Trial Outcomes & Findings for Safety and Immunogenicity of an Adjuvanted Trivalent Influenza Vaccine in Children 6 to <72 Months of Age in Mexico. (NCT NCT02255279)

Last Updated: 2017-01-27

Results Overview

Number of naive subjects 6 to \< 36 months old reporting solicited local and systemic AEs from Day 1 to Day 7 after first vaccination and from Day 29 to Day 35 after second vaccination.

Recruitment status

COMPLETED

Study phase

PHASE3

Target enrollment

287 participants

Primary outcome timeframe

From Day 1 to Day 7 by vaccination

Results posted on

2017-01-27

Participant Flow

Subjects were enrolled from 3 study centers in Mexico.

All enrolled subjects were included in study.

Participant milestones

Participant milestones
Measure	aTIV (6 Months to < 72 Months) A 0.25 mL (for children 6 to \<36 months old) and 0.5 mL (for children ≥36 months to \< 72 months old) dose of aTIV to be administered.	TIV (6 Months to < 72 Months) A 0.25 mL (for children 6 to \<36 months old) and 0.5 mL (for children ≥36 months to \< 72 months old) dose of TIV to be administered.
Overall Study STARTED	144	143
Overall Study COMPLETED	139	134
Overall Study NOT COMPLETED	5	9

Reasons for withdrawal

Reasons for withdrawal
Measure	aTIV (6 Months to < 72 Months) A 0.25 mL (for children 6 to \<36 months old) and 0.5 mL (for children ≥36 months to \< 72 months old) dose of aTIV to be administered.	TIV (6 Months to < 72 Months) A 0.25 mL (for children 6 to \<36 months old) and 0.5 mL (for children ≥36 months to \< 72 months old) dose of TIV to be administered.
Overall Study Lost to Follow-up	2	2
Overall Study Protocol Violation	0	1
Overall Study Withdrawal by Subject	3	6

Baseline Characteristics

Safety and Immunogenicity of an Adjuvanted Trivalent Influenza Vaccine in Children 6 to <72 Months of Age in Mexico.

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	aTIV (6 Months to < 72 Months) n=144 Participants A 0.25 mL (for children 6 to \<36 months old) and 0.5 mL (for children ≥36 months to \< 72 months old) dose of aTIV to be administered.	TIV (6 Months to < 72 Months) n=143 Participants A 0.25 mL (for children 6 to \<36 months old) and 0.5 mL (for children ≥36 months to \< 72 months old) dose of TIV to be administered.	Total n=287 Participants Total of all reporting groups
Age, Continuous	29.5 Months STANDARD_DEVIATION 18.2 • n=5 Participants	30.1 Months STANDARD_DEVIATION 19.1 • n=7 Participants	29.8 Months STANDARD_DEVIATION 18.6 • n=5 Participants
Gender FEMALE	68 Participants n=5 Participants	72 Participants n=7 Participants	140 Participants n=5 Participants
Gender MALE	76 Participants n=5 Participants	71 Participants n=7 Participants	147 Participants n=5 Participants

PRIMARY outcome

Timeframe: From Day 1 to Day 7 by vaccination

Population: Analysis performed on the Solicited Safety Set.

Number of naive subjects 6 to \< 36 months old reporting solicited local and systemic AEs from Day 1 to Day 7 after first vaccination and from Day 29 to Day 35 after second vaccination.

