Adverse Drug Event, Injection Site Reaction, Quality of Life, Systemic Reaction
Conditions
Keywords
COVID-19, Influenza, vaccine, mRNA COVID-19 vaccine, influenza vaccine, safety, quality of life, pain following vaccination, fever following vaccination
Brief summary
This study is a prospective, randomized clinical trial. During this study, participants will be randomly assigned to receive quadrivalent inactivated influenza vaccine (IIV4) and mRNA COVID-19 vaccine either simultaneously or sequentially, 7-14 days apart. Persons in the simultaneous group will receive mRNA COVID-19 and IIV4 at Visit 1 (Day 1) and a saline placebo injection at Visit 2. Persons in the sequential group will receive mRNA COVID-19 vaccine and a saline placebo at Visit 1 (Day 1) and IIV4 injection at Visit 2. For participants receiving their primary dose series, a second dose of mRNA COVID-19 vaccine will be administered either 3 to 8 weeks or 4 to 8 weeks following the first dose, depending upon the mRNA COVID-19 vaccine provided. For those receiving a booster dose of mRNA COVID-19 only a single mRNA COVID-19 will be received in this study. Solicited symptoms of reactogenicity and adverse events will be assessed on vaccination day and daily during the 7 days following each Vaccination Visit using either electronic or paper symptoms diaries, depending on study participant preference. Quality of life data will be collected using electronic or paper diaries on day of Vaccination Visit 1 and daily during the 7 days following the visit. Serious adverse events and adverse events of special interest will be collected throughout the duration of the study. Participants are followed through Day 121. Serum samples from participants will be collected for determination of SARS-CoV-2 seropositivity at baseline. Serum samples will be taken throughout the study to determine IIV4 and COVID-19 vaccine immunogenicity and for potential future studies.
Interventions
BIOLOGICALmRNA COVID-19
ACIP-CDC recommended vaccine
BIOLOGICALIIV4
ACIP recommended vaccine
OTHERPlacebo (saline)
Saline Control
Sponsors
Centers for Disease Control and Prevention
Johns Hopkins University
Children's Hospital Medical Center, Cincinnati
Duke University
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
TRIPLE (Subject, Caregiver, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
5 Years to No maximum
Healthy volunteers
Yes
Inclusion criteria
* Persons aged ≥5 years if receiving primary two-dose mRNA COVID-19 vaccine series or persons aged ≥12 years if receiving a booster mRNA COVID-19 vaccine dose according to FDA authorization or approval and ACIP recommendation. Note: receipt of an mRNA COVID-19 vaccine within 8 hours of enrollment is permitted \*Individuals age 5-11 receiving a booster may be enrolled in the event a booster for individuals age 5-11 is authorized or approved and recommended by the ACIP. * English or Spanish literate * Intention of receiving influenza vaccine and COVID-19 vaccine based on ACIP-CDC guidelines * Willing to provide written informed consent * Intention of being available for entire study period and complete all relevant study procedures, including follow-up phone calls and clinic visits
Exclusion criteria
* Currently pregnant, planning to become pregnant within the first three months of the study per participant self-report or likely to be pregnant per screening criteria as defined in Section 5.1 at Visit 1 * Prior receipt of IIV4 during the respective influenza season in which they are being enrolled * \<9 years of age and recommended to receive two doses of IIV4 during the respective influenza season in which they are being enrolled * Prior receipt of non-mRNA COVID-19 vaccine * Documented COVID-19 infection within 6 weeks prior to enrollment confirmed by either medical history or lab testing * History of severe allergic reaction after a previous dose of any influenza vaccine; or to an influenza vaccine component, including egg protein * History of severe adverse reaction associated with a vaccine and/or severe allergic reaction (e.g. anaphylaxis) to any component of an mRNA vaccine * Receipt of any licensed inactivated vaccine within 2 weeks prior to enrollment in this study, receipt of any licensed live vaccine within 4 weeks prior to enrollment in this study, or receipt of Shingrix (Zoster Vaccine Recombinant, Adjuvanted) or HEPLISAV-B (Hepatitis B Vaccine (Recombinant), Adjuvanted) vaccine within 6 weeks prior to enrollment in this study or planning receipt of any vaccines following enrollment until 6 weeks after receipt of the second dose of mRNA COVID-19 vaccine * Has an active neoplastic disease (excluding non-melanoma skin cancer or prostate cancer that is stable in the absence of therapy) or a history of any hematologic malignancy\* \*Participants with a history of malignancy may be included if, after previous treatment by surgical excision, chemotherapy or radiation therapy, the participant has been observed for a period that in the investigator's estimation provides a reasonable assurance of sustained cure * Thrombocytopenia, bleeding disorder, or anticoagulant use contraindicating intramuscular injection (a daily aspirin may be acceptable). * Has immunosuppression as a result of an underlying illness or medications, such as antirejection/transplant regimens or immunomodulatory agents. Stable HIV disease is permitted per the following parameters: a. Confirmed stable HIV disease defined as documented viral load \<50 copies/mL and CD4 count \>200 within 6 months before enrollment, and on stable antiretroviral therapy for at least 6 months * Has known hepatitis B (HBV) or hepatitis C (HBC). Stable HBV or HBC are permitted per the following parameters: 1. If known HBV: confirmed inactive chronic HBV infection: HBsAg present for ≥6 months and HBeAg negative, anti-HBe positive; serum HBV DNA \<2000 IU/mL; persistently normal ALT or AST levels; in those who had liver biopsy, findings that confirm absence of significant necroinflammation 2. If known HCV: evidence of sustained virological response for ≥12 weeks after treatment or without evidence of HCV RNA viremia (undetectable HCV RNA) * Use of oral, parenteral, or high-dose inhaled glucocorticoids\* \*For definition of high-dose inhaled glucocorticoids, reference Appendix B. * History of Guillain-Barré syndrome * Prior enrollment in this study during the 2021-22 flu season * Anyone who is already enrolled or plans to enroll in another clinical trial with an investigational product during the study period.\* \*Per protocol, co-enrollment in observational or behavioral intervention studies are permitted at any time. An investigational product may be permitted for therapy of an illness condition that occurs during the study period e.g. COVID-19 illness. * Hearing loss determined by the investigators to prevent successful communication over the phone * History of myocarditis or pericarditis * History of multisystem inflammatory syndrome in children (MIS-C) or adults (MIS-A). * Has injury or other reason why deltoid site on both arms cannot be used for vaccinations. * Any condition which, in the opinion of the investigators, may pose a health risk to the subject or interfere with the evaluation of the study objectives. * Anyone who is a relative of any research study personnel. * Anyone who is an employee of any research study personnel.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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 | Up to 7 Days Post Vaccination (combined for Visits 1 and 2) | Subjects will be asked to complete a memory aid to document symptoms and measure temperature daily. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| 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 | Up to 7 Days Post Vaccination | Subjects will be asked to complete a memory aid to document symptoms and measure temperature daily. |
| Number of Participants With Moderate or More Severe Fever, Chills, Myalgia, or Arthralgia in the Simultaneous Versus Sequential Group Following the Second Vaccination Visit | Up to 7 Days Post Vaccination | Subjects will be asked to complete a memory aid to document symptoms and measure temperature daily. |
| 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 | Up to 7 Days Post Vaccination | Subjects will be asked to complete a memory aid to document symptoms and measure temperature daily. |
| Number of Participants With Observed Serious Adverse Events | 120 Days | — |
Countries
United States
Participant flow
Recruitment details
Participants were recruited at 3 academic medical centers during the 2021-22 and 2022-23 flu seasons.
Pre-assignment details
Of the 348 enrolled participants, 335 met inclusion criteria and were randomized to treatment.
