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Safety and Immunogenicity of a Four Influenza Vaccines in Children Ages 6 Months Old to Less Than 48 Months Old

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ClinicalTrials.gov Identifier: NCT02035696
Recruitment Status : Completed
First Posted : January 14, 2014
Results First Posted : June 27, 2017
Last Update Posted : July 10, 2018
Sponsor:
Collaborator:
Novartis Vaccines
Information provided by (Responsible Party):
Seqirus

Study Type Interventional
Study Design Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor);   Primary Purpose: Prevention
Condition Influenza
Interventions Biological: Trivalent influenza vaccine (TIVc)
Biological: Trivalent influenza vaccine-licensed
Enrollment 671
Recruitment Details 6 centers in the United States, 1 center in Finland, 2 centers in Thailand, 2 centers in Philippines
Pre-assignment Details All enrolled Subjects were included in the trial
Arm/Group Title TIVc-High Dose TIVc-Full Dose TIVc- Half Dose TIVe
Hide Arm/Group Description Subjects (6 to <48 months old) received two doses of 0.75 mL of TIVc vaccine Subjects(6 to <48 months old) received two doses of 0.50 mL of TIVc vaccine Subjects (6 to <48 months old)received two doses of 0.25 mL of TIVc vaccine Subjects (6 to <48 months old) received two doses of TIVe vaccine
Period Title: Overall Study
Started 174 166 167 164
Completed 171 163 164 161
Not Completed 3 3 3 3
Reason Not Completed
Lost to Follow-up             0             3             1             2
Withdrawal by Subject             3             0             2             1
Arm/Group Title TIVc-High Dose TIVc-Full Dose TIVc- Half Dose TIVe Total
Hide Arm/Group Description Subjects (6 to <48 months old) received two doses of 0.75 mL of TIVc vaccine Subjects(6 to <48 months old) received two doses of 0.50 mL of TIVc vaccine Subjects (6 to <48 months old)received two doses of 0.25 mL of TIVc vaccine Subjects (6 to <48 months old) received two doses of TIVe vaccine Total of all reporting groups
Overall Number of Baseline Participants 174 166 167 164 671
Hide Baseline Analysis Population Description
[Not Specified]
Age, Continuous  
Mean (Standard Deviation)
Unit of measure:  Months
Number Analyzed 174 participants 166 participants 167 participants 164 participants 671 participants
25.3  (11.5) 25.0  (11.5) 25.6  (11.5) 25.3  (11.9) 25.3  (11.6)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 174 participants 166 participants 167 participants 164 participants 671 participants
FEMALE
84
  48.3%
82
  49.4%
77
  46.1%
87
  53.0%
330
  49.2%
MALE
90
  51.7%
84
  50.6%
90
  53.9%
77
  47.0%
341
  50.8%
1.Primary Outcome
Title Ratios of Geometric Mean Titer (GMT) in Subjects (6 to <48 Months Old) After Receiving Two Doses of Either TIVc or TIVe Vaccine
Hide Description Immunogenicity was assessed in terms of ratios of GMTs in subjects (6 to <48 months old), measured by hemagglutination inhibition (HI) assay, day 1 to day 50 after vaccination with two doses of either TIVc or TIVe vaccine
Time Frame Day 50/Day 1
Hide Outcome Measure Data
Hide Analysis Population Description
Analysis was done on Per Protocol (PP) population i.e. all subjects in the FAS Efficacy/Immunogenicity Set who are not excluded due to reasons defined prior to unblinding or analysis
Arm/Group Title TIVc-High Dose TIVc-Full Dose TIVc- Half Dose TIVe
Hide Arm/Group Description:
Subjects (6 to <48 months old) received two doses of 0.75 mL of TIVc vaccine
Subjects(6 to <48 months old) received two doses of 0.50 mL of TIVc vaccine
Subjects (6 to <48 months old)received two doses of 0.25 mL of TIVc vaccine
Subjects (6 to <48 months old) received two doses of TIVe vaccine
Overall Number of Participants Analyzed 156 147 141 145
Measure Type: Number
Number (95% Confidence Interval)
Unit of Measure: Ratios
A/H1N1
7.82
(4.3 to 14.21)
5.5
(3.01 to 10.04)
5.93
(3.21 to 10.96)
3.69
(2.02 to 6.74)
A/H3N2
10.53
(6.34 to 17.49)
10.84
(6.5 to 18.07)
6.47
(3.84 to 10.9)
11.95
(7.17 to 19.91)
B
5.18
(3.73 to 7.96)
4.27
(2.77 to 6.58)
3.87
(2.49 to 6.02)
6.65
(4.32 to 10.25)
Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection TIVc-High Dose, TIVe
Comments Non-inferiority of immune responses of a TIVc-High Dose to TIVe, assessed in terms of vaccine group GMT ratios against influenza strain A/H1N1 at Day 1
Type of Statistical Test Non-Inferiority or Equivalence
Comments Non-inferiority was established if the Lower limit of the 2-sided 95% CI of the vaccine group GMT ratio ≥ 0.67
Method of Estimation Estimation Parameter Vaccine Group Ratios at Day 1
Estimated Value 0.99
Confidence Interval (2-Sided) 95%
0.65 to 1.52
Estimation Comments [Not Specified]
Hide Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection TIVc-High Dose, TIVe
Comments Non-inferiority of immune responses of a TIVc-High Dose to TIVe, assessed in terms of vaccine group GMT ratios against influenza strain A/H1N1 at Day 50
Type of Statistical Test Non-Inferiority or Equivalence
Comments Non-inferiority was established if the Lower limit of the 2-sided 95% CI of the vaccine group GMT ratio ≥ 0.67
Method of Estimation Estimation Parameter Vaccine Group ratios at Day 50
Estimated Value 2.11
Confidence Interval (2-Sided) 95%
1.5 to 2.98
Estimation Comments [Not Specified]
Hide Statistical Analysis 3
Statistical Analysis Overview Comparison Group Selection TIVc-High Dose, TIVe
Comments Non-inferiority of immune responses of a TIVc-High Dose to TIVe, assessed in terms of vaccine group GMT ratios against influenza strain A/H3N2 at Day 1
Type of Statistical Test Non-Inferiority or Equivalence
Comments Non-inferiority was established if the Lower limit of the 2-sided 95% CI of the vaccine group GMT ratio ≥ 0.67
Method of Estimation Estimation Parameter Vaccine Group ratios at Day 1
Estimated Value 0.68
Confidence Interval (2-Sided) 95%
0.43 to 1.06
Estimation Comments [Not Specified]
Hide Statistical Analysis 4
Statistical Analysis Overview Comparison Group Selection TIVc-High Dose, TIVe
Comments Non-inferiority of immune responses of a TIVc-High Dose to TIVe, assessed in terms of vaccine group GMT ratios against influenza strain A/H3N2 at Day 50
Type of Statistical Test Non-Inferiority or Equivalence
Comments Non-inferiority was established if the Lower limit of the 2-sided 95% CI of the vaccine group GMT ratio ≥ 0.67
Method of Estimation Estimation Parameter Vaccine Group Ratios at Day 50
Estimated Value 0.71
Confidence Interval (2-Sided) 95%
