Clinical Study in Children, 6 Months to 3 Years of Age, t... | NCT00778895

Status Module

Description Module

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Fluviral F1 Group	Experimental	Subjects 6 months to 3 years of age received if primed, 1 dose of formulation 1 of Fluviral vaccine at Day 0 and if unprimed, 2 doses of formulation 1 of Fluviral vaccine at Day 0 and approximately Day 28. The vaccine was administered intramuscularly in the anterolateral part of the thigh (if the subject was less than 12 months) or in the deltoid region of the arm.	Biological: GSK Biologicals' influenza vaccine GSK1557482A
Fluviral F2 Group	Experimental	Subjects 6 months to 3 years of age received if primed, 1 dose of formulation 2 of Fluviral vaccine at Day 0 and if unprimed, 2 doses of formulation 1 of Fluviral vaccine at Day 0 and approximately Day 28. The vaccine was administered intramuscularly in the anterolateral part of the thigh (if the subject was less than 12 months) or in the deltoid region of the arm.	Biological: GSK Biologicals' influenza vaccine GSK1557482A
Vaxigrip Group	Active Comparator	Subjects 6 months to 3 years of age received if primed, 1 dose of Vaxigrip vaccine at Day 0 and if unprimed, 2 doses of Vaxigrip vaccine at Day 0 and approximately Day 28. The vaccine was administered intramuscularly in the anterolateral part of the thigh (if the subject was less than 12 months) or in the deltoid region of the arm.	Biological: Vaxigrip

Interventions

Name	Type	Description	Arm Group Labels	Other Names
GSK Biologicals' influenza vaccine GSK1557482A	Biological	one IM injection at Day 0 for primed subjects (defined as subjects who had a prior 2-dose priming influenza immunization) or two IM injections at Day 0 and approximately Day 28 for un-primed subjects (defined as subjects who have not previously received a complete 2-dose priming influenza immunization).

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Number of Subjects With Any and Grade 3 Solicited Local Symptoms After Vaccination	Solicited local symptoms assessed were pain, redness and swelling. Any was defined as any solicited local symptom reported regardless of intensity grade. Grade 3 pain = Cried when limb was moved/spontaneously painful. Grade 3 redness and swelling were defined as redness/swelling above 50 millimeters (mm). This primary outcome measure was assessed for Fluviral F1 Group and Fluviral F2 Group respectively as per the study protocol.	During the 4-day follow-up period (Days 0-3) after any vaccination
Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms After Vaccination	Symptoms assessed were drowsiness, irritability, loss of appetite and fever. Any was defined as occurrence of any general symptom regardless of their intensity grade or relationship to vaccination. Any fever = Axillary temperature ≥ 38.0 degrees Celsius (°C). Grade 3 fever = Axillary temperature ≥ 39.0°C. For other symptoms, grade 3 was defined as an adverse event which prevented normal everyday activities. Related = A general symptom assessed by the investigator as causally related to vaccination. This primary outcome measure was assessed for Fluviral F1 Group and Fluviral F2 Group respectively as per the study protocol.	During the 4-day follow-up period (Days 0-3) after any vaccination
Number of Subjects With Any, Grade 3 and Related Unsolicited Adverse Events (AEs) After Vaccination	Unsolicited AEs covers any AE reported in addition to those solicited during the clinical study and any solicited symptom with onset outside the specified period of follow-up for solicited symptoms. Any = Occurrence of any unsolicited symptom regardless of intensity grade or relation to vaccination. Grade 3 = Occurrence of any unsolicited AE that prevented normal, everyday activities. Related = Occurrence of an unsolicited AE assessed by the investigator to be causally related to study vaccination. This primary outcome measure was assessed for Fluviral F1 Group and Fluviral F2 Group respectively as per the study protocol.	During the 28-day follow-up period (Days 0-27) after vaccination

Secondary Outcomes

Measure	Description	Time Frame
Titers for Serum Hemagglutination Inhibition (HI) Antibodies	Titers are presented as geometric mean titers (GMTs). The reference cut-off value was the seropositivity cut-off of 1:10. Antibodies assessed were antibodies against the A/Brisbane (H1N1), A/Uruguay (H3N2) and B/Florida flu strains.	At Day 0 [PRE] and at Day 28 (for primed subjects) and Day 56 (for unprimed subjects) [POST]

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

A male or female child 6 months to < 3 years of age at the time of the vaccination, regardless of previous administration of influenza vaccine in a previous season;
Subjects must be in good health established by medical history and physical examination before entering into the study;
Subjects having a parent/guardian who the investigator believes can and will comply with the requirements of the protocol should be enrolled in the study;
Written informed consent obtained from the subject's parent/guardian.
Parents/guardian access to a consistent means of telephone contact, land line or mobile

