Trial Outcomes & Findings for Safety and Immunogenicity of BNT162b2 Coadministered With SIIV in Adults 18 Through 64 Years of Age (NCT NCT05310084)
NCT ID: NCT05310084
Last Updated: 2024-06-12
Results Overview
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.
Recruitment status
COMPLETED
Study phase
PHASE3
Target enrollment
1134 participants
Primary outcome timeframe
Within 7 Days After Vaccination 1
Results posted on
2024-06-12
Participant Flow
A total of 1165 participants were screened, out of which 31 were screen failures and 1134 were randomized into the study.
Participant milestones
| Measure |
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).
|
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).
|
|---|---|---|
|
Overall Study
STARTED
|
568
|
566
|
|
Overall Study
Vaccinated
|
564
|
564
|
|
Overall Study
COMPLETED
|
560
|
555
|
|
Overall Study
NOT COMPLETED
|
8
|
11
|
Reasons for withdrawal
| Measure |
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).
|
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).
|
|---|---|---|
|
Overall Study
Withdrawal by Subject
|
2
|
3
|
|
Overall Study
Participant availability
|
0
|
4
|
|
Overall Study
Lost to Follow-up
|
1
|
1
|
|
Overall Study
Adverse Event
|
1
|
1
|
|
Overall Study
Randomized but not vaccinated
|
4
|
2
|
Baseline Characteristics
Safety and Immunogenicity of BNT162b2 Coadministered With SIIV in Adults 18 Through 64 Years of Age
Baseline characteristics by cohort
| Measure |
Separate Administration Group
n=564 Participants
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).
|
Total
n=1128 Participants
Total of all reporting groups
|
Coadministration Group
n=564 Participants
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).
|
|---|---|---|---|
|
Age, Continuous
|
39.8 Years
STANDARD_DEVIATION 13.52 • n=7 Participants
|
39.7 Years
STANDARD_DEVIATION 13.35 • n=5 Participants
|
39.7 Years
STANDARD_DEVIATION 13.20 • n=5 Participants
|
|
Sex: Female, Male
Female
|
361 Participants
n=7 Participants
|
717 Participants
n=5 Participants
|
356 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
203 Participants
n=7 Participants
|
411 Participants
n=5 Participants
|
208 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
9 Participants
n=7 Participants
|
14 Participants
n=5 Participants
|
5 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
537 Participants
n=7 Participants
|
1076 Participants
n=5 Participants
|
539 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
18 Participants
n=7 Participants
|
38 Participants
n=5 Participants
|
20 Participants
n=5 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Asian
|
66 Participants
n=7 Participants
|
139 Participants
n=5 Participants
|
73 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
36 Participants
n=7 Participants
|
62 Participants
n=5 Participants
|
26 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Black or African American
|
2 Participants
n=7 Participants
|
3 Participants
n=5 Participants
|
1 Participants
n=5 Participants
|
|
Race (NIH/OMB)
White
|
439 Participants
n=7 Participants
|
885 Participants
n=5 Participants
|
446 Participants
n=5 Participants
|
|
Race (NIH/OMB)
More than one race
|
10 Participants
n=7 Participants
|
11 Participants
n=5 Participants
|
1 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
11 Participants
n=7 Participants
|
28 Participants
n=5 Participants
|
17 Participants
n=5 Participants
|
PRIMARY outcome
Timeframe: Within 7 Days After Vaccination 1Population: 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.
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.
Outcome measures
| Measure |
Coadministration Group
n=564 Participants
Participants were randomized to receive 30 microgram (mcg) intramuscular (IM) injection of BNT162b2 vaccine along with IM injection of Seasonal Inactivated Influenza Vaccine (SIIV) on Day 1 (Visit 1), and IM injection of Placebo 1 month later (Visit 2).
|
Separate Administration Group
n=563 Participants
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).
|
|---|---|---|
|
Percentage of Participants With Local Reactions Within 7 Days After Vaccination 1
Redness: Any
|
7.6 Percentage of participants
Interval 5.6 to 10.1
|
0.5 Percentage of participants
Interval 0.1 to 1.6
|
|
Percentage of Participants With Local Reactions Within 7 Days After Vaccination 1
Redness: Mild
|
6.2 Percentage of participants
Interval 4.4 to 8.5
|
0.5 Percentage of participants
Interval 0.1 to 1.6
|
|
Percentage of Participants With Local Reactions Within 7 Days After Vaccination 1
Redness: Moderate
|
1.2 Percentage of participants
Interval 0.5 to 2.5
|
0 Percentage of participants
Interval 0.0 to 0.7
|
|
Percentage of Participants With Local Reactions Within 7 Days After Vaccination 1
Redness: Severe
|
0.2 Percentage of participants
Interval 0.0 to 1.0
|
0 Percentage of participants
Interval 0.0 to 0.7
|
|
Percentage of Participants With Local Reactions Within 7 Days After Vaccination 1
Redness: Grade 4
|
0 Percentage of participants
Interval 0.0 to 0.7
|
0 Percentage of participants
Interval 0.0 to 0.7
|
|
Percentage of Participants With Local Reactions Within 7 Days After Vaccination 1
Swelling: Any
|
9.2 Percentage of participants
Interval 7.0 to 11.9
|
1.1 Percentage of participants
Interval 0.4 to 2.3
|
|
Percentage of Participants With Local Reactions Within 7 Days After Vaccination 1
Swelling: Mild
|
6.2 Percentage of participants
Interval 4.4 to 8.5
|
0.4 Percentage of participants
Interval 0.0 to 1.3
|
|
Percentage of Participants With Local Reactions Within 7 Days After Vaccination 1
Swelling: Moderate
|
3.0 Percentage of participants
Interval 1.8 to 4.8
|
0.7 Percentage of participants
Interval 0.2 to 1.8
|
|
Percentage of Participants With Local Reactions Within 7 Days After Vaccination 1
Swelling: Severe
|
0 Percentage of participants
Interval 0.0 to 0.7
|
0 Percentage of participants
Interval 0.0 to 0.7
|
|
Percentage of Participants With Local Reactions Within 7 Days After Vaccination 1
Swelling: Grade 4
|
0 Percentage of participants
Interval 0.0 to 0.7
|
0 Percentage of participants
Interval 0.0 to 0.7
|
|
Percentage of Participants With Local Reactions Within 7 Days After Vaccination 1
Pain at the injection site: Any
|
86.2 Percentage of participants
Interval 83.0 to 88.9
|
13.9 Percentage of participants
Interval 11.1 to 17.0
|
|
Percentage of Participants With Local Reactions Within 7 Days After Vaccination 1
Pain at the injection site: Mild
|
66.3 Percentage of participants
Interval 62.2 to 70.2
|
13.5 Percentage of participants
Interval 10.8 to 16.6
|
|
Percentage of Participants With Local Reactions Within 7 Days After Vaccination 1
Pain at the injection site: Moderate
|
19.9 Percentage of participants
Interval 16.6 to 23.4
|
0.4 Percentage of participants
Interval 0.0 to 1.3
|
|
Percentage of Participants With Local Reactions Within 7 Days After Vaccination 1
Pain at the injection site: Severe
|
0 Percentage of participants
Interval 0.0 to 0.7
|
0 Percentage of participants
Interval 0.0 to 0.7
|
|
Percentage of Participants With Local Reactions Within 7 Days After Vaccination 1
Pain at the injection site: Grade 4
|
0 Percentage of participants
Interval 0.0 to 0.7
|
0 Percentage of participants
Interval 0.0 to 0.7
|
PRIMARY outcome
Timeframe: Within 7 Days After Vaccination 2Population: 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.
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.
Outcome measures
| Measure |
Coadministration Group
n=557 Participants
Participants were randomized to receive 30 microgram (mcg) intramuscular (IM) injection of BNT162b2 vaccine along with IM injection of Seasonal Inactivated Influenza Vaccine (SIIV) on Day 1 (Visit 1), and IM injection of Placebo 1 month later (Visit 2).
|
Separate Administration Group
n=553 Participants
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).
|
|---|---|---|
|
Percentage of Participants With Local Reactions Within 7 Days After Vaccination 2
Redness: Severe
|
0 Percentage of participants
Interval 0.0 to 0.7
|
0 Percentage of participants
Interval 0.0 to 0.7
|
|
Percentage of Participants With Local Reactions Within 7 Days After Vaccination 2
Swelling: Moderate
|
0 Percentage of participants
Interval 0.0 to 0.7
|
3.1 Percentage of participants
Interval 1.8 to 4.9
|
|
Percentage of Participants With Local Reactions Within 7 Days After Vaccination 2
Swelling: Grade 4
|
0 Percentage of participants
Interval 0.0 to 0.7
|
0 Percentage of participants
Interval 0.0 to 0.7
|
|
Percentage of Participants With Local Reactions Within 7 Days After Vaccination 2
Pain at the injection site: Any
|
6.6 Percentage of participants
Interval 4.7 to 9.0
|
84.4 Percentage of participants
Interval 81.2 to 87.4
|
|
Percentage of Participants With Local Reactions Within 7 Days After Vaccination 2
Pain at the injection site: Moderate
|
0.4 Percentage of participants
Interval 0.0 to 1.3
|
22.4 Percentage of participants
Interval 19.0 to 26.1
|
|
Percentage of Participants With Local Reactions Within 7 Days After Vaccination 2
Pain at the injection site: Severe
|
0 Percentage of participants
Interval 0.0 to 0.7
|
0.4 Percentage of participants
Interval 0.0 to 1.3
|
|
Percentage of Participants With Local Reactions Within 7 Days After Vaccination 2
Redness: Any
|
0.2 Percentage of participants
Interval 0.0 to 1.0
|
4.7 Percentage of participants
Interval 3.1 to 6.8
|
|
Percentage of Participants With Local Reactions Within 7 Days After Vaccination 2
Redness: Mild
|
0.2 Percentage of participants
Interval 0.0 to 1.0
|
4.3 Percentage of participants
Interval 2.8 to 6.4
|
|
Percentage of Participants With Local Reactions Within 7 Days After Vaccination 2
Redness: Moderate
|
0 Percentage of participants
Interval 0.0 to 0.7
|
0.4 Percentage of participants
Interval 0.0 to 1.3
|
|
Percentage of Participants With Local Reactions Within 7 Days After Vaccination 2
Redness: Grade 4
|
0 Percentage of participants
Interval 0.0 to 0.7
|
0 Percentage of participants
Interval 0.0 to 0.7
|
|
Percentage of Participants With Local Reactions Within 7 Days After Vaccination 2
Swelling: Any
|
0.4 Percentage of participants
Interval 0.0 to 1.3
|
8.9 Percentage of participants
Interval 6.6 to 11.5
|
|
Percentage of Participants With Local Reactions Within 7 Days After Vaccination 2
Swelling: Mild
|
0.4 Percentage of participants
Interval 0.0 to 1.3
|
5.8 Percentage of participants
Interval 4.0 to 8.1
|
|
Percentage of Participants With Local Reactions Within 7 Days After Vaccination 2
Swelling: Severe
|
0 Percentage of participants
Interval 0.0 to 0.7
|
0 Percentage of participants
Interval 0.0 to 0.7
|
|
Percentage of Participants With Local Reactions Within 7 Days After Vaccination 2
Pain at the injection site: Mild
|
6.3 Percentage of participants
Interval 4.4 to 8.6
|
61.7 Percentage of participants
Interval 57.5 to 65.7
|
|
Percentage of Participants With Local Reactions Within 7 Days After Vaccination 2
Pain at the injection site: Grade 4
|
0 Percentage of participants
Interval 0.0 to 0.7
|
0 Percentage of participants
Interval 0.0 to 0.7
|
PRIMARY outcome
Timeframe: Within 7 Days After Vaccination 1Population: 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.
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.