Participants by arm
| Arm | Count |
|---|---|
| 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 | 169 |
| 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 | 166 |
| Total | 335 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 |
|---|---|---|---|
| Overall Study | Withdrawal by Subject | 1 | 0 |
Baseline characteristics
| Characteristic | Simultaneous Vaccination Group | Total | Sequential Vaccination Group |
|---|---|---|---|
| Age, Continuous | 33.7 years STANDARD_DEVIATION 8 | 33.4 years STANDARD_DEVIATION 15.1 | 33.1 years STANDARD_DEVIATION 9 |
| Ethnicity (NIH/OMB) Hispanic or Latino | 12 Participants | 21 Participants | 9 Participants |
| Ethnicity (NIH/OMB) Not Hispanic or Latino | 156 Participants | 312 Participants | 156 Participants |
| Ethnicity (NIH/OMB) Unknown or Not Reported | 1 Participants | 2 Participants | 1 Participants |
| Race (NIH/OMB) American Indian or Alaska Native | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Asian | 12 Participants | 27 Participants | 15 Participants |
| Race (NIH/OMB) Black or African American | 30 Participants | 60 Participants | 30 Participants |
| Race (NIH/OMB) More than one race | 9 Participants | 16 Participants | 7 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 1 Participants | 3 Participants | 2 Participants |
| Race (NIH/OMB) White | 117 Participants | 229 Participants | 112 Participants |
| Region of Enrollment United States | 169 Participants | 335 Participants | 166 Participants |
| Sex: Female, Male Female | 96 Participants | 211 Participants | 115 Participants |
| Sex: Female, Male Male | 73 Participants | 124 Participants | 51 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 0 / 169 | 0 / 166 |
| other Total, other adverse events | 18 / 169 | 9 / 166 |
| serious Total, serious adverse events | 1 / 169 | 1 / 166 |
Outcome results
Primary
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
Subjects will be asked to complete a memory aid to document symptoms and measure temperature daily.
Time frame: Up to 7 Days Post Vaccination (combined for Visits 1 and 2)
Population: Data combined for combined for Visits 1 and 2.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Simultaneous Vaccination Group | 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 |
| Sequential Vaccination Group | 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 | 52 Participants |
Comparison: The null hypothesis is the Simultaneous group is inferior (i.e., Simultaneous group will have a higher proportion) to the Sequential group in regards to the proportion of participants with at least one moderate or severe fever, chills, myalgia, or arthralgia event after visits 1 and 2 using 10% non-inferiority margin.p-value: 0.000795% CI: [-15.2, 4]Cochran-Mantel-Haenszel
Secondary
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
Subjects will be asked to complete a memory aid to document symptoms and measure temperature daily.
Time frame: Up to 7 Days Post Vaccination
Population: 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.
| Arm | Measure | Group | Category | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|---|
| Simultaneous Vaccination Group | 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 |
| Simultaneous Vaccination Group | 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 |
| Simultaneous Vaccination Group | 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 |
| Simultaneous Vaccination Group | 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 |
| Simultaneous Vaccination Group | 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 |
| Simultaneous Vaccination Group | 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 |
| Simultaneous Vaccination Group | 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 |
| Simultaneous Vaccination Group | 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 |
| Simultaneous Vaccination Group | 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 |
| Simultaneous Vaccination Group | 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 |
| Simultaneous Vaccination Group | 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 |
| Simultaneous Vaccination Group | 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 |
| Simultaneous Vaccination Group | 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 |
| Simultaneous Vaccination Group | 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 |
| Simultaneous Vaccination Group | 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 |
| Simultaneous Vaccination Group | 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 |
| Simultaneous Vaccination Group | 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 |
| Simultaneous Vaccination Group | 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 |
| Simultaneous Vaccination Group | 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 |
| Simultaneous Vaccination Group | 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 |
| Simultaneous Vaccination Group | 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 |
| Simultaneous Vaccination Group | 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 |
| Simultaneous Vaccination Group | 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 |
| Simultaneous Vaccination Group | 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 |
| Simultaneous Vaccination Group | 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 |
| Simultaneous Vaccination Group | 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 |
| Simultaneous Vaccination Group | 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 |
| Simultaneous Vaccination Group | 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 |
| Simultaneous Vaccination Group | 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 |
| Simultaneous Vaccination Group | 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 |
| Simultaneous Vaccination Group | 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 |
| Simultaneous Vaccination Group | 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 |
| Simultaneous Vaccination Group | 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 |
| Simultaneous Vaccination Group | 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 |
| Simultaneous Vaccination Group | 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 |
| Simultaneous Vaccination Group | 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 |
| Simultaneous Vaccination Group | 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 |
| Simultaneous Vaccination Group | 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 |
| Simultaneous Vaccination Group | 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 |
| Simultaneous Vaccination Group | 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 |
| Simultaneous Vaccination Group | 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 |
| Simultaneous Vaccination Group | 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 |
| Simultaneous Vaccination Group | 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 |
| Simultaneous Vaccination Group | 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 |