Exclusion Criteria:

Use of any investigational or non-registered product (drug or vaccine) within 30 days preceding the administration of the study vaccine or planned use during the study period. Routine, registered childhood vaccinations are not an exclusion criterion;
History of hypersensitivity to any vaccine;
History of allergy to or reactions likely to be exacerbated by, any component of the vaccine including egg, chicken protein, formaldehyde, or sodium deoxycholate;
History of any congenital, acquired, or iatrogenic immunodeficiency state (current or potential) including HIV infection, disorders of the lymphoid system or bone marrow, or chronic administration (defined as more than 14 consecutive days) of immunosuppressant or other immune-modifying drugs within 3 months prior to the administration of the study vaccine.
Acute disease at the time of enrolment.
History of Guillain Barré syndrome within 6 weeks of receipt of prior inactivated influenza virus vaccine;
Any significant disorder of blood coagulation or treatment with vitamin K antagonists; or any known disorder of hemostasis;
Receipt of any immunoglobulins and/or any blood products within three months of study enrollment or planned administration of any of these products during the study period.
Receipt of a non-study related influenza vaccine outside of this study and during the current (2008-09) influenza immunization campaign.
Any use of analgesics/antipyretics 12 hours before receipt of vaccine.

Name	Affiliation	Role
GSK Clinical Trials	GlaxoSmithKline	Study Director

Facility	Status	City	State	ZIP	Country	Contacts
GSK Investigational Site		Calgary	Alberta	T3B 6A8	Canada
GSK Investigational Site

References Module

Citations

PubMed Identifier	Type	Citation	Retractions
23687572	Derived	Langley JM, Vanderkooi OG, Garfield HA, Hebert J, Chandrasekaran V, Jain VK, Fries L. Immunogenicity and Safety of 2 Dose Levels of a Thimerosal-Free Trivalent Seasonal Influenza Vaccine in Children Aged 6-35 Months: A Randomized, Controlled Trial. J Pediatric Infect Dis Soc. 2012 Mar;1(1):55-63. doi: 10.1093/jpids/pis012. Epub 2012 Mar 1.

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
111635	Clinical Study Report	View IPD

Results Section

Participant Flow Module

Arm/Group Information

ID	Title	Description
FG000	Fluviral F1 Group	Subjects 6 months to 3 years of age received if primed, 1 dose of formulation 1 of Fluviral vaccine at Day 0 and if unprimed, 2 doses of formulation 1 of Fluviral vaccine at Day 0 and approximately Day 28. The vaccine was administered intramuscularly in the anterolateral part of the thigh (if the subject was less than 12 months) or in the deltoid region of the arm.

Baseline Characteristics Module

Outcome Measures Module

Adverse Events Module

More Info Module

Arm/Group Information

ID	Title	Description
BG000	Fluviral F1 Group	Subjects 6 months to 3 years of age received if primed, 1 dose of formulation 1 of Fluviral vaccine at Day 0 and if unprimed, 2 doses of formulation 1 of Fluviral vaccine at Day 0 and approximately Day 28. The vaccine was administered intramuscularly in the anterolateral part of the thigh (if the subject was less than 12 months) or in the deltoid region of the arm.
BG001	Fluviral F2 Group	Subjects 6 months to 3 years of age received if primed, 1 dose of formulation 2 of Fluviral vaccine at Day 0 and if unprimed, 2 doses of formulation 1 of Fluviral vaccine at Day 0 and approximately Day 28. The vaccine was administered intramuscularly in the anterolateral part of the thigh (if the subject was less than 12 months) or in the deltoid region of the arm.
BG002	Vaxigrip Group	Subjects 6 months to 3 years of age received if primed, 1 dose of Vaxigrip vaccine at Day 0 and if unprimed, 2 doses of Vaxigrip vaccine at Day 0 and approximately Day 28. The vaccine was administered intramuscularly in the anterolateral part of the thigh (if the subject was less than 12 months) or in the deltoid region of the arm.
BG003	Total	Total of all reporting groups

Type

Title

Description

Population Description

Reporting Status

Anticipated Posting Date

Parameter Type

Dispersion Type

Unit of Measure

Calculate Percentage

Time Frame

Units Analyzed

Denominator Units Selected

Arm/Group Information

Denominators

Classes

Analyses

Primary

Number of Subjects With Any and Grade 3 Solicited Local Symptoms After Vaccination

Solicited local symptoms assessed were pain, redness and swelling. Any was defined as any solicited local symptom reported regardless of intensity grade. Grade 3 pain = Cried when limb was moved/spontaneously painful. Grade 3 redness and swelling were defined as redness/swelling above 50 millimeters (mm). This primary outcome measure was assessed for Fluviral F1 Group and Fluviral F2 Group respectively as per the study protocol.