Outcome measures

Outcome measures
Measure	Naive_aTIV (6 to <36 Months) n=68 Participants A 0.25 mL (for children 6 to \<36 months old) dose of aTIV to be administered.	Naive_TIV (6 to <36 Months) n=69 Participants A 0.25 mL (for children 6 to \<36 months old) dose of TIV to be administered.
Number of Naive Subjects 6 to < 36 Months Old Reporting Solicited Local and Systemic Adverse Events (AEs) From Day 1 to Day 7 Following Each Vaccination. Any Local (Vac-1)	35 Participants	20 Participants
Number of Naive Subjects 6 to < 36 Months Old Reporting Solicited Local and Systemic Adverse Events (AEs) From Day 1 to Day 7 Following Each Vaccination. Any Local (Vac-2, N= 67,67)	21 Participants	15 Participants
Number of Naive Subjects 6 to < 36 Months Old Reporting Solicited Local and Systemic Adverse Events (AEs) From Day 1 to Day 7 Following Each Vaccination. Injection site ecchymosis (Vac-1, N= 65,69)	2 Participants	2 Participants
Number of Naive Subjects 6 to < 36 Months Old Reporting Solicited Local and Systemic Adverse Events (AEs) From Day 1 to Day 7 Following Each Vaccination. Injection site ecchymosis (Vac-2, N= 66,67)	1 Participants	1 Participants
Number of Naive Subjects 6 to < 36 Months Old Reporting Solicited Local and Systemic Adverse Events (AEs) From Day 1 to Day 7 Following Each Vaccination. Injection site induration (Vac-1, N= 66,69)	5 Participants	6 Participants
Number of Naive Subjects 6 to < 36 Months Old Reporting Solicited Local and Systemic Adverse Events (AEs) From Day 1 to Day 7 Following Each Vaccination. Injection site induration (Vac-2, N= 66,67)	3 Participants	4 Participants
Number of Naive Subjects 6 to < 36 Months Old Reporting Solicited Local and Systemic Adverse Events (AEs) From Day 1 to Day 7 Following Each Vaccination. Injection site swelling (Vac-1, N= 65,69)	8 Participants	2 Participants
Number of Naive Subjects 6 to < 36 Months Old Reporting Solicited Local and Systemic Adverse Events (AEs) From Day 1 to Day 7 Following Each Vaccination. Injection site swelling (Vac-2, N= 66,67)	2 Participants	2 Participants
Number of Naive Subjects 6 to < 36 Months Old Reporting Solicited Local and Systemic Adverse Events (AEs) From Day 1 to Day 7 Following Each Vaccination. Injection site erythema (Vac-1, N= 64,69)	9 Participants	8 Participants
Number of Naive Subjects 6 to < 36 Months Old Reporting Solicited Local and Systemic Adverse Events (AEs) From Day 1 to Day 7 Following Each Vaccination. Injection site erythema (Vac-2, N= 66,67)	7 Participants	4 Participants
Number of Naive Subjects 6 to < 36 Months Old Reporting Solicited Local and Systemic Adverse Events (AEs) From Day 1 to Day 7 Following Each Vaccination. Injection site tenderness (Vac-1, N= 66,69)	26 Participants	16 Participants
Number of Naive Subjects 6 to < 36 Months Old Reporting Solicited Local and Systemic Adverse Events (AEs) From Day 1 to Day 7 Following Each Vaccination. Injection site tenderness (Vac-1, N= 66,66)	17 Participants	13 Participants
Number of Naive Subjects 6 to < 36 Months Old Reporting Solicited Local and Systemic Adverse Events (AEs) From Day 1 to Day 7 Following Each Vaccination. Any Systemic (Vac-1)	34 Participants	27 Participants
Number of Naive Subjects 6 to < 36 Months Old Reporting Solicited Local and Systemic Adverse Events (AEs) From Day 1 to Day 7 Following Each Vaccination. Any Systemic (Vac-2, N=67,67)	27 Participants	22 Participants
Number of Naive Subjects 6 to < 36 Months Old Reporting Solicited Local and Systemic Adverse Events (AEs) From Day 1 to Day 7 Following Each Vaccination. Body Temperature (>=40°C) (Vac-1, N= 67,68)	0 Participants	0 Participants
Number of Naive Subjects 6 to < 36 Months Old Reporting Solicited Local and Systemic Adverse Events (AEs) From Day 1 to Day 7 Following Each Vaccination. Body Temperature (>=40°C) (Vac-2, N= 67,67)	0 Participants	0 Participants
Number of Naive Subjects 6 to < 36 Months Old Reporting Solicited Local and Systemic Adverse Events (AEs) From Day 1 to Day 7 Following Each Vaccination. Fever (Vac-1)	7 Participants	5 Participants
Number of Naive Subjects 6 to < 36 Months Old Reporting Solicited Local and Systemic Adverse Events (AEs) From Day 1 to Day 7 Following Each Vaccination. Fever (Vac-2, N= 67,67)	7 Participants	2 Participants
Number of Naive Subjects 6 to < 36 Months Old Reporting Solicited Local and Systemic Adverse Events (AEs) From Day 1 to Day 7 Following Each Vaccination. Change in eating habits (Vac-1, N= 67,69)	14 Participants	4 Participants
Number of Naive Subjects 6 to < 36 Months Old Reporting Solicited Local and Systemic Adverse Events (AEs) From Day 1 to Day 7 Following Each Vaccination. Change in eating habits (Vac-2, N= 66,67)	11 Participants	7 Participants
Number of Naive Subjects 6 to < 36 Months Old Reporting Solicited Local and Systemic Adverse Events (AEs) From Day 1 to Day 7 Following Each Vaccination. Diarrhea (Vac-1, N= 67,69)	15 Participants	15 Participants
Number of Naive Subjects 6 to < 36 Months Old Reporting Solicited Local and Systemic Adverse Events (AEs) From Day 1 to Day 7 Following Each Vaccination. Diarrhea (Vac-2, N= 66,67)	11 Participants	11 Participants
Number of Naive Subjects 6 to < 36 Months Old Reporting Solicited Local and Systemic Adverse Events (AEs) From Day 1 to Day 7 Following Each Vaccination. Irritability (Vac-1, N= 67,69)	18 Participants	13 Participants
Number of Naive Subjects 6 to < 36 Months Old Reporting Solicited Local and Systemic Adverse Events (AEs) From Day 1 to Day 7 Following Each Vaccination. Irritability (Vac-2, N= 66,67)	17 Participants	9 Participants
Number of Naive Subjects 6 to < 36 Months Old Reporting Solicited Local and Systemic Adverse Events (AEs) From Day 1 to Day 7 Following Each Vaccination. Persistent Crying (Vac-1, N= 67,69)	15 Participants	11 Participants
Number of Naive Subjects 6 to < 36 Months Old Reporting Solicited Local and Systemic Adverse Events (AEs) From Day 1 to Day 7 Following Each Vaccination. Persistent Crying (Vac-2, N= 66,67)	11 Participants	9 Participants
Number of Naive Subjects 6 to < 36 Months Old Reporting Solicited Local and Systemic Adverse Events (AEs) From Day 1 to Day 7 Following Each Vaccination. Sleepiness (Vac-1, N= 67,68)	10 Participants	11 Participants
Number of Naive Subjects 6 to < 36 Months Old Reporting Solicited Local and Systemic Adverse Events (AEs) From Day 1 to Day 7 Following Each Vaccination. Sleepiness (Vac-2, N= 65,67)	8 Participants	9 Participants
Number of Naive Subjects 6 to < 36 Months Old Reporting Solicited Local and Systemic Adverse Events (AEs) From Day 1 to Day 7 Following Each Vaccination. Vomiting (Vac-1, N= 67,68)	5 Participants	4 Participants
Number of Naive Subjects 6 to < 36 Months Old Reporting Solicited Local and Systemic Adverse Events (AEs) From Day 1 to Day 7 Following Each Vaccination. Vomiting (Vac-2, N= 65,67)	2 Participants	2 Participants
Number of Naive Subjects 6 to < 36 Months Old Reporting Solicited Local and Systemic Adverse Events (AEs) From Day 1 to Day 7 Following Each Vaccination. Prevention of Pain and or Fever (Vac-1, N= 67,67)	2 Participants	2 Participants
Number of Naive Subjects 6 to < 36 Months Old Reporting Solicited Local and Systemic Adverse Events (AEs) From Day 1 to Day 7 Following Each Vaccination. Prevention of Pain and or Fever (Vac-2, N= 64,67)	3 Participants	2 Participants
Number of Naive Subjects 6 to < 36 Months Old Reporting Solicited Local and Systemic Adverse Events (AEs) From Day 1 to Day 7 Following Each Vaccination. Treatment of Pain and or Fever (Vac-1, N= 67,67)	9 Participants	7 Participants
Number of Naive Subjects 6 to < 36 Months Old Reporting Solicited Local and Systemic Adverse Events (AEs) From Day 1 to Day 7 Following Each Vaccination. Treatment of Pain and or Fever (Vac-1, N= 66,67)	10 Participants	2 Participants

PRIMARY outcome

Timeframe: From Day 1 to Day 7

Population: Analysis performed on the Solicited Safety Set.

Number of non-naive subjects 6 to \< 36 months old reporting solicited local and systemic AEs from Day 1 to Day 7 after vaccination.

