Not provided
| ID | Type | Description | Link |
|---|---|---|---|
| NIAID CRMS ID#: 38814 | Other Identifier | DAIT NIAID |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Class |
|---|---|
| Immune Tolerance Network (ITN) | NETWORK |
| Rho Federal Systems Division, Inc. | INDUSTRY |
Not provided
Not provided
Not provided
Not provided
Background: Allergic reactions have been reported to occur after vaccination with both the Pfizer-BioNTech COVID-19 Vaccine and Moderna COVID-19 Vaccine. Allergic reactions range from mild to severe and include life- threatening anaphylactic reactions, although no deaths have been reported with either vaccine.
This study is designed with two principal aims:
This is a multicenter, randomized, initially blinded (masked), phase 2 trial to assess SARS-CoV-2 vaccination reactions in two populations:
Approximately 2040 HA/MCD and 1360 comparison participants will be enrolled across participating sites in the United States. Approximately two-thirds of participants enrolled in each of the 2 groups will be female. This is because the vast majority of cases of anaphylaxis to the COVID-19 vaccines have occurred in women. Enrollment of participants who qualify only on the basis of reactions to multiple unrelated drugs will be limited to approximately 300.
Enrollment of the MCD group is anticipated to be at least 200 participants, and not more than 300 participants.
Participants in each population will be randomized 2:2:1:1 to receive the Pfizer-BioNTech COVID-19 Vaccine, Moderna COVID-19 Vaccine, placebo + Pfizer-BioNTech COVID-19 Vaccine, or placebo + Moderna COVID-19 Vaccine, if enrolled in the initial study period under protocol versions 1.0 -4.0. Participants enrolled under protocol version 5.0 will be randomized 2:1 to receive the Pfizer-BioNTech COVID-19 Vaccine or placebo + Pfizer-BioNTech COVID-19 Vaccine. If enrollment under protocol version 5.0 is robust and sustained, the active vaccine randomization may be changed to the Moderna COVID-19 Vaccine.
Participants randomized to one of the placebo groups will receive placebo as a first dose and will receive two doses of their assigned active vaccine at subsequent visits. During the first visit, all participants will be initially-blinded to whether they are receiving placebo or vaccine, and to which vaccine they are receiving (if enrolling under protocol versions 1.0 -4.0).
Due to the different dosing schedules for the Pfizer-BioNTech COVID-19 Vaccine and Moderna COVID-19 Vaccine, it will become apparent to both the site staff and the study participant which vaccine has been assigned, once the second injection visit is scheduled. However, the blind over placebo versus vaccine will remain in effect until after the second visit. During a follow-up call, scheduled 3 days after the second injection, participants will be unblinded as to whether they received placebo or active vaccine.
However under protocol version 5.0, participants will be told if they received placebo as the first injection during the following up conducted 3 days after. Participants in this phase of the study will also know which company's vaccine they are receiving, as the vaccines are anticipated to be used sequentially and will also be noted in the consent form.
Study Duration: Randomized and vaccinated participants will complete study participation in approximately 29 days if vaccinated with the Pfizer-BioNTech COVID-19 Vaccine, 36 days if vaccinated with the Moderna COVID-19 Vaccine. Participants enrolled under protocol versions 1.0 -4.0 will complete study participation in 50 or 64 days if administered placebo before receiving two doses of either the Pfizer-BioNTech COVID-19 Vaccine or the Moderna COVID-19 Vaccine, respectively and participants enrolled under protocol version 5.0 will complete participation in approximately 36 of 43 days, respectively, if they receive placebo first.
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Moderna COVID-19 Vaccine | Experimental | The Moderna COVID-19 Vaccine (0.5 mL) will be administered intramuscularly in the deltoid, as a series of two doses (0.5 mL each) administered 1 month (28 days) apart. |
|
| Pfizer-BioNTech COVID-19 Vaccine | Experimental | The Pfizer-BioNTech COVID-19 Vaccine (0.3 mL) will be administered intramuscularly in the deltoid, as a series of two doses (0.3 mL each) administered 3 weeks (21 days) apart. |
|
| Placebo +Moderna COVID-19 Vaccine | Experimental | Participants will receive placebo as a first dose followed by two doses of their assigned active vaccine at subsequent visits. 0.5 mL of placebo will be administered intramuscularly in the deltoid. The placebo dose will be followed by two doses of Moderna COVID-19 Vaccine, with the first dose administered 1 month later. The Moderna COVID-19 Vaccine (0.5 mL) will be administered intramuscularly in the deltoid, as a series of two doses (0.5 mL each) administered 1 month (28 days) apart. |
|
| Placebo+Pfizer-BioNTech COVID-19 Vaccine | Experimental | Participants will receive placebo as a first dose followed by two doses of their assigned active vaccine at subsequent visits. 0.3 mL of placebo will be administered intramuscularly in the deltoid. The placebo dose will be followed by two doses of Pfizer-BioNTech COVID-19 Vaccine, with the first dose administered 1 month later. The Pfizer-BioNTech COVID-19 Vaccine (0.3 mL) will be administered intramuscularly in the deltoid, as a series of two doses (0.3 mL each) administered 3 weeks (21 days) apart. |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Moderna COVID-19 Vaccine | Biological | Intramuscular injection |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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. | 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. | Within the 90-minute post-vaccination observation period to either dose of the Pfizer-BioNTech COVID-19 Vaccine. |
| 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. | 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. | Within the 90-minute post-vaccination observation period to either dose of the Moderna COVID-19 Vaccine. |
| Measure | Description | Time Frame |
|---|---|---|
| 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. | 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. |
Not provided
Inclusion Criteria:
Individuals who meet all of the following criteria are eligible for enrollment as study participants:
Both groups (e.g., High-Allergy and Mast Cell Disorder (HA/MCD) Group and Comparison Group):
Able to understand and provide informed consent
Male or non-pregnant female ≥12 years of age on the date of first study vaccination/placebo administration (protocol versions 1.0 - 4.0) OR male or non-pregnant female 5-17 years of age on the date of first study vaccination/placebo administration (protocol version 5.0)
Females of childbearing potential must have a negative pregnancy test prior to the first vaccination and placebo administration, if applicable.