The analysis was performed on the Total Vaccinated cohort which included all subjects with at least one vaccine administration documented and symptom sheet completed.

Posted

Count of Participants

Participants

During the 4-day follow-up period (Days 0-3) after any vaccination

ID	Title	Description
OG000	Fluviral F1 Group	Subjects 6 months to 3 years of age received if primed, 1 dose of formulation 1 of Fluviral vaccine at Day 0 and if unprimed, 2 doses of formulation 1 of Fluviral vaccine at Day 0 and approximately Day 28. The vaccine was administered intramuscularly in the anterolateral part of the thigh (if the subject was less than 12 months) or in the deltoid region of the arm.
OG001	Fluviral F2 Group	Subjects 6 months to 3 years of age received if primed, 1 dose of formulation 2 of Fluviral vaccine at Day 0 and if unprimed, 2 doses of formulation 1 of Fluviral vaccine at Day 0 and approximately Day 28. The vaccine was administered intramuscularly in the anterolateral part of the thigh (if the subject was less than 12 months) or in the deltoid region of the arm.

Units	Counts
Participants	OG000161 OG001164

Title

Denominators

Categories

Any pain

Title	Measurements
	OG00045 OG00155

Grade 3 pain

Title	Measurements
	OG000

Primary

Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms After Vaccination

Symptoms assessed were drowsiness, irritability, loss of appetite and fever. Any was defined as occurrence of any general symptom regardless of their intensity grade or relationship to vaccination. Any fever = Axillary temperature ≥ 38.0 degrees Celsius (°C). Grade 3 fever = Axillary temperature ≥ 39.0°C. For other symptoms, grade 3 was defined as an adverse event which prevented normal everyday activities. Related = A general symptom assessed by the investigator as causally related to vaccination. This primary outcome measure was assessed for Fluviral F1 Group and Fluviral F2 Group respectively as per the study protocol.

The analysis was performed on the Total Vaccinated cohort which included all subjects with at least one vaccine administration documented and symptom sheet completed.

Posted

Count of Participants

Participants

During the 4-day follow-up period (Days 0-3) after any vaccination

ID	Title	Description
OG000	Fluviral F1 Group	Subjects 6 months to 3 years of age received if primed, 1 dose of formulation 1 of Fluviral vaccine at Day 0 and if unprimed, 2 doses of formulation 1 of Fluviral vaccine at Day 0 and approximately Day 28. The vaccine was administered intramuscularly in the anterolateral part of the thigh (if the subject was less than 12 months) or in the deltoid region of the arm.
OG001	Fluviral F2 Group	Subjects 6 months to 3 years of age received if primed, 1 dose of formulation 2 of Fluviral vaccine at Day 0 and if unprimed, 2 doses of formulation 1 of Fluviral vaccine at Day 0 and approximately Day 28. The vaccine was administered intramuscularly in the anterolateral part of the thigh (if the subject was less than 12 months) or in the deltoid region of the arm.

Primary

Number of Subjects With Any, Grade 3 and Related Unsolicited Adverse Events (AEs) After Vaccination

Unsolicited AEs covers any AE reported in addition to those solicited during the clinical study and any solicited symptom with onset outside the specified period of follow-up for solicited symptoms. Any = Occurrence of any unsolicited symptom regardless of intensity grade or relation to vaccination. Grade 3 = Occurrence of any unsolicited AE that prevented normal, everyday activities. Related = Occurrence of an unsolicited AE assessed by the investigator to be causally related to study vaccination. This primary outcome measure was assessed for Fluviral F1 Group and Fluviral F2 Group respectively as per the study protocol.

The analysis was performed on the Total Vaccinated cohort which included all subjects with at least one vaccine administration documented.

