Immunogenicity and Safety of GSK Biologicals' Influenza V... | NCT00764790

NCT00764790

Status Module

Sponsor/Collaborators Module

Oversight Module

No data available

No data is available for this block.

Description Module

Conditions Module

Design Module

Interventional Study Design

Biospecimen

No data available

No data is available for this block.

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Fluarix Dose A Group	Experimental	Subjects were administered 1 or 2 doses* of Fluarix vaccine (at Day 0 or at Days 0 and 28) intramuscularly, in the non-dominant upper arm (children >12 months of age) or in the anterolateral thigh (children <12 months of age). * Only those subjects who had no history of prior influenza vaccination (i.e. unprimed subjects) received 2 doses.	Biological: Fluarix
Fluarix Dose B Group	Experimental	Subjects were administered 1 or 2 doses, half the volume of dose A, of Fluarix vaccine (at Day 0 or at Days 0 and 28) intramuscularly, in the non-dominant upper arm (children >12 months of age) or in the anterolateral thigh (children <12 months of age). Only those subjects who had no history of prior influenza vaccination (i.e. unprimed subjects) received 2 doses.	Biological: Fluarix
Fluzone Group	Active Comparator	Subjects were administered 1 or 2 doses* of Fluzone vaccine (at Day 0 or at Days 0 and 28) intramuscularly, in the non-dominant upper arm (children >12 months of age) or in the anterolateral thigh (children <12 months of age). * Only those subjects who had no history of prior influenza vaccination (i.e. unprimed subjects) received 2 doses.	Biological: Fluzone

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Fluarix	Biological	One (Day 0) or two (Day 0 and Day 28) doses by intramuscular injection. Two different doses are tested.	Fluarix Dose A Group Fluarix Dose B Group

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Geometric Mean Titer (GMT) of Serum Anti-hemagglutinin (HA) Antibodies Against Each of the Influenza Vaccine Strains	GMTs and their 95% confidence interval are presented for all 3 viral strains comprised in the vaccine. Post-vaccination timepoints: Day 28 for primed or Day 56 for unprimed subjects	Day 0 (PRE), Day 28 or Day 56 (POST)
Number of Subjects Who Seroconverted	Seroconversion is defined as the number of subjects with either a pre-vaccination anti-HA 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. Post-vaccination timepoints: Day 28 for primed or Day 56 for unprimed subjects	Day 28 or Day 56

Secondary Outcomes

Measure	Description	Time Frame
Number of Seroprotected Subjects	A seroprotected subject is a subject with a serum anti-HA titer ≥ 1:40 Post-vaccination timepoints: Day 28 for primed or Day 56 for unprimed subjects	Day 0 (PRE), Day 28 or Day 56 (POST)
Seroconversion Factor

Eligibility Module

Contacts/Locations Module

Name	Affiliation	Role
GSK Clinical Trials	GlaxoSmithKline	Study Director

Facility	Status	City	State	ZIP	Country	Contacts
GSK Investigational Site		Birmingham	Alabama	35205	United States
GSK Investigational Site

References Module

Citations

PubMed Identifier	Type	Citation	Retractions
29465480	Derived	Li-Kim-Moy J, Wood N, Jones C, Macartney K, Booy R. Impact of Fever and Antipyretic Use on Influenza Vaccine Immune Reponses in Children. Pediatr Infect Dis J. 2018 Oct;37(10):971-975. doi: 10.1097/INF.0000000000001949.
23782962	Derived	Pavia-Ruz N, Angel Rodriguez Weber M, Lau YL, Nelson EA, Kerdpanich A, Huang LM, Silas P, Qaqundah P, Blatter M, Jeanfreau R, Lei P, Jain V, El Idrissi M, Feng Y, Innis B, Peeters M, Devaster JM. A randomized controlled study to evaluate the immunogenicity of a trivalent inactivated seasonal influenza vaccine at two dosages in children 6 to 35 months of age. Hum Vaccin Immunother. 2013 Sep;9(9):1978-88. doi: 10.4161/hv.25363. Epub 2013 Jun 19.