| Simultaneous Vaccination Group | 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 |
| Simultaneous Vaccination Group | 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 |
| Simultaneous Vaccination Group | 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 |
| Simultaneous Vaccination Group | 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 |
| Simultaneous Vaccination Group | 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 |
| Simultaneous Vaccination Group | 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 |
| Simultaneous Vaccination Group | 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 |
| Simultaneous Vaccination Group | 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 |
| Simultaneous Vaccination Group | 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 |
| Simultaneous Vaccination Group | 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 |
| Simultaneous Vaccination Group | 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 |
| Simultaneous Vaccination Group | 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 |
| Simultaneous Vaccination Group | 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 |
| Simultaneous Vaccination Group | 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 |
| Simultaneous Vaccination Group | 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 |
| Simultaneous Vaccination Group | 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 |
| Simultaneous Vaccination Group | 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 |
| Simultaneous Vaccination Group | 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 |
| Simultaneous Vaccination Group | 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 |
| Simultaneous Vaccination Group | 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 |
| Simultaneous Vaccination Group | 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 |
| Simultaneous Vaccination Group | 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 |
| Simultaneous Vaccination Group | 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 |
| Simultaneous Vaccination Group | 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 |
| Simultaneous Vaccination Group | 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 |
| Simultaneous Vaccination Group | 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 |
| Simultaneous Vaccination Group | 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 |
| Simultaneous Vaccination Group | 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 |
| Simultaneous Vaccination Group | 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 |
| Simultaneous Vaccination Group | 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 |
| Simultaneous Vaccination Group | 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 |
| Simultaneous Vaccination Group | 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 |
| Simultaneous Vaccination Group | 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 |
| Simultaneous Vaccination Group | 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 |
| Simultaneous Vaccination Group | 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 |
| Simultaneous Vaccination Group | 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 |
| Simultaneous Vaccination Group | 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 |
| Simultaneous Vaccination Group | 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 |
| Simultaneous Vaccination Group | 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 |
| Simultaneous Vaccination Group | 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 |
| Simultaneous Vaccination Group | 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 |
| Simultaneous Vaccination Group | 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 |
| Simultaneous Vaccination Group | 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 |
| Simultaneous Vaccination Group | 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 |
| Simultaneous Vaccination Group | 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 |
| Simultaneous Vaccination Group | 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 |
| Simultaneous Vaccination Group | 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 |
| Simultaneous Vaccination Group | 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 |
| Simultaneous Vaccination Group | 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 |
| Simultaneous Vaccination Group | 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 |
| Simultaneous Vaccination Group | 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 |
| Simultaneous Vaccination Group | 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 |
| Simultaneous Vaccination Group | 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 |
| Simultaneous Vaccination Group | 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 |
| Simultaneous Vaccination Group | 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 |
| Simultaneous Vaccination Group | 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 |
| Simultaneous Vaccination Group | 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 |
| Simultaneous Vaccination Group | 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 |
| Simultaneous Vaccination Group | 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 |
| Simultaneous Vaccination Group | 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 |
| Simultaneous Vaccination Group | 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 |
| Simultaneous Vaccination Group | 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 |
| Simultaneous Vaccination Group | 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 |
| Simultaneous Vaccination Group | 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 |
| Simultaneous Vaccination Group | 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 |
| Simultaneous Vaccination Group | 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 |
| Simultaneous Vaccination Group | 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 |
| Simultaneous Vaccination Group | 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 |
| Simultaneous Vaccination Group | 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 |
| Simultaneous Vaccination Group | 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 |
| Simultaneous Vaccination Group | 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 |
| Simultaneous Vaccination Group | 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 |
| Simultaneous Vaccination Group | 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 |
| Simultaneous Vaccination Group | 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 |
| Simultaneous Vaccination Group | 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 |
| Simultaneous Vaccination Group | 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 |
| Simultaneous Vaccination Group | 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 |
| Simultaneous Vaccination Group | 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 |