Posted

Count of Participants

Participants

During the 28-day follow-up period (Days 0-27) after vaccination

ID	Title	Description
OG000	Fluviral F1 Group	Subjects 6 months to 3 years of age received if primed, 1 dose of formulation 1 of Fluviral vaccine at Day 0 and if unprimed, 2 doses of formulation 1 of Fluviral vaccine at Day 0 and approximately Day 28. The vaccine was administered intramuscularly in the anterolateral part of the thigh (if the subject was less than 12 months) or in the deltoid region of the arm.
OG001	Fluviral F2 Group	Subjects 6 months to 3 years of age received if primed, 1 dose of formulation 2 of Fluviral vaccine at Day 0 and if unprimed, 2 doses of formulation 1 of Fluviral vaccine at Day 0 and approximately Day 28. The vaccine was administered intramuscularly in the anterolateral part of the thigh (if the subject was less than 12 months) or in the deltoid region of the arm.

Primary

Number of Subjects With Any, Grade 3 and Related Medically-attended Adverse Events (MAEs) After Vaccination

MAEs were defined as events for which the subject received medical attention defined as hospitalization, an emergency room visit, or a visit to or from medical personnel (medical doctor) for any reason. Any MAE(s) = Occurrence of any MAE(s) regardless of intensity grade or relation to vaccination.

Analysis of intensity and relationship to vaccination of MAEs was not performed.

This primary outcome measure was assessed for Fluviral F1 Group and Fluviral F2 Group respectively as per the study protocol.

The analysis was performed on the Total Vaccinated cohort which included all subjects with at least one vaccine administration documented.

Posted

Count of Participants

Participants

During the 28-day post-vaccination period

ID	Title	Description
OG000	Fluviral F1 Group	Subjects 6 months to 3 years of age received if primed, 1 dose of formulation 1 of Fluviral vaccine at Day 0 and if unprimed, 2 doses of formulation 1 of Fluviral vaccine at Day 0 and approximately Day 28. The vaccine was administered intramuscularly in the anterolateral part of the thigh (if the subject was less than 12 months) or in the deltoid region of the arm.
OG001	Fluviral F2 Group	Subjects 6 months to 3 years of age received if primed, 1 dose of formulation 2 of Fluviral vaccine at Day 0 and if unprimed, 2 doses of formulation 1 of Fluviral vaccine at Day 0 and approximately Day 28. The vaccine was administered intramuscularly in the anterolateral part of the thigh (if the subject was less than 12 months) or in the deltoid region of the arm.

Primary

Number of Subjects With Any, Grade 3 and Related Medically-attended Adverse Events (MAEs) After Vaccination

Analysis of intensity and relationship to vaccination of MAEs was not performed.

This primary outcome measure was assessed for Fluviral F1 Group and Fluviral F2 Group respectively as per the study protocol.

The analysis was performed on the Total Vaccinated cohort which included all subjects with at least one vaccine administration documented.

Posted

Count of Participants

Participants

During the 6-month safety follow up after vaccination

ID	Title	Description
OG000	Fluviral F1 Group	Subjects 6 months to 3 years of age received if primed, 1 dose of formulation 1 of Fluviral vaccine at Day 0 and if unprimed, 2 doses of formulation 1 of Fluviral vaccine at Day 0 and approximately Day 28. The vaccine was administered intramuscularly in the anterolateral part of the thigh (if the subject was less than 12 months) or in the deltoid region of the arm.
OG001	Fluviral F2 Group	Subjects 6 months to 3 years of age received if primed, 1 dose of formulation 2 of Fluviral vaccine at Day 0 and if unprimed, 2 doses of formulation 1 of Fluviral vaccine at Day 0 and approximately Day 28. The vaccine was administered intramuscularly in the anterolateral part of the thigh (if the subject was less than 12 months) or in the deltoid region of the arm.

Primary

Number of Subjects With Any and Related Serious Adverse Events (SAEs) After Vaccination

SAEs assessed include medical occurrences that result in death, are life threatening, require hospitalization or prolongation of hospitalization, result in disability/incapacity or are a congenital anomaly/birth defect in the offspring of a study subject. Any SAE(s) = Occurrence of any SAE(s) regardless of intensity grade or relation to vaccination. Related SAE(s) = Occurrence of any SAE(s) assessed by the investigator as causally related to vaccination.

This primary outcome measure was assessed for Fluviral F1 Group and Fluviral F2 Group respectively as per the study protocol.

The analysis was performed on the Total Vaccinated cohort which included all subjects with at least one vaccine administration documented.