Outcome measures

Outcome measures
Measure	Naive_aTIV (6 to <36 Months) n=22 Participants A 0.25 mL (for children 6 to \<36 months old) dose of aTIV to be administered.	Naive_TIV (6 to <36 Months) n=22 Participants A 0.25 mL (for children 6 to \<36 months old) dose of TIV to be administered.
Number of Non-naive Subjects 6 to < 36 Months Old Reporting Solicited Local and Systemic AEs From Day 1 to Day 7 After Vaccination. Any Local	10 Participants	7 Participants
Number of Non-naive Subjects 6 to < 36 Months Old Reporting Solicited Local and Systemic AEs From Day 1 to Day 7 After Vaccination. Injection site ecchymosis	0 Participants	1 Participants
Number of Non-naive Subjects 6 to < 36 Months Old Reporting Solicited Local and Systemic AEs From Day 1 to Day 7 After Vaccination. Injection site induration	2 Participants	0 Participants
Number of Non-naive Subjects 6 to < 36 Months Old Reporting Solicited Local and Systemic AEs From Day 1 to Day 7 After Vaccination. Injection site swelling	1 Participants	1 Participants
Number of Non-naive Subjects 6 to < 36 Months Old Reporting Solicited Local and Systemic AEs From Day 1 to Day 7 After Vaccination. Injection site erythema	2 Participants	4 Participants
Number of Non-naive Subjects 6 to < 36 Months Old Reporting Solicited Local and Systemic AEs From Day 1 to Day 7 After Vaccination. Injection site tenderness (N= 22,21)	9 Participants	4 Participants
Number of Non-naive Subjects 6 to < 36 Months Old Reporting Solicited Local and Systemic AEs From Day 1 to Day 7 After Vaccination. Any Systemic	9 Participants	7 Participants
Number of Non-naive Subjects 6 to < 36 Months Old Reporting Solicited Local and Systemic AEs From Day 1 to Day 7 After Vaccination. Body Temperature (>= 40.0°C)	0 Participants	0 Participants
Number of Non-naive Subjects 6 to < 36 Months Old Reporting Solicited Local and Systemic AEs From Day 1 to Day 7 After Vaccination. Fever	6 Participants	1 Participants
Number of Non-naive Subjects 6 to < 36 Months Old Reporting Solicited Local and Systemic AEs From Day 1 to Day 7 After Vaccination. Change in eating habits	4 Participants	3 Participants
Number of Non-naive Subjects 6 to < 36 Months Old Reporting Solicited Local and Systemic AEs From Day 1 to Day 7 After Vaccination. Diarrhea	3 Participants	6 Participants
Number of Non-naive Subjects 6 to < 36 Months Old Reporting Solicited Local and Systemic AEs From Day 1 to Day 7 After Vaccination. Irritability	4 Participants	3 Participants
Number of Non-naive Subjects 6 to < 36 Months Old Reporting Solicited Local and Systemic AEs From Day 1 to Day 7 After Vaccination. Persistent Crying	1 Participants	1 Participants
Number of Non-naive Subjects 6 to < 36 Months Old Reporting Solicited Local and Systemic AEs From Day 1 to Day 7 After Vaccination. Sleepiness	2 Participants	0 Participants
Number of Non-naive Subjects 6 to < 36 Months Old Reporting Solicited Local and Systemic AEs From Day 1 to Day 7 After Vaccination. Vomiting (N= 21,21)	1 Participants	1 Participants
Number of Non-naive Subjects 6 to < 36 Months Old Reporting Solicited Local and Systemic AEs From Day 1 to Day 7 After Vaccination. Prevention of Pain and or Fever (N= 21,22)	0 Participants	0 Participants
Number of Non-naive Subjects 6 to < 36 Months Old Reporting Solicited Local and Systemic AEs From Day 1 to Day 7 After Vaccination. Treatment of Pain and or Fever (N= 21,22)	2 Participants	1 Participants

PRIMARY outcome

Timeframe: From Day 1 to Day 7 by vaccination

Population: Analysis performed on the Solicited Safety Set.

Number of naive subjects ≥ 36 months to \< 72 months old reporting solicited local and systemic AEs from Day 1 to Day 7 after first vaccination and from Day 29 to Day 35 after second vaccination.

