mild | 6.2 Percentage of participants |
| Coadministration Group | Percentage of Participants With Local Reactions Within 7 Days After Vaccination 1 | Pain at the injection site: Moderate | 19.9 Percentage of participants |
| Coadministration Group | Percentage of Participants With Local Reactions Within 7 Days After Vaccination 1 | Redness: Moderate | 1.2 Percentage of participants |
| Coadministration Group | Percentage of Participants With Local Reactions Within 7 Days After Vaccination 1 | Pain at the injection site: Severe | 0 Percentage of participants |
| Coadministration Group | Percentage of Participants With Local Reactions Within 7 Days After Vaccination 1 | Swelling: Moderate | 3.0 Percentage of participants |
| Coadministration Group | Percentage of Participants With Local Reactions Within 7 Days After Vaccination 1 | Pain at the injection site: Grade 4 | 0 Percentage of participants |
| Coadministration Group | Percentage of Participants With Local Reactions Within 7 Days After Vaccination 1 | Redness: Any | 7.6 Percentage of participants |
| Separate Administration Group | Percentage of Participants With Local Reactions Within 7 Days After Vaccination 1 | Pain at the injection site: Grade 4 | 0 Percentage of participants |
| Separate Administration Group | Percentage of Participants With Local Reactions Within 7 Days After Vaccination 1 | Redness: Any | 0.5 Percentage of participants |
| Separate Administration Group | Percentage of Participants With Local Reactions Within 7 Days After Vaccination 1 | Redness: Mild | 0.5 Percentage of participants |
| Separate Administration Group | Percentage of Participants With Local Reactions Within 7 Days After Vaccination 1 | Redness: Moderate | 0 Percentage of participants |
| Separate Administration Group | Percentage of Participants With Local Reactions Within 7 Days After Vaccination 1 | Redness: Severe | 0 Percentage of participants |
| Separate Administration Group | Percentage of Participants With Local Reactions Within 7 Days After Vaccination 1 | Redness: Grade 4 | 0 Percentage of participants |
| Separate Administration Group | Percentage of Participants With Local Reactions Within 7 Days After Vaccination 1 | Swelling: Any | 1.1 Percentage of participants |
| Separate Administration Group | Percentage of Participants With Local Reactions Within 7 Days After Vaccination 1 | Swelling: Mild | 0.4 Percentage of participants |
| Separate Administration Group | Percentage of Participants With Local Reactions Within 7 Days After Vaccination 1 | Swelling: Moderate | 0.7 Percentage of participants |
| Separate Administration Group | Percentage of Participants With Local Reactions Within 7 Days After Vaccination 1 | Swelling: Severe | 0 Percentage of participants |
| Separate Administration Group | Percentage of Participants With Local Reactions Within 7 Days After Vaccination 1 | Swelling: Grade 4 | 0 Percentage of participants |
| Separate Administration Group | Percentage of Participants With Local Reactions Within 7 Days After Vaccination 1 | Pain at the injection site: Any | 13.9 Percentage of participants |
| Separate Administration Group | Percentage of Participants With Local Reactions Within 7 Days After Vaccination 1 | Pain at the injection site: Mild | 13.5 Percentage of participants |
| Separate Administration Group | Percentage of Participants With Local Reactions Within 7 Days After Vaccination 1 | Pain at the injection site: Moderate | 0.4 Percentage of participants |
| Separate Administration Group | Percentage of Participants With Local Reactions Within 7 Days After Vaccination 1 | Pain at the injection site: Severe | 0 Percentage of participants |
Primary
Percentage of Participants With Local Reactions Within 7 Days After Vaccination 2
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.
Time frame: Within 7 Days After Vaccination 2
Population: Safety population included all participants who received any of the study intervention. Here, Number of participants analyzed included participants who received Vaccination 2 and signifies number of participants evaluable for this outcome measure.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Coadministration Group | Percentage of Participants With Local Reactions Within 7 Days After Vaccination 2 | Redness: Grade 4 | 0 Percentage of participants |
| Coadministration Group | Percentage of Participants With Local Reactions Within 7 Days After Vaccination 2 | Swelling: Severe | 0 Percentage of participants |
| Coadministration Group | Percentage of Participants With Local Reactions Within 7 Days After Vaccination 2 | Redness: Mild | 0.2 Percentage of participants |
| Coadministration Group | Percentage of Participants With Local Reactions Within 7 Days After Vaccination 2 | Swelling: Grade 4 | 0 Percentage of participants |
| Coadministration Group | Percentage of Participants With Local Reactions Within 7 Days After Vaccination 2 | Swelling: Any | 0.4 Percentage of participants |
| Coadministration Group | Percentage of Participants With Local Reactions Within 7 Days After Vaccination 2 | Pain at the injection site: Any | 6.6 Percentage of participants |
| Coadministration Group | Percentage of Participants With Local Reactions Within 7 Days After Vaccination 2 | Redness: Severe | 0 Percentage of participants |
| Coadministration Group | Percentage of Participants With Local Reactions Within 7 Days After Vaccination 2 | Pain at the injection site: Mild | 6.3 Percentage of participants |
| Coadministration Group | Percentage of Participants With Local Reactions Within 7 Days After Vaccination 2 | Swelling: Mild | 0.4 Percentage of participants |
| Coadministration Group | Percentage of Participants With Local Reactions Within 7 Days After Vaccination 2 | Pain at the injection site: Moderate | 0.4 Percentage of participants |
| Coadministration Group | Percentage of Participants With Local Reactions Within 7 Days After Vaccination 2 | Redness: Moderate | 0 Percentage of participants |
| Coadministration Group | Percentage of Participants With Local Reactions Within 7 Days After Vaccination 2 | Pain at the injection site: Severe | 0 Percentage of participants |
| Coadministration Group | Percentage of Participants With Local Reactions Within 7 Days After Vaccination 2 | Swelling: Moderate | 0 Percentage of participants |
