Influenza
Conditions
Keywords
Influenza, Children, Hospitalizations, Spain, Burden
Brief summary
This study aims to quantify the inpatient and ER visits burden of laboratory-confirmed influenza, and compare the clinical features, severity, complications, risk factors and socioeconomic impact of influenza in children presenting with acute respiratory illness (ARI) and/or isolated fever, with or without laboratory-confirmed influenza.
Detailed description
The total medical cost associated with each hospitalization or ER visit will also be calculated at the end of this study. The study will be conducted from October, 2010, until May, 2011. Each subject will be followed-up for 21-30 days via telephone. The follow-up medical chart review will preferably be performed within 7 days after the telephone contact.
Interventions
PROCEDUREThroat swab and/or nasopharyngeal swab
Samples will be tested to quantify the inpatient and ER visits burden of laboratory-confirmed influenza.
OTHERData collection
Log Sheet will be used to collected data on a monthly basis for the following age groups: \< 6 months; 6-23 months; 24-59 months; \> 5 years.
Sponsors
GlaxoSmithKline
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
OTHER
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
No minimum to 15 Years
Healthy volunteers
No
Inclusion criteria
* Subjects for whom the investigator believes that they and/or their parents/guardians can and will comply with the requirements of the protocol. * A male or female \<15 years of age at the time of study entry. A subject will become ineligible on his/her 15th birthday. * Signed informed consent from the parents or guardians of the subject and signed assent from children ≥ 12 years old. * Presenting with a sudden onset clinical process comprising : * Isolated fever defined as: oral temperature ≥ 37.5°C / axillary temperature ≥ 37.5°C / Rectal temperature ≥ 38°C / tympanic temperature on oral setting ≥ 37.5°C / tympanic temperature on rectal setting ≥ 38°C without an obvious cause. And/or * ARI defined as one or more of the following symptoms: sore throat, coryza, cough, breathing difficulties.
Exclusion criteria
• Children in foster care.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Number of Subjects With Laboratory-confirmed Influenza Presenting With an Acute Respiratory Illness (ARI) and/or Isolated Fever | Day 0 till Day 28-37 | ARI was defined as one or more of the following symptoms: sore throat (in children greater than or equal to (≥) 3 years old), coryza (runny nose), cough, breathing difficulties. Isolated fever was defined as: oral temperature ≥37.5°C / axillary temperature ≥37.5°C / Rectal temperature ≥38°C / tympanic temperature on oral setting ≥37.5°C / tympanic temperature on rectal setting ≥38°C without an obvious cause. |
| Direct Medical Cost Per Hospitalization or ER Visit With Laboratory-confirmed Influenza | Day 0 till Day 28-37 | Ward specific room charge and Intensive Care Unit (ICU) were computed as daily charge multiplied by the number of days. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Number of Subjects With Secondary Bacterial Infections | Day 0 till Day 28-37 | The outcome assessed the various complications by laboratory-confirmed influenza status. |
| Number of Subjects With Potential Risk Factors at Study Start by Laboratory-confirmed Influenza Status | Day 0 till Day 28-37 | Risk factors were classified as pre-existing conditions, breast-feeding status and day-care status. |
| Number of Days of Hospitalization | Day 0 till Day 28-37 (between October 2010 until May 2011) | The outcomes was assessed in subjects with laboratory-confirmed influenza status |
| Number of Subjects Using Any ARI and/or Fever Related Medication Taken Prior to Hospitalization or ER Visit by Laboratory-confirmed Influenza Status | Day 0 till Day 28-37 | ARI and/or fever related medication included: antivirals, antibiotics, cough suppressants, pain medication, antipyretics and mucolytics. |
| Number of Subjects Using Any ARI and/or Fever Related Medication Prescribed During Hospitalization or ER Visit by Laboratory-confirmed Influenza Status | Day 0 till Day 28-37 | ARI and/or fever related medication included: antivirals, antibiotics, cough suppressants, pain medication, antipyretics and mucolytics. |
| Number of Subjects With Other Laboratory-confirmed Respiratory Viruses | Day 0 till Day 28-37 | Among the other laboratory-confirmed respiratory viruses there were:adenovirus, respiratory syncytial virus, parainfluenza virus 1, 2 and 3, metapneumovirus, bocavirus, rhinovirus or coronavirus. The outcome was assessed in subjects with an acute respiratory illness (ARI) and/or isolated fever episode. |
| Number of Subjects Using Any Non-prescribed ARI and/or Fever Related Medication Taken Since Hospitalization or ER Visit | Day 0 till Day 28-37 | ARI and/or fever related medication included: antivirals, antibiotics, cough suppressants, pain medication, antipyretics and mucolytics. |
| Number of Days of School Absenteeism | Day 0 till Day 28-37 | School absenteeism was assessed among patients during the follow-up period by laboratory-confirmed influenza status. |
| Number of Days of Parent or Caregiver Time Off Work | Day 0 till Day 28-37 | This outcome assessed absenteeism among caregivers to provide patient care during the follow-up period by laboratory-confirmed influenza status. |
| Number of Subjects With Household Members With Influenza-like Illness | Day 0 till Day 28-37 | This outcome assessed the number of cases with household contacts presenting influenza like illness symptoms during the follow-up period by laboratory-confirmed influenza status. |
| Proportion of Household Members Presenting Influenza Like Illness Symptoms (ARI and/or Isolated Fever) | Day 0 till Day 28-37 | This outcome assessed the proportion of influenza like illness (ILI) among household members of children \< 15 years with and without laboratory-confirmed influenza. |
| Number of Subjects Using Any ARI and/or Fever Related Medication Prescribed Since Hospitalization or ER Visit by Laboratory-confirmed Influenza Status | Day 0 till Day 28-37 | ARI and/or fever related medication included: antivirals, antibiotics, cough suppressants, pain medication, antipyretics and mucolytics. |
| Number of Subjects With Fatal Outcomes | Day 0 till Day 28-37 | Deaths from ARI and/or fever episodes by laboratory-confirmed influenza status were assessed. |
Countries
Spain
Participant flow
Recruitment details
Recruitment started in October, 2010, and last until May, 2011, or until the target sample size was enrolled.
