Influenza
Conditions
Brief summary
The purpose of this study is to determine the immunogenicity and safety profile of CSL Limited's Influenza Virus Vaccine compared to a US licensed comparator Influenza Virus Vaccine in a pediatric population aged greater than or equal to 6 months to less than 18 years.
Interventions
BIOLOGICALCSL's Influenza Virus Vaccine (Afluria)
0.25 mL (one or two doses) or 0.5 mL (one or two doses) by intramuscular injection as directed by immunization guidelines
BIOLOGICALInfluenza Virus Vaccine (Fluzone)
0.25 mL (one or two doses) or 0.5 mL (one or two doses) by intramuscular injection as directed by immunization guidelines
Sponsors
Seqirus
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
6 Months to 17 Years
Healthy volunteers
Yes
Inclusion criteria
* Healthy male or non-pregnant female participants aged ≥ 6 calendar months to \< 18 years at the time of the first study vaccination. * For participants aged ≥ 6 months to \< 9 years, born after a normal gestation period (between 36 and 42 weeks). * Females of childbearing potential (i.e., ovulating, pre-menopausal, not surgically sterile) must be abstinent or be willing to use a medically accepted contraceptive regimen for at least 2 months after vaccination. Females aged ≥ 9 years must also return a negative urine pregnancy test at enrollment.
Exclusion criteria
* Known hypersensitivity to a previous dose of influenza vaccine or allergy to eggs, chicken protein, neomycin, polymyxin, or any components of the Study Vaccine.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Geometric Mean Titer 30 Days After the Last Study Vaccination | 30 days after the last study vaccination | — |
| Percentage of Participants With Seroconversion 30 Days After the Last Study Vaccination | 30 days after the last study vaccination | Seroconversion rate was defined as the proportion of participants with either a titer of less than 1:10 before vaccination achieving a HI antibody titer of 1:40 or more after vaccination, or a HI titer of 1:10 or more before vaccination achieving a four-fold or greater increase in HI titer after vaccination. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Frequency and Intensity of Local and Systemic Solicited Symptoms, Cohort C | 7 days after vaccination | — |
| Frequency and Intensity of Unsolicited Adverse Events (UAEs) | 30 days after each vaccination | UAE stands for Unsolicited Adverse Events |
| New Onset of Chronic Illnesses (NOCIs) | 6 months after last study vaccination | New onset of chronic illness after any vaccine dose. A new onset of chronic illness was defined as the diagnosis of a new medical condition which was chronic in nature, including those potentially controllable by medication (e.g., diabetes, asthma). |
| Frequency and Intensity of Local and Systemic Solicited Symptoms, Cohort A (6 Months to < 3 Years) | 7 days after each vaccination | — |
| Duration of Local and Systemic Solicited Symptoms, Cohort A (6 Months to < 3 Years) | 7 days after each vaccination | — |
| Duration of Local and Systemic Solicited Symptoms, Cohort B | 7 days after each vaccination | — |
| Duration of Local and Systemic Solicited Symptoms, Cohort C | 7 days after vaccination | — |
| Serious Adverse Events (SAEs) | 6 months after last study vaccination | — |
| Frequency and Intensity of Local and Systemic Solicited Symptoms, Cohort B | 7 days after each vaccination | — |
Countries
United States
Participant flow
Recruitment details
Participants were enrolled into this study during the autumn of 2009 at 23 sites in the US.
Pre-assignment details
A total of 1474 participants were enrolled, vaccinated and analyzed.
Participants by arm
| Arm | Count |
|---|---|
| Afluria Cohort A Age 6 months to \< 3 years. Participants received one of two doses of the 2009/2010 influenza season formulation of Afluria. | 231 |
| Afluria Cohort B Age 3 to \< 9 years. Participants received one or two doses of the 2009/2010 influenza season formulation of Afluria. | 254 |
| Afluria Cohort C Age 9 to \< 18 years. Participants received one or two doses of the 2009/2010 influenza season formulation of Afluria. | 254 |
| Fluzone Cohort A Age 6 months to \< 3 years. Participants received one of two doses of the 2009/2010 influenza season formulation of Fluzone. | 228 |
| Fluzone Cohort B Age 3 to \< 9 years. Participants received one of two doses of the 2009/2010 influenza season formulation of Fluzone. | 257 |
| Fluzone Cohort C Age 9 to \< 18 years. Participants received one of two doses of the 2009/2010 influenza season formulation of Fluzone. | 250 |
| Total | 1,474 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 | FG002 | FG003 | FG004 | FG005 |
|---|---|---|---|---|---|---|---|
| Overall Study | Adverse Event | 1 | 0 | 0 | 0 | 0 | 0 |
| Overall Study | Contraindicated medication | 0 | 0 | 0 | 1 | 0 | 0 |
| Overall Study | Lost to Follow-up | 17 | 5 | 1 | 10 | 9 | 1 |
| Overall Study | Withdrawal by Subject | 0 | 2 | 0 | 0 | 0 | 0 |
Baseline characteristics
| Characteristic | Afluria Cohort B | Afluria Cohort C | Fluzone Cohort A | Afluria Cohort A | Fluzone Cohort B | Fluzone Cohort C | Total |
|---|---|---|---|---|---|---|---|
| Age, Categorical <=18 years | 254 Participants | 254 Participants | 228 Participants | 231 Participants | 257 Participants | 250 Participants | 1474 Participants |
| Age, Categorical >=65 years | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Age, Categorical Between 18 and 65 years | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Age, Continuous | 5.93 years STANDARD_DEVIATION 1.725 | 12.98 years STANDARD_DEVIATION 2.388 | 1.96 years STANDARD_DEVIATION 0.673 | 1.94 years STANDARD_DEVIATION 0.667 | 5.82 years STANDARD_DEVIATION 1.748 | 12.86 years STANDARD_DEVIATION 2.474 | 7.06 years STANDARD_DEVIATION 4.855 |
| Region of Enrollment United States | 254 participants | 254 participants | 228 participants | 231 participants | 257 participants | 250 participants | 1474 participants |
| Sex: Female, Male Female | 140 Participants | 121 Participants | 101 Participants | 119 Participants | 127 Participants | 120 Participants | 728 Participants |
| Sex: Female, Male Male | 114 Participants | 133 Participants | 127 Participants | 112 Participants | 130 Participants | 130 Participants | 746 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk | EG002 affected / at risk | EG003 affected / at risk | EG004 affected / at risk | EG005 affected / at risk |
|---|---|---|---|---|---|---|
| deaths Total, all-cause mortality | — / — | — / — | — / — | — / — | — / — | — / — |
| other Total, other adverse events | 210 / 231 | 216 / 254 | 214 / 254 | 187 / 228 | 202 / 257 | 202 / 250 |
| serious Total, serious adverse events | 4 / 229 | 3 / 252 | 2 / 254 | 4 / 228 | 0 / 255 | 0 / 250 |
Outcome results
Primary
Geometric Mean Titer 30 Days After the Last Study Vaccination
Time frame: 30 days after the last study vaccination
Population: Per-protocol population
| Arm | Measure | Group | Value (GEOMETRIC_MEAN) |
|---|---|---|---|
| Afluria Cohort A | Geometric Mean Titer 30 Days After the Last Study Vaccination | H3N2 ( A/Uruguay/716/2007) | 309.19 Titers |
| Afluria Cohort A | Geometric Mean Titer 30 Days After the Last Study Vaccination | H1N1 (A/Brisbane/59/2007) | 235.44 Titers |
| Afluria Cohort A | Geometric Mean Titer 30 Days After the Last Study Vaccination | B (B/Brisbane/60/2008) | 73.46 Titers |
| Fluzone Cohort A | Geometric Mean Titer 30 Days After the Last Study Vaccination | H3N2 ( A/Uruguay/716/2007) | 909.22 Titers |
| Fluzone Cohort A | Geometric Mean Titer 30 Days After the Last Study Vaccination | H1N1 (A/Brisbane/59/2007) | 345.50 Titers |
| Fluzone Cohort A | Geometric Mean Titer 30 Days After the Last Study Vaccination | B (B/Brisbane/60/2008) | 122.71 Titers |
| Afluria Cohort C | Geometric Mean Titer 30 Days After the Last Study Vaccination | H3N2 ( A/Uruguay/716/2007) | 948.86 Titers |
| Afluria Cohort C | Geometric Mean Titer 30 Days After the Last Study Vaccination | H1N1 (A/Brisbane/59/2007) | 652.99 Titers |
| Afluria Cohort C | Geometric Mean Titer 30 Days After the Last Study Vaccination | B (B/Brisbane/60/2008) | 107.92 Titers |
| Fluzone Cohort A | Geometric Mean Titer 30 Days After the Last Study Vaccination | H3N2 ( A/Uruguay/716/2007) | 340.49 Titers |
| Fluzone Cohort A | Geometric Mean Titer 30 Days After the Last Study Vaccination | H1N1 (A/Brisbane/59/2007) | 227.19 Titers |
| Fluzone Cohort A | Geometric Mean Titer 30 Days After the Last Study Vaccination | B (B/Brisbane/60/2008) | 57.92 Titers |
| Fluzone Cohort B | Geometric Mean Titer 30 Days After the Last Study Vaccination | H3N2 ( A/Uruguay/716/2007) | 870.34 Titers |
| Fluzone Cohort B | Geometric Mean Titer 30 Days After the Last Study Vaccination | H1N1 (A/Brisbane/59/2007) | 351.88 Titers |
| Fluzone Cohort B | Geometric Mean Titer 30 Days After the Last Study Vaccination | B (B/Brisbane/60/2008) | 104.91 Titers |
| Fluzone Cohort C | Geometric Mean Titer 30 Days After the Last Study Vaccination | H1N1 (A/Brisbane/59/2007) | 652.17 Titers |
| Fluzone Cohort C | Geometric Mean Titer 30 Days After the Last Study Vaccination | B (B/Brisbane/60/2008) | 126.99 Titers |
| Fluzone Cohort C | Geometric Mean Titer 30 Days After the Last Study Vaccination | H3N2 ( A/Uruguay/716/2007) | 1069.7 Titers |
Primary
Percentage of Participants With Seroconversion 30 Days After the Last Study Vaccination
Seroconversion rate was defined as the proportion of participants with either a titer of less than 1:10 before vaccination achieving a HI antibody titer of 1:40 or more after vaccination, or a HI titer of 1:10 or more before vaccination achieving a four-fold or greater increase in HI titer after vaccination.
