Influenza
Conditions
Keywords
Fluarix, Influenza
Brief summary
The purpose of this study is to compare two influenza vaccines (Fluzone and Fluarix) in terms of the immune response elicited and safety with a six month follow-up after first vaccination. The Protocol Posting has been updated in order to comply with the FDA Amendment Act, Sep 2007.
Interventions
BIOLOGICALFluarix™
Subjects were administered 1 or 2 doses\* intramuscularly, into the non-dominant upper arm for children \> 12 months of age, in the anterolateral thigh for children \< 12 months. \*Only those subjects between the age of 6 months and \< 9 years, who had no history of prior influenza vaccination, received 2 doses at months 0 & 1.
BIOLOGICALFluzone
Subjects were administered 1 or 2 doses\* intramuscularly, into the non-dominant upper arm for children \> 12 months of age, in the anterolateral thigh for children \< 12 months. \*Only those subjects between the age of 6 months and \< 9 years, who had no history of prior influenza vaccination, received 2 doses at months 0 & 1.
Sponsors
GlaxoSmithKline
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
SINGLE (Subject)
Eligibility
Sex/Gender
ALL
Age
6 Months to 17 Years
Healthy volunteers
Yes
Inclusion criteria
* A male or female child age 6 months to \< 18 years at the time of the vaccination; children who may or may not have had previous administration of influenza vaccine in a previous season are acceptable. * Subjects having a parent/guardian who the investigator believes can and will comply with the requirements of the protocol should be enrolled in the study. * Written informed consent obtained from the subject's parent/guardian; assent obtained in subjects \> 10 years. * Female subjects of childbearing potential must agree to take a pregnancy test.
Exclusion criteria
* Use of any investigational or non-registered product (drug or vaccine, other than the study vaccine) within 30 days preceding the administration of the study vaccine, or planned use during the study period. Routine, registered childhood vaccinations are not an exclusion. * History of hypersensitivity to any vaccine. * History of allergy or reactions likely to be exacerbated by any component of the vaccine. * Acute disease at the time of enrollment. * History of Guillain Barré syndrome within 6 weeks of receipt of prior inactivated influenza virus vaccine. * Pregnant or lactating female. * Receipt of an influenza vaccine outside of this study, during current (2006-07) flu season.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Geometric Mean Titer (GMT) of Serum Haemagglutination-inhibition (HI) Antibodies | 21 or 28 days after last vaccine dose | GMTs and their 95% confidence interval are presented for all 3 viral strains comprised in the vaccine. |
| Number of Seroconverted Subjects | 21 or 28 days after last vaccine dose | Seroconverted subjects are defined as subjects with either a pre-vaccination HI titer \<1:10 and a post-vaccination titer ≥ 1:40, or a pre-vaccination titer ≥ 1:10 and a minimum 4-fold increase at post-vaccination titer. Data are presented for all 3 viral strains comprised in the vaccine. |
| Number of Subjects Reporting Rare Serious Events | Up to 6 months after vaccination | Rare serious event is defined as any untoward medical event with an occurrence rate of ≥1/300 that: * resulted in death, * was life-threatening, * required hospitalization or prolongation of existing hospitalization, * resulted in disability/incapacity, or * was a congenital anomaly/birth defect in the offspring of a study subject. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Number of Subjects Reporting Unsolicited Adverse Events | Within 28 days following vaccination | An Adverse Event is any untoward medical occurrence in a clinical investigation subject, temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product. Any = at least one symptom irrespective of intensity and relationship to vaccination; Grade 3 = preventing normal activity; Related = considered by the investigator to be causally related to the study vaccination. |
| Number of Seroprotected Subjects | Before (PRE) and 21 or 28 days after (POST) the last vaccine dose | Seroprotected subjects are defined as vaccinees with a serum HI titer ≥ 1:40. Data are presented for all 3 viral strains comprised in the vaccine. |
