Trial Outcomes & Findings for Study on the Burden of Influenza-related Hospitalizations and Emergency Room (ER) Visits in Children in Spain (NCT NCT01592799)

Results Overview

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.

Recruitment status

COMPLETED

Study phase

NA

Target enrollment

501 participants

Primary outcome timeframe

Day 0 till Day 28-37

Results posted on

2018-07-27

Participant Flow

Recruitment started in October, 2010, and last until May, 2011, or until the target sample size was enrolled.

Participant milestones

Participant milestones
Measure	Influenza Group Children \<15 years of age hospitalized for or presenting to an Emergency Room (ER) for Acute Respiratory Illness (ARI) and/or isolated fever during the influenza season.
Overall Study STARTED	501
Overall Study COMPLETED	501
Overall Study NOT COMPLETED	0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Study on the Burden of Influenza-related Hospitalizations and Emergency Room (ER) Visits in Children in Spain

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Influenza Group n=501 Participants 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.
Age, Continuous	33.0 Months STANDARD_DEVIATION 37.44 • n=5 Participants
Sex: Female, Male Female	212 Participants n=5 Participants
Sex: Female, Male Male	289 Participants n=5 Participants

PRIMARY outcome

Timeframe: 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.

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.

Outcome measures

Outcome measures
Measure	Influenza Group n=501 Participants Children \<15 years of age hospitalized for or presenting to an ER for ARI and/or isolated fever during the influenza season.	Influenza Negative Group Children \<15 years of age with no laboratory test positive for influenza.
Number of Subjects With Laboratory-confirmed Influenza Presenting With an Acute Respiratory Illness (ARI) and/or Isolated Fever Emergency Room	120 Participants	—
Number of Subjects With Laboratory-confirmed Influenza Presenting With an Acute Respiratory Illness (ARI) and/or Isolated Fever Hospitalized	11 Participants	—

PRIMARY outcome

Timeframe: 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.

Ward specific room charge and Intensive Care Unit (ICU) were computed as daily charge multiplied by the number of days.

Outcome measures

Outcome measures
Measure	Influenza Group n=131 Participants Children \<15 years of age hospitalized for or presenting to an ER for ARI and/or isolated fever during the influenza season.	Influenza Negative Group Children \<15 years of age with no laboratory test positive for influenza.
Direct Medical Cost Per Hospitalization or ER Visit With Laboratory-confirmed Influenza Laboratory	57.27 Euros Standard Deviation 48.93	—
Direct Medical Cost Per Hospitalization or ER Visit With Laboratory-confirmed Influenza Radiology	16.94 Euros Standard Deviation 9.68	—
Direct Medical Cost Per Hospitalization or ER Visit With Laboratory-confirmed Influenza Other diagnostics	89.94 Euros Standard Deviation 80.25	—
Direct Medical Cost Per Hospitalization or ER Visit With Laboratory-confirmed Influenza Total for diagnostics	52.97 Euros Standard Deviation 63.77	—
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	—
Direct Medical Cost Per Hospitalization or ER Visit With Laboratory-confirmed Influenza Prescribed medication	12.28 Euros Standard Deviation 18.49	—
Direct Medical Cost Per Hospitalization or ER Visit With Laboratory-confirmed Influenza Non-prescribed medication	9.86 Euros Standard Deviation 12.56	—
Direct Medical Cost Per Hospitalization or ER Visit With Laboratory-confirmed Influenza Total for treatments	16.44 Euros Standard Deviation 21.68	—
Direct Medical Cost Per Hospitalization or ER Visit With Laboratory-confirmed Influenza Ward specific room charge	1774.55 Euros Standard Deviation 1062.94	—
Direct Medical Cost Per Hospitalization or ER Visit With Laboratory-confirmed Influenza ICU	1535.19 Euros Standard Deviation 0.0	—
Direct Medical Cost Per Hospitalization or ER Visit With Laboratory-confirmed Influenza Total for inpatient charge	1884.21 Euros Standard Deviation 1182.22	—
Direct Medical Cost Per Hospitalization or ER Visit With Laboratory-confirmed Influenza ER visit	170.16 Euros Standard Deviation 64.18	—
Direct Medical Cost Per Hospitalization or ER Visit With Laboratory-confirmed Influenza Others	136.77 Euros Standard Deviation 49.91	—

SECONDARY outcome

Timeframe: 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.