Participants by arm
| Arm | Count |
|---|---|
| Influenza Group Children less than (\<) 15 years of age hospitalized for or presenting to an ER for acute ARI and/or isolated fever during the influenza season. | 501 |
| Total | 501 |
Baseline characteristics
| Characteristic | Influenza Group |
|---|---|
| Age, Continuous | 33.0 Months STANDARD_DEVIATION 37.44 |
| Sex: Female, Male Female | 212 Participants |
| Sex: Female, Male Male | 289 Participants |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | — / — |
| other Total, other adverse events | 0 / 0 |
| serious Total, serious adverse events | 0 / 0 |
Outcome results
Primary
Direct Medical Cost Per Hospitalization or ER Visit With Laboratory-confirmed Influenza
Ward specific room charge and Intensive Care Unit (ICU) were computed as daily charge multiplied by the number of days.
Time frame: Day 0 till Day 28-37
Population: The analysis was performed on the according-to-protocol (ATP) cohort for analysis, which included all evaluable subjects (i.e. those meeting all eligibility criteria and complying with the procedures defined in the protocol) for whom data concerning endpoint measures were available and who were hospitalized or visited an emergency room.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Influenza Group | Direct Medical Cost Per Hospitalization or ER Visit With Laboratory-confirmed Influenza | Laboratory | 57.27 Euros | Standard Deviation 48.93 |
| Influenza Group | Direct Medical Cost Per Hospitalization or ER Visit With Laboratory-confirmed Influenza | Radiology | 16.94 Euros | Standard Deviation 9.68 |
| Influenza Group | Direct Medical Cost Per Hospitalization or ER Visit With Laboratory-confirmed Influenza | Other diagnostics | 89.94 Euros | Standard Deviation 80.25 |
| Influenza Group | Direct Medical Cost Per Hospitalization or ER Visit With Laboratory-confirmed Influenza | Total for diagnostics | 52.97 Euros | Standard Deviation 63.77 |
| Influenza Group | Direct Medical Cost Per Hospitalization or ER Visit With Laboratory-confirmed Influenza | Prescribed medication [given in the hospital] | 5.52 Euros | Standard Deviation 10.25 |
| Influenza Group | Direct Medical Cost Per Hospitalization or ER Visit With Laboratory-confirmed Influenza | Prescribed medication | 12.28 Euros | Standard Deviation 18.49 |
| Influenza Group | Direct Medical Cost Per Hospitalization or ER Visit With Laboratory-confirmed Influenza | Non-prescribed medication | 9.86 Euros | Standard Deviation 12.56 |
| Influenza Group | Direct Medical Cost Per Hospitalization or ER Visit With Laboratory-confirmed Influenza | Total for treatments | 16.44 Euros | Standard Deviation 21.68 |
| Influenza Group | Direct Medical Cost Per Hospitalization or ER Visit With Laboratory-confirmed Influenza | Ward specific room charge | 1774.55 Euros | Standard Deviation 1062.94 |
| Influenza Group | Direct Medical Cost Per Hospitalization or ER Visit With Laboratory-confirmed Influenza | ICU | 1535.19 Euros | Standard Deviation 0 |
| Influenza Group | Direct Medical Cost Per Hospitalization or ER Visit With Laboratory-confirmed Influenza | Total for inpatient charge | 1884.21 Euros | Standard Deviation 1182.22 |
| Influenza Group | Direct Medical Cost Per Hospitalization or ER Visit With Laboratory-confirmed Influenza | ER visit | 170.16 Euros | Standard Deviation 64.18 |
| Influenza Group | Direct Medical Cost Per Hospitalization or ER Visit With Laboratory-confirmed Influenza | Others | 136.77 Euros | Standard Deviation 49.91 |
Primary
Number of Subjects With Laboratory-confirmed Influenza Presenting With an Acute Respiratory Illness (ARI) and/or Isolated Fever
ARI was defined as one or more of the following symptoms: sore throat (in children greater than or equal to (≥) 3 years old), coryza (runny nose), cough, breathing difficulties. Isolated fever was defined as: oral temperature ≥37.5°C / axillary temperature ≥37.5°C / Rectal temperature ≥38°C / tympanic temperature on oral setting ≥37.5°C / tympanic temperature on rectal setting ≥38°C without an obvious cause.