Outcome measures

Outcome measures
Measure	Naive_aTIV (6 to <36 Months) n=6 Participants A 0.25 mL (for children 6 to \<36 months old) dose of aTIV to be administered.	Naive_TIV (6 to <36 Months) n=4 Participants A 0.25 mL (for children 6 to \<36 months old) dose of TIV to be administered.
Number of Naive Subjects ≥ 36 Months to < 72 Months Old Reporting Solicited Local and Systemic AEs From Day 1 to Day 7 Following Each Vaccination. Injection site erythema (Vac-2, N= 6,3)	0 Participants	0 Participants
Number of Naive Subjects ≥ 36 Months to < 72 Months Old Reporting Solicited Local and Systemic AEs From Day 1 to Day 7 Following Each Vaccination. Injection site pain (Vac-1)	3 Participants	2 Participants
Number of Naive Subjects ≥ 36 Months to < 72 Months Old Reporting Solicited Local and Systemic AEs From Day 1 to Day 7 Following Each Vaccination. Injection site pain (Vac-2, N= 6,3)	3 Participants	2 Participants
Number of Naive Subjects ≥ 36 Months to < 72 Months Old Reporting Solicited Local and Systemic AEs From Day 1 to Day 7 Following Each Vaccination. Any Systemic (Vac-1)	3 Participants	1 Participants
Number of Naive Subjects ≥ 36 Months to < 72 Months Old Reporting Solicited Local and Systemic AEs From Day 1 to Day 7 Following Each Vaccination. Any Systemic (Vac-2, N= 6,3)	2 Participants	0 Participants
Number of Naive Subjects ≥ 36 Months to < 72 Months Old Reporting Solicited Local and Systemic AEs From Day 1 to Day 7 Following Each Vaccination. Fatigue (Vac-1)	1 Participants	1 Participants
Number of Naive Subjects ≥ 36 Months to < 72 Months Old Reporting Solicited Local and Systemic AEs From Day 1 to Day 7 Following Each Vaccination. Fatigue (Vac-2, N= 6,3)	2 Participants	0 Participants
Number of Naive Subjects ≥ 36 Months to < 72 Months Old Reporting Solicited Local and Systemic AEs From Day 1 to Day 7 Following Each Vaccination. Myalgia (Vac-1)	2 Participants	0 Participants
Number of Naive Subjects ≥ 36 Months to < 72 Months Old Reporting Solicited Local and Systemic AEs From Day 1 to Day 7 Following Each Vaccination. Myalgia (Vac-2, N= 6,3)	1 Participants	0 Participants
Number of Naive Subjects ≥ 36 Months to < 72 Months Old Reporting Solicited Local and Systemic AEs From Day 1 to Day 7 Following Each Vaccination. Arthralgia (Vac-1)	0 Participants	0 Participants
Number of Naive Subjects ≥ 36 Months to < 72 Months Old Reporting Solicited Local and Systemic AEs From Day 1 to Day 7 Following Each Vaccination. Arthralgia (Vac-2, N= 6,2)	0 Participants	0 Participants
Number of Naive Subjects ≥ 36 Months to < 72 Months Old Reporting Solicited Local and Systemic AEs From Day 1 to Day 7 Following Each Vaccination. Headache (Vac-1)	1 Participants	1 Participants
Number of Naive Subjects ≥ 36 Months to < 72 Months Old Reporting Solicited Local and Systemic AEs From Day 1 to Day 7 Following Each Vaccination. Headache (Vac-2, N= 6,2)	1 Participants	0 Participants
Number of Naive Subjects ≥ 36 Months to < 72 Months Old Reporting Solicited Local and Systemic AEs From Day 1 to Day 7 Following Each Vaccination. Body Temperature (>= 40.0°C) (Vac-1)	0 Participants	0 Participants
Number of Naive Subjects ≥ 36 Months to < 72 Months Old Reporting Solicited Local and Systemic AEs From Day 1 to Day 7 Following Each Vaccination. Body Temperature (>= 40.0°C) (Vac-2, N= 6,3)	0 Participants	0 Participants
Number of Naive Subjects ≥ 36 Months to < 72 Months Old Reporting Solicited Local and Systemic AEs From Day 1 to Day 7 Following Each Vaccination. Fever (Vac-1)	2 Participants	0 Participants
Number of Naive Subjects ≥ 36 Months to < 72 Months Old Reporting Solicited Local and Systemic AEs From Day 1 to Day 7 Following Each Vaccination. Fever (Vac-2, N= 6,3)	1 Participants	0 Participants
Number of Naive Subjects ≥ 36 Months to < 72 Months Old Reporting Solicited Local and Systemic AEs From Day 1 to Day 7 Following Each Vaccination. Chills (Vac-1)	0 Participants	0 Participants
Number of Naive Subjects ≥ 36 Months to < 72 Months Old Reporting Solicited Local and Systemic AEs From Day 1 to Day 7 Following Each Vaccination. Chills (Vac-2, N= 6,3)	0 Participants	0 Participants
Number of Naive Subjects ≥ 36 Months to < 72 Months Old Reporting Solicited Local and Systemic AEs From Day 1 to Day 7 Following Each Vaccination. Change in Eating Habits (Vac-1, N= 5,4)	2 Participants	0 Participants
Number of Naive Subjects ≥ 36 Months to < 72 Months Old Reporting Solicited Local and Systemic AEs From Day 1 to Day 7 Following Each Vaccination. Change in Eating Habits (Vac-2, N= 6,3)	0 Participants	0 Participants
Number of Naive Subjects ≥ 36 Months to < 72 Months Old Reporting Solicited Local and Systemic AEs From Day 1 to Day 7 Following Each Vaccination. Diarrhea (Vac-1)	0 Participants	0 Participants
Number of Naive Subjects ≥ 36 Months to < 72 Months Old Reporting Solicited Local and Systemic AEs From Day 1 to Day 7 Following Each Vaccination. Diarrhea (Vac-2, N= 6,3)	0 Participants	0 Participants
Number of Naive Subjects ≥ 36 Months to < 72 Months Old Reporting Solicited Local and Systemic AEs From Day 1 to Day 7 Following Each Vaccination. Vomiting (Vac-1)	0 Participants	0 Participants
Number of Naive Subjects ≥ 36 Months to < 72 Months Old Reporting Solicited Local and Systemic AEs From Day 1 to Day 7 Following Each Vaccination. Vomiting (Vac-2, N= 6,3)	0 Participants	0 Participants
Number of Naive Subjects ≥ 36 Months to < 72 Months Old Reporting Solicited Local and Systemic AEs From Day 1 to Day 7 Following Each Vaccination. Prevention of Pain and or Fever (Vac-1, N= 6,2)	1 Participants	0 Participants
Number of Naive Subjects ≥ 36 Months to < 72 Months Old Reporting Solicited Local and Systemic AEs From Day 1 to Day 7 Following Each Vaccination. Prevention of Pain and or Fever (Vac-2, N= 4,2)	0 Participants	0 Participants
Number of Naive Subjects ≥ 36 Months to < 72 Months Old Reporting Solicited Local and Systemic AEs From Day 1 to Day 7 Following Each Vaccination. Treatment of Pain and or Fever (Vac-1, N= 6,2)	0 Participants	0 Participants
Number of Naive Subjects ≥ 36 Months to < 72 Months Old Reporting Solicited Local and Systemic AEs From Day 1 to Day 7 Following Each Vaccination. Treatment of Pain and or Fever (Vac-2, N= 5,2)	0 Participants	0 Participants
Number of Naive Subjects ≥ 36 Months to < 72 Months Old Reporting Solicited Local and Systemic AEs From Day 1 to Day 7 Following Each Vaccination. Any Local (Vac-1)	5 Participants	2 Participants
Number of Naive Subjects ≥ 36 Months to < 72 Months Old Reporting Solicited Local and Systemic AEs From Day 1 to Day 7 Following Each Vaccination. Any Local (Vac-2, N= 6,3)	4 Participants	2 Participants
Number of Naive Subjects ≥ 36 Months to < 72 Months Old Reporting Solicited Local and Systemic AEs From Day 1 to Day 7 Following Each Vaccination. Injection site ecchymosis (Vac-1)	0 Participants	0 Participants
Number of Naive Subjects ≥ 36 Months to < 72 Months Old Reporting Solicited Local and Systemic AEs From Day 1 to Day 7 Following Each Vaccination. Injection site ecchymosis (Vac-2, N= 6,3)	0 Participants	0 Participants
Number of Naive Subjects ≥ 36 Months to < 72 Months Old Reporting Solicited Local and Systemic AEs From Day 1 to Day 7 Following Each Vaccination. Injection site induration (Vac-1)	2 Participants	1 Participants
Number of Naive Subjects ≥ 36 Months to < 72 Months Old Reporting Solicited Local and Systemic AEs From Day 1 to Day 7 Following Each Vaccination. Injection site induration (Vac-2, N= 6,3)	2 Participants	0 Participants
Number of Naive Subjects ≥ 36 Months to < 72 Months Old Reporting Solicited Local and Systemic AEs From Day 1 to Day 7 Following Each Vaccination. Injection site swelling (Vac-1)	2 Participants	0 Participants
Number of Naive Subjects ≥ 36 Months to < 72 Months Old Reporting Solicited Local and Systemic AEs From Day 1 to Day 7 Following Each Vaccination. Injection site swelling (Vac-2, N= 6,3)	0 Participants	0 Participants
Number of Naive Subjects ≥ 36 Months to < 72 Months Old Reporting Solicited Local and Systemic AEs From Day 1 to Day 7 Following Each Vaccination. Injection site erythema (Vac-1)	1 Participants	0 Participants