--If a participant becomes pregnant after receiving a placebo dose but prior to receiving study vaccination, she will be discontinued from the study
Females of reproductive potential° and sexually active must agree to use FDA approved methods of birth control for the duration of the study. These include hormonal contraceptives, intrauterine device, double barrier contraception (i.e., condom plus diaphragm), or male partner with documented vasectomy.
High-Allergy and Mast Cell Disorder (HA/MCD) Group:
Individuals who meet at least one of the following criteria are eligible for enrollment in the HA/MCD group:
History of a severe allergic reaction to food(s), allergen immunotherapy, insect venom(s), or latex with use of epinephrine within the last 15 years
History of an Emergency Department visit with convincing evidence of a systemic allergic reaction (consistent with CoFAR Grade 3 or higher) to food(s), allergen immunotherapy, insect venom(s), or latex within the last 15 years
History of documented, immediate allergic reactions to 2 or more unrelated drugs within the last 15 years
A convincing clinical history, or a history that is accompanied by a positive skin test, of an immediate reaction to a drug, vaccine, or latex within the last 15 years
History of physician-diagnosed idiopathic anaphylaxis requiring epinephrine or an Emergency Department visit in the last 15 years
History of a physician-diagnosed mast cell disorder (e.g., mastocytosis, mast cell activation syndrome [MCAS], or hereditary alpha-tryptasemia). MCAS must meet consensus criteria as defined below:
Criterion A: Typical clinical signs of severe, recurrent (episodic) systemic Mast Cell Activation are present (often in form of anaphylaxis)
---Definition of systemic: involving at least 2 organ systems
Criterion B: Involvement of Mast Cell (MC) is documented by biochemical studies
--- Preferred marker: increase in serum tryptase level from the individual's baseline to plus 20% + 2 ng/ml
Criterion C: Response of symptoms to therapy with MC-stabilizing agents, drugs directed against MC mediator production or drugs blocking mediator release or effects of MC-derived mediators
NOTE: All 3 Mast Cell Activation Syndrome (MCAS) criteria (A + B + C) must be fulfilled to call a condition MCAS.
Comparison Group:
Individuals who meet all of the following criteria are eligible for enrollment in the comparison group:
Exclusion Criteria:
Individuals who meet any of these criteria are not eligible for enrollment as study participants:
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Affiliation | Role |
|---|---|---|
| James R. Baker Jr., MD | Mary H. Weiser Food Allergy Center and Michigan Nanotechnology Institute for Medicine and the Biological Sciences | Study Chair |
| Rebecca S. Gruchalla, MD, PhD | Division of Allergy and Immunology Departments of Internal Medicine and Pediatrics, University of Texas Southwestern | Study Chair |
| N. Franklin Atkinson Jr., MD | Graduate Training Program in Clinical Investigation Associate TP Director, Allergy-Immunology Johns Hopkins Asthma & Allergy Center | Study Chair |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University of Arizona Health Sciences, College of Medicine Tucson, Department of Medicine, Division of Pulmonary, Allergy, Critical Care and Sleep Medicine | Tucson | Arizona | 85724 | United States |
Not provided
| Label | URL |
|---|---|
| National Institutes of Health News Release Describing Study | View source |
| National Institute of Allergy and Infectious Diseases (NIAID) | View source |
| Division of Allergy, Immunology, and Transplantation (DAIT) |
Not provided
Participant level data access and additional relevant materials will be made available upon completion of the trial.
Not provided
After completion of the trial, within 24 months status post database lock.
Registration is available for the Immunology Database and Analysis Portal (ImmPort) at: https://www.immport.org/registration. Submit a rationale for the purpose of requesting study data access.
ImmPort is a long-term archive of clinical and mechanistic data, a National Institute of Allergy and Infectious Diseases Division of Allergy, Immunology and Transplantation (NIAID DAIT)-funded data repository. This archive is in support of the NIH mission to share data with the public. Data shared through ImmPort is provided by NIH-funded programs, other research organizations and individual scientists, ensuring these discoveries will be the foundation of future research.
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.
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.
Not provided
| ID | Title | Description |
|---|---|---|
| FG000 | 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. |
| FG001 |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Overall Study |
|
Not provided
Not provided
| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot | Yes | No | No | Study Protocol | Feb 16, 2022 | Jul 15, 2025 |
Not provided
Not provided
Not provided
Not provided
Not provided
Due to the different dosing schedules for the Pfizer-BioNTech COVID-19 Vaccine and Moderna COVID-19 Vaccine, it will become apparent to both the site staff and study participant which vaccine has been assigned, once their second injection is scheduled. Participants and the staff will be unblinded (unmasked) during the follow-up call 3 days after the second injection when a third appointment (for those who received a placebo injection first) is, or is not (active vaccinations only) scheduled.