Time frame: Day 0 till Day 28-37
Population: The analysis was performed on the according-to-protocol (ATP) cohort for analysis, which included all evaluable subjects (i.e. those meeting all eligibility criteria and complying with the procedures defined in the protocol) for whom data concerning endpoint measures were available.
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Influenza Group | Number of Subjects With Laboratory-confirmed Influenza Presenting With an Acute Respiratory Illness (ARI) and/or Isolated Fever | Emergency Room | 120 Participants |
| Influenza Group | Number of Subjects With Laboratory-confirmed Influenza Presenting With an Acute Respiratory Illness (ARI) and/or Isolated Fever | Hospitalized | 11 Participants |
Secondary
Number of Days of Hospitalization
The outcomes was assessed in subjects with laboratory-confirmed influenza status
Time frame: Day 0 till Day 28-37 (between October 2010 until May 2011)
Population: The analysis was performed on the according-to-protocol (ATP) cohort for analysis, which included all evaluable subjects (i.e. those meeting all eligibility criteria and complying with the procedures defined in the protocol) for whom data concerning endpoint measures were available.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Influenza Group | Number of Days of Hospitalization | 2.0 Days | Standard Deviation 0 |
| Influenza Negative Group | Number of Days of Hospitalization | 4.4 Days | Standard Deviation 4.34 |
Secondary
Number of Days of Parent or Caregiver Time Off Work
This outcome assessed absenteeism among caregivers to provide patient care during the follow-up period by laboratory-confirmed influenza status.
Time frame: Day 0 till Day 28-37
Population: The analysis was performed on the according-to-protocol (ATP) cohort for analysis, which included all evaluable subjects (i.e. those meeting all eligibility criteria and complying with the procedures defined in the protocol) for whom data concerning endpoint measures were available.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Influenza Group | Number of Days of Parent or Caregiver Time Off Work | 4.4 Days | Standard Deviation 2.76 |
| Influenza Negative Group | Number of Days of Parent or Caregiver Time Off Work | 4.1 Days | Standard Deviation 3.1 |
Secondary
Number of Days of School Absenteeism
School absenteeism was assessed among patients during the follow-up period by laboratory-confirmed influenza status.
Time frame: Day 0 till Day 28-37
Population: The analysis was performed on the according-to-protocol (ATP) cohort for analysis, which included all evaluable subjects (i.e. those meeting all eligibility criteria and complying with the procedures defined in the protocol) for whom data concerning endpoint measures were available.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Influenza Group | Number of Days of School Absenteeism | 6.6 Days | Standard Deviation 3.46 |
| Influenza Negative Group | Number of Days of School Absenteeism | 6.4 Days | Standard Deviation 3.66 |
Secondary
Number of Subjects Using Any ARI and/or Fever Related Medication Prescribed During Hospitalization or ER Visit by Laboratory-confirmed Influenza Status
ARI and/or fever related medication included: antivirals, antibiotics, cough suppressants, pain medication, antipyretics and mucolytics.
Time frame: Day 0 till Day 28-37
Population: The analysis was performed on the according-to-protocol (ATP) cohort for analysis, which included all evaluable subjects (i.e. those meeting all eligibility criteria and complying with the procedures defined in the protocol) for whom data concerning endpoint measures were available.