Label	URL
Researchers can use this site to request access to anonymised patient level data and/or supporting documents from clinical studies to conduct further research.	View source

ID	Type	URL	Comment
111751	Dataset Specification	View IPD

IPD Sharing Statement Module

Results Section

Participant Flow Module

Arm/Group Information

ID	Title	Description
FG000	Fluarix Dose A Group	Subjects were administered 1 or 2 doses* of Fluarix vaccine (at Day 0 or at Days 0 and 28) intramuscularly, in the non-dominant upper arm (children >12 months of age) or in the anterolateral thigh (children <12 months of age). * Only those subjects who had no history of prior influenza vaccination (i.e. unprimed subjects) received 2 doses.

Baseline Characteristics Module

Outcome Measures Module

Adverse Events Module

More Info Module

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Submission Tracking

No data available

No data is available for this block.

Condition Browse Module

Intervention Browse Module

Masking Info

Seroconversion factor is defined as the fold increase in serum anti-HA GMTs post-vaccination (Day 28 or 56) compared to pre-vaccination (Day 0).

Post-vaccination timepoints: Day 28 for primed or Day 56 for unprimed subjects

Type of Units Analyzed

Arm/Group Information

ID	Title	Description
BG000	Fluarix Dose A Group	Subjects were administered 1 or 2 doses* of Fluarix vaccine (at Day 0 or at Days 0 and 28) intramuscularly, in the non-dominant upper arm (children >12 months of age) or in the anterolateral thigh (children <12 months of age). * Only those subjects who had no history of prior influenza vaccination (i.e. unprimed subjects) received 2 doses.
BG001	Fluarix Dose B Group	Subjects were administered 1 or 2 doses, half the volume of dose A, of Fluarix vaccine (at Day 0 or at Days 0 and 28) intramuscularly, in the non-dominant upper arm (children >12 months of age) or in the anterolateral thigh (children <12 months of age). Only those subjects who had no history of prior influenza vaccination (i.e. unprimed subjects) received 2 doses.
BG002	Fluzone Group	Subjects were administered 1 or 2 doses* of Fluzone vaccine (at Day 0 or at Days 0 and 28) intramuscularly, in the non-dominant upper arm (children >12 months of age) or in the anterolateral thigh (children <12 months of age). * Only those subjects who had no history of prior influenza vaccination (i.e. unprimed subjects) received 2 doses.
BG003	Total	Total of all reporting groups

Baseline Measures

Title

Description

Population Description

Parameter Type

Dispersion Type

Unit of Measure

Calculate Percentage

Denominator Units Selected

Denominators

Classes

Age, Continuous

Mean

Standard Deviation

months

Title

Denominators

Categories

A/Brisbane (PRE)

- ParticipantsOG0001017
- ParticipantsOG0011013
- ParticipantsOG0021030

Title	Measurements

Primary

Number of Subjects Who Seroconverted

Seroconversion is defined as the number of subjects with either a pre-vaccination anti-HA 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.

Post-vaccination timepoints: Day 28 for primed or Day 56 for unprimed subjects

Analysis was performed on the ATP cohort for analysis of immunogenicity

Posted

Count of Participants

Participants

Day 28 or Day 56

ID	Title	Description
OG000	Fluarix Dose A Group	Subjects were administered 1 or 2 doses* of Fluarix vaccine (at Day 0 or at Days 0 and 28) intramuscularly, in the non-dominant upper arm (children >12 months of age) or in the anterolateral thigh (children <12 months of age). * Only those subjects who had no history of prior influenza vaccination (i.e. unprimed subjects) received 2 doses.
OG001	Fluarix Dose B Group	Subjects were administered 1 or 2 doses, half the volume of dose A, of Fluarix vaccine (at Day 0 or at Days 0 and 28) intramuscularly, in the non-dominant upper arm (children >12 months of age) or in the anterolateral thigh (children <12 months of age). Only those subjects who had no history of prior influenza vaccination (i.e. unprimed subjects) received 2 doses.
OG002	Fluzone Group

Secondary

Number of Seroprotected Subjects

A seroprotected subject is a subject with a serum anti-HA titer

≥ 1:40

Post-vaccination timepoints: Day 28 for primed or Day 56 for unprimed subjects

Analysis was performed on the ATP cohort for analysis of immunogenicity

Posted

Count of Participants

Participants

Day 0 (PRE), Day 28 or Day 56 (POST)