| Simultaneous Vaccination Group | 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 |
| Simultaneous Vaccination Group | 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 |
| Simultaneous Vaccination Group | 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 |
| Simultaneous Vaccination Group | 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 |
| Simultaneous Vaccination Group | 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 |
| Simultaneous Vaccination Group | 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 |
| Simultaneous Vaccination Group | 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 |
| Simultaneous Vaccination Group | 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 |
| Simultaneous Vaccination Group | 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 |
| Simultaneous Vaccination Group | 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 |
| Simultaneous Vaccination Group | 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 |
| Simultaneous Vaccination Group | 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 |
| Simultaneous Vaccination Group | 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 |
| Simultaneous Vaccination Group | 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 |
| Simultaneous Vaccination Group | 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 |
| Simultaneous Vaccination Group | 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 |
| Simultaneous Vaccination Group | 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 |
| Simultaneous Vaccination Group | 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 |
| Simultaneous Vaccination Group | 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 |
| Simultaneous Vaccination Group | 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 |
| Simultaneous Vaccination Group | 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 |
| Simultaneous Vaccination Group | 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 |
| Simultaneous Vaccination Group | 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 |
| Simultaneous Vaccination Group | 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 |
| Simultaneous Vaccination Group | 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 |
| Simultaneous Vaccination Group | 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 |
| Simultaneous Vaccination Group | 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 |
| Simultaneous Vaccination Group | 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 |
| Simultaneous Vaccination Group | 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 |
| Simultaneous Vaccination Group | 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 |
| Simultaneous Vaccination Group | 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 |
| Simultaneous Vaccination Group | 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 |
| Simultaneous Vaccination Group | 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 |
| Simultaneous Vaccination Group | 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 |
| Simultaneous Vaccination Group | 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 |
| Simultaneous Vaccination Group | 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 |
| Simultaneous Vaccination Group | 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 |
| Simultaneous Vaccination Group | 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 |
| Simultaneous Vaccination Group | 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 |
| Simultaneous Vaccination Group | 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 |
| Simultaneous Vaccination Group | 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 |
| Simultaneous Vaccination Group | 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 |
| Simultaneous Vaccination Group | 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 |
| Simultaneous Vaccination Group | 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 |
| Simultaneous Vaccination Group | 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 |
| Simultaneous Vaccination Group | 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 |
| Simultaneous Vaccination Group | 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 |
| Simultaneous Vaccination Group | 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 |
| Simultaneous Vaccination Group | 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 |
| Simultaneous Vaccination Group | 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 |
| Simultaneous Vaccination Group | 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 |
| Simultaneous Vaccination Group | 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 |
| Simultaneous Vaccination Group | 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 |
| Simultaneous Vaccination Group | 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 |
| Simultaneous Vaccination Group | 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 |
| Simultaneous Vaccination Group | 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 |
| Simultaneous Vaccination Group | 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 |
| Simultaneous Vaccination Group | 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 |
| Simultaneous Vaccination Group | 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 |
| Simultaneous Vaccination Group | 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 |
| Simultaneous Vaccination Group | 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 |
| Simultaneous Vaccination Group | 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 |
| Simultaneous Vaccination Group | 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 |
| Simultaneous Vaccination Group | 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 |
| Simultaneous Vaccination Group | 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 |
| Simultaneous Vaccination Group | 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 |
| Simultaneous Vaccination Group | 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 |
| Simultaneous Vaccination Group | 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 |
| Simultaneous Vaccination Group | 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 |
| Simultaneous Vaccination Group | 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 |
| Simultaneous Vaccination Group | 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 |
| Simultaneous Vaccination Group | 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 |
| Simultaneous Vaccination Group | 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 |
| Simultaneous Vaccination Group | 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 |
| Simultaneous Vaccination Group | 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 |
| Simultaneous Vaccination Group | 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 |
| Simultaneous Vaccination Group | 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 |
| Simultaneous Vaccination Group | 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 |
