Trial Outcomes & Findings for Simultaneous mRNA COVID-19 and IIV4 Vaccination Study (NCT NCT05028361)
NCT ID: NCT05028361
Last Updated: 2024-03-19
Results Overview
Subjects will be asked to complete a memory aid to document symptoms and measure temperature daily.
Recruitment status
COMPLETED
Study phase
PHASE4
Target enrollment
348 participants
Primary outcome timeframe
Up to 7 Days Post Vaccination (combined for Visits 1 and 2)
Results posted on
2024-03-19
Participant Flow
Participants were recruited at 3 academic medical centers during the 2021-22 and 2022-23 flu seasons.
Of the 348 enrolled participants, 335 met inclusion criteria and were randomized to treatment.
Participant milestones
| Measure |
Simultaneous Vaccination Group
Subjects will receive a dose of mRNA COVID-19 vaccine (either as a study procedure or standard of care) and IIV4 at Visit 1, saline placebo at Visit 2, and mRNA COVID-19 vaccine at Visit 3 for participants receiving their primary series of mRNA COVID-19 vaccine.
mRNA COVID-19: ACIP-CDC recommended vaccine
IIV4: ACIP recommended vaccine
Placebo: Saline Control
|
Sequential Vaccination Group
Subjects will receive a dose of mRNA COVID-19 vaccine (either as a study procedure or standard of care) and saline placebo at Visit 1, IIV4 at Visit 2, and mRNA COVID-19 vaccine at Visit 3 for participants receiving their primary series of mRNA COVID-19 vaccine.
mRNA COVID-19: ACIP-CDC recommended vaccine
IIV4: ACIP recommended vaccine
Placebo: Saline Control
|
|---|---|---|
|
Overall Study
STARTED
|
169
|
166
|
|
Overall Study
COMPLETED
|
168
|
166
|
|
Overall Study
NOT COMPLETED
|
1
|
0
|
Reasons for withdrawal
| Measure |
Simultaneous Vaccination Group
Subjects will receive a dose of mRNA COVID-19 vaccine (either as a study procedure or standard of care) and IIV4 at Visit 1, saline placebo at Visit 2, and mRNA COVID-19 vaccine at Visit 3 for participants receiving their primary series of mRNA COVID-19 vaccine.
mRNA COVID-19: ACIP-CDC recommended vaccine
IIV4: ACIP recommended vaccine
Placebo: Saline Control
|
Sequential Vaccination Group
Subjects will receive a dose of mRNA COVID-19 vaccine (either as a study procedure or standard of care) and saline placebo at Visit 1, IIV4 at Visit 2, and mRNA COVID-19 vaccine at Visit 3 for participants receiving their primary series of mRNA COVID-19 vaccine.
mRNA COVID-19: ACIP-CDC recommended vaccine
IIV4: ACIP recommended vaccine
Placebo: Saline Control
|
|---|---|---|
|
Overall Study
Withdrawal by Subject
|
1
|
0
|
Baseline Characteristics
Simultaneous mRNA COVID-19 and IIV4 Vaccination Study
Baseline characteristics by cohort
| Measure |
Simultaneous Vaccination Group
n=169 Participants
Subjects will receive a dose of mRNA COVID-19 vaccine (either as a study procedure or standard of care) and IIV4 at Visit 1, saline placebo at Visit 2, and mRNA COVID-19 vaccine at Visit 3 for participants receiving their primary series of mRNA COVID-19 vaccine.
mRNA COVID-19: ACIP-CDC recommended vaccine
IIV4: ACIP recommended vaccine
Placebo: Saline Control
|
Sequential Vaccination Group
n=166 Participants
Subjects will receive a dose of mRNA COVID-19 vaccine (either as a study procedure or standard of care) and saline placebo at Visit 1, IIV4 at Visit 2, and mRNA COVID-19 vaccine at Visit 3 for participants receiving their primary series of mRNA COVID-19 vaccine.
mRNA COVID-19: ACIP-CDC recommended vaccine
IIV4: ACIP recommended vaccine
Placebo: Saline Control
|
Total
n=335 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
33.7 years
STANDARD_DEVIATION 8.0 • n=5 Participants
|
33.1 years
STANDARD_DEVIATION 9.0 • n=7 Participants
|
33.4 years
STANDARD_DEVIATION 15.1 • n=5 Participants
|
|
Sex: Female, Male
Female
|
96 Participants
n=5 Participants
|
115 Participants
n=7 Participants
|
211 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
73 Participants
n=5 Participants
|
51 Participants
n=7 Participants
|
124 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
12 Participants
n=5 Participants
|
9 Participants
n=7 Participants
|
21 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
156 Participants
n=5 Participants
|
156 Participants
n=7 Participants
|
312 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
1 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
2 Participants
n=5 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Asian
|
12 Participants
n=5 Participants
|
15 Participants
n=7 Participants
|
27 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Black or African American
|
30 Participants
n=5 Participants
|
30 Participants
n=7 Participants
|
60 Participants
n=5 Participants
|
|
Race (NIH/OMB)
White
|
117 Participants
n=5 Participants
|
112 Participants
n=7 Participants
|
229 Participants
n=5 Participants
|
|
Race (NIH/OMB)
More than one race
|
9 Participants
n=5 Participants
|
7 Participants
n=7 Participants
|
16 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
1 Participants
n=5 Participants
|
2 Participants
n=7 Participants
|
3 Participants
n=5 Participants
|
|
Region of Enrollment
United States
|
169 Participants
n=5 Participants
|
166 Participants
n=7 Participants
|
335 Participants
n=5 Participants
|
PRIMARY outcome
Timeframe: Up to 7 Days Post Vaccination (combined for Visits 1 and 2)Population: Data combined for combined for Visits 1 and 2.
Subjects will be asked to complete a memory aid to document symptoms and measure temperature daily.
Outcome measures
| Measure |
Simultaneous Vaccination Group
n=168 Participants
Subjects will receive a dose of mRNA COVID-19 vaccine (either as a study procedure or standard of care) and IIV4 at Visit 1, saline placebo at Visit 2, and mRNA COVID-19 vaccine at Visit 3 for participants receiving their primary series of mRNA COVID-19 vaccine.
mRNA COVID-19: ACIP-CDC recommended vaccine
IIV4: ACIP recommended vaccine
Placebo: Saline Control
|
Sequential Vaccination Group
n=166 Participants
Subjects will receive a dose of mRNA COVID-19 vaccine (either as a study procedure or standard of care) and saline placebo at Visit 1, IIV4 at Visit 2, and mRNA COVID-19 vaccine at Visit 3 for participants receiving their primary series of mRNA COVID-19 vaccine.
mRNA COVID-19: ACIP-CDC recommended vaccine
IIV4: ACIP recommended vaccine
Placebo: Saline Control
|
|---|---|---|
|
Total Number of Participants With Moderate or More Severe Fever, Chills, Myalgia, or Arthralgia in the Simultaneous Group and the Sequential Group Following Both Vaccination Visit 1 and 2
|
43 Participants
|
52 Participants
|
SECONDARY outcome
Timeframe: Up to 7 Days Post VaccinationSubjects will be asked to complete a memory aid to document symptoms and measure temperature daily.
Outcome measures
| Measure |
Simultaneous Vaccination Group
n=168 Participants
Subjects will receive a dose of mRNA COVID-19 vaccine (either as a study procedure or standard of care) and IIV4 at Visit 1, saline placebo at Visit 2, and mRNA COVID-19 vaccine at Visit 3 for participants receiving their primary series of mRNA COVID-19 vaccine.
mRNA COVID-19: ACIP-CDC recommended vaccine
IIV4: ACIP recommended vaccine
Placebo: Saline Control
|
Sequential Vaccination Group
n=166 Participants
Subjects will receive a dose of mRNA COVID-19 vaccine (either as a study procedure or standard of care) and saline placebo at Visit 1, IIV4 at Visit 2, and mRNA COVID-19 vaccine at Visit 3 for participants receiving their primary series of mRNA COVID-19 vaccine.
mRNA COVID-19: ACIP-CDC recommended vaccine
IIV4: ACIP recommended vaccine
Placebo: Saline Control
|
|---|---|---|
|
Number of Participants With Moderate or More Severe Fever, Chills, Myalgia, or Arthralgia in the Simultaneous Versus the Sequential Group Following the First Vaccination Visit
|
40 Participants
|
47 Participants
|
SECONDARY outcome
Timeframe: Up to 7 Days Post VaccinationSubjects will be asked to complete a memory aid to document symptoms and measure temperature daily.
Outcome measures
| Measure |
Simultaneous Vaccination Group
n=168 Participants
Subjects will receive a dose of mRNA COVID-19 vaccine (either as a study procedure or standard of care) and IIV4 at Visit 1, saline placebo at Visit 2, and mRNA COVID-19 vaccine at Visit 3 for participants receiving their primary series of mRNA COVID-19 vaccine.
mRNA COVID-19: ACIP-CDC recommended vaccine
IIV4: ACIP recommended vaccine
Placebo: Saline Control
|
Sequential Vaccination Group
n=166 Participants
Subjects will receive a dose of mRNA COVID-19 vaccine (either as a study procedure or standard of care) and saline placebo at Visit 1, IIV4 at Visit 2, and mRNA COVID-19 vaccine at Visit 3 for participants receiving their primary series of mRNA COVID-19 vaccine.
mRNA COVID-19: ACIP-CDC recommended vaccine
IIV4: ACIP recommended vaccine
Placebo: Saline Control
|
|---|---|---|
|
Number of Participants With Moderate or More Severe Fever, Chills, Myalgia, or Arthralgia in the Simultaneous Versus Sequential Group Following the Second Vaccination Visit
|
5 Participants
|
9 Participants
|
SECONDARY outcome
Timeframe: Up to 7 Days Post VaccinationPopulation: This study allowed participants receiving their initial two dose COVID-19 vaccine series or a COVID-19 vaccine booster to enroll. Only 4 participants were enrolled in the study who received their initial two doses of COVID-19 vaccine, and they were all randomized to the Simultaneous group. These participants received their second COVID-19 vaccine at Visit 3. Those receiving a COVID-19 booster dose did not receive any vaccine/placebo at Visit 3.