0.58 to 0.87
Estimation Comments [Not Specified]
Hide Statistical Analysis 5
Statistical Analysis Overview Comparison Group Selection TIVc-High Dose, TIVe
Comments Non-inferiority of immune responses of a TIVc-High Dose to TIVe, assessed in terms of vaccine group GMT ratios against influenza strain B at Day 1
Type of Statistical Test Non-Inferiority or Equivalence
Comments Non-inferiority was established if the Lower limit of the 2-sided 95% CI of the vaccine group GMT ratio ≥ 0.67
Method of Estimation Estimation Parameter Vaccine Group Ratios at Day 1
Estimated Value 1
Confidence Interval (2-Sided) 95%
0.92 to 1.08
Estimation Comments [Not Specified]
Hide Statistical Analysis 6
Statistical Analysis Overview Comparison Group Selection TIVc-High Dose, TIVe
Comments Non-inferiority of immune responses of a TIVc-High Dose to TIVe, assessed in terms of vaccine group GMT ratios against influenza strain B at Day 50
Type of Statistical Test Non-Inferiority or Equivalence
Comments Non-inferiority was established if the Lower limit of the 2-sided 95% CI of the vaccine group GMT ratio ≥ 0.67
Method of Estimation Estimation Parameter Vaccine Group ratios at Day 50
Estimated Value 0.78
Confidence Interval (2-Sided) 95%
0.6 to 1.01
Estimation Comments [Not Specified]
Hide Statistical Analysis 7
Statistical Analysis Overview Comparison Group Selection TIVc-Full Dose, TIVe
Comments Non-inferiority of immune responses of a TIVc-Full Dose to TIVe, assessed in terms of vaccine group GMT ratios against influenza strain A/H1N1 at Day 1
Type of Statistical Test Non-Inferiority or Equivalence
Comments Non-inferiority was established if the Lower limit of the 2-sided 95% CI of the vaccine group GMT ratio ≥ 0.67
Method of Estimation Estimation Parameter Vaccine Group Ratios at Day 1
Estimated Value 1.27
Confidence Interval (2-Sided) 95%
0.83 to 1.96
Estimation Comments [Not Specified]
Hide Statistical Analysis 8
Statistical Analysis Overview Comparison Group Selection TIVc-Full Dose, TIVe
Comments Non-inferiority of immune responses of a TIVc-Full Dose to TIVe, assessed in terms of vaccine group GMT ratios against influenza strain A/H1N1 at Day 50
Type of Statistical Test Non-Inferiority or Equivalence
Comments Non-inferiority was established if the Lower limit of the 2-sided 95% CI of the vaccine group GMT ratio ≥ 0.67
Method of Estimation Estimation Parameter Vaccine Group Ratios at Day 50
Estimated Value 1.6
Confidence Interval (2-Sided) 95%
1.13 to 2.28
Estimation Comments [Not Specified]
Hide Statistical Analysis 9
Statistical Analysis Overview Comparison Group Selection TIVc-Full Dose, TIVe
Comments Non-inferiority of immune responses of a TIVc-Full Dose to TIVe, assessed in terms of vaccine group GMT ratios against influenza strain A/H3N2 at Day 1
Type of Statistical Test Non-Inferiority or Equivalence
Comments Non-inferiority was established if the Lower limit of the 2-sided 95% CI of the vaccine group GMT ratio ≥ 0.67
Method of Estimation Estimation Parameter Vaccine Group Ratios at Day 1
Estimated Value 0.52
Confidence Interval (2-Sided) 95%
0.33 to 0.81
Estimation Comments [Not Specified]
Hide Statistical Analysis 10
Statistical Analysis Overview Comparison Group Selection TIVc-Full Dose, TIVe
Comments Non-inferiority of immune responses of a TIVc-Full Dose to TIVe, assessed in terms of vaccine group GMT ratios against influenza strain A/H3N2 at Day 50
Type of Statistical Test Non-Inferiority or Equivalence
Comments Non-inferiority was established if the Lower limit of the 2-sided 95% CI of the vaccine group GMT ratio ≥ 0.67
Method of Estimation Estimation Parameter Vaccine Group Ratios at Day 50
Estimated Value 0.64
Confidence Interval (2-Sided) 95%
0.52 to 0.78
Estimation Comments [Not Specified]
Hide Statistical Analysis 11
Statistical Analysis Overview Comparison Group Selection TIVc-Full Dose, TIVe
Comments Non-inferiority of immune responses of a TIVc-Full Dose to TIVe, assessed in terms of vaccine group GMT ratios against influenza strain B at Day 1
Type of Statistical Test Non-Inferiority or Equivalence
Comments Non-inferiority was established if the Lower limit of the 2-sided 95% CI of the vaccine group GMT ratio ≥ 0.67
Method of Estimation Estimation Parameter Vaccine Group ratios at Day 1
Estimated Value 0.96
Confidence Interval (2-Sided) 95%
0.89 to 1.04
Estimation Comments [Not Specified]
Hide Statistical Analysis 12
Statistical Analysis Overview Comparison Group Selection TIVc-Full Dose, TIVe
Comments Non-inferiority of immune responses of a TIVc-Full Dose to TIVe, assessed in terms of vaccine group GMT ratios against influenza strain B at Day 50
Type of Statistical Test Non-Inferiority or Equivalence
Comments Non-inferiority was established if the Lower limit of the 2-sided 95% CI of the vaccine group GMT ratio ≥ 0.67
Method of Estimation Estimation Parameter Vaccine Group Ratios at Day 50
Estimated Value 0.64
Confidence Interval (2-Sided) 95%
0.49 to 0.84
Estimation Comments [Not Specified]
Hide Statistical Analysis 13
Statistical Analysis Overview Comparison Group Selection TIVc- Half Dose, TIVe
Comments Non-inferiority of immune responses of a TIVc- Half Dose to TIVe, assessed in terms of vaccine group GMT ratios against influenza strain A/H1N1 at Day 1
Type of Statistical Test Non-Inferiority or Equivalence
Comments Non-inferiority was established if the Lower limit of the 2-sided 95% CI of the vaccine group GMT ratio ≥ 0.67
Method of Estimation Estimation Parameter Vaccine Group Ratios at Day 1
Estimated Value 1.02
Confidence Interval (2-Sided) 95%
0.66 to 1.58
Estimation Comments [Not Specified]
Hide Statistical Analysis 14
Statistical Analysis Overview Comparison Group Selection TIVc- Half Dose, TIVe
Comments Non-inferiority of immune responses of a TIVc- Half Dose to TIVe, assessed in terms of vaccine group GMT ratios against influenza strain A/H1N1 at Day 50
Type of Statistical Test Non-Inferiority or Equivalence
Comments Non-inferiority was established if the Lower limit of the 2-sided 95% CI of the vaccine group GMT ratio ≥ 0.67
Method of Estimation Estimation Parameter Vaccine Group ratios at Day 50
Estimated Value 1.62
Confidence Interval (2-Sided) 95%
1.14 to 2.3
Estimation Comments [Not Specified]
Hide Statistical Analysis 15
Statistical Analysis Overview Comparison Group Selection TIVc- Half Dose, TIVe
Comments Non-inferiority of immune responses of a TIVc- Half Dose to TIVe, assessed in terms of vaccine group GMT ratios against influenza strain A/H3N2 at Day 1