ID	Title	Description
OG000	Fluarix Dose A Group	Subjects were administered 1 or 2 doses* of Fluarix vaccine (at Day 0 or at Days 0 and 28) intramuscularly, in the non-dominant upper arm (children >12 months of age) or in the anterolateral thigh (children <12 months of age). * Only those subjects who had no history of prior influenza vaccination (i.e. unprimed subjects) received 2 doses.
OG001	Fluarix Dose B Group	Subjects were administered 1 or 2 doses, half the volume of dose A, of Fluarix vaccine (at Day 0 or at Days 0 and 28) intramuscularly, in the non-dominant upper arm (children >12 months of age) or in the anterolateral thigh (children <12 months of age). Only those subjects who had no history of prior influenza vaccination (i.e. unprimed subjects) received 2 doses.
OG002	Fluzone Group	Subjects were administered 1 or 2 doses* of Fluzone vaccine (at Day 0 or at Days 0 and 28) intramuscularly, in the non-dominant upper arm (children >12 months of age) or in the anterolateral thigh (children <12 months of age). * Only those subjects who had no history of prior influenza vaccination (i.e. unprimed subjects) received 2 doses.

Secondary

Seroconversion Factor

Seroconversion factor is defined as the fold increase in serum anti-HA GMTs post-vaccination (Day 28 or 56) compared to pre-vaccination (Day 0).

Post-vaccination timepoints: Day 28 for primed or Day 56 for unprimed subjects

Analysis was performed on the ATP cohort for analysis of immunogenicity

Posted

Mean

95% Confidence Interval

fold increase

Day 28 or Day 56

ID	Title	Description
OG000	Fluarix Dose A Group	Subjects were administered 1 or 2 doses* of Fluarix vaccine (at Day 0 or at Days 0 and 28) intramuscularly, in the non-dominant upper arm (children >12 months of age) or in the anterolateral thigh (children <12 months of age). * Only those subjects who had no history of prior influenza vaccination (i.e. unprimed subjects) received 2 doses.
OG001	Fluarix Dose B Group	Subjects were administered 1 or 2 doses, half the volume of dose A, of Fluarix vaccine (at Day 0 or at Days 0 and 28) intramuscularly, in the non-dominant upper arm (children >12 months of age) or in the anterolateral thigh (children <12 months of age). Only those subjects who had no history of prior influenza vaccination (i.e. unprimed subjects) received 2 doses.
OG002	Fluzone Group

Secondary

Number of Subjects Reporting Solicited Local Symptoms

Solicited local symptoms assessed include pain, redness and swelling.

Analysis was performed on the Total Vaccinated Cohort, including all vaccinated subjects for whom data were available.

Posted

Count of Participants

Participants

During a 4-day follow-up period after vaccination

ID	Title	Description
OG000	Fluarix Dose A Group	Subjects were administered 1 or 2 doses* of Fluarix vaccine (at Day 0 or at Days 0 and 28) intramuscularly, in the non-dominant upper arm (children >12 months of age) or in the anterolateral thigh (children <12 months of age). * Only those subjects who had no history of prior influenza vaccination (i.e. unprimed subjects) received 2 doses.
OG001	Fluarix Dose B Group	Subjects were administered 1 or 2 doses, half the volume of dose A, of Fluarix vaccine (at Day 0 or at Days 0 and 28) intramuscularly, in the non-dominant upper arm (children >12 months of age) or in the anterolateral thigh (children <12 months of age). Only those subjects who had no history of prior influenza vaccination (i.e. unprimed subjects) received 2 doses.
OG002	Fluzone Group	Subjects were administered 1 or 2 doses* of Fluzone vaccine (at Day 0 or at Days 0 and 28) intramuscularly, in the non-dominant upper arm (children >12 months of age) or in the anterolateral thigh (children <12 months of age). * Only those subjects who had no history of prior influenza vaccination (i.e. unprimed subjects) received 2 doses.

Secondary

Number of Subjects Reporting Solicited General Symptoms

Solicited general symptoms assessed include drowsiness, irritability, loss of appetitie, and temperature.

Analysis was performed on the Total Vaccinated Cohort, including all vaccinated subjects for whom data were available.

