Trial Outcomes & Findings for COVID19 SARS Vaccinations: Systemic Allergic Reactions to SARS-CoV-2 Vaccinations (NCT NCT04761822)
NCT ID: NCT04761822
Last Updated: 2025-08-12
Results Overview
Allergic reactions were graded using the Consortium of Food Allergy Research (CoFAR) Grading Scale for Systemic Allergic Reactions, Version 3.0. The scale ranges from grade 1 through 5. The higher the grade, the more severe the allergic reaction. Tryptase is an enzyme released into the blood during an allergic reaction. An elevation in tryptase is defined as a value that is higher than 1.2 x the baseline tryptase plus 2 ng/ml. Subjects who did not receive their second dose of the vaccine were not included unless they reacted (per the endpoint) to the first dose. The comparison is between the High Allergy/Mast Cell Disorder and Comparison populations.
Recruitment status
COMPLETED
Study phase
PHASE2
Target enrollment
746 participants
Primary outcome timeframe
Within the 90-minute post-vaccination observation period to either dose of the Pfizer-BioNTech COVID-19 Vaccine.
Results posted on
2025-08-12
Participant Flow
746 participants were enrolled across 28 US sites between April 2021 and February 2022. Of those enrolled, 729 participants were randomized and 686 initiated study treatment. The 60 participants who did not initiate study treatment were terminated because they did not meet eligibility criteria, withdrew their consent, or were lost to follow-up.
Participants were allowed to be randomized up to 14 days prior to their first injection visit to allow for batch scheduling and minimization of vaccine waste. During this time, some participants failed or no longer met eligibility criteria, withdrew their consent, or were lost to follow-up.
Participant milestones
| Measure |
Pfizer-BioNTech COVID-19 Vaccine
The Pfizer-BioNTech COVID-19 Vaccine (0.3 mL for those 12 years and older, 0.2 mL for those aged 5 to 11 years) was administered intramuscularly in the deltoid, as a series of two doses (0.3 mL each for those 12 years and older, 0.2 mL for those aged 5 to 11 years), 3 weeks (21 days) apart.
|
Moderna COVID-19 Vaccine
The Moderna COVID-19 Vaccine (0.5 mL for those 12 years and older, 0.25 mL for those aged 5 to 11 years) was administered intramuscularly in the deltoid, as a series of two doses (0.5 mL each for those 12 years and older, 0.25 mL each for those aged 5 to 11 years), 1 month (28 days) apart.
|
Placebo + Pfizer-BioNTech COVID-19 Vaccine
The placebo dose (0.3 mL for those 12 years and older, 0.2 mL for those aged 5 to 11 years), a sterile, preservative-free 0.9% Sodium Chloride Injection, was administered intramuscularly in the deltoid as a first dose followed by two doses of Pfizer-BioNTech COVID-19 Vaccine starting either 7 or 21 days later, depending upon protocol version. The Pfizer-BioNTech COVID-19 Vaccine (0.3 mL for those 12 years and older, 0.2 mL for those aged 5 to 11 years) was administered intramuscularly in the deltoid, as a series of two doses (0.3 mL each for those 12 years and older, 0.2 mL for those aged 5 to 11 years) administered 3 weeks (21 days) apart.
|
Placebo + Moderna COVID-19 Vaccine
The placebo dose (0.5 mL for those 12 years and older, 0.25 mL for those aged 5 to 11 years), a sterile, preservative-free 0.9% Sodium Chloride Injection, was administered intramuscularly in the deltoid as a first dose followed by two doses of Moderna COVID-19 Vaccine starting either 7 or 28 days later, depending upon protocol version. The Moderna COVID-19 Vaccine (0.5 mL for those 12 years and older, 0.25 mL for those aged 5 to 11 years) was administered intramuscularly in the deltoid, as a series of two doses (0.5 mL each for those 12 years and older, 0.25 mL for those aged 5 to 11 years) administered 1 month (28 days) apart.
|
|---|---|---|---|---|
|
Overall Study
STARTED
|
227
|
219
|
117
|
123
|
|
Overall Study
COMPLETED
|
219
|
209
|
113
|
105
|
|
Overall Study
NOT COMPLETED
|
8
|
10
|
4
|
18
|
Reasons for withdrawal
| Measure |
Pfizer-BioNTech COVID-19 Vaccine
The Pfizer-BioNTech COVID-19 Vaccine (0.3 mL for those 12 years and older, 0.2 mL for those aged 5 to 11 years) was administered intramuscularly in the deltoid, as a series of two doses (0.3 mL each for those 12 years and older, 0.2 mL for those aged 5 to 11 years), 3 weeks (21 days) apart.
|
Moderna COVID-19 Vaccine
The Moderna COVID-19 Vaccine (0.5 mL for those 12 years and older, 0.25 mL for those aged 5 to 11 years) was administered intramuscularly in the deltoid, as a series of two doses (0.5 mL each for those 12 years and older, 0.25 mL each for those aged 5 to 11 years), 1 month (28 days) apart.
|
Placebo + Pfizer-BioNTech COVID-19 Vaccine
The placebo dose (0.3 mL for those 12 years and older, 0.2 mL for those aged 5 to 11 years), a sterile, preservative-free 0.9% Sodium Chloride Injection, was administered intramuscularly in the deltoid as a first dose followed by two doses of Pfizer-BioNTech COVID-19 Vaccine starting either 7 or 21 days later, depending upon protocol version. The Pfizer-BioNTech COVID-19 Vaccine (0.3 mL for those 12 years and older, 0.2 mL for those aged 5 to 11 years) was administered intramuscularly in the deltoid, as a series of two doses (0.3 mL each for those 12 years and older, 0.2 mL for those aged 5 to 11 years) administered 3 weeks (21 days) apart.
|
Placebo + Moderna COVID-19 Vaccine
The placebo dose (0.5 mL for those 12 years and older, 0.25 mL for those aged 5 to 11 years), a sterile, preservative-free 0.9% Sodium Chloride Injection, was administered intramuscularly in the deltoid as a first dose followed by two doses of Moderna COVID-19 Vaccine starting either 7 or 28 days later, depending upon protocol version. The Moderna COVID-19 Vaccine (0.5 mL for those 12 years and older, 0.25 mL for those aged 5 to 11 years) was administered intramuscularly in the deltoid, as a series of two doses (0.5 mL each for those 12 years and older, 0.25 mL for those aged 5 to 11 years) administered 1 month (28 days) apart.
|
|---|---|---|---|---|
|
Overall Study
Adverse Event
|
3
|
1
|
1
|
3
|
|
Overall Study
Lost to Follow-up
|
1
|
0
|
2
|
3
|
|
Overall Study
Physician Decision
|
0
|
1
|
0
|
0
|
|
Overall Study
Withdrawal by Subject
|
3
|
8
|
1
|
11
|
|
Overall Study
Previously rec'd COVID-19 vaccine
|
1
|
0
|
0
|
0
|
|
Overall Study
Participant requested unblinding
|
0
|
0
|
0
|
1
|
Baseline Characteristics
COVID19 SARS Vaccinations: Systemic Allergic Reactions to SARS-CoV-2 Vaccinations
Baseline characteristics by cohort
| Measure |
Pfizer-BioNTech COVID-19 Vaccine
n=227 Participants
The Pfizer-BioNTech COVID-19 Vaccine (0.3 mL for those 12 years and older, 0.2 mL for those aged 5 to 11 years) was administered intramuscularly in the deltoid, as a series of two doses (0.3 mL each for those 12 years and older, 0.2 mL for those aged 5 to 11 years), 3 weeks (21 days) apart.
|
Moderna COVID-19 Vaccine
n=219 Participants
The Moderna COVID-19 Vaccine (0.5 mL for those 12 years and older, 0.25 mL for those aged 5 to 11 years) was administered intramuscularly in the deltoid, as a series of two doses (0.5 mL each for those 12 years and older, 0.25 mL each for those aged 5 to 11 years), 1 month (28 days) apart.
|
Placebo + Pfizer-BioNTech COVID-19 Vaccine
n=117 Participants
The placebo dose (0.3 mL for those 12 years and older, 0.2 mL for those aged 5 to 11 years), a sterile, preservative-free 0.9% Sodium Chloride Injection, was administered intramuscularly in the deltoid as a first dose followed by two doses of Pfizer-BioNTech COVID-19 Vaccine starting either 7 or 21 days later, depending upon protocol version. The Pfizer-BioNTech COVID-19 Vaccine (0.3 mL for those 12 years and older, 0.2 mL for those aged 5 to 11 years) was administered intramuscularly in the deltoid, as a series of two doses (0.3 mL each mL for those 12 years and older, 0.2 mL for those aged 5 to 11 years) administered 3 weeks (21 days) apart.
|
Placebo + Moderna COVID-19 Vaccine
n=123 Participants
The placebo dose (0.5 mL for those 12 years and older, 0.25 mL for those aged 5 to 11 years), a sterile, preservative-free 0.9% Sodium Chloride Injection, was administered intramuscularly in the deltoid as a first dose followed by two doses of Pfizer-BioNTech COVID-19 Vaccine starting either 7 or 28 days later, depending upon protocol version. The Moderna COVID-19 Vaccine (0.5 mL for those 12 years and older, 0.25 mL for those aged 5 to 11 years) was administered intramuscularly in the deltoid, as a series of two doses (0.5 mL each for those 12 years and older, 0.25 mL for those aged 5 to 11 years) administered 1 month (28 days) apart.
|
Total
n=686 Participants
Total of all reporting groups
|
|---|---|---|---|---|---|
|
Age, Categorical
<=18 years
|
33 Participants
n=99 Participants
|
21 Participants
n=107 Participants
|
19 Participants
n=206 Participants
|
18 Participants
n=7 Participants
|
91 Participants
n=31 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
182 Participants
n=99 Participants
|
195 Participants
n=107 Participants
|
95 Participants
n=206 Participants
|
102 Participants
n=7 Participants
|
574 Participants
n=31 Participants
|
|
Age, Categorical
>=65 years
|
12 Participants
n=99 Participants
|
3 Participants
n=107 Participants
|
3 Participants
n=206 Participants
|
3 Participants
n=7 Participants
|
21 Participants
n=31 Participants
|
|
Age, Continuous
|
37.7 years
STANDARD_DEVIATION 16.97 • n=99 Participants
|
37.7 years
STANDARD_DEVIATION 15.10 • n=107 Participants
|
35.3 years
STANDARD_DEVIATION 16.38 • n=206 Participants
|
35.3 years
STANDARD_DEVIATION 15.89 • n=7 Participants
|
36.9 years
STANDARD_DEVIATION 16.10 • n=31 Participants
|
|
Sex: Female, Male
Female
|
152 Participants
n=99 Participants
|
145 Participants
n=107 Participants
|
80 Participants
n=206 Participants
|
80 Participants
n=7 Participants
|
457 Participants
n=31 Participants
|
|
Sex: Female, Male
Male
|
75 Participants
n=99 Participants
|
74 Participants
n=107 Participants
|
37 Participants
n=206 Participants
|
43 Participants
n=7 Participants
|
229 Participants
n=31 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
30 Participants
n=99 Participants
|
19 Participants
n=107 Participants
|
12 Participants
n=206 Participants
|
15 Participants
n=7 Participants
|
76 Participants
n=31 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
197 Participants
n=99 Participants
|
199 Participants
n=107 Participants
|
104 Participants
n=206 Participants
|
106 Participants
n=7 Participants
|
606 Participants
n=31 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=99 Participants
|
1 Participants
n=107 Participants
|
1 Participants
n=206 Participants
|
2 Participants
n=7 Participants
|
4 Participants
n=31 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
2 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
1 Participants
n=206 Participants
|
0 Participants
n=7 Participants
|
3 Participants
n=31 Participants
|
|
Race (NIH/OMB)
Asian
|
18 Participants
n=99 Participants
|
19 Participants
n=107 Participants
|
7 Participants
n=206 Participants
|
8 Participants
n=7 Participants
|
52 Participants
n=31 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=31 Participants
|
|
Race (NIH/OMB)
Black or African American
|
31 Participants
n=99 Participants
|
33 Participants
n=107 Participants
|
16 Participants
n=206 Participants
|
18 Participants
n=7 Participants
|
98 Participants
n=31 Participants
|
|
Race (NIH/OMB)
White
|
151 Participants
n=99 Participants
|
151 Participants
n=107 Participants
|
84 Participants
n=206 Participants
|
87 Participants
n=7 Participants
|
473 Participants
n=31 Participants
|
|
Race (NIH/OMB)
More than one race
|
10 Participants
n=99 Participants
|
7 Participants
n=107 Participants
|
3 Participants
n=206 Participants
|
4 Participants
n=7 Participants
|
24 Participants
n=31 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
15 Participants
n=99 Participants
|
9 Participants
n=107 Participants
|
6 Participants
n=206 Participants
|
6 Participants
n=7 Participants
|
36 Participants
n=31 Participants
|
|
Region of Enrollment
United States
|
227 participants
n=99 Participants
|
219 participants
n=107 Participants
|
117 participants
n=206 Participants
|
123 participants
n=7 Participants
|
686 participants
n=31 Participants
|
|
Cohort
HA/MCD
|
131 Participants
n=99 Participants
|
118 Participants
n=107 Participants
|
65 Participants
n=206 Participants
|
70 Participants
n=7 Participants
|
384 Participants
n=31 Participants
|
|
Cohort
Comparison
|
96 Participants
n=99 Participants
|
101 Participants
n=107 Participants
|
52 Participants
n=206 Participants
|
53 Participants
n=7 Participants
|
302 Participants
n=31 Participants
|
PRIMARY outcome
Timeframe: Within the 90-minute post-vaccination observation period to either dose of the Pfizer-BioNTech COVID-19 Vaccine.Population: Participants who received the Pfizer-BioNTech COVID-19 Vaccine (assigned to Pfizer-BioNTech COVID-19 Vaccine or Placebo + Pfizer-BioNTech COVID-19 Vaccine arms). Participants who did not receive their second dose were not included unless they reacted to the first dose; there were 5 in the HA/MCD group and 4 in the comparison group who were excluded.
Allergic reactions were graded using the Consortium of Food Allergy Research (CoFAR) Grading Scale for Systemic Allergic Reactions, Version 3.0. The scale ranges from grade 1 through 5. The higher the grade, the more severe the allergic reaction. Tryptase is an enzyme released into the blood during an allergic reaction. An elevation in tryptase is defined as a value that is higher than 1.2 x the baseline tryptase plus 2 ng/ml. Subjects who did not receive their second dose of the vaccine were not included unless they reacted (per the endpoint) to the first dose. The comparison is between the High Allergy/Mast Cell Disorder and Comparison populations.
