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Safety and Immunogenicity of Trivalent Subunit Inactivated Flu Vaccine Administered to Healthy Children and Adolescents 3 to 17 Years of Age

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ClinicalTrials.gov Identifier: NCT01209780
Recruitment Status : Completed
First Posted : September 27, 2010
Results First Posted : March 11, 2014
Last Update Posted : March 11, 2014
Sponsor:
Information provided by (Responsible Party):
Novartis ( Novartis Vaccines )

Study Type Interventional
Study Design Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor);   Primary Purpose: Prevention
Condition Seasonal Influenza
Interventions Biological: TIV
Biological: TIVf
Biological: Comparator TIV
Enrollment 3116
Recruitment Details The study was conducted in 13 centers across 4 countries: Mexico, Colombia, Panama and Philippines.
Pre-assignment Details Due to GCP non-compliance at the Mexico site, data of 312 subjects (3-8 year olds) enrolled from this site were excluded from the final immunogenicity and safety analysis. The population was analyzed in the enrolled set.
Arm/Group Title TIV (3-8 Years Old) Control (4-8 Years) Control (3 to < 4 Years) TIV (9-17 Years) Control (9-17 Years)
Hide Arm/Group Description The group consisted of naive (who have never received influenza vaccination or had received only one influenza vaccine dose in the same season) and non-naive subjects (who had a record of previous influenza vaccination). The non-naive subjects received one dose and naive subjects received two doses of investigational TIV. The group consisted of naive (who have never received influenza vaccination or had received only one influenza vaccine dose in the same season) and non-naive subjects (who had a record of previous influenza vaccination). The non-naive subjects received one dose and naive subjects received two doses of US licensed control vaccine- TIVf. The group consisted of naive (who have never received influenza vaccination or had received only one influenza vaccine dose in the same season) and non-naive subjects (who had a record of previous influenza vaccination.The non-naive subjects received one dose and naive subjects received two doses of US licensed control vaccine- comparator TIV. All subjects in this group were non-naive and received one dose of investigational TIV. All subjects in this group were non-naive and received one dose of US licensed control vaccine TIVf.
Period Title: Overall Study
Started 1042 485 48 817 412
Completed 1016 467 44 807 407
Not Completed 26 18 4 10 5
Reason Not Completed
Adverse Event             0             1             0             0             0
Withdrawal by Subject             9             2             1             1             0
Lost to Follow-up             17             12             3             9             4
Protocol Violation             0             1             0             0             0
Inappropriate enrollment             0             2             0             0             1
Arm/Group Title TIV (3-8 Years) Control (3-8 Years) TIV (9-17 Years) Control (9-17 Years) Total
Hide Arm/Group Description The group consisted of naive (who have never received influenza vaccination or had received only one influenza vaccine dose in the same season) and non-naive subjects (who had a record of previous influenza vaccination). The non-naive subjects received one dose and naive subjects received two doses of investigational TIV. The group [control (4-8 years) + control (3 to<4 years)] consisted of naive (who have never received influenza vaccination or had received only one influenza vaccine dose in the same season) and non-naive subjects (who had a record of previous influenza vaccination). Subjects (4-<9 years) received TIVf and subjects (3-<4 years) received comparator TIV. The non-naive subjects received one dose and naive subjects received two doses of vaccine. All subjects received one dose of investigational TIV. All subjects received one dose of control TIV (eTIV_f). Total of all reporting groups
Overall Number of Baseline Participants 1042 533 817 412 2804
Hide Baseline Analysis Population Description
Demography reported for all enrolled set except for 312 subjects (3-8 year olds) who were enrolled in the Mexico site.
Age, Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 1042 participants 533 participants 817 participants 412 participants 2804 participants
5.6  (1.6) 5.6  (1.6) 12.4  (2.4) 12.3  (2.3) 8.6  (3.9)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 1042 participants 533 participants 817 participants 412 participants 2804 participants
Female
517
  49.6%
269
  50.5%
398
  48.7%
215
  52.2%
1399
  49.9%
Male
525
  50.4%
264
  49.5%
419
  51.3%
197
  47.8%
1405
  50.1%
1.Primary Outcome
Title Comparison of Antibody Responses of Investigational TIV to Control Vaccine in Terms of the Percentage of Subjects Achieving Seroconversion
Hide Description

The non-inferiority of the antibody responses of investigational TIV compared to control TIV assessed in terms of the percentage of subjects achieving seroconversion, against the three homologous vaccine strains,in children 3 to 8 years of age, at 21 days after last vaccination.