PRIMARY outcome

Timeframe: From Day 1 to Day 7

Population: Analysis performed on the Solicited Safety Set.

Number of non-naive subjects ≥36 months to \< 72 months old reporting solicited local and systemic AEs from Day 1 to Day 7 after vaccination.

Outcome measures

Outcome measures
Measure	Naive_aTIV (6 to <36 Months) n=44 Participants A 0.25 mL (for children 6 to \<36 months old) dose of aTIV to be administered.	Naive_TIV (6 to <36 Months) n=41 Participants A 0.25 mL (for children 6 to \<36 months old) dose of TIV to be administered.
Number of Non-naive Subjects ≥36 Months to < 72 Months Old Reporting Solicited Local and Systemic AEs From Day 1 to Day 7 Following Each Vaccination. Any Local	17 Participants	20 Participants
Number of Non-naive Subjects ≥36 Months to < 72 Months Old Reporting Solicited Local and Systemic AEs From Day 1 to Day 7 Following Each Vaccination. Injection site ecchymosis	2 Participants	1 Participants
Number of Non-naive Subjects ≥36 Months to < 72 Months Old Reporting Solicited Local and Systemic AEs From Day 1 to Day 7 Following Each Vaccination. Injection site induration	6 Participants	3 Participants
Number of Non-naive Subjects ≥36 Months to < 72 Months Old Reporting Solicited Local and Systemic AEs From Day 1 to Day 7 Following Each Vaccination. Injection site swelling	4 Participants	3 Participants
Number of Non-naive Subjects ≥36 Months to < 72 Months Old Reporting Solicited Local and Systemic AEs From Day 1 to Day 7 Following Each Vaccination. Injection site erythema (N= 43,40)	6 Participants	7 Participants
Number of Non-naive Subjects ≥36 Months to < 72 Months Old Reporting Solicited Local and Systemic AEs From Day 1 to Day 7 Following Each Vaccination. Injection site pain (N= 44,40)	14 Participants	16 Participants
Number of Non-naive Subjects ≥36 Months to < 72 Months Old Reporting Solicited Local and Systemic AEs From Day 1 to Day 7 Following Each Vaccination. Injection site tenderness	0 Participants	0 Participants
Number of Non-naive Subjects ≥36 Months to < 72 Months Old Reporting Solicited Local and Systemic AEs From Day 1 to Day 7 Following Each Vaccination. Any Systemic	15 Participants	7 Participants
Number of Non-naive Subjects ≥36 Months to < 72 Months Old Reporting Solicited Local and Systemic AEs From Day 1 to Day 7 Following Each Vaccination. Fatigue (N= 44,40)	6 Participants	2 Participants
Number of Non-naive Subjects ≥36 Months to < 72 Months Old Reporting Solicited Local and Systemic AEs From Day 1 to Day 7 Following Each Vaccination. Myalgia (N= 44,40)	7 Participants	0 Participants
Number of Non-naive Subjects ≥36 Months to < 72 Months Old Reporting Solicited Local and Systemic AEs From Day 1 to Day 7 Following Each Vaccination. Arthralgia (N= 44,40)	4 Participants	0 Participants
Number of Non-naive Subjects ≥36 Months to < 72 Months Old Reporting Solicited Local and Systemic AEs From Day 1 to Day 7 Following Each Vaccination. Headache (N= 44,40)	3 Participants	2 Participants
Number of Non-naive Subjects ≥36 Months to < 72 Months Old Reporting Solicited Local and Systemic AEs From Day 1 to Day 7 Following Each Vaccination. Body Temperature (>= 40.0°C) (N= 44,40)	0 Participants	0 Participants
Number of Non-naive Subjects ≥36 Months to < 72 Months Old Reporting Solicited Local and Systemic AEs From Day 1 to Day 7 Following Each Vaccination. Fever	2 Participants	1 Participants
Number of Non-naive Subjects ≥36 Months to < 72 Months Old Reporting Solicited Local and Systemic AEs From Day 1 to Day 7 Following Each Vaccination. Chills (N= 44,40)	2 Participants	0 Participants
Number of Non-naive Subjects ≥36 Months to < 72 Months Old Reporting Solicited Local and Systemic AEs From Day 1 to Day 7 Following Each Vaccination. Change in eating habits (N= 44,39)	8 Participants	3 Participants
Number of Non-naive Subjects ≥36 Months to < 72 Months Old Reporting Solicited Local and Systemic AEs From Day 1 to Day 7 Following Each Vaccination. Diarrhea (N= 44,39)	4 Participants	3 Participants
Number of Non-naive Subjects ≥36 Months to < 72 Months Old Reporting Solicited Local and Systemic AEs From Day 1 to Day 7 Following Each Vaccination. Vomiting (N= 44,40)	2 Participants	1 Participants
Number of Non-naive Subjects ≥36 Months to < 72 Months Old Reporting Solicited Local and Systemic AEs From Day 1 to Day 7 Following Each Vaccination. Prevention of Pain and or Fever (N= 42,40)	0 Participants	0 Participants
Number of Non-naive Subjects ≥36 Months to < 72 Months Old Reporting Solicited Local and Systemic AEs From Day 1 to Day 7 Following Each Vaccination. Treatment of Pain and or Fever (N=42,40)	5 Participants	0 Participants

PRIMARY outcome

Timeframe: From Day 1 to Day 50

Population: Analysis performed on the Unsolicited Safety Set.