Outcome measures
| Measure |
Pfizer-BioNTech COVID-19 Vaccine: HA/MCD Cohort
n=191 Participants
Participants with a history of high allergy/mast cell disorder who received the Pfizer-BioNTech COVID-19 Vaccine (assigned to Pfizer-BioNTech COVID-19 Vaccine or Placebo + Pfizer-BioNTech COVID-19 Vaccine arms). There were 5 participants that did not receive their second dose for reasons other than a reaction to the first dose and were not included.
|
Pfizer-BioNTech COVID-19 Vaccine: Comparison Cohort
n=144 Participants
Participants without a history of high allergy/mast cell disorder who received the Pfizer-BioNTech COVID-19 Vaccine (assigned to Pfizer-BioNTech COVID-19 Vaccine or Placebo + Pfizer-BioNTech COVID-19 Vaccine arms). There were 4 participants that did not receive their second dose for reasons other than a reaction to the first dose and were not included.
|
|---|---|---|
|
Proportion of Participants Who Experienced a Systemic Allergic Reaction (CoFAR Grade 2+ Regardless of Tryptase or CoFAR Grade 1 With Elevated Tryptase) Within 90 Minutes Post-vaccination to Either Dose of Pfizer-BioNTech COVID-19 Vaccine.
|
5 Participants
|
0 Participants
|
PRIMARY outcome
Timeframe: Within the 90-minute post-vaccination observation period to either dose of the Moderna COVID-19 Vaccine.Population: Participants who received the Moderna COVID-19 Vaccine (assigned to Moderna COVID-19 Vaccine or Placebo + Moderna COVID-19 Vaccine arms). Participants who did not receive their second dose were not included unless they reacted to the first dose; there were 15 in the HA/MCD group and 10 in the comparison group who were excluded.
Allergic reactions were graded using the Consortium of Food Allergy Research (CoFAR) Grading Scale for Systemic Allergic Reactions, Version 3.0. The scale ranges from grade 1 through 5. The higher the grade, the more severe the allergic reaction. Tryptase is an enzyme released into the blood during an allergic reaction. An elevation in tryptase is defined as a value that is higher than 1.2 x the baseline tryptase plus 2 ng/ml. Subjects who did not receive their second dose of the vaccine were not included unless they reacted (per the endpoint) to the first dose. The comparison is between the High Allergy/Mast Cell Disorder and Comparison populations.
Outcome measures
| Measure |
Pfizer-BioNTech COVID-19 Vaccine: HA/MCD Cohort
n=173 Participants
Participants with a history of high allergy/mast cell disorder who received the Pfizer-BioNTech COVID-19 Vaccine (assigned to Pfizer-BioNTech COVID-19 Vaccine or Placebo + Pfizer-BioNTech COVID-19 Vaccine arms). There were 5 participants that did not receive their second dose for reasons other than a reaction to the first dose and were not included.
|
Pfizer-BioNTech COVID-19 Vaccine: Comparison Cohort
n=144 Participants
Participants without a history of high allergy/mast cell disorder who received the Pfizer-BioNTech COVID-19 Vaccine (assigned to Pfizer-BioNTech COVID-19 Vaccine or Placebo + Pfizer-BioNTech COVID-19 Vaccine arms). There were 4 participants that did not receive their second dose for reasons other than a reaction to the first dose and were not included.
|
|---|---|---|
|
Proportion of Participants Who Experienced a Systemic Allergic Reaction (CoFAR Grade 2+ Regardless of Tryptase or CoFAR Grade 1 With Elevated Tryptase) Within 90 Minutes Post-vaccination to Either Dose of the Moderna COVID-19 Vaccine.
|
2 Participants
|
0 Participants
|
SECONDARY outcome
Timeframe: Within the 90-minute post-vaccination observation period to either dose of the Pfizer-BioNTech COVID-19 Vaccine.Population: Participants who received the Pfizer-BioNTech COVID-19 Vaccine (assigned to Pfizer-BioNTech COVID-19 Vaccine or Placebo + Pfizer-BioNTech COVID-19 Vaccine arms). Participants who did not receive their second dose were not included unless they reacted to the first dose; there were 5 in the HA/MCD group and 4 in the comparison group who were excluded.
Allergic reactions were graded using the Consortium of Food Allergy Research (CoFAR) Grading Scale for Systemic Allergic Reactions, Version 3.0. The scale ranges from grade 1 through 5. The higher the grade, the more severe the allergic reaction. Subjects who did not receive their second dose of the vaccine were not included unless they reacted (per the endpoint) to the first dose. The comparison is between the High Allergy/Mast Cell Disorder and Comparison populations.
Outcome measures
| Measure |
Pfizer-BioNTech COVID-19 Vaccine: HA/MCD Cohort
n=191 Participants
Participants with a history of high allergy/mast cell disorder who received the Pfizer-BioNTech COVID-19 Vaccine (assigned to Pfizer-BioNTech COVID-19 Vaccine or Placebo + Pfizer-BioNTech COVID-19 Vaccine arms). There were 5 participants that did not receive their second dose for reasons other than a reaction to the first dose and were not included.
|
Pfizer-BioNTech COVID-19 Vaccine: Comparison Cohort
n=144 Participants
Participants without a history of high allergy/mast cell disorder who received the Pfizer-BioNTech COVID-19 Vaccine (assigned to Pfizer-BioNTech COVID-19 Vaccine or Placebo + Pfizer-BioNTech COVID-19 Vaccine arms). There were 4 participants that did not receive their second dose for reasons other than a reaction to the first dose and were not included.
|
|---|---|---|
|
The Proportion of Participants Who Experienced a Severe (CoFAR Grade 3+) Systemic Allergic Reaction Within 90 Minutes Post-vaccination to Either Dose of the Pfizer-BioNTech COVID-19 Vaccine.
|
3 Participants
|
0 Participants
|
SECONDARY outcome
Timeframe: Within the 90-minute post-vaccination observation period to either dose of the Moderna COVID-19 Vaccine.Population: Participants who received the Moderna COVID-19 Vaccine (assigned to Moderna COVID-19 Vaccine or Placebo + Moderna COVID-19 Vaccine arms). Participants who did not receive their second dose were not included unless they reacted to the first dose; there were 15 in the HA/MCD group and 10 in the comparison group who were excluded.
Allergic reactions were graded using the Consortium of Food Allergy Research (CoFAR) Grading Scale for Systemic Allergic Reactions, Version 3.0. The scale ranges from grade 1 through 5. The higher the grade, the more severe the allergic reaction. Subjects who did not receive their second dose of the vaccine were not included unless they reacted (per the endpoint) to the first dose. The comparison is between the High Allergy/Mast Cell Disorder and Comparison populations.
Outcome measures
| Measure |
Pfizer-BioNTech COVID-19 Vaccine: HA/MCD Cohort
n=173 Participants
Participants with a history of high allergy/mast cell disorder who received the Pfizer-BioNTech COVID-19 Vaccine (assigned to Pfizer-BioNTech COVID-19 Vaccine or Placebo + Pfizer-BioNTech COVID-19 Vaccine arms). There were 5 participants that did not receive their second dose for reasons other than a reaction to the first dose and were not included.
|
Pfizer-BioNTech COVID-19 Vaccine: Comparison Cohort
n=144 Participants
Participants without a history of high allergy/mast cell disorder who received the Pfizer-BioNTech COVID-19 Vaccine (assigned to Pfizer-BioNTech COVID-19 Vaccine or Placebo + Pfizer-BioNTech COVID-19 Vaccine arms). There were 4 participants that did not receive their second dose for reasons other than a reaction to the first dose and were not included.
|
|---|---|---|
|
The Proportion of Participants Who Experienced a Severe (CoFAR Grade 3+) Systemic Allergic Reaction Within the 90-minute Post-vaccination Observation Period to Either Dose of the Moderna COVID-19 Vaccine.
|
1 Participants
|
0 Participants
|
SECONDARY outcome
Timeframe: Within the 90-minute post-vaccination observation period to either dose of the Pfizer-BioNTech COVID-19 Vaccine.Population: Participants who received the Pfizer-BioNTech COVID-19 Vaccine (assigned to Pfizer-BioNTech COVID-19 Vaccine or Placebo + Pfizer-BioNTech COVID-19 Vaccine arm). Participants who did not receive their second dose were not included unless they reacted to the first dose; there were 5 in the HA/MCD group and 4 in the comparison group who were excluded.
Allergic reactions were graded using the Brighton Collaboration Criteria. The scale ranges from level 1 through 3. Level 1 represents the highest level of diagnostic certainty that a reported case is anaphylaxis, levels 2 and 3 represent successively lower levels of diagnostic certainty. Subjects who did not receive their second dose of the vaccine were not included unless they reacted (per the endpoint) to the first dose. The comparison is between the High Allergy/Mast Cell Disorder and Comparison populations.
Outcome measures
| Measure |
Pfizer-BioNTech COVID-19 Vaccine: HA/MCD Cohort
n=191 Participants
Participants with a history of high allergy/mast cell disorder who received the Pfizer-BioNTech COVID-19 Vaccine (assigned to Pfizer-BioNTech COVID-19 Vaccine or Placebo + Pfizer-BioNTech COVID-19 Vaccine arms). There were 5 participants that did not receive their second dose for reasons other than a reaction to the first dose and were not included.
|
Pfizer-BioNTech COVID-19 Vaccine: Comparison Cohort
n=144 Participants
Participants without a history of high allergy/mast cell disorder who received the Pfizer-BioNTech COVID-19 Vaccine (assigned to Pfizer-BioNTech COVID-19 Vaccine or Placebo + Pfizer-BioNTech COVID-19 Vaccine arms). There were 4 participants that did not receive their second dose for reasons other than a reaction to the first dose and were not included.
|
|---|---|---|
|
The Proportion of Participants Who Experienced an Anaphylactic Reaction Per Brighton Collaboration Criteria (Levels 1-3) Within 90 Minutes Post-vaccination to Either Dose of the Pfizer-BioNTech COVID-19 Vaccine.
|
3 Participants
|
0 Participants
|
SECONDARY outcome
Timeframe: Within the 90-minute post-vaccination observation period to either dose of the Moderna COVID-19 Vaccine.Population: Participants who received the Moderna COVID-19 Vaccine (assigned to Moderna COVID-19 Vaccine or Placebo + Moderna COVID-19 Vaccine arm). Participants who did not receive their second dose were not included unless they reacted to the first dose; there were 15 in the HA/MCD group and 10 in the comparison group who were excluded.
Allergic reactions were graded using the Brighton Collaboration Criteria. The scale ranges from level 1 through 3. Level 1 represents the highest level of diagnostic certainty that a reported case is anaphylaxis, levels 2 and 3 represent successively lower levels of diagnostic certainty. Subjects who did not receive their second dose of the vaccine were not included unless they reacted (per the endpoint) to the first dose. The comparison is between the High Allergy/Mast Cell Disorder and Comparison populations.
Outcome measures
| Measure |
Pfizer-BioNTech COVID-19 Vaccine: HA/MCD Cohort
n=173 Participants
Participants with a history of high allergy/mast cell disorder who received the Pfizer-BioNTech COVID-19 Vaccine (assigned to Pfizer-BioNTech COVID-19 Vaccine or Placebo + Pfizer-BioNTech COVID-19 Vaccine arms). There were 5 participants that did not receive their second dose for reasons other than a reaction to the first dose and were not included.
|
Pfizer-BioNTech COVID-19 Vaccine: Comparison Cohort
n=144 Participants
Participants without a history of high allergy/mast cell disorder who received the Pfizer-BioNTech COVID-19 Vaccine (assigned to Pfizer-BioNTech COVID-19 Vaccine or Placebo + Pfizer-BioNTech COVID-19 Vaccine arms). There were 4 participants that did not receive their second dose for reasons other than a reaction to the first dose and were not included.
|
|---|---|---|
|
The Proportion of Participants Who Experienced an Anaphylactic Reaction Per Brighton Collaboration Criteria (Levels 1-3) Within 90 Minutes Post-vaccination to Either Dose of the Moderna COVID-19 Vaccine.
|
1 Participants
|
0 Participants
|
SECONDARY outcome
Timeframe: Within the 90-minute post-vaccination observation period to the first dose of the Pfizer-BioNTech COVID-19 Vaccine.Population: Participants who received the Pfizer-BioNTech COVID-19 Vaccine (assigned to Pfizer-BioNTech COVID-19 Vaccine or Placebo + Pfizer-BioNTech COVID-19 Vaccine arm). Participants were only included from the HA/MCD cohort. One participant in the Placebo + Pfizer-BioNTech COVID-19 Vaccine arm was not included as they did not receive any active doses.
Allergic reactions were graded using the Consortium of Food Allergy Research (CoFAR) Grading Scale for Systemic Allergic Reactions, Version 3.0. The scale ranges from grade 1 through 5. The higher the grade, the more severe the allergic reaction. Tryptase is an enzyme released into the blood during an allergic reaction. An elevation in tryptase is defined as a value that is higher than 1.2 x the baseline tryptase plus 2 ng/ml. The comparison is between the participants who received active vaccine as their first, fully blinded, injection (assigned to the Pfizer-BioNTech COVID-19 Vaccine arm) and participants who received their first active vaccine as their second injection (assigned to the Placebo + Pfizer-BioNTech COVID-19 Vaccine arm). Due to the design of the trial, participants would have understood that the second dose in any arm must be an active vaccination.
Outcome measures
| Measure |
Pfizer-BioNTech COVID-19 Vaccine: HA/MCD Cohort
n=131 Participants
Participants with a history of high allergy/mast cell disorder who received the Pfizer-BioNTech COVID-19 Vaccine (assigned to Pfizer-BioNTech COVID-19 Vaccine or Placebo + Pfizer-BioNTech COVID-19 Vaccine arms). There were 5 participants that did not receive their second dose for reasons other than a reaction to the first dose and were not included.
|
Pfizer-BioNTech COVID-19 Vaccine: Comparison Cohort
n=64 Participants
Participants without a history of high allergy/mast cell disorder who received the Pfizer-BioNTech COVID-19 Vaccine (assigned to Pfizer-BioNTech COVID-19 Vaccine or Placebo + Pfizer-BioNTech COVID-19 Vaccine arms). There were 4 participants that did not receive their second dose for reasons other than a reaction to the first dose and were not included.
|
|---|---|---|
|
Proportion of Participants Who Experienced a Systemic Allergic Reaction (CoFAR Grade 2+ Regardless of Tryptase or CoFAR Grade 1 With Elevated Tryptase) Within 90 Minutes Post-vaccination to the First Dose of the Pfizer-BioNTech COVID-19 Vaccine.
|
2 Participants
|
0 Participants
|
SECONDARY outcome
Timeframe: Within the 90-minute post-vaccination observation period to the first dose of the Moderna COVID-19 Vaccine.Population: Participants who received the Moderna COVID-19 Vaccine (assigned to Moderna COVID-19 Vaccine or Placebo + Moderna COVID-19 Vaccine arms). Participants were only included from the HA/MCD cohort. Six participants in the Placebo + Moderna COVID-19 Vaccine arm were not included as they did not receive any active doses.
Allergic reactions were graded using the Consortium of Food Allergy Research (CoFAR) Grading Scale for Systemic Allergic Reactions, Version 3.0. The scale ranges from grade 1 through 5. The higher the grade, the more severe the allergic reaction. Tryptase is an enzyme released into the blood during an allergic reaction. An elevation in tryptase is defined as a value that is higher than 1.2 x the baseline tryptase plus 2 ng/ml. The comparison is between the participants who received active vaccine as their first, fully blinded, injection (assigned to the Moderna COVID-19 Vaccine arm) and participants who received their first active vaccine as their second injection (assigned to the Placebo + Moderna COVID-19 Vaccine arm). Due to the design of the trial, participants would have understood that the second dose in any arm must be an active vaccination.