| Sequential Vaccination Group | 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 |
| Sequential Vaccination Group | 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 | 27 Participants |
| Sequential Vaccination Group | 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 |
| Sequential Vaccination Group | 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 | 97 Participants |
| Sequential Vaccination Group | 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 | 156 Participants |
| Sequential Vaccination Group | 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 | 40 Participants |
| Sequential Vaccination Group | 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 |
| Sequential Vaccination Group | 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 | 2 Participants |
| Sequential Vaccination Group | 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 | 7 Participants |
| Sequential Vaccination Group | 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 |
| Sequential Vaccination Group | 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 | 0 Participants |
| Sequential Vaccination Group | 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 | 145 Participants |
| Sequential Vaccination Group | 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 | 3 Participants |
| Sequential Vaccination Group | 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 | 20 Participants |
| Sequential Vaccination Group | 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 |
| Sequential Vaccination Group | 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 | 1 Participants |
| Sequential Vaccination Group | 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 |
| Sequential Vaccination Group | 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 | 0 Participants |
| Sequential Vaccination Group | 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 |
| Sequential Vaccination Group | 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 |
| Sequential Vaccination Group | 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 |
| Sequential Vaccination Group | 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 | 156 Participants |
| Sequential Vaccination Group | 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 |
| Sequential Vaccination Group | 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 |
| Sequential Vaccination Group | 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 | 160 Participants |
| Sequential Vaccination Group | 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 | 5 Participants |
| Sequential Vaccination Group | 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 |
| Sequential Vaccination Group | 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 | 1 Participants |
| Sequential Vaccination Group | 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 |
| Sequential Vaccination Group | 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 |
| Sequential Vaccination Group | 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 | 0 Participants |
| Sequential Vaccination Group | 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 |
| Sequential Vaccination Group | 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 | 2 Participants |
| Sequential Vaccination Group | 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 | 1 Participants |
| Sequential Vaccination Group | 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 |
| Sequential Vaccination Group | 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 | 1 Participants |
| Sequential Vaccination Group | 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 |
| Sequential Vaccination Group | 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 |
| Sequential Vaccination Group | 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 |
| Sequential Vaccination Group | 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 |
| Sequential Vaccination Group | 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 |
| Sequential Vaccination Group | 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 | 157 Participants |
| Sequential Vaccination Group | 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 |
| Sequential Vaccination Group | 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 | 6 Participants |
| Sequential Vaccination Group | 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 | 152 Participants |
| Sequential Vaccination Group | 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 | 2 Participants |
| Sequential Vaccination Group | 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 |
| Sequential Vaccination Group | 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 | 1 Participants |
| Sequential Vaccination Group | 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 | 14 Participants |
| Sequential Vaccination Group | 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 |
| Sequential Vaccination Group | 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 | 0 Participants |
| Sequential Vaccination Group | 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 |
| Sequential Vaccination Group | 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 |
| Sequential Vaccination Group | 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 | 0 Participants |
| Sequential Vaccination Group | 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 |
| Sequential Vaccination Group | 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 |
| Sequential Vaccination Group | 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 |
| Sequential Vaccination Group | 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 | 0 Participants |
| Sequential Vaccination Group | 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 |
| Sequential Vaccination Group | 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 |
| Sequential Vaccination Group | 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 |
| Sequential Vaccination Group | 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 | 111 Participants |
| Sequential Vaccination Group | 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 |
| Sequential Vaccination Group | 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 | 43 Participants |
| Sequential Vaccination Group | 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 | 0 Participants |
| Sequential Vaccination Group | 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 | 11 Participants |
| Sequential Vaccination Group | 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 |
| Sequential Vaccination Group | 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 | 1 Participants |
| Sequential Vaccination Group | 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 |
| Sequential Vaccination Group | 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 |
| Sequential Vaccination Group | 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 | 0 Participants |
| Sequential Vaccination Group | 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 | 158 Participants |
| Sequential Vaccination Group | 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 |