| Number of Subjects Reporting New Onset Chronic Illnesses and/or Serious Adverse Events (SAE) | Up to 6 months after vaccination | SAE: any untoward medical occurrence that * resulted in death, * was life-threatening, * required hospitalization or prolongation of existing hospitalization, * resulted in disability/incapacity, or * was a congenital anomaly/birth defect in the offspring of a study subject. Examples of possible new onset chronic illnesses include but are not limited to diabetes, asthma, allergies, autoimmune disease, cancer, neuropathic disorders. |
| Number of Initially Unprotected Subjects With at Least a 4 Fold Increase in HI Titer | 21 or 28 days after last vaccine dose | Initially unprotected subjects are subjects with a baseline HI titer \< 1:40. Data are presented for all 3 viral strains comprised in the vaccine. |
| Number of Subjects Reporting Solicited Local and General Symptoms | During a 4-day follow-up period after each vaccination | Solicited local symptoms assessed include pain, redness, and swelling. Solicited general symptoms assessed include drowsiness, fever, irritability, loss of appetite, arthralgia, fatigue, headache, muscle aches, and shivering. Data across doses are presented. Any = at least one symptom irrespective of intensity/relationship to vaccination; Grade 3: symptom that prevented normal everyday activities; Related: considered by the investigator as related to the study vaccination. |
Countries
United States
Participant flow
Pre-assignment details
Two subjects, enrolled in the Fluzone Group, were not vaccinated; therefore, they were not included in the number of subjects included under STARTED.
Participants by arm
| Arm | Count |
|---|---|
| Fluarix Group Subjects in this group received Fluarix and will be further stratified by 3 age groups
* 1:1 in 6 months to \< 36 months
* 1:1 in 3 to \< 5 years
* 3:1 in 5 to \< 18 years | 2,115 |
| Fluzone Group Subjects in this group received Fluzone and will be further stratified by 3 age groups
* 1:1 in 6 months to \< 36 months
* 1:1 in 3 to \< 5 years
* 3:1 in 5 to \< 18 years | 1,210 |
| Total | 3,325 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 |
|---|---|---|---|
| Overall Study | Adverse Event | 1 | 0 |
| Overall Study | Lost to Follow-up | 68 | 61 |
| Overall Study | Other reason | 10 | 6 |
| Overall Study | Protocol Violation | 5 | 1 |
| Overall Study | Withdrawal by Subject | 27 | 18 |
Baseline characteristics
| Characteristic | Fluzone Group | Total | Fluarix Group |
|---|---|---|---|
| Age, Continuous | 5.5 years STANDARD_DEVIATION 4.75 | 6.8 years STANDARD_DEVIATION 4.99 | 7.6 years STANDARD_DEVIATION 4.97 |
| Race/Ethnicity, Customized African heritage / african american | 238 Participants | 582 Participants | 344 Participants |
| Race/Ethnicity, Customized American indian or alaskan native | 45 Participants | 123 Participants | 78 Participants |
| Race/Ethnicity, Customized Asian - central/south asian heritage | 7 Participants | 20 Participants | 13 Participants |
| Race/Ethnicity, Customized Asian - east asian heritage | 13 Participants | 28 Participants | 15 Participants |
| Race/Ethnicity, Customized Asian - japanese heritage | 1 Participants | 4 Participants | 3 Participants |
| Race/Ethnicity, Customized Asian - south east asian heritage | 17 Participants | 38 Participants | 21 Participants |
| Race/Ethnicity, Customized Native hawaiian or other pacific island | 10 Participants | 24 Participants | 14 Participants |
| Race/Ethnicity, Customized Unspecified | 68 Participants | 189 Participants | 121 Participants |
| Race/Ethnicity, Customized White - arabic / north african heritage | 17 Participants | 46 Participants | 29 Participants |
| Race/Ethnicity, Customized White - caucasian / european heritage | 794 Participants | 2271 Participants | 1477 Participants |
| Sex: Female, Male Female | 586 Participants | 1624 Participants | 1038 Participants |
| Sex: Female, Male Male | 624 Participants | 1701 Participants | 1077 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 0 / 0 | 0 / 0 |
| other Total, other adverse events | 1,480 / 2,115 | 781 / 1,210 |
| serious Total, serious adverse events | 11 / — | 11 / — |
Outcome results
Primary
Geometric Mean Titer (GMT) of Serum Haemagglutination-inhibition (HI) Antibodies
GMTs and their 95% confidence interval are presented for all 3 viral strains comprised in the vaccine.