Posted

Count of Participants

Participants

During the 28-day post-vaccination period

ID	Title	Description
OG000	Fluviral F1 Group	Subjects 6 months to 3 years of age received if primed, 1 dose of formulation 1 of Fluviral vaccine at Day 0 and if unprimed, 2 doses of formulation 1 of Fluviral vaccine at Day 0 and approximately Day 28. The vaccine was administered intramuscularly in the anterolateral part of the thigh (if the subject was less than 12 months) or in the deltoid region of the arm.
OG001	Fluviral F2 Group	Subjects 6 months to 3 years of age received if primed, 1 dose of formulation 2 of Fluviral vaccine at Day 0 and if unprimed, 2 doses of formulation 1 of Fluviral vaccine at Day 0 and approximately Day 28. The vaccine was administered intramuscularly in the anterolateral part of the thigh (if the subject was less than 12 months) or in the deltoid region of the arm.

Primary

Number of Subjects With Any and Related Serious Adverse Events (SAEs) After Vaccination

This primary outcome measure was assessed for Fluviral F1 Group and Fluviral F2 Group respectively as per the study protocol.

The analysis was performed on the Total Vaccinated cohort which included all subjects with at least one vaccine administration documented.

Posted

Count of Participants

Participants

During the 6-month safety follow up after vaccination

ID	Title	Description
OG000	Fluviral F1 Group	Subjects 6 months to 3 years of age received if primed, 1 dose of formulation 1 of Fluviral vaccine at Day 0 and if unprimed, 2 doses of formulation 1 of Fluviral vaccine at Day 0 and approximately Day 28. The vaccine was administered intramuscularly in the anterolateral part of the thigh (if the subject was less than 12 months) or in the deltoid region of the arm.
OG001	Fluviral F2 Group	Subjects 6 months to 3 years of age received if primed, 1 dose of formulation 2 of Fluviral vaccine at Day 0 and if unprimed, 2 doses of formulation 1 of Fluviral vaccine at Day 0 and approximately Day 28. The vaccine was administered intramuscularly in the anterolateral part of the thigh (if the subject was less than 12 months) or in the deltoid region of the arm.

Secondary

Titers for Serum Hemagglutination Inhibition (HI) Antibodies

Titers are presented as geometric mean titers (GMTs). The reference cut-off value was the seropositivity cut-off of 1:10. Antibodies assessed were antibodies against the A/Brisbane (H1N1), A/Uruguay (H3N2) and B/Florida flu strains.

The analysis was performed on the According-To-Protocol (ATP) cohort for immunogenicity which included all vaccinated and eligible subjects for whom data concerning immunogenicity outcome measures were available and for whom assay results were available for antibodies against at least one study vaccine antigen component after vaccination.

Posted

Geometric Mean

95% Confidence Interval

Titer

At Day 0 [PRE] and at Day 28 (for primed subjects) and Day 56 (for unprimed subjects) [POST]

ID	Title	Description
OG000	Fluviral F1 Group	Subjects 6 months to 3 years of age received if primed, 1 dose of formulation 1 of Fluviral vaccine at Day 0 and if unprimed, 2 doses of formulation 1 of Fluviral vaccine at Day 0 and approximately Day 28. The vaccine was administered intramuscularly in the anterolateral part of the thigh (if the subject was less than 12 months) or in the deltoid region of the arm.
OG001	Fluviral F2 Group	Subjects 6 months to 3 years of age received if primed, 1 dose of formulation 2 of Fluviral vaccine at Day 0 and if unprimed, 2 doses of formulation 1 of Fluviral vaccine at Day 0 and approximately Day 28. The vaccine was administered intramuscularly in the anterolateral part of the thigh (if the subject was less than 12 months) or in the deltoid region of the arm.

Secondary

Number of Subjects Seroconverted to HI Antibodies

A seroconverted subject was defined as a vaccinated subject who had either a pre-vaccination titer < 1:10 and a post-vaccination titer ≥1:40, or a pre-vaccination titer ≥1:10 and at least a four-fold increase in post-vaccination titer. The flu strains assessed were the A/Brisbane (H1N1), A/Uruguay (H3N2) and B/Florida.

Posted

Count of Participants

Participants

At Day 28 (for primed subjects) and at Day 56 (for unprimed subjects) [POST]

ID	Title	Description
OG000	Fluviral F1 Group	Subjects 6 months to 3 years of age received if primed, 1 dose of formulation 1 of Fluviral vaccine at Day 0 and if unprimed, 2 doses of formulation 1 of Fluviral vaccine at Day 0 and approximately Day 28. The vaccine was administered intramuscularly in the anterolateral part of the thigh (if the subject was less than 12 months) or in the deltoid region of the arm.
OG001	Fluviral F2 Group	Subjects 6 months to 3 years of age received if primed, 1 dose of formulation 2 of Fluviral vaccine at Day 0 and if unprimed, 2 doses of formulation 1 of Fluviral vaccine at Day 0 and approximately Day 28. The vaccine was administered intramuscularly in the anterolateral part of the thigh (if the subject was less than 12 months) or in the deltoid region of the arm.