Time frame: 30 days after the last study vaccination
Population: Per-Protocol Population
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Afluria Cohort A | Percentage of Participants With Seroconversion 30 Days After the Last Study Vaccination | H1N1 (A/Brisbane/59/2007) | 84 Percentage of participants |
| Afluria Cohort A | Percentage of Participants With Seroconversion 30 Days After the Last Study Vaccination | H3N2 ( A/Uruguay/716/2007) | 83 Percentage of participants |
| Afluria Cohort A | Percentage of Participants With Seroconversion 30 Days After the Last Study Vaccination | B (B/Brisbane/60/2008) | 67 Percentage of participants |
| Fluzone Cohort A | Percentage of Participants With Seroconversion 30 Days After the Last Study Vaccination | H3N2 ( A/Uruguay/716/2007) | 71 Percentage of participants |
| Fluzone Cohort A | Percentage of Participants With Seroconversion 30 Days After the Last Study Vaccination | H1N1 (A/Brisbane/59/2007) | 66 Percentage of participants |
| Fluzone Cohort A | Percentage of Participants With Seroconversion 30 Days After the Last Study Vaccination | B (B/Brisbane/60/2008) | 73 Percentage of participants |
| Afluria Cohort C | Percentage of Participants With Seroconversion 30 Days After the Last Study Vaccination | H3N2 ( A/Uruguay/716/2007) | 72 Percentage of participants |
| Afluria Cohort C | Percentage of Participants With Seroconversion 30 Days After the Last Study Vaccination | H1N1 (A/Brisbane/59/2007) | 64 Percentage of participants |
| Afluria Cohort C | Percentage of Participants With Seroconversion 30 Days After the Last Study Vaccination | B (B/Brisbane/60/2008) | 67 Percentage of participants |
| Fluzone Cohort A | Percentage of Participants With Seroconversion 30 Days After the Last Study Vaccination | B (B/Brisbane/60/2008) | 61 Percentage of participants |
| Fluzone Cohort A | Percentage of Participants With Seroconversion 30 Days After the Last Study Vaccination | H1N1 (A/Brisbane/59/2007) | 74 Percentage of participants |
| Fluzone Cohort A | Percentage of Participants With Seroconversion 30 Days After the Last Study Vaccination | H3N2 ( A/Uruguay/716/2007) | 85 Percentage of participants |
| Fluzone Cohort B | Percentage of Participants With Seroconversion 30 Days After the Last Study Vaccination | H3N2 ( A/Uruguay/716/2007) | 74 Percentage of participants |
| Fluzone Cohort B | Percentage of Participants With Seroconversion 30 Days After the Last Study Vaccination | H1N1 (A/Brisbane/59/2007) | 64 Percentage of participants |
| Fluzone Cohort B | Percentage of Participants With Seroconversion 30 Days After the Last Study Vaccination | B (B/Brisbane/60/2008) | 76 Percentage of participants |
| Fluzone Cohort C | Percentage of Participants With Seroconversion 30 Days After the Last Study Vaccination | H3N2 ( A/Uruguay/716/2007) | 73 Percentage of participants |
| Fluzone Cohort C | Percentage of Participants With Seroconversion 30 Days After the Last Study Vaccination | H1N1 (A/Brisbane/59/2007) | 61 Percentage of participants |
| Fluzone Cohort C | Percentage of Participants With Seroconversion 30 Days After the Last Study Vaccination | B (B/Brisbane/60/2008) | 73 Percentage of participants |
Secondary
Duration of Local and Systemic Solicited Symptoms, Cohort A (6 Months to < 3 Years)
Time frame: 7 days after each vaccination
Population: Safety population
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Afluria Cohort A | Duration of Local and Systemic Solicited Symptoms, Cohort A (6 Months to < 3 Years) | Any pain post-dose 1 | 1.57 Days | Standard Deviation 0.952 |
| Afluria Cohort A | Duration of Local and Systemic Solicited Symptoms, Cohort A (6 Months to < 3 Years) | Any redness (> 0 mm), post dose 1 | 2.09 Days | Standard Deviation 1.405 |
| Afluria Cohort A | Duration of Local and Systemic Solicited Symptoms, Cohort A (6 Months to < 3 Years) | Any swelling (> 0 mm), post dose 1 | 3.13 Days | Standard Deviation 2.93 |
| Afluria Cohort A | Duration of Local and Systemic Solicited Symptoms, Cohort A (6 Months to < 3 Years) | Any pain post-dose 2 | 1.54 Days | Standard Deviation 0.793 |
| Afluria Cohort A | Duration of Local and Systemic Solicited Symptoms, Cohort A (6 Months to < 3 Years) | Any redness (> 0 mm), post dose 2 | 1.80 Days | Standard Deviation 1.014 |
| Afluria Cohort A | Duration of Local and Systemic Solicited Symptoms, Cohort A (6 Months to < 3 Years) | Any swelling (> 0 mm), post dose 2 | 1.67 Days | Standard Deviation 0.707 |
| Afluria Cohort A | Duration of Local and Systemic Solicited Symptoms, Cohort A (6 Months to < 3 Years) | Any fever dose 1 (≥ 99.5°F ax or ≥ 100.4°F oral) | 1.38 Days | Standard Deviation 0.869 |
| Afluria Cohort A | Duration of Local and Systemic Solicited Symptoms, Cohort A (6 Months to < 3 Years) | Any nausea/vomiting, post dose 1 | 1.42 Days | Standard Deviation 1.119 |
| Afluria Cohort A | Duration of Local and Systemic Solicited Symptoms, Cohort A (6 Months to < 3 Years) | Any diarrhea, post dose 1 | 2.23 Days | Standard Deviation 2.157 |
| Afluria Cohort A | Duration of Local and Systemic Solicited Symptoms, Cohort A (6 Months to < 3 Years) | Any loss of appetite, post dose 1 | 2.61 Days | Standard Deviation 3.695 |
| Afluria Cohort A | Duration of Local and Systemic Solicited Symptoms, Cohort A (6 Months to < 3 Years) | Any irritability, post dose 1 | 2.26 Days | Standard Deviation 2.858 |
| Afluria Cohort A | Duration of Local and Systemic Solicited Symptoms, Cohort A (6 Months to < 3 Years) | Any fever dose 2 (≥ 99.5°F ax or ≥ 100.4°F oral) | 1.80 Days | Standard Deviation 1.146 |
| Afluria Cohort A | Duration of Local and Systemic Solicited Symptoms, Cohort A (6 Months to < 3 Years) | Any nausea/vomiting, post dose 2 | 2.50 Days | Standard Deviation 1.291 |
| Afluria Cohort A | Duration of Local and Systemic Solicited Symptoms, Cohort A (6 Months to < 3 Years) | Any diarrhea, post dose 2 | 2.83 Days | Standard Deviation 2.431 |
| Afluria Cohort A | Duration of Local and Systemic Solicited Symptoms, Cohort A (6 Months to < 3 Years) | Any loss of appetite, post dose 2 | 2.47 Days | Standard Deviation 1.586 |
| Afluria Cohort A | Duration of Local and Systemic Solicited Symptoms, Cohort A (6 Months to < 3 Years) | Any irritability, post dose 2 | 2.31 Days | Standard Deviation 1.732 |
| Fluzone Cohort A | Duration of Local and Systemic Solicited Symptoms, Cohort A (6 Months to < 3 Years) | Any irritability, post dose 2 | 2.17 Days | Standard Deviation 1.543 |
| Fluzone Cohort A | Duration of Local and Systemic Solicited Symptoms, Cohort A (6 Months to < 3 Years) | Any pain post-dose 1 | 1.43 Days | Standard Deviation 0.728 |
| Fluzone Cohort A | Duration of Local and Systemic Solicited Symptoms, Cohort A (6 Months to < 3 Years) | Any diarrhea, post dose 1 | 2.16 Days | Standard Deviation 2.189 |
| Fluzone Cohort A | Duration of Local and Systemic Solicited Symptoms, Cohort A (6 Months to < 3 Years) | Any redness (> 0 mm), post dose 1 | 2.22 Days | Standard Deviation 1.939 |
| Fluzone Cohort A | Duration of Local and Systemic Solicited Symptoms, Cohort A (6 Months to < 3 Years) | Any nausea/vomiting, post dose 2 | 1.78 Days | Standard Deviation 1.093 |
| Fluzone Cohort A | Duration of Local and Systemic Solicited Symptoms, Cohort A (6 Months to < 3 Years) | Any swelling (> 0 mm), post dose 1 | 2.00 Days | Standard Deviation 1.569 |
| Fluzone Cohort A | Duration of Local and Systemic Solicited Symptoms, Cohort A (6 Months to < 3 Years) | Any loss of appetite, post dose 1 | 2.85 Days | Standard Deviation 4.458 |
| Fluzone Cohort A | Duration of Local and Systemic Solicited Symptoms, Cohort A (6 Months to < 3 Years) | Any pain post-dose 2 | 1.45 Days | Standard Deviation 0.739 |
| Fluzone Cohort A | Duration of Local and Systemic Solicited Symptoms, Cohort A (6 Months to < 3 Years) | Any loss of appetite, post dose 2 | 2.33 Days | Standard Deviation 1.447 |
| Fluzone Cohort A | Duration of Local and Systemic Solicited Symptoms, Cohort A (6 Months to < 3 Years) | Any redness (> 0 mm), post dose 2 | 1.73 Days | Standard Deviation 0.935 |
| Fluzone Cohort A | Duration of Local and Systemic Solicited Symptoms, Cohort A (6 Months to < 3 Years) | Any irritability, post dose 1 | 2.64 Days | Standard Deviation 3.825 |