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Influenza Group | Number of Subjects Using Any ARI and/or Fever Related Medication Prescribed During Hospitalization or ER Visit by Laboratory-confirmed Influenza Status | Any medication prescribed | 122 Participants |
| Influenza Group | Number of Subjects Using Any ARI and/or Fever Related Medication Prescribed During Hospitalization or ER Visit by Laboratory-confirmed Influenza Status | Antivirals | 4 Participants |
| Influenza Group | Number of Subjects Using Any ARI and/or Fever Related Medication Prescribed During Hospitalization or ER Visit by Laboratory-confirmed Influenza Status | Antibiotics | 17 Participants |
| Influenza Group | Number of Subjects Using Any ARI and/or Fever Related Medication Prescribed During Hospitalization or ER Visit by Laboratory-confirmed Influenza Status | Cough suppressants | 1 Participants |
| Influenza Group | Number of Subjects Using Any ARI and/or Fever Related Medication Prescribed During Hospitalization or ER Visit by Laboratory-confirmed Influenza Status | Pain medication | 12 Participants |
| Influenza Group | Number of Subjects Using Any ARI and/or Fever Related Medication Prescribed During Hospitalization or ER Visit by Laboratory-confirmed Influenza Status | Antipyretics | 120 Participants |
| Influenza Group | Number of Subjects Using Any ARI and/or Fever Related Medication Prescribed During Hospitalization or ER Visit by Laboratory-confirmed Influenza Status | Mucolytics | 0 Participants |
| Influenza Group | Number of Subjects Using Any ARI and/or Fever Related Medication Prescribed During Hospitalization or ER Visit by Laboratory-confirmed Influenza Status | Other medication | 17 Participants |
| Influenza Negative Group | Number of Subjects Using Any ARI and/or Fever Related Medication Prescribed During Hospitalization or ER Visit by Laboratory-confirmed Influenza Status | Other medication | 114 Participants |
| Influenza Negative Group | Number of Subjects Using Any ARI and/or Fever Related Medication Prescribed During Hospitalization or ER Visit by Laboratory-confirmed Influenza Status | Any medication prescribed | 344 Participants |
| Influenza Negative Group | Number of Subjects Using Any ARI and/or Fever Related Medication Prescribed During Hospitalization or ER Visit by Laboratory-confirmed Influenza Status | Pain medication | 28 Participants |
| Influenza Negative Group | Number of Subjects Using Any ARI and/or Fever Related Medication Prescribed During Hospitalization or ER Visit by Laboratory-confirmed Influenza Status | Antivirals | 1 Participants |
| Influenza Negative Group | Number of Subjects Using Any ARI and/or Fever Related Medication Prescribed During Hospitalization or ER Visit by Laboratory-confirmed Influenza Status | Mucolytics | 1 Participants |
| Influenza Negative Group | Number of Subjects Using Any ARI and/or Fever Related Medication Prescribed During Hospitalization or ER Visit by Laboratory-confirmed Influenza Status | Antibiotics | 77 Participants |
| Influenza Negative Group | Number of Subjects Using Any ARI and/or Fever Related Medication Prescribed During Hospitalization or ER Visit by Laboratory-confirmed Influenza Status | Antipyretics | 284 Participants |
| Influenza Negative Group | Number of Subjects Using Any ARI and/or Fever Related Medication Prescribed During Hospitalization or ER Visit by Laboratory-confirmed Influenza Status | Cough suppressants | 0 Participants |
Secondary
Number of Subjects Using Any ARI and/or Fever Related Medication Prescribed Since Hospitalization or ER Visit by Laboratory-confirmed Influenza Status
ARI and/or fever related medication included: antivirals, antibiotics, cough suppressants, pain medication, antipyretics and mucolytics.
Time frame: Day 0 till Day 28-37
Population: The analysis was performed on the according-to-protocol (ATP) cohort for analysis, which included all evaluable subjects (i.e. those meeting all eligibility criteria and complying with the procedures defined in the protocol) for whom data concerning endpoint measures were available.
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Influenza Group | Number of Subjects Using Any ARI and/or Fever Related Medication Prescribed Since Hospitalization or ER Visit by Laboratory-confirmed Influenza Status | Antivirals | 3 Participants |
| Influenza Group | Number of Subjects Using Any ARI and/or Fever Related Medication Prescribed Since Hospitalization or ER Visit by Laboratory-confirmed Influenza Status | Pain medication | 7 Participants |
| Influenza Group | Number of Subjects Using Any ARI and/or Fever Related Medication Prescribed Since Hospitalization or ER Visit by Laboratory-confirmed Influenza Status | Cough suppressants | 6 Participants |
| Influenza Group | Number of Subjects Using Any ARI and/or Fever Related Medication Prescribed Since Hospitalization or ER Visit by Laboratory-confirmed Influenza Status | Antipyretics | 121 Participants |
| Influenza Group | Number of Subjects Using Any ARI and/or Fever Related Medication Prescribed Since Hospitalization or ER Visit by Laboratory-confirmed Influenza Status | Antibiotics | 41 Participants |
| Influenza Group | Number of Subjects Using Any ARI and/or Fever Related Medication Prescribed Since Hospitalization or ER Visit by Laboratory-confirmed Influenza Status | Mucolytics | 3 Participants |
| Influenza Group | Number of Subjects Using Any ARI and/or Fever Related Medication Prescribed Since Hospitalization or ER Visit by Laboratory-confirmed Influenza Status | Antihistamines | 0 Participants |
| Influenza Group | Number of Subjects Using Any ARI and/or Fever Related Medication Prescribed Since Hospitalization or ER Visit by Laboratory-confirmed Influenza Status | Other medication | 35 Participants |
| Influenza Group | Number of Subjects Using Any ARI and/or Fever Related Medication Prescribed Since Hospitalization or ER Visit by Laboratory-confirmed Influenza Status | Any medication prescribed | 130 Participants |
| Influenza Negative Group | Number of Subjects Using Any ARI and/or Fever Related Medication Prescribed Since Hospitalization or ER Visit by Laboratory-confirmed Influenza Status | Other medication | 162 Participants |