Subjects will be asked to complete a memory aid to document symptoms and measure temperature daily.
Outcome measures
| Measure |
Simultaneous Vaccination Group
n=168 Participants
Subjects will receive a dose of mRNA COVID-19 vaccine (either as a study procedure or standard of care) and IIV4 at Visit 1, saline placebo at Visit 2, and mRNA COVID-19 vaccine at Visit 3 for participants receiving their primary series of mRNA COVID-19 vaccine.
mRNA COVID-19: ACIP-CDC recommended vaccine
IIV4: ACIP recommended vaccine
Placebo: Saline Control
|
Sequential Vaccination Group
n=166 Participants
Subjects will receive a dose of mRNA COVID-19 vaccine (either as a study procedure or standard of care) and saline placebo at Visit 1, IIV4 at Visit 2, and mRNA COVID-19 vaccine at Visit 3 for participants receiving their primary series of mRNA COVID-19 vaccine.
mRNA COVID-19: ACIP-CDC recommended vaccine
IIV4: ACIP recommended vaccine
Placebo: Saline Control
|
|---|---|---|
|
Number of Participants in the Simultaneous and Sequential Vaccination Groups With Solicited Local and Systemic Reactogenicity Events According to Severity Grade After the First, Second and Third Vaccination Visit
Visit 2 Local Reaction - Swelling - Flu Vaccine/Placebo Site · Life Threatening
|
0 Participants
|
0 Participants
|
|
Number of Participants in the Simultaneous and Sequential Vaccination Groups With Solicited Local and Systemic Reactogenicity Events According to Severity Grade After the First, Second and Third Vaccination Visit
Visit 2 Local Reaction - Redness - Flu Vaccine/Placebo Site · None
|
168 Participants
|
164 Participants
|
|
Number of Participants in the Simultaneous and Sequential Vaccination Groups With Solicited Local and Systemic Reactogenicity Events According to Severity Grade After the First, Second and Third Vaccination Visit
Visit 2 Local Reaction - Redness - Flu Vaccine/Placebo Site · Mild
|
0 Participants
|
2 Participants
|
|
Number of Participants in the Simultaneous and Sequential Vaccination Groups With Solicited Local and Systemic Reactogenicity Events According to Severity Grade After the First, Second and Third Vaccination Visit
Visit 2 Local Reaction - Redness - Flu Vaccine/Placebo Site · Moderate
|
0 Participants
|
0 Participants
|
|
Number of Participants in the Simultaneous and Sequential Vaccination Groups With Solicited Local and Systemic Reactogenicity Events According to Severity Grade After the First, Second and Third Vaccination Visit
Visit 2 Local Reaction - Redness - Flu Vaccine/Placebo Site · Severe
|
0 Participants
|
0 Participants
|
|
Number of Participants in the Simultaneous and Sequential Vaccination Groups With Solicited Local and Systemic Reactogenicity Events According to Severity Grade After the First, Second and Third Vaccination Visit
Visit 2 Local Reaction - Redness - Flu Vaccine/Placebo Site · Life Threatening
|
0 Participants
|
0 Participants
|
|
Number of Participants in the Simultaneous and Sequential Vaccination Groups With Solicited Local and Systemic Reactogenicity Events According to Severity Grade After the First, Second and Third Vaccination Visit
Visit 2 Local Reaction - Axillary - Flu Vaccine/Placebo Site · None
|
165 Participants
|
141 Participants
|
|
Number of Participants in the Simultaneous and Sequential Vaccination Groups With Solicited Local and Systemic Reactogenicity Events According to Severity Grade After the First, Second and Third Vaccination Visit
Visit 2 Local Reaction - Swelling - Flu Vaccine/Placebo Site · Severe
|
0 Participants
|
0 Participants
|
|
Number of Participants in the Simultaneous and Sequential Vaccination Groups With Solicited Local and Systemic Reactogenicity Events According to Severity Grade After the First, Second and Third Vaccination Visit
Visit 1 Systemic Reaction - Diarrhea · Moderate
|
6 Participants
|
2 Participants
|
|
Number of Participants in the Simultaneous and Sequential Vaccination Groups With Solicited Local and Systemic Reactogenicity Events According to Severity Grade After the First, Second and Third Vaccination Visit
Visit 1 Systemic Reaction - Diarrhea · Severe
|
0 Participants
|
1 Participants
|
|
Number of Participants in the Simultaneous and Sequential Vaccination Groups With Solicited Local and Systemic Reactogenicity Events According to Severity Grade After the First, Second and Third Vaccination Visit
Visit 1 Systemic Reaction - Diarrhea · Life Threatening
|
0 Participants
|
0 Participants
|
|
Number of Participants in the Simultaneous and Sequential Vaccination Groups With Solicited Local and Systemic Reactogenicity Events According to Severity Grade After the First, Second and Third Vaccination Visit
Visit 2 Local Reaction - Pain - Flu Vaccine/Placebo Site · None
|
161 Participants
|
82 Participants
|
|
Number of Participants in the Simultaneous and Sequential Vaccination Groups With Solicited Local and Systemic Reactogenicity Events According to Severity Grade After the First, Second and Third Vaccination Visit
Visit 2 Local Reaction - Pain - Flu Vaccine/Placebo Site · Mild
|
6 Participants
|
75 Participants
|
|
Number of Participants in the Simultaneous and Sequential Vaccination Groups With Solicited Local and Systemic Reactogenicity Events According to Severity Grade After the First, Second and Third Vaccination Visit
Visit 2 Local Reaction - Pain - Flu Vaccine/Placebo Site · Moderate
|
0 Participants
|
8 Participants
|
|
Number of Participants in the Simultaneous and Sequential Vaccination Groups With Solicited Local and Systemic Reactogenicity Events According to Severity Grade After the First, Second and Third Vaccination Visit
Visit 2 Local Reaction - Pain - Flu Vaccine/Placebo Site · Severe
|
1 Participants
|
1 Participants
|
|
Number of Participants in the Simultaneous and Sequential Vaccination Groups With Solicited Local and Systemic Reactogenicity Events According to Severity Grade After the First, Second and Third Vaccination Visit
Visit 2 Local Reaction - Pain - Flu Vaccine/Placebo Site · Life Threatening
|
0 Participants
|
0 Participants
|
|
Number of Participants in the Simultaneous and Sequential Vaccination Groups With Solicited Local and Systemic Reactogenicity Events According to Severity Grade After the First, Second and Third Vaccination Visit
Visit 2 Local Reaction - Swelling - Flu Vaccine/Placebo Site · None
|
168 Participants
|
160 Participants
|
|
Number of Participants in the Simultaneous and Sequential Vaccination Groups With Solicited Local and Systemic Reactogenicity Events According to Severity Grade After the First, Second and Third Vaccination Visit
Visit 2 Local Reaction - Swelling - Flu Vaccine/Placebo Site · Mild
|
0 Participants
|
4 Participants
|
|
Number of Participants in the Simultaneous and Sequential Vaccination Groups With Solicited Local and Systemic Reactogenicity Events According to Severity Grade After the First, Second and Third Vaccination Visit
Visit 2 Local Reaction - Swelling - Flu Vaccine/Placebo Site · Moderate
|
0 Participants
|
2 Participants
|
|
Number of Participants in the Simultaneous and Sequential Vaccination Groups With Solicited Local and Systemic Reactogenicity Events According to Severity Grade After the First, Second and Third Vaccination Visit
Visit 1 Local Reaction - Pain - COVID-19 Vaccine Site · None
|
39 Participants
|
27 Participants
|
|
Number of Participants in the Simultaneous and Sequential Vaccination Groups With Solicited Local and Systemic Reactogenicity Events According to Severity Grade After the First, Second and Third Vaccination Visit
Visit 1 Local Reaction - Pain - COVID-19 Vaccine Site · Mild
|
102 Participants
|
97 Participants
|
|
Number of Participants in the Simultaneous and Sequential Vaccination Groups With Solicited Local and Systemic Reactogenicity Events According to Severity Grade After the First, Second and Third Vaccination Visit
Visit 1 Local Reaction - Pain - COVID-19 Vaccine Site · Moderate
|
27 Participants
|
40 Participants
|
|
Number of Participants in the Simultaneous and Sequential Vaccination Groups With Solicited Local and Systemic Reactogenicity Events According to Severity Grade After the First, Second and Third Vaccination Visit
Visit 1 Local Reaction - Pain - COVID-19 Vaccine Site · Severe
|
0 Participants
|
2 Participants
|
|
Number of Participants in the Simultaneous and Sequential Vaccination Groups With Solicited Local and Systemic Reactogenicity Events According to Severity Grade After the First, Second and Third Vaccination Visit
Visit 1 Local Reaction - Pain - COVID-19 Vaccine Site · Life Threatening
|
0 Participants
|
0 Participants
|
|
Number of Participants in the Simultaneous and Sequential Vaccination Groups With Solicited Local and Systemic Reactogenicity Events According to Severity Grade After the First, Second and Third Vaccination Visit
Visit 1 Local Reaction - Pain - Flu Vaccine/Placebo site · None
|
65 Participants
|
145 Participants
|
|
Number of Participants in the Simultaneous and Sequential Vaccination Groups With Solicited Local and Systemic Reactogenicity Events According to Severity Grade After the First, Second and Third Vaccination Visit
Visit 1 Local Reaction - Pain - Flu Vaccine/Placebo site · Mild
|
86 Participants
|
20 Participants
|
|
Number of Participants in the Simultaneous and Sequential Vaccination Groups With Solicited Local and Systemic Reactogenicity Events According to Severity Grade After the First, Second and Third Vaccination Visit
Visit 1 Local Reaction - Pain - Flu Vaccine/Placebo site · Moderate