Seroconversion was defined as a pre-vaccination haemagglutinin inhibition (HI) titer <1:10 and post-vaccination HI titer ≥1:40 or as a pre-vaccination HI titer ≥1:10 and at minimum four-fold rise in post-vaccination antibody titer

Time Frame Day 22 for non-naive/Day 50 for naive subjects
Hide Outcome Measure Data
Hide Analysis Population Description
Analysis was done on per protocol population i.e-all subjects who correctly received study vaccinations,provided evaluable serum samples at the relevant time points, and had no major protocol violation as defined prior to unblinding.
Arm/Group Title TIV (3-8 Years) Control (3-8 Years)
Hide Arm/Group Description:
The group consisted of naive (who have never received influenza vaccination or had received only one influenza vaccine dose in the same season) and non-naive subjects (who had a record of previous influenza vaccination). The non-naive subjects received one dose and naive subjects received two doses of investigational TIV.
The group [control (4-8 years) + control (3 to<4 years)] consisted of naive (who have never received influenza vaccination or had received only one influenza vaccine dose in the same season) and non-naive subjects (who had a record of previous influenza vaccination). Subjects (4-<9 years) received TIVf and subjects (3-<4 years) received comparator TIV. The non-naive subjects received one dose and naive subjects received two doses of control vaccine.
Overall Number of Participants Analyzed 918 468
Measure Type: Number
Number (95% Confidence Interval)
Unit of Measure: Percentages
H1N1 strain (N=916,467)
95
(93 to 96)
94
(91 to 96)
H3N2 strain (N=917,468)
78
(75 to 80)
87
(84 to 90)
B strain
87
(84 to 89)
85
(82 to 89)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection TIV (3-8 Years), Control (3-8 Years)
Comments Non-inferiority of investigational TIV to control TIV against A/H1N1 influenza strain
Type of Statistical Test Non-Inferiority or Equivalence
Comments The investigational TIV was to be considered non-inferior to the control TIV if for all three strains the upper bound of the two-sided 95% CI on the difference between the seroconversion rates (Seroconversion control – Seroconversion investigational) at 21 days after last vaccination does not exceed 10 percentage points.
Method of Estimation Estimation Parameter Vaccine group difference (%)
Estimated Value -1
Confidence Interval (2-Sided) 95%
-4 to 2
Estimation Comments [Not Specified]
Show Statistical Analysis 2 Hide Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection TIV (3-8 Years), Control (3-8 Years)
Comments Non-inferiority of investigational TIV to control TIV against A/H3N2 influenza strain
Type of Statistical Test Non-Inferiority or Equivalence
Comments The investigational TIV was to be considered non-inferior to the control TIV if, for all three strains, the upper bound of the two-sided 95% CI on the difference between the seroconversion rates (Seroconversion control - Seroconversion investigational), at 21 days after last vaccination, does not exceed 10 percentage points
Method of Estimation Estimation Parameter Vaccine group difference (%)
Estimated Value 10
Confidence Interval (2-Sided) 95%
6 to 14
Estimation Comments [Not Specified]
Show Statistical Analysis 3 Hide Statistical Analysis 3
Statistical Analysis Overview Comparison Group Selection TIV (3-8 Years), Control (3-8 Years)
Comments Non-inferiority of investigational TIV to the control TIV against B influenza strain
Type of Statistical Test Non-Inferiority or Equivalence
Comments The investigational TIV was to be considered non-inferior to the control TIV if, for all three strains, the upper bound of the two-sided 95% CI on the difference between the seroconversion rates (Seroconversion control - Seroconversion investigational), at 21 days after last vaccination, does not exceed 10 percentage points
Method of Estimation Estimation Parameter Vaccine group difference (%)
Estimated Value -1
Confidence Interval (2-Sided) 95%
-5 to 3
Estimation Comments [Not Specified]
2.Primary Outcome
Title Comparison of Antibody Responses of Investigational TIV to Control Vaccine in Terms of Post Vaccination Geometric Mean Titers (GMTs)