| Influenza Negative Group | Number of Subjects Using Any ARI and/or Fever Related Medication Prescribed Since Hospitalization or ER Visit by Laboratory-confirmed Influenza Status | Any medication prescribed | 367 Participants |
| Influenza Negative Group | Number of Subjects Using Any ARI and/or Fever Related Medication Prescribed Since Hospitalization or ER Visit by Laboratory-confirmed Influenza Status | Antivirals | 0 Participants |
| Influenza Negative Group | Number of Subjects Using Any ARI and/or Fever Related Medication Prescribed Since Hospitalization or ER Visit by Laboratory-confirmed Influenza Status | Antibiotics | 151 Participants |
| Influenza Negative Group | Number of Subjects Using Any ARI and/or Fever Related Medication Prescribed Since Hospitalization or ER Visit by Laboratory-confirmed Influenza Status | Cough suppressants | 3 Participants |
| Influenza Negative Group | Number of Subjects Using Any ARI and/or Fever Related Medication Prescribed Since Hospitalization or ER Visit by Laboratory-confirmed Influenza Status | Antihistamines | 4 Participants |
| Influenza Negative Group | Number of Subjects Using Any ARI and/or Fever Related Medication Prescribed Since Hospitalization or ER Visit by Laboratory-confirmed Influenza Status | Pain medication | 18 Participants |
| Influenza Negative Group | Number of Subjects Using Any ARI and/or Fever Related Medication Prescribed Since Hospitalization or ER Visit by Laboratory-confirmed Influenza Status | Antipyretics | 287 Participants |
| Influenza Negative Group | Number of Subjects Using Any ARI and/or Fever Related Medication Prescribed Since Hospitalization or ER Visit by Laboratory-confirmed Influenza Status | Mucolytics | 9 Participants |
Secondary
Number of Subjects Using Any ARI and/or Fever Related Medication Taken Prior to Hospitalization or ER Visit by Laboratory-confirmed Influenza Status
ARI and/or fever related medication included: antivirals, antibiotics, cough suppressants, pain medication, antipyretics and mucolytics.
Time frame: Day 0 till Day 28-37
Population: The analysis was performed on the according-to-protocol (ATP) cohort for analysis, which included all evaluable subjects (i.e. those meeting all eligibility criteria and complying with the procedures defined in the protocol) for whom data concerning endpoint measures were available.
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Influenza Group | Number of Subjects Using Any ARI and/or Fever Related Medication Taken Prior to Hospitalization or ER Visit by Laboratory-confirmed Influenza Status | Any medication | 119 Participants |
| Influenza Group | Number of Subjects Using Any ARI and/or Fever Related Medication Taken Prior to Hospitalization or ER Visit by Laboratory-confirmed Influenza Status | Antibiotics | 9 Participants |
| Influenza Group | Number of Subjects Using Any ARI and/or Fever Related Medication Taken Prior to Hospitalization or ER Visit by Laboratory-confirmed Influenza Status | Cough suppressants | 3 Participants |
| Influenza Group | Number of Subjects Using Any ARI and/or Fever Related Medication Taken Prior to Hospitalization or ER Visit by Laboratory-confirmed Influenza Status | Antihistamines | 1 Participants |
| Influenza Group | Number of Subjects Using Any ARI and/or Fever Related Medication Taken Prior to Hospitalization or ER Visit by Laboratory-confirmed Influenza Status | Pain medication | 12 Participants |
| Influenza Group | Number of Subjects Using Any ARI and/or Fever Related Medication Taken Prior to Hospitalization or ER Visit by Laboratory-confirmed Influenza Status | Antipyretics | 114 Participants |
| Influenza Group | Number of Subjects Using Any ARI and/or Fever Related Medication Taken Prior to Hospitalization or ER Visit by Laboratory-confirmed Influenza Status | Mucolytics | 1 Participants |
| Influenza Group | Number of Subjects Using Any ARI and/or Fever Related Medication Taken Prior to Hospitalization or ER Visit by Laboratory-confirmed Influenza Status | Other medication | 10 Participants |
| Influenza Negative Group | Number of Subjects Using Any ARI and/or Fever Related Medication Taken Prior to Hospitalization or ER Visit by Laboratory-confirmed Influenza Status | Other medication | 61 Participants |
| Influenza Negative Group | Number of Subjects Using Any ARI and/or Fever Related Medication Taken Prior to Hospitalization or ER Visit by Laboratory-confirmed Influenza Status | Any medication | 300 Participants |
| Influenza Negative Group | Number of Subjects Using Any ARI and/or Fever Related Medication Taken Prior to Hospitalization or ER Visit by Laboratory-confirmed Influenza Status | Pain medication | 21 Participants |
| Influenza Negative Group | Number of Subjects Using Any ARI and/or Fever Related Medication Taken Prior to Hospitalization or ER Visit by Laboratory-confirmed Influenza Status | Antibiotics | 21 Participants |
| Influenza Negative Group | Number of Subjects Using Any ARI and/or Fever Related Medication Taken Prior to Hospitalization or ER Visit by Laboratory-confirmed Influenza Status | Mucolytics | 5 Participants |
| Influenza Negative Group | Number of Subjects Using Any ARI and/or Fever Related Medication Taken Prior to Hospitalization or ER Visit by Laboratory-confirmed Influenza Status | Cough suppressants | 7 Participants |
| Influenza Negative Group | Number of Subjects Using Any ARI and/or Fever Related Medication Taken Prior to Hospitalization or ER Visit by Laboratory-confirmed Influenza Status | Antipyretics | 267 Participants |
| Influenza Negative Group | Number of Subjects Using Any ARI and/or Fever Related Medication Taken Prior to Hospitalization or ER Visit by Laboratory-confirmed Influenza Status | Antihistamines | 1 Participants |
Secondary
Number of Subjects Using Any Non-prescribed ARI and/or Fever Related Medication Taken Since Hospitalization or ER Visit
ARI and/or fever related medication included: antivirals, antibiotics, cough suppressants, pain medication, antipyretics and mucolytics.
