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A Trial Investigating the Safety and Effects of One BNT162 Vaccine Against COVID-19 in Healthy Adults

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04537949
Recruitment Status : Completed
First Posted : September 3, 2020
Results First Posted : March 24, 2022
Last Update Posted : March 24, 2022
Sponsor:
Information provided by (Responsible Party):
BioNTech SE

Study Type Interventional
Study Design Allocation: Non-Randomized;   Intervention Model: Sequential Assignment;   Masking: None (Open Label);   Primary Purpose: Prevention
Conditions Covid-19
Protection Against COVID-19
Intervention Biological: BNT162b3
Enrollment 96
Recruitment Details Study participants were selected from the volunteer panel at the clinical CRO, volunteers who responded to either generic or study-specific advertisements in social media, or volunteers who contacted the clinical CRO via a web-based study participant recruitment portal. Study participants were selected from this pool of volunteers according to inclusion and exclusion criteria. The first participant was enrolled on 09 Sep 2020. The last visit of the last participant was on 07 Feb 2022.
Pre-assignment Details All enrolled participants were allocated to treatment.
Arm/Group Title Part A Participants Aged 18 to 55 Years - 3 μg Part A Participants Aged 18 to 55 Years - 10 μg Part A Participants Aged 18 to 55 Years - 20 μg Part A Participants Aged 18 to 55 Years - 30 μg Part A Participants Aged 56 to 85 Years - 3 μg Part A Participants Aged 56 to 85 Years - 10 μg Part A Participants Aged 56 to 85 Years - 20 μg Part A Participants Aged 56 to 85 Years - 30 μg
Hide Arm/Group Description BNT162b3: Anti-viral RNA vaccine for active immunization against COVID-19 administered as intramuscular injection (Prime/Boost [P/B] regimen) BNT162b3: Anti-viral RNA vaccine for active immunization against COVID-19 administered as intramuscular injection (Prime/Boost [P/B] regimen) BNT162b3: Anti-viral RNA vaccine for active immunization against COVID-19 administered as intramuscular injection (Prime/Boost [P/B] regimen) BNT162b3: Anti-viral RNA vaccine for active immunization against COVID-19 administered as intramuscular injection (Prime regimen only, as decided by the Safety Review Committee). BNT162b3: Anti-viral RNA vaccine for active immunization against COVID-19 administered as intramuscular injection (Prime/Boost [P/B] regimen) BNT162b3: Anti-viral RNA vaccine for active immunization against COVID-19 administered as intramuscular injection (Prime/Boost [P/B] regimen) BNT162b3: Anti-viral RNA vaccine for active immunization against COVID-19 administered as intramuscular injection (Prime/Boost [P/B] regimen) BNT162b3: Anti-viral RNA vaccine for active immunization against COVID-19 administered as intramuscular injection (Prime/Boost [P/B] regimen)
Period Title: Overall Study
Started 12 12 12 12 12 12 12 12
Completed 11 12 12 12 12 12 12 12
Not Completed 1 0 0 0 0 0 0 0
Reason Not Completed
personal reasons not related to the IMP             1             0             0             0             0             0             0             0
Arm/Group Title Part A Participants Aged 18 to 55 Years - 3 μg Part A Participants Aged 18 to 55 Years - 10 μg Part A Participants Aged 18 to 55 Years - 20 μg Part A Participants Aged 18 to 55 Years - 30 μg Part A Participants Aged 56 to 85 Years - 3 μg Part A Participants Aged 56 to 85 Years - 10 μg Part A Participants Aged 56 to 85 Years - 20 μg Part A Participants Aged 56 to 85 Years - 30 μg Total
Hide Arm/Group Description BNT162b3: Anti-viral RNA vaccine for active immunization against COVID-19 administered as intramuscular injection (Prime/Boost [P/B] regimen) BNT162b3: Anti-viral RNA vaccine for active immunization against COVID-19 administered as intramuscular injection (Prime/Boost [P/B] regimen) BNT162b3: Anti-viral RNA vaccine for active immunization against COVID-19 administered as intramuscular injection (Prime/Boost [P/B] regimen) BNT162b3: Anti-viral RNA vaccine for active immunization against COVID-19 administered as intramuscular injection (Prime regimen only, as decided by the Safety Review Committee) BNT162b3: Anti-viral RNA vaccine for active immunization against COVID-19 administered as intramuscular injection (Prime/Boost [P/B] regimen) BNT162b3: Anti-viral RNA vaccine for active immunization against COVID-19 administered as intramuscular injection (Prime/Boost [P/B] regimen) BNT162b3: Anti-viral RNA vaccine for active immunization against COVID-19 administered as intramuscular injection (Prime/Boost [P/B] regimen) BNT162b3: Anti-viral RNA vaccine for active immunization against COVID-19 administered as intramuscular injection (Prime/Boost [P/B] regimen) Total of all reporting groups
Overall Number of Baseline Participants 12 12 12 12 12 12 12 12 96
Hide Baseline Analysis Population Description
[Not Specified]
Age, Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 12 participants 12 participants 12 participants 12 participants 12 participants 12 participants 12 participants 12 participants 96 participants
39.32  (9.79) 31.20  (9.11) 31.89  (13.51) 37.28  (6.40) 66.08  (7.16) 69.32  (8.74) 64.93  (6.63) 66.42  (6.82) 50.80  (18.28)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 12 participants 12 participants 12 participants 12 participants 12 participants 12 participants 12 participants 12 participants 96 participants
Female
3
  25.0%
4
  33.3%
7
  58.3%
8
  66.7%
9
  75.0%
8
  66.7%
9
  75.0%
6
  50.0%
54
  56.3%
Male
9
  75.0%
8
  66.7%
5
  41.7%
4
  33.3%
3
  25.0%
4
  33.3%
3
  25.0%
6
  50.0%
42
  43.8%
Ethnicity (NIH/OMB)  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 12 participants 12 participants 12 participants 12 participants 12 participants 12 participants 12 participants 12 participants 96 participants
Hispanic or Latino
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
Not Hispanic or Latino
12
 100.0%
12
 100.0%
12
 100.0%
12
 100.0%
12
 100.0%
12
 100.0%
12
 100.0%
12
 100.0%
96
 100.0%
Unknown or Not Reported
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
Race (NIH/OMB)  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 12 participants 12 participants 12 participants 12 participants 12 participants 12 participants 12 participants 12 participants 96 participants