Hide Description The non-inferiority of the antibody responses of investigational TIV compared to control vaccine assessed in terms of post vaccination GMTs, at 21 days after last vaccination against the three homologous vaccine strains in 3 to 8 year old children.
Time Frame Day 22 for non-naive/Day 50 for naive subjects
Hide Outcome Measure Data
Hide Analysis Population Description
Analysis was performed on the per protocol population.
Arm/Group Title TIV (3-8 Years) Control (3-8 Years)
Hide Arm/Group Description:
The group consisted of naive (who have never received influenza vaccination or had received only one influenza vaccine dose in the same season) and non-naive subjects (who had a record of previous influenza vaccination). The non-naive subjects received one dose and naive subjects received two doses of investigational TIV.
The group [control (4-8 years) + control (3 to<4 years)] consisted of naive (who have never received influenza vaccination or had received only one influenza vaccine dose in the same season) and non-naive subjects (who had a record of previous influenza vaccination). Subjects (4-<9 years) received TIVf and subjects (3-<4 years) received comparator TIV. The non-naive subjects received one dose and naive subjects received two doses of control vaccine.
Overall Number of Participants Analyzed 918 468
Geometric Mean (95% Confidence Interval)
Unit of Measure: Titers
Baseline (H1N1 strain, N=917,467)
26
(22 to 31)
28
(25 to 31)
Day 22 or Day 50 (H1N1 strain,N=917,468)
1157
(1052 to 1272)
1501
(1283 to 1756)
Baseline (H3N2 strain)
142
(127 to 158)
150
(129 to 175)
Day 22 or Day 50 (H3N2 strain, N=917,468)
1385
(1300 to 1475)
2032
(1843 to 2240)
Baseline (B strain)
12
(11 to 13)
13
(12 to 14)
Day 22 or Day 50 (B strain)
208
(193 to 224)
195
(174 to 217)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection TIV (3-8 Years), Control (3-8 Years)
Comments Non-inferiority of investigational TIV to licensed control TIV against A/H1N1 influenza strain
Type of Statistical Test Non-Inferiority or Equivalence
Comments The investigational TIV was to be considered non-inferior to the control TIV, if for all three strains, the upper bound of the two-sided 95% CI on the ratio of the GMTs (GMTcontrol/GMTinvestigational) at 21 days after last vaccination does not exceed 1.5
Method of Estimation Estimation Parameter Ratio of GMTs
Estimated Value 1.32
Confidence Interval (2-Sided) 95%
1.11 to 1.56
Estimation Comments [Not Specified]
Show Statistical Analysis 2 Hide Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection TIV (3-8 Years), Control (3-8 Years)
Comments Non-inferiority of investigational TIV to licensed control TIV against A/H3N2 influenza strain
Type of Statistical Test Non-Inferiority or Equivalence
Comments The investigational TIV was to be considered non-inferior to the control TIV, if for all three strains, the upper bound of the two-sided 95% CI on the ratio of the GMTs (GMTcontrol/GMTinvestigational) at 21 days after last vaccination does not exceed 1.5
Method of Estimation Estimation Parameter Ratio of GMTs
Estimated Value 1.48
Confidence Interval (2-Sided) 95%
1.34 to 1.64
Estimation Comments [Not Specified]
Show Statistical Analysis 3 Hide Statistical Analysis 3
Statistical Analysis Overview Comparison Group Selection TIV (3-8 Years), Control (3-8 Years)
Comments Non-inferiority of investigational TIV to licensed control TIV against B influenza strain
Type of Statistical Test Non-Inferiority or Equivalence
Comments The investigational TIV was to be considered non-inferior to the control TIV, if for all three strains, the upper bound of the two-sided 95% CI on the ratio of the GMTs (GMTcontrol/GMTinvestigational) at 21 days after last vaccination does not exceed 1.5
Method of Estimation Estimation Parameter Ratio of GMTs
Estimated Value 0.95
Confidence Interval (2-Sided) 95%
0.85 to 1.07
Estimation Comments [Not Specified]
3.Secondary Outcome
Title Percentages of Subjects Achieving HI Titers ≥40 Following Vaccination With Investigational TIV or Control Vaccine.
Hide Description