| Sequential Vaccination Group | 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 | 5 Participants |
| Sequential Vaccination Group | 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 |
| Sequential Vaccination Group | 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 | 3 Participants |
| Sequential Vaccination Group | 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 |
| Sequential Vaccination Group | 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 |
| Sequential Vaccination Group | 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 |
| Sequential Vaccination Group | 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 |
| Sequential Vaccination Group | 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 | 129 Participants |
| Sequential Vaccination Group | 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 | 155 Participants |
| Sequential Vaccination Group | 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 |
| Sequential Vaccination Group | 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 | 6 Participants |
| Sequential Vaccination Group | 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 | 21 Participants |
| Sequential Vaccination Group | 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 | 2 Participants |
| Sequential Vaccination Group | 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 | 0 Participants |
| Sequential Vaccination Group | 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 | 3 Participants |
| Sequential Vaccination Group | 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 | 11 Participants |
| Sequential Vaccination Group | 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 |
| Sequential Vaccination Group | 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 | 0 Participants |
| Sequential Vaccination Group | 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 | 116 Participants |
| Sequential Vaccination Group | 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 | 5 Participants |
| Sequential Vaccination Group | 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 | 26 Participants |
| Sequential Vaccination Group | 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 |
| Sequential Vaccination Group | 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 | 19 Participants |
| Sequential Vaccination Group | 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 |
| Sequential Vaccination Group | 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 | 5 Participants |
| Sequential Vaccination Group | 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 |
| Sequential Vaccination Group | 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 |
| Sequential Vaccination Group | 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 | 142 Participants |
| Sequential Vaccination Group | 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 | 61 Participants |
| Sequential Vaccination Group | 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 | 0 Participants |
| Sequential Vaccination Group | 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 | 61 Participants |
| Sequential Vaccination Group | 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 | 19 Participants |
| Sequential Vaccination Group | 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 | 34 Participants |
| Sequential Vaccination Group | 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 |
| Sequential Vaccination Group | 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 | 10 Participants |
| Sequential Vaccination Group | 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 | 3 Participants |
| Sequential Vaccination Group | 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 |
| Sequential Vaccination Group | 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 | 0 Participants |
| Sequential Vaccination Group | 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 | 65 Participants |
| Sequential Vaccination Group | 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 | 2 Participants |
| Sequential Vaccination Group | 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 | 60 Participants |
| Sequential Vaccination Group | 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 |
| Sequential Vaccination Group | 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 | 33 Participants |
| Sequential Vaccination Group | 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 |
| Sequential Vaccination Group | 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 | 8 Participants |
| Sequential Vaccination Group | 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 |
| Sequential Vaccination Group | 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 |
| Sequential Vaccination Group | 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 | 146 Participants |
| Sequential Vaccination Group | 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 | 80 Participants |
| Sequential Vaccination Group | 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 |
| Sequential Vaccination Group | 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 | 58 Participants |
| Sequential Vaccination Group | 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 | 17 Participants |
| Sequential Vaccination Group | 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 | 25 Participants |
| Sequential Vaccination Group | 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 | 0 Participants |
| Sequential Vaccination Group | 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 | 3 Participants |
| Sequential Vaccination Group | 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 | 2 Participants |
| Sequential Vaccination Group | 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 |
| Sequential Vaccination Group | 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 |
| Sequential Vaccination Group | 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 | 0 Participants |
| Sequential Vaccination Group | 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 | 164 Participants |
| Sequential Vaccination Group | 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 | 1 Participants |
| Sequential Vaccination Group | 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 | 2 Participants |
| Sequential Vaccination Group | 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 |
| Sequential Vaccination Group | 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 |
| Sequential Vaccination Group | 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 |
| Sequential Vaccination Group | 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 |
| Sequential Vaccination Group | 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 | 0 Participants |
| Sequential Vaccination Group | 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 |
| Sequential Vaccination Group | 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 | 82 Participants |
| Sequential Vaccination Group | 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 | 141 Participants |
| Sequential Vaccination Group | 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 |