|
| Pfizer-BioNTech COVID-19 Vaccine | Biological | Intramuscular injection |
|
|
| Placebo | Biological | Intramuscular injection |
|
|
| Within the 90-minute post-vaccination observation period to either dose of the Pfizer-BioNTech COVID-19 Vaccine. |
| 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. | 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. | Within the 90-minute post-vaccination observation period to either dose of the Moderna COVID-19 Vaccine. |
| 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. | 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. | Within the 90-minute post-vaccination observation period to either dose of the Pfizer-BioNTech COVID-19 Vaccine. |
| 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. | 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. | Within the 90-minute post-vaccination observation period to either dose of the Moderna COVID-19 Vaccine. |
| 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. | 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. | Within the 90-minute post-vaccination observation period to the first dose of the Pfizer-BioNTech COVID-19 Vaccine. |
| 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. | 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. | Within the 90-minute post-vaccination observation period to the first dose of the Moderna COVID-19 Vaccine. |
| 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. | 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. | Within the 90-minute post-vaccination observation period to the second dose of the Pfizer-BioNTech COVID-19 Vaccine. |
| 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. | 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. | Within the 90-minute post-vaccination observation period to the second dose of the Moderna COVID-19 Vaccine. |
| 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. | 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. | Within the 90-minute post-vaccination observation period to the first injection (placebo or active). |
| 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. | 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. | Within the 90-minute post-vaccination observation period to the first injection. |
| 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. | 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. | After the 90 minute observation period to 48-hours post-vaccination to either dose of the Pfizer-BioNTech COVID-19 Vaccine. |
| 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. | 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. | After the 90 minute observation period to 48-hours post-vaccination to either dose of the Moderna COVID-19 Vaccine. |
| Arkansas Children's, University of Arkansas for Medical Sciences | Little Rock | Arkansas | 72202 | United States |
| University of California, Los Angeles Medical Center | Los Angeles | California | 90095 | United States |
| Stanford Medicine, Sean N. Parker Center for Allergy & Asthma Research | Stanford | California | 94040 | United States |
| National Jewish Health | Denver | Colorado | 80206 | United States |
| University Health, University of Miami Health System | Miami | Florida | 33136 | United States |
| University of South Florida Asthma Allergy and Immunology Clinical Research Unit | Tampa | Florida | 33613 | United States |
| Emory University School of Medicine, Emory Healthcare: Emory Clinic Allergy and Immunology | Atlanta | Georgia | 30324 | United States |
| Sinus and Allergy Center of Northwestern University | Chicago | Illinois | 60611 | United States |
| NorthShore University HealthSystem, Dermatology Clinical Trials Unit | Skokie | Illinois | 60077 | United States |
| University of Iowa Health Care | Iowa City | Iowa | 52242 | United States |
| Johns Hopkins Bayview Medical Center | Baltimore | Maryland | 21224 | United States |
| Massachusetts General Hospital | Boston | Massachusetts | 02114 | United States |
| Brigham and Women's Hospital | Boston | Massachusetts | 02115 | United States |
| University of Michigan Health | Ann Arbor | Michigan | 48109 | United States |
| Henry Ford Hospital and Health System | Detroit | Michigan | 48202 | United States |
| Saint Louis University Care Center for Specialized Medicine | St Louis | Missouri | 63104 | United States |
| Mount Sinai Hospital, Department of Medicine, Division of Clinical Immunology | New York | New York | 10029 | United States |
| Columbia University Irving Medical Center | New York | New York | 10032 | United States |
| Rochester Regional Health | Rochester | New York | 14607 | United States |
| North Carolina Translational and Clinical Sciences Institute-Clinical & Translational Research Center (CTRC) at the University of North Carolina at Chapel Hill | Chapel Hill | North Carolina | 27599 | United States |
| Cleveland Clinic, Allergy & Clinical Immunology | Cleveland | Ohio | 44195 | United States |
| Penn State Health Allergy, Milton S. Hershey Medical Center | Hershey | Pennsylvania | 17033 | United States |
| Vanderbilt University Medical Center | Nashville | Tennessee | 37232 | United States |
| University of Texas Southwestern Medical Center | Dallas | Texas | 75390 | United States |
| Baylor College of Medicine Medical Center | Houston | Texas | 77030 | United States |
| University of Virginia Health System: Department of Medicine, Division of Allergy and Immunology | Charlottesville | Virginia | 22908 | United States |
| Virginia Commonwealth University, Department of Internal Medicine, Division of Rheumatology, Allergy & Immunology | Richmond | Virginia | 23298 | United States |
| University of Wisconsin Asthma Allergy Pulmonary Research | Madison | Wisconsin | 53792 | United States |
| View source |
| 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. |
| FG002 | 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. |
| FG003 | 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. |
| COMPLETED |
|
| NOT COMPLETED |
|
|
All participants who initiated study treatment.
Not provided
| ID | Title | Description |
|---|---|---|
| BG000 | 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. |
| BG001 | 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. |
| BG002 | 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 mL for those 12 years and older, 0.2 mL for those aged 5 to 11 years) administered 3 weeks (21 days) apart. |
| BG003 | 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 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. |
| BG004 | Total | Total of all reporting groups |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes | ||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Count of Participants | Participants |
| ||||||||||||||||
| Age, Continuous | Mean | Standard Deviation | years |
| |||||||||||||||
| Sex: Female, Male | Count of Participants | Participants |
| ||||||||||||||||
| Ethnicity (NIH/OMB) | Count of Participants | Participants |
| ||||||||||||||||
| Race (NIH/OMB) | Count of Participants | Participants |
| ||||||||||||||||
| Region of Enrollment | Number | participants |
| ||||||||||||||||
| Cohort | Participants with a history of: severe allergic reaction to food, allergen immunotherapy, insect venom, or latex in the last 15 years; allergic reactions to 2+ unrelated drugs; idiopathic anaphylaxis in the last 15 years; or mast cell disorder comprised the high allergy and mast cell disorder (HA/MCD) cohort. Participants with no history of: allergic asthma or atopic dermatitis in the last 10 years; chronic spontaneous urticaria or angioedema; allergic reaction to food or insect venom, allergic reaction to drugs or vaccines; anaphylaxis; or mast cell disorder comprised the comparison cohort. | Count of Participants | Participants |
|
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | 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. | 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. | 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. | Posted | Count of Participants | Participants | No | Within the 90-minute post-vaccination observation period to either dose of the Pfizer-BioNTech COVID-19 Vaccine. |
|
|
|
| |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Primary | 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. | 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. | 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. | Posted | Count of Participants | Participants | No | Within the 90-minute post-vaccination observation period to either dose of the Moderna COVID-19 Vaccine. |
| ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | 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. | 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. | 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. | Posted | Count of Participants | Participants | No | Within the 90-minute post-vaccination observation period to either dose of the Pfizer-BioNTech COVID-19 Vaccine. |
| ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | 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. | 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. | 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. | Posted | Count of Participants | Participants | No | Within the 90-minute post-vaccination observation period to either dose of the Moderna COVID-19 Vaccine. |
| ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | 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. | 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. | 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. | Posted | Count of Participants | Participants | No | Within the 90-minute post-vaccination observation period to either dose of the Pfizer-BioNTech COVID-19 Vaccine. |
| ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | 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. | 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. | 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. | Posted | Count of Participants | Participants | No | Within the 90-minute post-vaccination observation period to either dose of the Moderna COVID-19 Vaccine. |
| ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | 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. | 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. | 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. | Posted | Count of Participants | Participants | No | Within the 90-minute post-vaccination observation period to the first dose of the Pfizer-BioNTech COVID-19 Vaccine. |
| ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | 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. | 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. | 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. | Posted | Count of Participants | Participants | No | Within the 90-minute post-vaccination observation period to the first dose of the Moderna COVID-19 Vaccine. |
| ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | 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. | 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. | 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. | Posted | Count of Participants | Participants | No | Within the 90-minute post-vaccination observation period to the second dose of the Pfizer-BioNTech COVID-19 Vaccine. |
| ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | 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. | 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. | 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. | Posted | Count of Participants | Participants | No | Within the 90-minute post-vaccination observation period to the second dose of the Moderna COVID-19 Vaccine. |
| ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | 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. | 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. | 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. | Posted | Count of Participants | Participants | No | Within the 90-minute post-vaccination observation period to the first injection (placebo or active). |
| ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | 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. | 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. | 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. | Posted | Count of Participants | Participants | No | Within the 90-minute post-vaccination observation period to the first injection. |
| ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | 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. | 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. | 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. | Posted | Count of Participants | Participants | No | After the 90 minute observation period to 48-hours post-vaccination to either dose of the Pfizer-BioNTech COVID-19 Vaccine. |
| ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | 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. | 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. | 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. | Posted | Count of Participants | Participants | No | After the 90 minute observation period to 48-hours post-vaccination to either dose of the Moderna COVID-19 Vaccine. |
|
From start of study through end of study (up to 64 days).