| Fluzone Cohort A | Duration of Local and Systemic Solicited Symptoms, Cohort A (6 Months to < 3 Years) | Any swelling (> 0 mm), post dose 2 | 1.57 Days | Standard Deviation 0.787 |
| Fluzone Cohort A | Duration of Local and Systemic Solicited Symptoms, Cohort A (6 Months to < 3 Years) | Any diarrhea, post dose 2 | 2.44 Days | Standard Deviation 2.332 |
| Fluzone Cohort A | Duration of Local and Systemic Solicited Symptoms, Cohort A (6 Months to < 3 Years) | Any fever dose 1 (≥ 99.5°F ax or ≥ 100.4°F oral) | 1.49 Days | Standard Deviation 0.989 |
| Fluzone Cohort A | Duration of Local and Systemic Solicited Symptoms, Cohort A (6 Months to < 3 Years) | Any fever dose 2 (≥ 99.5°F ax or ≥ 100.4°F oral) | 1.81 Days | Standard Deviation 1.559 |
| Fluzone Cohort A | Duration of Local and Systemic Solicited Symptoms, Cohort A (6 Months to < 3 Years) | Any nausea/vomiting, post dose 1 | 1.29 Days | Standard Deviation 1.042 |
Secondary
Duration of Local and Systemic Solicited Symptoms, Cohort B
Time frame: 7 days after each vaccination
Population: Safety population
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Afluria Cohort A | Duration of Local and Systemic Solicited Symptoms, Cohort B | Any pain post-dose 1 | 1.89 Days | Standard Deviation 1.138 |
| Afluria Cohort A | Duration of Local and Systemic Solicited Symptoms, Cohort B | Any redness (> 0 mm), post dose 1 | 2.32 Days | Standard Deviation 1.621 |
| Afluria Cohort A | Duration of Local and Systemic Solicited Symptoms, Cohort B | Any swelling (> 0 mm), post dose 1 | 2.39 Days | Standard Deviation 2.021 |
| Afluria Cohort A | Duration of Local and Systemic Solicited Symptoms, Cohort B | Any pain post-dose 2 | 1.96 Days | Standard Deviation 1.637 |
| Afluria Cohort A | Duration of Local and Systemic Solicited Symptoms, Cohort B | Any redness (> 0 mm), post dose 2 | 2.40 Days | Standard Deviation 2.191 |
| Afluria Cohort A | Duration of Local and Systemic Solicited Symptoms, Cohort B | Any swelling (> 0 mm), post dose 2 | 3.00 Days | Standard Deviation 2.16 |
| Afluria Cohort A | Duration of Local and Systemic Solicited Symptoms, Cohort B | Any fever dose 1 (≥ 99.5°F ax or ≥ 100.4°F oral) | 1.45 Days | Standard Deviation 1.032 |
| Afluria Cohort A | Duration of Local and Systemic Solicited Symptoms, Cohort B | Any nausea/vomiting, post dose 1 | 1.27 Days | Standard Deviation 0.719 |
| Afluria Cohort A | Duration of Local and Systemic Solicited Symptoms, Cohort B | Any diarrhea, post dose 1 | 2.89 Days | Standard Deviation 4.988 |
| Afluria Cohort A | Duration of Local and Systemic Solicited Symptoms, Cohort B | Any malaise, post dose 1 | 1.86 Days | Standard Deviation 1.324 |
| Afluria Cohort A | Duration of Local and Systemic Solicited Symptoms, Cohort B | Any headache, post dose 1 | 1.50 Days | Standard Deviation 0.77 |
| Afluria Cohort A | Duration of Local and Systemic Solicited Symptoms, Cohort B | Any myalgia, post dose 1 | 1.72 Days | Standard Deviation 1.007 |
| Afluria Cohort A | Duration of Local and Systemic Solicited Symptoms, Cohort B | Any fever dose 2 (≥ 99.5°F ax or ≥ 100.4°F oral) | 1.50 Days | Standard Deviation 0.577 |
| Afluria Cohort A | Duration of Local and Systemic Solicited Symptoms, Cohort B | Any nausea/vomiting, post dose 2 | 1.00 Days | Standard Deviation 0 |
| Afluria Cohort A | Duration of Local and Systemic Solicited Symptoms, Cohort B | Any diarrhea, post dose 2 | 1.33 Days | Standard Deviation 0.816 |
| Afluria Cohort A | Duration of Local and Systemic Solicited Symptoms, Cohort B | Any malaise, post dose 2 | 1.83 Days | Standard Deviation 1.602 |
| Afluria Cohort A | Duration of Local and Systemic Solicited Symptoms, Cohort B | Any headache, post dose 2 | 1.00 Days | Standard Deviation 0 |
| Afluria Cohort A | Duration of Local and Systemic Solicited Symptoms, Cohort B | Any myalgia, post dose 2 | 2.00 Days | Standard Deviation 1.528 |
| Fluzone Cohort A | Duration of Local and Systemic Solicited Symptoms, Cohort B | Any nausea/vomiting, post dose 2 | 1.20 Days | Standard Deviation 0.447 |
| Fluzone Cohort A | Duration of Local and Systemic Solicited Symptoms, Cohort B | Any pain post-dose 1 | 1.89 Days | Standard Deviation 1.337 |
| Fluzone Cohort A | Duration of Local and Systemic Solicited Symptoms, Cohort B | Any malaise, post dose 1 | 1.74 Days | Standard Deviation 1.094 |
| Fluzone Cohort A | Duration of Local and Systemic Solicited Symptoms, Cohort B | Any redness (> 0 mm), post dose 1 | 2.10 Days | Standard Deviation 2.014 |
| Fluzone Cohort A | Duration of Local and Systemic Solicited Symptoms, Cohort B | Any myalgia, post dose 2 | 1.54 Days | Standard Deviation 0.66 |
| Fluzone Cohort A | Duration of Local and Systemic Solicited Symptoms, Cohort B | Any swelling (> 0 mm), post dose 1 | 2.09 Days | Standard Deviation 1.273 |
| Fluzone Cohort A | Duration of Local and Systemic Solicited Symptoms, Cohort B | Any headache, post dose 1 | 1.66 Days | Standard Deviation 1.328 |
| Fluzone Cohort A | Duration of Local and Systemic Solicited Symptoms, Cohort B | Any pain post-dose 2 | 1.65 Days | Standard Deviation 0.775 |
| Fluzone Cohort A | Duration of Local and Systemic Solicited Symptoms, Cohort B | Any diarrhea, post dose 2 | 2.20 Days | Standard Deviation 0.447 |
| Fluzone Cohort A | Duration of Local and Systemic Solicited Symptoms, Cohort B | Any redness (> 0 mm), post dose 2 | 1.77 Days | Standard Deviation 1.235 |
| Fluzone Cohort A | Duration of Local and Systemic Solicited Symptoms, Cohort B | Any myalgia, post dose 1 | 1.63 Days | Standard Deviation 1.009 |
| Fluzone Cohort A | Duration of Local and Systemic Solicited Symptoms, Cohort B | Any swelling (> 0 mm), post dose 2 | 1.69 Days | Standard Deviation 1.251 |
| Fluzone Cohort A | Duration of Local and Systemic Solicited Symptoms, Cohort B | Any headache, post dose 2 | 1.30 Days | Standard Deviation 0.483 |
| Fluzone Cohort A | Duration of Local and Systemic Solicited Symptoms, Cohort B | Any fever dose 1 (≥ 99.5°F ax or ≥ 100.4°F oral) | 1.40 Days | Standard Deviation 0.707 |
| Fluzone Cohort A | Duration of Local and Systemic Solicited Symptoms, Cohort B | Any fever dose 2 (≥ 99.5°F ax or ≥ 100.4°F oral) | 1.00 Days | Standard Deviation 0 |
| Fluzone Cohort A | Duration of Local and Systemic Solicited Symptoms, Cohort B | Any nausea/vomiting, post dose 1 | 1.43 Days | Standard Deviation 1.165 |
| Fluzone Cohort A | Duration of Local and Systemic Solicited Symptoms, Cohort B | Any malaise, post dose 2 | 1.71 Days | Standard Deviation 0.756 |
| Fluzone Cohort A | Duration of Local and Systemic Solicited Symptoms, Cohort B | Any diarrhea, post dose 1 | 1.44 Days | Standard Deviation 1.044 |
Secondary
Duration of Local and Systemic Solicited Symptoms, Cohort C
Time frame: 7 days after vaccination
Population: Safety population
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Afluria Cohort A | Duration of Local and Systemic Solicited Symptoms, Cohort C | Any redness (> 0 mm) | 2.02 Days | Standard Deviation 1.669 |
| Afluria Cohort A | Duration of Local and Systemic Solicited Symptoms, Cohort C | Any diarrhea | 1.18 Days | Standard Deviation 0.395 |
| Afluria Cohort A | Duration of Local and Systemic Solicited Symptoms, Cohort C | Any fever (≥ 99.5°F ax or ≥ 100.4°F oral) | 1.82 Days | Standard Deviation 1.59 |
| Afluria Cohort A | Duration of Local and Systemic Solicited Symptoms, Cohort C | Any malaise | 2.09 Days | Standard Deviation 1.487 |
| Afluria Cohort A | Duration of Local and Systemic Solicited Symptoms, Cohort C | Any swelling (> 0 mm) | 1.75 Days | Standard Deviation 1.171 |
| Afluria Cohort A | Duration of Local and Systemic Solicited Symptoms, Cohort C | Any headache | 1.77 Days | Standard Deviation 1.443 |
| Afluria Cohort A | Duration of Local and Systemic Solicited Symptoms, Cohort C | Any nausea/vomiting | 1.36 Days | Standard Deviation 0.569 |
| Afluria Cohort A | Duration of Local and Systemic Solicited Symptoms, Cohort C | Any myalgia | 1.76 Days | Standard Deviation 1.1 |
| Afluria Cohort A | Duration of Local and Systemic Solicited Symptoms, Cohort C | Any pain | 1.96 Days | Standard Deviation 1.087 |