American Indian or Alaska Native
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
Asian
0
   0.0%
0
   0.0%
1
   8.3%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
1
   1.0%
Native Hawaiian or Other Pacific Islander
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
Black or African American
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
White
12
 100.0%
12
 100.0%
11
  91.7%
12
 100.0%
12
 100.0%
12
 100.0%
12
 100.0%
12
 100.0%
95
  99.0%
More than one race
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
Unknown or Not Reported
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
Region of Enrollment  
Measure Type: Number
Unit of measure:  Participants
Germany Number Analyzed 12 participants 12 participants 12 participants 12 participants 12 participants 12 participants 12 participants 12 participants 96 participants
12 12 12 12 12 12 12 12 96
Weight  
Mean (Standard Deviation)
Unit of measure:  Kg
Number Analyzed 12 participants 12 participants 12 participants 12 participants 12 participants 12 participants 12 participants 12 participants 96 participants
72.74  (11.43) 71.68  (11.67) 71.40  (14.40) 71.02  (13.80) 76.05  (11.88) 70.90  (10.69) 69.06  (14.25) 84.43  (17.53) 73.41  (13.66)
Body mass index  
Mean (Standard Deviation)
Unit of measure:  Kg/m^2
Number Analyzed 12 participants 12 participants 12 participants 12 participants 12 participants 12 participants 12 participants 12 participants 96 participants
23.89  (2.92) 24.23  (3.68) 23.80  (2.74) 23.69  (2.03) 25.92  (1.66) 24.69  (3.09) 24.03  (3.17) 26.73  (2.75) 24.62  (2.91)
1.Primary Outcome
Title Number of Participants With Solicited Local Reactions at the Injection Site (Pain, Tenderness, Erythema/Redness, Induration/Swelling) Recorded up to 7 Days After Each IMP Dose
Hide Description Solicited local reactions at the injection site (pain, tenderness, erythema/redness, and induration/swelling) were monitored and graded using criteria based on the guidance given in US FDA Guidance for Industry "Toxicity Grading Scale for Healthy Adult and Adolescent Volunteers Enrolled in Preventive Vaccine Clinical Trials". The reporting of local reactions was based on the participant's assessments via daily solicited reports in the participant diaries.
Time Frame From Day 1 to Day 8 for Prime Immunization and from Day 22 to Day 29 for Boost Immunization
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Hide Analysis Population Description
Safety Set - All subjects who received at least one dose of the IMP.
Arm/Group Title Part A Participants Aged 18 to 55 Years - 3 μg Part A Participants Aged 18 to 55 Years - 10 μg Part A Participants Aged 18 to 55 Years - 20 μg Part A Participants Aged 18 to 55 Years - 30 μg Part A Participants Aged 56 to 85 Years - 3 μg Part A Participants Aged 56 to 85 Years - 10 μg Part A Participants Aged 56 to 85 Years - 20 μg Part A Participants Aged 56 to 85 Years - 30 μg
Hide Arm/Group Description:
BNT162b3: Anti-viral RNA vaccine for active immunization against COVID-19 administered as intramuscular injection (Prime/Boost [P/B] regimen)
BNT162b3: Anti-viral RNA vaccine for active immunization against COVID-19 administered as intramuscular injection (Prime/Boost [P/B] regimen)
BNT162b3: Anti-viral RNA vaccine for active immunization against COVID-19 administered as intramuscular injection (Prime/Boost [P/B] regimen)
BNT162b3: Anti-viral RNA vaccine for active immunization against COVID-19 administered as intramuscular injection (Prime regimen only, as decided by the Safety Review Committee)
BNT162b3: Anti-viral RNA vaccine for active immunization against COVID-19 administered as intramuscular injection (Prime/Boost [P/B] regimen)
BNT162b3: Anti-viral RNA vaccine for active immunization against COVID-19 administered as intramuscular injection (Prime/Boost [P/B] regimen)
BNT162b3: Anti-viral RNA vaccine for active immunization against COVID-19 administered as intramuscular injection (Prime/Boost [P/B] regimen)
BNT162b3: Anti-viral RNA vaccine for active immunization against COVID-19 administered as intramuscular injection (Prime/Boost [P/B] regimen)
Overall Number of Participants Analyzed 12 12 12 12 12 12 12 12
Measure Type: Count of Participants
Unit of Measure: Participants
Prime up to Day 7 after Prime: Number of participants with any local reaction Number Analyzed 12 participants 11 participants 12 participants 12 participants 12 participants 12 participants 12 participants 12 participants
9 9 12 12 4 10 10 9
Prime up to Day 7 after Prime: Number of participants with any grade >= 3 local reaction Number Analyzed 12 participants 11 participants 12 participants 12 participants 12 participants 12 participants 12 participants 12 participants
0 0 2 2 0 0 0 0
Boost up to Day 7 after Boost: Number of participants with any local reaction Number Analyzed 12 participants 12 participants 12 participants 0 participants 12 participants 11 participants 12 participants 12 participants
9 9 12 2 9 8 11
Boost up to Day 7 after Boost: Number of participants with any grade >= 3 local reaction Number Analyzed 12 participants 12 participants 12 participants 0 participants 12 participants 11 participants 12 participants 12 participants
0 0 1 0 0 0 0
2.Primary Outcome
Title Number of Participants With Solicited Systemic Reactions (Nausea, Vomiting, Diarrhea, Headache, Fatigue, Myalgia, Arthralgia, Chills, Loss of Appetite, Malaise, and Fever) Recorded up to 7 Days After Each IMP Dose
Hide Description Solicited systemic reactions (nausea, vomiting, diarrhea, headache, fatigue, myalgia, arthralgia, chills, loss of appetite, malaise, and fever) were monitored and graded using criteria based on the guidance given in US FDA Guidance for Industry "Toxicity Grading Scale for Healthy Adult and Adolescent Volunteers Enrolled in Preventive Vaccine Clinical Trials". The reporting of systemic reactions was based on the participant's assessments via daily solicited reports in the participant diaries.
Time Frame From Day 1 to Day 8 for Prime Immunization and from Day 22 to Day 29 for Boost Immunization
Hide Outcome Measure Data
Hide Analysis Population Description
Safety Set - All subjects who received at least one dose of the IMP.