The percentages of 3 to 8 year old subjects achieving HI titers ≥40 after receiving either one or two doses of investigational TIV or control vaccine, 21 days after last vaccination, are reported.

This criterion according to the US (CBER)guideline is met if the lower bound of the two sided 95%CI for percentage of subjects achieving HI titers ≥40, is ≥70%.

Time Frame Day 22 for non-naive/Day 50 for naive subjects
Hide Outcome Measure Data
Hide Analysis Population Description
Analysis was performed on per protocol population.
Arm/Group Title TIV (3-8 Years) Control (3-8 Years)
Hide Arm/Group Description:
The group consisted of naive (who have never received influenza vaccination or had received only one influenza vaccine dose in the same season) and non-naive subjects (who had a record of previous influenza vaccination). The non-naive subjects received one dose and naive subjects received two doses of investigational TIV.
The group [control (4-8 years) + control (3 to<4 years)] consisted of naive (who have never received influenza vaccination or had received only one influenza vaccine dose in the same season) and non-naive subjects (who had a record of previous influenza vaccination). Subjects (4-<9 years) received TIVf and subjects (3-<4 years) received comparator TIV. The non-naive subjects received one dose and naive subjects received two doses of control vaccine.
Overall Number of Participants Analyzed 918 468
Measure Type: Number
Number (95% Confidence Interval)
Unit of Measure: Percentages of subjects
Baseline (H1N1strain, N=917,467)
49
(46 to 53)
48
(44 to 53)
Day 22 or Day 50 (H1N1strain; N=917,468)
97
(95 to 98)
95
(93 to 97)
Baseline (H3N2 strain)
84
(81 to 86)
85
(82 to 88)
Day 22 or Day 50 (H3N2 strain; N=917,468)
100
(100 to 100)
100
(99 to 100)
Baseline (B strain)
23
(21 to 26)
26
(22 to 30)
Day 22 or Day 50 (B strain)
95
(93 to 96)
92
(90 to 95)
4.Secondary Outcome
Title Percentages of Subjects With Seroconversion in Antibody Titers Following Vaccination With Investigational TIV or Control Vaccine
Hide Description

The percentages of 3 to 8 years-old subjects achieving seroconversion in HI antibody titers after receiving either one or two doses of investigational TIV or control vaccine, at 21 days after last vaccination, are reported.

This criterion, according to the US (CBER) guideline, is met if the lower limit of 95% CI of percentage of subjects achieving seroconversion or significant increase at day 22 and day 50 (21 days after last vaccination) is ≥40.

Time Frame Day 22 for non-naive/Day 50 for naive
Hide Outcome Measure Data
Hide Analysis Population Description
Analysis was performed on the per protocol population.
Arm/Group Title TIV (3-8 Years) Control (3-8 Years)
Hide Arm/Group Description:
The group consisted of naive (who have never received influenza vaccination or had received only one influenza vaccine dose in the same season) and non-naive subjects (who had a record of previous influenza vaccination). The non-naive subjects received one dose and naive subjects received two doses of investigational TIV.
The group [control (4-8 years) + control (3 to<4 years)] consisted of naive (who have never received influenza vaccination or had received only one influenza vaccine dose in the same season) and non-naive subjects (who had a record of previous influenza vaccination). Subjects (4-<9 years) received TIVf and subjects (3-<4 years) received comparator TIV. The non-naive subjects received one dose and naive subjects received two doses of control vaccine.
Overall Number of Participants Analyzed 918 468
Measure Type: Number
Number (95% Confidence Interval)
Unit of Measure: Percentages of subjects
H1N1 strain (N= 916,467)
95
(93 to 96)
94
(91 to 96)
H3N2 strain ( N= 917,468)
78
(75 to 80)
87
(84 to 90)
B strain
87
(84 to 89)
85
(82 to 89)
5.Secondary Outcome
Title Percentages of Vaccine-naive Children Achieving HI Titers ≥40 After Receiving Two Doses of Investigational TIV or Control Vaccine.
Hide Description