Outcome measures
| Measure |
Pfizer-BioNTech COVID-19 Vaccine: HA/MCD Cohort
n=118 Participants
Participants with a history of high allergy/mast cell disorder who received the Pfizer-BioNTech COVID-19 Vaccine (assigned to Pfizer-BioNTech COVID-19 Vaccine or Placebo + Pfizer-BioNTech COVID-19 Vaccine arms). There were 5 participants that did not receive their second dose for reasons other than a reaction to the first dose and were not included.
|
Pfizer-BioNTech COVID-19 Vaccine: Comparison Cohort
n=64 Participants
Participants without a history of high allergy/mast cell disorder who received the Pfizer-BioNTech COVID-19 Vaccine (assigned to Pfizer-BioNTech COVID-19 Vaccine or Placebo + Pfizer-BioNTech COVID-19 Vaccine arms). There were 4 participants that did not receive their second dose for reasons other than a reaction to the first dose and were not included.
|
|---|---|---|
|
Proportion of Participants Who Experienced a Systemic Allergic Reaction (CoFAR Grade 2+ Regardless of Tryptase or CoFAR Grade 1 With Elevated Tryptase) Within 90 Minutes Post-vaccination to the First Dose of the Moderna COVID-19 Vaccine.
|
0 Participants
|
1 Participants
|
SECONDARY outcome
Timeframe: Within the 90-minute post-vaccination observation period to the second dose of the Pfizer-BioNTech COVID-19 Vaccine.Population: Participants from the HA/MCD cohort who received the Pfizer-BioNTech COVID-19 Vaccine (assigned to Pfizer-BioNTech COVID-19 Vaccine or Placebo + Pfizer-BioNTech COVID-19 Vaccine arm). Five (2 reaction to first dose, 3 missing second dose) and 1 (1 reaction to placebo dose) were excluded, respectively.
Allergic reactions were graded using the Consortium of Food Allergy Research (CoFAR) Grading Scale for Systemic Allergic Reactions, Version 3.0. The scale ranges from grade 1 through 5. The higher the grade, the more severe the allergic reaction. Tryptase is an enzyme released into the blood during an allergic reaction. An elevation in tryptase is defined as a value that is higher than 1.2 x the baseline tryptase plus 2 ng/ml. The comparison is between the participants who received the second active vaccine as their second injection (assigned to the Pfizer-BioNTech COVID-19 Vaccine arm) and participants who received the second active vaccine as their third injection (assigned to the Placebo + Pfizer-BioNTech COVID-19 Vaccine arm). This comparison is conditional on there being no systemic allergic reaction to the first dose.
Outcome measures
| Measure |
Pfizer-BioNTech COVID-19 Vaccine: HA/MCD Cohort
n=126 Participants
Participants with a history of high allergy/mast cell disorder who received the Pfizer-BioNTech COVID-19 Vaccine (assigned to Pfizer-BioNTech COVID-19 Vaccine or Placebo + Pfizer-BioNTech COVID-19 Vaccine arms). There were 5 participants that did not receive their second dose for reasons other than a reaction to the first dose and were not included.
|
Pfizer-BioNTech COVID-19 Vaccine: Comparison Cohort
n=64 Participants
Participants without a history of high allergy/mast cell disorder who received the Pfizer-BioNTech COVID-19 Vaccine (assigned to Pfizer-BioNTech COVID-19 Vaccine or Placebo + Pfizer-BioNTech COVID-19 Vaccine arms). There were 4 participants that did not receive their second dose for reasons other than a reaction to the first dose and were not included.
|
|---|---|---|
|
Proportion of Participants Who Experienced a Systemic Allergic Reaction (CoFAR Grade 2+ Regardless of Tryptase or CoFAR Grade 1 With Elevated Tryptase) Within 90 Minutes Post-vaccination to the Second Dose of the Pfizer-BioNTech COVID-19 Vaccine.
|
3 Participants
|
0 Participants
|
SECONDARY outcome
Timeframe: Within the 90-minute post-vaccination observation period to the second dose of the Moderna COVID-19 Vaccine.Population: Participants from the HA/MCD cohort who received the Moderna COVID-19 Vaccine (assigned to Moderna COVID-19 Vaccine or Placebo + Moderna COVID-19 Vaccine arm). Six (all missing second dose) and 6 (all missing second dose) were excluded, respectively.
Allergic reactions were graded using the Consortium of Food Allergy Research (CoFAR) Grading Scale for Systemic Allergic Reactions, Version 3.0. The scale is ranges from grade 1 through 5. The higher the grade, the more severe the allergic reaction. Tryptase is an enzyme released into the blood during an allergic reaction. An elevation in tryptase is defined as a value that is higher than 1.2 x the baseline tryptase plus 2 ng/ml. The comparison is between the participants who received the second active vaccine as their second injection (assigned to the Moderna COVID-19 Vaccine arm) and participants who received the second active vaccine as their third injection (assigned to the Placebo + Moderna COVID-19 Vaccine arm). This comparison is conditional on there being no systemic allergic reaction to the first dose.
Outcome measures
| Measure |
Pfizer-BioNTech COVID-19 Vaccine: HA/MCD Cohort
n=112 Participants
Participants with a history of high allergy/mast cell disorder who received the Pfizer-BioNTech COVID-19 Vaccine (assigned to Pfizer-BioNTech COVID-19 Vaccine or Placebo + Pfizer-BioNTech COVID-19 Vaccine arms). There were 5 participants that did not receive their second dose for reasons other than a reaction to the first dose and were not included.
|
Pfizer-BioNTech COVID-19 Vaccine: Comparison Cohort
n=64 Participants
Participants without a history of high allergy/mast cell disorder who received the Pfizer-BioNTech COVID-19 Vaccine (assigned to Pfizer-BioNTech COVID-19 Vaccine or Placebo + Pfizer-BioNTech COVID-19 Vaccine arms). There were 4 participants that did not receive their second dose for reasons other than a reaction to the first dose and were not included.
|
|---|---|---|
|
Proportion of Participants Who Experienced a Systemic Allergic Reaction (CoFAR Grade 2+ Regardless of Tryptase or CoFAR Grade 1 With Elevated Tryptase) Within 90 Minutes Post-vaccination to the Second Dose of the Moderna COVID-19 Vaccine.
|
1 Participants
|
1 Participants
|
SECONDARY outcome
Timeframe: Within the 90-minute post-vaccination observation period to the first injection (placebo or active).Population: Participants who received placebo as their first injection (assigned to Placebo + Pfizer-BioNTech COVID-19 Vaccine arm or Placebo + Moderna COVID-19 Vaccine arm) or received Pfizer-BioNTech COVID-19 Vaccine as their first dose (Pfizer-BioNTech COVID-19 Vaccine arm). Participants were only included from the HA/MCD cohort.
Allergic reactions were graded using the Consortium of Food Allergy Research (CoFAR) Grading Scale for Systemic Allergic Reactions, Version 3.0. The scale ranges from grade 1 through 5. The higher the grade, the more severe the allergic reaction. Tryptase is an enzyme released into the blood during an allergic reaction. An elevation in tryptase is defined as a value that is higher than 1.2 x the baseline tryptase plus 2 ng/ml. The comparison is between participants who had placebo as their first injection (either vaccine) and participants who had Pfizer-BioNTech COVID-19 Vaccine as their first injection. The comparison only includes subjects in the HA/MCD cohort.
Outcome measures
| Measure |
Pfizer-BioNTech COVID-19 Vaccine: HA/MCD Cohort
n=135 Participants
Participants with a history of high allergy/mast cell disorder who received the Pfizer-BioNTech COVID-19 Vaccine (assigned to Pfizer-BioNTech COVID-19 Vaccine or Placebo + Pfizer-BioNTech COVID-19 Vaccine arms). There were 5 participants that did not receive their second dose for reasons other than a reaction to the first dose and were not included.
|
Pfizer-BioNTech COVID-19 Vaccine: Comparison Cohort
n=131 Participants
Participants without a history of high allergy/mast cell disorder who received the Pfizer-BioNTech COVID-19 Vaccine (assigned to Pfizer-BioNTech COVID-19 Vaccine or Placebo + Pfizer-BioNTech COVID-19 Vaccine arms). There were 4 participants that did not receive their second dose for reasons other than a reaction to the first dose and were not included.
|
|---|---|---|
|
The Proportion of Participants Who Experienced a Systemic Allergic Reaction (CoFAR Grade 2+ Regardless of Tryptase or CoFAR Grade 1 With Elevated Tryptase) Within 90 Minutes Post-vaccination to the First Dose, Adjusting for Placebo.
|
2 Participants
|
2 Participants
|
SECONDARY outcome
Timeframe: Within the 90-minute post-vaccination observation period to the first injection.Population: Participants who received placebo as their first injection (assigned to Placebo + Pfizer-BioNTech COVID-19 Vaccine arm or Placebo + Moderna COVID-19 Vaccine arm) or received Moderna COVID-19 Vaccine as their first injection (Moderna COVID-19 Vaccine arm). Participants were only included from the HA/MCD cohort.
Allergic reactions were graded using the Consortium of Food Allergy Research (CoFAR) Grading Scale for Systemic Allergic Reactions, Version 3.0. The scale is ranges from grade 1 through 5. The higher the grade, the more severe the allergic reaction. Tryptase is an enzyme released into the blood during an allergic reaction. An elevation in tryptase is defined as a value that is higher than 1.2 x the baseline tryptase plus 2 ng/ml. The comparison is between participants who had placebo as their first injection and participants who had Moderna COVID-19 Vaccine as their first injection. The comparison only includes subjects in the HA/MCD cohort.
Outcome measures
| Measure |
Pfizer-BioNTech COVID-19 Vaccine: HA/MCD Cohort
n=135 Participants
Participants with a history of high allergy/mast cell disorder who received the Pfizer-BioNTech COVID-19 Vaccine (assigned to Pfizer-BioNTech COVID-19 Vaccine or Placebo + Pfizer-BioNTech COVID-19 Vaccine arms). There were 5 participants that did not receive their second dose for reasons other than a reaction to the first dose and were not included.
|
Pfizer-BioNTech COVID-19 Vaccine: Comparison Cohort
n=118 Participants
Participants without a history of high allergy/mast cell disorder who received the Pfizer-BioNTech COVID-19 Vaccine (assigned to Pfizer-BioNTech COVID-19 Vaccine or Placebo + Pfizer-BioNTech COVID-19 Vaccine arms). There were 4 participants that did not receive their second dose for reasons other than a reaction to the first dose and were not included.
|
|---|---|---|
|
The Proportion of Participants Who Experienced a Systemic Allergic Reaction (CoFAR Grade 2+ Regardless of Tryptase or CoFAR Grade 1 With Elevated Tryptase) Within 90 Minutes Post-vaccination to the First Dose, Adjusting for Placebo.
|
2 Participants
|
0 Participants
|
SECONDARY outcome
Timeframe: After the 90 minute observation period to 48-hours post-vaccination to either dose of the Pfizer-BioNTech COVID-19 Vaccine.Population: Participants who received the Pfizer-BioNTech COVID-19 Vaccine (assigned to Pfizer-BioNTech COVID-19 Vaccine or Placebo + Pfizer-BioNTech COVID-19 Vaccine arm). Participants who did not receive their second dose were not included unless they reacted to the first dose; there were 6 in the HA/MCD group and 4 in the comparison group who were excluded.
Allergic reactions were graded using the Consortium of Food Allergy Research (CoFAR) Grading Scale for Systemic Allergic Reactions, Version 3.0. The scale ranges from grade 1 through 5. The higher the grade, the more severe the allergic reaction. Subjects who did not receive their second dose of the vaccine were not included unless they reacted (per the endpoint) to the first dose. The comparison is between the High Allergy/Mast Cell Disorder and Comparison populations.
Outcome measures
| Measure |
Pfizer-BioNTech COVID-19 Vaccine: HA/MCD Cohort
n=190 Participants
Participants with a history of high allergy/mast cell disorder who received the Pfizer-BioNTech COVID-19 Vaccine (assigned to Pfizer-BioNTech COVID-19 Vaccine or Placebo + Pfizer-BioNTech COVID-19 Vaccine arms). There were 5 participants that did not receive their second dose for reasons other than a reaction to the first dose and were not included.
|
Pfizer-BioNTech COVID-19 Vaccine: Comparison Cohort
n=144 Participants
Participants without a history of high allergy/mast cell disorder who received the Pfizer-BioNTech COVID-19 Vaccine (assigned to Pfizer-BioNTech COVID-19 Vaccine or Placebo + Pfizer-BioNTech COVID-19 Vaccine arms). There were 4 participants that did not receive their second dose for reasons other than a reaction to the first dose and were not included.
|
|---|---|---|
|
The Proportion of Participants Who Experienced a Systemic Allergic Reaction (CoFAR Grade 2+) Within 48-hours Post-vaccination to Either Dose of the Pfizer-BioNTech COVID-19 Vaccine.
|
11 Participants
|
0 Participants
|
SECONDARY outcome
Timeframe: After the 90 minute observation period to 48-hours post-vaccination to either dose of the Moderna COVID-19 Vaccine.Population: Participants who received the Moderna COVID-19 Vaccine (assigned to Moderna COVID-19 Vaccine or Placebo + Moderna COVID-19 Vaccine arm). Participants who did not receive their second dose were not included unless they reacted to the first dose; there were 14 in the HA/MCD group and 10 in the comparison group who were excluded.
Allergic reactions were graded using the Consortium of Food Allergy Research (CoFAR) Grading Scale for Systemic Allergic Reactions, Version 3.0. The scale ranges from grade 1 through 5. The higher the grade, the more severe the allergic reaction. Subjects who did not receive their second dose of the vaccine were not included unless they reacted (per the endpoint) to the first dose. The comparison is between the High Allergy/Mast Cell Disorder and Comparison populations.