Not provided
Not provided
| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | 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. | 0 | 227 | 5 | 227 | 185 | 227 |
| EG001 | 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. | 0 | 219 | 2 | 219 | 195 | 219 |
| EG002 | 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 mL for those 12 years and older, 0.2 mL for those aged 5 to 11 years) administered 3 weeks (21 days) apart. | 0 | 117 | 2 | 117 | 100 | 117 |
| EG003 | 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 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. | 0 | 123 | 3 | 123 | 104 | 123 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Ventricular extrasystoles | Cardiac disorders | MedDRA 24.0 | Systematic Assessment |
| |
| Anaphylactic reaction | Immune system disorders | MedDRA 24.0 | Systematic Assessment |
| |
| Hypersensitivity | Immune system disorders | MedDRA 24.0 | Systematic Assessment |
| |
| Amoebiasis | Infections and infestations | MedDRA 24.0 | Systematic Assessment |
| |
| Vaccination complication | Injury, poisoning and procedural complications | MedDRA 24.0 | Systematic Assessment |
| |
| Hypocalcaemia | Metabolism and nutrition disorders | MedDRA 24.0 | Systematic Assessment |
| |
| Hypokalaemia | Metabolism and nutrition disorders | MedDRA 24.0 | Systematic Assessment |
| |
| Myalgia | Musculoskeletal and connective tissue disorders | MedDRA 24.0 | Systematic Assessment |
| |
| Presyncope | Nervous system disorders | MedDRA 24.0 | Systematic Assessment |
| |
| Cystitis haemorrhagic | Renal and urinary disorders | MedDRA 24.0 | Systematic Assessment |
| |
| Deep vein thrombosis | Vascular disorders | MedDRA 24.0 | Systematic Assessment |
|
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Anaemia | Blood and lymphatic system disorders | MedDRA 24.0 | Systematic Assessment |
| |
| Eosinophilia | Blood and lymphatic system disorders | MedDRA 24.0 | Systematic Assessment |
| |
| Iron deficiency anaemia | Blood and lymphatic system disorders | MedDRA 24.0 | Systematic Assessment |
| |
| Leukocytosis | Blood and lymphatic system disorders | MedDRA 24.0 | Systematic Assessment |
| |
| Lymphadenopathy | Blood and lymphatic system disorders | MedDRA 24.0 | Systematic Assessment |
| |
| Lymphopenia | Blood and lymphatic system disorders | MedDRA 24.0 | Systematic Assessment |
| |
| Mast cell activation syndrome | Blood and lymphatic system disorders | MedDRA 24.0 | Systematic Assessment |
| |
| Neutropenia | Blood and lymphatic system disorders | MedDRA 24.0 | Systematic Assessment |
| |
| Arrhythmia | Cardiac disorders | MedDRA 24.0 | Systematic Assessment |
| |
| Palpitations | Cardiac disorders | MedDRA 24.0 | Systematic Assessment |
| |
| Tachycardia | Cardiac disorders | MedDRA 24.0 | Systematic Assessment |
| |
| Ear discomfort | Ear and labyrinth disorders | MedDRA 24.0 | Systematic Assessment |
| |
| Ear pain | Ear and labyrinth disorders | MedDRA 24.0 | Systematic Assessment |
| |
| Tinnitus | Ear and labyrinth disorders | MedDRA 24.0 | Systematic Assessment |
| |
| Vertigo | Ear and labyrinth disorders | MedDRA 24.0 | Systematic Assessment |
| |
| Dry eye | Eye disorders | MedDRA 24.0 | Systematic Assessment |
| |
| Eye pain | Eye disorders | MedDRA 24.0 | Systematic Assessment |
| |
| Periorbital swelling | Eye disorders | MedDRA 24.0 | Systematic Assessment |
| |
| Swelling of eyelid | Eye disorders | MedDRA 24.0 | Systematic Assessment |
| |
| Vision blurred | Eye disorders | MedDRA 24.0 | Systematic Assessment |
| |
| Visual field defect | Eye disorders | MedDRA 24.0 | Systematic Assessment |
| |
| Vitreous floaters | Eye disorders | MedDRA 24.0 | Systematic Assessment |
| |
| Abdominal pain | Gastrointestinal disorders | MedDRA 24.0 | Systematic Assessment |
| |
| Abdominal pain upper | Gastrointestinal disorders | MedDRA 24.0 | Systematic Assessment |
| |
| Constipation | Gastrointestinal disorders | MedDRA 24.0 | Systematic Assessment |
| |
| Diarrhea | Gastrointestinal disorders | MedDRA 24.0 | Systematic Assessment |
| |
| Dyspepsia | Gastrointestinal disorders | MedDRA 24.0 | Systematic Assessment |
| |
| Dysphagia | Gastrointestinal disorders | MedDRA 24.0 | Systematic Assessment |
| |
| Epigastric discomfort | Gastrointestinal disorders | MedDRA 24.0 | Systematic Assessment |
| |
| Gastroesophageal reflux disease | Gastrointestinal disorders | MedDRA 24.0 | Systematic Assessment |
| |
| Hypoaesthesia oral | Gastrointestinal disorders | MedDRA 24.0 | Systematic Assessment |
| |
| Irritable bowel syndrome | Gastrointestinal disorders | MedDRA 24.0 | Systematic Assessment |
| |
| Lip erythema | Gastrointestinal disorders | MedDRA 24.0 | Systematic Assessment |
| |
| Lip swelling | Gastrointestinal disorders | MedDRA 24.0 | Systematic Assessment |
| |
| Nausea | Gastrointestinal disorders | MedDRA 24.0 | Systematic Assessment |
| |
| Oesophageal motility disorder | Gastrointestinal disorders | MedDRA 24.0 | Systematic Assessment |
| |