Posted

Count of Participants

Participants

During a 4-day follow-up period after vaccination

ID	Title	Description
OG000	Fluarix Dose A Group	Subjects were administered 1 or 2 doses* of Fluarix vaccine (at Day 0 or at Days 0 and 28) intramuscularly, in the non-dominant upper arm (children >12 months of age) or in the anterolateral thigh (children <12 months of age). * Only those subjects who had no history of prior influenza vaccination (i.e. unprimed subjects) received 2 doses.
OG001	Fluarix Dose B Group	Subjects were administered 1 or 2 doses, half the volume of dose A, of Fluarix vaccine (at Day 0 or at Days 0 and 28) intramuscularly, in the non-dominant upper arm (children >12 months of age) or in the anterolateral thigh (children <12 months of age). Only those subjects who had no history of prior influenza vaccination (i.e. unprimed subjects) received 2 doses.
OG002	Fluzone Group

Secondary

Number of Subjects Reporting Unsolicited Adverse Events (AE)

An AE 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

Posted

Count of Participants

Participants

During a 28-day follow-up period after vaccination

ID	Title	Description
OG000	Fluarix Dose A Group	Subjects were administered 1 or 2 doses* of Fluarix vaccine (at Day 0 or at Days 0 and 28) intramuscularly, in the non-dominant upper arm (children >12 months of age) or in the anterolateral thigh (children <12 months of age). * Only those subjects who had no history of prior influenza vaccination (i.e. unprimed subjects) received 2 doses.
OG001	Fluarix Dose B Group	Subjects were administered 1 or 2 doses, half the volume of dose A, of Fluarix vaccine (at Day 0 or at Days 0 and 28) intramuscularly, in the non-dominant upper arm (children >12 months of age) or in the anterolateral thigh (children <12 months of age). Only those subjects who had no history of prior influenza vaccination (i.e. unprimed subjects) received 2 doses.
OG002	Fluzone Group	Subjects were administered 1 or 2 doses* of Fluzone vaccine (at Day 0 or at Days 0 and 28) intramuscularly, in the non-dominant upper arm (children >12 months of age) or in the anterolateral thigh (children <12 months of age). * Only those subjects who had no history of prior influenza vaccination (i.e. unprimed subjects) received 2 doses.

Secondary

Number of Subjects Reporting Serious Adverse Events (SAE) and New Onset of Chronic Diseases (NOCD)

An SAE is any untoward medical occurrence that: results in death, is life-threatening, requires hospitalization or prolongation of existing hospitalization, results in disability/incapacity, is a congenital anomaly/birth defect in the offspring of a study subject, or may evolve into one of the outcomes listed above.

NOCDs assessed include for example: diabetes, asthma, allergies, autoimmune disease, cancer, neuropathic disorders

Posted

Count of Participants

Participants

During the entire study (Day 0 until Month 6)

ID	Title	Description
OG000	Fluarix Dose A Group	Subjects were administered 1 or 2 doses* of Fluarix vaccine (at Day 0 or at Days 0 and 28) intramuscularly, in the non-dominant upper arm (children >12 months of age) or in the anterolateral thigh (children <12 months of age). * Only those subjects who had no history of prior influenza vaccination (i.e. unprimed subjects) received 2 doses.
OG001	Fluarix Dose B Group	Subjects were administered 1 or 2 doses, half the volume of dose A, of Fluarix vaccine (at Day 0 or at Days 0 and 28) intramuscularly, in the non-dominant upper arm (children >12 months of age) or in the anterolateral thigh (children <12 months of age). Only those subjects who had no history of prior influenza vaccination (i.e. unprimed subjects) received 2 doses.

Secondary

Number of Subjects Reporting Rare Serious Events

Rare serious events have an occurrence rate of 1/300 (0.3%).

Posted

Count of Participants

Participants

During the entire study (Day 0 until Month 6)

ID	Title	Description
OG000	Fluarix Dose A Group	Subjects were administered 1 or 2 doses* of Fluarix vaccine (at Day 0 or at Days 0 and 28) intramuscularly, in the non-dominant upper arm (children >12 months of age) or in the anterolateral thigh (children <12 months of age). * Only those subjects who had no history of prior influenza vaccination (i.e. unprimed subjects) received 2 doses.
OG001	Fluarix Dose B Group	Subjects were administered 1 or 2 doses, half the volume of dose A, of Fluarix vaccine (at Day 0 or at Days 0 and 28) intramuscularly, in the non-dominant upper arm (children >12 months of age) or in the anterolateral thigh (children <12 months of age). Only those subjects who had no history of prior influenza vaccination (i.e. unprimed subjects) received 2 doses.
OG002	Fluzone Group	Subjects were administered 1 or 2 doses* of Fluzone vaccine (at Day 0 or at Days 0 and 28) intramuscularly, in the non-dominant upper arm (children >12 months of age) or in the anterolateral thigh (children <12 months of age). * Only those subjects who had no history of prior influenza vaccination (i.e. unprimed subjects) received 2 doses.