Outcome measures
| Measure |
Pfizer-BioNTech COVID-19 Vaccine: HA/MCD Cohort
n=174 Participants
Participants with a history of high allergy/mast cell disorder who received the Pfizer-BioNTech COVID-19 Vaccine (assigned to Pfizer-BioNTech COVID-19 Vaccine or Placebo + Pfizer-BioNTech COVID-19 Vaccine arms). There were 5 participants that did not receive their second dose for reasons other than a reaction to the first dose and were not included.
|
Pfizer-BioNTech COVID-19 Vaccine: Comparison Cohort
n=144 Participants
Participants without a history of high allergy/mast cell disorder who received the Pfizer-BioNTech COVID-19 Vaccine (assigned to Pfizer-BioNTech COVID-19 Vaccine or Placebo + Pfizer-BioNTech COVID-19 Vaccine arms). There were 4 participants that did not receive their second dose for reasons other than a reaction to the first dose and were not included.
|
|---|---|---|
|
The Proportion of Participants Who Experienced a Systemic Allergic Reaction (CoFAR Grade 2+) Within 48-hours Post-vaccination to Either Dose of the Moderna COVID-19 Vaccine.
|
13 Participants
|
0 Participants
|
Adverse Events
Pfizer-BioNTech COVID-19 Vaccine
Serious events: 5 serious events
Other events: 185 other events
Deaths: 0 deaths
Moderna COVID-19 Vaccine
Serious events: 2 serious events
Other events: 195 other events
Deaths: 0 deaths
Placebo + Pfizer-BioNTech COVID-19 Vaccine
Serious events: 2 serious events
Other events: 100 other events
Deaths: 0 deaths
Placebo + Moderna COVID-19 Vaccine
Serious events: 3 serious events
Other events: 104 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Pfizer-BioNTech COVID-19 Vaccine
n=227 participants at risk
The Pfizer-BioNTech COVID-19 Vaccine (0.3 mL for those 12 years and older, 0.2 mL for those aged 5 to 11 years) was administered intramuscularly in the deltoid, as a series of two doses (0.3 mL each for those 12 years and older, 0.2 mL for those aged 5 to 11 years), 3 weeks (21 days) apart.
|
Moderna COVID-19 Vaccine
n=219 participants at risk
The Moderna COVID-19 Vaccine (0.5 mL for those 12 years and older, 0.25 mL for those aged 5 to 11 years) was administered intramuscularly in the deltoid, as a series of two doses (0.5 mL each for those 12 years and older, 0.25 mL each for those aged 5 to 11 years), 1 month (28 days) apart.
|
Placebo + Pfizer-BioNTech COVID-19 Vaccine
n=117 participants at risk
The placebo dose (0.3 mL for those 12 years and older, 0.2 mL for those aged 5 to 11 years), a sterile, preservative-free 0.9% Sodium Chloride Injection, was administered intramuscularly in the deltoid as a first dose followed by two doses of Pfizer-BioNTech COVID-19 Vaccine starting either 7 or 21 days later, depending upon protocol version. The Pfizer-BioNTech COVID-19 Vaccine (0.3 mL for those 12 years and older, 0.2 mL for those aged 5 to 11 years) was administered intramuscularly in the deltoid, as a series of two doses (0.3 mL each mL for those 12 years and older, 0.2 mL for those aged 5 to 11 years) administered 3 weeks (21 days) apart.
|
Placebo + Moderna COVID-19 Vaccine
n=123 participants at risk
The placebo dose (0.5 mL for those 12 years and older, 0.25 mL for those aged 5 to 11 years), a sterile, preservative-free 0.9% Sodium Chloride Injection, was administered intramuscularly in the deltoid as a first dose followed by two doses of Pfizer-BioNTech COVID-19 Vaccine starting either 7 or 28 days later, depending upon protocol version. The Moderna COVID-19 Vaccine (0.5 mL for those 12 years and older, 0.25 mL for those aged 5 to 11 years) was administered intramuscularly in the deltoid, as a series of two doses (0.5 mL each for those 12 years and older, 0.25 mL for those aged 5 to 11 years) administered 1 month (28 days) apart.
|
|---|---|---|---|---|
|
Cardiac disorders
Ventricular extrasystoles
|
0.44%
1/227 • Number of events 1 • From start of study through end of study (up to 64 days).
|
0.00%
0/219 • From start of study through end of study (up to 64 days).
|
0.00%
0/117 • From start of study through end of study (up to 64 days).
|
0.00%
0/123 • From start of study through end of study (up to 64 days).
|
|
Immune system disorders
Anaphylactic reaction
|
0.00%
0/227 • From start of study through end of study (up to 64 days).
|
0.00%
0/219 • From start of study through end of study (up to 64 days).
|
0.00%
0/117 • From start of study through end of study (up to 64 days).
|
0.81%
1/123 • Number of events 1 • From start of study through end of study (up to 64 days).
|
|
Immune system disorders
Hypersensitivity
|
0.88%
2/227 • Number of events 2 • From start of study through end of study (up to 64 days).
|
0.46%
1/219 • Number of events 1 • From start of study through end of study (up to 64 days).
|
0.85%
1/117 • Number of events 1 • From start of study through end of study (up to 64 days).
|
0.81%
1/123 • Number of events 1 • From start of study through end of study (up to 64 days).
|
|
Infections and infestations
Amoebiasis
|
0.00%
0/227 • From start of study through end of study (up to 64 days).
|
0.00%
0/219 • From start of study through end of study (up to 64 days).
|
0.85%
1/117 • Number of events 1 • From start of study through end of study (up to 64 days).
|
0.00%
0/123 • From start of study through end of study (up to 64 days).
|
|
Injury, poisoning and procedural complications
Vaccination complication
|
0.44%
1/227 • Number of events 1 • From start of study through end of study (up to 64 days).
|
0.46%
1/219 • Number of events 1 • From start of study through end of study (up to 64 days).
|
0.00%
0/117 • From start of study through end of study (up to 64 days).
|
0.00%
0/123 • From start of study through end of study (up to 64 days).
|
|
Metabolism and nutrition disorders
Hypocalcaemia
|
0.00%
0/227 • From start of study through end of study (up to 64 days).
|
0.46%
1/219 • Number of events 1 • From start of study through end of study (up to 64 days).
|
0.00%
0/117 • From start of study through end of study (up to 64 days).
|
0.00%
0/123 • From start of study through end of study (up to 64 days).
|
|
Metabolism and nutrition disorders
Hypokalaemia
|
0.00%
0/227 • From start of study through end of study (up to 64 days).
|
0.46%
1/219 • Number of events 1 • From start of study through end of study (up to 64 days).
|
0.00%
0/117 • From start of study through end of study (up to 64 days).
|
0.00%
0/123 • From start of study through end of study (up to 64 days).
|
|
Musculoskeletal and connective tissue disorders
Myalgia
|
0.00%
0/227 • From start of study through end of study (up to 64 days).
|
0.46%
1/219 • Number of events 1 • From start of study through end of study (up to 64 days).
|
0.00%
0/117 • From start of study through end of study (up to 64 days).
|
0.00%
0/123 • From start of study through end of study (up to 64 days).
|
|
Nervous system disorders
Presyncope
|
0.00%
0/227 • From start of study through end of study (up to 64 days).
|
0.00%
0/219 • From start of study through end of study (up to 64 days).
|
0.00%
0/117 • From start of study through end of study (up to 64 days).
|
0.81%
1/123 • Number of events 1 • From start of study through end of study (up to 64 days).
|
|
Renal and urinary disorders
Cystitis haemorrhagic
|
0.00%
0/227 • From start of study through end of study (up to 64 days).
|
0.00%
0/219 • From start of study through end of study (up to 64 days).
|
0.00%
0/117 • From start of study through end of study (up to 64 days).
|
0.81%
1/123 • Number of events 1 • From start of study through end of study (up to 64 days).
|
|
Vascular disorders
Deep vein thrombosis
|
0.44%
1/227 • Number of events 1 • From start of study through end of study (up to 64 days).
|
0.00%
0/219 • From start of study through end of study (up to 64 days).
|
0.00%
0/117 • From start of study through end of study (up to 64 days).
|
0.00%
0/123 • From start of study through end of study (up to 64 days).
|
Other adverse events
| Measure |
Pfizer-BioNTech COVID-19 Vaccine
n=227 participants at risk
The Pfizer-BioNTech COVID-19 Vaccine (0.3 mL for those 12 years and older, 0.2 mL for those aged 5 to 11 years) was administered intramuscularly in the deltoid, as a series of two doses (0.3 mL each for those 12 years and older, 0.2 mL for those aged 5 to 11 years), 3 weeks (21 days) apart.
|
Moderna COVID-19 Vaccine
n=219 participants at risk
The Moderna COVID-19 Vaccine (0.5 mL for those 12 years and older, 0.25 mL for those aged 5 to 11 years) was administered intramuscularly in the deltoid, as a series of two doses (0.5 mL each for those 12 years and older, 0.25 mL each for those aged 5 to 11 years), 1 month (28 days) apart.
|
Placebo + Pfizer-BioNTech COVID-19 Vaccine
n=117 participants at risk
The placebo dose (0.3 mL for those 12 years and older, 0.2 mL for those aged 5 to 11 years), a sterile, preservative-free 0.9% Sodium Chloride Injection, was administered intramuscularly in the deltoid as a first dose followed by two doses of Pfizer-BioNTech COVID-19 Vaccine starting either 7 or 21 days later, depending upon protocol version. The Pfizer-BioNTech COVID-19 Vaccine (0.3 mL for those 12 years and older, 0.2 mL for those aged 5 to 11 years) was administered intramuscularly in the deltoid, as a series of two doses (0.3 mL each mL for those 12 years and older, 0.2 mL for those aged 5 to 11 years) administered 3 weeks (21 days) apart.
|
Placebo + Moderna COVID-19 Vaccine
n=123 participants at risk
The placebo dose (0.5 mL for those 12 years and older, 0.25 mL for those aged 5 to 11 years), a sterile, preservative-free 0.9% Sodium Chloride Injection, was administered intramuscularly in the deltoid as a first dose followed by two doses of Pfizer-BioNTech COVID-19 Vaccine starting either 7 or 28 days later, depending upon protocol version. The Moderna COVID-19 Vaccine (0.5 mL for those 12 years and older, 0.25 mL for those aged 5 to 11 years) was administered intramuscularly in the deltoid, as a series of two doses (0.5 mL each for those 12 years and older, 0.25 mL for those aged 5 to 11 years) administered 1 month (28 days) apart.
|
|---|---|---|---|---|
|
Blood and lymphatic system disorders
Anaemia
|
0.00%
0/227 • From start of study through end of study (up to 64 days).
|
0.00%
0/219 • From start of study through end of study (up to 64 days).
|
0.00%
0/117 • From start of study through end of study (up to 64 days).
|
1.6%
2/123 • Number of events 4 • From start of study through end of study (up to 64 days).
|
|
Blood and lymphatic system disorders
Eosinophilia
|
0.00%
0/227 • From start of study through end of study (up to 64 days).
|
0.46%
1/219 • Number of events 1 • From start of study through end of study (up to 64 days).
|
0.00%
0/117 • From start of study through end of study (up to 64 days).
|
0.81%
1/123 • Number of events 1 • From start of study through end of study (up to 64 days).
|
|
Blood and lymphatic system disorders
Iron deficiency anaemia
|
1.3%
3/227 • Number of events 3 • From start of study through end of study (up to 64 days).
|
0.00%
0/219 • From start of study through end of study (up to 64 days).
|
1.7%
2/117 • Number of events 2 • From start of study through end of study (up to 64 days).
|
0.00%
0/123 • From start of study through end of study (up to 64 days).
|
|
Blood and lymphatic system disorders
Leukocytosis
|
0.00%
0/227 • From start of study through end of study (up to 64 days).
|
0.46%
1/219 • Number of events 1 • From start of study through end of study (up to 64 days).
|
0.00%
0/117 • From start of study through end of study (up to 64 days).
|
0.00%
0/123 • From start of study through end of study (up to 64 days).
|
|
Blood and lymphatic system disorders
Lymphadenopathy
|
1.3%
3/227 • Number of events 3 • From start of study through end of study (up to 64 days).
|
0.46%
1/219 • Number of events 1 • From start of study through end of study (up to 64 days).
|
0.85%
1/117 • Number of events 1 • From start of study through end of study (up to 64 days).
|
0.81%
1/123 • Number of events 1 • From start of study through end of study (up to 64 days).
|
|
Blood and lymphatic system disorders
Lymphopenia
|
0.00%
0/227 • From start of study through end of study (up to 64 days).
|
0.46%
1/219 • Number of events 1 • From start of study through end of study (up to 64 days).
|
0.00%
0/117 • From start of study through end of study (up to 64 days).
|
0.00%
0/123 • From start of study through end of study (up to 64 days).
|
|
Blood and lymphatic system disorders
Mast cell activation syndrome
|
0.88%
2/227 • Number of events 2 • From start of study through end of study (up to 64 days).
|
0.00%
0/219 • From start of study through end of study (up to 64 days).
|
0.00%
0/117 • From start of study through end of study (up to 64 days).
|
0.00%
0/123 • From start of study through end of study (up to 64 days).
|
|
Blood and lymphatic system disorders
Neutropenia
|
0.00%
0/227 • From start of study through end of study (up to 64 days).
|
0.00%
0/219 • From start of study through end of study (up to 64 days).
|
0.85%
1/117 • Number of events 1 • From start of study through end of study (up to 64 days).
|
0.00%
0/123 • From start of study through end of study (up to 64 days).
|
|
Cardiac disorders
Arrhythmia
|
0.00%
0/227 • From start of study through end of study (up to 64 days).
|
0.00%
0/219 • From start of study through end of study (up to 64 days).
|
0.85%
1/117 • Number of events 1 • From start of study through end of study (up to 64 days).
|
0.00%
0/123 • From start of study through end of study (up to 64 days).
|
|
Cardiac disorders
Palpitations
|
0.00%
0/227 • From start of study through end of study (up to 64 days).
|
0.00%
0/219 • From start of study through end of study (up to 64 days).
|
1.7%
2/117 • Number of events 5 • From start of study through end of study (up to 64 days).
|
0.00%
0/123 • From start of study through end of study (up to 64 days).
|
|
Cardiac disorders
Tachycardia
|
0.00%
0/227 • From start of study through end of study (up to 64 days).
|
0.46%
1/219 • Number of events 1 • From start of study through end of study (up to 64 days).
|
0.00%
0/117 • From start of study through end of study (up to 64 days).
|
0.81%
1/123 • Number of events 3 • From start of study through end of study (up to 64 days).
|
|
Ear and labyrinth disorders
Ear discomfort
|
0.00%
0/227 • From start of study through end of study (up to 64 days).
|
0.46%
1/219 • Number of events 1 • From start of study through end of study (up to 64 days).
|
0.00%
0/117 • From start of study through end of study (up to 64 days).
|
0.00%
0/123 • From start of study through end of study (up to 64 days).
|
|
Ear and labyrinth disorders
Ear pain
|
0.00%
0/227 • From start of study through end of study (up to 64 days).
|
0.46%
1/219 • Number of events 1 • From start of study through end of study (up to 64 days).
|
0.00%
0/117 • From start of study through end of study (up to 64 days).
|
0.00%
0/123 • From start of study through end of study (up to 64 days).
|
|
Ear and labyrinth disorders
Tinnitus
|
0.44%
1/227 • Number of events 2 • From start of study through end of study (up to 64 days).
|
0.00%
0/219 • From start of study through end of study (up to 64 days).
|
0.85%
1/117 • Number of events 1 • From start of study through end of study (up to 64 days).
|
0.00%
0/123 • From start of study through end of study (up to 64 days).
|
|
Ear and labyrinth disorders
Vertigo
|
0.44%
1/227 • Number of events 1 • From start of study through end of study (up to 64 days).
|
0.00%
0/219 • From start of study through end of study (up to 64 days).
|
0.00%
0/117 • From start of study through end of study (up to 64 days).
|
0.00%
0/123 • From start of study through end of study (up to 64 days).
|
|
Eye disorders
Dry eye
|
0.00%
0/227 • From start of study through end of study (up to 64 days).
|
0.46%
1/219 • Number of events 1 • From start of study through end of study (up to 64 days).
|
0.00%
0/117 • From start of study through end of study (up to 64 days).
|
0.00%
0/123 • From start of study through end of study (up to 64 days).
|
|
Eye disorders
Eye pain
|
0.00%
0/227 • From start of study through end of study (up to 64 days).
|
0.46%
1/219 • Number of events 1 • From start of study through end of study (up to 64 days).
|
0.00%
0/117 • From start of study through end of study (up to 64 days).
|
0.00%
0/123 • From start of study through end of study (up to 64 days).
|
|
Eye disorders
Periorbital swelling
|
0.44%
1/227 • Number of events 1 • From start of study through end of study (up to 64 days).
|
0.00%
0/219 • From start of study through end of study (up to 64 days).
|
0.00%
0/117 • From start of study through end of study (up to 64 days).
|
0.81%
1/123 • Number of events 1 • From start of study through end of study (up to 64 days).
|
|
Eye disorders
Swelling of eyelid
|
0.00%
0/227 • From start of study through end of study (up to 64 days).