| Oesophageal pain | Gastrointestinal disorders | MedDRA 24.0 | Systematic Assessment |
| |
| Oral discomfort | Gastrointestinal disorders | MedDRA 24.0 | Systematic Assessment |
| |
| Oral pain | Gastrointestinal disorders | MedDRA 24.0 | Systematic Assessment |
| |
| Paraesthesia oral | Gastrointestinal disorders | MedDRA 24.0 | Systematic Assessment |
| |
| Swollen tongue | Gastrointestinal disorders | MedDRA 24.0 | Systematic Assessment |
| |
| Tongue discomfort | Gastrointestinal disorders | MedDRA 24.0 | Systematic Assessment |
| |
| Vomiting | Gastrointestinal disorders | MedDRA 24.0 | Systematic Assessment |
| |
| Asthenia | General disorders | MedDRA 24.0 | Systematic Assessment |
| |
| Axillary pain | General disorders | MedDRA 24.0 | Systematic Assessment |
| |
| Chest discomfort | General disorders | MedDRA 24.0 | Systematic Assessment |
| |
| Chest pain | General disorders | MedDRA 24.0 | Systematic Assessment |
| |
| Chills | General disorders | MedDRA 24.0 | Systematic Assessment |
| |
| Facial discomfort | General disorders | MedDRA 24.0 | Systematic Assessment |
| |
| Fatigue | General disorders | MedDRA 24.0 | Systematic Assessment |
| |
| Feeling abnormal | General disorders | MedDRA 24.0 | Systematic Assessment |
| |
| Feeling hot | General disorders | MedDRA 24.0 | Systematic Assessment |
| |
| Feeling jittery | General disorders | MedDRA 24.0 | Systematic Assessment |
| |
| Injection site erythema | General disorders | MedDRA 24.0 | Systematic Assessment |
| |
| Injection site nodule | General disorders | MedDRA 24.0 | Systematic Assessment |
| |
| Injection site pain | General disorders | MedDRA 24.0 | Systematic Assessment |
| |
| Injection site warmth | General disorders | MedDRA 24.0 | Systematic Assessment |
| |
| Oedema peripheral | General disorders | MedDRA 24.0 | Systematic Assessment |
| |
| Pain | General disorders | MedDRA 24.0 | Systematic Assessment |
| |
| Pyrexia | General disorders | MedDRA 24.0 | Systematic Assessment |
| |
| Sensation of foreign body | General disorders | MedDRA 24.0 | Systematic Assessment |
| |
| Vaccination site reaction | General disorders | MedDRA 24.0 | Systematic Assessment |
| |
| Vessel puncture site bruise | General disorders | MedDRA 24.0 | Systematic Assessment |
| |
| Anaphylactic reaction | Immune system disorders | MedDRA 24.0 | Systematic Assessment |
| |
| Hypersensitivity | Immune system disorders | MedDRA 24.0 | Systematic Assessment |
| |
| Milk allergy | Immune system disorders | MedDRA 24.0 | Systematic Assessment |
| |
| Seasonal allergy | Immune system disorders | MedDRA 24.0 | Systematic Assessment |
| |
| COVID-19 | Infections and infestations | MedDRA 24.0 | Systematic Assessment |
| |
| Cellulitis | Infections and infestations | MedDRA 24.0 | Systematic Assessment |
| |
| Ear infection | Infections and infestations | MedDRA 24.0 | Systematic Assessment |
| |
| Folliculitis | Infections and infestations | MedDRA 24.0 | Systematic Assessment |
| |
| Gastrointestinal viral infection | Infections and infestations | MedDRA 24.0 | Systematic Assessment |
| |
| Nasal herpes | Infections and infestations | MedDRA 24.0 | Systematic Assessment |
| |
| Nasopharyngitis | Infections and infestations | MedDRA 24.0 | Systematic Assessment |
| |
| Oral herpes | Infections and infestations | MedDRA 24.0 | Systematic Assessment |
| |
| Pharyngitis | Infections and infestations | MedDRA 24.0 | Systematic Assessment |
| |
| Sinusitis | Infections and infestations | MedDRA 24.0 | Systematic Assessment |
| |
| Sinusitis bacterial | Infections and infestations | MedDRA 24.0 | Systematic Assessment |
| |
| Upper respiratory tract infection | Infections and infestations | MedDRA 24.0 | Systematic Assessment |
| |
| Urinary tract infection | Infections and infestations | MedDRA 24.0 | Systematic Assessment |
| |
| Viral infection | Infections and infestations | MedDRA 24.0 | Systematic Assessment |
| |
| Animal bite | Injury, poisoning and procedural complications | MedDRA 24.0 | Systematic Assessment |
| |
| Arthropod bite | Injury, poisoning and procedural complications | MedDRA 24.0 | Systematic Assessment |
| |
| Facial bones fracture | Injury, poisoning and procedural complications | MedDRA 24.0 | Systematic Assessment |
| |
| Fall | Injury, poisoning and procedural complications | MedDRA 24.0 | Systematic Assessment |
| |
| Head injury | Injury, poisoning and procedural complications | MedDRA 24.0 | Systematic Assessment |
| |
| Ligament sprain | Injury, poisoning and procedural complications | MedDRA 24.0 | Systematic Assessment |
| |
| Muscle strain | Injury, poisoning and procedural complications | MedDRA 24.0 | Systematic Assessment |
| |
| Post procedural complication | Injury, poisoning and procedural complications | MedDRA 24.0 | Systematic Assessment |
| |
| Procedural dizziness | Injury, poisoning and procedural complications | MedDRA 24.0 | Systematic Assessment |
| |
| Procedural vomiting | Injury, poisoning and procedural complications | MedDRA 24.0 | Systematic Assessment |
| |