Arm/Groups

ID	Title	Description	Serious Events (Affected)	Serious Events (At Risk)	Other Events (Affected)	Other Events (At Risk)
EG000	Fluarix Dose A Group	Subjects were administered 1 or 2 doses* of Fluarix vaccine (at Day 0 or at Days 0 and 28) intramuscularly, in the non-dominant upper arm (children >12 months of age) or in the anterolateral thigh (children <12 months of age). * Only those subjects who had no history of prior influenza vaccination (i.e. unprimed subjects) received 2 doses.	35	1,107	805	1,107
EG001	Fluarix Dose B Group	Subjects were administered 1 or 2 doses, half the volume of dose A, of Fluarix vaccine (at Day 0 or at Days 0 and 28) intramuscularly, in the non-dominant upper arm (children >12 months of age) or in the anterolateral thigh (children <12 months of age). Only those subjects who had no history of prior influenza vaccination (i.e. unprimed subjects) received 2 doses.	29	1,106	791	1,106
EG002	Fluzone Group	Subjects were administered 1 or 2 doses* of Fluzone vaccine (at Day 0 or at Days 0 and 28) intramuscularly, in the non-dominant upper arm (children >12 months of age) or in the anterolateral thigh (children <12 months of age). * Only those subjects who had no history of prior influenza vaccination (i.e. unprimed subjects) received 2 doses.	31	1,104	808	1,104