|
0.46%
1/219 • Number of events 1 • From start of study through end of study (up to 64 days).
|
0.00%
0/117 • From start of study through end of study (up to 64 days).
|
0.00%
0/123 • From start of study through end of study (up to 64 days).
|
|
Eye disorders
Vision blurred
|
0.44%
1/227 • Number of events 1 • From start of study through end of study (up to 64 days).
|
0.46%
1/219 • Number of events 1 • From start of study through end of study (up to 64 days).
|
0.00%
0/117 • From start of study through end of study (up to 64 days).
|
0.00%
0/123 • From start of study through end of study (up to 64 days).
|
|
Eye disorders
Visual field defect
|
0.00%
0/227 • From start of study through end of study (up to 64 days).
|
0.00%
0/219 • From start of study through end of study (up to 64 days).
|
0.00%
0/117 • From start of study through end of study (up to 64 days).
|
0.81%
1/123 • Number of events 1 • From start of study through end of study (up to 64 days).
|
|
Eye disorders
Vitreous floaters
|
0.00%
0/227 • From start of study through end of study (up to 64 days).
|
0.00%
0/219 • From start of study through end of study (up to 64 days).
|
0.00%
0/117 • From start of study through end of study (up to 64 days).
|
0.81%
1/123 • Number of events 1 • From start of study through end of study (up to 64 days).
|
|
Gastrointestinal disorders
Abdominal pain
|
0.88%
2/227 • Number of events 2 • From start of study through end of study (up to 64 days).
|
0.91%
2/219 • Number of events 2 • From start of study through end of study (up to 64 days).
|
1.7%
2/117 • Number of events 2 • From start of study through end of study (up to 64 days).
|
0.81%
1/123 • Number of events 1 • From start of study through end of study (up to 64 days).
|
|
Gastrointestinal disorders
Abdominal pain upper
|
0.88%
2/227 • Number of events 2 • From start of study through end of study (up to 64 days).
|
0.00%
0/219 • From start of study through end of study (up to 64 days).
|
0.00%
0/117 • From start of study through end of study (up to 64 days).
|
0.00%
0/123 • From start of study through end of study (up to 64 days).
|
|
Gastrointestinal disorders
Constipation
|
0.44%
1/227 • Number of events 1 • From start of study through end of study (up to 64 days).
|
0.00%
0/219 • From start of study through end of study (up to 64 days).
|
0.85%
1/117 • Number of events 1 • From start of study through end of study (up to 64 days).
|
0.00%
0/123 • From start of study through end of study (up to 64 days).
|
|
Gastrointestinal disorders
Diarrhea
|
0.00%
0/227 • From start of study through end of study (up to 64 days).
|
0.00%
0/219 • From start of study through end of study (up to 64 days).
|
1.7%
2/117 • Number of events 3 • From start of study through end of study (up to 64 days).
|
0.00%
0/123 • From start of study through end of study (up to 64 days).
|
|
Gastrointestinal disorders
Dyspepsia
|
0.00%
0/227 • From start of study through end of study (up to 64 days).
|
0.46%
1/219 • Number of events 1 • From start of study through end of study (up to 64 days).
|
0.00%
0/117 • From start of study through end of study (up to 64 days).
|
0.00%
0/123 • From start of study through end of study (up to 64 days).
|
|
Gastrointestinal disorders
Dysphagia
|
0.44%
1/227 • Number of events 1 • From start of study through end of study (up to 64 days).
|
0.00%
0/219 • From start of study through end of study (up to 64 days).
|
1.7%
2/117 • Number of events 2 • From start of study through end of study (up to 64 days).
|
0.00%
0/123 • From start of study through end of study (up to 64 days).
|
|
Gastrointestinal disorders
Epigastric discomfort
|
0.00%
0/227 • From start of study through end of study (up to 64 days).
|
0.46%
1/219 • Number of events 1 • From start of study through end of study (up to 64 days).
|
0.00%
0/117 • From start of study through end of study (up to 64 days).
|
0.00%
0/123 • From start of study through end of study (up to 64 days).
|
|
Gastrointestinal disorders
Gastroesophageal reflux disease
|
0.44%
1/227 • Number of events 1 • From start of study through end of study (up to 64 days).
|
0.00%
0/219 • From start of study through end of study (up to 64 days).
|
0.00%
0/117 • From start of study through end of study (up to 64 days).
|
0.00%
0/123 • From start of study through end of study (up to 64 days).
|
|
Gastrointestinal disorders
Hypoaesthesia oral
|
0.00%
0/227 • From start of study through end of study (up to 64 days).
|
0.46%
1/219 • Number of events 1 • From start of study through end of study (up to 64 days).
|
0.00%
0/117 • From start of study through end of study (up to 64 days).
|
0.00%
0/123 • From start of study through end of study (up to 64 days).
|
|
Gastrointestinal disorders
Irritable bowel syndrome
|
0.00%
0/227 • From start of study through end of study (up to 64 days).
|
0.46%
1/219 • Number of events 1 • From start of study through end of study (up to 64 days).
|
0.85%
1/117 • Number of events 1 • From start of study through end of study (up to 64 days).
|
0.00%
0/123 • From start of study through end of study (up to 64 days).
|
|
Gastrointestinal disorders
Lip erythema
|
0.00%
0/227 • From start of study through end of study (up to 64 days).
|
0.00%
0/219 • From start of study through end of study (up to 64 days).
|
0.85%
1/117 • Number of events 1 • From start of study through end of study (up to 64 days).
|
0.00%
0/123 • From start of study through end of study (up to 64 days).
|
|
Gastrointestinal disorders
Lip swelling
|
0.00%
0/227 • From start of study through end of study (up to 64 days).
|
0.00%
0/219 • From start of study through end of study (up to 64 days).
|
0.85%
1/117 • Number of events 1 • From start of study through end of study (up to 64 days).
|
0.00%
0/123 • From start of study through end of study (up to 64 days).
|
|
Gastrointestinal disorders
Nausea
|
0.00%
0/227 • From start of study through end of study (up to 64 days).
|
0.46%
1/219 • Number of events 1 • From start of study through end of study (up to 64 days).
|
1.7%
2/117 • Number of events 3 • From start of study through end of study (up to 64 days).
|
0.00%
0/123 • From start of study through end of study (up to 64 days).
|
|
Gastrointestinal disorders
Oesophageal motility disorder
|
0.00%
0/227 • From start of study through end of study (up to 64 days).
|
0.00%
0/219 • From start of study through end of study (up to 64 days).
|
0.85%
1/117 • Number of events 1 • From start of study through end of study (up to 64 days).
|
0.00%
0/123 • From start of study through end of study (up to 64 days).
|
|
Gastrointestinal disorders
Oesophageal pain
|
0.00%
0/227 • From start of study through end of study (up to 64 days).
|
0.00%
0/219 • From start of study through end of study (up to 64 days).
|
0.85%
1/117 • Number of events 2 • From start of study through end of study (up to 64 days).
|
0.00%
0/123 • From start of study through end of study (up to 64 days).
|
|
Gastrointestinal disorders
Oral discomfort
|
0.88%
2/227 • Number of events 2 • From start of study through end of study (up to 64 days).
|
0.00%
0/219 • From start of study through end of study (up to 64 days).
|
0.85%
1/117 • Number of events 1 • From start of study through end of study (up to 64 days).
|
0.00%
0/123 • From start of study through end of study (up to 64 days).
|
|
Gastrointestinal disorders
Oral pain
|
0.00%
0/227 • From start of study through end of study (up to 64 days).
|
0.00%
0/219 • From start of study through end of study (up to 64 days).
|
0.00%
0/117 • From start of study through end of study (up to 64 days).
|
0.81%
1/123 • Number of events 1 • From start of study through end of study (up to 64 days).
|
|
Gastrointestinal disorders
Paraesthesia oral
|
0.44%
1/227 • Number of events 1 • From start of study through end of study (up to 64 days).
|
0.46%
1/219 • Number of events 1 • From start of study through end of study (up to 64 days).
|
0.85%
1/117 • Number of events 1 • From start of study through end of study (up to 64 days).
|
0.00%
0/123 • From start of study through end of study (up to 64 days).
|
|
Gastrointestinal disorders
Swollen tongue
|
0.00%
0/227 • From start of study through end of study (up to 64 days).
|
0.00%
0/219 • From start of study through end of study (up to 64 days).
|
0.00%
0/117 • From start of study through end of study (up to 64 days).
|
0.81%
1/123 • Number of events 1 • From start of study through end of study (up to 64 days).
|
|
Gastrointestinal disorders
Tongue discomfort
|
0.00%
0/227 • From start of study through end of study (up to 64 days).
|
0.00%
0/219 • From start of study through end of study (up to 64 days).
|
0.85%
1/117 • Number of events 1 • From start of study through end of study (up to 64 days).
|
0.00%
0/123 • From start of study through end of study (up to 64 days).
|
|
Gastrointestinal disorders
Vomiting
|
0.00%
0/227 • From start of study through end of study (up to 64 days).
|
0.00%
0/219 • From start of study through end of study (up to 64 days).
|
0.85%
1/117 • Number of events 1 • From start of study through end of study (up to 64 days).
|
0.00%
0/123 • From start of study through end of study (up to 64 days).
|
|
General disorders
Asthenia
|
0.00%
0/227 • From start of study through end of study (up to 64 days).
|
0.00%
0/219 • From start of study through end of study (up to 64 days).
|
0.85%
1/117 • Number of events 1 • From start of study through end of study (up to 64 days).
|
0.00%
0/123 • From start of study through end of study (up to 64 days).
|
|
General disorders
Axillary pain
|
0.44%
1/227 • Number of events 1 • From start of study through end of study (up to 64 days).
|
0.00%
0/219 • From start of study through end of study (up to 64 days).
|
0.00%
0/117 • From start of study through end of study (up to 64 days).
|
0.00%
0/123 • From start of study through end of study (up to 64 days).
|
|
General disorders
Chest discomfort
|
0.44%
1/227 • Number of events 2 • From start of study through end of study (up to 64 days).
|
0.46%
1/219 • Number of events 1 • From start of study through end of study (up to 64 days).
|
2.6%
3/117 • Number of events 3 • From start of study through end of study (up to 64 days).
|
0.00%
0/123 • From start of study through end of study (up to 64 days).
|
|
General disorders
Chest pain
|
0.00%
0/227 • From start of study through end of study (up to 64 days).
|
0.91%
2/219 • Number of events 2 • From start of study through end of study (up to 64 days).
|
1.7%
2/117 • Number of events 2 • From start of study through end of study (up to 64 days).
|
0.00%
0/123 • From start of study through end of study (up to 64 days).
|
|
General disorders
Chills
|
0.00%
0/227 • From start of study through end of study (up to 64 days).
|
0.46%
1/219 • Number of events 1 • From start of study through end of study (up to 64 days).
|
3.4%
4/117 • Number of events 4 • From start of study through end of study (up to 64 days).
|
0.81%
1/123 • Number of events 1 • From start of study through end of study (up to 64 days).
|
|
General disorders
Facial discomfort
|
0.00%
0/227 • From start of study through end of study (up to 64 days).
|
0.00%
0/219 • From start of study through end of study (up to 64 days).
|
0.85%
1/117 • Number of events 1 • From start of study through end of study (up to 64 days).
|
0.00%
0/123 • From start of study through end of study (up to 64 days).
|
|
General disorders
Fatigue
|
1.3%
3/227 • Number of events 3 • From start of study through end of study (up to 64 days).
|
1.8%
4/219 • Number of events 5 • From start of study through end of study (up to 64 days).
|
4.3%
5/117 • Number of events 7 • From start of study through end of study (up to 64 days).
|
2.4%
3/123 • Number of events 4 • From start of study through end of study (up to 64 days).
|
|
General disorders
Feeling abnormal
|
0.00%
0/227 • From start of study through end of study (up to 64 days).
|
1.4%
3/219 • Number of events 3 • From start of study through end of study (up to 64 days).
|
0.00%
0/117 • From start of study through end of study (up to 64 days).
|
0.00%
0/123 • From start of study through end of study (up to 64 days).
|
|
General disorders
Feeling hot
|
0.00%
0/227 • From start of study through end of study (up to 64 days).
|
0.00%
0/219 • From start of study through end of study (up to 64 days).
|
0.00%
0/117 • From start of study through end of study (up to 64 days).
|
0.81%
1/123 • Number of events 1 • From start of study through end of study (up to 64 days).
|
|
General disorders
Feeling jittery
|
0.00%
0/227 • From start of study through end of study (up to 64 days).
|
0.00%
0/219 • From start of study through end of study (up to 64 days).
|
0.00%
0/117 • From start of study through end of study (up to 64 days).
|
0.81%
1/123 • Number of events 1 • From start of study through end of study (up to 64 days).
|
|
General disorders
Injection site erythema
|
0.00%
0/227 • From start of study through end of study (up to 64 days).
|
0.46%
1/219 • Number of events 1 • From start of study through end of study (up to 64 days).
|
0.85%
1/117 • Number of events 1 • From start of study through end of study (up to 64 days).
|
0.00%
0/123 • From start of study through end of study (up to 64 days).
|
|
General disorders
Injection site nodule
|
0.00%
0/227 • From start of study through end of study (up to 64 days).
|
0.00%
0/219 • From start of study through end of study (up to 64 days).
|
1.7%
2/117 • Number of events 2 • From start of study through end of study (up to 64 days).
|
0.00%
0/123 • From start of study through end of study (up to 64 days).
|
|
General disorders
Injection site pain
|
0.00%
0/227 • From start of study through end of study (up to 64 days).
|
0.00%
0/219 • From start of study through end of study (up to 64 days).
|
0.85%
1/117 • Number of events 1 • From start of study through end of study (up to 64 days).
|
0.81%
1/123 • Number of events 1 • From start of study through end of study (up to 64 days).
|
|
General disorders
Injection site warmth
|
0.00%
0/227 • From start of study through end of study (up to 64 days).
|
0.00%
0/219 • From start of study through end of study (up to 64 days).
|
0.00%
0/117 • From start of study through end of study (up to 64 days).
|
0.81%
1/123 • Number of events 1 • From start of study through end of study (up to 64 days).
|
|
General disorders
Oedema peripheral
|
0.00%
0/227 • From start of study through end of study (up to 64 days).
|
0.46%
1/219 • Number of events 1 • From start of study through end of study (up to 64 days).
|
0.00%
0/117 • From start of study through end of study (up to 64 days).
|
0.00%
0/123 • From start of study through end of study (up to 64 days).
|
|
General disorders
Pain
|
0.00%
0/227 • From start of study through end of study (up to 64 days).
|
0.00%
0/219 • From start of study through end of study (up to 64 days).
|
0.85%
1/117 • Number of events 1 • From start of study through end of study (up to 64 days).
|
1.6%
2/123 • Number of events 2 • From start of study through end of study (up to 64 days).
|
|
General disorders
Pyrexia
|
0.00%
0/227 • From start of study through end of study (up to 64 days).
|
0.91%
2/219 • Number of events 2 • From start of study through end of study (up to 64 days).
|
0.00%
0/117 • From start of study through end of study (up to 64 days).
|
0.81%
1/123 • Number of events 1 • From start of study through end of study (up to 64 days).
|
|
General disorders
Sensation of foreign body
|
0.44%
1/227 • Number of events 1 • From start of study through end of study (up to 64 days).
|
0.00%
0/219 • From start of study through end of study (up to 64 days).