Arm/Group Title Part A Participants Aged 18 to 55 Years - 3 μg Part A Participants Aged 18 to 55 Years - 10 μg Part A Participants Aged 18 to 55 Years - 20 μg Part A Participants Aged 18 to 55 Years - 30 μg Part A Participants Aged 56 to 85 Years - 3 μg Part A Participants Aged 56 to 85 Years - 10 μg Part A Participants Aged 56 to 85 Years - 20 μg Part A Participants Aged 56 to 85 Years - 30 μg
Hide Arm/Group Description:
BNT162b3: Anti-viral RNA vaccine for active immunization against COVID-19 administered as intramuscular injection (Prime/Boost [P/B] regimen)
BNT162b3: Anti-viral RNA vaccine for active immunization against COVID-19 administered as intramuscular injection (Prime/Boost [P/B] regimen)
BNT162b3: Anti-viral RNA vaccine for active immunization against COVID-19 administered as intramuscular injection (Prime/Boost [P/B] regimen)
BNT162b3: Anti-viral RNA vaccine for active immunization against COVID-19 administered as intramuscular injection (Prime regimen only, as decided by the Safety Review Committee)
BNT162b3: Anti-viral RNA vaccine for active immunization against COVID-19 administered as intramuscular injection (Prime/Boost [P/B] regimen)
BNT162b3: Anti-viral RNA vaccine for active immunization against COVID-19 administered as intramuscular injection (Prime/Boost [P/B] regimen)
BNT162b3: Anti-viral RNA vaccine for active immunization against COVID-19 administered as intramuscular injection (Prime/Boost [P/B] regimen)
BNT162b3: Anti-viral RNA vaccine for active immunization against COVID-19 administered as intramuscular injection (Prime/Boost [P/B] regimen)
Overall Number of Participants Analyzed 12 12 12 12 12 12 12 12
Measure Type: Count of Participants
Unit of Measure: Participants
Prime up to Day 7 after Prime: Number of participants with any systemic reaction Number Analyzed 12 participants 11 participants 12 participants 12 participants 12 participants 12 participants 12 participants 12 participants
4 10 12 12 3 9 9 10
Prime up to Day 7 after Prime: Number of participants with any grade >= 3 systemic reaction Number Analyzed 12 participants 11 participants 12 participants 12 participants 12 participants 12 participants 12 participants 12 participants
0 0 1 3 0 3 0 2
Boost up to Day 7 after Boost: Number of participants with any systemic reaction Number Analyzed 12 participants 12 participants 12 participants 0 participants 12 participants 11 participants 12 participants 12 participants
10 9 12 2 10 9 12
Boost up to Day 7 after Boost: Number of participants with any grade >= 3 systemic reaction Number Analyzed 12 participants 12 participants 12 participants 0 participants 12 participants 11 participants 12 participants 12 participants
0 2 4 0 2 2 2
3.Primary Outcome
Title The Percentage of Participants With at Least 1 Unsolicited Treatment Emergent Adverse Event (TEAE) Occurring After Prime Immunization up to Boost Immunization or 28 Days After Prime Immunization
Hide Description Treatment emergent adverse events (TEAEs) were analyzed by age group, dose level, and for each IMP dose. The number and percentage of participants reporting at least one TEAE was summarized by adverse event types (any TEAE and any grade >=3 TEAE) using the Safety Set.
Time Frame 28 days following first IMP dose or up to second IMP dose (whichever was first)
Hide Outcome Measure Data
Hide Analysis Population Description
Safety Set - All participants who received at least one dose of the IMP.
Arm/Group Title Part A Participants Aged 18 to 55 Years - 3 μg Part A Participants Aged 18 to 55 Years - 10 μg Part A Participants Aged 18 to 55 Years - 20 μg Part A Participants Aged 18 to 55 Years - 30 μg Part A Participants Aged 56 to 85 Years - 3 μg Part A Participants Aged 56 to 85 Years - 10 μg Part A Participants Aged 56 to 85 Years - 20 μg Part A Participants Aged 56 to 85 Years - 30 μg
Hide Arm/Group Description:
BNT162b3: Anti-viral RNA vaccine for active immunization against COVID-19 administered as intramuscular injection (Prime/Boost [P/B] regimen)
BNT162b3: Anti-viral RNA vaccine for active immunization against COVID-19 administered as intramuscular injection (Prime/Boost [P/B] regimen)
BNT162b3: Anti-viral RNA vaccine for active immunization against COVID-19 administered as intramuscular injection (Prime/Boost [P/B] regimen)
BNT162b3: Anti-viral RNA vaccine for active immunization against COVID-19 administered as intramuscular injection (Prime regimen only, as decided by the Safety Review Committee)
BNT162b3: Anti-viral RNA vaccine for active immunization against COVID-19 administered as intramuscular injection (Prime/Boost [P/B] regimen)
BNT162b3: Anti-viral RNA vaccine for active immunization against COVID-19 administered as intramuscular injection (Prime/Boost [P/B] regimen)
BNT162b3: Anti-viral RNA vaccine for active immunization against COVID-19 administered as intramuscular injection (Prime/Boost [P/B] regimen)
BNT162b3: Anti-viral RNA vaccine for active immunization against COVID-19 administered as intramuscular injection (Prime/Boost [P/B] regimen)
Overall Number of Participants Analyzed 12 12 12 12 12 12 12 12
Measure Type: Number
Unit of Measure: percentage of participants
Any TEAE 42 25 25 50 17 17 25 42
Any grade >=3 TEAE 0 0 0 0 0 0 0 0
4.Primary Outcome
Title The Percentage of Participants With at Least 1 Unsolicited TEAE Occurring up to 28 Days After Boost Immunization or After Prime Immunization (if no Boost Immunization)
Hide Description Treatment emergent adverse events (TEAEs) were analyzed by age group, dose level, and for each IMP dose. The percentage of participants reporting at least one TEAE was summarized by adverse event types (any TEAE and any grade >=3 TEAE) using the Safety Set.
Time Frame 28 days following second IMP dose or first IMP dose (if no second IMP dose as given)
Hide Outcome Measure Data
Hide Analysis Population Description
Safety Set - All participants who received at least one dose of the IMP.
