Trial Outcomes & Findings for Clinical Study in Children, 6 Months to 3 Years of Age, to Assess Two Dose Levels of an Experimental Flu Vaccine, Using a Licensed Influenza Virus Vaccine, Vaxigrip® as the Control (NCT NCT00778895)

Results Overview

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.

Recruitment status

COMPLETED

Study phase

PHASE2

Target enrollment

390 participants

Primary outcome timeframe

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

Results posted on

2018-08-17

Participant Flow

Subjects were differentiated according to priming status. Primed Subjects - subjects who had a prior 2-dose priming influenza immunization received a 1-dose vaccination course in the study. Unprimed Subjects - subjects who had not previously received a complete 2-dose priming influenza immunization received a 2-dose vaccination course in the study.

Study comprised an Active phase of approximately 2 months and a post-vaccination 180 day extended safety follow-up period (ESFU phase). 374 subjects out of the 390 who were enrolled in the study were vaccinated. Remaining subjects were not included in the participant flow as started as they failed to meet protocol criteria.

Participant milestones

Participant milestones
Measure	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.	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.	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.
Active Phase STARTED	164	167	43
Active Phase COMPLETED	157	161	43
Active Phase NOT COMPLETED	7	6	0
ESFU Phase STARTED	164	167	43
ESFU Phase COMPLETED	153	155	41
ESFU Phase NOT COMPLETED	11	12	2

Reasons for withdrawal

Reasons for withdrawal
Measure	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.	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.	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.
Active Phase Adverse Event	3	1	0
Active Phase Withdrawal by Subject	1	4	0
Active Phase Lost to Follow-up	1	1	0
Active Phase Other	2	0	0
ESFU Phase Adverse Event	2	1	0
ESFU Phase Withdrawal by Subject	1	4	0
ESFU Phase Lost to Follow-up	6	7	2
ESFU Phase Other	2	0	0

Baseline Characteristics

Clinical Study in Children, 6 Months to 3 Years of Age, to Assess Two Dose Levels of an Experimental Flu Vaccine, Using a Licensed Influenza Virus Vaccine, Vaxigrip® as the Control

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Fluviral F1 Group n=164 Participants 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.	Fluviral F2 Group n=167 Participants 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.	Vaxigrip Group n=43 Participants 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.	Total n=374 Participants Total of all reporting groups
Age, Continuous	18.2 Years STANDARD_DEVIATION 9.06 • n=5 Participants	17.5 Years STANDARD_DEVIATION 8.27 • n=7 Participants	17.0 Years STANDARD_DEVIATION 8.33 • n=5 Participants	17.7 Years STANDARD_DEVIATION 8.62 • n=4 Participants
Sex: Female, Male Female	70 Participants n=5 Participants	83 Participants n=7 Participants	26 Participants n=5 Participants	179 Participants n=4 Participants
Sex: Female, Male Male	94 Participants n=5 Participants	84 Participants n=7 Participants	17 Participants n=5 Participants	195 Participants n=4 Participants

PRIMARY outcome

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

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

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.

Outcome measures

Outcome measures
Measure	Fluviral F1 Group n=161 Participants 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.	Fluviral F2 Group n=164 Participants 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.	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.
Number of Subjects With Any and Grade 3 Solicited Local Symptoms After Vaccination Any pain	45 Participants	55 Participants	—
Number of Subjects With Any and Grade 3 Solicited Local Symptoms After Vaccination Grade 3 pain	1 Participants	1 Participants	—
Number of Subjects With Any and Grade 3 Solicited Local Symptoms After Vaccination Any redness	49 Participants	54 Participants	—
Number of Subjects With Any and Grade 3 Solicited Local Symptoms After Vaccination Grade 3 redness	0 Participants	0 Participants	—
Number of Subjects With Any and Grade 3 Solicited Local Symptoms After Vaccination Any swelling	22 Participants	24 Participants	—
Number of Subjects With Any and Grade 3 Solicited Local Symptoms After Vaccination Grade 3 swelling	0 Participants	0 Participants	—

PRIMARY outcome

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

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

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.