| Road traffic accident | Injury, poisoning and procedural complications | MedDRA 24.0 | Systematic Assessment |
| |
| Skin laceration | Injury, poisoning and procedural complications | MedDRA 24.0 | Systematic Assessment |
| |
| Vaccination complication | Injury, poisoning and procedural complications | MedDRA 24.0 | Systematic Assessment |
| |
| Blood pressure increased | Investigations | MedDRA 24.0 | Systematic Assessment |
| |
| Blood urine present | Investigations | MedDRA 24.0 | Systematic Assessment |
| |
| Eosinophil count abnormal | Investigations | MedDRA 24.0 | Systematic Assessment |
| |
| Eosinophil count decreased | Investigations | MedDRA 24.0 | Systematic Assessment |
| |
| Eosinophil count increased | Investigations | MedDRA 24.0 | Systematic Assessment |
| |
| Haematocrit decreased | Investigations | MedDRA 24.0 | Systematic Assessment |
| |
| Haemoglobin | Investigations | MedDRA 24.0 | Systematic Assessment |
| |
| Haemoglobin abnormal | Investigations | MedDRA 24.0 | Systematic Assessment |
| |
| Haemoglobin decreased | Investigations | MedDRA 24.0 | Systematic Assessment |
| |
| Heart rate increased | Investigations | MedDRA 24.0 | Systematic Assessment |
| |
| Lymphocyte count decreased | Investigations | MedDRA 24.0 | Systematic Assessment |
| |
| Lymphocyte count increased | Investigations | MedDRA 24.0 | Systematic Assessment |
| |
| Mean cell haemoglobin concentration decreased | Investigations | MedDRA 24.0 | Systematic Assessment |
| |
| Monocyte count increased | Investigations | MedDRA 24.0 | Systematic Assessment |
| |
| Neutrophil count abnormal | Investigations | MedDRA 24.0 | Systematic Assessment |
| |
| Neutrophil count decreased | Investigations | MedDRA 24.0 | Systematic Assessment |
| |
| Platelet count decreased | Investigations | MedDRA 24.0 | Systematic Assessment |
| |
| Platelet count increased | Investigations | MedDRA 24.0 | Systematic Assessment |
| |
| Respiratory rate increased | Investigations | MedDRA 24.0 | Systematic Assessment |
| |
| White blood cell count decreased | Investigations | MedDRA 24.0 | Systematic Assessment |
| |
| White blood cell count increased | Investigations | MedDRA 24.0 | Systematic Assessment |
| |
| Dehydration | Metabolism and nutrition disorders | MedDRA 24.0 | Systematic Assessment |
| |
| Arthralgia | Musculoskeletal and connective tissue disorders | MedDRA 24.0 | Systematic Assessment |
| |
| Back pain | Musculoskeletal and connective tissue disorders | MedDRA 24.0 | Systematic Assessment |
| |
| Muscle spasms | Musculoskeletal and connective tissue disorders | MedDRA 24.0 | Systematic Assessment |
| |
| Muscular weakness | Musculoskeletal and connective tissue disorders | MedDRA 24.0 | Systematic Assessment |
| |
| Musculoskeletal stiffness | Musculoskeletal and connective tissue disorders | MedDRA 24.0 | Systematic Assessment |
| |
| Myalgia | Musculoskeletal and connective tissue disorders | MedDRA 24.0 | Systematic Assessment |
| |
| Neck pain | Musculoskeletal and connective tissue disorders | MedDRA 24.0 | Systematic Assessment |
| |
| Pain in extremity | Musculoskeletal and connective tissue disorders | MedDRA 24.0 | Systematic Assessment |
| |
| Dizziness | Nervous system disorders | MedDRA 24.0 | Systematic Assessment |
| |
| Dysgeusia | Nervous system disorders | MedDRA 24.0 | Systematic Assessment |
| |
| Headache | Nervous system disorders | MedDRA 24.0 | Systematic Assessment |
| |
| Hypoaesthesia | Nervous system disorders | MedDRA 24.0 | Systematic Assessment |
| |
| Lethargy | Nervous system disorders | MedDRA 24.0 | Systematic Assessment |
| |
| Migraine | Nervous system disorders | MedDRA 24.0 | Systematic Assessment |
| |
| Neurological symptom | Nervous system disorders | MedDRA 24.0 | Systematic Assessment |
| |
| Paraesthesia | Nervous system disorders | MedDRA 24.0 | Systematic Assessment |
| |
| Parosmia | Nervous system disorders | MedDRA 24.0 | Systematic Assessment |
| |
| Presyncope | Nervous system disorders | MedDRA 24.0 | Systematic Assessment |
| |
| Syncope | Nervous system disorders | MedDRA 24.0 | Systematic Assessment |
| |
| Hyperemesis gravidarum | Pregnancy, puerperium and perinatal conditions | MedDRA 24.0 | Systematic Assessment |
| |
| Anxiety | Psychiatric disorders | MedDRA 24.0 | Systematic Assessment |
| |
| Generalised anxiety disorder | Psychiatric disorders | MedDRA 24.0 | Systematic Assessment |
| |
| Hallucination | Psychiatric disorders | MedDRA 24.0 | Systematic Assessment |
| |
| Insomnia | Psychiatric disorders | MedDRA 24.0 | Systematic Assessment |
| |
| Mood altered | Psychiatric disorders | MedDRA 24.0 | Systematic Assessment |
| |
| Panic attack | Psychiatric disorders | MedDRA 24.0 | Systematic Assessment |
| |
| Sleep disorder | Psychiatric disorders | MedDRA 24.0 | Systematic Assessment |
| |
| Cystitis interstitial | Renal and urinary disorders | MedDRA 24.0 | Systematic Assessment |
| |
| Pollakiuria | Renal and urinary disorders | MedDRA 24.0 | Systematic Assessment |
| |