Type of Statistical Test Non-Inferiority or Equivalence
Comments Non-inferiority was established if the Lower limit of the 2-sided 95% CI of the vaccine group GMT ratio ≥ 0.67
Method of Estimation Estimation Parameter Vaccine Group Ratios at Day 1
Estimated Value 0.74
Confidence Interval (2-Sided) 95%
0.47 to 1.17
Estimation Comments [Not Specified]
Hide Statistical Analysis 16
Statistical Analysis Overview Comparison Group Selection TIVc- Half Dose, TIVe
Comments Non-inferiority of immune responses of a TIVc- Half Dose to TIVe, assessed in terms of vaccine group GMT ratios against influenza strain A/H3N2 at Day 50
Type of Statistical Test Non-Inferiority or Equivalence
Comments Non-inferiority was established if the Lower limit of the 2-sided 95% CI of the vaccine group GMT ratio ≥ 0.67
Method of Estimation Estimation Parameter Vaccine Group ratios at Day 50
Estimated Value 0.46
Confidence Interval (2-Sided) 95%
0.38 to 0.57
Estimation Comments [Not Specified]
Hide Statistical Analysis 17
Statistical Analysis Overview Comparison Group Selection TIVc- Half Dose, TIVe
Comments Non-inferiority of immune responses of a TIVc- Half Dose to TIVe, assessed in terms of vaccine group GMT ratios against influenza strain B at Day 1
Type of Statistical Test Non-Inferiority or Equivalence
Comments Non-inferiority was established if the Lower limit of the 2-sided 95% CI of the vaccine group GMT ratio ≥ 0.67
Method of Estimation Estimation Parameter Vaccine Group Ratios at Day 1
Estimated Value 0.94
Confidence Interval (2-Sided) 95%
0.87 to 1.02
Estimation Comments [Not Specified]
Hide Statistical Analysis 18
Statistical Analysis Overview Comparison Group Selection TIVc- Half Dose, TIVe
Comments Non-inferiority of immune responses of a TIVc- Half Dose to TIVe, assessed in terms of vaccine group GMT ratios against influenza strain B at Day 50
Type of Statistical Test Non-Inferiority or Equivalence
Comments Non-inferiority was established if the Lower limit of the 2-sided 95% CI of the vaccine group GMT ratio ≥ 0.67
Method of Estimation Estimation Parameter Vaccine Group Ratios at Day 50
Estimated Value 0.57
Confidence Interval (2-Sided) 95%
0.44 to 0.75
Estimation Comments [Not Specified]
2.Primary Outcome
Title Percentages of Subjects (6 to <48 Months Old) Achieving Seroconversion or Significant Increase After Receiving Two Doses of Either TIVc or TIVe Vaccine
Hide Description Immunogenicity was assessed in terms number (%) of subjects (6 to <48 months old) achieving seroconversion as measured by HI antibody titer, day 50 after vaccination with two doses of either TIVc or TIVe vaccine Seroconversion was defined as subjects with either a pre-vaccination (baseline) HI titer < 1:10 and post-vaccination HI titer ≥ 1:40 or with a pre-vaccination HI titer ≥ 1:10 and a ≥ 4-fold increase in post-vaccination HI antibody titer
Time Frame Day 50 post vaccination
Hide Outcome Measure Data
Hide Analysis Population Description
Analysis was done on PP population
Arm/Group Title TIVc-High Dose TIVc-Full Dose TIVc- Half Dose TIVe
Hide Arm/Group Description:
Subjects (6 to <48 months old) received two doses of 0.75 mL of TIVc vaccine
Subjects(6 to <48 months old) received two doses of 0.50 mL of TIVc vaccine
Subjects (6 to <48 months old)received two doses of 0.25 mL of TIVc vaccine
Subjects (6 to <48 months old) received two doses of TIVe vaccine
Overall Number of Participants Analyzed 156 147 141 145
Measure Type: Number
Number (95% Confidence Interval)
Unit of Measure: Percentages of subjects
A/H1N1_Day 50
83
(77 to 89)
81
(74 to 87)
79
(72 to 86)
74
(66 to 81)
A/H3N2_Day 50
94
(89 to 97)
90
(84 to 94)
87
(80 to 92)
92
(87 to 96)
B_Day 50
69
(61 to 76)
69
(61 to 77)
62
(54 to 70)
80
(73 to 86)
Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection TIVc-High Dose, TIVe
Comments Non-inferiority of immune responses of TIVc-High Dose to TIVe, assessed in terms of Vaccine Group Differences with seroconversion against influenza strain A/H1N1
Type of Statistical Test Non-Inferiority or Equivalence
Comments Non-inferiority was established if the Lower limit of the 2-sided 95% CI on the difference between seroconversion rates ≥ -10%
Method of Estimation Estimation Parameter Vaccine Group Differences
Estimated Value 10
Confidence Interval (2-Sided) 95%
0 to 18.9
Estimation Comments [Not Specified]
Hide Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection TIVc-High Dose, TIVe
Comments Non-inferiority of immune responses of TIVc-High Dose to TIVe, assessed in terms of Vaccine Group Differences with seroconversion against influenza strain A/H3N2
Type of Statistical Test Non-Inferiority or Equivalence
Comments Non-inferiority was established if the Lower limit of the 2-sided 95% CI on the difference between seroconversion rates ≥ -10%
Method of Estimation Estimation Parameter Vaccine Group Differences
Estimated Value 2
Confidence Interval (2-Sided) 95%
-4 to 8
Estimation Comments [Not Specified]
Hide Statistical Analysis 3
Statistical Analysis Overview Comparison Group Selection TIVc-High Dose, TIVe
Comments Non-inferiority of immune responses of TIVc-High Dose to TIVe, assessed in terms of Vaccine Group Differences with seroconversion against influenza strain B
Type of Statistical Test Non-Inferiority or Equivalence
Comments Non-inferiority was established if the Lower limit of the 2-sided 95% CI on the difference between seroconversion rates ≥ -10%
Method of Estimation Estimation Parameter Vaccine Group differences
Estimated Value -11
Confidence Interval (2-Sided) 95%
-21.1 to -1.5
Estimation Comments [Not Specified]
Hide Statistical Analysis 4
Statistical Analysis Overview Comparison Group Selection TIVc-Full Dose, TIVe
Comments Non-inferiority of immune responses of TIVc-Full Dose to TIVe, assessed in terms of Vaccine Group Differences with seroconversion against influenza strain A/H1N1
Type of Statistical Test Non-Inferiority or Equivalence
Comments Non-inferiority was established if the Lower limit of the 2-sided 95% CI on the difference between seroconversion rates ≥ -10%
Method of Estimation Estimation Parameter Vaccine Group Differences
Estimated Value 7
Confidence Interval (2-Sided) 95%
-2.5 to 16.8
Estimation Comments [Not Specified]
Hide Statistical Analysis 5
Statistical Analysis Overview Comparison Group Selection TIVc-Full Dose, TIVe
Comments Non-inferiority of immune responses of TIVc-Full Dose to TIVe, assessed in terms of Vaccine Group Differences with seroconversion against influenza strain A/H3N2