| Sequential Vaccination Group | 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 | 21 Participants |
| Sequential Vaccination Group | 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 | 75 Participants |
| Sequential Vaccination Group | 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 | 3 Participants |
| Sequential Vaccination Group | 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 |
| Sequential Vaccination Group | 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 | 1 Participants |
| Sequential Vaccination Group | 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 | 8 Participants |
| Sequential Vaccination Group | 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 |
| Sequential Vaccination Group | 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 |
| Sequential Vaccination Group | 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 | 162 Participants |
| Sequential Vaccination Group | 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 |
| Sequential Vaccination Group | 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 | 3 Participants |
| Sequential Vaccination Group | 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 |
| Sequential Vaccination Group | 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 |
| Sequential Vaccination Group | 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 |
| Sequential Vaccination Group | 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 |
| Sequential Vaccination Group | 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 |
| Sequential Vaccination Group | 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 |
| Sequential Vaccination Group | 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 | 160 Participants |
| Sequential Vaccination Group | 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 | 157 Participants |
| Sequential Vaccination Group | 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 |
| Sequential Vaccination Group | 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 | 7 Participants |
| Sequential Vaccination Group | 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 | 4 Participants |
| Sequential Vaccination Group | 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 | 2 Participants |
| Sequential Vaccination Group | 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 | 0 Participants |
| Sequential Vaccination Group | 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 |
| Sequential Vaccination Group | 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 | 2 Participants |
| Sequential Vaccination Group | 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 |
| Sequential Vaccination Group | 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 |
| Sequential Vaccination Group | 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 | 121 Participants |
| Sequential Vaccination Group | 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 |
| Sequential Vaccination Group | 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 | 34 Participants |
| Sequential Vaccination Group | 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 |
| Sequential Vaccination Group | 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 | 10 Participants |
| Sequential Vaccination Group | 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 | 0 Participants |
| Sequential Vaccination Group | 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 | 1 Participants |
| Sequential Vaccination Group | 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 |
| Sequential Vaccination Group | 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 |
| Sequential Vaccination Group | 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 |
| Sequential Vaccination Group | 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 | 124 Participants |
| Sequential Vaccination Group | 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 | 0 Participants |
| Sequential Vaccination Group | 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 | 34 Participants |
| Sequential Vaccination Group | 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 | 0 Participants |
| Sequential Vaccination Group | 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 | 7 Participants |
| Sequential Vaccination Group | 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 |
| Sequential Vaccination Group | 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 | 1 Participants |
| Sequential Vaccination Group | 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 |
| Sequential Vaccination Group | 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 |
| Sequential Vaccination Group | 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 |
| Sequential Vaccination Group | 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 | 129 Participants |
| Sequential Vaccination Group | 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 |
| Sequential Vaccination Group | 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 | 26 Participants |
| Sequential Vaccination Group | 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 |
| Sequential Vaccination Group | 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 | 11 Participants |
| Sequential Vaccination Group | 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 |
| Sequential Vaccination Group | 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 | 0 Participants |
| Sequential Vaccination Group | 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 |
Secondary
Number of Participants With Moderate or More Severe Fever, Chills, Myalgia, or Arthralgia in the Simultaneous Versus Sequential Group Following the Second Vaccination Visit
Subjects will be asked to complete a memory aid to document symptoms and measure temperature daily.
Time frame: Up to 7 Days Post Vaccination
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Simultaneous Vaccination Group | 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 |
| Sequential Vaccination Group | Number of Participants With Moderate or More Severe Fever, Chills, Myalgia, or Arthralgia in the Simultaneous Versus Sequential Group Following the Second Vaccination Visit | 9 Participants |
p-value: 0.2886Mantel Haenszel
Secondary
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
Subjects will be asked to complete a memory aid to document symptoms and measure temperature daily.
Time frame: Up to 7 Days Post Vaccination
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Simultaneous Vaccination Group | 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 |
| Sequential Vaccination Group | 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 | 47 Participants |
p-value: 0.3851Mantel Haenszel
Secondary
Number of Participants With Observed Serious Adverse Events
Time frame: 120 Days
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Simultaneous Vaccination Group | Number of Participants With Observed Serious Adverse Events | 1 Participants |
| Sequential Vaccination Group | Number of Participants With Observed Serious Adverse Events | 1 Participants |
95% CI: [-1.66, 1.64]