Serious Adverse Events

Term	Organ System	Assessment Type	Statistical Information
Acute sinusitis	Infections and infestations	Non-systematic Assessment	EG0000 affected1,107 at risk EG0010 affected1,106 at risk EG0021 affected1,104 at risk
Acute tonsillitis	Infections and infestations	Non-systematic Assessment	EG0001 affected1,107 at risk EG0010 affected1,106 at risk EG0020 affected1,104 at risk
Adverse drug reaction	General disorders	Non-systematic Assessment	EG0001 affected1,107 at risk EG0010 affected1,106 at risk EG0020 affected1,104 at risk
Apnoea	Respiratory, thoracic and mediastinal disorders	Non-systematic Assessment	EG0000 affected1,107 at risk EG0011 affected1,106 at risk EG0020 affected1,104 at risk
Asthma	Respiratory, thoracic and mediastinal disorders	Non-systematic Assessment	EG0002 affected1,107 at risk EG0011 affected1,106 at risk EG0022 affected1,104 at risk
Asthmatic crisis	Respiratory, thoracic and mediastinal disorders	Non-systematic Assessment	EG0001 affected1,107 at risk EG0010 affected1,106 at risk EG0020 affected1,104 at risk
Bronchial hyperreactivity	Respiratory, thoracic and mediastinal disorders	Non-systematic Assessment	EG0001 affected1,107 at risk EG0010 affected1,106 at risk EG0020 affected1,104 at risk
Bronchiolitis	Infections and infestations	Non-systematic Assessment	EG0004 affected1,107 at risk EG0013 affected1,106 at risk EG0023 affected1,104 at risk
Bronchitis	Infections and infestations	Non-systematic Assessment	EG0001 affected1,107 at risk EG0012 affected1,106 at risk EG0021 affected1,104 at risk
Bronchopneumonia	Infections and infestations	Non-systematic Assessment	EG0000 affected1,107 at risk EG0011 affected1,106 at risk EG0021 affected1,104 at risk
Clostridium difficile colitis	Infections and infestations	Non-systematic Assessment	EG0000 affected1,107 at risk EG0010 affected1,106 at risk EG0021 affected1,104 at risk
Coarctation of the aorta	Congenital, familial and genetic disorders	Non-systematic Assessment	EG0001 affected1,107 at risk EG0010 affected1,106 at risk EG0020 affected1,104 at risk
Concussion	Injury, poisoning and procedural complications	Non-systematic Assessment	EG0001 affected1,107 at risk EG0010 affected1,106 at risk EG0020 affected1,104 at risk
Convulsion	Nervous system disorders	Non-systematic Assessment	EG0000 affected1,107 at risk EG0011 affected1,106 at risk EG0020 affected1,104 at risk
Croup infectious	Infections and infestations	Non-systematic Assessment	EG0001 affected1,107 at risk EG0011 affected1,106 at risk EG0020 affected1,104 at risk
Cyanosis	Cardiac disorders	Non-systematic Assessment	EG0000 affected1,107 at risk EG0011 affected1,106 at risk EG0020 affected1,104 at risk
Dehydration	Metabolism and nutrition disorders	Non-systematic Assessment	EG0000 affected1,107 at risk EG0010 affected1,106 at risk EG0021 affected1,104 at risk
Eczema	Skin and subcutaneous tissue disorders	Non-systematic Assessment	EG0000 affected1,107 at risk EG0010 affected1,106 at risk EG0021 affected1,104 at risk
Electric shock	Injury, poisoning and procedural complications	Non-systematic Assessment	EG0000 affected1,107 at risk EG0010 affected1,106 at risk EG0021 affected1,104 at risk
Enterocolitis	Gastrointestinal disorders	Non-systematic Assessment	EG0000 affected1,107 at risk EG0011 affected1,106 at risk EG0020 affected1,104 at risk
Fall	Injury, poisoning and procedural complications	Non-systematic Assessment	EG0001 affected1,107 at risk EG0010 affected1,106 at risk EG0020 affected1,104 at risk
Febrile convulsion	Nervous system disorders	Non-systematic Assessment	EG0000 affected1,107 at risk EG0011 affected1,106 at risk EG0020 affected1,104 at risk
Femur fracture	Injury, poisoning and procedural complications	Non-systematic Assessment	EG0001 affected1,107 at risk EG0010 affected1,106 at risk EG0020 affected1,104 at risk
Foreign body trauma	Injury, poisoning and procedural complications	Non-systematic Assessment	EG0000 affected1,107 at risk EG0010 affected1,106 at risk EG0021 affected1,104 at risk
Gastritis	Gastrointestinal disorders	Non-systematic Assessment	EG0002 affected1,107 at risk EG0010 affected1,106 at risk EG0020 affected1,104 at risk
Gastroenteritis	Infections and infestations	Non-systematic Assessment	EG0006 affected1,107 at risk EG0014 affected1,106 at risk EG0022 affected1,104 at risk
Gastroenteritis norovirus	Infections and infestations	Non-systematic Assessment	EG0000 affected1,107 at risk EG0011 affected1,106 at risk EG0020 affected1,104 at risk
Gastroenteritis rotavirus	Infections and infestations	Non-systematic Assessment	EG0002 affected1,107 at risk EG0010 affected1,106 at risk EG0024 affected1,104 at risk
Haematochezia	Gastrointestinal disorders	Non-systematic Assessment	EG0000 affected1,107 at risk EG0010 affected1,106 at risk EG0021 affected1,104 at risk
Head injury	Injury, poisoning and procedural complications	Non-systematic Assessment	EG0001 affected1,107 at risk EG0011 affected1,106 at risk EG0020 affected1,104 at risk
Herpes simplex	Infections and infestations	Non-systematic Assessment	EG0000 affected1,107 at risk EG0010 affected1,106 at risk EG0021 affected1,104 at risk