Number of naive subjects aged 6 to \< 72 months reporting all unsolicited AEs, medically attended AEs, AE leading to study withdrawal and serious AEs (SAEs) from Day 1 to Day 50.

Outcome measures

Outcome measures
Measure	Naive_aTIV (6 to <36 Months) n=74 Participants A 0.25 mL (for children 6 to \<36 months old) dose of aTIV to be administered.	Naive_TIV (6 to <36 Months) n=73 Participants A 0.25 mL (for children 6 to \<36 months old) dose of TIV to be administered.
Number of Naive Subjects Aged 6 to < 72 Months Reporting All Unsolicited AEs From Day 1 to Day 50. Any AE	33 Participants	28 Participants
Number of Naive Subjects Aged 6 to < 72 Months Reporting All Unsolicited AEs From Day 1 to Day 50. At least Possibly related AE	4 Participants	4 Participants
Number of Naive Subjects Aged 6 to < 72 Months Reporting All Unsolicited AEs From Day 1 to Day 50. SAE	0 Participants	0 Participants
Number of Naive Subjects Aged 6 to < 72 Months Reporting All Unsolicited AEs From Day 1 to Day 50. At least possibly related SAE	0 Participants	0 Participants
Number of Naive Subjects Aged 6 to < 72 Months Reporting All Unsolicited AEs From Day 1 to Day 50. AE leading to study withdrawal	0 Participants	0 Participants
Number of Naive Subjects Aged 6 to < 72 Months Reporting All Unsolicited AEs From Day 1 to Day 50. Medically attended AE	26 Participants	25 Participants
Number of Naive Subjects Aged 6 to < 72 Months Reporting All Unsolicited AEs From Day 1 to Day 50. Death	0 Participants	0 Participants

PRIMARY outcome

Timeframe: From Day 1 to Day 22

Population: Analysis performed on the Unsolicited Safety Set.

Number of non-naive subjects aged 6 to \< 72 months reporting all unsolicited AEs, medically attended AEs, AE leading to study withdrawal and SAEs from Day 1 to Day 22.

Outcome measures

Outcome measures
Measure	Naive_aTIV (6 to <36 Months) n=66 Participants A 0.25 mL (for children 6 to \<36 months old) dose of aTIV to be administered.	Naive_TIV (6 to <36 Months) n=64 Participants A 0.25 mL (for children 6 to \<36 months old) dose of TIV to be administered.
Number of Non-naive Subjects Aged 6 to < 72 Months Reporting All Unsolicited AEs From Day 1 to Day 22 Any AE	9 Participants	6 Participants
Number of Non-naive Subjects Aged 6 to < 72 Months Reporting All Unsolicited AEs From Day 1 to Day 22 At least Possibly related AE	2 Participants	0 Participants
Number of Non-naive Subjects Aged 6 to < 72 Months Reporting All Unsolicited AEs From Day 1 to Day 22 SAE	0 Participants	0 Participants
Number of Non-naive Subjects Aged 6 to < 72 Months Reporting All Unsolicited AEs From Day 1 to Day 22 At least possibly related SAE	0 Participants	0 Participants
Number of Non-naive Subjects Aged 6 to < 72 Months Reporting All Unsolicited AEs From Day 1 to Day 22 AE leading to study withdrawal	0 Participants	0 Participants
Number of Non-naive Subjects Aged 6 to < 72 Months Reporting All Unsolicited AEs From Day 1 to Day 22 Medically attended AE	3 Participants	4 Participants
Number of Non-naive Subjects Aged 6 to < 72 Months Reporting All Unsolicited AEs From Day 1 to Day 22 Death	0 Participants	0 Participants

PRIMARY outcome

Timeframe: Day 1 and Day 22 (vaccine non-naïve subjects) or Day 50 (vaccine naïve subjects) post vaccination

Population: Analysis performed on the Per Protocol Set.

Antibody response was assessed in terms of GMTs in all three homologous virus strains, 21 days after last immunization, in subjects 6 to \<72 months of age. The study is considered a success if the 21 days after last immunization GMT ratios of aTIV relative to TIV demonstrate as non-inferior with the lower limit (LL) of the two sided 95% confidence interval (CI) above 0.67 (-0.176 on log10 scale) for each vaccine strain (Center for Biologics Evaluation and Research {CBER} Guideline on Seasonal Vaccines May 2007).

Outcome measures

Outcome measures
Measure	Naive_aTIV (6 to <36 Months) n=114 Participants A 0.25 mL (for children 6 to \<36 months old) dose of aTIV to be administered.	Naive_TIV (6 to <36 Months) n=112 Participants A 0.25 mL (for children 6 to \<36 months old) dose of TIV to be administered.
Geometric Mean Titers (GMTs), in All Three Homologous Virus Strains in Subjects 6 to < 72 Months of Age. A/H1N1 (Day 1) (N= 113,112)	14 Titers Interval 11.0 to 19.0	15 Titers Interval 11.0 to 20.0
Geometric Mean Titers (GMTs), in All Three Homologous Virus Strains in Subjects 6 to < 72 Months of Age. A/H1N1 (Day 22 or Day 50)	675 Titers Interval 536.0 to 849.0	166 Titers Interval 132.0 to 208.0
Geometric Mean Titers (GMTs), in All Three Homologous Virus Strains in Subjects 6 to < 72 Months of Age. A/H3N2 (Day 1)	59 Titers Interval 40.0 to 86.0	55 Titers Interval 38.0 to 81.0
Geometric Mean Titers (GMTs), in All Three Homologous Virus Strains in Subjects 6 to < 72 Months of Age. A/H3N2 (Day 22 or Day 50)	1280 Titers Interval 1077.0 to 1521.0	495 Titers Interval 417.0 to 588.0
Geometric Mean Titers (GMTs), in All Three Homologous Virus Strains in Subjects 6 to < 72 Months of Age. B (Day 1)	7.47 Titers Interval 6.41 to 8.71	6.92 Titers Interval 5.95 to 8.06
Geometric Mean Titers (GMTs), in All Three Homologous Virus Strains in Subjects 6 to < 72 Months of Age. B (Day 22 or Day 50)	76 Titers Interval 61.0 to 93.0	16 Titers Interval 13.0 to 20.0

SECONDARY outcome

Timeframe: Day 1 and Day 22 (vaccine non-naive subjects) or Day 50 (vaccine naive subjects) post vaccination

Population: Analysis performed on the Per Protocol Set.