| Heavy menstrual bleeding | Reproductive system and breast disorders | MedDRA 24.0 | Systematic Assessment |
| |
| Menstruation irregular | Reproductive system and breast disorders | MedDRA 24.0 | Systematic Assessment |
| |
| Premenstrual pain | Reproductive system and breast disorders | MedDRA 24.0 | Systematic Assessment |
| |
| Cough | Respiratory, thoracic and mediastinal disorders | MedDRA 24.0 | Systematic Assessment |
| |
| Dysphonia | Respiratory, thoracic and mediastinal disorders | MedDRA 24.0 | Systematic Assessment |
| |
| Dyspnoea | Respiratory, thoracic and mediastinal disorders | MedDRA 24.0 | Systematic Assessment |
| |
| Epistaxis | Respiratory, thoracic and mediastinal disorders | MedDRA 24.0 | Systematic Assessment |
| |
| Hiccups | Respiratory, thoracic and mediastinal disorders | MedDRA 24.0 | Systematic Assessment |
| |
| Nasal congestion | Respiratory, thoracic and mediastinal disorders | MedDRA 24.0 | Systematic Assessment |
| |
| Oropharyngeal pain | Respiratory, thoracic and mediastinal disorders | MedDRA 24.0 | Systematic Assessment |
| |
| Pharyngeal swelling | Respiratory, thoracic and mediastinal disorders | MedDRA 24.0 | Systematic Assessment |
| |
| Rhinorrhoea | Respiratory, thoracic and mediastinal disorders | MedDRA 24.0 | Systematic Assessment |
| |
| Sneezing | Respiratory, thoracic and mediastinal disorders | MedDRA 24.0 | Systematic Assessment |
| |
| Tachypnoea | Respiratory, thoracic and mediastinal disorders | MedDRA 24.0 | Systematic Assessment |
| |
| Throat irritation | Respiratory, thoracic and mediastinal disorders | MedDRA 24.0 | Systematic Assessment |
| |
| Throat tightness | Respiratory, thoracic and mediastinal disorders | MedDRA 24.0 | Systematic Assessment |
| |
| Tonsillolith | Respiratory, thoracic and mediastinal disorders | MedDRA 24.0 | Systematic Assessment |
| |
| Wheezing | Respiratory, thoracic and mediastinal disorders | MedDRA 24.0 | Systematic Assessment |
| |
| Acne | Skin and subcutaneous tissue disorders | MedDRA 24.0 | Systematic Assessment |
| |
| Angioedema | Skin and subcutaneous tissue disorders | MedDRA 24.0 | Systematic Assessment |
| |
| Cold sweat | Skin and subcutaneous tissue disorders | MedDRA 24.0 | Systematic Assessment |
| |
| Dermatitis contact | Skin and subcutaneous tissue disorders | MedDRA 24.0 | Systematic Assessment |
| |
| Eczema | Skin and subcutaneous tissue disorders | MedDRA 24.0 | Systematic Assessment |
| |
| Erythema | Skin and subcutaneous tissue disorders | MedDRA 24.0 | Systematic Assessment |
| |
| Hyperhidrosis | Skin and subcutaneous tissue disorders | MedDRA 24.0 | Systematic Assessment |
| |
| Pruritus | Skin and subcutaneous tissue disorders | MedDRA 24.0 | Systematic Assessment |
| |
| Rash | Skin and subcutaneous tissue disorders | MedDRA 24.0 | Systematic Assessment |
| |
| Rash erythematous | Skin and subcutaneous tissue disorders | MedDRA 24.0 | Systematic Assessment |
| |
| Skin lesion | Skin and subcutaneous tissue disorders | MedDRA 24.0 | Systematic Assessment |
| |
| Urticaria | Skin and subcutaneous tissue disorders | MedDRA 24.0 | Systematic Assessment |
| |
| Knee operation | Surgical and medical procedures | MedDRA 24.0 | Systematic Assessment |
| |
| Flushing | Vascular disorders | MedDRA 24.0 | Systematic Assessment |
| |
| Hot flush | Vascular disorders | MedDRA 24.0 | Systematic Assessment |
| |
| Hypertension | Vascular disorders | MedDRA 24.0 | Systematic Assessment |
| |
| Hypotension | Vascular disorders | MedDRA 24.0 | Systematic Assessment |
| |
| Pallor | Vascular disorders | MedDRA 24.0 | Systematic Assessment |
| |
| Peripheral coldness | Vascular disorders | MedDRA 24.0 | Systematic Assessment |
| |
| Raynaud's phenomenon | Vascular disorders | MedDRA 24.0 | Systematic Assessment |
|
Not provided
Not provided
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Director, Clinical Research Operations Program | DAIT/NIAID | 301-594-7669 | DAITClinicalTrialsGov@niaid.nih.gov |
| Prot_003.pdf |
| SAP | No | Yes | No | Statistical Analysis Plan | Feb 16, 2022 | Jan 17, 2023 | SAP_001.pdf |
| ICF | No | No | Yes | Informed Consent Form | Nov 30, 2021 | Feb 17, 2023 | ICF_002.pdf |
Not provided
| ID | Term |
|---|---|
| D045169 | Severe Acute Respiratory Syndrome |
| D000086382 | COVID-19 |
| D006967 | Hypersensitivity |
| D008415 | Mastocytosis |
| ID | Term |
|---|---|
| D012141 | Respiratory Tract Infections |
| D007239 | Infections |
| D018352 | Coronavirus Infections |
| D003333 | Coronaviridae Infections |
| D030341 | Nidovirales Infections |
| D012327 | RNA Virus Infections |
| D014777 | Virus Diseases |
| D012140 | Respiratory Tract Diseases |
| D011024 | Pneumonia, Viral |
| D011014 | Pneumonia |
| D008171 | Lung Diseases |
| D007154 | Immune System Diseases |
| D009372 | Neoplasms, Connective Tissue |
| D018204 | Neoplasms, Connective and Soft Tissue |
| D009370 | Neoplasms by Histologic Type |
| D009369 | Neoplasms |
| D000090362 | Mast Cell Activation Disorders |
Not provided
Not provided
| ID | Term |
|---|---|