|
16 Participants
|
1 Participants
|
|
Number of Participants in the Simultaneous and Sequential Vaccination Groups With Solicited Local and Systemic Reactogenicity Events According to Severity Grade After the First, Second and Third Vaccination Visit
Visit 1 Local Reaction - Pain - Flu Vaccine/Placebo site · Severe
|
1 Participants
|
0 Participants
|
|
Number of Participants in the Simultaneous and Sequential Vaccination Groups With Solicited Local and Systemic Reactogenicity Events According to Severity Grade After the First, Second and Third Vaccination Visit
Visit 1 Local Reaction - Pain - Flu Vaccine/Placebo site · Life Threatening
|
0 Participants
|
0 Participants
|
|
Number of Participants in the Simultaneous and Sequential Vaccination Groups With Solicited Local and Systemic Reactogenicity Events According to Severity Grade After the First, Second and Third Vaccination Visit
Visit 1 Local Reaction - Swelling - COVID-19 Vaccine Site · None
|
164 Participants
|
156 Participants
|
|
Number of Participants in the Simultaneous and Sequential Vaccination Groups With Solicited Local and Systemic Reactogenicity Events According to Severity Grade After the First, Second and Third Vaccination Visit
Visit 1 Local Reaction - Swelling - COVID-19 Vaccine Site · Mild
|
4 Participants
|
4 Participants
|
|
Number of Participants in the Simultaneous and Sequential Vaccination Groups With Solicited Local and Systemic Reactogenicity Events According to Severity Grade After the First, Second and Third Vaccination Visit
Visit 1 Local Reaction - Swelling - COVID-19 Vaccine Site · Moderate
|
0 Participants
|
5 Participants
|
|
Number of Participants in the Simultaneous and Sequential Vaccination Groups With Solicited Local and Systemic Reactogenicity Events According to Severity Grade After the First, Second and Third Vaccination Visit
Visit 1 Local Reaction - Swelling - COVID-19 Vaccine Site · Severe
|
0 Participants
|
1 Participants
|
|
Number of Participants in the Simultaneous and Sequential Vaccination Groups With Solicited Local and Systemic Reactogenicity Events According to Severity Grade After the First, Second and Third Vaccination Visit
Visit 1 Local Reaction - Swelling - COVID-19 Vaccine Site · Life Threatening
|
0 Participants
|
0 Participants
|
|
Number of Participants in the Simultaneous and Sequential Vaccination Groups With Solicited Local and Systemic Reactogenicity Events According to Severity Grade After the First, Second and Third Vaccination Visit
Visit 1 Local Reaction - Swelling - Flu Vaccine/Placebo Site · None
|
164 Participants
|
164 Participants
|
|
Number of Participants in the Simultaneous and Sequential Vaccination Groups With Solicited Local and Systemic Reactogenicity Events According to Severity Grade After the First, Second and Third Vaccination Visit
Visit 1 Local Reaction - Swelling - Flu Vaccine/Placebo Site · Mild
|
2 Participants
|
1 Participants
|
|
Number of Participants in the Simultaneous and Sequential Vaccination Groups With Solicited Local and Systemic Reactogenicity Events According to Severity Grade After the First, Second and Third Vaccination Visit
Visit 1 Local Reaction - Swelling - Flu Vaccine/Placebo Site · Moderate
|
2 Participants
|
1 Participants
|
|
Number of Participants in the Simultaneous and Sequential Vaccination Groups With Solicited Local and Systemic Reactogenicity Events According to Severity Grade After the First, Second and Third Vaccination Visit
Visit 1 Local Reaction - Swelling - Flu Vaccine/Placebo Site · Severe
|
0 Participants
|
0 Participants
|
|
Number of Participants in the Simultaneous and Sequential Vaccination Groups With Solicited Local and Systemic Reactogenicity Events According to Severity Grade After the First, Second and Third Vaccination Visit
Visit 1 Local Reaction - Swelling - Flu Vaccine/Placebo Site · Life Threatening
|
0 Participants
|
0 Participants
|
|
Number of Participants in the Simultaneous and Sequential Vaccination Groups With Solicited Local and Systemic Reactogenicity Events According to Severity Grade After the First, Second and Third Vaccination Visit
Visit 1 Local Reaction - Redness - COVID-19 Vaccine Site · None
|
164 Participants
|
157 Participants
|
|
Number of Participants in the Simultaneous and Sequential Vaccination Groups With Solicited Local and Systemic Reactogenicity Events According to Severity Grade After the First, Second and Third Vaccination Visit
Visit 1 Local Reaction - Redness - COVID-19 Vaccine Site · Mild
|
4 Participants
|
6 Participants
|
|
Number of Participants in the Simultaneous and Sequential Vaccination Groups With Solicited Local and Systemic Reactogenicity Events According to Severity Grade After the First, Second and Third Vaccination Visit
Visit 1 Local Reaction - Redness - COVID-19 Vaccine Site · Moderate
|
0 Participants
|
2 Participants
|
|
Number of Participants in the Simultaneous and Sequential Vaccination Groups With Solicited Local and Systemic Reactogenicity Events According to Severity Grade After the First, Second and Third Vaccination Visit
Visit 1 Local Reaction - Redness - COVID-19 Vaccine Site · Severe
|
0 Participants
|
1 Participants
|
|
Number of Participants in the Simultaneous and Sequential Vaccination Groups With Solicited Local and Systemic Reactogenicity Events According to Severity Grade After the First, Second and Third Vaccination Visit
Visit 1 Local Reaction - Redness - COVID-19 Vaccine Site · Life Threatening
|
0 Participants
|
0 Participants
|
|
Number of Participants in the Simultaneous and Sequential Vaccination Groups With Solicited Local and Systemic Reactogenicity Events According to Severity Grade After the First, Second and Third Vaccination Visit
Visit 1 Local Reaction - Redness - Flu Vaccine/Placebo Site · None
|
165 Participants
|
165 Participants
|
|
Number of Participants in the Simultaneous and Sequential Vaccination Groups With Solicited Local and Systemic Reactogenicity Events According to Severity Grade After the First, Second and Third Vaccination Visit
Visit 1 Local Reaction - Redness - Flu Vaccine/Placebo Site · Mild
|
1 Participants
|
0 Participants
|
|
Number of Participants in the Simultaneous and Sequential Vaccination Groups With Solicited Local and Systemic Reactogenicity Events According to Severity Grade After the First, Second and Third Vaccination Visit
Visit 1 Local Reaction - Redness - Flu Vaccine/Placebo Site · Moderate
|
1 Participants
|
1 Participants
|
|
Number of Participants in the Simultaneous and Sequential Vaccination Groups With Solicited Local and Systemic Reactogenicity Events According to Severity Grade After the First, Second and Third Vaccination Visit
Visit 1 Local Reaction - Redness - Flu Vaccine/Placebo Site · Severe
|
1 Participants
|
0 Participants
|
|
Number of Participants in the Simultaneous and Sequential Vaccination Groups With Solicited Local and Systemic Reactogenicity Events According to Severity Grade After the First, Second and Third Vaccination Visit
Visit 1 Local Reaction - Redness - Flu Vaccine/Placebo Site · Life Threatening
|
0 Participants
|
0 Participants
|
|
Number of Participants in the Simultaneous and Sequential Vaccination Groups With Solicited Local and Systemic Reactogenicity Events According to Severity Grade After the First, Second and Third Vaccination Visit
Visit 1 Local Reaction - Axillary - COVID-19 Vaccine Site · None
|
120 Participants
|
111 Participants
|
|
Number of Participants in the Simultaneous and Sequential Vaccination Groups With Solicited Local and Systemic Reactogenicity Events According to Severity Grade After the First, Second and Third Vaccination Visit
Visit 1 Local Reaction - Axillary - COVID-19 Vaccine Site · Mild
|
40 Participants
|
43 Participants
|
|
Number of Participants in the Simultaneous and Sequential Vaccination Groups With Solicited Local and Systemic Reactogenicity Events According to Severity Grade After the First, Second and Third Vaccination Visit
Visit 1 Local Reaction - Axillary - COVID-19 Vaccine Site · Moderate
|
8 Participants
|
11 Participants
|
|
Number of Participants in the Simultaneous and Sequential Vaccination Groups With Solicited Local and Systemic Reactogenicity Events According to Severity Grade After the First, Second and Third Vaccination Visit
Visit 1 Local Reaction - Axillary - COVID-19 Vaccine Site · Severe
|
0 Participants
|
1 Participants
|
|
Number of Participants in the Simultaneous and Sequential Vaccination Groups With Solicited Local and Systemic Reactogenicity Events According to Severity Grade After the First, Second and Third Vaccination Visit
Visit 1 Local Reaction - Axillary - COVID-19 Vaccine Site · Life Threatening
|
0 Participants
|
0 Participants
|
|
Number of Participants in the Simultaneous and Sequential Vaccination Groups With Solicited Local and Systemic Reactogenicity Events According to Severity Grade After the First, Second and Third Vaccination Visit
Visit 1 Local Reaction - Axillary - Flu Vaccine/Placebo Site · None
|
135 Participants
|
158 Participants
|
|
Number of Participants in the Simultaneous and Sequential Vaccination Groups With Solicited Local and Systemic Reactogenicity Events According to Severity Grade After the First, Second and Third Vaccination Visit
Visit 1 Local Reaction - Axillary - Flu Vaccine/Placebo Site · Mild
|
29 Participants
|
5 Participants
|
|
Number of Participants in the Simultaneous and Sequential Vaccination Groups With Solicited Local and Systemic Reactogenicity Events According to Severity Grade After the First, Second and Third Vaccination Visit