Type of Statistical Test Non-Inferiority or Equivalence
Comments Non-inferiority was established if the Lower limit of the 2-sided 95% CI on the difference between seroconversion rates ≥ -10%
Method of Estimation Estimation Parameter Vaccine Group differences
Estimated Value -3
Confidence Interval (2-Sided) 95%
-9.5 to 4.1
Estimation Comments [Not Specified]
Hide Statistical Analysis 6
Statistical Analysis Overview Comparison Group Selection TIVc-Full Dose, TIVe
Comments Non-inferiority of immune responses of TIVc-Full Dose to TIVe, assessed in terms of Vaccine Group Differences with seroconversion against influenza strain B
Type of Statistical Test Non-Inferiority or Equivalence
Comments Non-inferiority was established if the Lower limit of the 2-sided 95% CI on the difference between seroconversion rates ≥ -10%
Method of Estimation Estimation Parameter Vaccine Group Differences
Estimated Value -11
Confidence Interval (2-Sided) 95%
-20.5 to -1
Estimation Comments [Not Specified]
Hide Statistical Analysis 7
Statistical Analysis Overview Comparison Group Selection TIVc- Half Dose, TIVe
Comments Non-inferiority of immune responses of TIVc- Half Dose to TIVe, assessed in terms of Vaccine Group Differences with seroconversion against influenza strain A/H1N1
Type of Statistical Test Non-Inferiority or Equivalence
Comments Non-inferiority was established if the Lower limit of the 2-sided 95% CI on the difference between seroconversion rates ≥ -10%
Method of Estimation Estimation Parameter Vaccine Group Differences
Estimated Value 6
Confidence Interval (2-Sided) 95%
-4.2 to 15.4
Estimation Comments [Not Specified]
Hide Statistical Analysis 8
Statistical Analysis Overview Comparison Group Selection TIVc- Half Dose, TIVe
Comments Non-inferiority of immune responses of TIVc- Half Dose to TIVe, assessed in terms of Vaccine Group Differences with seroconversion against influenza strain A/H3N2
Type of Statistical Test Non-Inferiority or Equivalence
Comments Non-inferiority was established if the Lower limit of the 2-sided 95% CI on the difference between seroconversion rates ≥ -10%
Method of Estimation Estimation Parameter Vaccine Group Differences
Estimated Value -6
Confidence Interval (2-Sided) 95%
-13.4 to 1.3
Estimation Comments [Not Specified]
Hide Statistical Analysis 9
Statistical Analysis Overview Comparison Group Selection TIVc- Half Dose, TIVe
Comments Non-inferiority of immune responses of TIVc- Half Dose to TIVe, assessed in terms of Vaccine Group Differences with seroconversion against influenza strain B
Type of Statistical Test Non-Inferiority or Equivalence
Comments Non-inferiority was established if the Lower limit of the 2-sided 95% CI on the difference between seroconversion rates ≥ -10%
Method of Estimation Estimation Parameter Vaccine Group Differences
Estimated Value -18
Confidence Interval (2-Sided) 95%
-27.8 to -7.2
Estimation Comments [Not Specified]
3.Primary Outcome
Title Desirability Index Score of Subjects (6 to <48 Months Old) Reporting Severe Solicited Local and Systemic Reactions After Vaccination With Either TIVc or TIVe Vaccine
Hide Description Differences in percentages of subjects (6 to <48 months old) with severe local solicited AEs and severe solicited systemic AEs, 3 days after vaccination with either TIVc or TIVe vaccine was assessed in terms of an individual desirability index score (High dose, Full dose, Half dose TIVc vs. TIVe vaccine). An individual desirability index score was assigned to each (non-transformed) safety value based on predefined functions. Each desirability index score is assigned a value between 0 and 1, wherein 0 is an undesirable response and 1 is a highly desirable response.
Time Frame Day 1 to Day 3
Hide Outcome Measure Data
Hide Analysis Population Description
Analysis was done on PPSd-All subjects in the FASd who:Correctly received the vaccine (i.e., received the vaccine to which the subjects is randomized and at the scheduled time points).
Arm/Group Title TIVc-High Dose-TIVe TIVc-Full Dose-TIVe TIVc- Half Dose-TIVe
Hide Arm/Group Description:
Subjects (6 to <48 months old) received two doses of 0.75 mL of TIVc vaccine vs Subjects (6 to <48 months old) received two doses of TIVe vaccine
Subjects(6 to <48 months old) received two doses of 0.50 mL of TIVc vaccine vs Subjects (6 to <48 months old) received two doses of TIVe vaccine
Subjects (6 to <48 months old)received two doses of 0.25 mL of TIVc vaccine vs Subjects (6 to <48 months old) received two doses of TIVe vaccine
Overall Number of Participants Analyzed 305 294 291
Measure Type: Number
Unit of Measure: percentage of participants
Severe solicited local AEs 0.000 0.000 0.000
Severe solicited systemic AEs 0.040 0.000 0.000
Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection TIVc-High Dose-TIVe
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Method of Estimation Estimation Parameter Desirability Index Score
Estimated Value 0.000
Estimation Comments Desirability Score: If this difference is negative, then it is defined as non-desirable (D equal to 0), while if the difference is positive, then D will equal to the relative reduction calculated in the following way: D = (TIVe - TIVc Dose )/TIVe.
Hide Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection TIVc-Full Dose-TIVe
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Method of Estimation Estimation Parameter Desirability Index Score
Estimated Value 0.000
Estimation Comments Desirability Score: If this difference is negative, then it is defined as non-desirable (D equal to 0), while if the difference is positive, then D will equal to the relative reduction calculated in the following way: D = (TIVe - TIVc Dose )/TIVe.
Hide Statistical Analysis 3
Statistical Analysis Overview Comparison Group Selection TIVc- Half Dose-TIVe
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Method of Estimation Estimation Parameter Desirability Index Score
Estimated Value 0.000
Estimation Comments Desirability Score: If this difference is negative, then it is defined as non-desirable (D equal to 0), while if the difference is positive, then D will equal to the relative reduction calculated in the following way: D = (TIVe - TIVc Dose )/TIVe.
4.Secondary Outcome
Title Percentages of Subjects (6 to <48 Months Old) Achieving Seroconversion or Significant Increase After Receiving Two Doses of Either TIVc or TIVe Vaccine
Hide Description