| Fluzone Cohort A | Duration of Local and Systemic Solicited Symptoms, Cohort C | Any myalgia | 2.11 Days | Standard Deviation 1.491 |
| Fluzone Cohort A | Duration of Local and Systemic Solicited Symptoms, Cohort C | Any pain | 1.99 Days | Standard Deviation 1.136 |
| Fluzone Cohort A | Duration of Local and Systemic Solicited Symptoms, Cohort C | Any redness (> 0 mm) | 2.38 Days | Standard Deviation 1.992 |
| Fluzone Cohort A | Duration of Local and Systemic Solicited Symptoms, Cohort C | Any swelling (> 0 mm) | 2.38 Days | Standard Deviation 1.724 |
| Fluzone Cohort A | Duration of Local and Systemic Solicited Symptoms, Cohort C | Any fever (≥ 99.5°F ax or ≥ 100.4°F oral) | 3.10 Days | Standard Deviation 2.644 |
| Fluzone Cohort A | Duration of Local and Systemic Solicited Symptoms, Cohort C | Any nausea/vomiting | 2.88 Days | Standard Deviation 3.791 |
| Fluzone Cohort A | Duration of Local and Systemic Solicited Symptoms, Cohort C | Any diarrhea | 1.36 Days | Standard Deviation 0.911 |
| Fluzone Cohort A | Duration of Local and Systemic Solicited Symptoms, Cohort C | Any malaise | 2.82 Days | Standard Deviation 3.449 |
| Fluzone Cohort A | Duration of Local and Systemic Solicited Symptoms, Cohort C | Any headache | 2.05 Days | Standard Deviation 1.945 |
Secondary
Frequency and Intensity of Local and Systemic Solicited Symptoms, Cohort A (6 Months to < 3 Years)
Time frame: 7 days after each vaccination
Population: Safety population; Afluria Cohort A receiving 2 doses N=96, Fluzone Cohort A receiving 2 doses N=110
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Afluria Cohort A | Frequency and Intensity of Local and Systemic Solicited Symptoms, Cohort A (6 Months to < 3 Years) | Grade 3 pain (post dose 1) | 1 Participants |
| Afluria Cohort A | Frequency and Intensity of Local and Systemic Solicited Symptoms, Cohort A (6 Months to < 3 Years) | Any systemic solicited symptom post-dose 2 | 48 Participants |
| Afluria Cohort A | Frequency and Intensity of Local and Systemic Solicited Symptoms, Cohort A (6 Months to < 3 Years) | Any redness (> 0 mm) (post dose 1) | 53 Participants |
| Afluria Cohort A | Frequency and Intensity of Local and Systemic Solicited Symptoms, Cohort A (6 Months to < 3 Years) | Any diarrhea, dose 2 | 17 Participants |
| Afluria Cohort A | Frequency and Intensity of Local and Systemic Solicited Symptoms, Cohort A (6 Months to < 3 Years) | Grade 3 redness (> 30 mm) (post dose 1) | 0 Participants |
| Afluria Cohort A | Frequency and Intensity of Local and Systemic Solicited Symptoms, Cohort A (6 Months to < 3 Years) | Any irritability, dose 1 | 134 Participants |
| Afluria Cohort A | Frequency and Intensity of Local and Systemic Solicited Symptoms, Cohort A (6 Months to < 3 Years) | Any swelling (> 0 mm) (post dose 1) | 30 Participants |
| Afluria Cohort A | Frequency and Intensity of Local and Systemic Solicited Symptoms, Cohort A (6 Months to < 3 Years) | Grade3 diarrhea (prevented activities), dose 2 | 1 Participants |
| Afluria Cohort A | Frequency and Intensity of Local and Systemic Solicited Symptoms, Cohort A (6 Months to < 3 Years) | Grade 3 swelling (> 30 mm) (post dose 1) | 1 Participants |
| Afluria Cohort A | Frequency and Intensity of Local and Systemic Solicited Symptoms, Cohort A (6 Months to < 3 Years) | Any fever ≥ 99.5°F ax or≥ 100.4°F oral, dose 2 | 14 Participants |
| Afluria Cohort A | Frequency and Intensity of Local and Systemic Solicited Symptoms, Cohort A (6 Months to < 3 Years) | Any local solicited symptom post-dose 2 | 30 Participants |
| Afluria Cohort A | Frequency and Intensity of Local and Systemic Solicited Symptoms, Cohort A (6 Months to < 3 Years) | Any loss of appetite, dose 2 | 15 Participants |
| Afluria Cohort A | Frequency and Intensity of Local and Systemic Solicited Symptoms, Cohort A (6 Months to < 3 Years) | Any pain (post dose 2) | 28 Participants |
| Afluria Cohort A | Frequency and Intensity of Local and Systemic Solicited Symptoms, Cohort A (6 Months to < 3 Years) | Grade3 loss of appetite prevented activities dose1 | 3 Participants |
| Afluria Cohort A | Frequency and Intensity of Local and Systemic Solicited Symptoms, Cohort A (6 Months to < 3 Years) | Grade 3 pain (post dose 2) | 0 Participants |
| Afluria Cohort A | Frequency and Intensity of Local and Systemic Solicited Symptoms, Cohort A (6 Months to < 3 Years) | Grade3 loss of appetite prevented activities dose2 | 1 Participants |
| Afluria Cohort A | Frequency and Intensity of Local and Systemic Solicited Symptoms, Cohort A (6 Months to < 3 Years) | Any redness (> 0 mm) (post dose 2) | 15 Participants |
| Afluria Cohort A | Frequency and Intensity of Local and Systemic Solicited Symptoms, Cohort A (6 Months to < 3 Years) | Grade 3 fever > 103.1°F ax or> 104.0°F oral, dose2 | 1 Participants |
| Afluria Cohort A | Frequency and Intensity of Local and Systemic Solicited Symptoms, Cohort A (6 Months to < 3 Years) | Grade 3 redness (> 30 mm) (post dose 2) | 1 Participants |
| Afluria Cohort A | Frequency and Intensity of Local and Systemic Solicited Symptoms, Cohort A (6 Months to < 3 Years) | Any irritability, dose 2 | 38 Participants |
| Afluria Cohort A | Frequency and Intensity of Local and Systemic Solicited Symptoms, Cohort A (6 Months to < 3 Years) | Any swelling (> 0 mm) (post dose 2) | 9 Participants |
| Afluria Cohort A | Frequency and Intensity of Local and Systemic Solicited Symptoms, Cohort A (6 Months to < 3 Years) | Grade 3 irritability prevented activities dose 1 | 10 Participants |
| Afluria Cohort A | Frequency and Intensity of Local and Systemic Solicited Symptoms, Cohort A (6 Months to < 3 Years) | Grade 3 swelling (> 30 mm) (post dose 2) | 0 Participants |
| Afluria Cohort A | Frequency and Intensity of Local and Systemic Solicited Symptoms, Cohort A (6 Months to < 3 Years) | Grade 3 irritability prevented activities, dose 2 | 1 Participants |
| Afluria Cohort A | Frequency and Intensity of Local and Systemic Solicited Symptoms, Cohort A (6 Months to < 3 Years) | Any systemic solicited symptom, post dose 1 | 171 Participants |
| Afluria Cohort A | Frequency and Intensity of Local and Systemic Solicited Symptoms, Cohort A (6 Months to < 3 Years) | Any nausea/vomiting, dose 2 | 4 Participants |
| Afluria Cohort A | Frequency and Intensity of Local and Systemic Solicited Symptoms, Cohort A (6 Months to < 3 Years) | Any fever ≥ 99.5°F ax or≥ 100.4°F oral, dose1 | 85 Participants |
| Afluria Cohort A | Frequency and Intensity of Local and Systemic Solicited Symptoms, Cohort A (6 Months to < 3 Years) | Any local solicited symptom post-dose 1 | 116 Participants |
| Afluria Cohort A | Frequency and Intensity of Local and Systemic Solicited Symptoms, Cohort A (6 Months to < 3 Years) | Grade 3 fever > 103.1°F ax or> 104.0°F oral, dose1 | 6 Participants |
| Afluria Cohort A | Frequency and Intensity of Local and Systemic Solicited Symptoms, Cohort A (6 Months to < 3 Years) | Any loss of appetite, dose 1 | 73 Participants |
| Afluria Cohort A | Frequency and Intensity of Local and Systemic Solicited Symptoms, Cohort A (6 Months to < 3 Years) | Any nausea/vomiting, dose 1 | 27 Participants |
| Afluria Cohort A | Frequency and Intensity of Local and Systemic Solicited Symptoms, Cohort A (6 Months to < 3 Years) | Any pain (post dose 1) | 98 Participants |
| Afluria Cohort A | Frequency and Intensity of Local and Systemic Solicited Symptoms, Cohort A (6 Months to < 3 Years) | Grade 3 nausea/vomiting prevented activities,dose1 | 22 Participants |
| Afluria Cohort A | Frequency and Intensity of Local and Systemic Solicited Symptoms, Cohort A (6 Months to < 3 Years) | Grade3 nausea/vomiting prevented activities, dose2 | 2 Participants |
| Afluria Cohort A | Frequency and Intensity of Local and Systemic Solicited Symptoms, Cohort A (6 Months to < 3 Years) | Any diarrhea, dose 1 | 61 Participants |
| Afluria Cohort A | Frequency and Intensity of Local and Systemic Solicited Symptoms, Cohort A (6 Months to < 3 Years) | Grade 3 diarrhea prevented activities, dose 1 | 4 Participants |
| Fluzone Cohort A | Frequency and Intensity of Local and Systemic Solicited Symptoms, Cohort A (6 Months to < 3 Years) | Any diarrhea, dose 1 | 54 Participants |