The percentage of 3 to 8 years-old vaccine-naive subjects achieving HI titers ≥40, after receiving two doses of investigational TIV or control vaccine. The time frame of evaluation was 28 days after first (Day 29) and 21 days after second vaccine dose (Day 50).

This criterion according to the US (CBER) guideline is met if the lower bound of the two sided 95%CI for percentage of subjects achieving HI titers ≥40 is ≥70%, for each vaccine strain.

Time Frame Day 1, Day 29, and Day 50
Hide Outcome Measure Data
Hide Analysis Population Description
Analysis was done on the per protocol population.
Arm/Group Title TIV (3-8 Years) Control (3-8 Years)
Hide Arm/Group Description:
The group consisted of naive subjects (who have never received influenza vaccination or had received only one influenza vaccine dose in the same season) who received two doses of investigational TIV.
The group [control (4-8 years) + control (3 to <4 years)] consisted of naive subjects (who have never received influenza vaccination or had received only one influenza vaccine dose in the same season) who received two doses of control vaccine. Subjects (4-<9 years) received TIVf and subjects (3-<4 years) received two doses of comparator TIV.
Overall Number of Participants Analyzed 820 413
Measure Type: Number
Number (95% Confidence Interval)
Unit of Measure: Percentages of subjects
Day 1 (H1N1 strain, N=819,412)
49
(46 to 53)
48
(43 to 53)
Day 29 (H1N1 strain, N=819,413)
83
(80 to 86)
82
(78 to 86)
Day 50 (H1N1 strain, N= 819,413)
99
(98 to 100)
98
(96 to 99)
Day 1 (H3N2 strain)
88
(85 to 90)
90
(87 to 93)
Day 29 (H3N2 strain, N= 819, 413)
99
(98 to 100)
98
(96 to 99)
Day 50 (H3N2 strain,N= 819, 413)
100
(100 to 100)
100
(99 to 100)
Day 1 (B strain)
25
(22 to 28)
26
(22 to 31)
Day 29 (B strain, N= 820,412)
82
(79 to 84)
81
(77 to 85)
Day 50 (B strain)
98
(96 to 99)
94
(92 to 96)
6.Secondary Outcome
Title Percentages of Vaccine-naive Children Achieving Seroconversion in Antibody Titers, After Receiving Two Doses of Investigational TIV or Control Vaccine
Hide Description

The percentages of 3 to 8 years-old vaccine naive children achieving seroconversion or significant increase in HI antibody titers after receiving two doses of investigational TIV or control vaccine, are reported. The time frame of evaluation was 28 days after first (Day 29) and 21 days after the second dose (Day 50).

This criterion, according to the US (CBER) guideline, is met if the lower limit of 95% CI of percentage of subjects achieving seroconversion or significant increase at day 29 and day 50 is ≥40, for each vaccine strain.