Time frame: 21 or 28 days after last vaccine dose
Population: Per protocol, GMTs were assessed only in part of the According-To-Protocol (ATP) cohort for immunogenicity (children aged 6 months to \< 5 years).
| Arm | Measure | Group | Value (GEOMETRIC_MEAN) |
|---|---|---|---|
| Fluarix Group | Geometric Mean Titer (GMT) of Serum Haemagglutination-inhibition (HI) Antibodies | A/New Caledonia [6 to <36 months] | 52.4 Titer |
| Fluarix Group | Geometric Mean Titer (GMT) of Serum Haemagglutination-inhibition (HI) Antibodies | A/Wisconsin [6 to <36 months] | 80.5 Titer |
| Fluarix Group | Geometric Mean Titer (GMT) of Serum Haemagglutination-inhibition (HI) Antibodies | B/Malaysia [6 to <36 months] | 20.2 Titer |
| Fluarix Group | Geometric Mean Titer (GMT) of Serum Haemagglutination-inhibition (HI) Antibodies | A/New Caledonia [3 to < 5 years] | 130.3 Titer |
| Fluarix Group | Geometric Mean Titer (GMT) of Serum Haemagglutination-inhibition (HI) Antibodies | A/Wisconsin [3 to < 5 years] | 458.1 Titer |
| Fluarix Group | Geometric Mean Titer (GMT) of Serum Haemagglutination-inhibition (HI) Antibodies | B/Malaysia [3 to < 5 years] | 54.9 Titer |
| Fluzone Group | Geometric Mean Titer (GMT) of Serum Haemagglutination-inhibition (HI) Antibodies | A/Wisconsin [3 to < 5 years] | 483.4 Titer |
| Fluzone Group | Geometric Mean Titer (GMT) of Serum Haemagglutination-inhibition (HI) Antibodies | A/New Caledonia [6 to <36 months] | 101.4 Titer |
| Fluzone Group | Geometric Mean Titer (GMT) of Serum Haemagglutination-inhibition (HI) Antibodies | A/New Caledonia [3 to < 5 years] | 168.7 Titer |
| Fluzone Group | Geometric Mean Titer (GMT) of Serum Haemagglutination-inhibition (HI) Antibodies | A/Wisconsin [6 to <36 months] | 218.0 Titer |
| Fluzone Group | Geometric Mean Titer (GMT) of Serum Haemagglutination-inhibition (HI) Antibodies | B/Malaysia [3 to < 5 years] | 64.4 Titer |
| Fluzone Group | Geometric Mean Titer (GMT) of Serum Haemagglutination-inhibition (HI) Antibodies | B/Malaysia [6 to <36 months] | 40.6 Titer |
Primary
Number of Seroconverted Subjects
Seroconverted subjects are defined as subjects with either a pre-vaccination HI titer \<1:10 and a post-vaccination titer ≥ 1:40, or a pre-vaccination titer ≥ 1:10 and a minimum 4-fold increase at post-vaccination titer. Data are presented for all 3 viral strains comprised in the vaccine.
Time frame: 21 or 28 days after last vaccine dose
Population: As per protocol, seroconversion was assessed in part of the ATP cohort for immunogenicity: children aged 6 months to \< 5 years for whom post-vaccination results were available.