Outcome measures
| Measure |
Coadministration Group
n=564 Participants
Participants were randomized to receive 30 microgram (mcg) intramuscular (IM) injection of BNT162b2 vaccine along with IM injection of Seasonal Inactivated Influenza Vaccine (SIIV) on Day 1 (Visit 1), and IM injection of Placebo 1 month later (Visit 2).
|
Separate Administration Group
n=563 Participants
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).
|
|---|---|---|
|
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
Interval 0.0 to 1.3
|
0.4 Percentage of participants
Interval 0.0 to 1.3
|
|
Percentage of Participants With Systemic Events Within 7 Days After Vaccination 1
Fatigue: Grade 4
|
0 Percentage of participants
Interval 0.0 to 0.7
|
0 Percentage of participants
Interval 0.0 to 0.7
|
|
Percentage of Participants With Systemic Events Within 7 Days After Vaccination 1
Headache: Any
|
47.2 Percentage of participants
Interval 43.0 to 51.4
|
34.3 Percentage of participants
Interval 30.4 to 38.4
|
|
Percentage of Participants With Systemic Events Within 7 Days After Vaccination 1
Headache: Grade 4
|
0 Percentage of participants
Interval 0.0 to 0.7
|
0 Percentage of participants
Interval 0.0 to 0.7
|
|
Percentage of Participants With Systemic Events Within 7 Days After Vaccination 1
Chills: Any
|
19.9 Percentage of participants
Interval 16.6 to 23.4
|
6.2 Percentage of participants
Interval 4.4 to 8.6
|
|
Percentage of Participants With Systemic Events Within 7 Days After Vaccination 1
Chills: Mild
|
12.9 Percentage of participants
Interval 10.3 to 16.0
|
4.3 Percentage of participants
Interval 2.8 to 6.3
|
|
Percentage of Participants With Systemic Events Within 7 Days After Vaccination 1
Chills: Moderate
|
6.0 Percentage of participants
Interval 4.2 to 8.3
|
1.6 Percentage of participants
Interval 0.7 to 3.0
|
|
Percentage of Participants With Systemic Events Within 7 Days After Vaccination 1
Chills: Severe
|
0.9 Percentage of participants
Interval 0.3 to 2.1
|
0.4 Percentage of participants
Interval 0.0 to 1.3
|
|
Percentage of Participants With Systemic Events Within 7 Days After Vaccination 1
Chills: Grade 4
|
0 Percentage of participants
Interval 0.0 to 0.7
|
0 Percentage of participants
Interval 0.0 to 0.7
|
|
Percentage of Participants With Systemic Events Within 7 Days After Vaccination 1
Vomiting: Any
|
2.7 Percentage of participants
Interval 1.5 to 4.3
|
0.9 Percentage of participants
Interval 0.3 to 2.1
|
|
Percentage of Participants With Systemic Events Within 7 Days After Vaccination 1
Vomiting: Mild
|
2.3 Percentage of participants
Interval 1.2 to 3.9
|
0.7 Percentage of participants
Interval 0.2 to 1.8
|
|
Percentage of Participants With Systemic Events Within 7 Days After Vaccination 1
Vomiting: Moderate
|
0.4 Percentage of participants
Interval 0.0 to 1.3
|
0.2 Percentage of participants
Interval 0.0 to 1.0
|
|
Percentage of Participants With Systemic Events Within 7 Days After Vaccination 1
Vomiting: Grade 4
|
0 Percentage of participants
Interval 0.0 to 0.7
|
0 Percentage of participants
Interval 0.0 to 0.7
|
|
Percentage of Participants With Systemic Events Within 7 Days After Vaccination 1
Diarrhea: Any
|
11.5 Percentage of participants
Interval 9.0 to 14.5
|
10.1 Percentage of participants
Interval 7.8 to 12.9
|
|
Percentage of Participants With Systemic Events Within 7 Days After Vaccination 1
Diarrhea: Severe
|
0.2 Percentage of participants
Interval 0.0 to 1.0
|
0 Percentage of participants
Interval 0.0 to 0.7
|
|
Percentage of Participants With Systemic Events Within 7 Days After Vaccination 1
Diarrhea: Grade 4
|
0 Percentage of participants
Interval 0.0 to 0.7
|
0 Percentage of participants
Interval 0.0 to 0.7
|
|
Percentage of Participants With Systemic Events Within 7 Days After Vaccination 1
New or worsened muscle pain: Any
|
27.7 Percentage of participants
Interval 24.0 to 31.6
|
11.4 Percentage of participants
Interval 8.9 to 14.3
|
|
Percentage of Participants With Systemic Events Within 7 Days After Vaccination 1
New or worsened muscle pain: Mild
|
15.8 Percentage of participants
Interval 12.9 to 19.1
|
6.2 Percentage of participants
Interval 4.4 to 8.6
|
|
Percentage of Participants With Systemic Events Within 7 Days After Vaccination 1
New or worsened joint pain: Grade 4
|
0 Percentage of participants
Interval 0.0 to 0.7
|
0 Percentage of participants
Interval 0.0 to 0.7
|
|
Percentage of Participants With Systemic Events Within 7 Days After Vaccination 1
Fever: >=38.0 deg C
|
2.0 Percentage of participants
Interval 1.0 to 3.5
|
1.1 Percentage of participants
Interval 0.4 to 2.3
|
|
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
Interval 0.5 to 2.5
|
0.4 Percentage of participants
Interval 0.0 to 1.3
|
|
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
Interval 0.0 to 1.3
|
0.4 Percentage of participants
Interval 0.0 to 1.3
|
|
Percentage of Participants With Systemic Events Within 7 Days After Vaccination 1
Fever: >40.0 deg C
|
0.0 Percentage of participants
Interval 0.0 to 0.7
|
0.0 Percentage of participants
Interval 0.0 to 0.7
|
|
Percentage of Participants With Systemic Events Within 7 Days After Vaccination 1
Fatigue: Any
|
64.0 Percentage of participants
Interval 59.9 to 68.0
|
42.1 Percentage of participants
Interval 38.0 to 46.3
|
|
Percentage of Participants With Systemic Events Within 7 Days After Vaccination 1
Fatigue: Mild
|
31.9 Percentage of participants
Interval 28.1 to 35.9
|
24.7 Percentage of participants
Interval 21.2 to 28.5
|
|
Percentage of Participants With Systemic Events Within 7 Days After Vaccination 1
Fatigue: Moderate
|
30.9 Percentage of participants
Interval 27.1 to 34.8
|
16.3 Percentage of participants
Interval 13.4 to 19.7
|
|
Percentage of Participants With Systemic Events Within 7 Days After Vaccination 1
Fatigue: Severe
|
1.2 Percentage of participants
Interval 0.5 to 2.5
|
1.1 Percentage of participants
Interval 0.4 to 2.3
|
|
Percentage of Participants With Systemic Events Within 7 Days After Vaccination 1
Headache: Mild
|
28.2 Percentage of participants
Interval 24.5 to 32.1
|
23.3 Percentage of participants
Interval 19.9 to 27.0
|
|
Percentage of Participants With Systemic Events Within 7 Days After Vaccination 1
Headache: Moderate
|
17.9 Percentage of participants
Interval 14.8 to 21.3
|
10.3 Percentage of participants
Interval 7.9 to 13.1
|
|
Percentage of Participants With Systemic Events Within 7 Days After Vaccination 1
Headache: Severe
|
1.1 Percentage of participants
Interval 0.4 to 2.3
|
0.7 Percentage of participants
Interval 0.2 to 1.8
|
|
Percentage of Participants With Systemic Events Within 7 Days After Vaccination 1
Diarrhea: Moderate
|
1.4 Percentage of participants
Interval 0.6 to 2.8
|
1.2 Percentage of participants
Interval 0.5 to 2.5
|
|
Percentage of Participants With Systemic Events Within 7 Days After Vaccination 1
New or worsened muscle pain: Moderate
|
11.3 Percentage of participants
Interval 8.8 to 14.3
|
5.0 Percentage of participants
Interval 3.3 to 7.1
|
|
Percentage of Participants With Systemic Events Within 7 Days After Vaccination 1
New or worsened muscle pain: Severe
|
0.5 Percentage of participants
Interval 0.1 to 1.5
|
0.2 Percentage of participants
Interval 0.0 to 1.0
|
|
Percentage of Participants With Systemic Events Within 7 Days After Vaccination 1
New or worsened muscle pain: Grade 4
|
0 Percentage of participants
Interval 0.0 to 0.7
|
0 Percentage of participants
Interval 0.0 to 0.7
|
|
Percentage of Participants With Systemic Events Within 7 Days After Vaccination 1
New or worsened joint pain: Any
|
15.1 Percentage of participants
Interval 12.2 to 18.3
|
5.3 Percentage of participants
Interval 3.6 to 7.5
|
|
Percentage of Participants With Systemic Events Within 7 Days After Vaccination 1
New or worsened joint pain: Mild
|
10.3 Percentage of participants
Interval 7.9 to 13.1
|
2.7 Percentage of participants
Interval 1.5 to 4.4
|
|
Percentage of Participants With Systemic Events Within 7 Days After Vaccination 1
New or worsened joint pain: Moderate
|
4.8 Percentage of participants
Interval 3.2 to 6.9
|
2.7 Percentage of participants
Interval 1.5 to 4.4
|
|
Percentage of Participants With Systemic Events Within 7 Days After Vaccination 1
New or worsened joint pain: Severe
|
0 Percentage of participants
Interval 0.0 to 0.7
|
0 Percentage of participants
Interval 0.0 to 0.7
|
|
Percentage of Participants With Systemic Events Within 7 Days After Vaccination 1
Vomiting: Severe
|
0 Percentage of participants
Interval 0.0 to 0.7
|
0 Percentage of participants
Interval 0.0 to 0.7
|
|
Percentage of Participants With Systemic Events Within 7 Days After Vaccination 1
Diarrhea: Mild
|
9.9 Percentage of participants
Interval 7.6 to 12.7
|
8.9 Percentage of participants
Interval 6.7 to 11.6
|
PRIMARY outcome
Timeframe: Within 7 Days After Vaccination 2Population: 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.
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.
Outcome measures
| Measure |
Coadministration Group
n=557 Participants
Participants were randomized to receive 30 microgram (mcg) intramuscular (IM) injection of BNT162b2 vaccine along with IM injection of Seasonal Inactivated Influenza Vaccine (SIIV) on Day 1 (Visit 1), and IM injection of Placebo 1 month later (Visit 2).
|
Separate Administration Group
n=553 Participants
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).