Outcome measures

Outcome measures
Measure	Fluviral F1 Group n=161 Participants 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.	Fluviral F2 Group n=163 Participants 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.	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.
Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms After Vaccination Any drowsiness	54 Participants	65 Participants	—
Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms After Vaccination Grade 3 drowsiness	3 Participants	3 Participants	—
Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms After Vaccination Related drowsiness	44 Participants	52 Participants	—
Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms After Vaccination Any irritability	81 Participants	83 Participants	—
Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms After Vaccination Grade 3 irritability	9 Participants	7 Participants	—
Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms After Vaccination Related irritability	62 Participants	69 Participants	—
Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms After Vaccination Any loss of appetite	50 Participants	54 Participants	—
Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms After Vaccination Grade 3 loss of appetite	5 Participants	5 Participants	—
Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms After Vaccination Related loss of appetite	37 Participants	43 Participants	—
Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms After Vaccination Any fever	16 Participants	9 Participants	—
Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms After Vaccination Grade 3 fever	4 Participants	1 Participants	—
Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms After Vaccination Related fever	10 Participants	6 Participants	—

PRIMARY outcome

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

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

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.

Outcome measures

Outcome measures
Measure	Fluviral F1 Group n=164 Participants 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.	Fluviral F2 Group n=167 Participants 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.	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.
Number of Subjects With Any, Grade 3 and Related Unsolicited Adverse Events (AEs) After Vaccination Any unsolicited AE(s)	108 Participants	112 Participants	—
Number of Subjects With Any, Grade 3 and Related Unsolicited Adverse Events (AEs) After Vaccination Grade 3 unsolicited AE(s)	19 Participants	17 Participants	—
Number of Subjects With Any, Grade 3 and Related Unsolicited Adverse Events (AEs) After Vaccination Related unsolicited AE(s)	26 Participants	30 Participants	—

PRIMARY outcome

Timeframe: During the 28-day post-vaccination period

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

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.

Outcome measures

Outcome measures
Measure	Fluviral F1 Group n=164 Participants 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.	Fluviral F2 Group n=167 Participants 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.	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.
Number of Subjects With Any, Grade 3 and Related Medically-attended Adverse Events (MAEs) After Vaccination	52 Participants	40 Participants	—

PRIMARY outcome

Timeframe: During the 6-month safety follow up after vaccination

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

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.

Outcome measures

Outcome measures
Measure	Fluviral F1 Group n=164 Participants 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.	Fluviral F2 Group n=167 Participants 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.	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.
Number of Subjects With Any, Grade 3 and Related Medically-attended Adverse Events (MAEs) After Vaccination	73 Participants	57 Participants	—

PRIMARY outcome

Timeframe: During the 28-day post-vaccination period

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

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.

Outcome measures

Outcome measures
Measure	Fluviral F1 Group n=164 Participants 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.	Fluviral F2 Group n=167 Participants 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.	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.
Number of Subjects With Any and Related Serious Adverse Events (SAEs) After Vaccination Any SAE(s)	1 Participants	1 Participants	—
Number of Subjects With Any and Related Serious Adverse Events (SAEs) After Vaccination Related SAE(s)	0 Participants	0 Participants	—

PRIMARY outcome

Timeframe: During the 6-month safety follow up after vaccination

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

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.

Outcome measures

Outcome measures
Measure	Fluviral F1 Group n=164 Participants 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.	Fluviral F2 Group n=167 Participants 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.	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.
Number of Subjects With Any and Related Serious Adverse Events (SAEs) After Vaccination Any SAE(s)	1 Participants	1 Participants	—
Number of Subjects With Any and Related Serious Adverse Events (SAEs) After Vaccination Related SAE(s)	0 Participants	0 Participants	—

SECONDARY outcome

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

Population: 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.

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.

Outcome measures

Outcome measures
Measure	Fluviral F1 Group n=131 Participants 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.	Fluviral F2 Group n=132 Participants 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.	Vaxigrip Group n=36 Participants 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.
Titers for Serum Hemagglutination Inhibition (HI) Antibodies A/Brisbane (H1N1) strain [PRE]	8.3 Titer Interval 6.9 to 10.1	8.5 Titer Interval 7.0 to 10.3	8.1 Titer Interval 5.9 to 11.0
Titers for Serum Hemagglutination Inhibition (HI) Antibodies A/Brisbane (H1N1) strain [POST]	56.3 Titer Interval 39.5 to 80.2	70.7 Titer Interval 50.7 to 98.6	120.9 Titer Interval 73.4 to 199.0
Titers for Serum Hemagglutination Inhibition (HI) Antibodies A/Uruguay (H3N2) strain [PRE]	7.0 Titer Interval 5.9 to 8.3	9.2 Titer Interval 7.4 to 11.4	7.3 Titer Interval 4.9 to 11.1
Titers for Serum Hemagglutination Inhibition (HI) Antibodies A/Uruguay (H3N2) strain [POST]	64.5 Titer Interval 48.2 to 86.4	89.5 Titer Interval 67.4 to 119.0	97.8 Titer Interval 59.0 to 162.4
Titers for Serum Hemagglutination Inhibition (HI) Antibodies B/Florida strain [PRE]	7.9 Titer Interval 6.7 to 9.4	7.9 Titer Interval 6.6 to 9.4	10.8 Titer Interval 6.9 to 16.9
Titers for Serum Hemagglutination Inhibition (HI) Antibodies B/Florida strain [POST]	128.7 Titer Interval 100.3 to 165.1	163.7 Titer Interval 130.1 to 206.0	190.3 Titer Interval 119.0 to 304.3