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.

Outcome measures

Outcome measures
Measure	Influenza Group n=501 Participants Children \<15 years of age hospitalized for or presenting to an ER for ARI and/or isolated fever during the influenza season.	Influenza Negative Group Children \<15 years of age with no laboratory test positive for influenza.
Number of Subjects With Other Laboratory-confirmed Respiratory Viruses Emergency Room	98 Participants	—
Number of Subjects With Other Laboratory-confirmed Respiratory Viruses Hospitalized	47 Participants	—

SECONDARY outcome

Timeframe: 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.

Deaths from ARI and/or fever episodes by laboratory-confirmed influenza status were assessed.

Outcome measures

Outcome measures
Measure	Influenza Group n=131 Participants Children \<15 years of age hospitalized for or presenting to an ER for ARI and/or isolated fever during the influenza season.	Influenza Negative Group n=370 Participants Children \<15 years of age with no laboratory test positive for influenza.
Number of Subjects With Fatal Outcomes	0 Participants	0 Participants

SECONDARY outcome

Timeframe: 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.

The outcome assessed the various complications by laboratory-confirmed influenza status.

Outcome measures

Outcome measures
Measure	Influenza Group n=131 Participants Children \<15 years of age hospitalized for or presenting to an ER for ARI and/or isolated fever during the influenza season.	Influenza Negative Group n=370 Participants Children \<15 years of age with no laboratory test positive for influenza.
Number of Subjects With Secondary Bacterial Infections Any complication	37 Participants	145 Participants
Number of Subjects With Secondary Bacterial Infections Secondary bacterial pneumonia	11 Participants	34 Participants
Number of Subjects With Secondary Bacterial Infections Primary influenza viral pneumonia	3 Participants	7 Participants
Number of Subjects With Secondary Bacterial Infections Bronchiolitis	10 Participants	67 Participants
Number of Subjects With Secondary Bacterial Infections Acute Otitis Media	12 Participants	33 Participants
Number of Subjects With Secondary Bacterial Infections Myositis	2 Participants	1 Participants
Number of Subjects With Secondary Bacterial Infections Pericarditis	0 Participants	0 Participants
Number of Subjects With Secondary Bacterial Infections Conjunctivitis	3 Participants	16 Participants

SECONDARY outcome

Timeframe: 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.

Risk factors were classified as pre-existing conditions, breast-feeding status and day-care status.

Outcome measures

Outcome measures
Measure	Influenza Group n=131 Participants Children \<15 years of age hospitalized for or presenting to an ER for ARI and/or isolated fever during the influenza season.	Influenza Negative Group n=370 Participants Children \<15 years of age with no laboratory test positive for influenza.
Number of Subjects With Potential Risk Factors at Study Start by Laboratory-confirmed Influenza Status Any pre-existing conditions	32 Participants	82 Participants
Number of Subjects With Potential Risk Factors at Study Start by Laboratory-confirmed Influenza Status No pre-existing conditions	99 Participants	288 Participants
Number of Subjects With Potential Risk Factors at Study Start by Laboratory-confirmed Influenza Status Prematurity (<36 weeks gestation)	1 Participants	12 Participants
Number of Subjects With Potential Risk Factors at Study Start by Laboratory-confirmed Influenza Status Chronic pneumopathy (including asthma)	25 Participants	60 Participants
Number of Subjects With Potential Risk Factors at Study Start by Laboratory-confirmed Influenza Status Cardiovascular disease	1 Participants	2 Participants
Number of Subjects With Potential Risk Factors at Study Start by Laboratory-confirmed Influenza Status Neuromuscular diseases	0 Participants	1 Participants
Number of Subjects With Potential Risk Factors at Study Start by Laboratory-confirmed Influenza Status Other	7 Participants	15 Participants
Number of Subjects With Potential Risk Factors at Study Start by Laboratory-confirmed Influenza Status Breast fed	15 Participants	88 Participants
Number of Subjects With Potential Risk Factors at Study Start by Laboratory-confirmed Influenza Status Not breast fed	35 Participants	153 Participants
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	129 Participants
Number of Subjects With Potential Risk Factors at Study Start by Laboratory-confirmed Influenza Status In day-care attendance	60 Participants	176 Participants
Number of Subjects With Potential Risk Factors at Study Start by Laboratory-confirmed Influenza Status Not in day-care attendance	28 Participants	152 Participants
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	42 Participants