|
|---|---|---|
|
Percentage of Participants With Systemic Events Within 7 Days After Vaccination 2
Fever: >=38.0 deg C
|
1.1 Percentage of participants
Interval 0.4 to 2.3
|
1.6 Percentage of participants
Interval 0.7 to 3.1
|
|
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
Interval 0.0 to 0.7
|
0 Percentage of participants
Interval 0.0 to 0.7
|
|
Percentage of Participants With Systemic Events Within 7 Days After Vaccination 2
Fever: >40.0 deg C
|
0. Percentage of participants
Interval 0.0 to 0.7
|
0 Percentage of participants
Interval 0.0 to 0.7
|
|
Percentage of Participants With Systemic Events Within 7 Days After Vaccination 2
Fatigue: Grade 4
|
0 Percentage of participants
Interval 0.0 to 0.7
|
0 Percentage of participants
Interval 0.0 to 0.7
|
|
Percentage of Participants With Systemic Events Within 7 Days After Vaccination 2
Chills: Moderate
|
1.1 Percentage of participants
Interval 0.4 to 2.3
|
4.7 Percentage of participants
Interval 3.1 to 6.8
|
|
Percentage of Participants With Systemic Events Within 7 Days After Vaccination 2
Vomiting: Any
|
1.1 Percentage of participants
Interval 0.4 to 2.3
|
2.4 Percentage of participants
Interval 1.3 to 4.0
|
|
Percentage of Participants With Systemic Events Within 7 Days After Vaccination 2
Vomiting: Mild
|
0.7 Percentage of participants
Interval 0.2 to 1.8
|
1.8 Percentage of participants
Interval 0.9 to 3.3
|
|
Percentage of Participants With Systemic Events Within 7 Days After Vaccination 2
Vomiting: Moderate
|
0.4 Percentage of participants
Interval 0.0 to 1.3
|
0.5 Percentage of participants
Interval 0.1 to 1.6
|
|
Percentage of Participants With Systemic Events Within 7 Days After Vaccination 2
Vomiting: Severe
|
0 Percentage of participants
Interval 0.0 to 0.7
|
0 Percentage of participants
Interval 0.0 to 0.7
|
|
Percentage of Participants With Systemic Events Within 7 Days After Vaccination 2
Vomiting: Grade 4
|
0 Percentage of participants
Interval 0.0 to 0.7
|
0 Percentage of participants
Interval 0.0 to 0.7
|
|
Percentage of Participants With Systemic Events Within 7 Days After Vaccination 2
Diarrhea: Any
|
4.5 Percentage of participants
Interval 2.9 to 6.6
|
6.5 Percentage of participants
Interval 4.6 to 8.9
|
|
Percentage of Participants With Systemic Events Within 7 Days After Vaccination 2
Diarrhea: Mild
|
3.8 Percentage of participants
Interval 2.3 to 5.7
|
5.2 Percentage of participants
Interval 3.5 to 7.4
|
|
Percentage of Participants With Systemic Events Within 7 Days After Vaccination 2
New or worsened muscle pain: Mild
|
2.7 Percentage of participants
Interval 1.5 to 4.4
|
12.8 Percentage of participants
Interval 10.2 to 15.9
|
|
Percentage of Participants With Systemic Events Within 7 Days After Vaccination 2
New or worsened muscle pain: Grade 4
|
0 Percentage of participants
Interval 0.0 to 0.7
|
0 Percentage of participants
Interval 0.0 to 0.7
|
|
Percentage of Participants With Systemic Events Within 7 Days After Vaccination 2
New or worsened joint pain: Any
|
3.4 Percentage of participants
Interval 2.1 to 5.3
|
9.8 Percentage of participants
Interval 7.4 to 12.5
|
|
Percentage of Participants With Systemic Events Within 7 Days After Vaccination 2
New or worsened joint pain: Severe
|
0 Percentage of participants
Interval 0.0 to 0.7
|
0 Percentage of participants
Interval 0.0 to 0.7
|
|
Percentage of Participants With Systemic Events Within 7 Days After Vaccination 2
New or worsened joint pain: Grade 4
|
0 Percentage of participants
Interval 0.0 to 0.7
|
0 Percentage of participants
Interval 0.0 to 0.7
|
|
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
Interval 0.1 to 1.6
|
1.1 Percentage of participants
Interval 0.4 to 2.3
|
|
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
Interval 0.1 to 1.6
|
0.5 Percentage of participants
Interval 0.1 to 1.6
|
|
Percentage of Participants With Systemic Events Within 7 Days After Vaccination 2
Fatigue: Any
|
21.7 Percentage of participants
Interval 18.4 to 25.4
|
50.8 Percentage of participants
Interval 46.6 to 55.1
|
|
Percentage of Participants With Systemic Events Within 7 Days After Vaccination 2
Fatigue: Mild
|
12.4 Percentage of participants
Interval 9.8 to 15.4
|
27.3 Percentage of participants
Interval 23.6 to 31.2
|
|
Percentage of Participants With Systemic Events Within 7 Days After Vaccination 2
Fatigue: Moderate
|
8.6 Percentage of participants
Interval 6.4 to 11.3
|
22.1 Percentage of participants
Interval 18.7 to 25.8
|
|
Percentage of Participants With Systemic Events Within 7 Days After Vaccination 2
Fatigue: Severe
|
0.7 Percentage of participants
Interval 0.2 to 1.8
|
1.4 Percentage of participants
Interval 0.6 to 2.8
|
|
Percentage of Participants With Systemic Events Within 7 Days After Vaccination 2
Headache: Any
|
20.8 Percentage of participants
Interval 17.5 to 24.4
|
37.8 Percentage of participants
Interval 33.7 to 42.0
|
|
Percentage of Participants With Systemic Events Within 7 Days After Vaccination 2
Headache: Mild
|
13.1 Percentage of participants
Interval 10.4 to 16.2
|
25.0 Percentage of participants
Interval 21.4 to 28.8
|
|
Percentage of Participants With Systemic Events Within 7 Days After Vaccination 2
Headache: Moderate
|
7.5 Percentage of participants
Interval 5.5 to 10.1
|
12.1 Percentage of participants
Interval 9.5 to 15.1
|
|
Percentage of Participants With Systemic Events Within 7 Days After Vaccination 2
Headache: Severe
|
0.2 Percentage of participants
Interval 0.0 to 1.0
|
0.7 Percentage of participants
Interval 0.2 to 1.8
|
|
Percentage of Participants With Systemic Events Within 7 Days After Vaccination 2
Headache: Grade 4
|
0 Percentage of participants
Interval 0.0 to 0.7
|
0 Percentage of participants
Interval 0.0 to 0.7
|
|
Percentage of Participants With Systemic Events Within 7 Days After Vaccination 2
Chills: Any
|
3.4 Percentage of participants
Interval 2.1 to 5.3
|
13.4 Percentage of participants
Interval 10.7 to 16.5
|
|
Percentage of Participants With Systemic Events Within 7 Days After Vaccination 2
Chills: Mild
|
2.3 Percentage of participants
Interval 1.2 to 4.0
|
8.5 Percentage of participants
Interval 6.3 to 11.1
|
|
Percentage of Participants With Systemic Events Within 7 Days After Vaccination 2
Diarrhea: Moderate
|
0.7 Percentage of participants
Interval 0.2 to 1.8
|
0.9 Percentage of participants
Interval 0.3 to 2.1
|
|
Percentage of Participants With Systemic Events Within 7 Days After Vaccination 2
Diarrhea: Severe
|
0 Percentage of participants
Interval 0.0 to 0.7
|
0.4 Percentage of participants
Interval 0.0 to 1.3
|
|
Percentage of Participants With Systemic Events Within 7 Days After Vaccination 2
Diarrhea: Grade 4
|
0 Percentage of participants
Interval 0.0 to 0.7
|
0 Percentage of participants
Interval 0.0 to 0.7
|
|
Percentage of Participants With Systemic Events Within 7 Days After Vaccination 2
New or worsened muscle pain: Any
|
5.2 Percentage of participants
Interval 3.5 to 7.4
|
23.5 Percentage of participants
Interval 20.0 to 27.3
|
|
Percentage of Participants With Systemic Events Within 7 Days After Vaccination 2
New or worsened muscle pain: Moderate
|
2.5 Percentage of participants
Interval 1.4 to 4.2
|
10.5 Percentage of participants
Interval 8.1 to 13.3
|
|
Percentage of Participants With Systemic Events Within 7 Days After Vaccination 2
New or worsened muscle pain: Severe
|
0 Percentage of participants
Interval 0.0 to 0.7
|
0.2 Percentage of participants
Interval 0.0 to 1.0
|
|
Percentage of Participants With Systemic Events Within 7 Days After Vaccination 2
New or worsened joint pain: Mild
|
2.0 Percentage of participants
Interval 1.0 to 3.5
|
5.6 Percentage of participants
Interval 3.8 to 7.9
|
|
Percentage of Participants With Systemic Events Within 7 Days After Vaccination 2
New or worsened joint pain: Moderate
|
1.4 Percentage of participants
Interval 0.6 to 2.8
|
4.2 Percentage of participants
Interval 2.7 to 6.2
|
|
Percentage of Participants With Systemic Events Within 7 Days After Vaccination 2
Chills: Severe
|
0 Percentage of participants
Interval 0.0 to 0.7
|
0.2 Percentage of participants
Interval 0.0 to 1.0
|
|
Percentage of Participants With Systemic Events Within 7 Days After Vaccination 2
Chills: Grade 4
|
0 Percentage of participants
Interval 0.0 to 0.7
|
0 Percentage of participants
Interval 0.0 to 0.7
|
PRIMARY outcome
Timeframe: Within 1 month after Vaccination 1Population: Safety population included all participants who received any of the study intervention.
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.
Outcome measures
| Measure |
Coadministration Group
n=564 Participants
Participants were randomized to receive 30 microgram (mcg) intramuscular (IM) injection of BNT162b2 vaccine along with IM injection of Seasonal Inactivated Influenza Vaccine (SIIV) on Day 1 (Visit 1), and IM injection of Placebo 1 month later (Visit 2).
|
Separate Administration Group
n=564 Participants
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).
|
|---|---|---|
|
Percentage of Participants With Adverse Events Within 1 Month After Vaccination 1
|
31.6 Percentage of participants
Interval 27.7 to 35.6
|
30.5 Percentage of participants
Interval 26.7 to 34.5
|
PRIMARY outcome
Timeframe: Within 1 month after Vaccination 2Population: 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''.
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.
Outcome measures
| Measure |
Coadministration Group
n=562 Participants
Participants were randomized to receive 30 microgram (mcg) intramuscular (IM) injection of BNT162b2 vaccine along with IM injection of Seasonal Inactivated Influenza Vaccine (SIIV) on Day 1 (Visit 1), and IM injection of Placebo 1 month later (Visit 2).
|
Separate Administration Group
n=557 Participants
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).
|
|---|---|---|
|
Percentage of Participants With Adverse Events Within 1 Month After Vaccination 2
|
29.0 Percentage of participants
Interval 25.3 to 32.9
|
25.1 Percentage of participants
Interval 21.6 to 29.0
|
PRIMARY outcome
Timeframe: Within 1 Month After Vaccination 1Population: Safety population included all participants who received any of the study intervention.
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.
Outcome measures
| Measure |
Coadministration Group
n=564 Participants
Participants were randomized to receive 30 microgram (mcg) intramuscular (IM) injection of BNT162b2 vaccine along with IM injection of Seasonal Inactivated Influenza Vaccine (SIIV) on Day 1 (Visit 1), and IM injection of Placebo 1 month later (Visit 2).
|
Separate Administration Group
n=564 Participants
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).
|
|---|---|---|
|
Percentage of Participants With Serious Adverse Events Within 1 Month After Vaccination 1
|
0.4 Percentage of participants
Interval 0.0 to 1.3
|
0.2 Percentage of participants
Interval 0.0 to 1.0
|
PRIMARY outcome
Timeframe: Within 1 Month After Vaccination 2Population: 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''.
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.
Outcome measures
| Measure |
Coadministration Group
n=562 Participants
Participants were randomized to receive 30 microgram (mcg) intramuscular (IM) injection of BNT162b2 vaccine along with IM injection of Seasonal Inactivated Influenza Vaccine (SIIV) on Day 1 (Visit 1), and IM injection of Placebo 1 month later (Visit 2).
|
Separate Administration Group
n=557 Participants
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).
|
|---|---|---|
|
Percentage of Participants With Serious Adverse Events Within 1 Month After Vaccination 2
|
0.5 Percentage of participants
Interval 0.1 to 1.6
|
0.7 Percentage of participants
Interval 0.2 to 1.8
|
PRIMARY outcome
Timeframe: 1 Month After BNT162b2 vaccinationPopulation: 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.
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.
Outcome measures
| Measure |
Coadministration Group
n=499 Participants
Participants were randomized to receive 30 microgram (mcg) intramuscular (IM) injection of BNT162b2 vaccine along with IM injection of Seasonal Inactivated Influenza Vaccine (SIIV) on Day 1 (Visit 1), and IM injection of Placebo 1 month later (Visit 2).
|
Separate Administration Group
n=413 Participants
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).
|
|---|---|---|
|
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)
Interval 13110.0 to 14458.6
|
16644.5 Units per millilitre (U/mL)
Interval 15774.7 to 17562.3
|
PRIMARY outcome
Timeframe: 1 Month After SIIV vaccinationPopulation: 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.
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.
Outcome measures
| Measure |
Coadministration Group
n=515 Participants
Participants were randomized to receive 30 microgram (mcg) intramuscular (IM) injection of BNT162b2 vaccine along with IM injection of Seasonal Inactivated Influenza Vaccine (SIIV) on Day 1 (Visit 1), and IM injection of Placebo 1 month later (Visit 2).
|
Separate Administration Group
n=484 Participants
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).
|
|---|---|---|
|
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
Interval 71.7 to 89.6
|
89.7 Titer
Interval 80.0 to 100.7
|
|
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
Interval 74.4 to 88.9
|
81.3 Titer
Interval 74.2 to 89.2
|
|
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
Interval 207.2 to 248.3
|
235.6 Titer
Interval 214.6 to 258.7
|
|
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
Interval 273.1 to 333.4
|
316.5 Titer
Interval 285.5 to 350.9
|
SECONDARY outcome
Timeframe: Before BNT162b2 vaccination, and 1 month After BNT162b2 vaccinationPopulation: 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.
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''.