SECONDARY outcome

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

Population: 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.

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.

Outcome measures

Outcome measures
Measure	Fluviral F1 Group n=131 Participants 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.	Fluviral F2 Group n=132 Participants 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.	Vaxigrip Group n=36 Participants 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.
Number of Subjects Seroconverted to HI Antibodies A/Brisbane (H1N1) [POST]	67 Participants	82 Participants	29 Participants
Number of Subjects Seroconverted to HI Antibodies A/Uruguay (H3N2) [POST]	81 Participants	98 Participants	28 Participants
Number of Subjects Seroconverted to HI Antibodies B/Florida [POST]	106 Participants	114 Participants	31 Participants

SECONDARY outcome

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

Population: 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.

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.

Outcome measures

Outcome measures
Measure	Fluviral F1 Group n=131 Participants 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.	Fluviral F2 Group n=132 Participants 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.	Vaxigrip Group n=36 Participants 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.
Number of Subjects Seroprotected Against HI Antibodies A/Brisbane (H1N1) [PRE]	17 Participants	21 Participants	5 Participants
Number of Subjects Seroprotected Against HI Antibodies A/Brisbane (H1N1) [POST]	70 Participants	84 Participants	30 Participants
Number of Subjects Seroprotected Against HI Antibodies A/Uruguay (H3N2) [PRE]	10 Participants	23 Participants	3 Participants
Number of Subjects Seroprotected Against HI Antibodies A/Uruguay (H3N2) [POST]	82 Participants	99 Participants	30 Participants
Number of Subjects Seroprotected Against HI Antibodies B/Florida [PRE]	17 Participants	20 Participants	7 Participants
Number of Subjects Seroprotected Against HI Antibodies B/Florida [POST]	111 Participants	122 Participants	33 Participants

SECONDARY outcome

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

Population: 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.

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.

Outcome measures

Outcome measures
Measure	Fluviral F1 Group n=131 Participants 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.	Fluviral F2 Group n=132 Participants 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.	Vaxigrip Group n=36 Participants 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.
Seroconversion Factor for HI Antibodies A/Brisbane (H1N1) [POST]	6.8 fold increase Interval 5.2 to 8.9	8.3 fold increase Interval 6.6 to 10.6	14.9 fold increase Interval 9.6 to 23.3
Seroconversion Factor for HI Antibodies A/Uruguay (H3N2) [POST]	9.2 fold increase Interval 7.3 to 11.7	9.7 fold increase Interval 8.0 to 11.9	13.3 fold increase Interval 8.9 to 19.9
Seroconversion Factor for HI Antibodies B/Florida [POST]	16.2 fold increase Interval 12.8 to 20.5	20.7 fold increase Interval 16.3 to 26.2	17.6 fold increase Interval 10.4 to 29.9

SECONDARY outcome

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

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

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

Outcome measures

Outcome measures
Measure	Fluviral F1 Group n=43 Participants 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.	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.	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.
Number of Subjects With Any and Grade 3 Solicited Local Symptoms After Vaccination Any pain	17 Participants	—	—
Number of Subjects With Any and Grade 3 Solicited Local Symptoms After Vaccination Grade 3 pain	0 Participants	—	—
Number of Subjects With Any and Grade 3 Solicited Local Symptoms After Vaccination Any redness	13 Participants	—	—
Number of Subjects With Any and Grade 3 Solicited Local Symptoms After Vaccination Grade 3 redness	0 Participants	—	—
Number of Subjects With Any and Grade 3 Solicited Local Symptoms After Vaccination Any swelling	5 Participants	—	—
Number of Subjects With Any and Grade 3 Solicited Local Symptoms After Vaccination Grade 3 swelling	0 Participants	—	—