Time frame: Day 0 till Day 28-37
Population: The analysis was performed on the according-to-protocol (ATP) cohort for analysis, which included all evaluable subjects (i.e. those meeting all eligibility criteria and complying with the procedures defined in the protocol) for whom data concerning endpoint measures were available.
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Influenza Group | Number of Subjects Using Any Non-prescribed ARI and/or Fever Related Medication Taken Since Hospitalization or ER Visit | Antihistamines | 0 Participants |
| Influenza Group | Number of Subjects Using Any Non-prescribed ARI and/or Fever Related Medication Taken Since Hospitalization or ER Visit | Antipyretics | 0 Participants |
| Influenza Group | Number of Subjects Using Any Non-prescribed ARI and/or Fever Related Medication Taken Since Hospitalization or ER Visit | Antibiotics | 2 Participants |
| Influenza Group | Number of Subjects Using Any Non-prescribed ARI and/or Fever Related Medication Taken Since Hospitalization or ER Visit | Mucolytics | 0 Participants |
| Influenza Group | Number of Subjects Using Any Non-prescribed ARI and/or Fever Related Medication Taken Since Hospitalization or ER Visit | Pain medication | 1 Participants |
| Influenza Group | Number of Subjects Using Any Non-prescribed ARI and/or Fever Related Medication Taken Since Hospitalization or ER Visit | Other medication | 6 Participants |
| Influenza Group | Number of Subjects Using Any Non-prescribed ARI and/or Fever Related Medication Taken Since Hospitalization or ER Visit | Any non-prescribed medication | 9 Participants |
| Influenza Negative Group | Number of Subjects Using Any Non-prescribed ARI and/or Fever Related Medication Taken Since Hospitalization or ER Visit | Other medication | 16 Participants |
| Influenza Negative Group | Number of Subjects Using Any Non-prescribed ARI and/or Fever Related Medication Taken Since Hospitalization or ER Visit | Any non-prescribed medication | 30 Participants |
| Influenza Negative Group | Number of Subjects Using Any Non-prescribed ARI and/or Fever Related Medication Taken Since Hospitalization or ER Visit | Antibiotics | 11 Participants |
| Influenza Negative Group | Number of Subjects Using Any Non-prescribed ARI and/or Fever Related Medication Taken Since Hospitalization or ER Visit | Antihistamines | 1 Participants |
| Influenza Negative Group | Number of Subjects Using Any Non-prescribed ARI and/or Fever Related Medication Taken Since Hospitalization or ER Visit | Pain medication | 3 Participants |
| Influenza Negative Group | Number of Subjects Using Any Non-prescribed ARI and/or Fever Related Medication Taken Since Hospitalization or ER Visit | Antipyretics | 2 Participants |
| Influenza Negative Group | Number of Subjects Using Any Non-prescribed ARI and/or Fever Related Medication Taken Since Hospitalization or ER Visit | Mucolytics | 1 Participants |
Secondary
Number of Subjects With Fatal Outcomes
Deaths from ARI and/or fever episodes by laboratory-confirmed influenza status were assessed.
Time frame: Day 0 till Day 28-37
Population: The analysis was performed on the according-to-protocol (ATP) cohort for analysis, which included all evaluable subjects (i.e. those meeting all eligibility criteria and complying with the procedures defined in the protocol) for whom data concerning endpoint measures were available.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Influenza Group | Number of Subjects With Fatal Outcomes | 0 Participants |
| Influenza Negative Group | Number of Subjects With Fatal Outcomes | 0 Participants |
Secondary
Number of Subjects With Household Members With Influenza-like Illness
This outcome assessed the number of cases with household contacts presenting influenza like illness symptoms during the follow-up period by laboratory-confirmed influenza status.