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Fluarix Group | Number of Seroconverted Subjects | A/New Caledonia [6 to <36 months] | 105 Participants |
| Fluarix Group | Number of Seroconverted Subjects | A/Wisconsin [6 to <36 months] | 117 Participants |
| Fluarix Group | Number of Seroconverted Subjects | B/Malaysia [6 to <36 months] | 48 Participants |
| Fluarix Group | Number of Seroconverted Subjects | A/New Caledonia [3 to <5 years] | 160 Participants |
| Fluarix Group | Number of Seroconverted Subjects | A/Wisconsin [3 to <5 years] | 156 Participants |
| Fluarix Group | Number of Seroconverted Subjects | B/Malaysia [3 to <5 years] | 117 Participants |
| Fluzone Group | Number of Seroconverted Subjects | A/Wisconsin [3 to <5 years] | 155 Participants |
| Fluzone Group | Number of Seroconverted Subjects | A/New Caledonia [6 to <36 months] | 179 Participants |
| Fluzone Group | Number of Seroconverted Subjects | A/New Caledonia [3 to <5 years] | 159 Participants |
| Fluzone Group | Number of Seroconverted Subjects | A/Wisconsin [6 to <36 months] | 190 Participants |
| Fluzone Group | Number of Seroconverted Subjects | B/Malaysia [3 to <5 years] | 122 Participants |
| Fluzone Group | Number of Seroconverted Subjects | B/Malaysia [6 to <36 months] | 114 Participants |
Primary
Number of Subjects Reporting Rare Serious Events
Rare serious event is defined as any untoward medical event with an occurrence rate of ≥1/300 that: * resulted in death, * was life-threatening, * required hospitalization or prolongation of existing hospitalization, * resulted in disability/incapacity, or * was a congenital anomaly/birth defect in the offspring of a study subject.
Time frame: Up to 6 months after vaccination
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Fluarix Group | Number of Subjects Reporting Rare Serious Events | 11 Participants |
| Fluzone Group | Number of Subjects Reporting Rare Serious Events | 11 Participants |
Secondary
Number of Initially Unprotected Subjects With at Least a 4 Fold Increase in HI Titer
Initially unprotected subjects are subjects with a baseline HI titer \< 1:40. Data are presented for all 3 viral strains comprised in the vaccine.
Time frame: 21 or 28 days after last vaccine dose
Population: As per protocol, only subjects from the ATP cohort for immunogenicity aged 6 months to \< 5 years and with a baseline titre \< 1:40 were analysed for this Outcome Measure.
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Fluarix Group | Number of Initially Unprotected Subjects With at Least a 4 Fold Increase in HI Titer | A/New Caledonia [3 to <5 years] | 163 Participants |
| Fluarix Group | Number of Initially Unprotected Subjects With at Least a 4 Fold Increase in HI Titer | A/New Caledonia [6 to <36 months] | 125 Participants |
| Fluarix Group | Number of Initially Unprotected Subjects With at Least a 4 Fold Increase in HI Titer | A/Wisconsin [3 to <5 years] | 75 Participants |
| Fluarix Group | Number of Initially Unprotected Subjects With at Least a 4 Fold Increase in HI Titer | B/Malaysia [6 to <36 months] | 74 Participants |
| Fluarix Group | Number of Initially Unprotected Subjects With at Least a 4 Fold Increase in HI Titer | B/Malaysia [3 to <5 years] | 115 Participants |
| Fluarix Group | Number of Initially Unprotected Subjects With at Least a 4 Fold Increase in HI Titer | A/Wisconsin [6 to <36 months] | 114 Participants |
| Fluzone Group | Number of Initially Unprotected Subjects With at Least a 4 Fold Increase in HI Titer | B/Malaysia [3 to <5 years] | 125 Participants |
| Fluzone Group | Number of Initially Unprotected Subjects With at Least a 4 Fold Increase in HI Titer | A/Wisconsin [6 to <36 months] | 173 Participants |
| Fluzone Group | Number of Initially Unprotected Subjects With at Least a 4 Fold Increase in HI Titer | B/Malaysia [6 to <36 months] | 129 Participants |
| Fluzone Group | Number of Initially Unprotected Subjects With at Least a 4 Fold Increase in HI Titer | A/New Caledonia [3 to <5 years] | 155 Participants |
| Fluzone Group | Number of Initially Unprotected Subjects With at Least a 4 Fold Increase in HI Titer | A/Wisconsin [3 to <5 years] | 92 Participants |
| Fluzone Group | Number of Initially Unprotected Subjects With at Least a 4 Fold Increase in HI Titer | A/New Caledonia [6 to <36 months] | 117 Participants |
Secondary
Number of Seroprotected Subjects
Seroprotected subjects are defined as vaccinees with a serum HI titer ≥ 1:40. Data are presented for all 3 viral strains comprised in the vaccine.