Arm/Group Title Part A Participants Aged 18 to 55 Years - 3 μg Part A Participants Aged 18 to 55 Years - 10 μg Part A Participants Aged 18 to 55 Years - 20 μg Part A Participants Aged 18 to 55 Years - 30 μg Part A Participants Aged 56 to 85 Years - 3 μg Part A Participants Aged 56 to 85 Years - 10 μg Part A Participants Aged 56 to 85 Years - 20 μg Part A Participants Aged 56 to 85 Years - 30 μg
Hide Arm/Group Description:
BNT162b3: Anti-viral RNA vaccine for active immunization against COVID-19 administered as intramuscular injection (Prime/Boost [P/B] regimen)
BNT162b3: Anti-viral RNA vaccine for active immunization against COVID-19 administered as intramuscular injection (Prime/Boost [P/B] regimen)
BNT162b3: Anti-viral RNA vaccine for active immunization against COVID-19 administered as intramuscular injection (Prime/Boost [P/B] regimen)
BNT162b3: Anti-viral RNA vaccine for active immunization against COVID-19 administered as intramuscular injection (Prime regimen only, as decided by the Safety Review Committee)
BNT162b3: Anti-viral RNA vaccine for active immunization against COVID-19 administered as intramuscular injection (Prime/Boost [P/B] regimen)
BNT162b3: Anti-viral RNA vaccine for active immunization against COVID-19 administered as intramuscular injection (Prime/Boost [P/B] regimen)
BNT162b3: Anti-viral RNA vaccine for active immunization against COVID-19 administered as intramuscular injection (Prime/Boost [P/B] regimen)
BNT162b3: Anti-viral RNA vaccine for active immunization against COVID-19 administered as intramuscular injection (Prime/Boost [P/B] regimen)
Overall Number of Participants Analyzed 12 12 12 12 12 12 12 12
Measure Type: Number
Unit of Measure: percentage of participants
Any TEAE 50 33 42 50 58 25 42 50
Any grade >=3 TEAE 0 0 0 0 0 0 0 8
5.Secondary Outcome
Title Functional Antibody Responses
Hide Description At 7 and 21 days after primary immunization and at 7, 14, 21, 28 days after boost immunization.
Time Frame up to 50 days following first IMP dose
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Hide Analysis Population Description

Immunogenicity set - all participants who received at least one dose of IMP and had at least one post-baseline functional antibody titer immunogenicity assessment.

Boost immunization withheld for 30 μg younger cohort following Safety Review Committee decision.

Arm/Group Title Part A Participants Aged 18 to 55 Years - 3 μg Part A Participants Aged 18 to 55 Years - 10 μg Part A Participants Aged 18 to 55 Years - 20 μg Part A Participants Aged 18 to 55 Years - 30 μg Part A Participants Aged 56 to 85 Years - 3 μg Part A Participants Aged 56 to 85 Years - 10 μg Part A Participants Aged 56 to 85 Years - 20 μg Part A Participants Aged 56 to 85 Years - 30 μg
Hide Arm/Group Description:
BNT162b3: Anti-viral RNA vaccine for active immunization against COVID-19 administered as intramuscular injection (Prime/Boost [P/B] regimen)
BNT162b3: Anti-viral RNA vaccine for active immunization against COVID-19 administered as intramuscular injection (Prime/Boost [P/B] regimen)
BNT162b3: Anti-viral RNA vaccine for active immunization against COVID-19 administered as intramuscular injection (Prime/Boost [P/B] regimen)
BNT162b3: Anti-viral RNA vaccine for active immunization against COVID-19 administered as intramuscular injection (Prime regimen only, as decided by the Safety Review Committee)
BNT162b3: Anti-viral RNA vaccine for active immunization against COVID-19 administered as intramuscular injection (Prime/Boost [P/B] regimen)
BNT162b3: Anti-viral RNA vaccine for active immunization against COVID-19 administered as intramuscular injection (Prime/Boost [P/B] regimen)
BNT162b3: Anti-viral RNA vaccine for active immunization against COVID-19 administered as intramuscular injection (Prime/Boost [P/B] regimen)
BNT162b3: Anti-viral RNA vaccine for active immunization against COVID-19 administered as intramuscular injection (Prime/Boost [P/B] regimen)
Overall Number of Participants Analyzed 12 12 12 12 12 12 12 12
Geometric Mean (95% Confidence Interval)
Unit of Measure: titer
7 days after Prime Immunization (Day 8)
5.0
(5.0 to 5.0)
5.1
(4.8 to 5.5)
5.0
(5.0 to 5.0)
5.0
(5.0 to 5.0)
5.0
(5.0 to 5.0)
5.0
(5.0 to 5.0)
7.3
(3.2 to 16.6)
5.0
(5.0 to 5.0)
21 days after Prime Immunization (Day 22)
6.1
(4.5 to 8.4)
25.9
(13.8 to 48.7)
8.9
(6.0 to 13.3)
12.2
(7.5 to 20.0)
6.3
(4.8 to 8.3)
5.3
(4.9 to 5.8)
15.0
(5.9 to 37.9)
9.4
(5.4 to 16.4)
7 days after Boost Immunization (Day 29)
51.5
(26.4 to 100.3)
479.5
(300.3 to 765.5)
106.8
(58.2 to 196.0)
10.0
(6.5 to 15.4)
53.4
(25.1 to 113.7)
51.9
(25.0 to 107.4)
320.0
(189.7 to 539.7)
207.5
(118.0 to 364.8)
14 days after Boost Immunization (Day 36)
60.6
(33.5 to 109.8)
NA [1] 
(NA to NA)
NA [2] 
(NA to NA)
10.3
(6.9 to 15.4)
77.7
(40.4 to 149.4)
219.8
(148.5 to 325.4)
320.0
(169.3 to 604.9)
359.2
(204.0 to 632.6)
21 days after Boost Immunization (Day 43)
36.4
(20.0 to 66.2)
116.5
(79.6 to 170.4)
201.6
(104.9 to 387.2)
9.7
(5.7 to 16.5)
53.4
(27.5 to 103.6)
155.4
(105.0 to 230.1)
285.1
(152.6 to 532.7)
261.4
(136.0 to 502.6)
28 days after Boost Immunization (Day 50)
31.7
(18.5 to 54.6)
80.0
(49.1 to 130.4)
219.8
(117.5 to 411.1)
7.9
(5.0 to 12.5)
41.2
(20.5 to 82.8)
138.5
(87.9 to 218.2)
232.9
(131.1 to 413.8)
195.8
(109.4 to 350.6)
[1]
Missing Day 36 data of 10 μg younger cohort as they have only re-consented to Clinical Trial Protocol 7.0 (introducing visit 5a/Day 36) on/after their Day 43.
[2]
Missing Day 36 data of 20 μg younger cohort as they have only re-consented to Clinical Trial Protocol 7.0 (introducing visit 5a/Day 36) on/after their Day 43.
6.Secondary Outcome
Title Fold Increase in Functional Antibody Titers
Hide Description At 7 and 21 days after primary immunization and at 7, 14, 21, and 28 days after the boost immunization.