Time frame: Day 0 till Day 28-37
Population: The analysis was performed on the according-to-protocol (ATP) cohort for analysis, which included all evaluable subjects (i.e. those meeting all eligibility criteria and complying with the procedures defined in the protocol) for whom data concerning endpoint measures were available.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Influenza Group | Number of Subjects With Household Members With Influenza-like Illness | Household members with influenza-like illness | 73 Household members |
| Influenza Group | Number of Subjects With Household Members With Influenza-like Illness | Household members with no influenza-like illness | 58 Household members |
| Influenza Group | Number of Subjects With Household Members With Influenza-like Illness | 1-2 household members with ARI/fever | 19 Household members |
| Influenza Group | Number of Subjects With Household Members With Influenza-like Illness | 3-4 household members with ARI/fever | 48 Household members |
| Influenza Group | Number of Subjects With Household Members With Influenza-like Illness | >4 household members with ARI/fever | 6 Household members |
| Influenza Group | Number of Subjects With Household Members With Influenza-like Illness | Missing confirmed | 0 Household members |
| Influenza Negative Group | Number of Subjects With Household Members With Influenza-like Illness | >4 household members with ARI/fever | 12 Household members |
| Influenza Negative Group | Number of Subjects With Household Members With Influenza-like Illness | Household members with influenza-like illness | 146 Household members |
| Influenza Negative Group | Number of Subjects With Household Members With Influenza-like Illness | 3-4 household members with ARI/fever | 98 Household members |
| Influenza Negative Group | Number of Subjects With Household Members With Influenza-like Illness | Household members with no influenza-like illness | 224 Household members |
| Influenza Negative Group | Number of Subjects With Household Members With Influenza-like Illness | Missing confirmed | 1 Household members |
| Influenza Negative Group | Number of Subjects With Household Members With Influenza-like Illness | 1-2 household members with ARI/fever | 35 Household members |
Secondary
Number of Subjects With Other Laboratory-confirmed Respiratory Viruses
Among the other laboratory-confirmed respiratory viruses there were:adenovirus, respiratory syncytial virus, parainfluenza virus 1, 2 and 3, metapneumovirus, bocavirus, rhinovirus or coronavirus. The outcome was assessed in subjects with an acute respiratory illness (ARI) and/or isolated fever episode.
Time frame: Day 0 till Day 28-37
Population: The analysis was performed on the according-to-protocol (ATP) cohort for analysis, which included all evaluable subjects (i.e. those meeting all eligibility criteria and complying with the procedures defined in the protocol) for whom data concerning endpoint measures were available.
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Influenza Group | Number of Subjects With Other Laboratory-confirmed Respiratory Viruses | Emergency Room | 98 Participants |
| Influenza Group | Number of Subjects With Other Laboratory-confirmed Respiratory Viruses | Hospitalized | 47 Participants |
Secondary
Number of Subjects With Potential Risk Factors at Study Start by Laboratory-confirmed Influenza Status
Risk factors were classified as pre-existing conditions, breast-feeding status and day-care status.
Time frame: Day 0 till Day 28-37
Population: The analysis was performed on the according-to-protocol (ATP) cohort for analysis, which included all evaluable subjects (i.e. those meeting all eligibility criteria and complying with the procedures defined in the protocol) for whom data concerning endpoint measures were available.
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Influenza Group | Number of Subjects With Potential Risk Factors at Study Start by Laboratory-confirmed Influenza Status | Prematurity (<36 weeks gestation) | 1 Participants |
| Influenza Group | Number of Subjects With Potential Risk Factors at Study Start by Laboratory-confirmed Influenza Status | Breast fed | 15 Participants |
| Influenza Group | Number of Subjects With Potential Risk Factors at Study Start by Laboratory-confirmed Influenza Status | Cardiovascular disease | 1 Participants |
| Influenza Group | Number of Subjects With Potential Risk Factors at Study Start by Laboratory-confirmed Influenza Status | Not breast fed | 35 Participants |
| Influenza Group | Number of Subjects With Potential Risk Factors at Study Start by Laboratory-confirmed Influenza Status | No pre-existing conditions | 99 Participants |
| Influenza Group | Number of Subjects With Potential Risk Factors at Study Start by Laboratory-confirmed Influenza Status | Breast feeding status not known (>2 years old) | 81 Participants |
| Influenza Group | Number of Subjects With Potential Risk Factors at Study Start by Laboratory-confirmed Influenza Status | Neuromuscular diseases | 0 Participants |
| Influenza Group | Number of Subjects With Potential Risk Factors at Study Start by Laboratory-confirmed Influenza Status | In day-care attendance | 60 Participants |
| Influenza Group | Number of Subjects With Potential Risk Factors at Study Start by Laboratory-confirmed Influenza Status | Chronic pneumopathy (including asthma) | 25 Participants |
| Influenza Group | Number of Subjects With Potential Risk Factors at Study Start by Laboratory-confirmed Influenza Status | Not in day-care attendance | 28 Participants |
| Influenza Group | Number of Subjects With Potential Risk Factors at Study Start by Laboratory-confirmed Influenza Status | Other | 7 Participants |
| Influenza Group | Number of Subjects With Potential Risk Factors at Study Start by Laboratory-confirmed Influenza Status | Not known if in day-care attendance (>5 years old) | 43 Participants |