Outcome measures
| Measure |
Coadministration Group
n=499 Participants
Participants were randomized to receive 30 microgram (mcg) intramuscular (IM) injection of BNT162b2 vaccine along with IM injection of Seasonal Inactivated Influenza Vaccine (SIIV) on Day 1 (Visit 1), and IM injection of Placebo 1 month later (Visit 2).
|
Separate Administration Group
n=413 Participants
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).
|
|---|---|---|
|
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)
Interval 5034.7 to 6052.8
|
5272.3 Units per millilitre (U/mL)
Interval 4704.3 to 5909.0
|
|
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)
Interval 12838.9 to 14847.0
|
16254.6 Units per millilitre (U/mL)
Interval 15035.5 to 17572.5
|
SECONDARY outcome
Timeframe: From before BNT162b2 vaccination to 1 month After BNT162b2 vaccinationPopulation: 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.
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''.
Outcome measures
| Measure |
Coadministration Group
n=499 Participants
Participants were randomized to receive 30 microgram (mcg) intramuscular (IM) injection of BNT162b2 vaccine along with IM injection of Seasonal Inactivated Influenza Vaccine (SIIV) on Day 1 (Visit 1), and IM injection of Placebo 1 month later (Visit 2).
|
Separate Administration Group
n=413 Participants
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).
|
|---|---|---|
|
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
Interval 2.4 to 2.7
|
3.1 Fold rise
Interval 2.9 to 3.3
|
SECONDARY outcome
Timeframe: Before BNT162b2 vaccination, and 1 month after BNT162b2 vaccinationPopulation: 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.
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.
Outcome measures
| Measure |
Coadministration Group
n=100 Participants
Participants were randomized to receive 30 microgram (mcg) intramuscular (IM) injection of BNT162b2 vaccine along with IM injection of Seasonal Inactivated Influenza Vaccine (SIIV) on Day 1 (Visit 1), and IM injection of Placebo 1 month later (Visit 2).
|
Separate Administration Group
n=100 Participants
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).
|
|---|---|---|
|
Geometric Mean Titer (GMT) of SARS-CoV-2 Neutralizing Titers Before Vaccination and 1 Month After BNT162b2 Vaccination
Before BNT162b2 Vaccination
|
2755.9 Titer
Interval 2107.6 to 3603.4
|
2421.2 Titer
Interval 1780.1 to 3293.3
|
|
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
Interval 5545.0 to 8275.3
|
7886.6 Titer
Interval 6264.9 to 9928.2
|
SECONDARY outcome
Timeframe: From before BNT162b2 vaccination to 1 month after BNT162b2 vaccinationPopulation: 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.
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.
Outcome measures
| Measure |
Coadministration Group
n=100 Participants
Participants were randomized to receive 30 microgram (mcg) intramuscular (IM) injection of BNT162b2 vaccine along with IM injection of Seasonal Inactivated Influenza Vaccine (SIIV) on Day 1 (Visit 1), and IM injection of Placebo 1 month later (Visit 2).
|
Separate Administration Group
n=100 Participants
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).
|
|---|---|---|
|
Geometric Mean Fold Rise (GMFR) of SARS-CoV-2 Neutralizing Titers From Before Vaccination to 1 Month After BNT162b2 Vaccination
|
2.5 Fold rise
Interval 2.1 to 2.9
|
3.3 Fold rise
Interval 2.7 to 3.9
|
SECONDARY outcome
Timeframe: Before SIIV vaccination, and 1 month after SIIV vaccinationPopulation: 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.
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.
Outcome measures
| Measure |
Coadministration Group
n=520 Participants
Participants were randomized to receive 30 microgram (mcg) intramuscular (IM) injection of BNT162b2 vaccine along with IM injection of Seasonal Inactivated Influenza Vaccine (SIIV) on Day 1 (Visit 1), and IM injection of Placebo 1 month later (Visit 2).
|
Separate Administration Group
n=496 Participants
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).
|
|---|---|---|
|
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
Interval 64.2 to 81.7
|
78.3 Titer
Interval 69.3 to 88.5
|
|
Geometric Mean Titer (GMT) of Strain-Specific HAI Titers Before Vaccination and 1 Month After SIIV Vaccination
B/Phuket: Before Vaccination
|
26.4 Titer
Interval 23.8 to 29.4
|
25.7 Titer
Interval 23.0 to 28.6
|
|
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
Interval 79.7 to 95.7
|
86.3 Titer
Interval 78.4 to 94.9
|
|
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
Interval 49.5 to 65.6
|
56.3 Titer
Interval 48.9 to 64.7
|
|
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
Interval 312.4 to 379.3
|
362.3 Titer
Interval 326.8 to 401.6
|
|
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
Interval 35.6 to 43.7
|
38.4 Titer
Interval 34.5 to 42.8
|
|
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
Interval 209.5 to 253.8
|
242.2 Titer
Interval 221.2 to 265.2
|
|
Geometric Mean Titer (GMT) of Strain-Specific HAI Titers Before Vaccination and 1 Month After SIIV Vaccination
B/Austria: Before Vaccination
|
13.0 Titer
Interval 11.7 to 14.5
|
12.7 Titer
Interval 11.5 to 14.1
|
SECONDARY outcome
Timeframe: From before vaccination to 1 month after SIIV vaccinationPopulation: 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.
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.
Outcome measures
| Measure |
Coadministration Group
n=515 Participants
Participants were randomized to receive 30 microgram (mcg) intramuscular (IM) injection of BNT162b2 vaccine along with IM injection of Seasonal Inactivated Influenza Vaccine (SIIV) on Day 1 (Visit 1), and IM injection of Placebo 1 month later (Visit 2).
|
Separate Administration Group
n=484 Participants
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).
|
|---|---|---|
|
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
Interval 4.9 to 6.2
|
6.3 Fold rise
Interval 5.6 to 7.1
|
|
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
Interval 2.9 to 3.7
|
3.4 Fold rise
Interval 3.0 to 3.8
|
|
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
Interval 5.1 to 7.0
|
6.4 Fold rise
Interval 5.5 to 7.5
|
|
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
Interval 5.3 to 6.6
|
6.3 Fold rise
Interval 5.6 to 7.1
|
Adverse Events
Coadministration Group (Visit 1)
Serious events: 2 serious events
Other events: 532 other events
Deaths: 0 deaths
Coadministration Group (Visit 2)
Serious events: 3 serious events
Other events: 261 other events
Deaths: 0 deaths
Separate Administration Group (Visit 1)
Serious events: 1 serious events
Other events: 364 other events
Deaths: 0 deaths
Separate Administration Group (Visit 2)
Serious events: 4 serious events
Other events: 502 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Coadministration Group (Visit 1)
n=564 participants at risk
Participants were randomized to receive 30 microgram (mcg) intramuscular (IM) injection of BNT162b2 vaccine along with IM injection of Seasonal Inactivated Influenza Vaccine (SIIV) on Day 1 (Visit 1), and IM injection of Placebo 1 month later (Visit 2).
|
Coadministration Group (Visit 2)
n=562 participants at risk
Participants were randomized to receive 30 microgram (mcg) intramuscular (IM) injection of BNT162b2 vaccine along with IM injection of Seasonal Inactivated Influenza Vaccine (SIIV) on Day 1 (Visit 1), and IM injection of Placebo 1 month later (Visit 2).
|
Separate Administration Group (Visit 1)
n=564 participants at risk
Participants were randomized to receive an intramuscular (IM) injection of Placebo along with IM injection of Seasonal Inactivated Influenza Vaccine (SIIV) on Day 1 (Visit 1), and 30 mcg IM injection of BNT162b2 vaccine 1 month later (Visit 2).
|
Separate Administration Group (Visit 2)
n=557 participants at risk
Participants were randomized to receive an intramuscular (IM) injection of Placebo along with IM injection of Seasonal Inactivated Influenza Vaccine (SIIV) on Day 1 (Visit 1), and 30 mcg IM injection of BNT162b2 vaccine 1 month later (Visit 2).
|
|---|---|---|---|---|
|
Cardiac disorders
Atrial fibrillation
|
0.00%
0/564 • AEs and SAEs: From Day 1 (Visit 1) to 1 month after last dose of study vaccine (approximately 2 months after Visit 1 [Day1]); Local reactions (at the BNT162b2/placebo injection site) and systemic events: Within 7 days after each vaccination
An AE may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may experience both serious and non-serious AE during the study. Safety population included all participants who received any of the study intervention. AEs included events collected in electronic diary (local and systemic reactions; systematic assessment) and events collected on case report form at each visit (non-systematic assessment).
|
0.00%
0/562 • AEs and SAEs: From Day 1 (Visit 1) to 1 month after last dose of study vaccine (approximately 2 months after Visit 1 [Day1]); Local reactions (at the BNT162b2/placebo injection site) and systemic events: Within 7 days after each vaccination
An AE may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may experience both serious and non-serious AE during the study. Safety population included all participants who received any of the study intervention. AEs included events collected in electronic diary (local and systemic reactions; systematic assessment) and events collected on case report form at each visit (non-systematic assessment).
|
0.00%
0/564 • AEs and SAEs: From Day 1 (Visit 1) to 1 month after last dose of study vaccine (approximately 2 months after Visit 1 [Day1]); Local reactions (at the BNT162b2/placebo injection site) and systemic events: Within 7 days after each vaccination
An AE may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may experience both serious and non-serious AE during the study. Safety population included all participants who received any of the study intervention. AEs included events collected in electronic diary (local and systemic reactions; systematic assessment) and events collected on case report form at each visit (non-systematic assessment).
|
0.18%
1/557 • AEs and SAEs: From Day 1 (Visit 1) to 1 month after last dose of study vaccine (approximately 2 months after Visit 1 [Day1]); Local reactions (at the BNT162b2/placebo injection site) and systemic events: Within 7 days after each vaccination
An AE may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may experience both serious and non-serious AE during the study. Safety population included all participants who received any of the study intervention. AEs included events collected in electronic diary (local and systemic reactions; systematic assessment) and events collected on case report form at each visit (non-systematic assessment).
|
|
Gastrointestinal disorders
Intestinal perforation
|
0.00%
0/564 • AEs and SAEs: From Day 1 (Visit 1) to 1 month after last dose of study vaccine (approximately 2 months after Visit 1 [Day1]); Local reactions (at the BNT162b2/placebo injection site) and systemic events: Within 7 days after each vaccination
An AE may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may experience both serious and non-serious AE during the study. Safety population included all participants who received any of the study intervention. AEs included events collected in electronic diary (local and systemic reactions; systematic assessment) and events collected on case report form at each visit (non-systematic assessment).
|
0.18%
1/562 • AEs and SAEs: From Day 1 (Visit 1) to 1 month after last dose of study vaccine (approximately 2 months after Visit 1 [Day1]); Local reactions (at the BNT162b2/placebo injection site) and systemic events: Within 7 days after each vaccination
An AE may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may experience both serious and non-serious AE during the study. Safety population included all participants who received any of the study intervention. AEs included events collected in electronic diary (local and systemic reactions; systematic assessment) and events collected on case report form at each visit (non-systematic assessment).
|
0.00%
0/564 • AEs and SAEs: From Day 1 (Visit 1) to 1 month after last dose of study vaccine (approximately 2 months after Visit 1 [Day1]); Local reactions (at the BNT162b2/placebo injection site) and systemic events: Within 7 days after each vaccination
An AE may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may experience both serious and non-serious AE during the study. Safety population included all participants who received any of the study intervention. AEs included events collected in electronic diary (local and systemic reactions; systematic assessment) and events collected on case report form at each visit (non-systematic assessment).
|
0.00%
0/557 • AEs and SAEs: From Day 1 (Visit 1) to 1 month after last dose of study vaccine (approximately 2 months after Visit 1 [Day1]); Local reactions (at the BNT162b2/placebo injection site) and systemic events: Within 7 days after each vaccination
An AE may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may experience both serious and non-serious AE during the study. Safety population included all participants who received any of the study intervention. AEs included events collected in electronic diary (local and systemic reactions; systematic assessment) and events collected on case report form at each visit (non-systematic assessment).