|
0.00%
0/117 • From start of study through end of study (up to 64 days).
|
0.00%
0/123 • From start of study through end of study (up to 64 days).
|
|
General disorders
Vaccination site reaction
|
57.7%
131/227 • Number of events 242 • From start of study through end of study (up to 64 days).
|
65.3%
143/219 • Number of events 255 • From start of study through end of study (up to 64 days).
|
63.2%
74/117 • Number of events 133 • From start of study through end of study (up to 64 days).
|
56.1%
69/123 • Number of events 130 • From start of study through end of study (up to 64 days).
|
|
General disorders
Vessel puncture site bruise
|
0.00%
0/227 • From start of study through end of study (up to 64 days).
|
0.91%
2/219 • Number of events 2 • From start of study through end of study (up to 64 days).
|
0.00%
0/117 • From start of study through end of study (up to 64 days).
|
0.00%
0/123 • From start of study through end of study (up to 64 days).
|
|
Immune system disorders
Anaphylactic reaction
|
0.00%
0/227 • From start of study through end of study (up to 64 days).
|
0.46%
1/219 • Number of events 1 • From start of study through end of study (up to 64 days).
|
0.00%
0/117 • From start of study through end of study (up to 64 days).
|
0.00%
0/123 • From start of study through end of study (up to 64 days).
|
|
Immune system disorders
Hypersensitivity
|
11.0%
25/227 • Number of events 44 • From start of study through end of study (up to 64 days).
|
11.4%
25/219 • Number of events 31 • From start of study through end of study (up to 64 days).
|
12.8%
15/117 • Number of events 35 • From start of study through end of study (up to 64 days).
|
13.0%
16/123 • Number of events 31 • From start of study through end of study (up to 64 days).
|
|
Immune system disorders
Milk allergy
|
0.00%
0/227 • From start of study through end of study (up to 64 days).
|
0.00%
0/219 • From start of study through end of study (up to 64 days).
|
0.00%
0/117 • From start of study through end of study (up to 64 days).
|
0.81%
1/123 • Number of events 1 • From start of study through end of study (up to 64 days).
|
|
Immune system disorders
Seasonal allergy
|
0.00%
0/227 • From start of study through end of study (up to 64 days).
|
0.00%
0/219 • From start of study through end of study (up to 64 days).
|
0.00%
0/117 • From start of study through end of study (up to 64 days).
|
0.81%
1/123 • Number of events 1 • From start of study through end of study (up to 64 days).
|
|
Infections and infestations
COVID-19
|
0.88%
2/227 • Number of events 2 • From start of study through end of study (up to 64 days).
|
0.46%
1/219 • Number of events 1 • From start of study through end of study (up to 64 days).
|
0.85%
1/117 • Number of events 1 • From start of study through end of study (up to 64 days).
|
2.4%
3/123 • Number of events 3 • From start of study through end of study (up to 64 days).
|
|
Infections and infestations
Cellulitis
|
0.00%
0/227 • From start of study through end of study (up to 64 days).
|
0.00%
0/219 • From start of study through end of study (up to 64 days).
|
0.00%
0/117 • From start of study through end of study (up to 64 days).
|
0.81%
1/123 • Number of events 1 • From start of study through end of study (up to 64 days).
|
|
Infections and infestations
Ear infection
|
0.44%
1/227 • Number of events 1 • From start of study through end of study (up to 64 days).
|
0.00%
0/219 • From start of study through end of study (up to 64 days).
|
0.00%
0/117 • From start of study through end of study (up to 64 days).
|
0.00%
0/123 • From start of study through end of study (up to 64 days).
|
|
Infections and infestations
Folliculitis
|
0.00%
0/227 • From start of study through end of study (up to 64 days).
|
0.00%
0/219 • From start of study through end of study (up to 64 days).
|
0.00%
0/117 • From start of study through end of study (up to 64 days).
|
0.81%
1/123 • Number of events 1 • From start of study through end of study (up to 64 days).
|
|
Infections and infestations
Gastrointestinal viral infection
|
0.00%
0/227 • From start of study through end of study (up to 64 days).
|
0.00%
0/219 • From start of study through end of study (up to 64 days).
|
0.85%
1/117 • Number of events 1 • From start of study through end of study (up to 64 days).
|
0.00%
0/123 • From start of study through end of study (up to 64 days).
|
|
Infections and infestations
Nasal herpes
|
0.00%
0/227 • From start of study through end of study (up to 64 days).
|
0.46%
1/219 • Number of events 1 • From start of study through end of study (up to 64 days).
|
0.00%
0/117 • From start of study through end of study (up to 64 days).
|
0.00%
0/123 • From start of study through end of study (up to 64 days).
|
|
Infections and infestations
Nasopharyngitis
|
0.00%
0/227 • From start of study through end of study (up to 64 days).
|
0.00%
0/219 • From start of study through end of study (up to 64 days).
|
0.00%
0/117 • From start of study through end of study (up to 64 days).
|
1.6%
2/123 • Number of events 2 • From start of study through end of study (up to 64 days).
|
|
Infections and infestations
Oral herpes
|
0.00%
0/227 • From start of study through end of study (up to 64 days).
|
0.00%
0/219 • From start of study through end of study (up to 64 days).
|
0.85%
1/117 • Number of events 1 • From start of study through end of study (up to 64 days).
|
0.00%
0/123 • From start of study through end of study (up to 64 days).
|
|
Infections and infestations
Pharyngitis
|
0.00%
0/227 • From start of study through end of study (up to 64 days).
|
0.46%
1/219 • Number of events 1 • From start of study through end of study (up to 64 days).
|
0.00%
0/117 • From start of study through end of study (up to 64 days).
|
0.00%
0/123 • From start of study through end of study (up to 64 days).
|
|
Infections and infestations
Sinusitis
|
0.00%
0/227 • From start of study through end of study (up to 64 days).
|
0.00%
0/219 • From start of study through end of study (up to 64 days).
|
0.85%
1/117 • Number of events 1 • From start of study through end of study (up to 64 days).
|
0.00%
0/123 • From start of study through end of study (up to 64 days).
|
|
Infections and infestations
Sinusitis bacterial
|
0.00%
0/227 • From start of study through end of study (up to 64 days).
|
0.46%
1/219 • Number of events 1 • From start of study through end of study (up to 64 days).
|
0.00%
0/117 • From start of study through end of study (up to 64 days).
|
0.00%
0/123 • From start of study through end of study (up to 64 days).
|
|
Infections and infestations
Upper respiratory tract infection
|
0.00%
0/227 • From start of study through end of study (up to 64 days).
|
0.00%
0/219 • From start of study through end of study (up to 64 days).
|
0.00%
0/117 • From start of study through end of study (up to 64 days).
|
1.6%
2/123 • Number of events 2 • From start of study through end of study (up to 64 days).
|
|
Infections and infestations
Urinary tract infection
|
0.44%
1/227 • Number of events 1 • From start of study through end of study (up to 64 days).
|
0.00%
0/219 • From start of study through end of study (up to 64 days).
|
0.00%
0/117 • From start of study through end of study (up to 64 days).
|
0.81%
1/123 • Number of events 1 • From start of study through end of study (up to 64 days).
|
|
Infections and infestations
Viral infection
|
0.00%
0/227 • From start of study through end of study (up to 64 days).
|
0.00%
0/219 • From start of study through end of study (up to 64 days).
|
1.7%
2/117 • Number of events 2 • From start of study through end of study (up to 64 days).
|
0.00%
0/123 • From start of study through end of study (up to 64 days).
|
|
Injury, poisoning and procedural complications
Animal bite
|
0.00%
0/227 • From start of study through end of study (up to 64 days).
|
0.46%
1/219 • Number of events 1 • From start of study through end of study (up to 64 days).
|
0.00%
0/117 • From start of study through end of study (up to 64 days).
|
0.00%
0/123 • From start of study through end of study (up to 64 days).
|
|
Injury, poisoning and procedural complications
Arthropod bite
|
0.88%
2/227 • Number of events 2 • From start of study through end of study (up to 64 days).
|
0.46%
1/219 • Number of events 1 • From start of study through end of study (up to 64 days).
|
0.00%
0/117 • From start of study through end of study (up to 64 days).
|
0.00%
0/123 • From start of study through end of study (up to 64 days).
|
|
Injury, poisoning and procedural complications
Facial bones fracture
|
0.00%
0/227 • From start of study through end of study (up to 64 days).
|
0.00%
0/219 • From start of study through end of study (up to 64 days).
|
0.85%
1/117 • Number of events 2 • From start of study through end of study (up to 64 days).
|
0.00%
0/123 • From start of study through end of study (up to 64 days).
|
|
Injury, poisoning and procedural complications
Fall
|
0.00%
0/227 • From start of study through end of study (up to 64 days).
|
0.00%
0/219 • From start of study through end of study (up to 64 days).
|
0.85%
1/117 • Number of events 1 • From start of study through end of study (up to 64 days).
|
0.00%
0/123 • From start of study through end of study (up to 64 days).
|
|
Injury, poisoning and procedural complications
Head injury
|
0.00%
0/227 • From start of study through end of study (up to 64 days).
|
0.00%
0/219 • From start of study through end of study (up to 64 days).
|
0.00%
0/117 • From start of study through end of study (up to 64 days).
|
0.81%
1/123 • Number of events 1 • From start of study through end of study (up to 64 days).
|
|
Injury, poisoning and procedural complications
Ligament sprain
|
0.00%
0/227 • From start of study through end of study (up to 64 days).
|
0.00%
0/219 • From start of study through end of study (up to 64 days).
|
0.85%
1/117 • Number of events 2 • From start of study through end of study (up to 64 days).
|
0.00%
0/123 • From start of study through end of study (up to 64 days).
|
|
Injury, poisoning and procedural complications
Muscle strain
|
0.44%
1/227 • Number of events 1 • From start of study through end of study (up to 64 days).
|
0.00%
0/219 • From start of study through end of study (up to 64 days).
|
0.00%
0/117 • From start of study through end of study (up to 64 days).
|
0.00%
0/123 • From start of study through end of study (up to 64 days).
|
|
Injury, poisoning and procedural complications
Post procedural complication
|
0.44%
1/227 • Number of events 1 • From start of study through end of study (up to 64 days).
|
0.00%
0/219 • From start of study through end of study (up to 64 days).
|
0.00%
0/117 • From start of study through end of study (up to 64 days).
|
0.00%
0/123 • From start of study through end of study (up to 64 days).
|
|
Injury, poisoning and procedural complications
Procedural dizziness
|
0.88%
2/227 • Number of events 2 • From start of study through end of study (up to 64 days).
|
0.00%
0/219 • From start of study through end of study (up to 64 days).
|
0.00%
0/117 • From start of study through end of study (up to 64 days).
|
0.81%
1/123 • Number of events 1 • From start of study through end of study (up to 64 days).
|
|
Injury, poisoning and procedural complications
Procedural vomiting
|
0.44%
1/227 • Number of events 1 • From start of study through end of study (up to 64 days).
|
0.00%
0/219 • From start of study through end of study (up to 64 days).
|
0.00%
0/117 • From start of study through end of study (up to 64 days).
|
0.00%
0/123 • From start of study through end of study (up to 64 days).
|
|
Injury, poisoning and procedural complications
Road traffic accident
|
0.00%
0/227 • From start of study through end of study (up to 64 days).
|
0.00%
0/219 • From start of study through end of study (up to 64 days).
|
0.85%
1/117 • Number of events 1 • From start of study through end of study (up to 64 days).
|
0.00%
0/123 • From start of study through end of study (up to 64 days).
|
|
Injury, poisoning and procedural complications
Skin laceration
|
0.00%
0/227 • From start of study through end of study (up to 64 days).
|
0.46%
1/219 • Number of events 1 • From start of study through end of study (up to 64 days).
|
0.85%
1/117 • Number of events 1 • From start of study through end of study (up to 64 days).
|
0.00%
0/123 • From start of study through end of study (up to 64 days).
|
|
Injury, poisoning and procedural complications
Vaccination complication
|
67.4%
153/227 • Number of events 357 • From start of study through end of study (up to 64 days).
|
74.4%
163/219 • Number of events 378 • From start of study through end of study (up to 64 days).
|
70.9%
83/117 • Number of events 276 • From start of study through end of study (up to 64 days).
|
72.4%
89/123 • Number of events 260 • From start of study through end of study (up to 64 days).
|
|
Investigations
Blood pressure increased
|
0.00%
0/227 • From start of study through end of study (up to 64 days).
|
0.00%
0/219 • From start of study through end of study (up to 64 days).
|
0.85%
1/117 • Number of events 1 • From start of study through end of study (up to 64 days).
|
0.81%
1/123 • Number of events 1 • From start of study through end of study (up to 64 days).
|
|
Investigations
Blood urine present
|
0.00%
0/227 • From start of study through end of study (up to 64 days).
|
0.00%
0/219 • From start of study through end of study (up to 64 days).
|
0.85%
1/117 • Number of events 1 • From start of study through end of study (up to 64 days).
|
0.00%
0/123 • From start of study through end of study (up to 64 days).
|
|
Investigations
Eosinophil count abnormal
|
0.00%
0/227 • From start of study through end of study (up to 64 days).
|
0.46%
1/219 • Number of events 1 • From start of study through end of study (up to 64 days).
|
0.00%
0/117 • From start of study through end of study (up to 64 days).
|
0.00%
0/123 • From start of study through end of study (up to 64 days).
|
|
Investigations
Eosinophil count decreased
|
0.44%
1/227 • Number of events 1 • From start of study through end of study (up to 64 days).
|
0.00%
0/219 • From start of study through end of study (up to 64 days).
|
0.00%
0/117 • From start of study through end of study (up to 64 days).
|
1.6%
2/123 • Number of events 2 • From start of study through end of study (up to 64 days).
|
|
Investigations
Eosinophil count increased
|
1.8%
4/227 • Number of events 4 • From start of study through end of study (up to 64 days).
|
0.91%
2/219 • Number of events 2 • From start of study through end of study (up to 64 days).
|
1.7%
2/117 • Number of events 2 • From start of study through end of study (up to 64 days).
|
1.6%
2/123 • Number of events 4 • From start of study through end of study (up to 64 days).
|
|
Investigations
Haematocrit decreased
|
0.00%
0/227 • From start of study through end of study (up to 64 days).
|
0.46%
1/219 • Number of events 1 • From start of study through end of study (up to 64 days).
|
0.00%
0/117 • From start of study through end of study (up to 64 days).
|
0.81%
1/123 • Number of events 1 • From start of study through end of study (up to 64 days).
|
|
Investigations
Haemoglobin
|
0.00%
0/227 • From start of study through end of study (up to 64 days).
|
0.00%
0/219 • From start of study through end of study (up to 64 days).
|
0.00%
0/117 • From start of study through end of study (up to 64 days).
|
0.81%
1/123 • Number of events 1 • From start of study through end of study (up to 64 days).
|
|
Investigations
Haemoglobin abnormal
|
0.00%
0/227 • From start of study through end of study (up to 64 days).
|
0.46%
1/219 • Number of events 1 • From start of study through end of study (up to 64 days).
|
0.00%
0/117 • From start of study through end of study (up to 64 days).
|
0.00%
0/123 • From start of study through end of study (up to 64 days).
|
|
Investigations
Haemoglobin decreased
|
6.2%
14/227 • Number of events 15 • From start of study through end of study (up to 64 days).