| Coadministration Group | Percentage of Participants With Local Reactions Within 7 Days After Vaccination 2 | Pain at the injection site: Grade 4 | 0 Percentage of participants |
| Coadministration Group | Percentage of Participants With Local Reactions Within 7 Days After Vaccination 2 | Redness: Any | 0.2 Percentage of participants |
| Separate Administration Group | Percentage of Participants With Local Reactions Within 7 Days After Vaccination 2 | Pain at the injection site: Grade 4 | 0 Percentage of participants |
| Separate Administration Group | Percentage of Participants With Local Reactions Within 7 Days After Vaccination 2 | Redness: Any | 4.7 Percentage of participants |
| Separate Administration Group | Percentage of Participants With Local Reactions Within 7 Days After Vaccination 2 | Redness: Mild | 4.3 Percentage of participants |
| Separate Administration Group | Percentage of Participants With Local Reactions Within 7 Days After Vaccination 2 | Redness: Moderate | 0.4 Percentage of participants |
| Separate Administration Group | Percentage of Participants With Local Reactions Within 7 Days After Vaccination 2 | Redness: Severe | 0 Percentage of participants |
| Separate Administration Group | Percentage of Participants With Local Reactions Within 7 Days After Vaccination 2 | Redness: Grade 4 | 0 Percentage of participants |
| Separate Administration Group | Percentage of Participants With Local Reactions Within 7 Days After Vaccination 2 | Swelling: Any | 8.9 Percentage of participants |
| Separate Administration Group | Percentage of Participants With Local Reactions Within 7 Days After Vaccination 2 | Swelling: Mild | 5.8 Percentage of participants |
| Separate Administration Group | Percentage of Participants With Local Reactions Within 7 Days After Vaccination 2 | Swelling: Moderate | 3.1 Percentage of participants |
| Separate Administration Group | Percentage of Participants With Local Reactions Within 7 Days After Vaccination 2 | Swelling: Severe | 0 Percentage of participants |
| Separate Administration Group | Percentage of Participants With Local Reactions Within 7 Days After Vaccination 2 | Swelling: Grade 4 | 0 Percentage of participants |
| Separate Administration Group | Percentage of Participants With Local Reactions Within 7 Days After Vaccination 2 | Pain at the injection site: Any | 84.4 Percentage of participants |
| Separate Administration Group | Percentage of Participants With Local Reactions Within 7 Days After Vaccination 2 | Pain at the injection site: Mild | 61.7 Percentage of participants |
| Separate Administration Group | Percentage of Participants With Local Reactions Within 7 Days After Vaccination 2 | Pain at the injection site: Moderate | 22.4 Percentage of participants |
| Separate Administration Group | Percentage of Participants With Local Reactions Within 7 Days After Vaccination 2 | Pain at the injection site: Severe | 0.4 Percentage of participants |
Primary
Percentage of Participants With Serious Adverse Events Within 1 Month After Vaccination 1
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.
Time frame: Within 1 Month After Vaccination 1
Population: Safety population included all participants who received any of the study intervention.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Coadministration Group | Percentage of Participants With Serious Adverse Events Within 1 Month After Vaccination 1 | 0.4 Percentage of participants |
| Separate Administration Group | Percentage of Participants With Serious Adverse Events Within 1 Month After Vaccination 1 | 0.2 Percentage of participants |
Primary
Percentage of Participants With Serious Adverse Events Within 1 Month After Vaccination 2
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.
Time frame: Within 1 Month After Vaccination 2
Population: Safety population included all participants who received any of the study intervention. Here, Number of participants analyzed signifies number of participants evaluable for this outcome measure''.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Coadministration Group | Percentage of Participants With Serious Adverse Events Within 1 Month After Vaccination 2 | 0.5 Percentage of participants |
| Separate Administration Group | Percentage of Participants With Serious Adverse Events Within 1 Month After Vaccination 2 | 0.7 Percentage of participants |
Primary
Percentage of Participants With Systemic Events Within 7 Days After Vaccination 1
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.
Time frame: Within 7 Days After Vaccination 1
Population: Safety population included all participants who received any of the study intervention. Here, Number of participants analyzed signifies number of participants evaluable and Number Analyzed (n) signifies number of participants evaluable for specified rows for this outcome measure.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Coadministration Group | Percentage of Participants With Systemic Events Within 7 Days After Vaccination 1 | Headache: Severe | 1.1 Percentage of participants |
| Coadministration Group | Percentage of Participants With Systemic Events Within 7 Days After Vaccination 1 | Headache: Grade 4 | 0 Percentage of participants |
| Coadministration Group | Percentage of Participants With Systemic Events Within 7 Days After Vaccination 1 | Chills: Any | 19.9 Percentage of participants |
| Coadministration Group | Percentage of Participants With Systemic Events Within 7 Days After Vaccination 1 | Chills: Mild | 12.9 Percentage of participants |
| Coadministration Group | Percentage of Participants With Systemic Events Within 7 Days After Vaccination 1 | Chills: Moderate | 6.0 Percentage of participants |
| Coadministration Group | Percentage of Participants With Systemic Events Within 7 Days After Vaccination 1 | Chills: Grade 4 | 0 Percentage of participants |
| Coadministration Group | Percentage of Participants With Systemic Events Within 7 Days After Vaccination 1 | Vomiting: Any | 2.7 Percentage of participants |
| Coadministration Group | Percentage of Participants With Systemic Events Within 7 Days After Vaccination 1 | Vomiting: Mild | 2.3 Percentage of participants |