Visit 1 Local Reaction - Axillary - Flu Vaccine/Placebo Site · Moderate
|
4 Participants
|
3 Participants
|
|
Number of Participants in the Simultaneous and Sequential Vaccination Groups With Solicited Local and Systemic Reactogenicity Events According to Severity Grade After the First, Second and Third Vaccination Visit
Visit 1 Local Reaction - Axillary - Flu Vaccine/Placebo Site · Severe
|
0 Participants
|
0 Participants
|
|
Number of Participants in the Simultaneous and Sequential Vaccination Groups With Solicited Local and Systemic Reactogenicity Events According to Severity Grade After the First, Second and Third Vaccination Visit
Visit 1 Local Reaction - Axillary - Flu Vaccine/Placebo Site · Life Threatening
|
0 Participants
|
0 Participants
|
|
Number of Participants in the Simultaneous and Sequential Vaccination Groups With Solicited Local and Systemic Reactogenicity Events According to Severity Grade After the First, Second and Third Vaccination Visit
Visit 1 Systemic Reaction - Fever · None
|
159 Participants
|
155 Participants
|
|
Number of Participants in the Simultaneous and Sequential Vaccination Groups With Solicited Local and Systemic Reactogenicity Events According to Severity Grade After the First, Second and Third Vaccination Visit
Visit 1 Systemic Reaction - Fever · Mild
|
4 Participants
|
6 Participants
|
|
Number of Participants in the Simultaneous and Sequential Vaccination Groups With Solicited Local and Systemic Reactogenicity Events According to Severity Grade After the First, Second and Third Vaccination Visit
Visit 1 Systemic Reaction - Fever · Moderate
|
3 Participants
|
2 Participants
|
|
Number of Participants in the Simultaneous and Sequential Vaccination Groups With Solicited Local and Systemic Reactogenicity Events According to Severity Grade After the First, Second and Third Vaccination Visit
Visit 1 Systemic Reaction - Fever · Severe
|
2 Participants
|
3 Participants
|
|
Number of Participants in the Simultaneous and Sequential Vaccination Groups With Solicited Local and Systemic Reactogenicity Events According to Severity Grade After the First, Second and Third Vaccination Visit
Visit 1 Systemic Reaction - Fever · Life Threatening
|
0 Participants
|
0 Participants
|
|
Number of Participants in the Simultaneous and Sequential Vaccination Groups With Solicited Local and Systemic Reactogenicity Events According to Severity Grade After the First, Second and Third Vaccination Visit
Visit 1 Systemic Reaction - Chills · None
|
121 Participants
|
116 Participants
|
|
Number of Participants in the Simultaneous and Sequential Vaccination Groups With Solicited Local and Systemic Reactogenicity Events According to Severity Grade After the First, Second and Third Vaccination Visit
Visit 1 Systemic Reaction - Chills · Mild
|
29 Participants
|
26 Participants
|
|
Number of Participants in the Simultaneous and Sequential Vaccination Groups With Solicited Local and Systemic Reactogenicity Events According to Severity Grade After the First, Second and Third Vaccination Visit
Visit 1 Systemic Reaction - Chills · Moderate
|
15 Participants
|
19 Participants
|
|
Number of Participants in the Simultaneous and Sequential Vaccination Groups With Solicited Local and Systemic Reactogenicity Events According to Severity Grade After the First, Second and Third Vaccination Visit
Visit 1 Systemic Reaction - Chills · Severe
|
3 Participants
|
5 Participants
|
|
Number of Participants in the Simultaneous and Sequential Vaccination Groups With Solicited Local and Systemic Reactogenicity Events According to Severity Grade After the First, Second and Third Vaccination Visit
Visit 1 Systemic Reaction - Chills · Life Threatening
|
0 Participants
|
0 Participants
|
|
Number of Participants in the Simultaneous and Sequential Vaccination Groups With Solicited Local and Systemic Reactogenicity Events According to Severity Grade After the First, Second and Third Vaccination Visit
Visit 1 Systemic Reaction - Fatigue · None
|
73 Participants
|
61 Participants
|
|
Number of Participants in the Simultaneous and Sequential Vaccination Groups With Solicited Local and Systemic Reactogenicity Events According to Severity Grade After the First, Second and Third Vaccination Visit
Visit 1 Systemic Reaction - Fatigue · Mild
|
50 Participants
|
61 Participants
|
|
Number of Participants in the Simultaneous and Sequential Vaccination Groups With Solicited Local and Systemic Reactogenicity Events According to Severity Grade After the First, Second and Third Vaccination Visit
Visit 1 Systemic Reaction - Fatigue · Moderate
|
41 Participants
|
34 Participants
|
|
Number of Participants in the Simultaneous and Sequential Vaccination Groups With Solicited Local and Systemic Reactogenicity Events According to Severity Grade After the First, Second and Third Vaccination Visit
Visit 1 Systemic Reaction - Fatigue · Severe
|
4 Participants
|
10 Participants
|
|
Number of Participants in the Simultaneous and Sequential Vaccination Groups With Solicited Local and Systemic Reactogenicity Events According to Severity Grade After the First, Second and Third Vaccination Visit
Visit 1 Systemic Reaction - Fatigue · Life Threatening
|
0 Participants
|
0 Participants
|
|
Number of Participants in the Simultaneous and Sequential Vaccination Groups With Solicited Local and Systemic Reactogenicity Events According to Severity Grade After the First, Second and Third Vaccination Visit
Visit 1 Systemic Reaction - Myalgia · None
|
71 Participants
|
65 Participants
|
|
Number of Participants in the Simultaneous and Sequential Vaccination Groups With Solicited Local and Systemic Reactogenicity Events According to Severity Grade After the First, Second and Third Vaccination Visit
Visit 1 Systemic Reaction - Myalgia · Mild
|
62 Participants
|
60 Participants
|
|
Number of Participants in the Simultaneous and Sequential Vaccination Groups With Solicited Local and Systemic Reactogenicity Events According to Severity Grade After the First, Second and Third Vaccination Visit
Visit 1 Systemic Reaction - Myalgia · Moderate
|
31 Participants
|
33 Participants
|
|
Number of Participants in the Simultaneous and Sequential Vaccination Groups With Solicited Local and Systemic Reactogenicity Events According to Severity Grade After the First, Second and Third Vaccination Visit
Visit 1 Systemic Reaction - Myalgia · Severe
|
4 Participants
|
8 Participants
|
|
Number of Participants in the Simultaneous and Sequential Vaccination Groups With Solicited Local and Systemic Reactogenicity Events According to Severity Grade After the First, Second and Third Vaccination Visit
Visit 1 Systemic Reaction - Myalgia · Life Threatening
|
0 Participants
|
0 Participants
|
|
Number of Participants in the Simultaneous and Sequential Vaccination Groups With Solicited Local and Systemic Reactogenicity Events According to Severity Grade After the First, Second and Third Vaccination Visit
Visit 1 Systemic Reaction - Headache · None
|
90 Participants
|
80 Participants
|
|
Number of Participants in the Simultaneous and Sequential Vaccination Groups With Solicited Local and Systemic Reactogenicity Events According to Severity Grade After the First, Second and Third Vaccination Visit
Visit 1 Systemic Reaction - Headache · Mild
|
53 Participants
|
58 Participants
|
|
Number of Participants in the Simultaneous and Sequential Vaccination Groups With Solicited Local and Systemic Reactogenicity Events According to Severity Grade After the First, Second and Third Vaccination Visit
Visit 1 Systemic Reaction - Headache · Moderate
|
21 Participants
|
25 Participants
|
|
Number of Participants in the Simultaneous and Sequential Vaccination Groups With Solicited Local and Systemic Reactogenicity Events According to Severity Grade After the First, Second and Third Vaccination Visit
Visit 1 Systemic Reaction - Headache · Severe
|
4 Participants
|
3 Participants
|
|
Number of Participants in the Simultaneous and Sequential Vaccination Groups With Solicited Local and Systemic Reactogenicity Events According to Severity Grade After the First, Second and Third Vaccination Visit
Visit 1 Systemic Reaction - Headache · Life Threatening
|
0 Participants
|
0 Participants
|
|
Number of Participants in the Simultaneous and Sequential Vaccination Groups With Solicited Local and Systemic Reactogenicity Events According to Severity Grade After the First, Second and Third Vaccination Visit
Visit 1 Systemic Reaction - Arthralgia · None
|
141 Participants
|
129 Participants
|
|
Number of Participants in the Simultaneous and Sequential Vaccination Groups With Solicited Local and Systemic Reactogenicity Events According to Severity Grade After the First, Second and Third Vaccination Visit
Visit 1 Systemic Reaction - Arthralgia · Mild
|
14 Participants
|
21 Participants
|
|
Number of Participants in the Simultaneous and Sequential Vaccination Groups With Solicited Local and Systemic Reactogenicity Events According to Severity Grade After the First, Second and Third Vaccination Visit
Visit 1 Systemic Reaction - Arthralgia · Moderate
|
12 Participants
|
11 Participants
|
|
Number of Participants in the Simultaneous and Sequential Vaccination Groups With Solicited Local and Systemic Reactogenicity Events According to Severity Grade After the First, Second and Third Vaccination Visit
Visit 1 Systemic Reaction - Arthralgia · Severe
|
1 Participants
|
5 Participants