| D000090983 | 2019-nCoV Vaccine mRNA-1273 |
| D000090982 | BNT162 Vaccine |
| D012965 | Sodium Chloride |
| ID | Term |
|---|---|
| D000087503 | mRNA Vaccines |
| D000087504 | Nucleic Acid-Based Vaccines |
| D014614 | Vaccines, Synthetic |
| D011994 | Recombinant Proteins |
| D011506 | Proteins |
| D000602 | Amino Acids, Peptides, and Proteins |
| D014612 | Vaccines |
| D001688 | Biological Products |
| D045424 | Complex Mixtures |
| D000086663 | COVID-19 Vaccines |
| D014765 | Viral Vaccines |
| D000941 | Antigens |
| D001685 | Biological Factors |
| D002712 | Chlorides |
| D006851 | Hydrochloric Acid |
| D017606 | Chlorine Compounds |
| D007287 | Inorganic Chemicals |
| D017670 | Sodium Compounds |
Not provided
Not provided
| Between 18 and 65 years |
|
| >=65 years |
|
| Male |
|
| Not Hispanic or Latino |
|
| Unknown or Not Reported |
|
| Asian |
|
| Native Hawaiian or Other Pacific Islander |
|
| Black or African American |
|
| White |
|
| More than one race |
|
| Unknown or Not Reported |
|
| Comparison |
|
| OG001 | Moderna COVID-19 Vaccine: Comparison Cohort | Participants without a history of high allergy/mast cell disorder who received the Moderna COVID-19 Vaccine (assigned to Moderna COVID-19 Vaccine or Placebo + Moderna COVID-19 Vaccine arms). There were 10 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 |
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. |
|
|
|
| Moderna COVID-19 Vaccine: Comparison Cohort |
Participants without a history of high allergy/mast cell disorder who received the Moderna COVID-19 Vaccine (assigned to Moderna COVID-19 Vaccine or Placebo + Moderna COVID-19 Vaccine arms). There were 10 participants that did not receive their second dose for reasons other than a reaction to the first dose and were not included. |
|
|
|
| OG001 | Pfizer-BioNTech COVID-19 Vaccine: Comparison Cohort | 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. |
|
|
|
| Moderna COVID-19 Vaccine: Comparison Cohort |
Participants without a history of high allergy/mast cell disorder who received the Moderna COVID-19 Vaccine (assigned to Moderna COVID-19 Vaccine or Placebo + Moderna COVID-19 Vaccine arms). There were 10 participants that did not receive their second dose for reasons other than a reaction to the first dose and were not included. |
|
|
|
Participants with a history of high allergy/mast cell disorder who received the first active dose of Pfizer-BioNTech COVID-19 Vaccine as their first injection (assigned to Pfizer-BioNTech COVID-19 Vaccine).
| OG001 | Placebo + Pfizer-BioNTech COVID-19 Vaccine First Active Dose: HA/MCD Cohort | Participants with a history of high allergy/mast cell disorder who received the first active dose of Pfizer-BioNTech COVID-19 Vaccine as their second injection (assigned to Placebo + Pfizer-BioNTech COVID-19 Vaccine arm). One participant was not included as they did not receive any active doses. |
|
|
|
| OG001 | Placebo + Moderna COVID-19 Vaccine First Active Dose: HA/MCD Cohort | Participants with a history of high allergy/mast cell disorder who received the first active dose of Moderna COVID-19 Vaccine as their second injection (assigned to Placebo + Moderna COVID-19 Vaccine arm). Six participants were not included as they did not receive any active doses. |
|
|
|
| OG001 | Placebo + Pfizer-BioNTech COVID-19 Vaccine Second Active Dose: HA/MCD Cohort | Participants with a history of high allergy/mast cell disorder who received the second active dose of Pfizer-BioNTech COVID-19 Vaccine as their third injection (assigned to Placebo + Pfizer-BioNTech COVID-19 Vaccine arm). One participant was not included as they did not receive any active doses. |
|
|
|
| OG001 | Placebo + Moderna COVID-19 Vaccine Second Active Dose: HA/MCD Cohort | Participants with a history of high allergy/mast cell disorder who received the second active dose of Moderna COVID-19 Vaccine as their third injection (assigned to Placebo + Moderna COVID-19 Vaccine arm). Six participants were not included as they did not receive second doses. |
|
|
|
| OG001 | Pfizer-BioNTech COVID-19 Vaccine First Injection: HA/MCD | Participants with a history of high allergy/mast cell disorder who received the active injection of Pfizer-BioNTech COVID-19 Vaccine as their first injection (assigned to Pfizer-BioNTech COVID-19 Vaccine). |
|
|
|
| Moderna COVID-19 Vaccine First Injection: HA/MCD |
Participants with a history of high allergy/mast cell disorder who received the active dose of Moderna COVID-19 Vaccine as their first injection (assigned to Moderna COVID-19 Vaccine). |
|
|
|
| OG001 |
| Pfizer-BioNTech COVID-19 Vaccine: Comparison Cohort |
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. |
|
|
|
Participants without a history of high allergy/mast cell disorder who received the Moderna COVID-19 Vaccine (assigned to Moderna COVID-19 Vaccine or Placebo + Moderna COVID-19 Vaccine arms). There were 10 participants that did not receive their second dose for reasons other than a reaction to the first dose and were not included. |
|
|
|