Percentages of subjects with seroconversion in all three homologous virus strains, 21 days after last immunization, in subjects 6 to \<72 months of age, defined as: HI ≥ 40 subject with a pre-vaccination HI titer \<10; a minimum 4-fold increase HI titer for subjects with a prevaccination HI titer ≥10, on Day 22 (non-naive subjects) or Day 50 (naive subjects), as applicable.

Outcome measures

Outcome measures
Measure	Naive_aTIV (6 to <36 Months) n=114 Participants A 0.25 mL (for children 6 to \<36 months old) dose of aTIV to be administered.	Naive_TIV (6 to <36 Months) n=112 Participants A 0.25 mL (for children 6 to \<36 months old) dose of TIV to be administered.
Percentages of Subjects Achieving Seroconversion in Hemagglutination Inhibition (HI) Titers and Vaccine Group Differences at Day 1 and 21 Days After Last Vaccination With aTIV or TIV in Naive and Non-naive Subjects. H1N1 strain (N= 113,112)	90 Percentages of subjects Interval 83.2 to 95.0	75 Percentages of subjects Interval 65.9 to 82.7
Percentages of Subjects Achieving Seroconversion in Hemagglutination Inhibition (HI) Titers and Vaccine Group Differences at Day 1 and 21 Days After Last Vaccination With aTIV or TIV in Naive and Non-naive Subjects. H3N2 strain	77 Percentages of subjects Interval 68.4 to 84.5	67 Percentages of subjects Interval 57.4 to 75.6
Percentages of Subjects Achieving Seroconversion in Hemagglutination Inhibition (HI) Titers and Vaccine Group Differences at Day 1 and 21 Days After Last Vaccination With aTIV or TIV in Naive and Non-naive Subjects. B strain	78 Percentages of subjects Interval 69.4 to 85.3	22 Percentages of subjects Interval 15.0 to 31.2

SECONDARY outcome

Timeframe: Day 1 and Day 22 (vaccine non-naive subjects) or Day 50 (vaccine naive subjects) post vaccination

Population: Analysis performed on the Per Protocol Set.

GMRs of HI, day 22/day 1 (non-naive subjects) or day 50/day 1 (naive subjects) in all three homologous virus strains, 21 days after last immunization, in subjects 6 to \<72 months of age. As the non-inferiority of aTIV to TIV has been established, GMT ratio of aTIV relative to TIV in all three homologous virus strains, 21 days after last immunization in subjects 6 to \<72 months of age was evaluated using margins greater than the non-inferiority cut-off of 0.67.

Outcome measures

Outcome measures
Measure	Naive_aTIV (6 to <36 Months) n=114 Participants A 0.25 mL (for children 6 to \<36 months old) dose of aTIV to be administered.	Naive_TIV (6 to <36 Months) n=112 Participants A 0.25 mL (for children 6 to \<36 months old) dose of TIV to be administered.
Geometric Mean Ratios (GMRs) of HI and Vaccine Group Differences at Day 1 and 21 Days After Last Vaccination With aTIV or TIV in Naive and Non-naive Subjects. H1N1 strain (N=113,112)	46 Ratios Interval 34.0 to 62.0	11 Ratios Interval 8.12 to 15.0
Geometric Mean Ratios (GMRs) of HI and Vaccine Group Differences at Day 1 and 21 Days After Last Vaccination With aTIV or TIV in Naive and Non-naive Subjects. H3N2 strain	21 Ratios Interval 16.0 to 28.0	8.39 Ratios Interval 6.26 to 11.0
Geometric Mean Ratios (GMRs) of HI and Vaccine Group Differences at Day 1 and 21 Days After Last Vaccination With aTIV or TIV in Naive and Non-naive Subjects. B strain	10 Ratios Interval 8.25 to 13.0	2.30 Ratios Interval 1.84 to 2.87

SECONDARY outcome

Timeframe: Day 1 and Day 22 (vaccine non-naive subjects) or Day 50 (vaccine naive subjects) post vaccination

Population: Analysis performed on the Per Protocol Set.

Percentage of subjects with a HI titer ≥ 40, ≥110 and ≥330 on Day 1, Day 22 (non naïve subjects) or Day 50 (naïve subjects), in all three homologous virus strains, 21 days after last immunization, in subjects 6 to \<72 months of age.