Time frame: Before (PRE) and 21 or 28 days after (POST) the last vaccine dose
Population: As per protocol, seroprotection was assessed in part of the ATP cohort for immunogenicity: children aged 6 months to \< 5 years for whom results were available.
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Fluarix Group | Number of Seroprotected Subjects | A/New Caledonia [6 to <36 months] PRE | 15 Participants |
| Fluarix Group | Number of Seroprotected Subjects | A/New Caledonia [6 to <36 months] POST | 122 Participants |
| Fluarix Group | Number of Seroprotected Subjects | A/Wisconsin [6 to <36 months] PRE | 39 Participants |
| Fluarix Group | Number of Seroprotected Subjects | A/Wisconsin [6 to <36 months] POST | 135 Participants |
| Fluarix Group | Number of Seroprotected Subjects | B/Malaysia [6 to <36 months] PRE | 11 Participants |
| Fluarix Group | Number of Seroprotected Subjects | B/Malaysia [6 to <36 months] POST | 50 Participants |
| Fluarix Group | Number of Seroprotected Subjects | A/New Caledonia [3 to <5 years] PRE | 38 Participants |
| Fluarix Group | Number of Seroprotected Subjects | A/New Caledonia [3 to <5 years] POST | 180 Participants |
| Fluarix Group | Number of Seroprotected Subjects | A/Wisconsin [3 to <5 years] PRE | 131 Participants |
| Fluarix Group | Number of Seroprotected Subjects | A/Wisconsin [3 to <5 years] POST | 194 Participants |
| Fluarix Group | Number of Seroprotected Subjects | B/Malaysia [3 to <5 years] PRE | 30 Participants |
| Fluarix Group | Number of Seroprotected Subjects | B/Malaysia [3 to <5 years] POST | 121 Participants |
| Fluzone Group | Number of Seroprotected Subjects | B/Malaysia [3 to <5 years] PRE | 26 Participants |
| Fluzone Group | Number of Seroprotected Subjects | A/New Caledonia [6 to <36 months] PRE | 16 Participants |
| Fluzone Group | Number of Seroprotected Subjects | A/New Caledonia [3 to <5 years] PRE | 45 Participants |
| Fluzone Group | Number of Seroprotected Subjects | A/New Caledonia [6 to <36 months] POST | 193 Participants |
| Fluzone Group | Number of Seroprotected Subjects | A/Wisconsin [3 to <5 years] POST | 207 Participants |
| Fluzone Group | Number of Seroprotected Subjects | A/Wisconsin [6 to <36 months] PRE | 44 Participants |
| Fluzone Group | Number of Seroprotected Subjects | A/New Caledonia [3 to <5 years] POST | 189 Participants |
| Fluzone Group | Number of Seroprotected Subjects | A/Wisconsin [6 to <36 months] POST | 211 Participants |
| Fluzone Group | Number of Seroprotected Subjects | B/Malaysia [3 to <5 years] POST | 129 Participants |
| Fluzone Group | Number of Seroprotected Subjects | B/Malaysia [6 to <36 months] PRE | 12 Participants |
| Fluzone Group | Number of Seroprotected Subjects | A/Wisconsin [3 to <5 years] PRE | 122 Participants |
| Fluzone Group | Number of Seroprotected Subjects | B/Malaysia [6 to <36 months] POST | 115 Participants |
Secondary
Number of Subjects Reporting New Onset Chronic Illnesses and/or Serious Adverse Events (SAE)
SAE: any untoward medical occurrence that * resulted in death, * was life-threatening, * required hospitalization or prolongation of existing hospitalization, * resulted in disability/incapacity, or * was a congenital anomaly/birth defect in the offspring of a study subject. Examples of possible new onset chronic illnesses include but are not limited to diabetes, asthma, allergies, autoimmune disease, cancer, neuropathic disorders.