SECONDARY outcome

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

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

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

Outcome measures

Outcome measures
Measure	Fluviral F1 Group n=43 Participants 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.	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.	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.
Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms After Vaccination Any drowsiness	16 Participants	—	—
Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms After Vaccination Grade 3 drowsiness	0 Participants	—	—
Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms After Vaccination Related drowsiness	11 Participants	—	—
Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms After Vaccination Any irritability	22 Participants	—	—
Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms After Vaccination Grade 3 irritability	1 Participants	—	—
Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms After Vaccination Related irritability	15 Participants	—	—
Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms After Vaccination Any loss of appetite	14 Participants	—	—
Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms After Vaccination Grade 3 loss of appetite	0 Participants	—	—
Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms After Vaccination Related loss of appetite	9 Participants	—	—
Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms After Vaccination Any fever	3 Participants	—	—
Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms After Vaccination Grade 3 fever	0 Participants	—	—
Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms After Vaccination Related fever	2 Participants	—	—

SECONDARY outcome

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

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

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

Outcome measures

Outcome measures
Measure	Fluviral F1 Group n=43 Participants 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.	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.	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.
Number of Subjects With Any, Grade 3 and Related Unsolicited Adverse Events (AEs) After Vaccination Any unsolicited AE(s)	24 Participants	—	—
Number of Subjects With Any, Grade 3 and Related Unsolicited Adverse Events (AEs) After Vaccination Grade 3 unsolicited AE(s)	3 Participants	—	—
Number of Subjects With Any, Grade 3 and Related Unsolicited Adverse Events (AEs) After Vaccination Related unsolicited AE(s)	8 Participants	—	—

SECONDARY outcome

Timeframe: During the 28-day post-vaccination period after vaccination

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

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

Outcome measures

Outcome measures
Measure	Fluviral F1 Group n=43 Participants 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.	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.	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.
Number of Subjects With Any, Grade 3 and Related Medically-attended Adverse Events (MAEs) After Vaccination	9 Participants	—	—

SECONDARY outcome

Timeframe: During the 6-month safety follow up after vaccination

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

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

Outcome measures

Outcome measures
Measure	Fluviral F1 Group n=43 Participants 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.	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.	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.
Number of Subjects With Any, Grade 3 and Related Medically-attended Adverse Events (MAEs) After Vaccination	14 Participants	—	—

SECONDARY outcome

Timeframe: During the 28-day post-vaccination period

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

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

Outcome measures

Outcome measures
Measure	Fluviral F1 Group n=43 Participants 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.	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.	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.
Number of Subjects With Any and Related Serious Adverse Events (SAEs) After Vaccination Any SAE(s)	0 Participants	—	—
Number of Subjects With Any and Related Serious Adverse Events (SAEs) After Vaccination Related SAE(s)	0 Participants	—	—

SECONDARY outcome

Timeframe: During the 6-month safety follow up after vaccination

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

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

Outcome measures

Outcome measures
Measure	Fluviral F1 Group n=43 Participants 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.	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.	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.
Number of Subjects With Any and Related Serious Adverse Events (SAEs) After Vaccination Any SAE(s)	0 Participants	—	—
Number of Subjects With Any and Related Serious Adverse Events (SAEs) After Vaccination Related SAE(s)	0 Participants	—	—