Time Frame Day 29 and Day 50
Hide Outcome Measure Data
Hide Analysis Population Description
Analysis was done on the per protocol population.
Arm/Group Title TIV (3-8 Years) Control (3-8 Years)
Hide Arm/Group Description:
The group consisted of naive subjects (who have never received influenza vaccination or had received only one influenza vaccine dose in the same season) who received two doses of investigational TIV.
The group [control (4-8 years) + control (3 to <4 years)] consisted of naive subjects (who have never received influenza vaccination or had received only one influenza vaccine dose in the same season) who received two doses of control vaccine. Subjects (4-<9 years) received TIVf and subjects (3-<4 years) received two doses of comparator TIV.
Overall Number of Participants Analyzed 820 413
Measure Type: Number
Number (95% Confidence Interval)
Unit of Measure: Percentages of subjects
Day 29 (H1N1 strain, N= 818,412)
82
(79 to 84)
81
(77 to 85)
Day 50 (H1N1 strain, N= 818,412)
98
(96 to 99)
96
(94 to 98)
Day 29 (H3N2 strain, N= 819,413)
74
(71 to 77)
87
(83 to 90)
Day 50 (H3N2 strain, N= 819,413)
78
(75 to 80)
87
(84 to 90)
Day 29 (B strain, N= 820,412)
74
(71 to 77)
73
(68 to 77)
Day 50 (B strain)
89
(87 to 91)
88
(85 to 91)
7.Secondary Outcome
Title Number of Subjects Reporting Solicited Adverse Events After Vaccination With Investigational TIV and Control Vaccine
Hide Description The number of 3-17 year old children with solicited local and systemic adverse events and other adverse events, after receiving either one or two doses of investigational TIV as compared to control vaccine are reported.
Time Frame Day 1 to 7 after vaccination
Hide Outcome Measure Data
Hide Analysis Population Description
Analysis was done on the safety set population i.e all subjects who received at least one study vaccine and provided post vaccination safety data.
Arm/Group Title TIV (3-8 Years) Control (3-8 Years) TIV (9-17 Years) Control (9-17 Years)
Hide Arm/Group Description:
The group consisted of naive (who have never received influenza vaccination or had received only one influenza vaccine dose in the same season) and non-naive subjects (who had a record of previous influenza vaccination). The non-naive subjects received one dose and naive subjects received two doses of investigational TIV.
The group [control (4-8 years) + control (3 to<4 years)] consisted of naive (who have never received influenza vaccination or had received only one influenza vaccine dose in the same season) and non-naive subjects (who had a record of previous influenza vaccination). Subjects (4-<9 years) received TIVf and subjects (3-<4 years) received comparator TIV. The non-naive subjects received one dose and naive subjects received two doses of control vaccine.
All subjects received one dose of investigational TIV.
All subjects received one dose of control vaccine(TIVf).
Overall Number of Participants Analyzed 1037 531 817 412
Measure Type: Number
Unit of Measure: Subjects
Any local 364 216 270 148
Injection site pain 363 215 268 146
Injection site ecchymosis 1 1 2 0
Injection site erythema 1 1 2 1
Injection site induration 10 6 5 6
Injection site swelling 11 11 6 3
Any systemic 262 161 193 94
Chills 37 20 38 8
Malaise 77 51 68 27
Myalgia 78 50 54 34
Arthralgia 41 20 26 12
Headache (N=1037,531,817,411) 101 52 93 38
Sweating 37 29 43 22
Fatigue 34 22 52 21
Fever (≥ 38°C) 116 68 39 12
Other 153 89 103 54
Analgesic/Antipyretic med.used(N=1032,531,816,412) 91 52 22 9
Stayed at home due to reaction(N=1019,524,809,411) 93 54 89 49
8.Secondary Outcome
Title Number of Subjects Reporting Unsolicited Adverse Events After Vaccination With Investigational TIV and Control Vaccine
Hide Description The number of 3-17 year old children reporting any unsolicited adverse event and any serious adverse event (SAE) after receiving either one or two doses of investigational TIV and control vaccine are reported.
Time Frame Day 1 to 180 (non-naive )/Day 1 to 209 (naive)
Hide Outcome Measure Data
Hide Analysis Population Description
Analysis was done on the safety set population.
Arm/Group Title TIV (3-8 Years) Control (3-8 Years) TIV (9-17 Years) Control (9-17 Years)
Hide Arm/Group Description:
The group consisted of naive (who have never received influenza vaccination or had received only one influenza vaccine dose in the same season) and non-naive subjects (who had a record of previous influenza vaccination). The non-naive subjects received one dose and naive subjects received two doses of investigational TIV.
The group [control (4-8 years) + control (3 to<4 years)] consisted of naive (who have never received influenza vaccination or had received only one influenza vaccine dose in the same season) and non-naive subjects (who had a record of previous influenza vaccination). Subjects (4-<9 years) received TIVf and subjects (3-<4 years) received comparator TIV. The non-naive subjects received one dose and naive subjects received two doses of control vaccine.
All subjects received one dose of investigational TIV.
All subjects received one dose of control vaccine (TIVf).
Overall Number of Participants Analyzed 1039 531 817 412
Measure Type: Number
Unit of Measure: Subjects
Any adverse event 395 194 101 58
At least possibly related adverse event 64 36 23 11
Serious adverse event 14 3 4 3
At least possibly related serious adverse event 1 0 0 0
Time Frame Solicited adverse events collected from Day 1-7 after each vaccination. Serious adverse events and other unsolicited adverse events were collected from Day 1-180 for non-naive and Day 1-209 for vaccine-naive subjects.
Adverse Event Reporting Description The population analyzed here is the safety set.
 