Time frame: Up to 6 months after vaccination
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Fluarix Group | Number of Subjects Reporting New Onset Chronic Illnesses and/or Serious Adverse Events (SAE) | New onset chronic illnesses | 11 Participants |
| Fluarix Group | Number of Subjects Reporting New Onset Chronic Illnesses and/or Serious Adverse Events (SAE) | Serious adverse events | 11 Participants |
| Fluzone Group | Number of Subjects Reporting New Onset Chronic Illnesses and/or Serious Adverse Events (SAE) | New onset chronic illnesses | 3 Participants |
| Fluzone Group | Number of Subjects Reporting New Onset Chronic Illnesses and/or Serious Adverse Events (SAE) | Serious adverse events | 11 Participants |
Secondary
Number of Subjects Reporting Solicited Local and General Symptoms
Solicited local symptoms assessed include pain, redness, and swelling. Solicited general symptoms assessed include drowsiness, fever, irritability, loss of appetite, arthralgia, fatigue, headache, muscle aches, and shivering. Data across doses are presented. Any = at least one symptom irrespective of intensity/relationship to vaccination; Grade 3: symptom that prevented normal everyday activities; Related: considered by the investigator as related to the study vaccination.
Time frame: During a 4-day follow-up period after each vaccination
Population: Analysis was performed on vaccinated subjects with available data.~* Pain, redness, swelling and fever were assessed in all age cohorts.~* Drowsiness, irritability and loss of appetite were assessed in the 6 months to \< 5 years cohort only.~* Arthralgia, fatigue, headache, muscle aches and shivering were assessed in the 5 to \< 18 years cohort only.
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Fluarix Group | Number of Subjects Reporting Solicited Local and General Symptoms | Pain [Grade 3] | 31 Participants |
| Fluarix Group | Number of Subjects Reporting Solicited Local and General Symptoms | Loss of appetite [Related] | 103 Participants |
| Fluarix Group | Number of Subjects Reporting Solicited Local and General Symptoms | Fever [≥37.5°C] | 152 Participants |
| Fluarix Group | Number of Subjects Reporting Solicited Local and General Symptoms | Arthralgia [Any] | 85 Participants |
| Fluarix Group | Number of Subjects Reporting Solicited Local and General Symptoms | Swelling [> 50 mm] | 22 Participants |
| Fluarix Group | Number of Subjects Reporting Solicited Local and General Symptoms | Arthralgia [Grade 3] | 2 Participants |
| Fluarix Group | Number of Subjects Reporting Solicited Local and General Symptoms | Fever [> 39°C] | 20 Participants |
| Fluarix Group | Number of Subjects Reporting Solicited Local and General Symptoms | Arthralgia [Related] | 74 Participants |
| Fluarix Group | Number of Subjects Reporting Solicited Local and General Symptoms | Redness [> 50 mm] | 16 Participants |
| Fluarix Group | Number of Subjects Reporting Solicited Local and General Symptoms | Fatigue [Any] | 285 Participants |
| Fluarix Group | Number of Subjects Reporting Solicited Local and General Symptoms | Fever [Related] | 69 Participants |
| Fluarix Group | Number of Subjects Reporting Solicited Local and General Symptoms | Fatigue [Grade 3] | 15 Participants |
| Fluarix Group | Number of Subjects Reporting Solicited Local and General Symptoms | Drowsiness [Any] | 160 Participants |
| Fluarix Group | Number of Subjects Reporting Solicited Local and General Symptoms | Fatigue [Related] | 225 Participants |
| Fluarix Group | Number of Subjects Reporting Solicited Local and General Symptoms | Irritability [Any] | 232 Participants |
| Fluarix Group | Number of Subjects Reporting Solicited Local and General Symptoms | Headache [Any] | 218 Participants |