| Fluzone Cohort A | Frequency and Intensity of Local and Systemic Solicited Symptoms, Cohort A (6 Months to < 3 Years) | Grade 3 diarrhea prevented activities, dose 1 | 3 Participants |
| Fluzone Cohort A | Frequency and Intensity of Local and Systemic Solicited Symptoms, Cohort A (6 Months to < 3 Years) | Any loss of appetite, dose 1 | 45 Participants |
| Fluzone Cohort A | Frequency and Intensity of Local and Systemic Solicited Symptoms, Cohort A (6 Months to < 3 Years) | Grade3 loss of appetite prevented activities dose1 | 1 Participants |
| Fluzone Cohort A | Frequency and Intensity of Local and Systemic Solicited Symptoms, Cohort A (6 Months to < 3 Years) | Any irritability, dose 1 | 85 Participants |
| Fluzone Cohort A | Frequency and Intensity of Local and Systemic Solicited Symptoms, Cohort A (6 Months to < 3 Years) | Grade 3 irritability prevented activities dose 1 | 5 Participants |
| Fluzone Cohort A | Frequency and Intensity of Local and Systemic Solicited Symptoms, Cohort A (6 Months to < 3 Years) | Any systemic solicited symptom post-dose 2 | 44 Participants |
| Fluzone Cohort A | Frequency and Intensity of Local and Systemic Solicited Symptoms, Cohort A (6 Months to < 3 Years) | Any fever ≥ 99.5°F ax or≥ 100.4°F oral, dose 2 | 15 Participants |
| Fluzone Cohort A | Frequency and Intensity of Local and Systemic Solicited Symptoms, Cohort A (6 Months to < 3 Years) | Grade 3 fever > 103.1°F ax or> 104.0°F oral, dose2 | 0 Participants |
| Fluzone Cohort A | Frequency and Intensity of Local and Systemic Solicited Symptoms, Cohort A (6 Months to < 3 Years) | Any nausea/vomiting, dose 2 | 8 Participants |
| Fluzone Cohort A | Frequency and Intensity of Local and Systemic Solicited Symptoms, Cohort A (6 Months to < 3 Years) | Grade3 nausea/vomiting prevented activities, dose2 | 0 Participants |
| Fluzone Cohort A | Frequency and Intensity of Local and Systemic Solicited Symptoms, Cohort A (6 Months to < 3 Years) | Any diarrhea, dose 2 | 16 Participants |
| Fluzone Cohort A | Frequency and Intensity of Local and Systemic Solicited Symptoms, Cohort A (6 Months to < 3 Years) | Grade3 diarrhea (prevented activities), dose 2 | 0 Participants |
| Fluzone Cohort A | Frequency and Intensity of Local and Systemic Solicited Symptoms, Cohort A (6 Months to < 3 Years) | Any loss of appetite, dose 2 | 14 Participants |
| Fluzone Cohort A | Frequency and Intensity of Local and Systemic Solicited Symptoms, Cohort A (6 Months to < 3 Years) | Grade3 loss of appetite prevented activities dose2 | 0 Participants |
| Fluzone Cohort A | Frequency and Intensity of Local and Systemic Solicited Symptoms, Cohort A (6 Months to < 3 Years) | Any irritability, dose 2 | 31 Participants |
| Fluzone Cohort A | Frequency and Intensity of Local and Systemic Solicited Symptoms, Cohort A (6 Months to < 3 Years) | Grade 3 irritability prevented activities, dose 2 | 0 Participants |
| Fluzone Cohort A | Frequency and Intensity of Local and Systemic Solicited Symptoms, Cohort A (6 Months to < 3 Years) | Any local solicited symptom post-dose 1 | 100 Participants |
| Fluzone Cohort A | Frequency and Intensity of Local and Systemic Solicited Symptoms, Cohort A (6 Months to < 3 Years) | Any pain (post dose 1) | 78 Participants |
| Fluzone Cohort A | Frequency and Intensity of Local and Systemic Solicited Symptoms, Cohort A (6 Months to < 3 Years) | Grade 3 pain (post dose 1) | 0 Participants |
| Fluzone Cohort A | Frequency and Intensity of Local and Systemic Solicited Symptoms, Cohort A (6 Months to < 3 Years) | Any redness (> 0 mm) (post dose 1) | 53 Participants |
| Fluzone Cohort A | Frequency and Intensity of Local and Systemic Solicited Symptoms, Cohort A (6 Months to < 3 Years) | Grade 3 redness (> 30 mm) (post dose 1) | 1 Participants |
| Fluzone Cohort A | Frequency and Intensity of Local and Systemic Solicited Symptoms, Cohort A (6 Months to < 3 Years) | Any swelling (> 0 mm) (post dose 1) | 26 Participants |
| Fluzone Cohort A | Frequency and Intensity of Local and Systemic Solicited Symptoms, Cohort A (6 Months to < 3 Years) | Grade 3 swelling (> 30 mm) (post dose 1) | 0 Participants |
| Fluzone Cohort A | Frequency and Intensity of Local and Systemic Solicited Symptoms, Cohort A (6 Months to < 3 Years) | Any local solicited symptom post-dose 2 | 32 Participants |
| Fluzone Cohort A | Frequency and Intensity of Local and Systemic Solicited Symptoms, Cohort A (6 Months to < 3 Years) | Any pain (post dose 2) | 22 Participants |
| Fluzone Cohort A | Frequency and Intensity of Local and Systemic Solicited Symptoms, Cohort A (6 Months to < 3 Years) | Grade 3 pain (post dose 2) | 0 Participants |
| Fluzone Cohort A | Frequency and Intensity of Local and Systemic Solicited Symptoms, Cohort A (6 Months to < 3 Years) | Any redness (> 0 mm) (post dose 2) | 22 Participants |
| Fluzone Cohort A | Frequency and Intensity of Local and Systemic Solicited Symptoms, Cohort A (6 Months to < 3 Years) | Grade 3 redness (> 30 mm) (post dose 2) | 0 Participants |
| Fluzone Cohort A | Frequency and Intensity of Local and Systemic Solicited Symptoms, Cohort A (6 Months to < 3 Years) | Any swelling (> 0 mm) (post dose 2) | 7 Participants |
| Fluzone Cohort A | Frequency and Intensity of Local and Systemic Solicited Symptoms, Cohort A (6 Months to < 3 Years) | Grade 3 swelling (> 30 mm) (post dose 2) | 0 Participants |
| Fluzone Cohort A | Frequency and Intensity of Local and Systemic Solicited Symptoms, Cohort A (6 Months to < 3 Years) | Any systemic solicited symptom, post dose 1 | 121 Participants |
| Fluzone Cohort A | Frequency and Intensity of Local and Systemic Solicited Symptoms, Cohort A (6 Months to < 3 Years) | Any fever ≥ 99.5°F ax or≥ 100.4°F oral, dose1 | 31 Participants |
| Fluzone Cohort A | Frequency and Intensity of Local and Systemic Solicited Symptoms, Cohort A (6 Months to < 3 Years) | Grade 3 fever > 103.1°F ax or> 104.0°F oral, dose1 | 0 Participants |
| Fluzone Cohort A | Frequency and Intensity of Local and Systemic Solicited Symptoms, Cohort A (6 Months to < 3 Years) | Any nausea/vomiting, dose 1 | 17 Participants |
| Fluzone Cohort A | Frequency and Intensity of Local and Systemic Solicited Symptoms, Cohort A (6 Months to < 3 Years) | Grade 3 nausea/vomiting prevented activities,dose1 | 6 Participants |
Secondary
Frequency and Intensity of Local and Systemic Solicited Symptoms, Cohort B
Time frame: 7 days after each vaccination
Population: Safety population; Afluria cohort B receiving 2 doses N=68, Fluzone cohort B receiving 2 doses N=78
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Afluria Cohort A | Frequency and Intensity of Local and Systemic Solicited Symptoms, Cohort B | Grade 3 pain, post dose 2 | 0 Participants |
| Afluria Cohort A | Frequency and Intensity of Local and Systemic Solicited Symptoms, Cohort B | Any malaise, dose 2 | 6 Participants |
| Afluria Cohort A | Frequency and Intensity of Local and Systemic Solicited Symptoms, Cohort B | Any local solicited symptom post-dose 1 | 164 Participants |
| Afluria Cohort A | Frequency and Intensity of Local and Systemic Solicited Symptoms, Cohort B | Any pain, post dose 1 | 149 Participants |
| Afluria Cohort A | Frequency and Intensity of Local and Systemic Solicited Symptoms, Cohort B | Grade 3 pain, post dose 1 | 1 Participants |
| Afluria Cohort A | Frequency and Intensity of Local and Systemic Solicited Symptoms, Cohort B | Any redness (> 0 mm), post dose 1 | 59 Participants |
| Afluria Cohort A | Frequency and Intensity of Local and Systemic Solicited Symptoms, Cohort B | Grade 3 redness (> 30 mm), post dose 1 | 7 Participants |
| Afluria Cohort A | Frequency and Intensity of Local and Systemic Solicited Symptoms, Cohort B | Any swelling (> 0 mm), post dose 1 | 36 Participants |
| Afluria Cohort A | Frequency and Intensity of Local and Systemic Solicited Symptoms, Cohort B | Grade 3 swelling (> 30 mm), post dose 1 | 6 Participants |
| Afluria Cohort A | Frequency and Intensity of Local and Systemic Solicited Symptoms, Cohort B | Any local solicited symptom post-dose 2 | 24 Participants |
| Afluria Cohort A | Frequency and Intensity of Local and Systemic Solicited Symptoms, Cohort B | Any pain, post dose 2 | 23 Participants |