| Coadministration Group | Percentage of Participants With Systemic Events Within 7 Days After Vaccination 1 | Vomiting: Moderate | 0.4 Percentage of participants |
| Coadministration Group | Percentage of Participants With Systemic Events Within 7 Days After Vaccination 1 | Diarrhea: Moderate | 1.4 Percentage of participants |
| Coadministration Group | Percentage of Participants With Systemic Events Within 7 Days After Vaccination 1 | New or worsened joint pain: Mild | 10.3 Percentage of participants |
| Coadministration Group | Percentage of Participants With Systemic Events Within 7 Days After Vaccination 1 | Diarrhea: Severe | 0.2 Percentage of participants |
| Coadministration Group | Percentage of Participants With Systemic Events Within 7 Days After Vaccination 1 | Fever: >=38.0 deg C | 2.0 Percentage of participants |
| Coadministration Group | Percentage of Participants With Systemic Events Within 7 Days After Vaccination 1 | Fever: >=38.0 deg C to 38.4 deg C | 1.2 Percentage of participants |
| Coadministration Group | Percentage of Participants With Systemic Events Within 7 Days After Vaccination 1 | Fever: >38.4 deg C to 38.9 deg C | 0.4 Percentage of participants |
| Coadministration Group | Percentage of Participants With Systemic Events Within 7 Days After Vaccination 1 | Fever: >38.9 deg C to 40.0 deg C | 0.4 Percentage of participants |
| Coadministration Group | Percentage of Participants With Systemic Events Within 7 Days After Vaccination 1 | Fever: >40.0 deg C | 0.0 Percentage of participants |
| Coadministration Group | Percentage of Participants With Systemic Events Within 7 Days After Vaccination 1 | Fatigue: Any | 64.0 Percentage of participants |
| Coadministration Group | Percentage of Participants With Systemic Events Within 7 Days After Vaccination 1 | Fatigue: Mild | 31.9 Percentage of participants |
| Coadministration Group | Percentage of Participants With Systemic Events Within 7 Days After Vaccination 1 | Fatigue: Moderate | 30.9 Percentage of participants |
| Coadministration Group | Percentage of Participants With Systemic Events Within 7 Days After Vaccination 1 | Fatigue: Severe | 1.2 Percentage of participants |
| Coadministration Group | Percentage of Participants With Systemic Events Within 7 Days After Vaccination 1 | Fatigue: Grade 4 | 0 Percentage of participants |
| Coadministration Group | Percentage of Participants With Systemic Events Within 7 Days After Vaccination 1 | Headache: Any | 47.2 Percentage of participants |
| Coadministration Group | Percentage of Participants With Systemic Events Within 7 Days After Vaccination 1 | Headache: Mild | 28.2 Percentage of participants |
| Coadministration Group | Percentage of Participants With Systemic Events Within 7 Days After Vaccination 1 | Headache: Moderate | 17.9 Percentage of participants |
| Coadministration Group | Percentage of Participants With Systemic Events Within 7 Days After Vaccination 1 | Diarrhea: Grade 4 | 0 Percentage of participants |
| Coadministration Group | Percentage of Participants With Systemic Events Within 7 Days After Vaccination 1 | New or worsened muscle pain: Any | 27.7 Percentage of participants |
| Coadministration Group | Percentage of Participants With Systemic Events Within 7 Days After Vaccination 1 | Chills: Severe | 0.9 Percentage of participants |
| Coadministration Group | Percentage of Participants With Systemic Events Within 7 Days After Vaccination 1 | Vomiting: Severe | 0 Percentage of participants |
| Coadministration Group | Percentage of Participants With Systemic Events Within 7 Days After Vaccination 1 | New or worsened muscle pain: Mild | 15.8 Percentage of participants |
| Coadministration Group | Percentage of Participants With Systemic Events Within 7 Days After Vaccination 1 | New or worsened muscle pain: Moderate | 11.3 Percentage of participants |
| Coadministration Group | Percentage of Participants With Systemic Events Within 7 Days After Vaccination 1 | New or worsened muscle pain: Severe | 0.5 Percentage of participants |
| Coadministration Group | Percentage of Participants With Systemic Events Within 7 Days After Vaccination 1 | New or worsened muscle pain: Grade 4 | 0 Percentage of participants |
| Coadministration Group | Percentage of Participants With Systemic Events Within 7 Days After Vaccination 1 | New or worsened joint pain: Any | 15.1 Percentage of participants |
| Coadministration Group | Percentage of Participants With Systemic Events Within 7 Days After Vaccination 1 | New or worsened joint pain: Moderate | 4.8 Percentage of participants |
| Coadministration Group | Percentage of Participants With Systemic Events Within 7 Days After Vaccination 1 | New or worsened joint pain: Severe | 0 Percentage of participants |
| Coadministration Group | Percentage of Participants With Systemic Events Within 7 Days After Vaccination 1 | New or worsened joint pain: Grade 4 | 0 Percentage of participants |
| Coadministration Group | Percentage of Participants With Systemic Events Within 7 Days After Vaccination 1 | Vomiting: Grade 4 | 0 Percentage of participants |
| Coadministration Group | Percentage of Participants With Systemic Events Within 7 Days After Vaccination 1 | Diarrhea: Any | 11.5 Percentage of participants |
| Coadministration Group | Percentage of Participants With Systemic Events Within 7 Days After Vaccination 1 | Diarrhea: Mild | 9.9 Percentage of participants |
| Separate Administration Group | Percentage of Participants With Systemic Events Within 7 Days After Vaccination 1 | Fatigue: Moderate | 16.3 Percentage of participants |
| Separate Administration Group | Percentage of Participants With Systemic Events Within 7 Days After Vaccination 1 | Headache: Severe | 0.7 Percentage of participants |
| Separate Administration Group | Percentage of Participants With Systemic Events Within 7 Days After Vaccination 1 | New or worsened joint pain: Moderate | 2.7 Percentage of participants |
| Separate Administration Group | Percentage of Participants With Systemic Events Within 7 Days After Vaccination 1 | Headache: Grade 4 | 0 Percentage of participants |
| Separate Administration Group | Percentage of Participants With Systemic Events Within 7 Days After Vaccination 1 | Fatigue: Severe | 1.1 Percentage of participants |