Time Frame up to 50 days following first IMP dose
Hide Outcome Measure Data
Hide Analysis Population Description

Immunogenicity set - all participants who received at least one dose of IMP and had at least one post-baseline functional antibody titer immunogenicity assessment.

Boost immunization withheld for 30 μg younger cohort following Safety Review Committee decision.

Arm/Group Title Part A Participants Aged 18 to 55 Years - 3 μg Part A Participants Aged 18 to 55 Years - 10 μg Part A Participants Aged 18 to 55 Years - 20 μg Part A Participants Aged 18 to 55 Years - 30 μg Part A Participants Aged 56 to 85 Years - 3 μg Part A Participants Aged 56 to 85 Years - 10 μg Part A Participants Aged 56 to 85 Years - 20 μg Part A Participants Aged 56 to 85 Years - 30 μg
Hide Arm/Group Description:
BNT162b3: Anti-viral RNA vaccine for active immunization against COVID-19 administered as intramuscular injection (Prime/Boost [P/B] regimen)
BNT162b3: Anti-viral RNA vaccine for active immunization against COVID-19 administered as intramuscular injection (Prime/Boost [P/B] regimen)
BNT162b3: Anti-viral RNA vaccine for active immunization against COVID-19 administered as intramuscular injection (Prime/Boost [P/B] regimen)
BNT162b3: Anti-viral RNA vaccine for active immunization against COVID-19 administered as intramuscular injection (Prime regimen only, as decided by the Safety Review Committee)
BNT162b3: Anti-viral RNA vaccine for active immunization against COVID-19 administered as intramuscular injection (Prime/Boost [P/B] regimen)
BNT162b3: Anti-viral RNA vaccine for active immunization against COVID-19 administered as intramuscular injection (Prime/Boost [P/B] regimen)
BNT162b3: Anti-viral RNA vaccine for active immunization against COVID-19 administered as intramuscular injection (Prime/Boost [P/B] regimen)
BNT162b3: Anti-viral RNA vaccine for active immunization against COVID-19 administered as intramuscular injection (Prime/Boost [P/B] regimen)
Overall Number of Participants Analyzed 12 12 12 12 12 12 12 12
Geometric Mean (95% Confidence Interval)
Unit of Measure: Fold rise
7 days after Prime Immunization (Day 8) Number Analyzed 12 participants 12 participants 12 participants 12 participants 12 participants 12 participants 12 participants 12 participants
1.0
(1.0 to 1.0)
1.0
(1.0 to 1.1)
1.0
(1.0 to 1.0)
1.0
(1.0 to 1.0)
1.0
(1.0 to 1.0)
1.0
(1.0 to 1.0)
1.3
(0.8 to 2.1)
1.0
(1.0 to 1.0)
21 days after Prime Immunization (Day 22) Number Analyzed 12 participants 12 participants 12 participants 12 participants 12 participants 12 participants 12 participants 12 participants
1.2
(0.9 to 1.7)
5.2
(2.8 to 9.7)
1.8
(1.2 to 2.7)
2.4
(1.5 to 4.0)
1.3
(1.0 to 1.7)
1.1
(1.0 to 1.2)
2.6
(1.3 to 5.0)
1.9
(1.1 to 3.3)
7 days after Boost Immunization (Day 29) Number Analyzed 11 participants 12 participants 12 participants 12 participants 12 participants 12 participants 12 participants 12 participants
10.3
(5.3 to 20.1)
95.9
(60.1 to 153.1)
21.4
(11.6 to 39.2)
2.0
(1.3 to 3.1)
10.7
(5.0 to 22.7)
10.4
(5.0 to 21.5)
55.4
(35.5 to 86.4)
41.5
(23.6 to 73.0)
14 days after Boost Immunization (Day 36) Number Analyzed 10 participants 0 participants 0 participants 12 participants 12 participants 12 participants 12 participants 12 participants
12.1
(6.7 to 22.0)
2.1
(1.4 to 3.1)
15.5
(8.1 to 29.9)
44.0
(29.7 to 65.1)
55.4
(31.2 to 98.4)
71.8
(40.8 to 126.5)
21 days after Boost Immunization (Day 43) Number Analyzed 11 participants 12 participants 12 participants 12 participants 12 participants 12 participants 12 participants 12 participants
7.3
(4.0 to 13.2)
23.3
(15.9 to 34.1)
40.3
(21.0 to 77.4)
1.9
(1.1 to 3.3)
10.7
(5.5 to 20.7)
31.1
(21.0 to 46.0)
49.4
(29.7 to 81.9)
52.3
(27.2 to 100.5)
28 days after Boost Immunization (Day 50) Number Analyzed 12 participants 11 participants 12 participants 12 participants 12 participants 12 participants 12 participants 12 participants
6.3
(3.7 to 10.9)
16.0
(9.8 to 26.1)
44.0
(23.5 to 82.2)
1.6
(1.0 to 2.5)
8.2
(4.1 to 16.6)
27.7
(17.6 to 43.6)
40.3
(26.7 to 60.9)
39.2
(21.9 to 70.1)
7.Secondary Outcome
Title Number of Subjects With Seroconversion Defined as a Minimum of 4-fold Increase of Functional Antibody Titers as Compared to Baseline
Hide Description At 7 and 21 days after primary immunization and at 7, 14, 21, and 28 days after the boost immunization.
Time Frame up to 50 days following first IMP dose
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Hide Analysis Population Description

Immunogenicity set - all subjects who received at least one dose of IMP and had at least one post-baseline functional antibody titer immunogenicity assessment.

Boost immunization withheld for 30 μg younger cohort following Safety Review Committee decision.