Outcome measures

Outcome measures
Measure	Naive_aTIV (6 to <36 Months) n=114 Participants A 0.25 mL (for children 6 to \<36 months old) dose of aTIV to be administered.	Naive_TIV (6 to <36 Months) n=112 Participants A 0.25 mL (for children 6 to \<36 months old) dose of TIV to be administered.
Percentages of Subjects With a HI Titer ≥ 40, ≥110 and ≥330 and Vaccine Group Differences at Day 1 and 21 Days After Last Vaccination With aTIV or TIV in Naive and Non-naive Subjects. H1N1 strain (HI titer ≥ 40, Day 1) (N=113,112)	32 Percentage of subjects Interval 23.4 to 41.3	33 Percentage of subjects Interval 24.4 to 42.6
Percentages of Subjects With a HI Titer ≥ 40, ≥110 and ≥330 and Vaccine Group Differences at Day 1 and 21 Days After Last Vaccination With aTIV or TIV in Naive and Non-naive Subjects. H1N1 strain (HI titer ≥ 40, Day 22 or Day 50)	99 Percentage of subjects Interval 95.2 to 99.98	88 Percentage of subjects Interval 81.0 to 93.7
Percentages of Subjects With a HI Titer ≥ 40, ≥110 and ≥330 and Vaccine Group Differences at Day 1 and 21 Days After Last Vaccination With aTIV or TIV in Naive and Non-naive Subjects. H1N1 strain (HI titer ≥ 110, Day 1) (N=113,112)	19 Percentage of subjects Interval 11.9 to 27.0	20 Percentage of subjects Interval 12.7 to 28.2
Percentages of Subjects With a HI Titer ≥ 40, ≥110 and ≥330 and Vaccine Group Differences at Day 1 and 21 Days After Last Vaccination With aTIV or TIV in Naive and Non-naive Subjects. H1N1 strain (HI titer ≥ 110, Day 22 or Day 50)	96 Percentage of subjects Interval 90.1 to 98.6	68 Percentage of subjects Interval 58.4 to 76.4
Percentages of Subjects With a HI Titer ≥ 40, ≥110 and ≥330 and Vaccine Group Differences at Day 1 and 21 Days After Last Vaccination With aTIV or TIV in Naive and Non-naive Subjects. H1N1 strain (HI titer ≥ 330, Day 1)	4 Percentage of subjects Interval 1.5 to 10.0	7 Percentage of subjects Interval 3.1 to 13.6
Percentages of Subjects With a HI Titer ≥ 40, ≥110 and ≥330 and Vaccine Group Differences at Day 1 and 21 Days After Last Vaccination With aTIV or TIV in Naive and Non-naive Subjects. H1N1 strain (HI titer ≥ 330, Day 22 or Day 50)	78 Percentage of subjects Interval 69.4 to 85.3	37 Percentage of subjects Interval 27.7 to 46.2
Percentages of Subjects With a HI Titer ≥ 40, ≥110 and ≥330 and Vaccine Group Differences at Day 1 and 21 Days After Last Vaccination With aTIV or TIV in Naive and Non-naive Subjects. H3N2 strain (HI titer ≥ 40, Day 1)	56 Percentage of subjects Interval 46.5 to 65.4	58 Percentage of subjects Interval 48.3 to 67.3
Percentages of Subjects With a HI Titer ≥ 40, ≥110 and ≥330 and Vaccine Group Differences at Day 1 and 21 Days After Last Vaccination With aTIV or TIV in Naive and Non-naive Subjects. H3N2 strain (HI titer ≥ 40, Day 22 or Day 50)	100 Percentage of subjects Interval 96.8 to 100.0	97 Percentage of subjects Interval 92.4 to 99.4
Percentages of Subjects With a HI Titer ≥ 40, ≥110 and ≥330 and Vaccine Group Differences at Day 1 and 21 Days After Last Vaccination With aTIV or TIV in Naive and Non-naive Subjects. H3N2 strain (HI titer ≥ 110, Day 1)	44 Percentage of subjects Interval 34.6 to 53.5	44 Percentage of subjects Interval 34.4 to 53.4
Percentages of Subjects With a HI Titer ≥ 40, ≥110 and ≥330 and Vaccine Group Differences at Day 1 and 21 Days After Last Vaccination With aTIV or TIV in Naive and Non-naive Subjects. H3N2 strain (HI titer ≥ 110, Day 22 or Day 50)	99 Percentage of subjects Interval 95.2 to 99.98	84 Percentage of subjects Interval 75.8 to 90.2
Percentages of Subjects With a HI Titer ≥ 40, ≥110 and ≥330 and Vaccine Group Differences at Day 1 and 21 Days After Last Vaccination With aTIV or TIV in Naive and Non-naive Subjects. H3N2 strain (HI titer ≥ 330, Day 1)	33 Percentage of subjects Interval 24.8 to 42.8	30 Percentage of subjects Interval 22.0 to 39.8
Percentages of Subjects With a HI Titer ≥ 40, ≥110 and ≥330 and Vaccine Group Differences at Day 1 and 21 Days After Last Vaccination With aTIV or TIV in Naive and Non-naive Subjects. H3N2 strain (HI titer ≥ 330, Day 22 or Day 50)	86 Percentage of subjects Interval 78.2 to 91.8	61 Percentage of subjects Interval 51.0 to 69.8
Percentages of Subjects With a HI Titer ≥ 40, ≥110 and ≥330 and Vaccine Group Differences at Day 1 and 21 Days After Last Vaccination With aTIV or TIV in Naive and Non-naive Subjects. B strain (HI titer ≥ 40, Day 1)	9 Percentage of subjects Interval 4.3 to 15.5	9 Percentage of subjects Interval 4.4 to 15.8
Percentages of Subjects With a HI Titer ≥ 40, ≥110 and ≥330 and Vaccine Group Differences at Day 1 and 21 Days After Last Vaccination With aTIV or TIV in Naive and Non-naive Subjects. B strain (HI titer ≥ 40, Day 22 or Day 50)	84 Percentage of subjects Interval 76.2 to 90.4	32 Percentage of subjects Interval 23.6 to 41.6
Percentages of Subjects With a HI Titer ≥ 40, ≥110 and ≥330 and Vaccine Group Differences at Day 1 and 21 Days After Last Vaccination With aTIV or TIV in Naive and Non-naive Subjects. B strain (HI titer ≥ 110, Day 1)	2 Percentage of subjects Interval 0.21 to 6.2	1 Percentage of subjects Interval 0.02 to 4.9
Percentages of Subjects With a HI Titer ≥ 40, ≥110 and ≥330 and Vaccine Group Differences at Day 1 and 21 Days After Last Vaccination With aTIV or TIV in Naive and Non-naive Subjects. B strain (HI titer ≥ 110, Day 22 or Day 50)	43 Percentage of subjects Interval 33.7 to 52.6	6 Percentage of subjects Interval 2.5 to 12.5
Percentages of Subjects With a HI Titer ≥ 40, ≥110 and ≥330 and Vaccine Group Differences at Day 1 and 21 Days After Last Vaccination With aTIV or TIV in Naive and Non-naive Subjects. B strain (HI titer ≥ 330, Day 1)	0 Percentage of subjects Interval 0.0 to 3.2	0 Percentage of subjects Interval 0.0 to 3.2
Percentages of Subjects With a HI Titer ≥ 40, ≥110 and ≥330 and Vaccine Group Differences at Day 1 and 21 Days After Last Vaccination With aTIV or TIV in Naive and Non-naive Subjects. B strain (HI titer ≥ 330, Day 22 or Day 50)	8 Percentage of subjects Interval 3.7 to 14.5	0 Percentage of subjects Interval 0.0 to 3.2

Adverse Events

Naive_aTIV (6 Months to < 72 Months)

Serious events: 0 serious events

Other events: 58 other events

Deaths: 0 deaths

Naive_TIV (6 Months to < 72 Months)

Serious events: 0 serious events

Other events: 52 other events

Deaths: 0 deaths

Non-naive_aTIV (6 Months to < 72 Months)

Serious events: 0 serious events

Other events: 35 other events

Deaths: 0 deaths

Non-naive_TIV (6 Months to < 72 Months)

Serious events: 0 serious events

Other events: 31 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Additional Information

Posting Director

Novartis Vaccines

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee The terms and conditions of Novartis' agreement with its investigators may vary. However, Novartis does not prohibit any investigator from publishing. Any publications from a single-site are postponed until the publications of the pooled data (i.e., data from all sites) in the clinical trial.
Publication restrictions are in place

Restriction type: OTHER