|
|
Number of Participants in the Simultaneous and Sequential Vaccination Groups With Solicited Local and Systemic Reactogenicity Events According to Severity Grade After the First, Second and Third Vaccination Visit
Visit 1 Systemic Reaction - Arthralgia · Life Threatening
|
0 Participants
|
0 Participants
|
|
Number of Participants in the Simultaneous and Sequential Vaccination Groups With Solicited Local and Systemic Reactogenicity Events According to Severity Grade After the First, Second and Third Vaccination Visit
Visit 1 Systemic Reaction - Nausea/Vomitting · None
|
145 Participants
|
142 Participants
|
|
Number of Participants in the Simultaneous and Sequential Vaccination Groups With Solicited Local and Systemic Reactogenicity Events According to Severity Grade After the First, Second and Third Vaccination Visit
Visit 1 Systemic Reaction - Nausea/Vomitting · Mild
|
15 Participants
|
19 Participants
|
|
Number of Participants in the Simultaneous and Sequential Vaccination Groups With Solicited Local and Systemic Reactogenicity Events According to Severity Grade After the First, Second and Third Vaccination Visit
Visit 1 Systemic Reaction - Nausea/Vomitting · Moderate
|
7 Participants
|
3 Participants
|
|
Number of Participants in the Simultaneous and Sequential Vaccination Groups With Solicited Local and Systemic Reactogenicity Events According to Severity Grade After the First, Second and Third Vaccination Visit
Visit 1 Systemic Reaction - Nausea/Vomitting · Severe
|
1 Participants
|
2 Participants
|
|
Number of Participants in the Simultaneous and Sequential Vaccination Groups With Solicited Local and Systemic Reactogenicity Events According to Severity Grade After the First, Second and Third Vaccination Visit
Visit 1 Systemic Reaction - Nausea/Vomitting · Life Threatening
|
0 Participants
|
0 Participants
|
|
Number of Participants in the Simultaneous and Sequential Vaccination Groups With Solicited Local and Systemic Reactogenicity Events According to Severity Grade After the First, Second and Third Vaccination Visit
Visit 1 Systemic Reaction - Diarrhea · None
|
151 Participants
|
146 Participants
|
|
Number of Participants in the Simultaneous and Sequential Vaccination Groups With Solicited Local and Systemic Reactogenicity Events According to Severity Grade After the First, Second and Third Vaccination Visit
Visit 1 Systemic Reaction - Diarrhea · Mild
|
11 Participants
|
17 Participants
|
|
Number of Participants in the Simultaneous and Sequential Vaccination Groups With Solicited Local and Systemic Reactogenicity Events According to Severity Grade After the First, Second and Third Vaccination Visit
Visit 2 Local Reaction - Axillary - Flu Vaccine/Placebo Site · Mild
|
3 Participants
|
21 Participants
|
|
Number of Participants in the Simultaneous and Sequential Vaccination Groups With Solicited Local and Systemic Reactogenicity Events According to Severity Grade After the First, Second and Third Vaccination Visit
Visit 2 Local Reaction - Axillary - Flu Vaccine/Placebo Site · Moderate
|
0 Participants
|
3 Participants
|
|
Number of Participants in the Simultaneous and Sequential Vaccination Groups With Solicited Local and Systemic Reactogenicity Events According to Severity Grade After the First, Second and Third Vaccination Visit
Visit 2 Local Reaction - Axillary - Flu Vaccine/Placebo Site · Severe
|
0 Participants
|
1 Participants
|
|
Number of Participants in the Simultaneous and Sequential Vaccination Groups With Solicited Local and Systemic Reactogenicity Events According to Severity Grade After the First, Second and Third Vaccination Visit
Visit 2 Local Reaction - Axillary - Flu Vaccine/Placebo Site · Life Threatening
|
0 Participants
|
0 Participants
|
|
Number of Participants in the Simultaneous and Sequential Vaccination Groups With Solicited Local and Systemic Reactogenicity Events According to Severity Grade After the First, Second and Third Vaccination Visit
Visit 2 Systemic Reaction - Fever · None
|
165 Participants
|
162 Participants
|
|
Number of Participants in the Simultaneous and Sequential Vaccination Groups With Solicited Local and Systemic Reactogenicity Events According to Severity Grade After the First, Second and Third Vaccination Visit
Visit 2 Systemic Reaction - Fever · Mild
|
2 Participants
|
3 Participants
|
|
Number of Participants in the Simultaneous and Sequential Vaccination Groups With Solicited Local and Systemic Reactogenicity Events According to Severity Grade After the First, Second and Third Vaccination Visit
Visit 2 Systemic Reaction - Fever · Moderate
|
1 Participants
|
1 Participants
|
|
Number of Participants in the Simultaneous and Sequential Vaccination Groups With Solicited Local and Systemic Reactogenicity Events According to Severity Grade After the First, Second and Third Vaccination Visit
Visit 2 Systemic Reaction - Fever · Severe
|
0 Participants
|
0 Participants
|
|
Number of Participants in the Simultaneous and Sequential Vaccination Groups With Solicited Local and Systemic Reactogenicity Events According to Severity Grade After the First, Second and Third Vaccination Visit
Visit 2 Systemic Reaction - Fever · Life Threatening
|
0 Participants
|
0 Participants
|
|
Number of Participants in the Simultaneous and Sequential Vaccination Groups With Solicited Local and Systemic Reactogenicity Events According to Severity Grade After the First, Second and Third Vaccination Visit
Visit 2 - Systemic Reaction - Chills · None
|
167 Participants
|
157 Participants
|
|
Number of Participants in the Simultaneous and Sequential Vaccination Groups With Solicited Local and Systemic Reactogenicity Events According to Severity Grade After the First, Second and Third Vaccination Visit
Visit 2 - Systemic Reaction - Chills · Mild
|
0 Participants
|
7 Participants
|
|
Number of Participants in the Simultaneous and Sequential Vaccination Groups With Solicited Local and Systemic Reactogenicity Events According to Severity Grade After the First, Second and Third Vaccination Visit
Visit 2 - Systemic Reaction - Chills · Moderate
|
1 Participants
|
2 Participants
|
|
Number of Participants in the Simultaneous and Sequential Vaccination Groups With Solicited Local and Systemic Reactogenicity Events According to Severity Grade After the First, Second and Third Vaccination Visit
Visit 2 - Systemic Reaction - Chills · Severe
|
0 Participants
|
0 Participants
|
|
Number of Participants in the Simultaneous and Sequential Vaccination Groups With Solicited Local and Systemic Reactogenicity Events According to Severity Grade After the First, Second and Third Vaccination Visit
Visit 2 - Systemic Reaction - Chills · Life Threatening
|
0 Participants
|
0 Participants
|
|
Number of Participants in the Simultaneous and Sequential Vaccination Groups With Solicited Local and Systemic Reactogenicity Events According to Severity Grade After the First, Second and Third Vaccination Visit
Visit 2 - Systemic Reaction - Fatigue · None
|
150 Participants
|
121 Participants
|
|
Number of Participants in the Simultaneous and Sequential Vaccination Groups With Solicited Local and Systemic Reactogenicity Events According to Severity Grade After the First, Second and Third Vaccination Visit
Visit 2 - Systemic Reaction - Fatigue · Mild
|
10 Participants
|
34 Participants
|
|
Number of Participants in the Simultaneous and Sequential Vaccination Groups With Solicited Local and Systemic Reactogenicity Events According to Severity Grade After the First, Second and Third Vaccination Visit
Visit 2 - Systemic Reaction - Fatigue · Moderate
|
4 Participants
|
10 Participants
|
|
Number of Participants in the Simultaneous and Sequential Vaccination Groups With Solicited Local and Systemic Reactogenicity Events According to Severity Grade After the First, Second and Third Vaccination Visit
Visit 2 - Systemic Reaction - Fatigue · Severe
|
4 Participants
|
1 Participants
|
|
Number of Participants in the Simultaneous and Sequential Vaccination Groups With Solicited Local and Systemic Reactogenicity Events According to Severity Grade After the First, Second and Third Vaccination Visit
Visit 2 - Systemic Reaction - Fatigue · Life Threatening
|
0 Participants
|
0 Participants
|
|
Number of Participants in the Simultaneous and Sequential Vaccination Groups With Solicited Local and Systemic Reactogenicity Events According to Severity Grade After the First, Second and Third Vaccination Visit
Visit 2 - Systemic Reaction - Myalgia · None
|
159 Participants
|
124 Participants
|
|
Number of Participants in the Simultaneous and Sequential Vaccination Groups With Solicited Local and Systemic Reactogenicity Events According to Severity Grade After the First, Second and Third Vaccination Visit
Visit 2 - Systemic Reaction - Myalgia · Mild
|
5 Participants
|
34 Participants
|
|
Number of Participants in the Simultaneous and Sequential Vaccination Groups With Solicited Local and Systemic Reactogenicity Events According to Severity Grade After the First, Second and Third Vaccination Visit
Visit 2 - Systemic Reaction - Myalgia · Moderate
|
4 Participants
|
7 Participants
|
|
Number of Participants in the Simultaneous and Sequential Vaccination Groups With Solicited Local and Systemic Reactogenicity Events According to Severity Grade After the First, Second and Third Vaccination Visit
Visit 2 - Systemic Reaction - Myalgia · Severe
|
0 Participants
|
1 Participants
|
|