| Separate Administration Group | Percentage of Participants With Systemic Events Within 7 Days After Vaccination 1 | Chills: Any | 6.2 Percentage of participants |
| Separate Administration Group | Percentage of Participants With Systemic Events Within 7 Days After Vaccination 1 | New or worsened muscle pain: Moderate | 5.0 Percentage of participants |
| Separate Administration Group | Percentage of Participants With Systemic Events Within 7 Days After Vaccination 1 | Chills: Mild | 4.3 Percentage of participants |
| Separate Administration Group | Percentage of Participants With Systemic Events Within 7 Days After Vaccination 1 | Fatigue: Grade 4 | 0 Percentage of participants |
| Separate Administration Group | Percentage of Participants With Systemic Events Within 7 Days After Vaccination 1 | Chills: Severe | 0.4 Percentage of participants |
| Separate Administration Group | Percentage of Participants With Systemic Events Within 7 Days After Vaccination 1 | Vomiting: Grade 4 | 0 Percentage of participants |
| Separate Administration Group | Percentage of Participants With Systemic Events Within 7 Days After Vaccination 1 | Chills: Grade 4 | 0 Percentage of participants |
| Separate Administration Group | Percentage of Participants With Systemic Events Within 7 Days After Vaccination 1 | Headache: Any | 34.3 Percentage of participants |
| Separate Administration Group | Percentage of Participants With Systemic Events Within 7 Days After Vaccination 1 | Vomiting: Any | 0.9 Percentage of participants |
| Separate Administration Group | Percentage of Participants With Systemic Events Within 7 Days After Vaccination 1 | New or worsened muscle pain: Severe | 0.2 Percentage of participants |
| Separate Administration Group | Percentage of Participants With Systemic Events Within 7 Days After Vaccination 1 | Vomiting: Mild | 0.7 Percentage of participants |
| Separate Administration Group | Percentage of Participants With Systemic Events Within 7 Days After Vaccination 1 | Headache: Mild | 23.3 Percentage of participants |
| Separate Administration Group | Percentage of Participants With Systemic Events Within 7 Days After Vaccination 1 | Vomiting: Moderate | 0.2 Percentage of participants |
| Separate Administration Group | Percentage of Participants With Systemic Events Within 7 Days After Vaccination 1 | Vomiting: Severe | 0 Percentage of participants |
| Separate Administration Group | Percentage of Participants With Systemic Events Within 7 Days After Vaccination 1 | New or worsened joint pain: Severe | 0 Percentage of participants |
| Separate Administration Group | Percentage of Participants With Systemic Events Within 7 Days After Vaccination 1 | New or worsened muscle pain: Mild | 6.2 Percentage of participants |
| Separate Administration Group | Percentage of Participants With Systemic Events Within 7 Days After Vaccination 1 | Headache: Moderate | 10.3 Percentage of participants |
| Separate Administration Group | Percentage of Participants With Systemic Events Within 7 Days After Vaccination 1 | New or worsened joint pain: Grade 4 | 0 Percentage of participants |
| Separate Administration Group | Percentage of Participants With Systemic Events Within 7 Days After Vaccination 1 | Diarrhea: Moderate | 1.2 Percentage of participants |
| Separate Administration Group | Percentage of Participants With Systemic Events Within 7 Days After Vaccination 1 | Diarrhea: Severe | 0 Percentage of participants |
| Separate Administration Group | Percentage of Participants With Systemic Events Within 7 Days After Vaccination 1 | New or worsened muscle pain: Grade 4 | 0 Percentage of participants |
| Separate Administration Group | Percentage of Participants With Systemic Events Within 7 Days After Vaccination 1 | Fever: >=38.0 deg C | 1.1 Percentage of participants |
| Separate Administration Group | Percentage of Participants With Systemic Events Within 7 Days After Vaccination 1 | Diarrhea: Grade 4 | 0 Percentage of participants |
| Separate Administration Group | Percentage of Participants With Systemic Events Within 7 Days After Vaccination 1 | Fever: >=38.0 deg C to 38.4 deg C | 0.4 Percentage of participants |
| Separate Administration Group | Percentage of Participants With Systemic Events Within 7 Days After Vaccination 1 | Diarrhea: Mild | 8.9 Percentage of participants |
| Separate Administration Group | Percentage of Participants With Systemic Events Within 7 Days After Vaccination 1 | Fever: >38.4 deg C to 38.9 deg C | 0.4 Percentage of participants |
| Separate Administration Group | Percentage of Participants With Systemic Events Within 7 Days After Vaccination 1 | New or worsened muscle pain: Any | 11.4 Percentage of participants |
| Separate Administration Group | Percentage of Participants With Systemic Events Within 7 Days After Vaccination 1 | Fever: >38.9 deg C to 40.0 deg C | 0.4 Percentage of participants |
| Separate Administration Group | Percentage of Participants With Systemic Events Within 7 Days After Vaccination 1 | Chills: Moderate | 1.6 Percentage of participants |
| Separate Administration Group | Percentage of Participants With Systemic Events Within 7 Days After Vaccination 1 | Fever: >40.0 deg C | 0.0 Percentage of participants |
| Separate Administration Group | Percentage of Participants With Systemic Events Within 7 Days After Vaccination 1 | New or worsened joint pain: Any | 5.3 Percentage of participants |
| Separate Administration Group | Percentage of Participants With Systemic Events Within 7 Days After Vaccination 1 | Fatigue: Any | 42.1 Percentage of participants |
| Separate Administration Group | Percentage of Participants With Systemic Events Within 7 Days After Vaccination 1 | New or worsened joint pain: Mild | 2.7 Percentage of participants |
| Separate Administration Group | Percentage of Participants With Systemic Events Within 7 Days After Vaccination 1 | Fatigue: Mild | 24.7 Percentage of participants |
| Separate Administration Group | Percentage of Participants With Systemic Events Within 7 Days After Vaccination 1 | Diarrhea: Any | 10.1 Percentage of participants |
Primary
Percentage of Participants With Systemic Events Within 7 Days After Vaccination 2
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.