SECONDARY outcome

Timeframe: 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.

The outcomes was assessed in subjects with laboratory-confirmed influenza status

Outcome measures

Outcome measures
Measure	Influenza Group n=131 Participants Children \<15 years of age hospitalized for or presenting to an ER for ARI and/or isolated fever during the influenza season.	Influenza Negative Group n=370 Participants Children \<15 years of age with no laboratory test positive for influenza.
Number of Days of Hospitalization	2.0 Days Standard Deviation 0.00	4.4 Days Standard Deviation 4.34

SECONDARY outcome

Timeframe: 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.

ARI and/or fever related medication included: antivirals, antibiotics, cough suppressants, pain medication, antipyretics and mucolytics.

Outcome measures

Outcome measures
Measure	Influenza Group n=131 Participants Children \<15 years of age hospitalized for or presenting to an ER for ARI and/or isolated fever during the influenza season.	Influenza Negative Group n=370 Participants Children \<15 years of age with no laboratory test positive for influenza.
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	300 Participants
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	21 Participants
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	7 Participants
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	1 Participants
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	21 Participants
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	267 Participants
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	5 Participants
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	61 Participants

SECONDARY outcome

Timeframe: 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.

ARI and/or fever related medication included: antivirals, antibiotics, cough suppressants, pain medication, antipyretics and mucolytics.

Outcome measures

Outcome measures
Measure	Influenza Group n=131 Participants Children \<15 years of age hospitalized for or presenting to an ER for ARI and/or isolated fever during the influenza season.	Influenza Negative Group n=370 Participants Children \<15 years of age with no laboratory test positive for influenza.
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	344 Participants
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	1 Participants
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	77 Participants
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	0 Participants
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	28 Participants
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	284 Participants
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	1 Participants
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	114 Participants

SECONDARY outcome

Timeframe: 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.

ARI and/or fever related medication included: antivirals, antibiotics, cough suppressants, pain medication, antipyretics and mucolytics.

Outcome measures

Outcome measures
Measure	Influenza Group n=131 Participants Children \<15 years of age hospitalized for or presenting to an ER for ARI and/or isolated fever during the influenza season.	Influenza Negative Group n=370 Participants Children \<15 years of age with no laboratory test positive for influenza.
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	367 Participants
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	0 Participants
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	151 Participants
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	3 Participants
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	4 Participants
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	18 Participants
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	287 Participants
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	9 Participants
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	162 Participants

SECONDARY outcome

Timeframe: 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.

ARI and/or fever related medication included: antivirals, antibiotics, cough suppressants, pain medication, antipyretics and mucolytics.

Outcome measures

Outcome measures
Measure	Influenza Group n=131 Participants Children \<15 years of age hospitalized for or presenting to an ER for ARI and/or isolated fever during the influenza season.	Influenza Negative Group n=370 Participants Children \<15 years of age with no laboratory test positive for influenza.
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	30 Participants
Number of Subjects Using Any Non-prescribed ARI and/or Fever Related Medication Taken Since Hospitalization or ER Visit Antibiotics	2 Participants	11 Participants
Number of Subjects Using Any Non-prescribed ARI and/or Fever Related Medication Taken Since Hospitalization or ER Visit Antihistamines	0 Participants	1 Participants
Number of Subjects Using Any Non-prescribed ARI and/or Fever Related Medication Taken Since Hospitalization or ER Visit Pain medication	1 Participants	3 Participants
Number of Subjects Using Any Non-prescribed ARI and/or Fever Related Medication Taken Since Hospitalization or ER Visit Antipyretics	0 Participants	2 Participants
Number of Subjects Using Any Non-prescribed ARI and/or Fever Related Medication Taken Since Hospitalization or ER Visit Mucolytics	0 Participants	1 Participants
Number of Subjects Using Any Non-prescribed ARI and/or Fever Related Medication Taken Since Hospitalization or ER Visit Other medication	6 Participants	16 Participants