Number of Participants in the Simultaneous and Sequential Vaccination Groups With Solicited Local and Systemic Reactogenicity Events According to Severity Grade After the First, Second and Third Vaccination Visit
Visit 2 - Systemic Reaction - Myalgia · Life Threatening
|
0 Participants
|
0 Participants
|
|
Number of Participants in the Simultaneous and Sequential Vaccination Groups With Solicited Local and Systemic Reactogenicity Events According to Severity Grade After the First, Second and Third Vaccination Visit
Visit 2 - Systemic Reaction - Headache · None
|
141 Participants
|
129 Participants
|
|
Number of Participants in the Simultaneous and Sequential Vaccination Groups With Solicited Local and Systemic Reactogenicity Events According to Severity Grade After the First, Second and Third Vaccination Visit
Visit 2 - Systemic Reaction - Headache · Mild
|
17 Participants
|
26 Participants
|
|
Number of Participants in the Simultaneous and Sequential Vaccination Groups With Solicited Local and Systemic Reactogenicity Events According to Severity Grade After the First, Second and Third Vaccination Visit
Visit 2 - Systemic Reaction - Headache · Moderate
|
9 Participants
|
11 Participants
|
|
Number of Participants in the Simultaneous and Sequential Vaccination Groups With Solicited Local and Systemic Reactogenicity Events According to Severity Grade After the First, Second and Third Vaccination Visit
Visit 2 - Systemic Reaction - Headache · Severe
|
1 Participants
|
0 Participants
|
|
Number of Participants in the Simultaneous and Sequential Vaccination Groups With Solicited Local and Systemic Reactogenicity Events According to Severity Grade After the First, Second and Third Vaccination Visit
Visit 2 - Systemic Reaction - Headache · Life Threatening
|
0 Participants
|
0 Participants
|
|
Number of Participants in the Simultaneous and Sequential Vaccination Groups With Solicited Local and Systemic Reactogenicity Events According to Severity Grade After the First, Second and Third Vaccination Visit
Visit 2 - Systemic Reaction - Arthralgia · None
|
161 Participants
|
156 Participants
|
|
Number of Participants in the Simultaneous and Sequential Vaccination Groups With Solicited Local and Systemic Reactogenicity Events According to Severity Grade After the First, Second and Third Vaccination Visit
Visit 2 - Systemic Reaction - Arthralgia · Mild
|
5 Participants
|
7 Participants
|
|
Number of Participants in the Simultaneous and Sequential Vaccination Groups With Solicited Local and Systemic Reactogenicity Events According to Severity Grade After the First, Second and Third Vaccination Visit
Visit 2 - Systemic Reaction - Arthralgia · Moderate
|
2 Participants
|
3 Participants
|
|
Number of Participants in the Simultaneous and Sequential Vaccination Groups With Solicited Local and Systemic Reactogenicity Events According to Severity Grade After the First, Second and Third Vaccination Visit
Visit 2 - Systemic Reaction - Arthralgia · Severe
|
0 Participants
|
0 Participants
|
|
Number of Participants in the Simultaneous and Sequential Vaccination Groups With Solicited Local and Systemic Reactogenicity Events According to Severity Grade After the First, Second and Third Vaccination Visit
Visit 2 - Systemic Reaction - Arthralgia · Life Threatening
|
0 Participants
|
0 Participants
|
|
Number of Participants in the Simultaneous and Sequential Vaccination Groups With Solicited Local and Systemic Reactogenicity Events According to Severity Grade After the First, Second and Third Vaccination Visit
Visit 2 - Systemic Reaction - Nausea/Vomiting · None
|
163 Participants
|
160 Participants
|
|
Number of Participants in the Simultaneous and Sequential Vaccination Groups With Solicited Local and Systemic Reactogenicity Events According to Severity Grade After the First, Second and Third Vaccination Visit
Visit 2 - Systemic Reaction - Nausea/Vomiting · Mild
|
4 Participants
|
4 Participants
|
|
Number of Participants in the Simultaneous and Sequential Vaccination Groups With Solicited Local and Systemic Reactogenicity Events According to Severity Grade After the First, Second and Third Vaccination Visit
Visit 2 - Systemic Reaction - Nausea/Vomiting · Moderate
|
1 Participants
|
2 Participants
|
|
Number of Participants in the Simultaneous and Sequential Vaccination Groups With Solicited Local and Systemic Reactogenicity Events According to Severity Grade After the First, Second and Third Vaccination Visit
Visit 2 - Systemic Reaction - Nausea/Vomiting · Severe
|
0 Participants
|
0 Participants
|
|
Number of Participants in the Simultaneous and Sequential Vaccination Groups With Solicited Local and Systemic Reactogenicity Events According to Severity Grade After the First, Second and Third Vaccination Visit
Visit 2 - Systemic Reaction - Nausea/Vomiting · Life Threatening
|
0 Participants
|
0 Participants
|
|
Number of Participants in the Simultaneous and Sequential Vaccination Groups With Solicited Local and Systemic Reactogenicity Events According to Severity Grade After the First, Second and Third Vaccination Visit
Visit 2 - Systemic Reaction - Diarrhea · None
|
163 Participants
|
152 Participants
|
|
Number of Participants in the Simultaneous and Sequential Vaccination Groups With Solicited Local and Systemic Reactogenicity Events According to Severity Grade After the First, Second and Third Vaccination Visit
Visit 2 - Systemic Reaction - Diarrhea · Mild
|
5 Participants
|
14 Participants
|
|
Number of Participants in the Simultaneous and Sequential Vaccination Groups With Solicited Local and Systemic Reactogenicity Events According to Severity Grade After the First, Second and Third Vaccination Visit
Visit 2 - Systemic Reaction - Diarrhea · Moderate
|
0 Participants
|
0 Participants
|
|
Number of Participants in the Simultaneous and Sequential Vaccination Groups With Solicited Local and Systemic Reactogenicity Events According to Severity Grade After the First, Second and Third Vaccination Visit
Visit 2 - Systemic Reaction - Diarrhea · Severe
|
0 Participants
|
0 Participants
|
|
Number of Participants in the Simultaneous and Sequential Vaccination Groups With Solicited Local and Systemic Reactogenicity Events According to Severity Grade After the First, Second and Third Vaccination Visit
Visit 2 - Systemic Reaction - Diarrhea · Life Threatening
|
0 Participants
|
0 Participants
|
|
Number of Participants in the Simultaneous and Sequential Vaccination Groups With Solicited Local and Systemic Reactogenicity Events According to Severity Grade After the First, Second and Third Vaccination Visit
Visit 3 - Local Reaction - Pain - COVID-19 Vaccine · None
|
4 Participants
|
0 Participants
|
|
Number of Participants in the Simultaneous and Sequential Vaccination Groups With Solicited Local and Systemic Reactogenicity Events According to Severity Grade After the First, Second and Third Vaccination Visit
Visit 3 - Local Reaction - Pain - COVID-19 Vaccine · Mild
|
0 Participants
|
0 Participants
|
|
Number of Participants in the Simultaneous and Sequential Vaccination Groups With Solicited Local and Systemic Reactogenicity Events According to Severity Grade After the First, Second and Third Vaccination Visit
Visit 3 - Local Reaction - Pain - COVID-19 Vaccine · Moderate
|
0 Participants
|
0 Participants
|
|
Number of Participants in the Simultaneous and Sequential Vaccination Groups With Solicited Local and Systemic Reactogenicity Events According to Severity Grade After the First, Second and Third Vaccination Visit
Visit 3 - Local Reaction - Pain - COVID-19 Vaccine · Severe
|
0 Participants
|
0 Participants
|
|
Number of Participants in the Simultaneous and Sequential Vaccination Groups With Solicited Local and Systemic Reactogenicity Events According to Severity Grade After the First, Second and Third Vaccination Visit
Visit 3 - Local Reaction - Pain - COVID-19 Vaccine · Life Threatening
|
0 Participants
|
0 Participants
|
|
Number of Participants in the Simultaneous and Sequential Vaccination Groups With Solicited Local and Systemic Reactogenicity Events According to Severity Grade After the First, Second and Third Vaccination Visit
Visit 3 - Local Reaction - Swelling - COVID-19 Vaccine · None
|
4 Participants
|
0 Participants
|
|
Number of Participants in the Simultaneous and Sequential Vaccination Groups With Solicited Local and Systemic Reactogenicity Events According to Severity Grade After the First, Second and Third Vaccination Visit
Visit 3 - Local Reaction - Swelling - COVID-19 Vaccine · Mild
|
0 Participants
|
0 Participants
|
|
Number of Participants in the Simultaneous and Sequential Vaccination Groups With Solicited Local and Systemic Reactogenicity Events According to Severity Grade After the First, Second and Third Vaccination Visit
Visit 3 - Local Reaction - Swelling - COVID-19 Vaccine · Moderate
|
0 Participants
|
0 Participants
|
|
Number of Participants in the Simultaneous and Sequential Vaccination Groups With Solicited Local and Systemic Reactogenicity Events According to Severity Grade After the First, Second and Third Vaccination Visit
Visit 3 - Local Reaction - Swelling - COVID-19 Vaccine · Severe
|
0 Participants
|
0 Participants
|
|
Number of Participants in the Simultaneous and Sequential Vaccination Groups With Solicited Local and Systemic Reactogenicity Events According to Severity Grade After the First, Second and Third Vaccination Visit
Visit 3 - Local Reaction - Swelling - COVID-19 Vaccine · Life Threatening
|
0 Participants
|
0 Participants
|
|