| Afluria Cohort A | Frequency and Intensity of Local and Systemic Solicited Symptoms, Cohort B | Any redness (> 0 mm), post dose 2 | 5 Participants |
| Afluria Cohort A | Frequency and Intensity of Local and Systemic Solicited Symptoms, Cohort B | Grade 3 redness (> 30 mm), post dose 2 | 0 Participants |
| Afluria Cohort A | Frequency and Intensity of Local and Systemic Solicited Symptoms, Cohort B | Any swelling (> 0 mm), post dose 2 | 4 Participants |
| Afluria Cohort A | Frequency and Intensity of Local and Systemic Solicited Symptoms, Cohort B | Grade 3 swelling (> 30 mm), post dose 2 | 0 Participants |
| Afluria Cohort A | Frequency and Intensity of Local and Systemic Solicited Symptoms, Cohort B | Any systemic solicited symptom post-dose 1 | 140 Participants |
| Afluria Cohort A | Frequency and Intensity of Local and Systemic Solicited Symptoms, Cohort B | Any fever ≥ 99.5°F ax or ≥ 100.4°F oral, dose 1 | 55 Participants |
| Afluria Cohort A | Frequency and Intensity of Local and Systemic Solicited Symptoms, Cohort B | Grade 3 fever > 103.1°F ax or > 104.0°F oral dose1 | 3 Participants |
| Afluria Cohort A | Frequency and Intensity of Local and Systemic Solicited Symptoms, Cohort B | Any nausea/vomiting, dose 1 | 33 Participants |
| Afluria Cohort A | Frequency and Intensity of Local and Systemic Solicited Symptoms, Cohort B | Grade3 nausea/vomiting prevented activities, dose1 | 2 Participants |
| Afluria Cohort A | Frequency and Intensity of Local and Systemic Solicited Symptoms, Cohort B | Any diarrhea, dose 1 | 17 Participants |
| Afluria Cohort A | Frequency and Intensity of Local and Systemic Solicited Symptoms, Cohort B | Grade 3 diarrhea (prevented activities), dose 1 | 0 Participants |
| Afluria Cohort A | Frequency and Intensity of Local and Systemic Solicited Symptoms, Cohort B | Any malaise, dose 1 | 72 Participants |
| Afluria Cohort A | Frequency and Intensity of Local and Systemic Solicited Symptoms, Cohort B | Grade 3 malaise (prevented activities), dose 1 | 9 Participants |
| Afluria Cohort A | Frequency and Intensity of Local and Systemic Solicited Symptoms, Cohort B | Any headache, dose 1 | 54 Participants |
| Afluria Cohort A | Frequency and Intensity of Local and Systemic Solicited Symptoms, Cohort B | Grade 3 headache (prevented activities), dose 1 | 5 Participants |
| Afluria Cohort A | Frequency and Intensity of Local and Systemic Solicited Symptoms, Cohort B | Any myalgia, dose 1 | 82 Participants |
| Afluria Cohort A | Frequency and Intensity of Local and Systemic Solicited Symptoms, Cohort B | Grade 3 myalgia (prevented activities), dose 1 | 1 Participants |
| Afluria Cohort A | Frequency and Intensity of Local and Systemic Solicited Symptoms, Cohort B | Any systemic solicited symptom post-dose 2 | 17 Participants |
| Afluria Cohort A | Frequency and Intensity of Local and Systemic Solicited Symptoms, Cohort B | Any fever ≥ 99.5°F ax or ≥ 100.4°F oral dose 2 | 4 Participants |
| Afluria Cohort A | Frequency and Intensity of Local and Systemic Solicited Symptoms, Cohort B | Grade3 fever > 103.1°F ax or> 104.0°F oral, dose 2 | 1 Participants |
| Afluria Cohort A | Frequency and Intensity of Local and Systemic Solicited Symptoms, Cohort B | Any nausea/vomiting, dose 2 | 2 Participants |
| Afluria Cohort A | Frequency and Intensity of Local and Systemic Solicited Symptoms, Cohort B | Grade3 nausea/vomiting prevented activities ,dose2 | 1 Participants |
| Afluria Cohort A | Frequency and Intensity of Local and Systemic Solicited Symptoms, Cohort B | Any diarrhea, dose 2 | 6 Participants |
| Afluria Cohort A | Frequency and Intensity of Local and Systemic Solicited Symptoms, Cohort B | Grade 3 diarrhea (prevented activities), dose 2 | 0 Participants |
| Afluria Cohort A | Frequency and Intensity of Local and Systemic Solicited Symptoms, Cohort B | Grade 3 malaise (prevented activities), dose 2 | 0 Participants |
| Afluria Cohort A | Frequency and Intensity of Local and Systemic Solicited Symptoms, Cohort B | Any headache, dose 2 | 6 Participants |
| Afluria Cohort A | Frequency and Intensity of Local and Systemic Solicited Symptoms, Cohort B | Grade 3 headache (prevented activities), dose 2 | 0 Participants |
| Afluria Cohort A | Frequency and Intensity of Local and Systemic Solicited Symptoms, Cohort B | Any myalgia, dose 2 | 7 Participants |
| Afluria Cohort A | Frequency and Intensity of Local and Systemic Solicited Symptoms, Cohort B | Grade 3 myalgia (prevented activities), dose 2 | 0 Participants |
| Fluzone Cohort A | Frequency and Intensity of Local and Systemic Solicited Symptoms, Cohort B | Grade 3 headache (prevented activities), dose 2 | 0 Participants |
| Fluzone Cohort A | Frequency and Intensity of Local and Systemic Solicited Symptoms, Cohort B | Any diarrhea, dose 1 | 24 Participants |
| Fluzone Cohort A | Frequency and Intensity of Local and Systemic Solicited Symptoms, Cohort B | Grade3 fever > 103.1°F ax or> 104.0°F oral, dose 2 | 0 Participants |
| Fluzone Cohort A | Frequency and Intensity of Local and Systemic Solicited Symptoms, Cohort B | Any local solicited symptom post-dose 1 | 152 Participants |
| Fluzone Cohort A | Frequency and Intensity of Local and Systemic Solicited Symptoms, Cohort B | Grade 3 diarrhea (prevented activities), dose 1 | 0 Participants |
| Fluzone Cohort A | Frequency and Intensity of Local and Systemic Solicited Symptoms, Cohort B | Any pain, post dose 1 | 131 Participants |
| Fluzone Cohort A | Frequency and Intensity of Local and Systemic Solicited Symptoms, Cohort B | Grade 3 malaise (prevented activities), dose 2 | 0 Participants |
| Fluzone Cohort A | Frequency and Intensity of Local and Systemic Solicited Symptoms, Cohort B | Grade 3 pain, post dose 1 | 4 Participants |
| Fluzone Cohort A | Frequency and Intensity of Local and Systemic Solicited Symptoms, Cohort B | Any malaise, dose 1 | 34 Participants |
| Fluzone Cohort A | Frequency and Intensity of Local and Systemic Solicited Symptoms, Cohort B | Any redness (> 0 mm), post dose 1 | 60 Participants |
| Fluzone Cohort A | Frequency and Intensity of Local and Systemic Solicited Symptoms, Cohort B | Any nausea/vomiting, dose 2 | 4 Participants |
| Fluzone Cohort A | Frequency and Intensity of Local and Systemic Solicited Symptoms, Cohort B | Grade 3 redness (> 30 mm), post dose 1 | 4 Participants |
| Fluzone Cohort A | Frequency and Intensity of Local and Systemic Solicited Symptoms, Cohort B | Grade 3 malaise (prevented activities), dose 1 | 1 Participants |
| Fluzone Cohort A | Frequency and Intensity of Local and Systemic Solicited Symptoms, Cohort B | Any swelling (> 0 mm), post dose 1 | 43 Participants |
| Fluzone Cohort A | Frequency and Intensity of Local and Systemic Solicited Symptoms, Cohort B | Grade 3 myalgia (prevented activities), dose 2 | 0 Participants |
| Fluzone Cohort A | Frequency and Intensity of Local and Systemic Solicited Symptoms, Cohort B | Grade 3 swelling (> 30 mm), post dose 1 | 2 Participants |
| Fluzone Cohort A | Frequency and Intensity of Local and Systemic Solicited Symptoms, Cohort B | Any headache, dose 1 | 41 Participants |
| Fluzone Cohort A | Frequency and Intensity of Local and Systemic Solicited Symptoms, Cohort B | Any local solicited symptom post-dose 2 | 26 Participants |
| Fluzone Cohort A | Frequency and Intensity of Local and Systemic Solicited Symptoms, Cohort B | Grade3 nausea/vomiting prevented activities ,dose2 | 0 Participants |
| Fluzone Cohort A | Frequency and Intensity of Local and Systemic Solicited Symptoms, Cohort B | Any pain, post dose 2 | 23 Participants |
| Fluzone Cohort A | Frequency and Intensity of Local and Systemic Solicited Symptoms, Cohort B | Any malaise, dose 2 | 6 Participants |
| Fluzone Cohort A | Frequency and Intensity of Local and Systemic Solicited Symptoms, Cohort B | Grade 3 pain, post dose 2 | 0 Participants |
| Fluzone Cohort A | Frequency and Intensity of Local and Systemic Solicited Symptoms, Cohort B | Grade 3 headache (prevented activities), dose 1 | 0 Participants |
| Fluzone Cohort A | Frequency and Intensity of Local and Systemic Solicited Symptoms, Cohort B | Any redness (> 0 mm), post dose 2 | 13 Participants |
| Fluzone Cohort A | Frequency and Intensity of Local and Systemic Solicited Symptoms, Cohort B | Any headache, dose 2 | 8 Participants |