Time frame: Within 7 Days After Vaccination 2
Population: Safety population included all participants who received any of the study intervention. Here, Number of participants analyzed included participants who received Vaccination 2 and signifies number of participants evaluable for this outcome measure.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Coadministration Group | Percentage of Participants With Systemic Events Within 7 Days After Vaccination 2 | Diarrhea: Severe | 0 Percentage of participants |
| Coadministration Group | Percentage of Participants With Systemic Events Within 7 Days After Vaccination 2 | Headache: Mild | 13.1 Percentage of participants |
| Coadministration Group | Percentage of Participants With Systemic Events Within 7 Days After Vaccination 2 | Diarrhea: Grade 4 | 0 Percentage of participants |
| Coadministration Group | Percentage of Participants With Systemic Events Within 7 Days After Vaccination 2 | New or worsened muscle pain: Any | 5.2 Percentage of participants |
| Coadministration Group | Percentage of Participants With Systemic Events Within 7 Days After Vaccination 2 | Chills: Severe | 0 Percentage of participants |
| Coadministration Group | Percentage of Participants With Systemic Events Within 7 Days After Vaccination 2 | New or worsened muscle pain: Mild | 2.7 Percentage of participants |
| Coadministration Group | Percentage of Participants With Systemic Events Within 7 Days After Vaccination 2 | Fatigue: Mild | 12.4 Percentage of participants |
| Coadministration Group | Percentage of Participants With Systemic Events Within 7 Days After Vaccination 2 | New or worsened muscle pain: Moderate | 2.5 Percentage of participants |
| Coadministration Group | Percentage of Participants With Systemic Events Within 7 Days After Vaccination 2 | Chills: Grade 4 | 0 Percentage of participants |
| Coadministration Group | Percentage of Participants With Systemic Events Within 7 Days After Vaccination 2 | New or worsened muscle pain: Severe | 0 Percentage of participants |
| Coadministration Group | Percentage of Participants With Systemic Events Within 7 Days After Vaccination 2 | Headache: Moderate | 7.5 Percentage of participants |
| Coadministration Group | Percentage of Participants With Systemic Events Within 7 Days After Vaccination 2 | New or worsened muscle pain: Grade 4 | 0 Percentage of participants |
| Coadministration Group | Percentage of Participants With Systemic Events Within 7 Days After Vaccination 2 | Vomiting: Any | 1.1 Percentage of participants |
| Coadministration Group | Percentage of Participants With Systemic Events Within 7 Days After Vaccination 2 | New or worsened joint pain: Any | 3.4 Percentage of participants |
| Coadministration Group | Percentage of Participants With Systemic Events Within 7 Days After Vaccination 2 | New or worsened joint pain: Mild | 2.0 Percentage of participants |
| Coadministration Group | Percentage of Participants With Systemic Events Within 7 Days After Vaccination 2 | Headache: Severe | 0.2 Percentage of participants |
| Coadministration Group | Percentage of Participants With Systemic Events Within 7 Days After Vaccination 2 | New or worsened joint pain: Moderate | 1.4 Percentage of participants |
| Coadministration Group | Percentage of Participants With Systemic Events Within 7 Days After Vaccination 2 | Fever: >=38.0 deg C to 38.4 deg C | 0.5 Percentage of participants |
| Coadministration Group | Percentage of Participants With Systemic Events Within 7 Days After Vaccination 2 | New or worsened joint pain: Severe | 0 Percentage of participants |
| Coadministration Group | Percentage of Participants With Systemic Events Within 7 Days After Vaccination 2 | Vomiting: Mild | 0.7 Percentage of participants |
| Coadministration Group | Percentage of Participants With Systemic Events Within 7 Days After Vaccination 2 | New or worsened joint pain: Grade 4 | 0 Percentage of participants |
| Coadministration Group | Percentage of Participants With Systemic Events Within 7 Days After Vaccination 2 | Headache: Grade 4 | 0 Percentage of participants |
| Coadministration Group | Percentage of Participants With Systemic Events Within 7 Days After Vaccination 2 | Fever: >=38.0 deg C | 1.1 Percentage of participants |
| Coadministration Group | Percentage of Participants With Systemic Events Within 7 Days After Vaccination 2 | Vomiting: Moderate | 0.4 Percentage of participants |
| Coadministration Group | Percentage of Participants With Systemic Events Within 7 Days After Vaccination 2 | Fever: >38.4 deg C to 38.9 deg C | 0.5 Percentage of participants |
| Coadministration Group | Percentage of Participants With Systemic Events Within 7 Days After Vaccination 2 | Fever: >38.9 deg C to 40.0 deg C | 0 Percentage of participants |
| Coadministration Group | Percentage of Participants With Systemic Events Within 7 Days After Vaccination 2 | Chills: Any | 3.4 Percentage of participants |
| Coadministration Group | Percentage of Participants With Systemic Events Within 7 Days After Vaccination 2 | Fatigue: Any | 21.7 Percentage of participants |
| Coadministration Group | Percentage of Participants With Systemic Events Within 7 Days After Vaccination 2 | Vomiting: Severe | 0 Percentage of participants |
| Coadministration Group | Percentage of Participants With Systemic Events Within 7 Days After Vaccination 2 | Fatigue: Moderate | 8.6 Percentage of participants |
| Coadministration Group | Percentage of Participants With Systemic Events Within 7 Days After Vaccination 2 | Headache: Any | 20.8 Percentage of participants |
| Coadministration Group | Percentage of Participants With Systemic Events Within 7 Days After Vaccination 2 | Fatigue: Severe | 0.7 Percentage of participants |
| Coadministration Group | Percentage of Participants With Systemic Events Within 7 Days After Vaccination 2 | Vomiting: Grade 4 | 0 Percentage of participants |
| Coadministration Group | Percentage of Participants With Systemic Events Within 7 Days After Vaccination 2 | Fatigue: Grade 4 | 0 Percentage of participants |
| Coadministration Group | Percentage of Participants With Systemic Events Within 7 Days After Vaccination 2 | Diarrhea: Any | 4.5 Percentage of participants |
| Coadministration Group | Percentage of Participants With Systemic Events Within 7 Days After Vaccination 2 | Chills: Mild | 2.3 Percentage of participants |
| Coadministration Group | Percentage of Participants With Systemic Events Within 7 Days After Vaccination 2 | Diarrhea: Mild | 3.8 Percentage of participants |
| Coadministration Group | Percentage of Participants With Systemic Events Within 7 Days After Vaccination 2 | Fever: >40.0 deg C | 0. Percentage of participants |
| Coadministration Group | Percentage of Participants With Systemic Events Within 7 Days After Vaccination 2 | Diarrhea: Moderate | 0.7 Percentage of participants |
| Coadministration Group | Percentage of Participants With Systemic Events Within 7 Days After Vaccination 2 | Chills: Moderate | 1.1 Percentage of participants |