Immunogenicity was assessed in terms of number (%) of subjects (6 to <48 months old) achieving seroconversion as measured by HI assay, day 50 after vaccination with two doses of either TIVc or TIVe vaccine

Seroconversion was defined as subjects with either a pre-vaccination (baseline) HI titer < 1:10 and post-vaccination HI titer ≥ 1:40 or with a pre-vaccination HI titer ≥ 1:10 and a ≥ 4-fold increase in post-vaccination HI antibody titer

The Center for Biologics Evaluation, Research, and Review (CBER) criterion for pediatric population is that the lower bound of the two-sided 95% confidence interval (CI) for the percentage of subjects achieving seroconversion for HI antibody should meet or exceed 40%

The Committee for Medicinal Products for Human Use (CHMP) criterion for pediatric population is that the percentage of subjects achieving seroconversion or significant increase in HI antibody titers >40%

Time Frame Day 50 post vaccination
Hide Outcome Measure Data
Hide Analysis Population Description
Analysis was done on Full analysis set
Arm/Group Title TIVc-High Dose TIVc-Full Dose TIVc- Half Dose TIVe
Hide Arm/Group Description:
Subjects (6 to <48 months old) received two doses of 0.75 mL of TIVc vaccine
Subjects(6 to <48 months old) received two doses of 0.50 mL of TIVc vaccine
Subjects (6 to <48 months old)received two doses of 0.25 mL of TIVc vaccine
Subjects (6 to <48 months old) received two doses of TIVe vaccine
Overall Number of Participants Analyzed 170 164 161 159
Measure Type: Number
Number (95% Confidence Interval)
Unit of Measure: Percentages of subjects
A/H1N1
84
(77 to 89)
80
(74 to 86)
82
(75 to 88)
73
(65 to 80)
A/H3N2
94
(89 to 97)
91
(85 to 95)
88
(81 to 92)
93
(88 to 96)
B
68
(61 to 75)
70
(62 to 76)
63
(55 to 70)
79
(72 to 85)
5.Secondary Outcome
Title Percentages of Subjects (6 to <48 Months Old) Achieving HI Titer ≥1:40 After Receiving Two Doses of Either TIVc or TIVe Vaccine
Hide Description

Immunogenicity was assessed in terms of number (%) of subjects (6 to <48 months old) achieving HI titer ≥1:40 as measured by HI assay, day 50 after vaccination with two doses of either TIVc or TIVe vaccine

The CBER criterion for pediatric population is that the lower bound of the two-sided 95% CI for the percentage of subjects achieving an HI antibody titer ≥1:40 should meet or exceed 70%

The CHMP criterion for pediatric population is that the percentage of subjects achieving HI antibody titers ≥1:40 should be >70%

Time Frame Day 1, Day 50 post vaccination
Hide Outcome Measure Data
Hide Analysis Population Description
Analysis was done on FAS
Arm/Group Title TIVc-High Dose TIVc-Full Dose TIVc- Half Dose TIVe
Hide Arm/Group Description:
Subjects (6 to <48 months old) received two doses of 0.75 mL of TIVc vaccine
Subjects(6 to <48 months old) received two doses of 0.50 mL of TIVc vaccine
Subjects (6 to <48 months old)received two doses of 0.25 mL of TIVc vaccine
Subjects (6 to <48 months old) received two doses of TIVe vaccine
Overall Number of Participants Analyzed 170 164 161 159
Measure Type: Number
Number (95% Confidence Interval)
Unit of Measure: Percentages of subjects
A/H1N1: Day 1
26
(20 to 34)
32
(25 to 39)
29
(22 to 37)
26
(20 to 34)
A/H1N1: Day 50
86
(80 to 91)
85
(78 to 90)
86
(79 to 91)
77
(69 to 83)
A/H3N2: Day 1
45
(37 to 53)
40
(33 to 48)
48
(41 to 56)
52
(44 to 60)
A/H3N2: Day 50
98
(95 to 100)
98
(94 to 99)
97
(93 to 99)
99
(97 to 100)
B: Day 1
2
(0 to 5)
0
(0 to 2)
1
(0.016 to 3)
3
(1 to 7)
B: Day 50
69
(61 to 76)
70
(62 to 76)
63
(55 to 70)
80
(73 to 86)
6.Secondary Outcome
Title Geometric Mean Ratios (GMR) in Subjects (6 to <48 Months Old) After Receiving Two Doses of Either TIVc or TIVe Vaccine
Hide Description

Immunogenicity was assessed in terms of GMR in subjects (6 to <48 months old) as measured by HI assay, day 50 after vaccination with two doses of either TIVc or TIVe vaccine