|
7.8%
17/219 • Number of events 20 • From start of study through end of study (up to 64 days).
|
7.7%
9/117 • Number of events 11 • From start of study through end of study (up to 64 days).
|
2.4%
3/123 • Number of events 4 • From start of study through end of study (up to 64 days).
|
|
Investigations
Heart rate increased
|
0.00%
0/227 • From start of study through end of study (up to 64 days).
|
0.00%
0/219 • From start of study through end of study (up to 64 days).
|
0.85%
1/117 • Number of events 1 • From start of study through end of study (up to 64 days).
|
0.00%
0/123 • From start of study through end of study (up to 64 days).
|
|
Investigations
Lymphocyte count decreased
|
3.5%
8/227 • Number of events 8 • From start of study through end of study (up to 64 days).
|
3.2%
7/219 • Number of events 7 • From start of study through end of study (up to 64 days).
|
2.6%
3/117 • Number of events 4 • From start of study through end of study (up to 64 days).
|
3.3%
4/123 • Number of events 4 • From start of study through end of study (up to 64 days).
|
|
Investigations
Lymphocyte count increased
|
0.00%
0/227 • From start of study through end of study (up to 64 days).
|
0.46%
1/219 • Number of events 1 • From start of study through end of study (up to 64 days).
|
1.7%
2/117 • Number of events 2 • From start of study through end of study (up to 64 days).
|
1.6%
2/123 • Number of events 2 • From start of study through end of study (up to 64 days).
|
|
Investigations
Mean cell haemoglobin concentration decreased
|
0.00%
0/227 • From start of study through end of study (up to 64 days).
|
0.46%
1/219 • Number of events 1 • From start of study through end of study (up to 64 days).
|
0.00%
0/117 • From start of study through end of study (up to 64 days).
|
0.00%
0/123 • From start of study through end of study (up to 64 days).
|
|
Investigations
Monocyte count increased
|
0.00%
0/227 • From start of study through end of study (up to 64 days).
|
0.46%
1/219 • Number of events 1 • From start of study through end of study (up to 64 days).
|
0.85%
1/117 • Number of events 1 • From start of study through end of study (up to 64 days).
|
0.00%
0/123 • From start of study through end of study (up to 64 days).
|
|
Investigations
Neutrophil count abnormal
|
0.44%
1/227 • Number of events 1 • From start of study through end of study (up to 64 days).
|
0.00%
0/219 • From start of study through end of study (up to 64 days).
|
0.00%
0/117 • From start of study through end of study (up to 64 days).
|
0.00%
0/123 • From start of study through end of study (up to 64 days).
|
|
Investigations
Neutrophil count decreased
|
1.3%
3/227 • Number of events 3 • From start of study through end of study (up to 64 days).
|
2.7%
6/219 • Number of events 7 • From start of study through end of study (up to 64 days).
|
3.4%
4/117 • Number of events 6 • From start of study through end of study (up to 64 days).
|
2.4%
3/123 • Number of events 5 • From start of study through end of study (up to 64 days).
|
|
Investigations
Platelet count decreased
|
0.44%
1/227 • Number of events 1 • From start of study through end of study (up to 64 days).
|
0.91%
2/219 • Number of events 3 • From start of study through end of study (up to 64 days).
|
0.85%
1/117 • Number of events 2 • From start of study through end of study (up to 64 days).
|
0.00%
0/123 • From start of study through end of study (up to 64 days).
|
|
Investigations
Platelet count increased
|
0.00%
0/227 • From start of study through end of study (up to 64 days).
|
0.00%
0/219 • From start of study through end of study (up to 64 days).
|
0.00%
0/117 • From start of study through end of study (up to 64 days).
|
0.81%
1/123 • Number of events 1 • From start of study through end of study (up to 64 days).
|
|
Investigations
Respiratory rate increased
|
0.00%
0/227 • From start of study through end of study (up to 64 days).
|
0.46%
1/219 • Number of events 1 • From start of study through end of study (up to 64 days).
|
0.00%
0/117 • From start of study through end of study (up to 64 days).
|
0.00%
0/123 • From start of study through end of study (up to 64 days).
|
|
Investigations
White blood cell count decreased
|
1.8%
4/227 • Number of events 4 • From start of study through end of study (up to 64 days).
|
1.8%
4/219 • Number of events 6 • From start of study through end of study (up to 64 days).
|
4.3%
5/117 • Number of events 5 • From start of study through end of study (up to 64 days).
|
2.4%
3/123 • Number of events 4 • From start of study through end of study (up to 64 days).
|
|
Investigations
White blood cell count increased
|
1.3%
3/227 • Number of events 3 • From start of study through end of study (up to 64 days).
|
2.7%
6/219 • Number of events 6 • From start of study through end of study (up to 64 days).
|
2.6%
3/117 • Number of events 3 • From start of study through end of study (up to 64 days).
|
4.1%
5/123 • Number of events 5 • From start of study through end of study (up to 64 days).
|
|
Metabolism and nutrition disorders
Dehydration
|
1.3%
3/227 • Number of events 4 • From start of study through end of study (up to 64 days).
|
0.00%
0/219 • From start of study through end of study (up to 64 days).
|
0.00%
0/117 • From start of study through end of study (up to 64 days).
|
0.00%
0/123 • From start of study through end of study (up to 64 days).
|
|
Musculoskeletal and connective tissue disorders
Arthralgia
|
0.44%
1/227 • Number of events 1 • From start of study through end of study (up to 64 days).
|
0.91%
2/219 • Number of events 2 • From start of study through end of study (up to 64 days).
|
0.85%
1/117 • Number of events 1 • From start of study through end of study (up to 64 days).
|
0.00%
0/123 • From start of study through end of study (up to 64 days).
|
|
Musculoskeletal and connective tissue disorders
Back pain
|
0.44%
1/227 • Number of events 1 • From start of study through end of study (up to 64 days).
|
0.91%
2/219 • Number of events 2 • From start of study through end of study (up to 64 days).
|
2.6%
3/117 • Number of events 3 • From start of study through end of study (up to 64 days).
|
0.81%
1/123 • Number of events 1 • From start of study through end of study (up to 64 days).
|
|
Musculoskeletal and connective tissue disorders
Muscle spasms
|
0.44%
1/227 • Number of events 1 • From start of study through end of study (up to 64 days).
|
0.91%
2/219 • Number of events 2 • From start of study through end of study (up to 64 days).
|
0.00%
0/117 • From start of study through end of study (up to 64 days).
|
0.81%
1/123 • Number of events 1 • From start of study through end of study (up to 64 days).
|
|
Musculoskeletal and connective tissue disorders
Muscular weakness
|
0.44%
1/227 • Number of events 1 • From start of study through end of study (up to 64 days).
|
0.00%
0/219 • From start of study through end of study (up to 64 days).
|
0.00%
0/117 • From start of study through end of study (up to 64 days).
|
0.00%
0/123 • From start of study through end of study (up to 64 days).
|
|
Musculoskeletal and connective tissue disorders
Musculoskeletal stiffness
|
0.44%
1/227 • Number of events 1 • From start of study through end of study (up to 64 days).
|
0.46%
1/219 • Number of events 1 • From start of study through end of study (up to 64 days).
|
0.00%
0/117 • From start of study through end of study (up to 64 days).
|
0.81%
1/123 • Number of events 1 • From start of study through end of study (up to 64 days).
|
|
Musculoskeletal and connective tissue disorders
Myalgia
|
0.00%
0/227 • From start of study through end of study (up to 64 days).
|
0.00%
0/219 • From start of study through end of study (up to 64 days).
|
2.6%
3/117 • Number of events 7 • From start of study through end of study (up to 64 days).
|
0.81%
1/123 • Number of events 1 • From start of study through end of study (up to 64 days).
|
|
Musculoskeletal and connective tissue disorders
Neck pain
|
0.44%
1/227 • Number of events 1 • From start of study through end of study (up to 64 days).
|
0.00%
0/219 • From start of study through end of study (up to 64 days).
|
1.7%
2/117 • Number of events 2 • From start of study through end of study (up to 64 days).
|
0.00%
0/123 • From start of study through end of study (up to 64 days).
|
|
Musculoskeletal and connective tissue disorders
Pain in extremity
|
0.44%
1/227 • Number of events 1 • From start of study through end of study (up to 64 days).
|
0.00%
0/219 • From start of study through end of study (up to 64 days).
|
0.85%
1/117 • Number of events 1 • From start of study through end of study (up to 64 days).
|
0.00%
0/123 • From start of study through end of study (up to 64 days).
|
|
Nervous system disorders
Dizziness
|
1.8%
4/227 • Number of events 4 • From start of study through end of study (up to 64 days).
|
0.46%
1/219 • Number of events 1 • From start of study through end of study (up to 64 days).
|
2.6%
3/117 • Number of events 3 • From start of study through end of study (up to 64 days).
|
0.00%
0/123 • From start of study through end of study (up to 64 days).
|
|
Nervous system disorders
Dysgeusia
|
0.00%
0/227 • From start of study through end of study (up to 64 days).
|
0.00%
0/219 • From start of study through end of study (up to 64 days).
|
0.85%
1/117 • Number of events 1 • From start of study through end of study (up to 64 days).
|
0.81%
1/123 • Number of events 1 • From start of study through end of study (up to 64 days).
|
|
Nervous system disorders
Headache
|
2.6%
6/227 • Number of events 7 • From start of study through end of study (up to 64 days).
|
1.4%
3/219 • Number of events 3 • From start of study through end of study (up to 64 days).
|
3.4%
4/117 • Number of events 6 • From start of study through end of study (up to 64 days).
|
0.81%
1/123 • Number of events 1 • From start of study through end of study (up to 64 days).
|
|
Nervous system disorders
Hypoaesthesia
|
0.00%
0/227 • From start of study through end of study (up to 64 days).
|
0.46%
1/219 • Number of events 1 • From start of study through end of study (up to 64 days).
|
0.00%
0/117 • From start of study through end of study (up to 64 days).
|
0.81%
1/123 • Number of events 1 • From start of study through end of study (up to 64 days).
|
|
Nervous system disorders
Lethargy
|
0.00%
0/227 • From start of study through end of study (up to 64 days).
|
0.00%
0/219 • From start of study through end of study (up to 64 days).
|
0.85%
1/117 • Number of events 1 • From start of study through end of study (up to 64 days).
|
0.00%
0/123 • From start of study through end of study (up to 64 days).
|
|
Nervous system disorders
Migraine
|
0.00%
0/227 • From start of study through end of study (up to 64 days).
|
0.00%
0/219 • From start of study through end of study (up to 64 days).
|
0.85%
1/117 • Number of events 1 • From start of study through end of study (up to 64 days).
|
0.00%
0/123 • From start of study through end of study (up to 64 days).
|
|
Nervous system disorders
Neurological symptom
|
0.00%
0/227 • From start of study through end of study (up to 64 days).
|
0.46%
1/219 • Number of events 1 • From start of study through end of study (up to 64 days).
|
0.00%
0/117 • From start of study through end of study (up to 64 days).
|
0.00%
0/123 • From start of study through end of study (up to 64 days).
|
|
Nervous system disorders
Paraesthesia
|
0.88%
2/227 • Number of events 2 • From start of study through end of study (up to 64 days).
|
0.00%
0/219 • From start of study through end of study (up to 64 days).
|
0.00%
0/117 • From start of study through end of study (up to 64 days).
|
0.81%
1/123 • Number of events 1 • From start of study through end of study (up to 64 days).
|
|
Nervous system disorders
Parosmia
|
0.44%
1/227 • Number of events 1 • From start of study through end of study (up to 64 days).
|
0.00%
0/219 • From start of study through end of study (up to 64 days).
|
0.00%
0/117 • From start of study through end of study (up to 64 days).
|
0.00%
0/123 • From start of study through end of study (up to 64 days).
|
|
Nervous system disorders
Presyncope
|
1.3%
3/227 • Number of events 3 • From start of study through end of study (up to 64 days).
|
0.91%
2/219 • Number of events 2 • From start of study through end of study (up to 64 days).
|
1.7%
2/117 • Number of events 3 • From start of study through end of study (up to 64 days).
|
0.00%
0/123 • From start of study through end of study (up to 64 days).
|
|
Nervous system disorders
Syncope
|
0.44%
1/227 • Number of events 1 • From start of study through end of study (up to 64 days).
|
0.00%
0/219 • From start of study through end of study (up to 64 days).
|
0.00%
0/117 • From start of study through end of study (up to 64 days).
|
0.00%
0/123 • From start of study through end of study (up to 64 days).
|
|
Pregnancy, puerperium and perinatal conditions
Hyperemesis gravidarum
|
0.44%
1/227 • Number of events 2 • From start of study through end of study (up to 64 days).
|
0.00%
0/219 • From start of study through end of study (up to 64 days).
|
0.00%
0/117 • From start of study through end of study (up to 64 days).
|
0.00%
0/123 • From start of study through end of study (up to 64 days).
|
|
Psychiatric disorders
Anxiety
|
0.00%
0/227 • From start of study through end of study (up to 64 days).
|
0.46%
1/219 • Number of events 1 • From start of study through end of study (up to 64 days).
|
0.85%
1/117 • Number of events 3 • From start of study through end of study (up to 64 days).
|
0.00%
0/123 • From start of study through end of study (up to 64 days).
|
|
Psychiatric disorders
Generalised anxiety disorder
|
0.44%
1/227 • Number of events 1 • From start of study through end of study (up to 64 days).
|
0.00%
0/219 • From start of study through end of study (up to 64 days).
|
0.00%
0/117 • From start of study through end of study (up to 64 days).
|
0.00%
0/123 • From start of study through end of study (up to 64 days).
|
|
Psychiatric disorders
Hallucination
|
0.00%
0/227 • From start of study through end of study (up to 64 days).
|
0.00%
0/219 • From start of study through end of study (up to 64 days).
|
0.00%
0/117 • From start of study through end of study (up to 64 days).
|
0.81%
1/123 • Number of events 1 • From start of study through end of study (up to 64 days).
|
|
Psychiatric disorders
Insomnia
|
0.00%
0/227 • From start of study through end of study (up to 64 days).
|
0.00%
0/219 • From start of study through end of study (up to 64 days).
|
0.85%
1/117 • Number of events 1 • From start of study through end of study (up to 64 days).
|
0.00%
0/123 • From start of study through end of study (up to 64 days).
|
|
Psychiatric disorders
Mood altered
|
0.00%
0/227 • From start of study through end of study (up to 64 days).
|
0.46%
1/219 • Number of events 1 • From start of study through end of study (up to 64 days).
|
0.00%
0/117 • From start of study through end of study (up to 64 days).
|
0.00%
0/123 • From start of study through end of study (up to 64 days).
|
|
Psychiatric disorders
Panic attack
|
0.00%
0/227 • From start of study through end of study (up to 64 days).
|
0.46%
1/219 • Number of events 1 • From start of study through end of study (up to 64 days).
|
0.85%
1/117 • Number of events 1 • From start of study through end of study (up to 64 days).
|
0.00%
0/123 • From start of study through end of study (up to 64 days).
|
|
Psychiatric disorders
Sleep disorder
|
0.88%
2/227 • Number of events 2 • From start of study through end of study (up to 64 days).
|
0.00%
0/219 • From start of study through end of study (up to 64 days).
|
0.00%
0/117 • From start of study through end of study (up to 64 days).
|
0.00%
0/123 • From start of study through end of study (up to 64 days).
|
|
Renal and urinary disorders
Cystitis interstitial
|
0.00%
0/227 • From start of study through end of study (up to 64 days).
|
0.46%
1/219 • Number of events 1 • From start of study through end of study (up to 64 days).
|
0.00%
0/117 • From start of study through end of study (up to 64 days).
|
0.00%
0/123 • From start of study through end of study (up to 64 days).
|
|
Renal and urinary disorders
Pollakiuria
|
0.00%
0/227 • From start of study through end of study (up to 64 days).
|
0.00%
0/219 • From start of study through end of study (up to 64 days).
|
0.85%
1/117 • Number of events 1 • From start of study through end of study (up to 64 days).
|
0.00%
0/123 • From start of study through end of study (up to 64 days).
|
|
Reproductive system and breast disorders
Heavy menstrual bleeding
|
0.44%
1/227 • Number of events 1 • From start of study through end of study (up to 64 days).
|
0.00%
0/219 • From start of study through end of study (up to 64 days).
|
0.00%
0/117 • From start of study through end of study (up to 64 days).
|
0.00%
0/123 • From start of study through end of study (up to 64 days).
|
|
Reproductive system and breast disorders
Menstruation irregular
|
0.00%
0/227 • From start of study through end of study (up to 64 days).
|
0.46%
1/219 • Number of events 1 • From start of study through end of study (up to 64 days).
|
0.00%
0/117 • From start of study through end of study (up to 64 days).
|
0.00%
0/123 • From start of study through end of study (up to 64 days).
|
|
Reproductive system and breast disorders
Premenstrual pain
|
0.00%
0/227 • From start of study through end of study (up to 64 days).
|
0.00%
0/219 • From start of study through end of study (up to 64 days).
|
0.85%
1/117 • Number of events 1 • From start of study through end of study (up to 64 days).
|
0.00%
0/123 • From start of study through end of study (up to 64 days).