| Separate Administration Group | Percentage of Participants With Systemic Events Within 7 Days After Vaccination 2 | New or worsened joint pain: Grade 4 | 0 Percentage of participants |
| Separate Administration Group | Percentage of Participants With Systemic Events Within 7 Days After Vaccination 2 | Fever: >38.9 deg C to 40.0 deg C | 0 Percentage of participants |
| Separate Administration Group | Percentage of Participants With Systemic Events Within 7 Days After Vaccination 2 | Fatigue: Mild | 27.3 Percentage of participants |
| Separate Administration Group | Percentage of Participants With Systemic Events Within 7 Days After Vaccination 2 | Headache: Any | 37.8 Percentage of participants |
| Separate Administration Group | Percentage of Participants With Systemic Events Within 7 Days After Vaccination 2 | Headache: Mild | 25.0 Percentage of participants |
| Separate Administration Group | Percentage of Participants With Systemic Events Within 7 Days After Vaccination 2 | Headache: Severe | 0.7 Percentage of participants |
| Separate Administration Group | Percentage of Participants With Systemic Events Within 7 Days After Vaccination 2 | Chills: Any | 13.4 Percentage of participants |
| Separate Administration Group | Percentage of Participants With Systemic Events Within 7 Days After Vaccination 2 | Chills: Mild | 8.5 Percentage of participants |
| Separate Administration Group | Percentage of Participants With Systemic Events Within 7 Days After Vaccination 2 | Chills: Moderate | 4.7 Percentage of participants |
| Separate Administration Group | Percentage of Participants With Systemic Events Within 7 Days After Vaccination 2 | Chills: Severe | 0.2 Percentage of participants |
| Separate Administration Group | Percentage of Participants With Systemic Events Within 7 Days After Vaccination 2 | Chills: Grade 4 | 0 Percentage of participants |
| Separate Administration Group | Percentage of Participants With Systemic Events Within 7 Days After Vaccination 2 | Vomiting: Grade 4 | 0 Percentage of participants |
| Separate Administration Group | Percentage of Participants With Systemic Events Within 7 Days After Vaccination 2 | Vomiting: Any | 2.4 Percentage of participants |
| Separate Administration Group | Percentage of Participants With Systemic Events Within 7 Days After Vaccination 2 | Vomiting: Mild | 1.8 Percentage of participants |
| Separate Administration Group | Percentage of Participants With Systemic Events Within 7 Days After Vaccination 2 | Vomiting: Moderate | 0.5 Percentage of participants |
| Separate Administration Group | Percentage of Participants With Systemic Events Within 7 Days After Vaccination 2 | Vomiting: Severe | 0 Percentage of participants |
| Separate Administration Group | Percentage of Participants With Systemic Events Within 7 Days After Vaccination 2 | Diarrhea: Any | 6.5 Percentage of participants |
| Separate Administration Group | Percentage of Participants With Systemic Events Within 7 Days After Vaccination 2 | Diarrhea: Mild | 5.2 Percentage of participants |
| Separate Administration Group | Percentage of Participants With Systemic Events Within 7 Days After Vaccination 2 | Diarrhea: Moderate | 0.9 Percentage of participants |
| Separate Administration Group | Percentage of Participants With Systemic Events Within 7 Days After Vaccination 2 | Diarrhea: Severe | 0.4 Percentage of participants |
| Separate Administration Group | Percentage of Participants With Systemic Events Within 7 Days After Vaccination 2 | New or worsened muscle pain: Any | 23.5 Percentage of participants |
| Separate Administration Group | Percentage of Participants With Systemic Events Within 7 Days After Vaccination 2 | New or worsened muscle pain: Mild | 12.8 Percentage of participants |
| Separate Administration Group | Percentage of Participants With Systemic Events Within 7 Days After Vaccination 2 | New or worsened muscle pain: Moderate | 10.5 Percentage of participants |
| Separate Administration Group | Percentage of Participants With Systemic Events Within 7 Days After Vaccination 2 | New or worsened muscle pain: Severe | 0.2 Percentage of participants |
| Separate Administration Group | Percentage of Participants With Systemic Events Within 7 Days After Vaccination 2 | New or worsened muscle pain: Grade 4 | 0 Percentage of participants |
| Separate Administration Group | Percentage of Participants With Systemic Events Within 7 Days After Vaccination 2 | New or worsened joint pain: Mild | 5.6 Percentage of participants |
| Separate Administration Group | Percentage of Participants With Systemic Events Within 7 Days After Vaccination 2 | New or worsened joint pain: Moderate | 4.2 Percentage of participants |
| Separate Administration Group | Percentage of Participants With Systemic Events Within 7 Days After Vaccination 2 | New or worsened joint pain: Severe | 0 Percentage of participants |
| Separate Administration Group | Percentage of Participants With Systemic Events Within 7 Days After Vaccination 2 | Fever: >38.4 deg C to 38.9 deg C | 0.5 Percentage of participants |
| Separate Administration Group | Percentage of Participants With Systemic Events Within 7 Days After Vaccination 2 | Fever: >=38.0 deg C to 38.4 deg C | 1.1 Percentage of participants |
| Separate Administration Group | Percentage of Participants With Systemic Events Within 7 Days After Vaccination 2 | Fever: >40.0 deg C | 0 Percentage of participants |
| Separate Administration Group | Percentage of Participants With Systemic Events Within 7 Days After Vaccination 2 | Fatigue: Any | 50.8 Percentage of participants |
| Separate Administration Group | Percentage of Participants With Systemic Events Within 7 Days After Vaccination 2 | Fatigue: Moderate | 22.1 Percentage of participants |
| Separate Administration Group | Percentage of Participants With Systemic Events Within 7 Days After Vaccination 2 | Fatigue: Severe | 1.4 Percentage of participants |
| Separate Administration Group | Percentage of Participants With Systemic Events Within 7 Days After Vaccination 2 | Fatigue: Grade 4 | 0 Percentage of participants |
| Separate Administration Group | Percentage of Participants With Systemic Events Within 7 Days After Vaccination 2 | Headache: Moderate | 12.1 Percentage of participants |
| Separate Administration Group | Percentage of Participants With Systemic Events Within 7 Days After Vaccination 2 | Headache: Grade 4 | 0 Percentage of participants |
| Separate Administration Group | Percentage of Participants With Systemic Events Within 7 Days After Vaccination 2 | Diarrhea: Grade 4 | 0 Percentage of participants |
| Separate Administration Group | Percentage of Participants With Systemic Events Within 7 Days After Vaccination 2 | New or worsened joint pain: Any | 9.8 Percentage of participants |
| Separate Administration Group | Percentage of Participants With Systemic Events Within 7 Days After Vaccination 2 | Fever: >=38.0 deg C | 1.6 Percentage of participants |
Secondary
Geometric Mean Concentration (GMC) of Full-Length S-binding IgG Levels Before Vaccination and 1 Month After BNT162b2 Vaccination
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''.