The CHMP criterion is mean geometric ratio (GMR) >2.5

Time Frame Day 50 post vaccination over day 1
Hide Outcome Measure Data
Hide Analysis Population Description
Analysis was done on FAS
Arm/Group Title TIVc-High Dose TIVc-Full Dose TIVc- Half Dose TIVe
Hide Arm/Group Description:
Subjects (6 to <48 months old) received two doses of 0.75 mL of TIVc vaccine
Subjects(6 to <48 months old) received two doses of 0.50 mL of TIVc vaccine
Subjects (6 to <48 months old)received two doses of 0.25 mL of TIVc vaccine
Subjects (6 to <48 months old) received two doses of TIVe vaccine
Overall Number of Participants Analyzed 170 164 161 159
Measure Type: Number
Number (95% Confidence Interval)
Unit of Measure: Ratios
A/H1N1
12
(7.05 to 19)
8.58
(5.08 to 14)
8.94
(5.28 to 15)
5.14
(3.04 to 8.68)
A/H3N2
12
(7.83 to 19)
13
(8.05 to 20)
7.68
(4.91 to 12)
14
(8.83 to 22)
B
6.14
(4.27 to 8.84)
5.29
(3.64 to 7.7)
4.72
(3.24 to 6.88)
7.57
(5.21 to 11)
7.Secondary Outcome
Title Geometric Mean Ratios (GMR) in Subjects (6 to <48 Months Old) After Receiving Two Doses of Either TIVc or TIVe Vaccine
Hide Description Immunogenicity was assessed in terms of GMR in subjects (6 to <48 months old) as measured by MN assay, day 50 after vaccination with two doses of either TIVc or TIVe vaccine
Time Frame Day 50 post vaccination over day 1
Hide Outcome Measure Data
Hide Analysis Population Description
Analysis was done on PPS
Arm/Group Title TIVc-High Dose TIVc-Full Dose TIVc- Half Dose TIVe
Hide Arm/Group Description:
Subjects (6 to <48 months old) received two doses of 0.75 mL of TIVc vaccine
Subjects(6 to <48 months old) received two doses of 0.50 mL of TIVc vaccine
Subjects (6 to <48 months old)received two doses of 0.25 mL of TIVc vaccine
Subjects (6 to <48 months old) received two doses of TIVe vaccine
Overall Number of Participants Analyzed 156 148 141 147
Measure Type: Number
Number (95% Confidence Interval)
Unit of Measure: Ratios
A/H1N1
7.84
(4.29 to 14.33)
5.81
(3.17 to 10.65)
5.98
(3.22 to 11.09)
17.82
(9.73 to 32.62)
A/H3N2
8.4
(5 to 14.12)
8.97
(5.32 to 15.12)
5.58
(3.28 to 9.51)
8.9
(5.28 to 14.98)
B
12.78
(8.09 to 20.2)
10.43
(6.58 to 16.52)
9.99
(6.25 to 15.99)
17.55
(11.08 to 27.78)
8.Secondary Outcome
Title Percentages of Subjects (6 to <48 Months Old) With High Post Vaccination HI Titers (i.e. HI Titers ≥1:110, ≥1:150, ≥1:330 and ≥1:629) After Receiving Two Doses of Either TIVc or TIVe Vaccine
Hide Description Immunogenicity was assessed in terms of number (%) of subjects (6 to <48 months old) achieving post vaccination HI titers (i.e. HI titers ≥1:110, ≥1:150, ≥1:330 and ≥1:629) as measured by HI assay, day 50 after vaccination with two doses of either TIVc or TIVe vaccine
Time Frame Day 1 and Day 50 post vaccination
Hide Outcome Measure Data
Hide Analysis Population Description
Analysis was done on PPS
Arm/Group Title TIVc-High Dose TIVc-Full Dose TIVc- Half Dose TIVe
Hide Arm/Group Description:
Subjects (6 to <48 months old) received two doses of 0.75 mL of TIVc vaccine
Subjects(6 to <48 months old) received two doses of 0.50 mL of TIVc vaccine
Subjects (6 to <48 months old)received two doses of 0.25 mL of TIVc vaccine
Subjects (6 to <48 months old) received two doses of TIVe vaccine
Overall Number of Participants Analyzed 156 147 141 145
Measure Type: Number
Number (95% Confidence Interval)
Unit of Measure: Percentages of subjects
A/H1N1: Day 1: HI titers ≥1:110
26
(19 to 33)
31
(24 to 39)
26
(19 to 34)
26
(19 to 33)
A/H1N1: Day 50: HI titers ≥1:110
78
(70 to 84)
80
(72 to 86)
71
(63 to 78)
59
(51 to 67)
A/H3N2: Day 1: HI titers ≥1:110
40
(33 to 49)
37
(29 to 45)
43
(34 to 51)
47
(39 to 55)
A/H3N2: Day 50: HI titers ≥1:110
88
(82 to 93)
86
(80 to 91)
82
(74 to 88)
97
(93 to 99)
B: Day 1: HI titers ≥1:110
1
(0.016 to 4)
0
(0 to 2)
0
(0 to 3)
0
(0 to 3)
B: Day 50: HI titers ≥1:110
40
(33 to 49)
30
(23 to 38)
24
(17 to 32)
39
(31 to 47)
A/H1N1: Day 1: HI titers ≥1:151
25
(18 to 33)
30
(23 to 38)
26
(19 to 34)
25
(18 to 33)
A/H1N1: Day 50: HI titers ≥1:151
76
(69 to 83)
76
(68 to 83)
70
(62 to 78)
58
(49 to 66)
A/H3N2: Day 1: HI titers ≥1:151
40
(33 to 49)
37
(29 to 45)
43
(34 to 51)
47
(39 to 55)
A/H3N2: Day 50: HI titers ≥1:150
88
(82 to 93)
86
(80 to 91)
81
(73 to 87)
97
(93 to 99)
B: Day 1: HI titers ≥1:151
0
(0 to 2)
0
(0 to 2)
0
(0 to 3)
0
(0 to 3)
B: Day 50: HI titers ≥1:151
40
(32 to 48)
30
(23 to 38)
23
(17 to 31)
39
(31 to 47)
A/H1N1: Day 1: HI titers ≥1:330
12
(7 to 18)
14
(9 to 21)
11
(7 to 18)
11
(6 to 17)
A/H1N1: Day 50: HI titers ≥1:330
51
(43 to 59)
50
(42 to 59)
43
(35 to 52)
34
(26 to 42)
A/H3N2: Day 1: HI titers ≥1:330
16
(11 to 23)
12
(7 to 18)
13
(8 to 19)
21
(15 to 29)
A/H3N2: Day 50: HI titers ≥1:330
62
(53 to 69)
56
(48 to 65)
52
(43 to 60)
68
(59 to 75)
B: Day 1: HI titers ≥1:330
0
(0 to 2)
0
(0 to 2)
0
(0 to 3)
0
(0 to 3)
B: Day 50: HI titers ≥1:330
4
(2 to 9)
4
(2 to 9)
3
(1 to 7)
8
(4 to 13)
A/H1N1: Day 1: HI titers ≥1:629
9
(5 to 15)
12
(7 to 18)
11
(6 to 17)
8
(4 to 14)
A/H1N1: Day 50: HI titers ≥1:629
48
(40 to 56)
47
(39 to 55)
43
(35 to 52)
33
(26 to 41)
A/H3N2: Day 1: HI titers ≥1:629
16
(11 to 23)
12
(7 to 18)
12
(7 to 19)
21
(15 to 29)
A/H3N2: Day 50: HI titers ≥1:629
62
(53 to 69)
56
(47 to 64)
52
(43 to 60)
68
(59 to 75)
B: Day 1: HI titers ≥1:629
0
(0 to 2)
0
(0 to 2)
0
(0 to 3)
0
(0 to 3)
B: Day 50: HI titers ≥1:629
4
(2 to 9)
3
(1 to 8)
3
(1 to 7)
7
(3 to 12)
9.Secondary Outcome
Title Percentages of Subjects (6 to <48 Months Old) Achieving MN Titer ≥1:20 After Receiving Two Doses of Either TIVc or TIVe Vaccine
Hide Description

Immunogenicity was assessed in terms of number (%) of subjects (6 to <48 months old) achieving MN titer ≥1:20 as measured by MN assay, day 50 after vaccination with two doses of either TIVc or TIVe vaccine

Post-vaccination MN titer ≥1:20 was defined as for subjects with baseline (day 1) MN titer <1:10, or a minimum 2-fold increase in titer on day 50 for subjects with baseline titer ≥1:10 and corresponding 95% CI

Time Frame Day 1 and Day 50 post vaccination
Hide Outcome Measure Data
Hide Analysis Population Description
Analysis was done on PPS
Arm/Group Title TIVc-High Dose TIVc-Full Dose TIVc- Half Dose TIVe
Hide Arm/Group Description:
Subjects (6 to <48 months old) received two doses of 0.75 mL of TIVc vaccine
Subjects(6 to <48 months old) received two doses of 0.50 mL of TIVc vaccine
Subjects (6 to <48 months old)received two doses of 0.25 mL of TIVc vaccine
Subjects (6 to <48 months old) received two doses of TIVe vaccine
Overall Number of Participants Analyzed 156 148 141 147
Measure Type: Number
Number (95% Confidence Interval)
Unit of Measure: Percentage of subjects
A/H1N1
94
(89 to 97)
93
(88 to 97)
91
(86 to 96)
97
(93 to 99)
A/H3N2
95
(90 to 98)
94
(89 to 97)
94
(89 to 98)
94
(89 to 97)
B
92
(86 to 95)
92
(86 to 96)
93
(87 to 97)
97
(93 to 99)
10.Secondary Outcome
Title Percentages of Subjects (6 to <48 Months Old) Achieving MN Titer ≥1:40 After Receiving Two Doses of Either TIVc or TIVe Vaccine
Hide Description

Immunogenicity was assessed in terms of number (%) of subjects (6 to <48 months old) achieving MN titer ≥1:40 as measured by MN assay, day 50 after vaccination with two doses of either TIVc or TIVe vaccine

Post-vaccination MN titer ≥1:40 was defined as for subjects with baseline (day 1) MN titer <1:10, or a minimum 4-fold increase in titer on day 50 for subjects with baseline titer ≥1:10 and corresponding 95% CI