Arm/Group Title TIV (3-8 Years) Control (3-8 Years) TIV (9-17 Years) Control (9-17 Years)
Hide Arm/Group Description The group consisted of naive (who have never received influenza vaccination or had received only one influenza vaccine dose in the same season) and non-naive subjects (who had a record of previous influenza vaccination). The non-naive subjects received one dose and naive subjects received two doses of investigational TIV. The group [control (4-8 years) + control (3 to<4 years)] consisted of naive (who have never received influenza vaccination or had received only one influenza vaccine dose in the same season) and non-naive subjects (who had a record of previous influenza vaccination). Subjects (4-<9 years) received TIVf and subjects (3-<4 years) received comparator TIV. The non-naive subjects received one dose and naive subjects received two doses of control vaccine. All subjects received one dose of investigational TIV. All subjects received one dose of control vaccine (TIV_f).
All-Cause Mortality
TIV (3-8 Years) Control (3-8 Years) TIV (9-17 Years) Control (9-17 Years)
Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%)
Total   --/--   --/--   --/--   --/-- 
Show Serious Adverse Events Hide Serious Adverse Events
TIV (3-8 Years) Control (3-8 Years) TIV (9-17 Years) Control (9-17 Years)
Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%)
Total   14/1039 (1.35%)   3/531 (0.56%)   4/817 (0.49%)   3/412 (0.73%) 
Infections and infestations         
Abscess * 1  1/1039 (0.10%)  0/531 (0.00%)  0/817 (0.00%)  0/412 (0.00%) 
Amoebiasis * 1  1/1039 (0.10%)  0/531 (0.00%)  0/817 (0.00%)  0/412 (0.00%) 
Appendicitis * 1  0/1039 (0.00%)  0/531 (0.00%)  0/817 (0.00%)  1/412 (0.24%) 
Ascariasis * 1  1/1039 (0.10%)  0/531 (0.00%)  0/817 (0.00%)  0/412 (0.00%) 
Bronchopneumonia * 1  1/1039 (0.10%)  0/531 (0.00%)  0/817 (0.00%)  0/412 (0.00%) 
Cellulitis * 1  1/1039 (0.10%)  0/531 (0.00%)  0/817 (0.00%)  0/412 (0.00%) 
Cholera * 1  1/1039 (0.10%)  0/531 (0.00%)  0/817 (0.00%)  0/412 (0.00%) 
Dengue fever * 1  1/1039 (0.10%)  0/531 (0.00%)  1/817 (0.12%)  1/412 (0.24%) 
Gastroenteritis * 1  1/1039 (0.10%)  0/531 (0.00%)  0/817 (0.00%)  0/412 (0.00%) 
Gastroenteritis bacterial * 1  2/1039 (0.19%)  0/531 (0.00%)  0/817 (0.00%)  0/412 (0.00%) 
Gastroenteritis viral * 1  0/1039 (0.00%)  1/531 (0.19%)  0/817 (0.00%)  0/412 (0.00%) 
Measles * 1  1/1039 (0.10%)  0/531 (0.00%)  0/817 (0.00%)  0/412 (0.00%) 
Pneumonia * 1  0/1039 (0.00%)  1/531 (0.19%)  0/817 (0.00%)  0/412 (0.00%) 
Urinary tract infection * 1  2/1039 (0.19%)  0/531 (0.00%)  1/817 (0.12%)  0/412 (0.00%) 
Injury, poisoning and procedural complications         
Injury * 1  1/1039 (0.10%)  0/531 (0.00%)  0/817 (0.00%)  0/412 (0.00%) 