Time frame: Before BNT162b2 vaccination, and 1 month After BNT162b2 vaccination
Population: Evaluable BNT162b2 immunogenicity population: Eligible participants who received all vaccinations(Vax) at Visit1(V1) (coadministration group) or all Vax at V1 and V2 (separate administration group) as randomized, had at least 1 valid full-length S-binding IgG result from blood sample collected 28 to 42 days after BNT162b2 vax, had no reported COVID-19/new SARS-CoV-2 infection after V1 through 1 month after BNT162b2 vax, and had no other important protocol deviations as determined by clinician.
| Arm | Measure | Group | Value (GEOMETRIC_MEAN) |
|---|---|---|---|
| Coadministration Group | Geometric Mean Concentration (GMC) of Full-Length S-binding IgG Levels Before Vaccination and 1 Month After BNT162b2 Vaccination | Before BNT162b2 Vaccination | 5520.3 Units per millilitre (U/mL) |
| Coadministration Group | Geometric Mean Concentration (GMC) of Full-Length S-binding IgG Levels Before Vaccination and 1 Month After BNT162b2 Vaccination | 1 Month After BNT162b2 Vaccination | 13806.5 Units per millilitre (U/mL) |
| Separate Administration Group | Geometric Mean Concentration (GMC) of Full-Length S-binding IgG Levels Before Vaccination and 1 Month After BNT162b2 Vaccination | 1 Month After BNT162b2 Vaccination | 16254.6 Units per millilitre (U/mL) |
| Separate Administration Group | Geometric Mean Concentration (GMC) of Full-Length S-binding IgG Levels Before Vaccination and 1 Month After BNT162b2 Vaccination | Before BNT162b2 Vaccination | 5272.3 Units per millilitre (U/mL) |
Secondary
Geometric Mean Fold Rise (GMFR) of Full-Length S-binding IgG Levels From Before Vaccination to 1 Month After BNT162b2 Vaccination
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''.
Time frame: From before BNT162b2 vaccination to 1 month After BNT162b2 vaccination
Population: Evaluable BNT162b2 immunogenicity population: Eligible participants who received all vaccinations(Vax) at Visit1(V1) (coadministration group) or all Vax at V1 and V2 (separate administration group) as randomized, had at least 1 valid full-length S-binding IgG result from blood sample collected 28 to 42 days after BNT162b2 vax, had no reported COVID-19/new SARS-CoV-2 infection after V1 through 1 month after BNT162b2 vax, and had no other important protocol deviations as determined by clinician.
| Arm | Measure | Value (GEOMETRIC_MEAN) |
|---|---|---|
| Coadministration Group | Geometric Mean Fold Rise (GMFR) of Full-Length S-binding IgG Levels From Before Vaccination to 1 Month After BNT162b2 Vaccination | 2.5 Fold rise |
| Separate Administration Group | Geometric Mean Fold Rise (GMFR) of Full-Length S-binding IgG Levels From Before Vaccination to 1 Month After BNT162b2 Vaccination | 3.1 Fold rise |
Secondary
Geometric Mean Fold Rise (GMFR) of SARS-CoV-2 Neutralizing Titers From Before Vaccination to 1 Month After BNT162b2 Vaccination
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.
Time frame: From before BNT162b2 vaccination to 1 month after BNT162b2 vaccination
Population: Evaluable BNT162b2 immunogenicity population: Eligible participants who received all Vax at V1 (coadministration group) or all Vax at V1 and V2 (separate administration group) as randomized, had at least 1 valid SARS-CoV-2 neutralizing titers result from blood sample collected 28 to 42 days after BNT162b2 vax, had no reported COVID-19/new SARS-CoV-2 infection after V1 through 1 month after BNT162b2 vax, and had no other important protocol deviations as determined by clinician.
| Arm | Measure | Value (GEOMETRIC_MEAN) |
|---|---|---|
| Coadministration Group | Geometric Mean Fold Rise (GMFR) of SARS-CoV-2 Neutralizing Titers From Before Vaccination to 1 Month After BNT162b2 Vaccination | 2.5 Fold rise |
| Separate Administration Group | Geometric Mean Fold Rise (GMFR) of SARS-CoV-2 Neutralizing Titers From Before Vaccination to 1 Month After BNT162b2 Vaccination | 3.3 Fold rise |
Secondary
Geometric Mean Fold Rise (GMFR) of Strain-Specific HAI Titers From Before Vaccination to 1 Month After SIIV Vaccination
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.
Time frame: From before vaccination to 1 month after SIIV vaccination
Population: Evaluable SIIV immunogenicity population: eligible randomized participants who received all vaccinations at Visit 1 as randomized, had at least 1 valid and determinate HAI titer result from blood sample collected for 28 to 42 days after SIIV vax, and had no other important protocol deviations as determined by clinician. Here, N signifies number of participants evaluable, and n signifies number of participants evaluable for specified rows for this outcome measure.
| Arm | Measure | Group | Value (GEOMETRIC_MEAN) |
|---|---|---|---|
| Coadministration Group | Geometric Mean Fold Rise (GMFR) of Strain-Specific HAI Titers From Before Vaccination to 1 Month After SIIV Vaccination | B/Austria | 5.5 Fold rise |
| Coadministration Group | Geometric Mean Fold Rise (GMFR) of Strain-Specific HAI Titers From Before Vaccination to 1 Month After SIIV Vaccination | B/Phuket | 3.3 Fold rise |
| Coadministration Group | Geometric Mean Fold Rise (GMFR) of Strain-Specific HAI Titers From Before Vaccination to 1 Month After SIIV Vaccination | H1N1 A/Victoria | 6.0 Fold rise |
| Coadministration Group | Geometric Mean Fold Rise (GMFR) of Strain-Specific HAI Titers From Before Vaccination to 1 Month After SIIV Vaccination | H3N2 A/Darwin | 5.9 Fold rise |
| Separate Administration Group | Geometric Mean Fold Rise (GMFR) of Strain-Specific HAI Titers From Before Vaccination to 1 Month After SIIV Vaccination | H3N2 A/Darwin | 6.3 Fold rise |
| Separate Administration Group | Geometric Mean Fold Rise (GMFR) of Strain-Specific HAI Titers From Before Vaccination to 1 Month After SIIV Vaccination | B/Austria | 6.3 Fold rise |
| Separate Administration Group | Geometric Mean Fold Rise (GMFR) of Strain-Specific HAI Titers From Before Vaccination to 1 Month After SIIV Vaccination | H1N1 A/Victoria | 6.4 Fold rise |
| Separate Administration Group | Geometric Mean Fold Rise (GMFR) of Strain-Specific HAI Titers From Before Vaccination to 1 Month After SIIV Vaccination | B/Phuket | 3.4 Fold rise |
Secondary
Geometric Mean Titer (GMT) of SARS-CoV-2 Neutralizing Titers Before Vaccination and 1 Month After BNT162b2 Vaccination
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.