|
|
Infections and infestations
Abscess limb
|
0.00%
0/564 • AEs and SAEs: From Day 1 (Visit 1) to 1 month after last dose of study vaccine (approximately 2 months after Visit 1 [Day1]); Local reactions (at the BNT162b2/placebo injection site) and systemic events: Within 7 days after each vaccination
An AE may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may experience both serious and non-serious AE during the study. Safety population included all participants who received any of the study intervention. AEs included events collected in electronic diary (local and systemic reactions; systematic assessment) and events collected on case report form at each visit (non-systematic assessment).
|
0.00%
0/562 • AEs and SAEs: From Day 1 (Visit 1) to 1 month after last dose of study vaccine (approximately 2 months after Visit 1 [Day1]); Local reactions (at the BNT162b2/placebo injection site) and systemic events: Within 7 days after each vaccination
An AE may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may experience both serious and non-serious AE during the study. Safety population included all participants who received any of the study intervention. AEs included events collected in electronic diary (local and systemic reactions; systematic assessment) and events collected on case report form at each visit (non-systematic assessment).
|
0.18%
1/564 • AEs and SAEs: From Day 1 (Visit 1) to 1 month after last dose of study vaccine (approximately 2 months after Visit 1 [Day1]); Local reactions (at the BNT162b2/placebo injection site) and systemic events: Within 7 days after each vaccination
An AE may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may experience both serious and non-serious AE during the study. Safety population included all participants who received any of the study intervention. AEs included events collected in electronic diary (local and systemic reactions; systematic assessment) and events collected on case report form at each visit (non-systematic assessment).
|
0.00%
0/557 • AEs and SAEs: From Day 1 (Visit 1) to 1 month after last dose of study vaccine (approximately 2 months after Visit 1 [Day1]); Local reactions (at the BNT162b2/placebo injection site) and systemic events: Within 7 days after each vaccination
An AE may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may experience both serious and non-serious AE during the study. Safety population included all participants who received any of the study intervention. AEs included events collected in electronic diary (local and systemic reactions; systematic assessment) and events collected on case report form at each visit (non-systematic assessment).
|
|
Infections and infestations
Wound infection
|
0.18%
1/564 • AEs and SAEs: From Day 1 (Visit 1) to 1 month after last dose of study vaccine (approximately 2 months after Visit 1 [Day1]); Local reactions (at the BNT162b2/placebo injection site) and systemic events: Within 7 days after each vaccination
An AE may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may experience both serious and non-serious AE during the study. Safety population included all participants who received any of the study intervention. AEs included events collected in electronic diary (local and systemic reactions; systematic assessment) and events collected on case report form at each visit (non-systematic assessment).
|
0.00%
0/562 • AEs and SAEs: From Day 1 (Visit 1) to 1 month after last dose of study vaccine (approximately 2 months after Visit 1 [Day1]); Local reactions (at the BNT162b2/placebo injection site) and systemic events: Within 7 days after each vaccination
An AE may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may experience both serious and non-serious AE during the study. Safety population included all participants who received any of the study intervention. AEs included events collected in electronic diary (local and systemic reactions; systematic assessment) and events collected on case report form at each visit (non-systematic assessment).
|
0.00%
0/564 • AEs and SAEs: From Day 1 (Visit 1) to 1 month after last dose of study vaccine (approximately 2 months after Visit 1 [Day1]); Local reactions (at the BNT162b2/placebo injection site) and systemic events: Within 7 days after each vaccination
An AE may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may experience both serious and non-serious AE during the study. Safety population included all participants who received any of the study intervention. AEs included events collected in electronic diary (local and systemic reactions; systematic assessment) and events collected on case report form at each visit (non-systematic assessment).
|
0.00%
0/557 • AEs and SAEs: From Day 1 (Visit 1) to 1 month after last dose of study vaccine (approximately 2 months after Visit 1 [Day1]); Local reactions (at the BNT162b2/placebo injection site) and systemic events: Within 7 days after each vaccination
An AE may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may experience both serious and non-serious AE during the study. Safety population included all participants who received any of the study intervention. AEs included events collected in electronic diary (local and systemic reactions; systematic assessment) and events collected on case report form at each visit (non-systematic assessment).
|
|
Injury, poisoning and procedural complications
Concussion
|
0.00%
0/564 • AEs and SAEs: From Day 1 (Visit 1) to 1 month after last dose of study vaccine (approximately 2 months after Visit 1 [Day1]); Local reactions (at the BNT162b2/placebo injection site) and systemic events: Within 7 days after each vaccination
An AE may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may experience both serious and non-serious AE during the study. Safety population included all participants who received any of the study intervention. AEs included events collected in electronic diary (local and systemic reactions; systematic assessment) and events collected on case report form at each visit (non-systematic assessment).
|
0.00%
0/562 • AEs and SAEs: From Day 1 (Visit 1) to 1 month after last dose of study vaccine (approximately 2 months after Visit 1 [Day1]); Local reactions (at the BNT162b2/placebo injection site) and systemic events: Within 7 days after each vaccination
An AE may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may experience both serious and non-serious AE during the study. Safety population included all participants who received any of the study intervention. AEs included events collected in electronic diary (local and systemic reactions; systematic assessment) and events collected on case report form at each visit (non-systematic assessment).
|
0.00%
0/564 • AEs and SAEs: From Day 1 (Visit 1) to 1 month after last dose of study vaccine (approximately 2 months after Visit 1 [Day1]); Local reactions (at the BNT162b2/placebo injection site) and systemic events: Within 7 days after each vaccination
An AE may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may experience both serious and non-serious AE during the study. Safety population included all participants who received any of the study intervention. AEs included events collected in electronic diary (local and systemic reactions; systematic assessment) and events collected on case report form at each visit (non-systematic assessment).
|
0.18%
1/557 • AEs and SAEs: From Day 1 (Visit 1) to 1 month after last dose of study vaccine (approximately 2 months after Visit 1 [Day1]); Local reactions (at the BNT162b2/placebo injection site) and systemic events: Within 7 days after each vaccination
An AE may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may experience both serious and non-serious AE during the study. Safety population included all participants who received any of the study intervention. AEs included events collected in electronic diary (local and systemic reactions; systematic assessment) and events collected on case report form at each visit (non-systematic assessment).
|
|
Injury, poisoning and procedural complications
Ligament sprain
|
0.00%
0/564 • AEs and SAEs: From Day 1 (Visit 1) to 1 month after last dose of study vaccine (approximately 2 months after Visit 1 [Day1]); Local reactions (at the BNT162b2/placebo injection site) and systemic events: Within 7 days after each vaccination
An AE may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may experience both serious and non-serious AE during the study. Safety population included all participants who received any of the study intervention. AEs included events collected in electronic diary (local and systemic reactions; systematic assessment) and events collected on case report form at each visit (non-systematic assessment).
|
0.00%
0/562 • AEs and SAEs: From Day 1 (Visit 1) to 1 month after last dose of study vaccine (approximately 2 months after Visit 1 [Day1]); Local reactions (at the BNT162b2/placebo injection site) and systemic events: Within 7 days after each vaccination
An AE may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may experience both serious and non-serious AE during the study. Safety population included all participants who received any of the study intervention. AEs included events collected in electronic diary (local and systemic reactions; systematic assessment) and events collected on case report form at each visit (non-systematic assessment).
|
0.00%
0/564 • AEs and SAEs: From Day 1 (Visit 1) to 1 month after last dose of study vaccine (approximately 2 months after Visit 1 [Day1]); Local reactions (at the BNT162b2/placebo injection site) and systemic events: Within 7 days after each vaccination
An AE may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may experience both serious and non-serious AE during the study. Safety population included all participants who received any of the study intervention. AEs included events collected in electronic diary (local and systemic reactions; systematic assessment) and events collected on case report form at each visit (non-systematic assessment).
|
0.18%
1/557 • AEs and SAEs: From Day 1 (Visit 1) to 1 month after last dose of study vaccine (approximately 2 months after Visit 1 [Day1]); Local reactions (at the BNT162b2/placebo injection site) and systemic events: Within 7 days after each vaccination
An AE may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may experience both serious and non-serious AE during the study. Safety population included all participants who received any of the study intervention. AEs included events collected in electronic diary (local and systemic reactions; systematic assessment) and events collected on case report form at each visit (non-systematic assessment).
|
|
Injury, poisoning and procedural complications
Pneumocephalus
|
0.00%
0/564 • AEs and SAEs: From Day 1 (Visit 1) to 1 month after last dose of study vaccine (approximately 2 months after Visit 1 [Day1]); Local reactions (at the BNT162b2/placebo injection site) and systemic events: Within 7 days after each vaccination
An AE may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may experience both serious and non-serious AE during the study. Safety population included all participants who received any of the study intervention. AEs included events collected in electronic diary (local and systemic reactions; systematic assessment) and events collected on case report form at each visit (non-systematic assessment).
|
0.00%
0/562 • AEs and SAEs: From Day 1 (Visit 1) to 1 month after last dose of study vaccine (approximately 2 months after Visit 1 [Day1]); Local reactions (at the BNT162b2/placebo injection site) and systemic events: Within 7 days after each vaccination
An AE may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may experience both serious and non-serious AE during the study. Safety population included all participants who received any of the study intervention. AEs included events collected in electronic diary (local and systemic reactions; systematic assessment) and events collected on case report form at each visit (non-systematic assessment).
|
0.00%
0/564 • AEs and SAEs: From Day 1 (Visit 1) to 1 month after last dose of study vaccine (approximately 2 months after Visit 1 [Day1]); Local reactions (at the BNT162b2/placebo injection site) and systemic events: Within 7 days after each vaccination
An AE may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may experience both serious and non-serious AE during the study. Safety population included all participants who received any of the study intervention. AEs included events collected in electronic diary (local and systemic reactions; systematic assessment) and events collected on case report form at each visit (non-systematic assessment).
|
0.18%
1/557 • AEs and SAEs: From Day 1 (Visit 1) to 1 month after last dose of study vaccine (approximately 2 months after Visit 1 [Day1]); Local reactions (at the BNT162b2/placebo injection site) and systemic events: Within 7 days after each vaccination
An AE may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may experience both serious and non-serious AE during the study. Safety population included all participants who received any of the study intervention. AEs included events collected in electronic diary (local and systemic reactions; systematic assessment) and events collected on case report form at each visit (non-systematic assessment).
|
|
Injury, poisoning and procedural complications
Skull fracture
|
0.00%
0/564 • AEs and SAEs: From Day 1 (Visit 1) to 1 month after last dose of study vaccine (approximately 2 months after Visit 1 [Day1]); Local reactions (at the BNT162b2/placebo injection site) and systemic events: Within 7 days after each vaccination
An AE may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may experience both serious and non-serious AE during the study. Safety population included all participants who received any of the study intervention. AEs included events collected in electronic diary (local and systemic reactions; systematic assessment) and events collected on case report form at each visit (non-systematic assessment).
|
0.00%
0/562 • AEs and SAEs: From Day 1 (Visit 1) to 1 month after last dose of study vaccine (approximately 2 months after Visit 1 [Day1]); Local reactions (at the BNT162b2/placebo injection site) and systemic events: Within 7 days after each vaccination
An AE may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may experience both serious and non-serious AE during the study. Safety population included all participants who received any of the study intervention. AEs included events collected in electronic diary (local and systemic reactions; systematic assessment) and events collected on case report form at each visit (non-systematic assessment).
|
0.00%
0/564 • AEs and SAEs: From Day 1 (Visit 1) to 1 month after last dose of study vaccine (approximately 2 months after Visit 1 [Day1]); Local reactions (at the BNT162b2/placebo injection site) and systemic events: Within 7 days after each vaccination
An AE may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may experience both serious and non-serious AE during the study. Safety population included all participants who received any of the study intervention. AEs included events collected in electronic diary (local and systemic reactions; systematic assessment) and events collected on case report form at each visit (non-systematic assessment).
|
0.18%
1/557 • AEs and SAEs: From Day 1 (Visit 1) to 1 month after last dose of study vaccine (approximately 2 months after Visit 1 [Day1]); Local reactions (at the BNT162b2/placebo injection site) and systemic events: Within 7 days after each vaccination
An AE may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may experience both serious and non-serious AE during the study. Safety population included all participants who received any of the study intervention. AEs included events collected in electronic diary (local and systemic reactions; systematic assessment) and events collected on case report form at each visit (non-systematic assessment).