Hyponatraemia	Metabolism and nutrition disorders	Non-systematic Assessment	EG0000 affected1,107 at risk EG0011 affected1,106 at risk EG0020 affected1,104 at risk
Hypoxia	Respiratory, thoracic and mediastinal disorders	Non-systematic Assessment	EG0000 affected1,107 at risk EG0010 affected1,106 at risk EG0021 affected1,104 at risk
Idiopathic urticaria	Skin and subcutaneous tissue disorders	Non-systematic Assessment	EG0000 affected1,107 at risk EG0010 affected1,106 at risk EG0021 affected1,104 at risk
Influenza	Infections and infestations	Non-systematic Assessment	EG0001 affected1,107 at risk EG0010 affected1,106 at risk EG0020 affected1,104 at risk
Injury corneal	Injury, poisoning and procedural complications	Non-systematic Assessment	EG0000 affected1,107 at risk EG0010 affected1,106 at risk EG0021 affected1,104 at risk
Intussusception	Gastrointestinal disorders	Non-systematic Assessment	EG0000 affected1,107 at risk EG0012 affected1,106 at risk EG0020 affected1,104 at risk
Lobar pneumonia	Infections and infestations	Non-systematic Assessment	EG0001 affected1,107 at risk EG0010 affected1,106 at risk EG0020 affected1,104 at risk
Mental status changes	Psychiatric disorders	Non-systematic Assessment	EG0000 affected1,107 at risk EG0010 affected1,106 at risk EG0021 affected1,104 at risk
Neutropenia	Blood and lymphatic system disorders	Non-systematic Assessment	EG0000 affected1,107 at risk EG0011 affected1,106 at risk EG0020 affected1,104 at risk
Oral herpes	Infections and infestations	Non-systematic Assessment	EG0001 affected1,107 at risk EG0010 affected1,106 at risk EG0020 affected1,104 at risk
Otitis media	Infections and infestations		EG0001 affected1,107 at risk EG0010 affected1,106 at risk EG0021 affected1,104 at risk
Otitis media acute	Infections and infestations	Non-systematic Assessment	EG0000 affected1,107 at risk EG0010 affected1,106 at risk EG0022 affected1,104 at risk
Overdose	Injury, poisoning and procedural complications	Non-systematic Assessment	EG0000 affected1,107 at risk EG0011 affected1,106 at risk EG0020 affected1,104 at risk
Pharyngitis	Infections and infestations	Non-systematic Assessment	EG0001 affected1,107 at risk EG0010 affected1,106 at risk EG0020 affected1,104 at risk
Pharyngotonsillitis	Infections and infestations	Non-systematic Assessment	EG0000 affected1,107 at risk EG0011 affected1,106 at risk EG0020 affected1,104 at risk
Pneumonia	Infections and infestations	Non-systematic Assessment	EG0004 affected1,107 at risk EG0014 affected1,106 at risk EG0023 affected1,104 at risk
Pneumonia pneumococcal	Infections and infestations	Non-systematic Assessment	EG0000 affected1,107 at risk EG0011 affected1,106 at risk EG0020 affected1,104 at risk
Pneumonia primary atypical	Infections and infestations	Non-systematic Assessment	EG0001 affected1,107 at risk EG0010 affected1,106 at risk EG0020 affected1,104 at risk
Pneumonia respiratory syncytial viral	Infections and infestations	Non-systematic Assessment	EG0000 affected1,107 at risk EG0010 affected1,106 at risk EG0021 affected1,104 at risk
Pneumonia viral	Infections and infestations	Non-systematic Assessment	EG0001 affected1,107 at risk EG0011 affected1,106 at risk EG0020 affected1,104 at risk
Pneumonitis	Respiratory, thoracic and mediastinal disorders	Non-systematic Assessment	EG0001 affected1,107 at risk EG0010 affected1,106 at risk EG0020 affected1,104 at risk
Respiratory syncytial virus bronchiolitis	Infections and infestations	Non-systematic Assessment	EG0000 affected1,107 at risk EG0010 affected1,106 at risk EG0022 affected1,104 at risk
Respiratory syncytial virus infection	Infections and infestations	Non-systematic Assessment	EG0000 affected1,107 at risk EG0010 affected1,106 at risk EG0021 affected1,104 at risk
Skull fracture	Injury, poisoning and procedural complications	Non-systematic Assessment	EG0002 affected1,107 at risk EG0010 affected1,106 at risk EG0020 affected1,104 at risk
Thermal burn	Injury, poisoning and procedural complications	Non-systematic Assessment	EG0000 affected1,107 at risk EG0010 affected1,106 at risk EG0022 affected1,104 at risk
Thrombocytopenia	Blood and lymphatic system disorders	Non-systematic Assessment	EG0000 affected1,107 at risk EG0011 affected1,106 at risk EG0020 affected1,104 at risk
Tonsillitis	Infections and infestations	Non-systematic Assessment	EG0000 affected1,107 at risk EG0011 affected1,106 at risk EG0020 affected1,104 at risk
Upper respiratory tract infection	Infections and infestations	Non-systematic Assessment	EG0007 affected1,107 at risk EG0014 affected1,106 at risk EG0024 affected1,104 at risk
Urinary tract infection	Infections and infestations	Non-systematic Assessment	EG0000 affected1,107 at risk EG0011 affected1,106 at risk EG0020 affected1,104 at risk
Viral rash	Infections and infestations	Non-systematic Assessment	EG0000 affected1,107 at risk EG0010 affected1,106 at risk EG0022 affected1,104 at risk
Viral upper respiratory tract infection	Infections and infestations	Non-systematic Assessment	EG0000 affected1,107 at risk EG0010 affected1,106 at risk EG0021 affected1,104 at risk
Vomiting	Gastrointestinal disorders	Non-systematic Assessment	EG0000 affected1,107 at risk EG0010 affected1,106 at risk EG0021 affected1,104 at risk