| Fluarix Group | Number of Subjects Reporting Solicited Local and General Symptoms | Redness [Any] | 421 Participants |
| Fluarix Group | Number of Subjects Reporting Solicited Local and General Symptoms | Headache [Grade 3] | 8 Participants |
| Fluarix Group | Number of Subjects Reporting Solicited Local and General Symptoms | Irritability [Grade 3] | 20 Participants |
| Fluarix Group | Number of Subjects Reporting Solicited Local and General Symptoms | Headache [Related] | 171 Participants |
| Fluarix Group | Number of Subjects Reporting Solicited Local and General Symptoms | Drowsiness [Grade 3] | 15 Participants |
| Fluarix Group | Number of Subjects Reporting Solicited Local and General Symptoms | Muscle aches [Any] | 410 Participants |
| Fluarix Group | Number of Subjects Reporting Solicited Local and General Symptoms | Irritability [Related] | 201 Participants |
| Fluarix Group | Number of Subjects Reporting Solicited Local and General Symptoms | Muscle aches [Grade 3] | 6 Participants |
| Fluarix Group | Number of Subjects Reporting Solicited Local and General Symptoms | Swelling [Any] | 308 Participants |
| Fluarix Group | Number of Subjects Reporting Solicited Local and General Symptoms | Muscle aches [Related] | 367 Participants |
| Fluarix Group | Number of Subjects Reporting Solicited Local and General Symptoms | Loss of appetite [Any] | 131 Participants |
| Fluarix Group | Number of Subjects Reporting Solicited Local and General Symptoms | Shivering [Any] | 45 Participants |
| Fluarix Group | Number of Subjects Reporting Solicited Local and General Symptoms | Drowsiness [Related] | 127 Participants |
| Fluarix Group | Number of Subjects Reporting Solicited Local and General Symptoms | Shivering [Grade 3] | 2 Participants |
| Fluarix Group | Number of Subjects Reporting Solicited Local and General Symptoms | Loss of appetite [Grade 3] | 9 Participants |
| Fluarix Group | Number of Subjects Reporting Solicited Local and General Symptoms | Shivering [Related] | 37 Participants |
| Fluarix Group | Number of Subjects Reporting Solicited Local and General Symptoms | Pain [Any] | 1072 Participants |
| Fluzone Group | Number of Subjects Reporting Solicited Local and General Symptoms | Shivering [Related] | 14 Participants |
| Fluzone Group | Number of Subjects Reporting Solicited Local and General Symptoms | Pain [Any] | 526 Participants |
| Fluzone Group | Number of Subjects Reporting Solicited Local and General Symptoms | Pain [Grade 3] | 19 Participants |
| Fluzone Group | Number of Subjects Reporting Solicited Local and General Symptoms | Redness [Any] | 233 Participants |
| Fluzone Group | Number of Subjects Reporting Solicited Local and General Symptoms | Redness [> 50 mm] | 4 Participants |
| Fluzone Group | Number of Subjects Reporting Solicited Local and General Symptoms | Swelling [Any] | 152 Participants |
| Fluzone Group | Number of Subjects Reporting Solicited Local and General Symptoms | Swelling [> 50 mm] | 4 Participants |
| Fluzone Group | Number of Subjects Reporting Solicited Local and General Symptoms | Drowsiness [Any] | 177 Participants |
| Fluzone Group | Number of Subjects Reporting Solicited Local and General Symptoms | Drowsiness [Grade 3] | 16 Participants |
| Fluzone Group | Number of Subjects Reporting Solicited Local and General Symptoms | Drowsiness [Related] | 125 Participants |
| Fluzone Group | Number of Subjects Reporting Solicited Local and General Symptoms | Fever [≥37.5°C] | 85 Participants |
| Fluzone Group | Number of Subjects Reporting Solicited Local and General Symptoms | Fever [> 39°C] | 12 Participants |
| Fluzone Group | Number of Subjects Reporting Solicited Local and General Symptoms | Fever [Related] | 48 Participants |