Number of Participants in the Simultaneous and Sequential Vaccination Groups With Solicited Local and Systemic Reactogenicity Events According to Severity Grade After the First, Second and Third Vaccination Visit
Visit 3 - Local Reaction - Redness - COVID-19 Vaccine · None
|
4 Participants
|
0 Participants
|
|
Number of Participants in the Simultaneous and Sequential Vaccination Groups With Solicited Local and Systemic Reactogenicity Events According to Severity Grade After the First, Second and Third Vaccination Visit
Visit 3 - Local Reaction - Redness - COVID-19 Vaccine · Mild
|
0 Participants
|
0 Participants
|
|
Number of Participants in the Simultaneous and Sequential Vaccination Groups With Solicited Local and Systemic Reactogenicity Events According to Severity Grade After the First, Second and Third Vaccination Visit
Visit 3 - Local Reaction - Redness - COVID-19 Vaccine · Moderate
|
0 Participants
|
0 Participants
|
|
Number of Participants in the Simultaneous and Sequential Vaccination Groups With Solicited Local and Systemic Reactogenicity Events According to Severity Grade After the First, Second and Third Vaccination Visit
Visit 3 - Local Reaction - Redness - COVID-19 Vaccine · Severe
|
0 Participants
|
0 Participants
|
|
Number of Participants in the Simultaneous and Sequential Vaccination Groups With Solicited Local and Systemic Reactogenicity Events According to Severity Grade After the First, Second and Third Vaccination Visit
Visit 3 - Local Reaction - Redness - COVID-19 Vaccine · Life Threatening
|
0 Participants
|
0 Participants
|
|
Number of Participants in the Simultaneous and Sequential Vaccination Groups With Solicited Local and Systemic Reactogenicity Events According to Severity Grade After the First, Second and Third Vaccination Visit
Visit 3 - Local Reaction - Axillary - COVID-19 Vaccine · None
|
3 Participants
|
0 Participants
|
|
Number of Participants in the Simultaneous and Sequential Vaccination Groups With Solicited Local and Systemic Reactogenicity Events According to Severity Grade After the First, Second and Third Vaccination Visit
Visit 3 - Local Reaction - Axillary - COVID-19 Vaccine · Mild
|
1 Participants
|
0 Participants
|
|
Number of Participants in the Simultaneous and Sequential Vaccination Groups With Solicited Local and Systemic Reactogenicity Events According to Severity Grade After the First, Second and Third Vaccination Visit
Visit 3 - Local Reaction - Axillary - COVID-19 Vaccine · Moderate
|
0 Participants
|
0 Participants
|
|
Number of Participants in the Simultaneous and Sequential Vaccination Groups With Solicited Local and Systemic Reactogenicity Events According to Severity Grade After the First, Second and Third Vaccination Visit
Visit 3 - Local Reaction - Axillary - COVID-19 Vaccine · Severe
|
0 Participants
|
0 Participants
|
|
Number of Participants in the Simultaneous and Sequential Vaccination Groups With Solicited Local and Systemic Reactogenicity Events According to Severity Grade After the First, Second and Third Vaccination Visit
Visit 3 - Local Reaction - Axillary - COVID-19 Vaccine · Life Threatening
|
0 Participants
|
0 Participants
|
|
Number of Participants in the Simultaneous and Sequential Vaccination Groups With Solicited Local and Systemic Reactogenicity Events According to Severity Grade After the First, Second and Third Vaccination Visit
Visit 3 - Systemic Reaction - Fever · None
|
4 Participants
|
0 Participants
|
|
Number of Participants in the Simultaneous and Sequential Vaccination Groups With Solicited Local and Systemic Reactogenicity Events According to Severity Grade After the First, Second and Third Vaccination Visit
Visit 3 - Systemic Reaction - Fever · Mild
|
0 Participants
|
0 Participants
|
|
Number of Participants in the Simultaneous and Sequential Vaccination Groups With Solicited Local and Systemic Reactogenicity Events According to Severity Grade After the First, Second and Third Vaccination Visit
Visit 3 - Systemic Reaction - Fever · Moderate
|
0 Participants
|
0 Participants
|
|
Number of Participants in the Simultaneous and Sequential Vaccination Groups With Solicited Local and Systemic Reactogenicity Events According to Severity Grade After the First, Second and Third Vaccination Visit
Visit 3 - Systemic Reaction - Fever · Severe
|
0 Participants
|
0 Participants
|
|
Number of Participants in the Simultaneous and Sequential Vaccination Groups With Solicited Local and Systemic Reactogenicity Events According to Severity Grade After the First, Second and Third Vaccination Visit
Visit 3 - Systemic Reaction - Fever · Life Threatening
|
0 Participants
|
0 Participants
|
|
Number of Participants in the Simultaneous and Sequential Vaccination Groups With Solicited Local and Systemic Reactogenicity Events According to Severity Grade After the First, Second and Third Vaccination Visit
Visit 3 - Systemic Reaction - Chills · None
|
4 Participants
|
0 Participants
|
|
Number of Participants in the Simultaneous and Sequential Vaccination Groups With Solicited Local and Systemic Reactogenicity Events According to Severity Grade After the First, Second and Third Vaccination Visit
Visit 3 - Systemic Reaction - Chills · Mild
|
0 Participants
|
0 Participants
|
|
Number of Participants in the Simultaneous and Sequential Vaccination Groups With Solicited Local and Systemic Reactogenicity Events According to Severity Grade After the First, Second and Third Vaccination Visit
Visit 3 - Systemic Reaction - Chills · Moderate
|
0 Participants
|
0 Participants
|
|
Number of Participants in the Simultaneous and Sequential Vaccination Groups With Solicited Local and Systemic Reactogenicity Events According to Severity Grade After the First, Second and Third Vaccination Visit
Visit 3 - Systemic Reaction - Chills · Severe
|
0 Participants
|
0 Participants
|
|
Number of Participants in the Simultaneous and Sequential Vaccination Groups With Solicited Local and Systemic Reactogenicity Events According to Severity Grade After the First, Second and Third Vaccination Visit
Visit 3 - Systemic Reaction - Chills · Life Threatening
|
0 Participants
|
0 Participants
|
|
Number of Participants in the Simultaneous and Sequential Vaccination Groups With Solicited Local and Systemic Reactogenicity Events According to Severity Grade After the First, Second and Third Vaccination Visit
Visit 3 - Systemic Reaction - Fatigue · None
|
3 Participants
|
0 Participants
|
|
Number of Participants in the Simultaneous and Sequential Vaccination Groups With Solicited Local and Systemic Reactogenicity Events According to Severity Grade After the First, Second and Third Vaccination Visit
Visit 3 - Systemic Reaction - Fatigue · Mild
|
1 Participants
|
0 Participants
|
|
Number of Participants in the Simultaneous and Sequential Vaccination Groups With Solicited Local and Systemic Reactogenicity Events According to Severity Grade After the First, Second and Third Vaccination Visit
Visit 3 - Systemic Reaction - Fatigue · Moderate
|
0 Participants
|
0 Participants
|
|
Number of Participants in the Simultaneous and Sequential Vaccination Groups With Solicited Local and Systemic Reactogenicity Events According to Severity Grade After the First, Second and Third Vaccination Visit
Visit 3 - Systemic Reaction - Fatigue · Severe
|
0 Participants
|
0 Participants
|
|
Number of Participants in the Simultaneous and Sequential Vaccination Groups With Solicited Local and Systemic Reactogenicity Events According to Severity Grade After the First, Second and Third Vaccination Visit
Visit 3 - Systemic Reaction - Fatigue · Life Threatening
|
0 Participants
|
0 Participants
|
|
Number of Participants in the Simultaneous and Sequential Vaccination Groups With Solicited Local and Systemic Reactogenicity Events According to Severity Grade After the First, Second and Third Vaccination Visit
Visit 3 - Systemic Reaction - Myalgia · None
|
4 Participants
|
0 Participants
|
|
Number of Participants in the Simultaneous and Sequential Vaccination Groups With Solicited Local and Systemic Reactogenicity Events According to Severity Grade After the First, Second and Third Vaccination Visit
Visit 3 - Systemic Reaction - Myalgia · Mild
|
0 Participants
|
0 Participants
|
|
Number of Participants in the Simultaneous and Sequential Vaccination Groups With Solicited Local and Systemic Reactogenicity Events According to Severity Grade After the First, Second and Third Vaccination Visit
Visit 3 - Systemic Reaction - Myalgia · Moderate
|
0 Participants
|
0 Participants
|
|
Number of Participants in the Simultaneous and Sequential Vaccination Groups With Solicited Local and Systemic Reactogenicity Events According to Severity Grade After the First, Second and Third Vaccination Visit
Visit 3 - Systemic Reaction - Myalgia · Severe
|
0 Participants
|
0 Participants
|
|
Number of Participants in the Simultaneous and Sequential Vaccination Groups With Solicited Local and Systemic Reactogenicity Events According to Severity Grade After the First, Second and Third Vaccination Visit
Visit 3 - Systemic Reaction - Myalgia · Life Threatening
|
0 Participants
|
0 Participants
|
|
Number of Participants in the Simultaneous and Sequential Vaccination Groups With Solicited Local and Systemic Reactogenicity Events According to Severity Grade After the First, Second and Third Vaccination Visit
Visit 3 - Systemic Reaction - Headache · None
|
3 Participants
|
0 Participants
|
|
Number of Participants in the Simultaneous and Sequential Vaccination Groups With Solicited Local and Systemic Reactogenicity Events According to Severity Grade After the First, Second and Third Vaccination Visit