| Fluzone Cohort A | Frequency and Intensity of Local and Systemic Solicited Symptoms, Cohort B | Grade 3 redness (> 30 mm), post dose 2 | 0 Participants |
| Fluzone Cohort A | Frequency and Intensity of Local and Systemic Solicited Symptoms, Cohort B | Any myalgia, dose 1 | 63 Participants |
| Fluzone Cohort A | Frequency and Intensity of Local and Systemic Solicited Symptoms, Cohort B | Any swelling (> 0 mm), post dose 2 | 11 Participants |
| Fluzone Cohort A | Frequency and Intensity of Local and Systemic Solicited Symptoms, Cohort B | Any diarrhea, dose 2 | 5 Participants |
| Fluzone Cohort A | Frequency and Intensity of Local and Systemic Solicited Symptoms, Cohort B | Grade 3 swelling (> 30 mm), post dose 2 | 0 Participants |
| Fluzone Cohort A | Frequency and Intensity of Local and Systemic Solicited Symptoms, Cohort B | Grade 3 myalgia (prevented activities), dose 1 | 1 Participants |
| Fluzone Cohort A | Frequency and Intensity of Local and Systemic Solicited Symptoms, Cohort B | Any systemic solicited symptom post-dose 1 | 113 Participants |
| Fluzone Cohort A | Frequency and Intensity of Local and Systemic Solicited Symptoms, Cohort B | Any myalgia, dose 2 | 12 Participants |
| Fluzone Cohort A | Frequency and Intensity of Local and Systemic Solicited Symptoms, Cohort B | Any fever ≥ 99.5°F ax or ≥ 100.4°F oral, dose 1 | 24 Participants |
| Fluzone Cohort A | Frequency and Intensity of Local and Systemic Solicited Symptoms, Cohort B | Any systemic solicited symptom post-dose 2 | 18 Participants |
| Fluzone Cohort A | Frequency and Intensity of Local and Systemic Solicited Symptoms, Cohort B | Grade 3 fever > 103.1°F ax or > 104.0°F oral dose1 | 1 Participants |
| Fluzone Cohort A | Frequency and Intensity of Local and Systemic Solicited Symptoms, Cohort B | Grade 3 diarrhea (prevented activities), dose 2 | 0 Participants |
| Fluzone Cohort A | Frequency and Intensity of Local and Systemic Solicited Symptoms, Cohort B | Any nausea/vomiting, dose 1 | 20 Participants |
| Fluzone Cohort A | Frequency and Intensity of Local and Systemic Solicited Symptoms, Cohort B | Any fever ≥ 99.5°F ax or ≥ 100.4°F oral dose 2 | 5 Participants |
| Fluzone Cohort A | Frequency and Intensity of Local and Systemic Solicited Symptoms, Cohort B | Grade3 nausea/vomiting prevented activities, dose1 | 1 Participants |
Secondary
Frequency and Intensity of Local and Systemic Solicited Symptoms, Cohort C
Time frame: 7 days after vaccination
Population: Safety population
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Afluria Cohort A | Frequency and Intensity of Local and Systemic Solicited Symptoms, Cohort C | Grade 3 fever (> 103.1°F ax or > 104.0°F oral) | 2 Participants |
| Afluria Cohort A | Frequency and Intensity of Local and Systemic Solicited Symptoms, Cohort C | Grade 3 redness (> 30 mm) | 1 Participants |
| Afluria Cohort A | Frequency and Intensity of Local and Systemic Solicited Symptoms, Cohort C | Any nausea/vomiting | 23 Participants |
| Afluria Cohort A | Frequency and Intensity of Local and Systemic Solicited Symptoms, Cohort C | Any local solicited symptom post-dose 1 | 174 Participants |
| Afluria Cohort A | Frequency and Intensity of Local and Systemic Solicited Symptoms, Cohort C | Grade 3 nausea/vomiting (prevented activities) | 3 Participants |
| Afluria Cohort A | Frequency and Intensity of Local and Systemic Solicited Symptoms, Cohort C | Any swelling (> 0 mm) | 39 Participants |
| Afluria Cohort A | Frequency and Intensity of Local and Systemic Solicited Symptoms, Cohort C | Any diarrhea | 20 Participants |
| Afluria Cohort A | Frequency and Intensity of Local and Systemic Solicited Symptoms, Cohort C | Grade 3 pain (prevented activities) | 1 Participants |
| Afluria Cohort A | Frequency and Intensity of Local and Systemic Solicited Symptoms, Cohort C | Grade 3 diarrhea (prevented activities) | 1 Participants |
| Afluria Cohort A | Frequency and Intensity of Local and Systemic Solicited Symptoms, Cohort C | Grade 3 swelling (> 30 mm) | 4 Participants |
| Afluria Cohort A | Frequency and Intensity of Local and Systemic Solicited Symptoms, Cohort C | Any malaise | 55 Participants |
| Afluria Cohort A | Frequency and Intensity of Local and Systemic Solicited Symptoms, Cohort C | Any headache | 69 Participants |
| Afluria Cohort A | Frequency and Intensity of Local and Systemic Solicited Symptoms, Cohort C | Grade 3 malaise (prevented activities) | 10 Participants |
| Afluria Cohort A | Frequency and Intensity of Local and Systemic Solicited Symptoms, Cohort C | Any systemic solicited symptom post-dose 1 | 144 Participants |
| Afluria Cohort A | Frequency and Intensity of Local and Systemic Solicited Symptoms, Cohort C | Grade 3 headache (prevented activities) | 7 Participants |
| Afluria Cohort A | Frequency and Intensity of Local and Systemic Solicited Symptoms, Cohort C | Any redness (> 0 mm) | 43 Participants |
| Afluria Cohort A | Frequency and Intensity of Local and Systemic Solicited Symptoms, Cohort C | Any myalgia | 101 Participants |
| Afluria Cohort A | Frequency and Intensity of Local and Systemic Solicited Symptoms, Cohort C | Any fever (≥ 99.5°F ax or ≥ 100.4°F oral) | 16 Participants |
| Afluria Cohort A | Frequency and Intensity of Local and Systemic Solicited Symptoms, Cohort C | Grade 3 myalgia (prevented activities) | 5 Participants |
| Afluria Cohort A | Frequency and Intensity of Local and Systemic Solicited Symptoms, Cohort C | Any pain | 167 Participants |
| Fluzone Cohort A | Frequency and Intensity of Local and Systemic Solicited Symptoms, Cohort C | Grade 3 myalgia (prevented activities) | 4 Participants |
| Fluzone Cohort A | Frequency and Intensity of Local and Systemic Solicited Symptoms, Cohort C | Any local solicited symptom post-dose 1 | 169 Participants |
| Fluzone Cohort A | Frequency and Intensity of Local and Systemic Solicited Symptoms, Cohort C | Any pain | 151 Participants |
| Fluzone Cohort A | Frequency and Intensity of Local and Systemic Solicited Symptoms, Cohort C | Grade 3 pain (prevented activities) | 4 Participants |
| Fluzone Cohort A | Frequency and Intensity of Local and Systemic Solicited Symptoms, Cohort C | Any redness (> 0 mm) | 43 Participants |
| Fluzone Cohort A | Frequency and Intensity of Local and Systemic Solicited Symptoms, Cohort C | Grade 3 redness (> 30 mm) | 3 Participants |
| Fluzone Cohort A | Frequency and Intensity of Local and Systemic Solicited Symptoms, Cohort C | Any swelling (> 0 mm) | 41 Participants |
| Fluzone Cohort A | Frequency and Intensity of Local and Systemic Solicited Symptoms, Cohort C | Grade 3 swelling (> 30 mm) | 7 Participants |
| Fluzone Cohort A | Frequency and Intensity of Local and Systemic Solicited Symptoms, Cohort C | Any systemic solicited symptom post-dose 1 | 126 Participants |
| Fluzone Cohort A | Frequency and Intensity of Local and Systemic Solicited Symptoms, Cohort C | Any fever (≥ 99.5°F ax or ≥ 100.4°F oral) | 10 Participants |
| Fluzone Cohort A | Frequency and Intensity of Local and Systemic Solicited Symptoms, Cohort C | Grade 3 fever (> 103.1°F ax or > 104.0°F oral) | 0 Participants |
| Fluzone Cohort A | Frequency and Intensity of Local and Systemic Solicited Symptoms, Cohort C | Any nausea/vomiting | 24 Participants |
| Fluzone Cohort A | Frequency and Intensity of Local and Systemic Solicited Symptoms, Cohort C | Grade 3 nausea/vomiting (prevented activities) | 3 Participants |
| Fluzone Cohort A | Frequency and Intensity of Local and Systemic Solicited Symptoms, Cohort C | Any diarrhea | 25 Participants |
| Fluzone Cohort A | Frequency and Intensity of Local and Systemic Solicited Symptoms, Cohort C | Grade 3 diarrhea (prevented activities) | 0 Participants |
| Fluzone Cohort A | Frequency and Intensity of Local and Systemic Solicited Symptoms, Cohort C | Any malaise | 51 Participants |
| Fluzone Cohort A | Frequency and Intensity of Local and Systemic Solicited Symptoms, Cohort C | Any headache | 66 Participants |
| Fluzone Cohort A | Frequency and Intensity of Local and Systemic Solicited Symptoms, Cohort C | Grade 3 headache (prevented activities) | 3 Participants |