|
|
Musculoskeletal and connective tissue disorders
Costochondritis
|
0.00%
0/564 • AEs and SAEs: From Day 1 (Visit 1) to 1 month after last dose of study vaccine (approximately 2 months after Visit 1 [Day1]); Local reactions (at the BNT162b2/placebo injection site) and systemic events: Within 7 days after each vaccination
An AE may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may experience both serious and non-serious AE during the study. Safety population included all participants who received any of the study intervention. AEs included events collected in electronic diary (local and systemic reactions; systematic assessment) and events collected on case report form at each visit (non-systematic assessment).
|
0.18%
1/562 • AEs and SAEs: From Day 1 (Visit 1) to 1 month after last dose of study vaccine (approximately 2 months after Visit 1 [Day1]); Local reactions (at the BNT162b2/placebo injection site) and systemic events: Within 7 days after each vaccination
An AE may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may experience both serious and non-serious AE during the study. Safety population included all participants who received any of the study intervention. AEs included events collected in electronic diary (local and systemic reactions; systematic assessment) and events collected on case report form at each visit (non-systematic assessment).
|
0.00%
0/564 • AEs and SAEs: From Day 1 (Visit 1) to 1 month after last dose of study vaccine (approximately 2 months after Visit 1 [Day1]); Local reactions (at the BNT162b2/placebo injection site) and systemic events: Within 7 days after each vaccination
An AE may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may experience both serious and non-serious AE during the study. Safety population included all participants who received any of the study intervention. AEs included events collected in electronic diary (local and systemic reactions; systematic assessment) and events collected on case report form at each visit (non-systematic assessment).
|
0.00%
0/557 • AEs and SAEs: From Day 1 (Visit 1) to 1 month after last dose of study vaccine (approximately 2 months after Visit 1 [Day1]); Local reactions (at the BNT162b2/placebo injection site) and systemic events: Within 7 days after each vaccination
An AE may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may experience both serious and non-serious AE during the study. Safety population included all participants who received any of the study intervention. AEs included events collected in electronic diary (local and systemic reactions; systematic assessment) and events collected on case report form at each visit (non-systematic assessment).
|
|
Musculoskeletal and connective tissue disorders
Musculoskeletal chest pain
|
0.18%
1/564 • AEs and SAEs: From Day 1 (Visit 1) to 1 month after last dose of study vaccine (approximately 2 months after Visit 1 [Day1]); Local reactions (at the BNT162b2/placebo injection site) and systemic events: Within 7 days after each vaccination
An AE may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may experience both serious and non-serious AE during the study. Safety population included all participants who received any of the study intervention. AEs included events collected in electronic diary (local and systemic reactions; systematic assessment) and events collected on case report form at each visit (non-systematic assessment).
|
0.00%
0/562 • AEs and SAEs: From Day 1 (Visit 1) to 1 month after last dose of study vaccine (approximately 2 months after Visit 1 [Day1]); Local reactions (at the BNT162b2/placebo injection site) and systemic events: Within 7 days after each vaccination
An AE may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may experience both serious and non-serious AE during the study. Safety population included all participants who received any of the study intervention. AEs included events collected in electronic diary (local and systemic reactions; systematic assessment) and events collected on case report form at each visit (non-systematic assessment).
|
0.00%
0/564 • AEs and SAEs: From Day 1 (Visit 1) to 1 month after last dose of study vaccine (approximately 2 months after Visit 1 [Day1]); Local reactions (at the BNT162b2/placebo injection site) and systemic events: Within 7 days after each vaccination
An AE may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may experience both serious and non-serious AE during the study. Safety population included all participants who received any of the study intervention. AEs included events collected in electronic diary (local and systemic reactions; systematic assessment) and events collected on case report form at each visit (non-systematic assessment).
|
0.18%
1/557 • AEs and SAEs: From Day 1 (Visit 1) to 1 month after last dose of study vaccine (approximately 2 months after Visit 1 [Day1]); Local reactions (at the BNT162b2/placebo injection site) and systemic events: Within 7 days after each vaccination
An AE may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may experience both serious and non-serious AE during the study. Safety population included all participants who received any of the study intervention. AEs included events collected in electronic diary (local and systemic reactions; systematic assessment) and events collected on case report form at each visit (non-systematic assessment).
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Malignant melanoma stage II
|
0.00%
0/564 • AEs and SAEs: From Day 1 (Visit 1) to 1 month after last dose of study vaccine (approximately 2 months after Visit 1 [Day1]); Local reactions (at the BNT162b2/placebo injection site) and systemic events: Within 7 days after each vaccination
An AE may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may experience both serious and non-serious AE during the study. Safety population included all participants who received any of the study intervention. AEs included events collected in electronic diary (local and systemic reactions; systematic assessment) and events collected on case report form at each visit (non-systematic assessment).
|
0.18%
1/562 • AEs and SAEs: From Day 1 (Visit 1) to 1 month after last dose of study vaccine (approximately 2 months after Visit 1 [Day1]); Local reactions (at the BNT162b2/placebo injection site) and systemic events: Within 7 days after each vaccination
An AE may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may experience both serious and non-serious AE during the study. Safety population included all participants who received any of the study intervention. AEs included events collected in electronic diary (local and systemic reactions; systematic assessment) and events collected on case report form at each visit (non-systematic assessment).
|
0.00%
0/564 • AEs and SAEs: From Day 1 (Visit 1) to 1 month after last dose of study vaccine (approximately 2 months after Visit 1 [Day1]); Local reactions (at the BNT162b2/placebo injection site) and systemic events: Within 7 days after each vaccination
An AE may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may experience both serious and non-serious AE during the study. Safety population included all participants who received any of the study intervention. AEs included events collected in electronic diary (local and systemic reactions; systematic assessment) and events collected on case report form at each visit (non-systematic assessment).
|
0.00%
0/557 • AEs and SAEs: From Day 1 (Visit 1) to 1 month after last dose of study vaccine (approximately 2 months after Visit 1 [Day1]); Local reactions (at the BNT162b2/placebo injection site) and systemic events: Within 7 days after each vaccination
An AE may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may experience both serious and non-serious AE during the study. Safety population included all participants who received any of the study intervention. AEs included events collected in electronic diary (local and systemic reactions; systematic assessment) and events collected on case report form at each visit (non-systematic assessment).
|
Other adverse events
| Measure |
Coadministration Group (Visit 1)
n=564 participants at risk
Participants were randomized to receive 30 microgram (mcg) intramuscular (IM) injection of BNT162b2 vaccine along with IM injection of Seasonal Inactivated Influenza Vaccine (SIIV) on Day 1 (Visit 1), and IM injection of Placebo 1 month later (Visit 2).
|
Coadministration Group (Visit 2)
n=562 participants at risk
Participants were randomized to receive 30 microgram (mcg) intramuscular (IM) injection of BNT162b2 vaccine along with IM injection of Seasonal Inactivated Influenza Vaccine (SIIV) on Day 1 (Visit 1), and IM injection of Placebo 1 month later (Visit 2).
|
Separate Administration Group (Visit 1)
n=564 participants at risk
Participants were randomized to receive an intramuscular (IM) injection of Placebo along with IM injection of Seasonal Inactivated Influenza Vaccine (SIIV) on Day 1 (Visit 1), and 30 mcg IM injection of BNT162b2 vaccine 1 month later (Visit 2).
|
Separate Administration Group (Visit 2)
n=557 participants at risk
Participants were randomized to receive an intramuscular (IM) injection of Placebo along with IM injection of Seasonal Inactivated Influenza Vaccine (SIIV) on Day 1 (Visit 1), and 30 mcg IM injection of BNT162b2 vaccine 1 month later (Visit 2).
|
|---|---|---|---|---|
|
Gastrointestinal disorders
Diarrhoea
|
11.5%
65/564 • AEs and SAEs: From Day 1 (Visit 1) to 1 month after last dose of study vaccine (approximately 2 months after Visit 1 [Day1]); Local reactions (at the BNT162b2/placebo injection site) and systemic events: Within 7 days after each vaccination
An AE may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may experience both serious and non-serious AE during the study. Safety population included all participants who received any of the study intervention. AEs included events collected in electronic diary (local and systemic reactions; systematic assessment) and events collected on case report form at each visit (non-systematic assessment).
|
4.4%
25/562 • AEs and SAEs: From Day 1 (Visit 1) to 1 month after last dose of study vaccine (approximately 2 months after Visit 1 [Day1]); Local reactions (at the BNT162b2/placebo injection site) and systemic events: Within 7 days after each vaccination
An AE may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may experience both serious and non-serious AE during the study. Safety population included all participants who received any of the study intervention. AEs included events collected in electronic diary (local and systemic reactions; systematic assessment) and events collected on case report form at each visit (non-systematic assessment).
|
10.1%
57/564 • AEs and SAEs: From Day 1 (Visit 1) to 1 month after last dose of study vaccine (approximately 2 months after Visit 1 [Day1]); Local reactions (at the BNT162b2/placebo injection site) and systemic events: Within 7 days after each vaccination
An AE may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may experience both serious and non-serious AE during the study. Safety population included all participants who received any of the study intervention. AEs included events collected in electronic diary (local and systemic reactions; systematic assessment) and events collected on case report form at each visit (non-systematic assessment).
|
6.5%
36/557 • AEs and SAEs: From Day 1 (Visit 1) to 1 month after last dose of study vaccine (approximately 2 months after Visit 1 [Day1]); Local reactions (at the BNT162b2/placebo injection site) and systemic events: Within 7 days after each vaccination
An AE may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may experience both serious and non-serious AE during the study. Safety population included all participants who received any of the study intervention. AEs included events collected in electronic diary (local and systemic reactions; systematic assessment) and events collected on case report form at each visit (non-systematic assessment).
|
|
Gastrointestinal disorders
Vomiting
|
2.7%
15/564 • AEs and SAEs: From Day 1 (Visit 1) to 1 month after last dose of study vaccine (approximately 2 months after Visit 1 [Day1]); Local reactions (at the BNT162b2/placebo injection site) and systemic events: Within 7 days after each vaccination
An AE may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may experience both serious and non-serious AE during the study. Safety population included all participants who received any of the study intervention. AEs included events collected in electronic diary (local and systemic reactions; systematic assessment) and events collected on case report form at each visit (non-systematic assessment).
|
1.1%
6/562 • AEs and SAEs: From Day 1 (Visit 1) to 1 month after last dose of study vaccine (approximately 2 months after Visit 1 [Day1]); Local reactions (at the BNT162b2/placebo injection site) and systemic events: Within 7 days after each vaccination
An AE may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may experience both serious and non-serious AE during the study. Safety population included all participants who received any of the study intervention. AEs included events collected in electronic diary (local and systemic reactions; systematic assessment) and events collected on case report form at each visit (non-systematic assessment).
|
0.89%
5/564 • AEs and SAEs: From Day 1 (Visit 1) to 1 month after last dose of study vaccine (approximately 2 months after Visit 1 [Day1]); Local reactions (at the BNT162b2/placebo injection site) and systemic events: Within 7 days after each vaccination
An AE may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may experience both serious and non-serious AE during the study. Safety population included all participants who received any of the study intervention. AEs included events collected in electronic diary (local and systemic reactions; systematic assessment) and events collected on case report form at each visit (non-systematic assessment).
|
2.3%
13/557 • AEs and SAEs: From Day 1 (Visit 1) to 1 month after last dose of study vaccine (approximately 2 months after Visit 1 [Day1]); Local reactions (at the BNT162b2/placebo injection site) and systemic events: Within 7 days after each vaccination
An AE may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may experience both serious and non-serious AE during the study. Safety population included all participants who received any of the study intervention. AEs included events collected in electronic diary (local and systemic reactions; systematic assessment) and events collected on case report form at each visit (non-systematic assessment).
|
|
General disorders
Chills
|
19.9%
112/564 • AEs and SAEs: From Day 1 (Visit 1) to 1 month after last dose of study vaccine (approximately 2 months after Visit 1 [Day1]); Local reactions (at the BNT162b2/placebo injection site) and systemic events: Within 7 days after each vaccination
An AE may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may experience both serious and non-serious AE during the study. Safety population included all participants who received any of the study intervention. AEs included events collected in electronic diary (local and systemic reactions; systematic assessment) and events collected on case report form at each visit (non-systematic assessment).