Arm/Group Title Part A Participants Aged 18 to 55 Years - 3 μg Part A Participants Aged 18 to 55 Years - 10 μg Part A Participants Aged 18 to 55 Years - 20 μg Part A Participants Aged 18 to 55 Years - 30 μg Part A Participants Aged 56 to 85 Years - 3 μg Part A Participants Aged 56 to 85 Years - 10 μg Part A Participants Aged 56 to 85 Years - 20 μg Part A Participants Aged 56 to 85 Years - 30 μg
Hide Arm/Group Description:
BNT162b3: Anti-viral RNA vaccine for active immunization against COVID-19 administered as intramuscular injection (Prime/Boost [P/B] regimen)
BNT162b3: Anti-viral RNA vaccine for active immunization against COVID-19 administered as intramuscular injection (Prime/Boost [P/B] regimen)
BNT162b3: Anti-viral RNA vaccine for active immunization against COVID-19 administered as intramuscular injection (Prime/Boost [P/B] regimen)
BNT162b3: Anti-viral RNA vaccine for active immunization against COVID-19 administered as intramuscular injection (Prime regimen only, as decided by the Safety Review Committee)
BNT162b3: Anti-viral RNA vaccine for active immunization against COVID-19 administered as intramuscular injection (Prime/Boost [P/B] regimen)
BNT162b3: Anti-viral RNA vaccine for active immunization against COVID-19 administered as intramuscular injection (Prime/Boost [P/B] regimen)
BNT162b3: Anti-viral RNA vaccine for active immunization against COVID-19 administered as intramuscular injection (Prime/Boost [P/B] regimen)
BNT162b3: Anti-viral RNA vaccine for active immunization against COVID-19 administered as intramuscular injection (Prime/Boost [P/B] regimen)
Overall Number of Participants Analyzed 12 12 12 12 12 12 12 12
Measure Type: Count of Participants
Unit of Measure: Participants
7 days after Prime Immunization (Day 8) Number Analyzed 12 participants 12 participants 12 participants 12 participants 12 participants 12 participants 12 participants 12 participants
0 0 0 0 0 0 1 0
21 days after Prime Immunization (Day 22) Number Analyzed 12 participants 12 participants 12 participants 12 participants 12 participants 12 participants 12 participants 12 participants
1 9 2 5 1 0 4 2
7 days after Boost Immunization (Day 29) Number Analyzed 11 participants 12 participants 12 participants 12 participants 12 participants 12 participants 12 participants 12 participants
9 12 12 3 10 10 12 12
14 days after Boost Immunization (Day 36) Number Analyzed 10 participants 0 participants 0 participants 12 participants 12 participants 12 participants 12 participants 12 participants
9 4 11 12 12 12
21 days after Boost Immunization (Day 43) Number Analyzed 11 participants 12 participants 12 participants 12 participants 12 participants 12 participants 12 participants 12 participants
8 12 12 3 9 12 12 12
28 days after Boost Immunization (Day 50) Number Analyzed 12 participants 11 participants 12 participants 12 participants 12 participants 12 participants 12 participants 12 participants
8 11 12 1 9 12 12 12
8.Secondary Outcome
Title Functional Antibody Responses
Hide Description At 63, 162, 365 days after boost immunization.
Time Frame From 51 to up to 365 days following first IMP dose
Outcome Measure Data Not Reported
9.Secondary Outcome
Title Fold Increase in Functional Antibody Titers
Hide Description At 63, 162, 365 days after boost immunization.
Time Frame From 51 to up to 365 days following first IMP dose
Outcome Measure Data Not Reported
10.Secondary Outcome
Title Number of Subjects With Seroconversion Defined as a Minimum of 4-fold Increase of Functional Antibody Titers as Compared to Baseline
Hide Description At 63, 162, 365 days after boost immunization.
Time Frame From 51 to up to 365 days following first IMP dose
Outcome Measure Data Not Reported
Time Frame From Day 1 (Prime Immunization) up to Day 50 (with or without Boost Immunization)
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title Part A Participants Aged 18 to 55 Years - 3 μg Part A Participants Aged 18 to 55 Years - 10 μg Part A Participants Aged 18 to 55 Years - 20 μg Part A Participants Aged 18 to 55 Years - 30 μg Part A Participants Aged 56 to 85 Years - 3 μg Part A Participants Aged 56 to 85 Years - 10 μg Part A Participants Aged 56 to 85 Years - 20 μg Part A Participants Aged 56 to 85 Years - 30 μg
Hide Arm/Group Description BNT162b3: Anti-viral RNA vaccine for active immunization against COVID-19 administered as intramuscular injection (Prime/Boost [P/B] regimen) BNT162b3: Anti-viral RNA vaccine for active immunization against COVID-19 administered as intramuscular injection (Prime/Boost [P/B] regimen) BNT162b3: Anti-viral RNA vaccine for active immunization against COVID-19 administered as intramuscular injection (Prime/Boost [P/B] regimen) BNT162b3: Anti-viral RNA vaccine for active immunization against COVID-19 administered as intramuscular injection (Prime regimen only, as decided by the Safety Review Committee) BNT162b3: Anti-viral RNA vaccine for active immunization against COVID-19 administered as intramuscular injection (Prime/Boost [P/B] regimen) BNT162b3: Anti-viral RNA vaccine for active immunization against COVID-19 administered as intramuscular injection (Prime/Boost [P/B] regimen) BNT162b3: Anti-viral RNA vaccine for active immunization against COVID-19 administered as intramuscular injection (Prime/Boost [P/B] regimen) BNT162b3: Anti-viral RNA vaccine for active immunization against COVID-19 administered as intramuscular injection (Prime/Boost [P/B] regimen)