Secondary

Number of Subjects Seroprotected Against HI Antibodies

A seroprotected subject was defined as a vaccinated subject with serum HI titer ≥ 1:40.

The flu strains assessed were the A/Brisbane (H1N1), A/Uruguay (H3N2) and B/Florida.

Posted

Count of Participants

Participants

At Day 0 [PRE] and at Day 28 (for primed subjects) and at Day 56 (for unprimed subjects) [POST]

ID	Title	Description
OG000	Fluviral F1 Group	Subjects 6 months to 3 years of age received if primed, 1 dose of formulation 1 of Fluviral vaccine at Day 0 and if unprimed, 2 doses of formulation 1 of Fluviral vaccine at Day 0 and approximately Day 28. The vaccine was administered intramuscularly in the anterolateral part of the thigh (if the subject was less than 12 months) or in the deltoid region of the arm.
OG001	Fluviral F2 Group	Subjects 6 months to 3 years of age received if primed, 1 dose of formulation 2 of Fluviral vaccine at Day 0 and if unprimed, 2 doses of formulation 1 of Fluviral vaccine at Day 0 and approximately Day 28. The vaccine was administered intramuscularly in the anterolateral part of the thigh (if the subject was less than 12 months) or in the deltoid region of the arm.

Secondary

Seroconversion Factor for HI Antibodies

The seroconversion factor (SCF) was defined as the fold increase in serum HI geometric mean titers (GMTs) post-vaccination (at Day 28 for primed subjects and at Day 56 for unprimed subjects) compared to pre-vaccination (Day 0).

The flu strains assessed were the A/Brisbane (H1N1), A/Uruguay (H3N2) and B/Florida.

Posted

Geometric Mean

95% Confidence Interval

fold increase

At Day 28 (for primed subjects) and at Day 56 (for unprimed subjects) [POST]

ID	Title	Description
OG000	Fluviral F1 Group	Subjects 6 months to 3 years of age received if primed, 1 dose of formulation 1 of Fluviral vaccine at Day 0 and if unprimed, 2 doses of formulation 1 of Fluviral vaccine at Day 0 and approximately Day 28. The vaccine was administered intramuscularly in the anterolateral part of the thigh (if the subject was less than 12 months) or in the deltoid region of the arm.
OG001	Fluviral F2 Group	Subjects 6 months to 3 years of age received if primed, 1 dose of formulation 2 of Fluviral vaccine at Day 0 and if unprimed, 2 doses of formulation 1 of Fluviral vaccine at Day 0 and approximately Day 28. The vaccine was administered intramuscularly in the anterolateral part of the thigh (if the subject was less than 12 months) or in the deltoid region of the arm.

Secondary

Number of Subjects With Any and Grade 3 Solicited Local Symptoms After Vaccination

This secondary outcome measure was assessed for the Vaxigrip Group as per the study protocol.

The analysis was performed on the Total Vaccinated cohort which included all subjects with at least one vaccine administration documented and symptom sheet completed.

Posted

Count of Participants

Participants

During the 4-day follow-up period (Days 0-3) after any vaccination

ID	Title	Description
OG000	Vaxigrip Group	Subjects 6 months to 3 years of age received if primed, 1 dose of Vaxigrip vaccine at Day 0 and if unprimed, 2 doses of Vaxigrip vaccine at Day 0 and approximately Day 28. The vaccine was administered intramuscularly in the anterolateral part of the thigh (if the subject was less than 12 months) or in the deltoid region of the arm.

Units	Counts
Participants	OG000

Secondary

Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms After Vaccination

This secondary outcome measure was assessed for the Vaxigrip Group as per the study protocol.

The analysis was performed on the Total Vaccinated cohort which included all subjects with at least one vaccine administration documented and symptom sheet completed.

Posted

Count of Participants

Participants

During the 4-day follow-up period (Days 0-3) after any vaccination

ID	Title	Description
OG000	Vaxigrip Group	Subjects 6 months to 3 years of age received if primed, 1 dose of Vaxigrip vaccine at Day 0 and if unprimed, 2 doses of Vaxigrip vaccine at Day 0 and approximately Day 28. The vaccine was administered intramuscularly in the anterolateral part of the thigh (if the subject was less than 12 months) or in the deltoid region of the arm.

Units	Counts
Participants

Secondary

Number of Subjects With Any, Grade 3 and Related Unsolicited Adverse Events (AEs) After Vaccination

This secondary outcome measure was assessed for the Vaxigrip Group as per the study protocol.