|
3.4%
19/562 • AEs and SAEs: From Day 1 (Visit 1) to 1 month after last dose of study vaccine (approximately 2 months after Visit 1 [Day1]); Local reactions (at the BNT162b2/placebo injection site) and systemic events: Within 7 days after each vaccination
An AE may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may experience both serious and non-serious AE during the study. Safety population included all participants who received any of the study intervention. AEs included events collected in electronic diary (local and systemic reactions; systematic assessment) and events collected on case report form at each visit (non-systematic assessment).
|
6.2%
35/564 • AEs and SAEs: From Day 1 (Visit 1) to 1 month after last dose of study vaccine (approximately 2 months after Visit 1 [Day1]); Local reactions (at the BNT162b2/placebo injection site) and systemic events: Within 7 days after each vaccination
An AE may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may experience both serious and non-serious AE during the study. Safety population included all participants who received any of the study intervention. AEs included events collected in electronic diary (local and systemic reactions; systematic assessment) and events collected on case report form at each visit (non-systematic assessment).
|
13.3%
74/557 • AEs and SAEs: From Day 1 (Visit 1) to 1 month after last dose of study vaccine (approximately 2 months after Visit 1 [Day1]); Local reactions (at the BNT162b2/placebo injection site) and systemic events: Within 7 days after each vaccination
An AE may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may experience both serious and non-serious AE during the study. Safety population included all participants who received any of the study intervention. AEs included events collected in electronic diary (local and systemic reactions; systematic assessment) and events collected on case report form at each visit (non-systematic assessment).
|
|
General disorders
Fatigue
|
64.0%
361/564 • AEs and SAEs: From Day 1 (Visit 1) to 1 month after last dose of study vaccine (approximately 2 months after Visit 1 [Day1]); Local reactions (at the BNT162b2/placebo injection site) and systemic events: Within 7 days after each vaccination
An AE may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may experience both serious and non-serious AE during the study. Safety population included all participants who received any of the study intervention. AEs included events collected in electronic diary (local and systemic reactions; systematic assessment) and events collected on case report form at each visit (non-systematic assessment).
|
21.5%
121/562 • AEs and SAEs: From Day 1 (Visit 1) to 1 month after last dose of study vaccine (approximately 2 months after Visit 1 [Day1]); Local reactions (at the BNT162b2/placebo injection site) and systemic events: Within 7 days after each vaccination
An AE may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may experience both serious and non-serious AE during the study. Safety population included all participants who received any of the study intervention. AEs included events collected in electronic diary (local and systemic reactions; systematic assessment) and events collected on case report form at each visit (non-systematic assessment).
|
42.0%
237/564 • AEs and SAEs: From Day 1 (Visit 1) to 1 month after last dose of study vaccine (approximately 2 months after Visit 1 [Day1]); Local reactions (at the BNT162b2/placebo injection site) and systemic events: Within 7 days after each vaccination
An AE may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may experience both serious and non-serious AE during the study. Safety population included all participants who received any of the study intervention. AEs included events collected in electronic diary (local and systemic reactions; systematic assessment) and events collected on case report form at each visit (non-systematic assessment).
|
50.4%
281/557 • AEs and SAEs: From Day 1 (Visit 1) to 1 month after last dose of study vaccine (approximately 2 months after Visit 1 [Day1]); Local reactions (at the BNT162b2/placebo injection site) and systemic events: Within 7 days after each vaccination
An AE may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may experience both serious and non-serious AE during the study. Safety population included all participants who received any of the study intervention. AEs included events collected in electronic diary (local and systemic reactions; systematic assessment) and events collected on case report form at each visit (non-systematic assessment).
|
|
General disorders
Influenza like illness
|
1.6%
9/564 • AEs and SAEs: From Day 1 (Visit 1) to 1 month after last dose of study vaccine (approximately 2 months after Visit 1 [Day1]); Local reactions (at the BNT162b2/placebo injection site) and systemic events: Within 7 days after each vaccination
An AE may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may experience both serious and non-serious AE during the study. Safety population included all participants who received any of the study intervention. AEs included events collected in electronic diary (local and systemic reactions; systematic assessment) and events collected on case report form at each visit (non-systematic assessment).
|
1.6%
9/562 • AEs and SAEs: From Day 1 (Visit 1) to 1 month after last dose of study vaccine (approximately 2 months after Visit 1 [Day1]); Local reactions (at the BNT162b2/placebo injection site) and systemic events: Within 7 days after each vaccination
An AE may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may experience both serious and non-serious AE during the study. Safety population included all participants who received any of the study intervention. AEs included events collected in electronic diary (local and systemic reactions; systematic assessment) and events collected on case report form at each visit (non-systematic assessment).
|
2.1%
12/564 • AEs and SAEs: From Day 1 (Visit 1) to 1 month after last dose of study vaccine (approximately 2 months after Visit 1 [Day1]); Local reactions (at the BNT162b2/placebo injection site) and systemic events: Within 7 days after each vaccination
An AE may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may experience both serious and non-serious AE during the study. Safety population included all participants who received any of the study intervention. AEs included events collected in electronic diary (local and systemic reactions; systematic assessment) and events collected on case report form at each visit (non-systematic assessment).
|
1.3%
7/557 • AEs and SAEs: From Day 1 (Visit 1) to 1 month after last dose of study vaccine (approximately 2 months after Visit 1 [Day1]); Local reactions (at the BNT162b2/placebo injection site) and systemic events: Within 7 days after each vaccination
An AE may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may experience both serious and non-serious AE during the study. Safety population included all participants who received any of the study intervention. AEs included events collected in electronic diary (local and systemic reactions; systematic assessment) and events collected on case report form at each visit (non-systematic assessment).
|
|
General disorders
Injection site erythema
|
7.6%
43/564 • AEs and SAEs: From Day 1 (Visit 1) to 1 month after last dose of study vaccine (approximately 2 months after Visit 1 [Day1]); Local reactions (at the BNT162b2/placebo injection site) and systemic events: Within 7 days after each vaccination
An AE may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may experience both serious and non-serious AE during the study. Safety population included all participants who received any of the study intervention. AEs included events collected in electronic diary (local and systemic reactions; systematic assessment) and events collected on case report form at each visit (non-systematic assessment).
|
0.18%
1/562 • AEs and SAEs: From Day 1 (Visit 1) to 1 month after last dose of study vaccine (approximately 2 months after Visit 1 [Day1]); Local reactions (at the BNT162b2/placebo injection site) and systemic events: Within 7 days after each vaccination
An AE may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may experience both serious and non-serious AE during the study. Safety population included all participants who received any of the study intervention. AEs included events collected in electronic diary (local and systemic reactions; systematic assessment) and events collected on case report form at each visit (non-systematic assessment).
|
0.53%
3/564 • AEs and SAEs: From Day 1 (Visit 1) to 1 month after last dose of study vaccine (approximately 2 months after Visit 1 [Day1]); Local reactions (at the BNT162b2/placebo injection site) and systemic events: Within 7 days after each vaccination
An AE may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may experience both serious and non-serious AE during the study. Safety population included all participants who received any of the study intervention. AEs included events collected in electronic diary (local and systemic reactions; systematic assessment) and events collected on case report form at each visit (non-systematic assessment).
|
4.7%
26/557 • AEs and SAEs: From Day 1 (Visit 1) to 1 month after last dose of study vaccine (approximately 2 months after Visit 1 [Day1]); Local reactions (at the BNT162b2/placebo injection site) and systemic events: Within 7 days after each vaccination
An AE may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may experience both serious and non-serious AE during the study. Safety population included all participants who received any of the study intervention. AEs included events collected in electronic diary (local and systemic reactions; systematic assessment) and events collected on case report form at each visit (non-systematic assessment).
|
|
General disorders
Injection site pain
|
2.8%
16/564 • AEs and SAEs: From Day 1 (Visit 1) to 1 month after last dose of study vaccine (approximately 2 months after Visit 1 [Day1]); Local reactions (at the BNT162b2/placebo injection site) and systemic events: Within 7 days after each vaccination
An AE may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may experience both serious and non-serious AE during the study. Safety population included all participants who received any of the study intervention. AEs included events collected in electronic diary (local and systemic reactions; systematic assessment) and events collected on case report form at each visit (non-systematic assessment).
|
0.18%
1/562 • AEs and SAEs: From Day 1 (Visit 1) to 1 month after last dose of study vaccine (approximately 2 months after Visit 1 [Day1]); Local reactions (at the BNT162b2/placebo injection site) and systemic events: Within 7 days after each vaccination
An AE may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may experience both serious and non-serious AE during the study. Safety population included all participants who received any of the study intervention. AEs included events collected in electronic diary (local and systemic reactions; systematic assessment) and events collected on case report form at each visit (non-systematic assessment).
|
2.5%
14/564 • AEs and SAEs: From Day 1 (Visit 1) to 1 month after last dose of study vaccine (approximately 2 months after Visit 1 [Day1]); Local reactions (at the BNT162b2/placebo injection site) and systemic events: Within 7 days after each vaccination
An AE may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may experience both serious and non-serious AE during the study. Safety population included all participants who received any of the study intervention. AEs included events collected in electronic diary (local and systemic reactions; systematic assessment) and events collected on case report form at each visit (non-systematic assessment).
|
0.18%
1/557 • AEs and SAEs: From Day 1 (Visit 1) to 1 month after last dose of study vaccine (approximately 2 months after Visit 1 [Day1]); Local reactions (at the BNT162b2/placebo injection site) and systemic events: Within 7 days after each vaccination
An AE may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may experience both serious and non-serious AE during the study. Safety population included all participants who received any of the study intervention. AEs included events collected in electronic diary (local and systemic reactions; systematic assessment) and events collected on case report form at each visit (non-systematic assessment).
|
|
General disorders
Injection site swelling
|
9.2%
52/564 • AEs and SAEs: From Day 1 (Visit 1) to 1 month after last dose of study vaccine (approximately 2 months after Visit 1 [Day1]); Local reactions (at the BNT162b2/placebo injection site) and systemic events: Within 7 days after each vaccination
An AE may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may experience both serious and non-serious AE during the study. Safety population included all participants who received any of the study intervention. AEs included events collected in electronic diary (local and systemic reactions; systematic assessment) and events collected on case report form at each visit (non-systematic assessment).
|
0.36%
2/562 • AEs and SAEs: From Day 1 (Visit 1) to 1 month after last dose of study vaccine (approximately 2 months after Visit 1 [Day1]); Local reactions (at the BNT162b2/placebo injection site) and systemic events: Within 7 days after each vaccination
An AE may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may experience both serious and non-serious AE during the study. Safety population included all participants who received any of the study intervention. AEs included events collected in electronic diary (local and systemic reactions; systematic assessment) and events collected on case report form at each visit (non-systematic assessment).
|
1.1%
6/564 • AEs and SAEs: From Day 1 (Visit 1) to 1 month after last dose of study vaccine (approximately 2 months after Visit 1 [Day1]); Local reactions (at the BNT162b2/placebo injection site) and systemic events: Within 7 days after each vaccination
An AE may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may experience both serious and non-serious AE during the study. Safety population included all participants who received any of the study intervention. AEs included events collected in electronic diary (local and systemic reactions; systematic assessment) and events collected on case report form at each visit (non-systematic assessment).
|
8.8%
49/557 • AEs and SAEs: From Day 1 (Visit 1) to 1 month after last dose of study vaccine (approximately 2 months after Visit 1 [Day1]); Local reactions (at the BNT162b2/placebo injection site) and systemic events: Within 7 days after each vaccination
An AE may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may experience both serious and non-serious AE during the study. Safety population included all participants who received any of the study intervention. AEs included events collected in electronic diary (local and systemic reactions; systematic assessment) and events collected on case report form at each visit (non-systematic assessment).
|
|
General disorders
Pyrexia
|
2.0%
11/564 • AEs and SAEs: From Day 1 (Visit 1) to 1 month after last dose of study vaccine (approximately 2 months after Visit 1 [Day1]); Local reactions (at the BNT162b2/placebo injection site) and systemic events: Within 7 days after each vaccination
An AE may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may experience both serious and non-serious AE during the study. Safety population included all participants who received any of the study intervention. AEs included events collected in electronic diary (local and systemic reactions; systematic assessment) and events collected on case report form at each visit (non-systematic assessment).