| Fluzone Cohort A | Frequency and Intensity of Local and Systemic Solicited Symptoms, Cohort C | Any myalgia | 93 Participants |
| Fluzone Cohort A | Frequency and Intensity of Local and Systemic Solicited Symptoms, Cohort C | Grade 3 malaise (prevented activities) | 3 Participants |
Secondary
Frequency and Intensity of Unsolicited Adverse Events (UAEs)
UAE stands for Unsolicited Adverse Events
Time frame: 30 days after each vaccination
Population: Safety population
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Afluria Cohort A | Frequency and Intensity of Unsolicited Adverse Events (UAEs) | Any related | 37 Participants |
| Afluria Cohort A | Frequency and Intensity of Unsolicited Adverse Events (UAEs) | Grade 3 | 28 Participants |
| Afluria Cohort A | Frequency and Intensity of Unsolicited Adverse Events (UAEs) | Any | 123 Participants |
| Fluzone Cohort A | Frequency and Intensity of Unsolicited Adverse Events (UAEs) | Grade 3 | 25 Participants |
| Fluzone Cohort A | Frequency and Intensity of Unsolicited Adverse Events (UAEs) | Any | 100 Participants |
| Fluzone Cohort A | Frequency and Intensity of Unsolicited Adverse Events (UAEs) | Any related | 24 Participants |
| Afluria Cohort C | Frequency and Intensity of Unsolicited Adverse Events (UAEs) | Any related | 20 Participants |
| Afluria Cohort C | Frequency and Intensity of Unsolicited Adverse Events (UAEs) | Any | 88 Participants |
| Afluria Cohort C | Frequency and Intensity of Unsolicited Adverse Events (UAEs) | Grade 3 | 17 Participants |
| Fluzone Cohort A | Frequency and Intensity of Unsolicited Adverse Events (UAEs) | Any | 112 Participants |
| Fluzone Cohort A | Frequency and Intensity of Unsolicited Adverse Events (UAEs) | Any related | 16 Participants |
| Fluzone Cohort A | Frequency and Intensity of Unsolicited Adverse Events (UAEs) | Grade 3 | 24 Participants |
| Fluzone Cohort B | Frequency and Intensity of Unsolicited Adverse Events (UAEs) | Grade 3 | 22 Participants |
| Fluzone Cohort B | Frequency and Intensity of Unsolicited Adverse Events (UAEs) | Any | 84 Participants |
| Fluzone Cohort B | Frequency and Intensity of Unsolicited Adverse Events (UAEs) | Any related | 18 Participants |
| Fluzone Cohort C | Frequency and Intensity of Unsolicited Adverse Events (UAEs) | Any related | 14 Participants |
| Fluzone Cohort C | Frequency and Intensity of Unsolicited Adverse Events (UAEs) | Any | 70 Participants |
| Fluzone Cohort C | Frequency and Intensity of Unsolicited Adverse Events (UAEs) | Grade 3 | 16 Participants |
Secondary
New Onset of Chronic Illnesses (NOCIs)
New onset of chronic illness after any vaccine dose. A new onset of chronic illness was defined as the diagnosis of a new medical condition which was chronic in nature, including those potentially controllable by medication (e.g., diabetes, asthma).
Time frame: 6 months after last study vaccination
Population: Safety population
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Afluria Cohort A | New Onset of Chronic Illnesses (NOCIs) | Total number of participants with NOCI | 2 Participants |
| Afluria Cohort A | New Onset of Chronic Illnesses (NOCIs) | Number of participants with related NOCI | 0 Participants |
| Afluria Cohort A | New Onset of Chronic Illnesses (NOCIs) | Asthma | 1 Participants |
| Afluria Cohort A | New Onset of Chronic Illnesses (NOCIs) | Von Willebrand's Disease | 1 Participants |
| Afluria Cohort A | New Onset of Chronic Illnesses (NOCIs) | Eczema | 0 Participants |
| Afluria Cohort A | New Onset of Chronic Illnesses (NOCIs) | Attention deficit disorder | 0 Participants |
| Fluzone Cohort A | New Onset of Chronic Illnesses (NOCIs) | Number of participants with related NOCI | 0 Participants |
| Fluzone Cohort A | New Onset of Chronic Illnesses (NOCIs) | Von Willebrand's Disease | 0 Participants |
| Fluzone Cohort A | New Onset of Chronic Illnesses (NOCIs) | Attention deficit disorder | 0 Participants |
| Fluzone Cohort A | New Onset of Chronic Illnesses (NOCIs) | Total number of participants with NOCI | 0 Participants |
| Fluzone Cohort A | New Onset of Chronic Illnesses (NOCIs) | Asthma | 0 Participants |
| Fluzone Cohort A | New Onset of Chronic Illnesses (NOCIs) | Eczema | 0 Participants |
| Afluria Cohort C | New Onset of Chronic Illnesses (NOCIs) | Attention deficit disorder | 0 Participants |
| Afluria Cohort C | New Onset of Chronic Illnesses (NOCIs) | Eczema | 0 Participants |
| Afluria Cohort C | New Onset of Chronic Illnesses (NOCIs) | Von Willebrand's Disease | 0 Participants |
| Afluria Cohort C | New Onset of Chronic Illnesses (NOCIs) | Asthma | 2 Participants |
| Afluria Cohort C | New Onset of Chronic Illnesses (NOCIs) | Total number of participants with NOCI | 2 Participants |
| Afluria Cohort C | New Onset of Chronic Illnesses (NOCIs) | Number of participants with related NOCI | 0 Participants |
| Fluzone Cohort A | New Onset of Chronic Illnesses (NOCIs) | Von Willebrand's Disease | 0 Participants |
| Fluzone Cohort A | New Onset of Chronic Illnesses (NOCIs) | Number of participants with related NOCI | 0 Participants |
| Fluzone Cohort A | New Onset of Chronic Illnesses (NOCIs) | Asthma | 1 Participants |
| Fluzone Cohort A | New Onset of Chronic Illnesses (NOCIs) | Attention deficit disorder | 0 Participants |
| Fluzone Cohort A | New Onset of Chronic Illnesses (NOCIs) | Eczema | 1 Participants |
| Fluzone Cohort A | New Onset of Chronic Illnesses (NOCIs) | Total number of participants with NOCI | 2 Participants |
| Fluzone Cohort B | New Onset of Chronic Illnesses (NOCIs) | Total number of participants with NOCI | 1 Participants |
| Fluzone Cohort B | New Onset of Chronic Illnesses (NOCIs) | Eczema | 0 Participants |
| Fluzone Cohort B | New Onset of Chronic Illnesses (NOCIs) | Number of participants with related NOCI | 0 Participants |
| Fluzone Cohort B | New Onset of Chronic Illnesses (NOCIs) | Asthma | 0 Participants |
| Fluzone Cohort B | New Onset of Chronic Illnesses (NOCIs) | Von Willebrand's Disease | 0 Participants |
| Fluzone Cohort B | New Onset of Chronic Illnesses (NOCIs) | Attention deficit disorder | 1 Participants |
| Fluzone Cohort C | New Onset of Chronic Illnesses (NOCIs) | Von Willebrand's Disease | 0 Participants |
| Fluzone Cohort C | New Onset of Chronic Illnesses (NOCIs) | Asthma | 0 Participants |
| Fluzone Cohort C | New Onset of Chronic Illnesses (NOCIs) | Eczema | 0 Participants |
| Fluzone Cohort C | New Onset of Chronic Illnesses (NOCIs) | Attention deficit disorder | 0 Participants |
| Fluzone Cohort C | New Onset of Chronic Illnesses (NOCIs) | Number of participants with related NOCI | 0 Participants |
| Fluzone Cohort C | New Onset of Chronic Illnesses (NOCIs) | Total number of participants with NOCI | 0 Participants |
Secondary
Serious Adverse Events (SAEs)
Time frame: 6 months after last study vaccination
Population: Safety Population
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Afluria Cohort A | Serious Adverse Events (SAEs) | Number of participants with SAEs | 4 Participants |
| Afluria Cohort A | Serious Adverse Events (SAEs) | Number of participants with related SAEs | 0 Participants |
| Fluzone Cohort A | Serious Adverse Events (SAEs) | Number of participants with SAEs | 2 Participants |
| Fluzone Cohort A | Serious Adverse Events (SAEs) | Number of participants with related SAEs | 0 Participants |
| Afluria Cohort C | Serious Adverse Events (SAEs) | Number of participants with SAEs | 2 Participants |
| Afluria Cohort C | Serious Adverse Events (SAEs) | Number of participants with related SAEs | 0 Participants |
| Fluzone Cohort A | Serious Adverse Events (SAEs) | Number of participants with SAEs | 4 Participants |
| Fluzone Cohort A | Serious Adverse Events (SAEs) | Number of participants with related SAEs | 0 Participants |
| Fluzone Cohort B | Serious Adverse Events (SAEs) | Number of participants with SAEs | 0 Participants |
| Fluzone Cohort B | Serious Adverse Events (SAEs) | Number of participants with related SAEs | 0 Participants |
| Fluzone Cohort C | Serious Adverse Events (SAEs) | Number of participants with SAEs | 0 Participants |
| Fluzone Cohort C | Serious Adverse Events (SAEs) | Number of participants with related SAEs | 0 Participants |