Time frame: Before BNT162b2 vaccination, and 1 month after BNT162b2 vaccination
Population: Evaluable BNT162b2 immunogenicity population: Eligible participants who received all Vax at V1 (coadministration group) or all Vax at V1 and V2 (separate administration group) as randomized, had at least 1 valid SARS-CoV-2 neutralizing titers result from blood sample collected 28 to 42 days after BNT162b2 vax, had no reported COVID-19/new SARS-CoV-2 infection after V1 through 1 month after BNT162b2 vax, and had no other important protocol deviations as determined by clinician.
| Arm | Measure | Group | Value (GEOMETRIC_MEAN) |
|---|---|---|---|
| Coadministration Group | Geometric Mean Titer (GMT) of SARS-CoV-2 Neutralizing Titers Before Vaccination and 1 Month After BNT162b2 Vaccination | Before BNT162b2 Vaccination | 2755.9 Titer |
| Coadministration Group | Geometric Mean Titer (GMT) of SARS-CoV-2 Neutralizing Titers Before Vaccination and 1 Month After BNT162b2 Vaccination | 1 Month After BNT162b2 Vaccination | 6773.9 Titer |
| Separate Administration Group | Geometric Mean Titer (GMT) of SARS-CoV-2 Neutralizing Titers Before Vaccination and 1 Month After BNT162b2 Vaccination | Before BNT162b2 Vaccination | 2421.2 Titer |
| Separate Administration Group | Geometric Mean Titer (GMT) of SARS-CoV-2 Neutralizing Titers Before Vaccination and 1 Month After BNT162b2 Vaccination | 1 Month After BNT162b2 Vaccination | 7886.6 Titer |
Secondary
Geometric Mean Titer (GMT) of Strain-Specific HAI Titers Before Vaccination and 1 Month After SIIV Vaccination
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.
Time frame: Before SIIV vaccination, and 1 month after SIIV vaccination
Population: Evaluable SIIV immunogenicity population: eligible randomized participants who received all vaccinations at Visit 1 as randomized, had at least 1 valid and determinate HAI titer result from the blood sample collected for 28 to 42 days after SIIV vax, and had no other important protocol deviations as determined by the clinician. Here, N signifies number of participants evaluable, and n signifies number of participants evaluable for specified rows for this outcome measure.
| Arm | Measure | Group | Value (GEOMETRIC_MEAN) |
|---|---|---|---|
| Coadministration Group | Geometric Mean Titer (GMT) of Strain-Specific HAI Titers Before Vaccination and 1 Month After SIIV Vaccination | B/Austria: Before Vaccination | 13.0 Titer |
| Coadministration Group | Geometric Mean Titer (GMT) of Strain-Specific HAI Titers Before Vaccination and 1 Month After SIIV Vaccination | B/Austria: 1 Month After SIIV Vaccination | 72.4 Titer |
| Coadministration Group | Geometric Mean Titer (GMT) of Strain-Specific HAI Titers Before Vaccination and 1 Month After SIIV Vaccination | B/Phuket: Before Vaccination | 26.4 Titer |
| Coadministration Group | Geometric Mean Titer (GMT) of Strain-Specific HAI Titers Before Vaccination and 1 Month After SIIV Vaccination | B/Phuket: 1 Month After SIIV Vaccination | 87.4 Titer |
| Coadministration Group | Geometric Mean Titer (GMT) of Strain-Specific HAI Titers Before Vaccination and 1 Month After SIIV Vaccination | H1N1 A/Victoria: Before Vaccination | 57.0 Titer |
| Coadministration Group | Geometric Mean Titer (GMT) of Strain-Specific HAI Titers Before Vaccination and 1 Month After SIIV Vaccination | H3N2 A/Darwin: Before Vaccination | 39.5 Titer |
| Coadministration Group | Geometric Mean Titer (GMT) of Strain-Specific HAI Titers Before Vaccination and 1 Month After SIIV Vaccination | H3N2 A/Darwin: 1 Month After SIIV Vaccination | 230.6 Titer |
| Coadministration Group | Geometric Mean Titer (GMT) of Strain-Specific HAI Titers Before Vaccination and 1 Month After SIIV Vaccination | H1N1 A/Victoria: 1 Month After SIIV Vaccination | 344.3 Titer |
| Separate Administration Group | Geometric Mean Titer (GMT) of Strain-Specific HAI Titers Before Vaccination and 1 Month After SIIV Vaccination | H1N1 A/Victoria: Before Vaccination | 56.3 Titer |
| Separate Administration Group | Geometric Mean Titer (GMT) of Strain-Specific HAI Titers Before Vaccination and 1 Month After SIIV Vaccination | B/Austria: Before Vaccination | 12.7 Titer |
| Separate Administration Group | Geometric Mean Titer (GMT) of Strain-Specific HAI Titers Before Vaccination and 1 Month After SIIV Vaccination | H3N2 A/Darwin: Before Vaccination | 38.4 Titer |
| Separate Administration Group | Geometric Mean Titer (GMT) of Strain-Specific HAI Titers Before Vaccination and 1 Month After SIIV Vaccination | H1N1 A/Victoria: 1 Month After SIIV Vaccination | 362.3 Titer |
| Separate Administration Group | Geometric Mean Titer (GMT) of Strain-Specific HAI Titers Before Vaccination and 1 Month After SIIV Vaccination | B/Phuket: Before Vaccination | 25.7 Titer |
| Separate Administration Group | Geometric Mean Titer (GMT) of Strain-Specific HAI Titers Before Vaccination and 1 Month After SIIV Vaccination | H3N2 A/Darwin: 1 Month After SIIV Vaccination | 242.2 Titer |
| Separate Administration Group | Geometric Mean Titer (GMT) of Strain-Specific HAI Titers Before Vaccination and 1 Month After SIIV Vaccination | B/Phuket: 1 Month After SIIV Vaccination | 86.3 Titer |
| Separate Administration Group | Geometric Mean Titer (GMT) of Strain-Specific HAI Titers Before Vaccination and 1 Month After SIIV Vaccination | B/Austria: 1 Month After SIIV Vaccination | 78.3 Titer |