| Influenza Group | Number of Subjects With Potential Risk Factors at Study Start by Laboratory-confirmed Influenza Status | Any pre-existing conditions | 32 Participants |
| Influenza Negative Group | Number of Subjects With Potential Risk Factors at Study Start by Laboratory-confirmed Influenza Status | Not known if in day-care attendance (>5 years old) | 42 Participants |
| Influenza Negative Group | Number of Subjects With Potential Risk Factors at Study Start by Laboratory-confirmed Influenza Status | Any pre-existing conditions | 82 Participants |
| Influenza Negative Group | Number of Subjects With Potential Risk Factors at Study Start by Laboratory-confirmed Influenza Status | No pre-existing conditions | 288 Participants |
| Influenza Negative Group | Number of Subjects With Potential Risk Factors at Study Start by Laboratory-confirmed Influenza Status | Prematurity (<36 weeks gestation) | 12 Participants |
| Influenza Negative Group | Number of Subjects With Potential Risk Factors at Study Start by Laboratory-confirmed Influenza Status | Chronic pneumopathy (including asthma) | 60 Participants |
| Influenza Negative Group | Number of Subjects With Potential Risk Factors at Study Start by Laboratory-confirmed Influenza Status | Cardiovascular disease | 2 Participants |
| Influenza Negative Group | Number of Subjects With Potential Risk Factors at Study Start by Laboratory-confirmed Influenza Status | Neuromuscular diseases | 1 Participants |
| Influenza Negative Group | Number of Subjects With Potential Risk Factors at Study Start by Laboratory-confirmed Influenza Status | Other | 15 Participants |
| Influenza Negative Group | Number of Subjects With Potential Risk Factors at Study Start by Laboratory-confirmed Influenza Status | Breast fed | 88 Participants |
| Influenza Negative Group | Number of Subjects With Potential Risk Factors at Study Start by Laboratory-confirmed Influenza Status | Not breast fed | 153 Participants |
| Influenza Negative Group | Number of Subjects With Potential Risk Factors at Study Start by Laboratory-confirmed Influenza Status | Breast feeding status not known (>2 years old) | 129 Participants |
| Influenza Negative Group | Number of Subjects With Potential Risk Factors at Study Start by Laboratory-confirmed Influenza Status | In day-care attendance | 176 Participants |
| Influenza Negative Group | Number of Subjects With Potential Risk Factors at Study Start by Laboratory-confirmed Influenza Status | Not in day-care attendance | 152 Participants |
Secondary
Number of Subjects With Secondary Bacterial Infections
The outcome assessed the various complications by laboratory-confirmed influenza status.
Time frame: Day 0 till Day 28-37
Population: The analysis was performed on the according-to-protocol (ATP) cohort for analysis, which included all evaluable subjects (i.e. those meeting all eligibility criteria and complying with the procedures defined in the protocol) for whom data concerning endpoint measures were available.
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Influenza Group | Number of Subjects With Secondary Bacterial Infections | Conjunctivitis | 3 Participants |
| Influenza Group | Number of Subjects With Secondary Bacterial Infections | Any complication | 37 Participants |
| Influenza Group | Number of Subjects With Secondary Bacterial Infections | Secondary bacterial pneumonia | 11 Participants |
| Influenza Group | Number of Subjects With Secondary Bacterial Infections | Primary influenza viral pneumonia | 3 Participants |
| Influenza Group | Number of Subjects With Secondary Bacterial Infections | Bronchiolitis | 10 Participants |
| Influenza Group | Number of Subjects With Secondary Bacterial Infections | Acute Otitis Media | 12 Participants |
| Influenza Group | Number of Subjects With Secondary Bacterial Infections | Myositis | 2 Participants |
| Influenza Group | Number of Subjects With Secondary Bacterial Infections | Pericarditis | 0 Participants |
| Influenza Negative Group | Number of Subjects With Secondary Bacterial Infections | Pericarditis | 0 Participants |
| Influenza Negative Group | Number of Subjects With Secondary Bacterial Infections | Conjunctivitis | 16 Participants |
| Influenza Negative Group | Number of Subjects With Secondary Bacterial Infections | Bronchiolitis | 67 Participants |
| Influenza Negative Group | Number of Subjects With Secondary Bacterial Infections | Any complication | 145 Participants |
| Influenza Negative Group | Number of Subjects With Secondary Bacterial Infections | Myositis | 1 Participants |
| Influenza Negative Group | Number of Subjects With Secondary Bacterial Infections | Secondary bacterial pneumonia | 34 Participants |
| Influenza Negative Group | Number of Subjects With Secondary Bacterial Infections | Acute Otitis Media | 33 Participants |
| Influenza Negative Group | Number of Subjects With Secondary Bacterial Infections | Primary influenza viral pneumonia | 7 Participants |
Secondary
Proportion of Household Members Presenting Influenza Like Illness Symptoms (ARI and/or Isolated Fever)
This outcome assessed the proportion of influenza like illness (ILI) among household members of children \< 15 years with and without laboratory-confirmed influenza.
Time frame: Day 0 till Day 28-37
Population: The analysis was performed on the according-to-protocol (ATP) cohort for analysis, which included all evaluable subjects (i.e. those meeting all eligibility criteria and complying with the procedures defined in the protocol) for whom data concerning endpoint measures were available.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Influenza Group | Proportion of Household Members Presenting Influenza Like Illness Symptoms (ARI and/or Isolated Fever) | 25.80 Percentage of household members |
| Influenza Negative Group | Proportion of Household Members Presenting Influenza Like Illness Symptoms (ARI and/or Isolated Fever) | 17.45 Percentage of household members |