Visit 3 - Systemic Reaction - Headache · Mild
|
1 Participants
|
0 Participants
|
|
Number of Participants in the Simultaneous and Sequential Vaccination Groups With Solicited Local and Systemic Reactogenicity Events According to Severity Grade After the First, Second and Third Vaccination Visit
Visit 3 - Systemic Reaction - Headache · Moderate
|
0 Participants
|
0 Participants
|
|
Number of Participants in the Simultaneous and Sequential Vaccination Groups With Solicited Local and Systemic Reactogenicity Events According to Severity Grade After the First, Second and Third Vaccination Visit
Visit 3 - Systemic Reaction - Headache · Severe
|
0 Participants
|
0 Participants
|
|
Number of Participants in the Simultaneous and Sequential Vaccination Groups With Solicited Local and Systemic Reactogenicity Events According to Severity Grade After the First, Second and Third Vaccination Visit
Visit 3 - Systemic Reaction - Headache · Life Threatening
|
0 Participants
|
0 Participants
|
|
Number of Participants in the Simultaneous and Sequential Vaccination Groups With Solicited Local and Systemic Reactogenicity Events According to Severity Grade After the First, Second and Third Vaccination Visit
Visit 3 - Systemic Reaction - Arthralgia · None
|
4 Participants
|
0 Participants
|
|
Number of Participants in the Simultaneous and Sequential Vaccination Groups With Solicited Local and Systemic Reactogenicity Events According to Severity Grade After the First, Second and Third Vaccination Visit
Visit 3 - Systemic Reaction - Arthralgia · Mild
|
0 Participants
|
0 Participants
|
|
Number of Participants in the Simultaneous and Sequential Vaccination Groups With Solicited Local and Systemic Reactogenicity Events According to Severity Grade After the First, Second and Third Vaccination Visit
Visit 3 - Systemic Reaction - Arthralgia · Moderate
|
0 Participants
|
0 Participants
|
|
Number of Participants in the Simultaneous and Sequential Vaccination Groups With Solicited Local and Systemic Reactogenicity Events According to Severity Grade After the First, Second and Third Vaccination Visit
Visit 3 - Systemic Reaction - Arthralgia · Severe
|
0 Participants
|
0 Participants
|
|
Number of Participants in the Simultaneous and Sequential Vaccination Groups With Solicited Local and Systemic Reactogenicity Events According to Severity Grade After the First, Second and Third Vaccination Visit
Visit 3 - Systemic Reaction - Arthralgia · Life Threatening
|
0 Participants
|
0 Participants
|
|
Number of Participants in the Simultaneous and Sequential Vaccination Groups With Solicited Local and Systemic Reactogenicity Events According to Severity Grade After the First, Second and Third Vaccination Visit
Visit 3 - Systemic Reaction - Nausea/Vomiting · None
|
3 Participants
|
0 Participants
|
|
Number of Participants in the Simultaneous and Sequential Vaccination Groups With Solicited Local and Systemic Reactogenicity Events According to Severity Grade After the First, Second and Third Vaccination Visit
Visit 3 - Systemic Reaction - Nausea/Vomiting · Mild
|
1 Participants
|
0 Participants
|
|
Number of Participants in the Simultaneous and Sequential Vaccination Groups With Solicited Local and Systemic Reactogenicity Events According to Severity Grade After the First, Second and Third Vaccination Visit
Visit 3 - Systemic Reaction - Nausea/Vomiting · Moderate
|
0 Participants
|
0 Participants
|
|
Number of Participants in the Simultaneous and Sequential Vaccination Groups With Solicited Local and Systemic Reactogenicity Events According to Severity Grade After the First, Second and Third Vaccination Visit
Visit 3 - Systemic Reaction - Nausea/Vomiting · Severe
|
0 Participants
|
0 Participants
|
|
Number of Participants in the Simultaneous and Sequential Vaccination Groups With Solicited Local and Systemic Reactogenicity Events According to Severity Grade After the First, Second and Third Vaccination Visit
Visit 3 - Systemic Reaction - Nausea/Vomiting · Life Threatening
|
0 Participants
|
0 Participants
|
|
Number of Participants in the Simultaneous and Sequential Vaccination Groups With Solicited Local and Systemic Reactogenicity Events According to Severity Grade After the First, Second and Third Vaccination Visit
Visit 3 - Systemic Reaction - Diarrhea · None
|
4 Participants
|
0 Participants
|
|
Number of Participants in the Simultaneous and Sequential Vaccination Groups With Solicited Local and Systemic Reactogenicity Events According to Severity Grade After the First, Second and Third Vaccination Visit
Visit 3 - Systemic Reaction - Diarrhea · Mild
|
0 Participants
|
0 Participants
|
|
Number of Participants in the Simultaneous and Sequential Vaccination Groups With Solicited Local and Systemic Reactogenicity Events According to Severity Grade After the First, Second and Third Vaccination Visit
Visit 3 - Systemic Reaction - Diarrhea · Moderate
|
0 Participants
|
0 Participants
|
|
Number of Participants in the Simultaneous and Sequential Vaccination Groups With Solicited Local and Systemic Reactogenicity Events According to Severity Grade After the First, Second and Third Vaccination Visit
Visit 3 - Systemic Reaction - Diarrhea · Severe
|
0 Participants
|
0 Participants
|
|
Number of Participants in the Simultaneous and Sequential Vaccination Groups With Solicited Local and Systemic Reactogenicity Events According to Severity Grade After the First, Second and Third Vaccination Visit
Visit 3 - Systemic Reaction - Diarrhea · Life Threatening
|
0 Participants
|
0 Participants
|
SECONDARY outcome
Timeframe: 120 DaysOutcome measures
| Measure |
Simultaneous Vaccination Group
n=169 Participants
Subjects will receive a dose of mRNA COVID-19 vaccine (either as a study procedure or standard of care) and IIV4 at Visit 1, saline placebo at Visit 2, and mRNA COVID-19 vaccine at Visit 3 for participants receiving their primary series of mRNA COVID-19 vaccine.
mRNA COVID-19: ACIP-CDC recommended vaccine
IIV4: ACIP recommended vaccine
Placebo: Saline Control
|
Sequential Vaccination Group
n=166 Participants
Subjects will receive a dose of mRNA COVID-19 vaccine (either as a study procedure or standard of care) and saline placebo at Visit 1, IIV4 at Visit 2, and mRNA COVID-19 vaccine at Visit 3 for participants receiving their primary series of mRNA COVID-19 vaccine.
mRNA COVID-19: ACIP-CDC recommended vaccine
IIV4: ACIP recommended vaccine
Placebo: Saline Control
|
|---|---|---|
|
Number of Participants With Observed Serious Adverse Events
|
1 Participants
|
1 Participants
|
Adverse Events
Simultaneous Vaccination Group
Serious events: 1 serious events
Other events: 18 other events
Deaths: 0 deaths
Sequential Vaccination Group
Serious events: 1 serious events
Other events: 9 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Simultaneous Vaccination Group
n=169 participants at risk
Subjects will receive a dose of mRNA COVID-19 vaccine (either as a study procedure or standard of care) and IIV4 at Visit 1, saline placebo at Visit 2, and mRNA COVID-19 vaccine at Visit 3 for participants receiving their primary series of mRNA COVID-19 vaccine.
mRNA COVID-19: ACIP-CDC recommended vaccine
IIV4: ACIP recommended vaccine
Placebo: Saline Control
|
Sequential Vaccination Group
n=166 participants at risk
Subjects will receive a dose of mRNA COVID-19 vaccine (either as a study procedure or standard of care) and saline placebo at Visit 1, IIV4 at Visit 2, and mRNA COVID-19 vaccine at Visit 3 for participants receiving their primary series of mRNA COVID-19 vaccine.
mRNA COVID-19: ACIP-CDC recommended vaccine
IIV4: ACIP recommended vaccine
Placebo: Saline Control
|
|---|---|---|
|
Pregnancy, puerperium and perinatal conditions
Spontaneous Complete Abortion
|
0.59%
1/169 • Number of events 1 • Adverse event data was collected over 120 days (approximately 4 months).
|
0.00%
0/166 • Adverse event data was collected over 120 days (approximately 4 months).
|
|
Gastrointestinal disorders
Small Bowel Obstruction
|
0.00%
0/169 • Adverse event data was collected over 120 days (approximately 4 months).
|
0.60%
1/166 • Number of events 1 • Adverse event data was collected over 120 days (approximately 4 months).
|
Other adverse events
| Measure |
Simultaneous Vaccination Group
n=169 participants at risk
Subjects will receive a dose of mRNA COVID-19 vaccine (either as a study procedure or standard of care) and IIV4 at Visit 1, saline placebo at Visit 2, and mRNA COVID-19 vaccine at Visit 3 for participants receiving their primary series of mRNA COVID-19 vaccine.
mRNA COVID-19: ACIP-CDC recommended vaccine
IIV4: ACIP recommended vaccine
Placebo: Saline Control
|
Sequential Vaccination Group
n=166 participants at risk
Subjects will receive a dose of mRNA COVID-19 vaccine (either as a study procedure or standard of care) and saline placebo at Visit 1, IIV4 at Visit 2, and mRNA COVID-19 vaccine at Visit 3 for participants receiving their primary series of mRNA COVID-19 vaccine.
mRNA COVID-19: ACIP-CDC recommended vaccine
IIV4: ACIP recommended vaccine
Placebo: Saline Control
|
|---|---|---|
|
Infections and infestations
COVID-19 Illness
|
10.7%
18/169 • Number of events 18 • Adverse event data was collected over 120 days (approximately 4 months).
|
5.4%
9/166 • Number of events 9 • Adverse event data was collected over 120 days (approximately 4 months).
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place