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
0.88%
2/227 • Number of events 3 • From start of study through end of study (up to 64 days).
|
0.00%
0/219 • From start of study through end of study (up to 64 days).
|
1.7%
2/117 • Number of events 3 • From start of study through end of study (up to 64 days).
|
0.81%
1/123 • Number of events 1 • From start of study through end of study (up to 64 days).
|
|
Respiratory, thoracic and mediastinal disorders
Dysphonia
|
0.44%
1/227 • Number of events 1 • From start of study through end of study (up to 64 days).
|
0.00%
0/219 • From start of study through end of study (up to 64 days).
|
0.00%
0/117 • From start of study through end of study (up to 64 days).
|
0.00%
0/123 • From start of study through end of study (up to 64 days).
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnoea
|
0.00%
0/227 • From start of study through end of study (up to 64 days).
|
0.00%
0/219 • From start of study through end of study (up to 64 days).
|
0.85%
1/117 • Number of events 1 • From start of study through end of study (up to 64 days).
|
0.00%
0/123 • From start of study through end of study (up to 64 days).
|
|
Respiratory, thoracic and mediastinal disorders
Epistaxis
|
0.44%
1/227 • Number of events 1 • From start of study through end of study (up to 64 days).
|
0.00%
0/219 • From start of study through end of study (up to 64 days).
|
0.85%
1/117 • Number of events 1 • From start of study through end of study (up to 64 days).
|
0.00%
0/123 • From start of study through end of study (up to 64 days).
|
|
Respiratory, thoracic and mediastinal disorders
Hiccups
|
0.00%
0/227 • From start of study through end of study (up to 64 days).
|
0.46%
1/219 • Number of events 1 • From start of study through end of study (up to 64 days).
|
0.00%
0/117 • From start of study through end of study (up to 64 days).
|
0.00%
0/123 • From start of study through end of study (up to 64 days).
|
|
Respiratory, thoracic and mediastinal disorders
Nasal congestion
|
0.00%
0/227 • From start of study through end of study (up to 64 days).
|
0.00%
0/219 • From start of study through end of study (up to 64 days).
|
1.7%
2/117 • Number of events 3 • From start of study through end of study (up to 64 days).
|
0.81%
1/123 • Number of events 1 • From start of study through end of study (up to 64 days).
|
|
Respiratory, thoracic and mediastinal disorders
Oropharyngeal pain
|
0.88%
2/227 • Number of events 2 • From start of study through end of study (up to 64 days).
|
0.46%
1/219 • Number of events 1 • From start of study through end of study (up to 64 days).
|
3.4%
4/117 • Number of events 5 • From start of study through end of study (up to 64 days).
|
0.00%
0/123 • From start of study through end of study (up to 64 days).
|
|
Respiratory, thoracic and mediastinal disorders
Pharyngeal swelling
|
0.00%
0/227 • From start of study through end of study (up to 64 days).
|
0.00%
0/219 • From start of study through end of study (up to 64 days).
|
0.00%
0/117 • From start of study through end of study (up to 64 days).
|
0.81%
1/123 • Number of events 1 • From start of study through end of study (up to 64 days).
|
|
Respiratory, thoracic and mediastinal disorders
Rhinorrhoea
|
0.44%
1/227 • Number of events 1 • From start of study through end of study (up to 64 days).
|
0.91%
2/219 • Number of events 2 • From start of study through end of study (up to 64 days).
|
0.00%
0/117 • From start of study through end of study (up to 64 days).
|
0.00%
0/123 • From start of study through end of study (up to 64 days).
|
|
Respiratory, thoracic and mediastinal disorders
Sneezing
|
0.88%
2/227 • Number of events 2 • From start of study through end of study (up to 64 days).
|
0.00%
0/219 • From start of study through end of study (up to 64 days).
|
1.7%
2/117 • Number of events 3 • From start of study through end of study (up to 64 days).
|
0.00%
0/123 • From start of study through end of study (up to 64 days).
|
|
Respiratory, thoracic and mediastinal disorders
Tachypnoea
|
4.8%
11/227 • Number of events 17 • From start of study through end of study (up to 64 days).
|
3.7%
8/219 • Number of events 13 • From start of study through end of study (up to 64 days).
|
4.3%
5/117 • Number of events 9 • From start of study through end of study (up to 64 days).
|
4.1%
5/123 • Number of events 12 • From start of study through end of study (up to 64 days).
|
|
Respiratory, thoracic and mediastinal disorders
Throat irritation
|
0.44%
1/227 • Number of events 2 • From start of study through end of study (up to 64 days).
|
0.00%
0/219 • From start of study through end of study (up to 64 days).
|
0.00%
0/117 • From start of study through end of study (up to 64 days).
|
0.00%
0/123 • From start of study through end of study (up to 64 days).
|
|
Respiratory, thoracic and mediastinal disorders
Throat tightness
|
0.44%
1/227 • Number of events 2 • From start of study through end of study (up to 64 days).
|
0.00%
0/219 • From start of study through end of study (up to 64 days).
|
1.7%
2/117 • Number of events 3 • From start of study through end of study (up to 64 days).
|
0.81%
1/123 • Number of events 1 • From start of study through end of study (up to 64 days).
|
|
Respiratory, thoracic and mediastinal disorders
Tonsillolith
|
0.44%
1/227 • Number of events 1 • From start of study through end of study (up to 64 days).
|
0.00%
0/219 • From start of study through end of study (up to 64 days).
|
0.00%
0/117 • From start of study through end of study (up to 64 days).
|
0.00%
0/123 • From start of study through end of study (up to 64 days).
|
|
Respiratory, thoracic and mediastinal disorders
Wheezing
|
0.44%
1/227 • Number of events 1 • From start of study through end of study (up to 64 days).
|
0.00%
0/219 • From start of study through end of study (up to 64 days).
|
0.85%
1/117 • Number of events 1 • From start of study through end of study (up to 64 days).
|
0.00%
0/123 • From start of study through end of study (up to 64 days).
|
|
Skin and subcutaneous tissue disorders
Acne
|
0.00%
0/227 • From start of study through end of study (up to 64 days).
|
0.46%
1/219 • Number of events 1 • From start of study through end of study (up to 64 days).
|
0.00%
0/117 • From start of study through end of study (up to 64 days).
|
0.00%
0/123 • From start of study through end of study (up to 64 days).
|
|
Skin and subcutaneous tissue disorders
Angioedema
|
0.44%
1/227 • Number of events 1 • From start of study through end of study (up to 64 days).
|
0.00%
0/219 • From start of study through end of study (up to 64 days).
|
0.00%
0/117 • From start of study through end of study (up to 64 days).
|
0.00%
0/123 • From start of study through end of study (up to 64 days).
|
|
Skin and subcutaneous tissue disorders
Cold sweat
|
0.44%
1/227 • Number of events 1 • From start of study through end of study (up to 64 days).
|
0.46%
1/219 • Number of events 1 • From start of study through end of study (up to 64 days).
|
0.00%
0/117 • From start of study through end of study (up to 64 days).
|
0.00%
0/123 • From start of study through end of study (up to 64 days).
|
|
Skin and subcutaneous tissue disorders
Dermatitis contact
|
0.00%
0/227 • From start of study through end of study (up to 64 days).
|
0.46%
1/219 • Number of events 1 • From start of study through end of study (up to 64 days).
|
0.85%
1/117 • Number of events 1 • From start of study through end of study (up to 64 days).
|
0.00%
0/123 • From start of study through end of study (up to 64 days).
|
|
Skin and subcutaneous tissue disorders
Eczema
|
0.00%
0/227 • From start of study through end of study (up to 64 days).
|
0.46%
1/219 • Number of events 1 • From start of study through end of study (up to 64 days).
|
0.85%
1/117 • Number of events 1 • From start of study through end of study (up to 64 days).
|
0.00%
0/123 • From start of study through end of study (up to 64 days).
|
|
Skin and subcutaneous tissue disorders
Erythema
|
0.44%
1/227 • Number of events 1 • From start of study through end of study (up to 64 days).
|
0.00%
0/219 • From start of study through end of study (up to 64 days).
|
0.00%
0/117 • From start of study through end of study (up to 64 days).
|
0.00%
0/123 • From start of study through end of study (up to 64 days).
|
|
Skin and subcutaneous tissue disorders
Hyperhidrosis
|
0.44%
1/227 • Number of events 1 • From start of study through end of study (up to 64 days).
|
0.00%
0/219 • From start of study through end of study (up to 64 days).
|
0.00%
0/117 • From start of study through end of study (up to 64 days).
|
0.81%
1/123 • Number of events 1 • From start of study through end of study (up to 64 days).
|
|
Skin and subcutaneous tissue disorders
Pruritus
|
1.3%
3/227 • Number of events 3 • From start of study through end of study (up to 64 days).
|
0.46%
1/219 • Number of events 1 • From start of study through end of study (up to 64 days).
|
1.7%
2/117 • Number of events 2 • From start of study through end of study (up to 64 days).
|
0.81%
1/123 • Number of events 1 • From start of study through end of study (up to 64 days).
|
|
Skin and subcutaneous tissue disorders
Rash
|
0.00%
0/227 • From start of study through end of study (up to 64 days).
|
0.46%
1/219 • Number of events 1 • From start of study through end of study (up to 64 days).
|
0.85%
1/117 • Number of events 1 • From start of study through end of study (up to 64 days).
|
0.00%
0/123 • From start of study through end of study (up to 64 days).
|
|
Skin and subcutaneous tissue disorders
Rash erythematous
|
0.00%
0/227 • From start of study through end of study (up to 64 days).
|
0.00%
0/219 • From start of study through end of study (up to 64 days).
|
0.85%
1/117 • Number of events 1 • From start of study through end of study (up to 64 days).
|
0.00%
0/123 • From start of study through end of study (up to 64 days).
|
|
Skin and subcutaneous tissue disorders
Skin lesion
|
0.00%
0/227 • From start of study through end of study (up to 64 days).
|
0.46%
1/219 • Number of events 1 • From start of study through end of study (up to 64 days).
|
0.00%
0/117 • From start of study through end of study (up to 64 days).
|
0.00%
0/123 • From start of study through end of study (up to 64 days).
|
|
Skin and subcutaneous tissue disorders
Urticaria
|
0.44%
1/227 • Number of events 1 • From start of study through end of study (up to 64 days).
|
0.46%
1/219 • Number of events 1 • From start of study through end of study (up to 64 days).
|
0.00%
0/117 • From start of study through end of study (up to 64 days).
|
0.81%
1/123 • Number of events 1 • From start of study through end of study (up to 64 days).
|
|
Surgical and medical procedures
Knee operation
|
0.00%
0/227 • From start of study through end of study (up to 64 days).
|
0.00%
0/219 • From start of study through end of study (up to 64 days).
|
0.00%
0/117 • From start of study through end of study (up to 64 days).
|
0.81%
1/123 • Number of events 1 • From start of study through end of study (up to 64 days).
|
|
Vascular disorders
Flushing
|
0.00%
0/227 • From start of study through end of study (up to 64 days).
|
0.00%
0/219 • From start of study through end of study (up to 64 days).
|
0.85%
1/117 • Number of events 3 • From start of study through end of study (up to 64 days).
|
0.81%
1/123 • Number of events 1 • From start of study through end of study (up to 64 days).
|
|
Vascular disorders
Hot flush
|
0.00%
0/227 • From start of study through end of study (up to 64 days).
|
0.00%
0/219 • From start of study through end of study (up to 64 days).
|
0.85%
1/117 • Number of events 1 • From start of study through end of study (up to 64 days).
|
0.00%
0/123 • From start of study through end of study (up to 64 days).
|
|
Vascular disorders
Hypertension
|
2.6%
6/227 • Number of events 7 • From start of study through end of study (up to 64 days).
|
0.91%
2/219 • Number of events 3 • From start of study through end of study (up to 64 days).
|
1.7%
2/117 • Number of events 2 • From start of study through end of study (up to 64 days).
|
4.1%
5/123 • Number of events 6 • From start of study through end of study (up to 64 days).
|
|
Vascular disorders
Hypotension
|
0.00%
0/227 • From start of study through end of study (up to 64 days).
|
0.00%
0/219 • From start of study through end of study (up to 64 days).
|
0.85%
1/117 • Number of events 1 • From start of study through end of study (up to 64 days).
|
0.00%
0/123 • From start of study through end of study (up to 64 days).
|
|
Vascular disorders
Pallor
|
0.44%
1/227 • Number of events 1 • From start of study through end of study (up to 64 days).
|
0.00%
0/219 • From start of study through end of study (up to 64 days).
|
0.00%
0/117 • From start of study through end of study (up to 64 days).
|
0.00%
0/123 • From start of study through end of study (up to 64 days).
|
|
Vascular disorders
Peripheral coldness
|
0.00%
0/227 • From start of study through end of study (up to 64 days).
|
0.46%
1/219 • Number of events 1 • From start of study through end of study (up to 64 days).
|
0.00%
0/117 • From start of study through end of study (up to 64 days).
|
0.00%
0/123 • From start of study through end of study (up to 64 days).
|
|
Vascular disorders
Raynaud's phenomenon
|
0.44%
1/227 • Number of events 1 • From start of study through end of study (up to 64 days).
|
0.00%
0/219 • From start of study through end of study (up to 64 days).
|
0.00%
0/117 • From start of study through end of study (up to 64 days).
|
0.00%
0/123 • From start of study through end of study (up to 64 days).
|
Additional Information
Director, Clinical Research Operations Program
DAIT/NIAID
Phone: 301-594-7669
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place