Adverse Events

Fluviral F1 Group

Serious events: 2 serious events

Other events: 129 other events

Deaths: 0 deaths

Fluviral F2 Group

Serious events: 2 serious events

Other events: 138 other events

Deaths: 0 deaths

Vaxigrip Group

Serious events: 0 serious events

Other events: 34 other events

Deaths: 0 deaths

Serious adverse events

Serious adverse events
Measure	Fluviral F1 Group n=164 participants at risk 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.	Fluviral F2 Group n=167 participants at risk 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.	Vaxigrip Group n=43 participants at risk 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.
Infections and infestations Pneumonia	0.61% 1/164 • Serious adverse events were assessed during the 28 day post vaccination period and the 6-month safety follow-up period. Systematically and non-systematically assessed frequent adverse events were assessed during 4 day and 28 day post vaccination periods. For the systematically assessed other (non-serious) adverse events, the number of participants at risk included those from Total Vaccinated cohort who had the symptom sheet completed. No related SAEs were reported.	0.00% 0/167 • Serious adverse events were assessed during the 28 day post vaccination period and the 6-month safety follow-up period. Systematically and non-systematically assessed frequent adverse events were assessed during 4 day and 28 day post vaccination periods. For the systematically assessed other (non-serious) adverse events, the number of participants at risk included those from Total Vaccinated cohort who had the symptom sheet completed. No related SAEs were reported.	0.00% 0/43 • Serious adverse events were assessed during the 28 day post vaccination period and the 6-month safety follow-up period. Systematically and non-systematically assessed frequent adverse events were assessed during 4 day and 28 day post vaccination periods. For the systematically assessed other (non-serious) adverse events, the number of participants at risk included those from Total Vaccinated cohort who had the symptom sheet completed. No related SAEs were reported.
Respiratory, thoracic and mediastinal disorders Bronchial hyperreactivity	0.00% 0/164 • Serious adverse events were assessed during the 28 day post vaccination period and the 6-month safety follow-up period. Systematically and non-systematically assessed frequent adverse events were assessed during 4 day and 28 day post vaccination periods. For the systematically assessed other (non-serious) adverse events, the number of participants at risk included those from Total Vaccinated cohort who had the symptom sheet completed. No related SAEs were reported.	0.60% 1/167 • Serious adverse events were assessed during the 28 day post vaccination period and the 6-month safety follow-up period. Systematically and non-systematically assessed frequent adverse events were assessed during 4 day and 28 day post vaccination periods. For the systematically assessed other (non-serious) adverse events, the number of participants at risk included those from Total Vaccinated cohort who had the symptom sheet completed. No related SAEs were reported.	0.00% 0/43 • Serious adverse events were assessed during the 28 day post vaccination period and the 6-month safety follow-up period. Systematically and non-systematically assessed frequent adverse events were assessed during 4 day and 28 day post vaccination periods. For the systematically assessed other (non-serious) adverse events, the number of participants at risk included those from Total Vaccinated cohort who had the symptom sheet completed. No related SAEs were reported.
Infections and infestations Lobar pneumonia	0.61% 1/164 • Serious adverse events were assessed during the 28 day post vaccination period and the 6-month safety follow-up period. Systematically and non-systematically assessed frequent adverse events were assessed during 4 day and 28 day post vaccination periods. For the systematically assessed other (non-serious) adverse events, the number of participants at risk included those from Total Vaccinated cohort who had the symptom sheet completed. No related SAEs were reported.	0.00% 0/167 • Serious adverse events were assessed during the 28 day post vaccination period and the 6-month safety follow-up period. Systematically and non-systematically assessed frequent adverse events were assessed during 4 day and 28 day post vaccination periods. For the systematically assessed other (non-serious) adverse events, the number of participants at risk included those from Total Vaccinated cohort who had the symptom sheet completed. No related SAEs were reported.	0.00% 0/43 • Serious adverse events were assessed during the 28 day post vaccination period and the 6-month safety follow-up period. Systematically and non-systematically assessed frequent adverse events were assessed during 4 day and 28 day post vaccination periods. For the systematically assessed other (non-serious) adverse events, the number of participants at risk included those from Total Vaccinated cohort who had the symptom sheet completed. No related SAEs were reported.
Infections and infestations Viral pharyngitis	0.00% 0/164 • Serious adverse events were assessed during the 28 day post vaccination period and the 6-month safety follow-up period. Systematically and non-systematically assessed frequent adverse events were assessed during 4 day and 28 day post vaccination periods. For the systematically assessed other (non-serious) adverse events, the number of participants at risk included those from Total Vaccinated cohort who had the symptom sheet completed. No related SAEs were reported.	0.60% 1/167 • Serious adverse events were assessed during the 28 day post vaccination period and the 6-month safety follow-up period. Systematically and non-systematically assessed frequent adverse events were assessed during 4 day and 28 day post vaccination periods. For the systematically assessed other (non-serious) adverse events, the number of participants at risk included those from Total Vaccinated cohort who had the symptom sheet completed. No related SAEs were reported.	0.00% 0/43 • Serious adverse events were assessed during the 28 day post vaccination period and the 6-month safety follow-up period. Systematically and non-systematically assessed frequent adverse events were assessed during 4 day and 28 day post vaccination periods. For the systematically assessed other (non-serious) adverse events, the number of participants at risk included those from Total Vaccinated cohort who had the symptom sheet completed. No related SAEs were reported.

Other adverse events

Additional Information

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