All-Cause Mortality
Part A Participants Aged 18 to 55 Years - 3 μg Part A Participants Aged 18 to 55 Years - 10 μg Part A Participants Aged 18 to 55 Years - 20 μg Part A Participants Aged 18 to 55 Years - 30 μg Part A Participants Aged 56 to 85 Years - 3 μg Part A Participants Aged 56 to 85 Years - 10 μg Part A Participants Aged 56 to 85 Years - 20 μg Part A Participants Aged 56 to 85 Years - 30 μg
Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%)
Total   0/12 (0.00%)   0/12 (0.00%)   0/12 (0.00%)   0/12 (0.00%)   0/12 (0.00%)   0/12 (0.00%)   0/12 (0.00%)   0/12 (0.00%) 
Hide Serious Adverse Events
Part A Participants Aged 18 to 55 Years - 3 μg Part A Participants Aged 18 to 55 Years - 10 μg Part A Participants Aged 18 to 55 Years - 20 μg Part A Participants Aged 18 to 55 Years - 30 μg Part A Participants Aged 56 to 85 Years - 3 μg Part A Participants Aged 56 to 85 Years - 10 μg Part A Participants Aged 56 to 85 Years - 20 μg Part A Participants Aged 56 to 85 Years - 30 μg
Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%)
Total   0/12 (0.00%)   0/12 (0.00%)   0/12 (0.00%)   0/12 (0.00%)   0/12 (0.00%)   0/12 (0.00%)   0/12 (0.00%)   0/12 (0.00%) 
Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 0%
Part A Participants Aged 18 to 55 Years - 3 μg Part A Participants Aged 18 to 55 Years - 10 μg Part A Participants Aged 18 to 55 Years - 20 μg Part A Participants Aged 18 to 55 Years - 30 μg Part A Participants Aged 56 to 85 Years - 3 μg Part A Participants Aged 56 to 85 Years - 10 μg Part A Participants Aged 56 to 85 Years - 20 μg Part A Participants Aged 56 to 85 Years - 30 μg
Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%)
Total   7/12 (58.33%)   4/12 (33.33%)   5/12 (41.67%)   6/12 (50.00%)   7/12 (58.33%)   5/12 (41.67%)   5/12 (41.67%)   6/12 (50.00%) 
Cardiac disorders                 
Palpitations * 1  0/12 (0.00%)  0/12 (0.00%)  0/12 (0.00%)  0/12 (0.00%)  0/12 (0.00%)  1/12 (8.33%)  0/12 (0.00%)  0/12 (0.00%) 
Ear and labyrinth disorders                 
Ear pain * 1  0/12 (0.00%)  0/12 (0.00%)  0/12 (0.00%)  0/12 (0.00%)  0/12 (0.00%)  0/12 (0.00%)  1/12 (8.33%)  0/12 (0.00%) 
Vertigo * 1  0/12 (0.00%)  0/12 (0.00%)  0/12 (0.00%)  0/12 (0.00%)  0/12 (0.00%)  0/12 (0.00%)  0/12 (0.00%)  1/12 (8.33%) 
Eye disorders                 
Meibomian gland dysfunction * 1  1/12 (8.33%)  0/12 (0.00%)  0/12 (0.00%)  0/12 (0.00%)  0/12 (0.00%)  0/12 (0.00%)  0/12 (0.00%)  0/12 (0.00%) 
Gastrointestinal disorders                 
Dyspepsia * 1  0/12 (0.00%)  0/12 (0.00%)  0/12 (0.00%)  0/12 (0.00%)  0/12 (0.00%)  0/12 (0.00%)  1/12 (8.33%)  0/12 (0.00%) 
Flatulence * 1  1/12 (8.33%)  0/12 (0.00%)  0/12 (0.00%)  0/12 (0.00%)  0/12 (0.00%)  0/12 (0.00%)  0/12 (0.00%)  0/12 (0.00%) 
Paraesthesia oral * 1  0/12 (0.00%)  0/12 (0.00%)  1/12 (8.33%)  0/12 (0.00%)  0/12 (0.00%)  0/12 (0.00%)  0/12 (0.00%)  0/12 (0.00%) 
Toothache * 1  1/12 (8.33%)  0/12 (0.00%)  0/12 (0.00%)  0/12 (0.00%)  0/12 (0.00%)  0/12 (0.00%)  0/12 (0.00%)  0/12 (0.00%) 
General disorders                 
Chest pain * 1  0/12 (0.00%)  0/12 (0.00%)  1/12 (8.33%)  0/12 (0.00%)  0/12 (0.00%)  0/12 (0.00%)  0/12 (0.00%)  0/12 (0.00%) 
Fatigue * 1  1/12 (8.33%)  0/12 (0.00%)  0/12 (0.00%)  0/12 (0.00%)  0/12 (0.00%)  0/12 (0.00%)  0/12 (0.00%)  0/12 (0.00%) 
Influenza like illness * 1  0/12 (0.00%)  0/12 (0.00%)  0/12 (0.00%)  0/12 (0.00%)  0/12 (0.00%)  1/12 (8.33%)  0/12 (0.00%)  0/12 (0.00%) 
Injection site reaction * 1  0/12 (0.00%)  0/12 (0.00%)  0/12 (0.00%)  0/12 (0.00%)  0/12 (0.00%)  1/12 (8.33%)  0/12 (0.00%)  0/12 (0.00%) 
Malaise * 1  0/12 (0.00%)  0/12 (0.00%)  0/12 (0.00%)  1/12 (8.33%)  0/12 (0.00%)  0/12 (0.00%)  0/12 (0.00%)  1/12 (8.33%) 
Tenderness * 1  0/12 (0.00%)  0/12 (0.00%)  0/12 (0.00%)  1/12 (8.33%)  0/12 (0.00%)  0/12 (0.00%)  0/12 (0.00%)  0/12 (0.00%) 
Immune system disorders                 
Seasonal allergy * 1  0/12 (0.00%)  0/12 (0.00%)  0/12 (0.00%)  0/12 (0.00%)  0/12 (0.00%)  0/12 (0.00%)  0/12 (0.00%)  1/12 (8.33%) 
Infections and infestations                 
Cystitis * 1  0/12 (0.00%)  0/12 (0.00%)  1/12 (8.33%)  1/12 (8.33%)  0/12 (0.00%)  0/12 (0.00%)  0/12 (0.00%)  0/12 (0.00%) 
Nasopharyngitis * 1  0/12 (0.00%)  0/12 (0.00%)  0/12 (0.00%)  1/12 (8.33%)  0/12 (0.00%)  0/12 (0.00%)  0/12 (0.00%)  0/12 (0.00%) 
Oral herpes * 1  0/12 (0.00%)  1/12 (8.33%)  0/12 (0.00%)  1/12 (8.33%)  0/12 (0.00%)  0/12 (0.00%)  0/12 (0.00%)  0/12 (0.00%) 