Time Frame Day 1 and Day 50 post vaccination
Hide Outcome Measure Data
Hide Analysis Population Description
Analysis was done on PPS
Arm/Group Title TIVc-High Dose TIVc-Full Dose TIVc- Half Dose TIVe
Hide Arm/Group Description:
Subjects (6 to <48 months old) received two doses of 0.75 mL of TIVc vaccine
Subjects(6 to <48 months old) received two doses of 0.50 mL of TIVc vaccine
Subjects (6 to <48 months old)received two doses of 0.25 mL of TIVc vaccine
Subjects (6 to <48 months old) received two doses of TIVe vaccine
Overall Number of Participants Analyzed 156 148 141 147
Measure Type: Number
Number (95% Confidence Interval)
Unit of Measure: Percentages of subjects
A/H1N1
87
(80 to 91)
89
(82 to 93)
84
(77 to 90)
95
(90 to 98)
A/H3N2
85
(79 to 90)
85
(78 to 90)
82
(74 to 88)
80
(73 to 86)
B
83
(76 to 88)
87
(81 to 92)
83
(76 to 89)
96
(91 to 98)
11.Secondary Outcome
Title Number of Subjects (6 to <48 Months Old) Reporting Solicited Local (Grading Type I) and Systemic Adverse Events (AEs) After Two Doses of Either TIVc or TIVe Vaccine
Hide Description Safety was assessed in terms of number of subjects (6 to <48 months old) reporting solicited local and systemic reactions, day 1 to day 7 after vaccination with two doses of either TIVc or TIVe vaccine (By Any Vaccination)
Time Frame Day 1 to Day 7
Hide Outcome Measure Data
Hide Analysis Population Description
Analyses was done on solicited safety data set. 4 subjects (3 subjects from the TIVe group, and 1 subject from the full dose TIVc group, were excluded from the solicited safety set analyses (6h -day3, day4-day7 and 6h - day 7) as these subjects did not provide any post vaccination solicited safety data
Arm/Group Title TIVc-High Dose TIVc-Full Dose TIVc- Half Dose TIVe
Hide Arm/Group Description:
Subjects (6 to <48 months old) received two doses of 0.75 mL of TIVc vaccine
Subjects(6 to <48 months old) received two doses of 0.50 mL of TIVc vaccine
Subjects (6 to <48 months old)received two doses of 0.25 mL of TIVc vaccine
Subjects (6 to <48 months old) received two doses of TIVe vaccine
Overall Number of Participants Analyzed 174 165 167 161
Measure Type: Number
Unit of Measure: Subjects
Any local AEs 64 56 60 54
Injection site tenderness 50 43 42 45
Injection site erythema 19 24 24 17
Injection site induration 13 14 9 8
Injection site ecchymosis 9 9 7 7
Any Systemic 78 72 69 66
Chills 7 5 7 9
Change in eating habits 29 35 28 29
Sleepiness 30 28 21 24
Irritability 30 31 29 27
Vomiting 21 20 22 14
Diarrhea 31 31 29 34
Fever (≥ 38°C ) 15 20 21 21
Prophylactic use of antipyretics/analgesics 9 21 25 13
Therapeutic use of antipyretics/analgesics 17 21 24 22
12.Secondary Outcome
Title Number of Subjects (6 to <48 Months Old) Reporting Unsolicited Adverse Events (AEs) After Two Doses of Either TIVc or TIVe Vaccine
Hide Description Safety was assessed in terms of number of subjects (6 to <48 months old) reporting unsolicited reactions after Each /any Vaccination from Day 1 [Post Vaccination] to Day 29 [Pre Clinic Visit] and Day 29 [Post Vaccination] to Day 50 [Pre Clinic Visit] , Serious Adverse Events (SAEs), AEs leading to New Onset of Chronic Diseases (NOCD), AEs leading to withdrawal from the study and concomitant medications (day 1 to day 209) after vaccination with two doses of either TIVc or TIVe vaccine (By Any Vaccination)
Time Frame Unsolicited AEs after Each/any Vaccination from Day 1 to Day 29 and Day 29 to Day 50 , Day 1 to Day 209
Hide Outcome Measure Data
Hide Analysis Population Description
Analyses was done on unsolicited safety data set i.e. all subjects in the exposed set who have post-vaccination unsolicited AE data
Arm/Group Title TIVc-High Dose TIVc-Full Dose TIVc- Half Dose TIVe
Hide Arm/Group Description:
Subjects (6 to <48 months old) received two doses of 0.75 mL of TIVc vaccine
Subjects(6 to <48 months old) received two doses of 0.50 mL of TIVc vaccine
Subjects (6 to <48 months old)received two doses of 0.25 mL of TIVc vaccine
Subjects (6 to <48 months old) received two doses of TIVe vaccine
Overall Number of Participants Analyzed 174 166 167 164
Measure Type: Number
Unit of Measure: Subjects
Any AEs(after any vaccination) 102 107 91 94
Possibly/probably related AEs (after any vaccin.) 38 43 43 35
Any AEs(after vaccination 1) 79 84 69 76
Any AEs(after vaccination 2) 56 64 50 48
Possibly/probably related AEs (after vaccination 1 30 33 31 31
Possibly/probably related AEs (after vaccination 2 11 20 18 14
Any SAE 4 8 10 6
Any possibly/probably related SAE 0 0 0 0
Any AE leading to premature withdrawal from study 0 0 0 0
New onset of chronic disease 0 1 1 1
Death 0 0 0 0
Time Frame Throughout the study period, up to day 209 post vaccination.
Adverse Event Reporting Description

Solicited AEs were collected from day 1 to day 7 post vaccination, unsolicited AEs were collected from day 1 to day 50 post vaccination and SAEs -collected from day 1 to day 209 post vaccination.

A systematic adverse event is equivalent to an event that was solicited by the diary card, whereas a non-systematic event is an unsolicited adverse event