|
1.1%
6/562 • AEs and SAEs: From Day 1 (Visit 1) to 1 month after last dose of study vaccine (approximately 2 months after Visit 1 [Day1]); Local reactions (at the BNT162b2/placebo injection site) and systemic events: Within 7 days after each vaccination
An AE may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may experience both serious and non-serious AE during the study. Safety population included all participants who received any of the study intervention. AEs included events collected in electronic diary (local and systemic reactions; systematic assessment) and events collected on case report form at each visit (non-systematic assessment).
|
1.1%
6/564 • AEs and SAEs: From Day 1 (Visit 1) to 1 month after last dose of study vaccine (approximately 2 months after Visit 1 [Day1]); Local reactions (at the BNT162b2/placebo injection site) and systemic events: Within 7 days after each vaccination
An AE may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may experience both serious and non-serious AE during the study. Safety population included all participants who received any of the study intervention. AEs included events collected in electronic diary (local and systemic reactions; systematic assessment) and events collected on case report form at each visit (non-systematic assessment).
|
1.6%
9/557 • AEs and SAEs: From Day 1 (Visit 1) to 1 month after last dose of study vaccine (approximately 2 months after Visit 1 [Day1]); Local reactions (at the BNT162b2/placebo injection site) and systemic events: Within 7 days after each vaccination
An AE may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may experience both serious and non-serious AE during the study. Safety population included all participants who received any of the study intervention. AEs included events collected in electronic diary (local and systemic reactions; systematic assessment) and events collected on case report form at each visit (non-systematic assessment).
|
|
Infections and infestations
COVID-19
|
8.2%
46/564 • AEs and SAEs: From Day 1 (Visit 1) to 1 month after last dose of study vaccine (approximately 2 months after Visit 1 [Day1]); Local reactions (at the BNT162b2/placebo injection site) and systemic events: Within 7 days after each vaccination
An AE may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may experience both serious and non-serious AE during the study. Safety population included all participants who received any of the study intervention. AEs included events collected in electronic diary (local and systemic reactions; systematic assessment) and events collected on case report form at each visit (non-systematic assessment).
|
11.2%
63/562 • AEs and SAEs: From Day 1 (Visit 1) to 1 month after last dose of study vaccine (approximately 2 months after Visit 1 [Day1]); Local reactions (at the BNT162b2/placebo injection site) and systemic events: Within 7 days after each vaccination
An AE may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may experience both serious and non-serious AE during the study. Safety population included all participants who received any of the study intervention. AEs included events collected in electronic diary (local and systemic reactions; systematic assessment) and events collected on case report form at each visit (non-systematic assessment).
|
9.9%
56/564 • AEs and SAEs: From Day 1 (Visit 1) to 1 month after last dose of study vaccine (approximately 2 months after Visit 1 [Day1]); Local reactions (at the BNT162b2/placebo injection site) and systemic events: Within 7 days after each vaccination
An AE may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may experience both serious and non-serious AE during the study. Safety population included all participants who received any of the study intervention. AEs included events collected in electronic diary (local and systemic reactions; systematic assessment) and events collected on case report form at each visit (non-systematic assessment).
|
8.6%
48/557 • AEs and SAEs: From Day 1 (Visit 1) to 1 month after last dose of study vaccine (approximately 2 months after Visit 1 [Day1]); Local reactions (at the BNT162b2/placebo injection site) and systemic events: Within 7 days after each vaccination
An AE may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may experience both serious and non-serious AE during the study. Safety population included all participants who received any of the study intervention. AEs included events collected in electronic diary (local and systemic reactions; systematic assessment) and events collected on case report form at each visit (non-systematic assessment).
|
|
Infections and infestations
Gastroenteritis
|
1.4%
8/564 • AEs and SAEs: From Day 1 (Visit 1) to 1 month after last dose of study vaccine (approximately 2 months after Visit 1 [Day1]); Local reactions (at the BNT162b2/placebo injection site) and systemic events: Within 7 days after each vaccination
An AE may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may experience both serious and non-serious AE during the study. Safety population included all participants who received any of the study intervention. AEs included events collected in electronic diary (local and systemic reactions; systematic assessment) and events collected on case report form at each visit (non-systematic assessment).
|
1.1%
6/562 • AEs and SAEs: From Day 1 (Visit 1) to 1 month after last dose of study vaccine (approximately 2 months after Visit 1 [Day1]); Local reactions (at the BNT162b2/placebo injection site) and systemic events: Within 7 days after each vaccination
An AE may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may experience both serious and non-serious AE during the study. Safety population included all participants who received any of the study intervention. AEs included events collected in electronic diary (local and systemic reactions; systematic assessment) and events collected on case report form at each visit (non-systematic assessment).
|
1.2%
7/564 • AEs and SAEs: From Day 1 (Visit 1) to 1 month after last dose of study vaccine (approximately 2 months after Visit 1 [Day1]); Local reactions (at the BNT162b2/placebo injection site) and systemic events: Within 7 days after each vaccination
An AE may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may experience both serious and non-serious AE during the study. Safety population included all participants who received any of the study intervention. AEs included events collected in electronic diary (local and systemic reactions; systematic assessment) and events collected on case report form at each visit (non-systematic assessment).
|
0.90%
5/557 • AEs and SAEs: From Day 1 (Visit 1) to 1 month after last dose of study vaccine (approximately 2 months after Visit 1 [Day1]); Local reactions (at the BNT162b2/placebo injection site) and systemic events: Within 7 days after each vaccination
An AE may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may experience both serious and non-serious AE during the study. Safety population included all participants who received any of the study intervention. AEs included events collected in electronic diary (local and systemic reactions; systematic assessment) and events collected on case report form at each visit (non-systematic assessment).
|
|
Infections and infestations
Upper respiratory tract infection
|
4.8%
27/564 • AEs and SAEs: From Day 1 (Visit 1) to 1 month after last dose of study vaccine (approximately 2 months after Visit 1 [Day1]); Local reactions (at the BNT162b2/placebo injection site) and systemic events: Within 7 days after each vaccination
An AE may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may experience both serious and non-serious AE during the study. Safety population included all participants who received any of the study intervention. AEs included events collected in electronic diary (local and systemic reactions; systematic assessment) and events collected on case report form at each visit (non-systematic assessment).
|
5.5%
31/562 • AEs and SAEs: From Day 1 (Visit 1) to 1 month after last dose of study vaccine (approximately 2 months after Visit 1 [Day1]); Local reactions (at the BNT162b2/placebo injection site) and systemic events: Within 7 days after each vaccination
An AE may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may experience both serious and non-serious AE during the study. Safety population included all participants who received any of the study intervention. AEs included events collected in electronic diary (local and systemic reactions; systematic assessment) and events collected on case report form at each visit (non-systematic assessment).
|
4.3%
24/564 • AEs and SAEs: From Day 1 (Visit 1) to 1 month after last dose of study vaccine (approximately 2 months after Visit 1 [Day1]); Local reactions (at the BNT162b2/placebo injection site) and systemic events: Within 7 days after each vaccination
An AE may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may experience both serious and non-serious AE during the study. Safety population included all participants who received any of the study intervention. AEs included events collected in electronic diary (local and systemic reactions; systematic assessment) and events collected on case report form at each visit (non-systematic assessment).
|
3.9%
22/557 • AEs and SAEs: From Day 1 (Visit 1) to 1 month after last dose of study vaccine (approximately 2 months after Visit 1 [Day1]); Local reactions (at the BNT162b2/placebo injection site) and systemic events: Within 7 days after each vaccination
An AE may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may experience both serious and non-serious AE during the study. Safety population included all participants who received any of the study intervention. AEs included events collected in electronic diary (local and systemic reactions; systematic assessment) and events collected on case report form at each visit (non-systematic assessment).
|
|
Infections and infestations
Viral upper respiratory tract infection
|
0.71%
4/564 • AEs and SAEs: From Day 1 (Visit 1) to 1 month after last dose of study vaccine (approximately 2 months after Visit 1 [Day1]); Local reactions (at the BNT162b2/placebo injection site) and systemic events: Within 7 days after each vaccination
An AE may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may experience both serious and non-serious AE during the study. Safety population included all participants who received any of the study intervention. AEs included events collected in electronic diary (local and systemic reactions; systematic assessment) and events collected on case report form at each visit (non-systematic assessment).
|
1.1%
6/562 • AEs and SAEs: From Day 1 (Visit 1) to 1 month after last dose of study vaccine (approximately 2 months after Visit 1 [Day1]); Local reactions (at the BNT162b2/placebo injection site) and systemic events: Within 7 days after each vaccination
An AE may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may experience both serious and non-serious AE during the study. Safety population included all participants who received any of the study intervention. AEs included events collected in electronic diary (local and systemic reactions; systematic assessment) and events collected on case report form at each visit (non-systematic assessment).
|
1.1%
6/564 • AEs and SAEs: From Day 1 (Visit 1) to 1 month after last dose of study vaccine (approximately 2 months after Visit 1 [Day1]); Local reactions (at the BNT162b2/placebo injection site) and systemic events: Within 7 days after each vaccination
An AE may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may experience both serious and non-serious AE during the study. Safety population included all participants who received any of the study intervention. AEs included events collected in electronic diary (local and systemic reactions; systematic assessment) and events collected on case report form at each visit (non-systematic assessment).
|
1.3%
7/557 • AEs and SAEs: From Day 1 (Visit 1) to 1 month after last dose of study vaccine (approximately 2 months after Visit 1 [Day1]); Local reactions (at the BNT162b2/placebo injection site) and systemic events: Within 7 days after each vaccination
An AE may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may experience both serious and non-serious AE during the study. Safety population included all participants who received any of the study intervention. AEs included events collected in electronic diary (local and systemic reactions; systematic assessment) and events collected on case report form at each visit (non-systematic assessment).
|
|
Nervous system disorders
Headache
|
47.2%
266/564 • AEs and SAEs: From Day 1 (Visit 1) to 1 month after last dose of study vaccine (approximately 2 months after Visit 1 [Day1]); Local reactions (at the BNT162b2/placebo injection site) and systemic events: Within 7 days after each vaccination
An AE may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may experience both serious and non-serious AE during the study. Safety population included all participants who received any of the study intervention. AEs included events collected in electronic diary (local and systemic reactions; systematic assessment) and events collected on case report form at each visit (non-systematic assessment).
|
20.6%
116/562 • AEs and SAEs: From Day 1 (Visit 1) to 1 month after last dose of study vaccine (approximately 2 months after Visit 1 [Day1]); Local reactions (at the BNT162b2/placebo injection site) and systemic events: Within 7 days after each vaccination
An AE may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may experience both serious and non-serious AE during the study. Safety population included all participants who received any of the study intervention. AEs included events collected in electronic diary (local and systemic reactions; systematic assessment) and events collected on case report form at each visit (non-systematic assessment).
|
34.2%
193/564 • AEs and SAEs: From Day 1 (Visit 1) to 1 month after last dose of study vaccine (approximately 2 months after Visit 1 [Day1]); Local reactions (at the BNT162b2/placebo injection site) and systemic events: Within 7 days after each vaccination
An AE may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may experience both serious and non-serious AE during the study. Safety population included all participants who received any of the study intervention. AEs included events collected in electronic diary (local and systemic reactions; systematic assessment) and events collected on case report form at each visit (non-systematic assessment).
|
37.5%
209/557 • AEs and SAEs: From Day 1 (Visit 1) to 1 month after last dose of study vaccine (approximately 2 months after Visit 1 [Day1]); Local reactions (at the BNT162b2/placebo injection site) and systemic events: Within 7 days after each vaccination
An AE may be categorized as serious in 1 participant and non-serious in another participant, or 1 participant may experience both serious and non-serious AE during the study. Safety population included all participants who received any of the study intervention. AEs included events collected in electronic diary (local and systemic reactions; systematic assessment) and events collected on case report form at each visit (non-systematic assessment).
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee Pfizer has the right to review disclosures, requesting a delay of less than 60 days. Investigator will postpone single center publications until after disclosure of pooled data (all sites), less than 12 months from study completion/termination at all participating sites. Investigator may not disclose previously undisclosed confidential information other than study results.
- Publication restrictions are in place
Restriction type: OTHER