The analysis was performed on the Total Vaccinated cohort which included all subjects with at least one vaccine administration documented.

Posted

Count of Participants

Participants

During the 28-day follow-up period (Days 0-27) after vaccination

ID	Title	Description
OG000	Vaxigrip Group	Subjects 6 months to 3 years of age received if primed, 1 dose of Vaxigrip vaccine at Day 0 and if unprimed, 2 doses of Vaxigrip vaccine at Day 0 and approximately Day 28. The vaccine was administered intramuscularly in the anterolateral part of the thigh (if the subject was less than 12 months) or in the deltoid region of the arm.

Units	Counts
Participants

Secondary

Number of Subjects With Any, Grade 3 and Related Medically-attended Adverse Events (MAEs) After Vaccination

Analysis of intensity and relationship to vaccination of MAEs was not performed.

This secondary outcome measure was assessed for the Vaxigrip Group as per the study protocol.

The analysis was performed on the Total Vaccinated cohort which included all subjects with at least one vaccine administration documented.

Posted

Count of Participants

Participants

During the 28-day post-vaccination period after vaccination

ID	Title	Description
OG000	Vaxigrip Group	Subjects 6 months to 3 years of age received if primed, 1 dose of Vaxigrip vaccine at Day 0 and if unprimed, 2 doses of Vaxigrip vaccine at Day 0 and approximately Day 28. The vaccine was administered intramuscularly in the anterolateral part of the thigh (if the subject was less than 12 months) or in the deltoid region of the arm.

Units	Counts
Participants

Secondary

Number of Subjects With Any, Grade 3 and Related Medically-attended Adverse Events (MAEs) After Vaccination

Analysis of intensity and relationship to vaccination of MAEs was not performed.

This secondary outcome measure was assessed for the Vaxigrip Group as per the study protocol.

The analysis was performed on the Total Vaccinated cohort which included all subjects with at least one vaccine administration documented.

Posted

Count of Participants

Participants

During the 6-month safety follow up after vaccination

ID	Title	Description
OG000	Vaxigrip Group	Subjects 6 months to 3 years of age received if primed, 1 dose of Vaxigrip vaccine at Day 0 and if unprimed, 2 doses of Vaxigrip vaccine at Day 0 and approximately Day 28. The vaccine was administered intramuscularly in the anterolateral part of the thigh (if the subject was less than 12 months) or in the deltoid region of the arm.

Units	Counts
Participants

Secondary

Number of Subjects With Any and Related Serious Adverse Events (SAEs) After Vaccination

This secondary outcome measure was assessed for the Vaxigrip Group as per the study protocol.

The analysis was performed on the Total Vaccinated cohort which included all subjects with at least one vaccine administration documented.

Posted

Count of Participants

Participants

During the 28-day post-vaccination period

ID	Title	Description
OG000	Vaxigrip Group	Subjects 6 months to 3 years of age received if primed, 1 dose of Vaxigrip vaccine at Day 0 and if unprimed, 2 doses of Vaxigrip vaccine at Day 0 and approximately Day 28. The vaccine was administered intramuscularly in the anterolateral part of the thigh (if the subject was less than 12 months) or in the deltoid region of the arm.

Units	Counts
Participants

Secondary

Number of Subjects With Any and Related Serious Adverse Events (SAEs) After Vaccination

This secondary outcome measure was assessed for the Vaxigrip Group as per the study protocol.

The analysis was performed on the Total Vaccinated cohort which included all subjects with at least one vaccine administration documented.

Posted

Count of Participants

Participants

During the 6-month safety follow up after vaccination

ID	Title	Description
OG000	Vaxigrip Group	Subjects 6 months to 3 years of age received if primed, 1 dose of Vaxigrip vaccine at Day 0 and if unprimed, 2 doses of Vaxigrip vaccine at Day 0 and approximately Day 28. The vaccine was administered intramuscularly in the anterolateral part of the thigh (if the subject was less than 12 months) or in the deltoid region of the arm.