Pulpitis dental * 1  0/12 (0.00%)  0/12 (0.00%)  0/12 (0.00%)  0/12 (0.00%)  1/12 (8.33%)  0/12 (0.00%)  0/12 (0.00%)  0/12 (0.00%) 
Rhinitis * 1  0/12 (0.00%)  0/12 (0.00%)  0/12 (0.00%)  1/12 (8.33%)  1/12 (8.33%)  0/12 (0.00%)  0/12 (0.00%)  0/12 (0.00%) 
Sinusitis * 1  0/12 (0.00%)  0/12 (0.00%)  1/12 (8.33%)  0/12 (0.00%)  0/12 (0.00%)  0/12 (0.00%)  0/12 (0.00%)  0/12 (0.00%) 
Urinary tract infection * 1  0/12 (0.00%)  0/12 (0.00%)  0/12 (0.00%)  0/12 (0.00%)  1/12 (8.33%)  0/12 (0.00%)  0/12 (0.00%)  0/12 (0.00%) 
Injury, poisoning and procedural complications                 
Skin laceration * 1  1/12 (8.33%)  0/12 (0.00%)  0/12 (0.00%)  0/12 (0.00%)  0/12 (0.00%)  0/12 (0.00%)  0/12 (0.00%)  0/12 (0.00%) 
Investigations                 
Gamma-glutamyltransferase increased * 1  0/12 (0.00%)  0/12 (0.00%)  0/12 (0.00%)  0/12 (0.00%)  0/12 (0.00%)  0/12 (0.00%)  1/12 (8.33%)  0/12 (0.00%) 
Lipase increased * 1  0/12 (0.00%)  0/12 (0.00%)  0/12 (0.00%)  0/12 (0.00%)  0/12 (0.00%)  0/12 (0.00%)  1/12 (8.33%)  0/12 (0.00%) 
Musculoskeletal and connective tissue disorders                 
Arthralgia * 1  1/12 (8.33%)  0/12 (0.00%)  0/12 (0.00%)  1/12 (8.33%)  2/12 (16.67%)  0/12 (0.00%)  0/12 (0.00%)  0/12 (0.00%) 
Myalgia * 1  2/12 (16.67%)  0/12 (0.00%)  0/12 (0.00%)  0/12 (0.00%)  0/12 (0.00%)  0/12 (0.00%)  0/12 (0.00%)  0/12 (0.00%) 
Myofascial pain syndrome * 1  0/12 (0.00%)  0/12 (0.00%)  0/12 (0.00%)  1/12 (8.33%)  0/12 (0.00%)  0/12 (0.00%)  0/12 (0.00%)  0/12 (0.00%) 
Pain in extremity * 1  0/12 (0.00%)  0/12 (0.00%)  0/12 (0.00%)  0/12 (0.00%)  0/12 (0.00%)  0/12 (0.00%)  0/12 (0.00%)  1/12 (8.33%) 
Nervous system disorders                 
Dizziness * 1  0/12 (0.00%)  1/12 (8.33%)  0/12 (0.00%)  0/12 (0.00%)  0/12 (0.00%)  1/12 (8.33%)  1/12 (8.33%)  0/12 (0.00%) 
Headache * 1  1/12 (8.33%)  2/12 (16.67%)  2/12 (16.67%)  3/12 (25.00%)  1/12 (8.33%)  0/12 (0.00%)  0/12 (0.00%)  0/12 (0.00%) 
Hyperaesthesia * 1  0/12 (0.00%)  0/12 (0.00%)  0/12 (0.00%)  0/12 (0.00%)  0/12 (0.00%)  0/12 (0.00%)  1/12 (8.33%)  0/12 (0.00%) 
Sciatica * 1  0/12 (0.00%)  0/12 (0.00%)  0/12 (0.00%)  0/12 (0.00%)  0/12 (0.00%)  0/12 (0.00%)  0/12 (0.00%)  1/12 (8.33%) 
Psychiatric disorders                 
Restlessness * 1  0/12 (0.00%)  0/12 (0.00%)  0/12 (0.00%)  0/12 (0.00%)  0/12 (0.00%)  1/12 (8.33%)  0/12 (0.00%)  0/12 (0.00%) 
Sleep disorder * 1  1/12 (8.33%)  0/12 (0.00%)  0/12 (0.00%)  0/12 (0.00%)  1/12 (8.33%)  0/12 (0.00%)  0/12 (0.00%)  0/12 (0.00%) 
Reproductive system and breast disorders                 
Dysmenorrhoea * 1  0/12 (0.00%)  0/12 (0.00%)  1/12 (8.33%)  0/12 (0.00%)  0/12 (0.00%)  0/12 (0.00%)  0/12 (0.00%)  0/12 (0.00%) 
Respiratory, thoracic and mediastinal disorders                 
Cough * 1  0/12 (0.00%)  0/12 (0.00%)  0/12 (0.00%)  0/12 (0.00%)  1/12 (8.33%)  0/12 (0.00%)  0/12 (0.00%)  2/12 (16.67%) 
Nasal discomfort * 1  0/12 (0.00%)  0/12 (0.00%)  0/12 (0.00%)  0/12 (0.00%)  1/12 (8.33%)  0/12 (0.00%)  0/12 (0.00%)  0/12 (0.00%) 
Oropharyngeal pain * 1  0/12 (0.00%)  0/12 (0.00%)  0/12 (0.00%)  1/12 (8.33%)  1/12 (8.33%)  0/12 (0.00%)  0/12 (0.00%)  0/12 (0.00%) 
Rhinorrhoea * 1  0/12 (0.00%)  0/12 (0.00%)  0/12 (0.00%)  0/12 (0.00%)  0/12 (0.00%)  0/12 (0.00%)  0/12 (0.00%)  1/12 (8.33%) 
Skin and subcutaneous tissue disorders                 
Pruritus * 1  0/12 (0.00%)  1/12 (8.33%)  0/12 (0.00%)  0/12 (0.00%)  0/12 (0.00%)  0/12 (0.00%)  0/12 (0.00%)  0/12 (0.00%) 
Surgical and medical procedures                 
Dental care * 1  1/12 (8.33%)  0/12 (0.00%)  0/12 (0.00%)  0/12 (0.00%)  0/12 (0.00%)  0/12 (0.00%)  0/12 (0.00%)  0/12 (0.00%) 
Vascular disorders                 
Hypertension * 1  0/12 (0.00%)  0/12 (0.00%)  0/12 (0.00%)  0/12 (0.00%)  0/12 (0.00%)  1/12 (8.33%)  0/12 (0.00%)  0/12 (0.00%) 
1
Term from vocabulary, MedDRA (23.1)
*
Indicates events were collected by non-systematic assessment
Certain Agreements
Principal Investigators are NOT employed by the organization sponsoring the study.
There IS an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.
PIs respectively trial sites shall not publish or refer to in writing or orally, in whole or in part, any data, information or materials generated from the study and the services, without the prior written consent of the sponsor.
Results Point of Contact
Layout table for Results Point of Contact information
Name/Title: BioNTech clinical trials patient information
Organization: BioNTech SE
Phone: +49 6131 9084 ext 0
EMail: patients@biontech.de
Layout table for additonal information
Responsible Party: BioNTech SE
ClinicalTrials.gov Identifier: NCT04537949    
Other Study ID Numbers: BNT162-04
2020-003267-26 ( EudraCT Number )
U1111-1254-4840 ( Other Identifier: WHO Universal Trial Number (UTN) )
First Submitted: September 2, 2020
First Posted: September 3, 2020
Results First Submitted: February 14, 2022
Results First Posted: March 24, 2022
Last Update Posted: March 24, 2022