 
Arm/Group Title TIVc-High Dose TIVc-Full Dose TIVc- Half Dose TIVe Total
Hide Arm/Group Description Subjects (6 to <48 months old) received two doses of 0.75 mL of TIVc vaccine Subjects(6 to <48 months old) received two doses of 0.50 mL of TIVc vaccine Subjects (6 to <48 months old)received two doses of 0.25 mL of TIVc vaccine Subjects (6 to <48 months old) received two doses of TIVe vaccine Total number of subjects
All-Cause Mortality
TIVc-High Dose TIVc-Full Dose TIVc- Half Dose TIVe Total
Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%)
Total   --/--   --/--   --/--   --/--   --/-- 
Hide Serious Adverse Events
TIVc-High Dose TIVc-Full Dose TIVc- Half Dose TIVe Total
Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%)
Total   4/174 (2.30%)   8/166 (4.82%)   10/167 (5.99%)   6/164 (3.66%)   28/671 (4.17%) 
Gastrointestinal disorders           
GASTRITIS * 1  1/174 (0.57%)  0/166 (0.00%)  0/167 (0.00%)  0/164 (0.00%)  1/671 (0.15%) 
INGUINAL HERNIA * 1  0/174 (0.00%)  0/166 (0.00%)  1/167 (0.60%)  0/164 (0.00%)  1/671 (0.15%) 
General disorders           
PYREXIA * 1  0/174 (0.00%)  0/166 (0.00%)  1/167 (0.60%)  0/164 (0.00%)  1/671 (0.15%) 
Infections and infestations           
BRONCHITIS * 1  0/174 (0.00%)  2/166 (1.20%)  0/167 (0.00%)  1/164 (0.61%)  3/671 (0.45%) 
PHARYNGITIS * 1  0/174 (0.00%)  0/166 (0.00%)  1/167 (0.60%)  0/164 (0.00%)  1/671 (0.15%) 
PNEUMONIA * 1  0/174 (0.00%)  2/166 (1.20%)  2/167 (1.20%)  0/164 (0.00%)  4/671 (0.60%) 
VARICELLA * 1  0/174 (0.00%)  0/166 (0.00%)  0/167 (0.00%)  1/164 (0.61%)  1/671 (0.15%) 
ABSCESS * 1  0/174 (0.00%)  0/166 (0.00%)  1/167 (0.60%)  0/164 (0.00%)  1/671 (0.15%) 
AMOEBIASIS * 1  0/174 (0.00%)  0/166 (0.00%)  1/167 (0.60%)  1/164 (0.61%)  2/671 (0.30%) 
GASTROENTERITIS * 1  2/174 (1.15%)  0/166 (0.00%)  1/167 (0.60%)  1/164 (0.61%)  4/671 (0.60%) 
HAND-FOOT-AND-MOUTH DISEASE * 1  0/174 (0.00%)  0/166 (0.00%)  0/167 (0.00%)  1/164 (0.61%)  1/671 (0.15%) 
PERIORBITAL CELLULITIS * 1  0/174 (0.00%)  1/166 (0.60%)  0/167 (0.00%)  0/164 (0.00%)  1/671 (0.15%) 
PHARYNGOTONSILLITIS * 1  0/174 (0.00%)  0/166 (0.00%)  1/167 (0.60%)  0/164 (0.00%)  1/671 (0.15%) 
PSEUDOMONAL SEPSIS * 1  0/174 (0.00%)  0/166 (0.00%)  0/167 (0.00%)  1/164 (0.61%)  1/671 (0.15%) 
SUBCUTANEOUS ABSCESS * 1  0/174 (0.00%)  1/166 (0.60%)  0/167 (0.00%)  0/164 (0.00%)  1/671 (0.15%) 
UPPER RESPIRATORY TRACT INFECTION * 1  0/174 (0.00%)  0/166 (0.00%)  1/167 (0.60%)  0/164 (0.00%)  1/671 (0.15%) 
VIRAL INFECTION * 1  0/174 (0.00%)  0/166 (0.00%)  0/167 (0.00%)  1/164 (0.61%)  1/671 (0.15%) 
Injury, poisoning and procedural complications           
ANIMAL BITE * 1  1/174 (0.57%)  2/166 (1.20%)  1/167 (0.60%)  1/164 (0.61%)  5/671 (0.75%) 
Nervous system disorders           
FEBRILE CONVULSION * 1  1/174 (0.57%)  2/166 (1.20%)  1/167 (0.60%)  3/164 (1.83%)  7/671 (1.04%) 
Respiratory, thoracic and mediastinal disorders           
ASTHMA * 1  0/174 (0.00%)  2/166 (1.20%)  1/167 (0.60%)  0/164 (0.00%)  3/671 (0.45%) 
Skin and subcutaneous tissue disorders           
URTICARIA * 1  1/174 (0.57%)  0/166 (0.00%)  0/167 (0.00%)  0/164 (0.00%)  1/671 (0.15%) 
*
Indicates events were collected by non-systematic assessment
1
Term from vocabulary, MedDRA (18.0)
Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 5%
TIVc-High Dose TIVc-Full Dose TIVc- Half Dose TIVe Total
Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%)
Total   142/174 (81.61%)   133/166 (80.12%)   141/167 (84.43%)   127/164 (77.44%)   543/671 (80.92%) 
Gastrointestinal disorders           
DIARRHOEA  1  32/174 (18.39%)  32/166 (19.28%)  30/167 (17.96%)  36/164 (21.95%)  130/671 (19.37%) 
VOMITING  1  21/174 (12.07%)  20/166 (12.05%)  22/167 (13.17%)  14/164 (8.54%)  77/671 (11.48%) 
General disorders           
INFLUENZA LIKE ILLNESS * 1  20/174 (11.49%)  38/166 (22.89%)  35/167 (20.96%)  37/164 (22.56%)  130/671 (19.37%) 
INJECTION SITE ERYTHEMA  1  30/174 (17.24%)  36/166 (21.69%)  32/167 (19.16%)  29/164 (17.68%)  127/671 (18.93%) 
INJECTION SITE HAEMORRHAGE * 1  9/174 (5.17%)  10/166 (6.02%)  8/167 (4.79%)  7/164 (4.27%)  34/671 (5.07%) 
INJECTION SITE INDURATION  1  13/174 (7.47%)  16/166 (9.64%)  12/167 (7.19%)  10/164 (6.10%)  51/671 (7.60%) 
INJECTION SITE PAIN * 1  56/174 (32.18%)  48/166 (28.92%)  47/167 (28.14%)  47/164 (28.66%)  198/671 (29.51%) 
PYREXIA * 1  22/174 (12.64%)  28/166 (16.87%)  32/167 (19.16%)  22/164 (13.41%)  104/671 (15.50%) 
CHILLS  1  7/174 (4.02%)  5/166 (3.01%)  7/167 (4.19%)  9/164 (5.49%)  28/671 (4.17%) 
Infections and infestations           
NASOPHARYNGITIS * 1  19/174 (10.92%)  17/166 (10.24%)  22/167 (13.17%)  25/164 (15.24%)  83/671 (12.37%) 
RHINITIS * 1  22/174 (12.64%)  30/166 (18.07%)  19/167 (11.38%)  26/164 (15.85%)  97/671 (14.46%) 
UPPER RESPIRATORY TRACT INFECTION * 1  48/174 (27.59%)  44/166 (26.51%)  53/167 (31.74%)  41/164 (25.00%)  186/671 (27.72%) 
BRONCHITIS * 1  6/174 (3.45%)  11/166 (6.63%)  12/167 (7.19%)  12/164 (7.32%)  41/671 (6.11%) 
Gastroenteritis * 1  17/174 (9.77%)  17/166 (10.24%)  15/167 (8.98%)  15/164 (9.15%)  64/671 (9.54%) 
Impetigo * 1  6/174 (3.45%)  8/166 (4.82%)  10/167 (5.99%)  6/164 (3.66%)  30/671 (4.47%) 
Nervous system disorders           
SOMNOLENCE  1  30/174 (17.24%)  28/166 (16.87%)  21/167 (12.57%)  24/164 (14.63%)  103/671 (15.35%) 
Psychiatric disorders           
EATING DISORDER  1  29/174 (16.67%)  35/166 (21.08%)  28/167 (16.77%)  29/164 (17.68%)  121/671 (18.03%) 
IRRITABILITY  1  34/174 (19.54%)  37/166 (22.29%)  34/167 (20.36%)  29/164 (17.68%)  134/671 (19.97%) 
Indicates events were collected by systematic assessment
*
Indicates events were collected by non-systematic assessment
1
Term from vocabulary, MedDRA (18.0)
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
Layout table for Results Point of Contact information
Name/Title: Clinical Trial Disclosure Manager
Organization: Seqirus
EMail: Seqirus.ClinicalTrials@Seqirus.com
Layout table for additonal information
Responsible Party: Seqirus
ClinicalTrials.gov Identifier: NCT02035696    
Other Study ID Numbers: V58P16
2013-002081-39 ( EudraCT Number )
First Submitted: January 7, 2014
First Posted: January 14, 2014
Results First Submitted: August 19, 2015
Results First Posted: June 27, 2017
Last Update Posted: July 10, 2018