Units	Counts
Participants

Arm/Groups

ID	Title	Description	Serious Events (Affected)	Serious Events (At Risk)	Other Events (Affected)	Other Events (At Risk)
EG000	Fluviral F1 Group	Subjects 6 months to 3 years of age received if primed, 1 dose of formulation 1 of Fluviral vaccine at Day 0 and if unprimed, 2 doses of formulation 1 of Fluviral vaccine at Day 0 and approximately Day 28. The vaccine was administered intramuscularly in the anterolateral part of the thigh (if the subject was less than 12 months) or in the deltoid region of the arm.	2	164	129	164
EG001	Fluviral F2 Group	Subjects 6 months to 3 years of age received if primed, 1 dose of formulation 2 of Fluviral vaccine at Day 0 and if unprimed, 2 doses of formulation 1 of Fluviral vaccine at Day 0 and approximately Day 28. The vaccine was administered intramuscularly in the anterolateral part of the thigh (if the subject was less than 12 months) or in the deltoid region of the arm.	2	167	138	167
EG002	Vaxigrip Group	Subjects 6 months to 3 years of age received if primed, 1 dose of Vaxigrip vaccine at Day 0 and if unprimed, 2 doses of Vaxigrip vaccine at Day 0 and approximately Day 28. The vaccine was administered intramuscularly in the anterolateral part of the thigh (if the subject was less than 12 months) or in the deltoid region of the arm.	0	43	34	43

Serious Adverse Events

Term	Organ System	Assessment Type	Notes	Statistical Information
Pneumonia	Infections and infestations	Non-systematic Assessment	SAE was assessed within the 28-day post vaccination period.	EG0001 affected164 at risk EG0010 affected167 at risk EG0020 affected43 at risk
Bronchial hyperreactivity	Respiratory, thoracic and mediastinal disorders	Non-systematic Assessment	SAE was assessed within the 28-day post vaccination period.	EG0000 affected164 at risk EG0011 affected167 at risk EG0020 affected43 at risk
Lobar pneumonia	Infections and infestations	Non-systematic Assessment	SAE was assessed through the 6-month safety follow-up period.	EG0001 affected164 at risk EG0010 affected167 at risk EG0020 affected43 at risk
Viral pharyngitis	Infections and infestations	Non-systematic Assessment	SAE was assessed through the 6-month safety follow-up period.	EG0000 affected164 at risk EG0011 affected167 at risk EG0020 affected43 at risk

Other Adverse Events

Term	Organ System	Assessment Type	Statistical Information
Pain	General disorders	Systematic Assessment	EG00045 affected161 at risk EG00155 affected164 at risk EG00217 affected43 at risk
Redness	General disorders	Systematic Assessment	EG00049 affected161 at risk EG00154 affected164 at risk EG00213 affected43 at risk
Swelling	General disorders	Systematic Assessment	EG00022 affected161 at risk EG00124 affected164 at risk EG0025 affected43 at risk
Drowsiness	General disorders	Systematic Assessment	EG00054 affected161 at risk EG00165 affected163 at risk EG00216 affected43 at risk
Irritability	General disorders	Systematic Assessment	EG00081 affected161 at risk EG00183 affected163 at risk EG00222 affected43 at risk
Loss of appetite	General disorders	Systematic Assessment	EG00050 affected161 at risk EG00154 affected163 at risk EG00214 affected43 at risk
Fever	General disorders	Systematic Assessment	EG00016 affected161 at risk EG0019 affected163 at risk EG0023 affected43 at risk
Diarrhoea	Gastrointestinal disorders	Non-systematic Assessment	EG0008 affected164 at risk EG0019 affected167 at risk EG0026 affected43 at risk
Teething	Gastrointestinal disorders	Non-systematic Assessment	EG00011 affected164 at risk EG00110 affected167 at risk EG0024 affected43 at risk
Vomiting	Gastrointestinal disorders	Non-systematic Assessment	EG00013 affected164 at risk EG00116 affected167 at risk EG0023 affected43 at risk
Pyrexia	General disorders	Non-systematic Assessment	EG00019 affected164 at risk EG00115 affected167 at risk EG0025 affected43 at risk
Nasopharyngitis	Infections and infestations	Non-systematic Assessment	EG00014 affected164 at risk EG00118 affected167 at risk EG0024 affected43 at risk
Upper respiratory tract infection	Infections and infestations	Non-systematic Assessment	EG00029 affected164 at risk EG00116 affected167 at risk EG0022 affected43 at risk
Cough	Respiratory, thoracic and mediastinal disorders	Non-systematic Assessment	EG00018 affected164 at risk EG00124 affected167 at risk EG0023 affected43 at risk
Rhinorrhoea	Respiratory, thoracic and mediastinal disorders	Non-systematic Assessment	EG0008 affected164 at risk EG0019 affected167 at risk EG0022 affected43 at risk

ID	Term
D007251	Influenza, Human
D014777	Virus Diseases

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

ID	Term
D007252	Influenza Vaccines
C478242	vaxigrip

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