SECONDARY outcome

Timeframe: 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.

School absenteeism was assessed among patients during the follow-up period by laboratory-confirmed influenza status.

Outcome measures

Outcome measures
Measure	Influenza Group n=131 Participants Children \<15 years of age hospitalized for or presenting to an ER for ARI and/or isolated fever during the influenza season.	Influenza Negative Group n=370 Participants Children \<15 years of age with no laboratory test positive for influenza.
Number of Days of School Absenteeism	6.6 Days Standard Deviation 3.46	6.4 Days Standard Deviation 3.66

SECONDARY outcome

Timeframe: 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.

This outcome assessed absenteeism among caregivers to provide patient care during the follow-up period by laboratory-confirmed influenza status.

Outcome measures

Outcome measures
Measure	Influenza Group n=131 Participants Children \<15 years of age hospitalized for or presenting to an ER for ARI and/or isolated fever during the influenza season.	Influenza Negative Group n=370 Participants Children \<15 years of age with no laboratory test positive for influenza.
Number of Days of Parent or Caregiver Time Off Work	4.4 Days Standard Deviation 2.76	4.1 Days Standard Deviation 3.10

SECONDARY outcome

Timeframe: 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.

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.

Outcome measures

Outcome measures
Measure	Influenza Group n=131 Participants Children \<15 years of age hospitalized for or presenting to an ER for ARI and/or isolated fever during the influenza season.	Influenza Negative Group n=370 Participants Children \<15 years of age with no laboratory test positive for influenza.
Number of Subjects With Household Members With Influenza-like Illness Household members with influenza-like illness	73 Household members	146 Household members
Number of Subjects With Household Members With Influenza-like Illness Household members with no influenza-like illness	58 Household members	224 Household members
Number of Subjects With Household Members With Influenza-like Illness 1-2 household members with ARI/fever	19 Household members	35 Household members
Number of Subjects With Household Members With Influenza-like Illness >4 household members with ARI/fever	6 Household members	12 Household members
Number of Subjects With Household Members With Influenza-like Illness Missing confirmed	0 Household members	1 Household members
Number of Subjects With Household Members With Influenza-like Illness 3-4 household members with ARI/fever	48 Household members	98 Household members

SECONDARY outcome

Timeframe: 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.

This outcome assessed the proportion of influenza like illness (ILI) among household members of children \< 15 years with and without laboratory-confirmed influenza.

Outcome measures

Outcome measures
Measure	Influenza Group n=131 Participants Children \<15 years of age hospitalized for or presenting to an ER for ARI and/or isolated fever during the influenza season.	Influenza Negative Group n=370 Participants Children \<15 years of age with no laboratory test positive for influenza.
Proportion of Household Members Presenting Influenza Like Illness Symptoms (ARI and/or Isolated Fever)	25.80 Percentage of household members Interval 21.16 to 31.06	17.45 Percentage of household members Interval 15.02 to 20.18

Adverse Events

Influenza Group

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Adverse event data not reported

Additional Information

GSK Response Center

GlaxoSmithKline

Phone: 866-435-7343

Results disclosure agreements

Principal investigator is a sponsor employee GSK agreements may vary with individual investigators, but will not prohibit any investigator from publishing. GSK supports the publication of results from all centers of a multi-center trial but requests that reports based on single-site data not precede the primary publication of the entire clinical trial.
Publication restrictions are in place

Restriction type: OTHER