| Fluzone Group | Number of Subjects Reporting Solicited Local and General Symptoms | Irritability [Any] | 246 Participants |
| Fluzone Group | Number of Subjects Reporting Solicited Local and General Symptoms | Irritability [Grade 3] | 18 Participants |
| Fluzone Group | Number of Subjects Reporting Solicited Local and General Symptoms | Irritability [Related] | 199 Participants |
| Fluzone Group | Number of Subjects Reporting Solicited Local and General Symptoms | Loss of appetite [Any] | 128 Participants |
| Fluzone Group | Number of Subjects Reporting Solicited Local and General Symptoms | Loss of appetite [Grade 3] | 13 Participants |
| Fluzone Group | Number of Subjects Reporting Solicited Local and General Symptoms | Loss of appetite [Related] | 96 Participants |
| Fluzone Group | Number of Subjects Reporting Solicited Local and General Symptoms | Arthralgia [Any] | 30 Participants |
| Fluzone Group | Number of Subjects Reporting Solicited Local and General Symptoms | Arthralgia [Grade 3] | 1 Participants |
| Fluzone Group | Number of Subjects Reporting Solicited Local and General Symptoms | Arthralgia [Related] | 27 Participants |
| Fluzone Group | Number of Subjects Reporting Solicited Local and General Symptoms | Fatigue [Any] | 88 Participants |
| Fluzone Group | Number of Subjects Reporting Solicited Local and General Symptoms | Fatigue [Grade 3] | 6 Participants |
| Fluzone Group | Number of Subjects Reporting Solicited Local and General Symptoms | Fatigue [Related] | 72 Participants |
| Fluzone Group | Number of Subjects Reporting Solicited Local and General Symptoms | Headache [Any] | 76 Participants |
| Fluzone Group | Number of Subjects Reporting Solicited Local and General Symptoms | Headache [Grade 3] | 4 Participants |
| Fluzone Group | Number of Subjects Reporting Solicited Local and General Symptoms | Headache [Related] | 61 Participants |
| Fluzone Group | Number of Subjects Reporting Solicited Local and General Symptoms | Muscle aches [Any] | 133 Participants |
| Fluzone Group | Number of Subjects Reporting Solicited Local and General Symptoms | Muscle aches [Grade 3] | 3 Participants |
| Fluzone Group | Number of Subjects Reporting Solicited Local and General Symptoms | Muscle aches [Related] | 121 Participants |
| Fluzone Group | Number of Subjects Reporting Solicited Local and General Symptoms | Shivering [Any] | 17 Participants |
| Fluzone Group | Number of Subjects Reporting Solicited Local and General Symptoms | Shivering [Grade 3] | 1 Participants |
Secondary
Number of Subjects Reporting Unsolicited Adverse Events
An Adverse Event is any untoward medical occurrence in a clinical investigation subject, temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product. Any = at least one symptom irrespective of intensity and relationship to vaccination; Grade 3 = preventing normal activity; Related = considered by the investigator to be causally related to the study vaccination.
Time frame: Within 28 days following vaccination
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Fluarix Group | Number of Subjects Reporting Unsolicited Adverse Events | Any | 700 Participants |
| Fluarix Group | Number of Subjects Reporting Unsolicited Adverse Events | Grade 3 | 102 Participants |
| Fluarix Group | Number of Subjects Reporting Unsolicited Adverse Events | Related | 112 Participants |
| Fluzone Group | Number of Subjects Reporting Unsolicited Adverse Events | Any | 458 Participants |
| Fluzone Group | Number of Subjects Reporting Unsolicited Adverse Events | Grade 3 | 62 Participants |
| Fluzone Group | Number of Subjects Reporting Unsolicited Adverse Events | Related | 75 Participants |