Road traffic accident * 1  1/1039 (0.10%)  0/531 (0.00%)  0/817 (0.00%)  0/412 (0.00%) 
Soft tissue injury * 1  1/1039 (0.10%)  0/531 (0.00%)  0/817 (0.00%)  0/412 (0.00%) 
Thermal burn * 1  0/1039 (0.00%)  1/531 (0.19%)  0/817 (0.00%)  0/412 (0.00%) 
Nervous system disorders         
Headache *  0/1039 (0.00%)  0/531 (0.00%)  1/817 (0.12%)  0/412 (0.00%) 
Psychiatric disorders         
Suicide attempt * 1  0/1039 (0.00%)  0/531 (0.00%)  0/817 (0.00%)  1/412 (0.24%) 
Respiratory, thoracic and mediastinal disorders         
Asthma *  1/1039 (0.10%)  0/531 (0.00%)  1/817 (0.12%)  0/412 (0.00%) 
*
Indicates events were collected by non-systematic assessment
1
Term from vocabulary, MedDRA
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 5%
TIV (3-8 Years) Control (3-8 Years) TIV (9-17 Years) Control (9-17 Years)
Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%)
Total   657/1039 (63.23%)   342/531 (64.41%)   385/817 (47.12%)   196/412 (47.57%) 
General disorders         
injection site pain   363/1039 (34.94%)  215/531 (40.49%)  268/817 (32.80%)  146/412 (35.44%) 
malaise   77/1039 (7.41%)  52/531 (9.79%)  68/817 (8.32%)  27/412 (6.55%) 
pyrexia  164/1039 (15.78%)  91/531 (17.14%)  43/817 (5.26%)  15/412 (3.64%) 
fatigue   0/1039 (0.00%)  0/531 (0.00%)  52/817 (6.36%)  21/412 (5.10%) 
Infections and infestations         
nasopharingitis  85/1039 (8.18%)  37/531 (6.97%)  0/817 (0.00%)  0/412 (0.00%) 
upper respiratory tract infection  102/1039 (9.82%)  41/531 (7.72%)  0/817 (0.00%)  0/412 (0.00%) 
Musculoskeletal and connective tissue disorders         
myalgia   79/1039 (7.60%)  51/531 (9.60%)  54/817 (6.61%)  34/412 (8.25%) 
Nervous system disorders         
headache   106/1039 (10.20%)  54/531 (10.17%)  94/817 (11.51%)  41/412 (9.95%) 
Skin and subcutaneous tissue disorders         
hyperhidrosis *  37/1039 (3.56%)  29/531 (5.46%)  43/817 (5.26%)  22/412 (5.34%) 
Indicates events were collected by systematic assessment
*
Indicates events were collected by non-systematic assessment
Due to GCP non-compliance at the Mexico site, data of 312 subjects (3-8 year olds) enrolled from this site were excluded from the final immunogenicity and safety analysis.
Certain Agreements
Principal Investigators are NOT employed by the organization sponsoring the study.
There IS an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.
Results Point of Contact
Name/Title: Posting Director
Organization: Novartis Vaccines and Diagnostics
Responsible Party: Novartis ( Novartis Vaccines )
ClinicalTrials.gov Identifier: NCT01209780     History of Changes
Other Study ID Numbers: V71_18
First Submitted: September 24, 2010
First Posted: September 27, 2010
Results First Submitted: December 10, 2013
Results First Posted: March 11, 2014
Last Update Posted: March 11, 2014