Other Adverse Events

Term	Organ System	Assessment Type	Statistical Information
Upper respiratory tract infection	Infections and infestations	Non-systematic Assessment	EG000135 affected1,107 at risk EG001116 affected1,106 at risk EG002139 affected1,104 at risk
Nasopharyngitis	Infections and infestations	Non-systematic Assessment	EG000139 affected1,107 at risk EG001119 affected1,106 at risk EG002123 affected1,104 at risk
Cough	Respiratory, thoracic and mediastinal disorders	Non-systematic Assessment	EG00059 affected1,107 at risk EG00170 affected1,106 at risk EG00260 affected1,104 at risk
Pyrexia	General disorders	Non-systematic Assessment	EG00053 affected1,107 at risk EG00152 affected1,106 at risk EG00262 affected1,104 at risk
Diarrhoea	Gastrointestinal disorders	Non-systematic Assessment	EG00062 affected1,107 at risk EG00142 affected1,106 at risk EG00260 affected1,104 at risk
Pharyngitis	Infections and infestations	Non-systematic Assessment	EG00049 affected1,107 at risk EG00160 affected1,106 at risk EG00252 affected1,104 at risk
Pain	General disorders	Systematic Assessment	EG000403 affected1,107 at risk EG001406 affected1,106 at risk EG002363 affected1,104 at risk
Redness	General disorders	Systematic Assessment	EG000259 affected1,107 at risk EG001249 affected1,106 at risk EG002253 affected1,104 at risk
Swelling	General disorders	Systematic Assessment	EG000152 affected1,107 at risk EG001170 affected1,106 at risk EG002129 affected1,104 at risk
Drowsiness	General disorders	Systematic Assessment	EG000293 affected1,107 at risk EG001317 affected1,106 at risk EG002298 affected1,104 at risk
Irritability	General disorders	Systematic Assessment	EG000386 affected1,107 at risk EG001387 affected1,106 at risk EG002375 affected1,104 at risk
Loss of appetite	General disorders	Systematic Assessment	EG000281 affected1,107 at risk EG001273 affected1,106 at risk EG002270 affected1,104 at risk
Temperature	General disorders	Systematic Assessment	EG00067 affected1,107 at risk EG00169 affected1,106 at risk EG00272 affected1,104 at risk

ID	Term
D007251	Influenza, Human

ID	Term
C510903	fluarix
D007252	Influenza Vaccines

OG00010.4(9.7 to 11.1)

OG00110.6(9.8 to 11.4)

OG00210.9(10.1 to 11.7)

Subjects were administered 1 or 2 doses* of Fluzone vaccine (at Day 0 or at Days 0 and 28) intramuscularly, in the non-dominant upper arm (children >12 months of age) or in the anterolateral thigh (children <12 months of age).

* Only those subjects who had no history of prior influenza vaccination (i.e. unprimed subjects) received 2 doses.

ID	Term
D012141	Respiratory Tract Infections
D007239	Infections
D009976	Orthomyxoviridae Infections
D012327	RNA Virus Infections
D014777	Virus Diseases
D012140	Respiratory Tract Diseases

ID	Term
D014765	Viral Vaccines
D014612	Vaccines
D001688	Biological Products
D045424	Complex Mixtures