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A Study to Evaluate the Reactogenicity, Safety and Immunogenicity of GlaxoSmithKline (GSK) Biologicals' Investigational Supra-seasonal Universal Influenza Vaccines - Inactivated (SUIVs) (GSK3816302A) in Healthy Adults Aged 18 to 39 Years

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ClinicalTrials.gov Identifier: NCT03275389
Recruitment Status : Completed
First Posted : September 7, 2017
Results First Posted : May 7, 2021
Last Update Posted : May 7, 2021
Sponsor:
Information provided by (Responsible Party):
GlaxoSmithKline

Study Type Interventional
Study Design Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: Triple (Participant, Investigator, Outcomes Assessor);   Primary Purpose: Prevention
Condition Influenza, Human
Interventions Biological: D-SUIV cH8/1N1+AS03
Biological: D-SUIV cH5/1N1+AS03
Biological: D-SUIV cH11/1N1+AS03
Biological: D-SUIV cH8/1N1+AS01
Biological: D-SUIV cH5/1N1+AS01
Biological: D-SUIV cH11/1N1+AS01
Biological: D-SUIV cH8/1N1
Biological: D-SUIV cH5/1N1
Biological: D-SUIV cH11/1N1
Biological: Placebo
Biological: Fluarix Quadrivalent
Enrollment 470
Recruitment Details  
Pre-assignment Details 470 subjects were enrolled and randomized in the study, however, while 2 subjects were allocated subjects numbers, they did not receive any vaccine dose.
Arm/Group Title D-SUIV Adjuvanted Group 1 D-SUIV Adjuvanted Group 2 D-SUIV Adjuvanted Group 3 D-SUIV Adjuvanted Group 4 D-SUIV Adjuvanted Group 5 D-SUIV Adjuvanted Group 6 D-SUIV Unadjuvanted Group 1 D-SUIV Unadjuvanted Group 2 D-SUIV Unadjuvanted Group 3 IIV4 Group
Hide Arm/Group Description Subjects received one dose of D-SUIV cH8/1N1+AS03 vaccine at Day 1, one dose of Placebo at Day 57 and one booster dose of D-SUIV cH5/1N1+AS03 vaccine at Month 14. All doses were administered intramuscularly in the non-dominant arm. Subjects received one dose of D-SUIV cH5/1N1+AS03 vaccine at Day 1, one dose of Placebo at Day 57 and one booster dose of D-SUIV cH8/1N1+AS03 vaccine at Month 14. All doses were administered intramuscularly in the non-dominant arm. Subjects received one dose of D-SUIV cH8/1N1+AS03 vaccine at Day 1, one dose D-SUIV cH5/1N1+AS03 vaccine at Day 57 and one booster dose of D-SUIV cH11/1N1+AS03 vaccine at Month 14. All doses were administered intramuscularly in the non-dominant arm. Subjects received one dose of D-SUIV cH8/1N1+AS01 vaccine at Day 1, one dose of Placebo at Day 57 and one booster dose of D-SUIV cH5/1N1+AS01 vaccine at Month 14. All doses were administered intramuscularly in the non-dominant arm. Subjects received one dose of D-SUIV cH5/1N1+AS01 vaccine at Day 1, one dose of Placebo at Day 57 and one booster dose of D-SUIV cH8/1N1+AS01 vaccine at Month 14. All doses were administered intramuscularly in the non-dominant arm. Subjects received one dose of D-SUIV cH8/1N1+AS01 vaccine at Day 1, one dose of D-SUIV cH5/1N1+AS01 vaccine at Day 57 and one booster dose of D-SUIV cH11/1N1+AS01 vaccine at Month 14. All doses were administered intramuscularly in the non-dominant arm. Subjects received one dose of D-SUIV cH8/1N1 vaccine at Day 1, one dose of Placebo at Day 57 and one booster dose of D-SUIV cH5/1N1 vaccine at Month 14. All doses were administered intramuscularly in the non-dominant arm. Subjects received one dose of D-SUIV cH5/1N1 vaccine at Day 1, one dose of Placebo at Day 57 and one booster dose of D-SUIV cH8/1N1 vaccine at Month 14. All doses were administered intramuscularly in the non-dominant arm. Subjects received one dose of D-SUIV cH8/1N1 vaccine at Day 1, one dose of D-SUIV cH5/1N1 vaccine at Day 57 and one booster dose of D-SUIV cH11/1N1 vaccine at Month 14. All doses were administered intramuscularly in the non-dominant arm. Subjects received one dose of Fluarix Quadrivalent (IIV4) vaccine at Day 1, one dose of Placebo at Day 57 and one dose of Fluarix Quadrivalent vaccine at Month 14. All doses were administered intramuscularly in the non-dominant arm.
Period Title: Overall Study
Started 45 46 47 47 48 47 47 48 46 47
Completed 34 30 24 25 32 29 22 30 31 29
Not Completed 11 16 23 22 16 18 25 18 15 18
Reason Not Completed
Lost to Follow-up             10             10             19             12             11             12             21             15             12             14
SERIOUS ADVERSE EVENT AND/OR PIMD             0             0             0             0             0             1             0             0             0             1
CONSENT WITHDRAWAL NOT DUE TO ADV. EVENT             1             0             0             5             3             3             3             3             2             2
MIGRATED / MOVED FROM THE STUDY AREA             0             2             0             3             0             0             1             0             0             0
NOT WILLING TO PARTICIPATE THIS VISIT             0             0             1             0             0             0             0             0             0             1
Other             0             4             3             2             2             2             0             0             1             0
Arm/Group Title D-SUIV Adjuvanted Group 1 D-SUIV Adjuvanted Group 2 D-SUIV Adjuvanted Group 3 D-SUIV Adjuvanted Group 4 D-SUIV Adjuvanted Group 5 D-SUIV Adjuvanted Group 6 D-SUIV Unadjuvanted Group 1 D-SUIV Unadjuvanted Group 2 D-SUIV Unadjuvanted Group 3 IIV4 Group Total
Hide Arm/Group Description Subjects received one dose of D-SUIV cH8/1N1+AS03 vaccine at Day 1, one dose of Placebo at Day 57 and one booster dose of D-SUIV cH5/1N1+AS03 vaccine at Month 14. All doses were administered intramuscularly in the non-dominant arm. Subjects received one dose of D-SUIV cH5/1N1+AS03 vaccine at Day 1, one dose of Placebo at Day 57 and one booster dose of D-SUIV cH8/1N1+AS03 vaccine at Month 14. All doses were administered intramuscularly in the non-dominant arm. Subjects received one dose of D-SUIV cH8/1N1+AS03 vaccine at Day 1, one dose D-SUIV cH5/1N1+AS03 vaccine at Day 57 and one booster dose of D-SUIV cH11/1N1+AS03 vaccine at Month 14. All doses were administered intramuscularly in the non-dominant arm. Subjects received one dose of D-SUIV cH8/1N1+AS01 vaccine at Day 1, one dose of Placebo at Day 57 and one booster dose of D-SUIV cH5/1N1+AS01 vaccine at Month 14. All doses were administered intramuscularly in the non-dominant arm. Subjects received one dose of D-SUIV cH5/1N1+AS01 vaccine at Day 1, one dose of Placebo at Day 57 and one booster dose of D-SUIV cH8/1N1+AS01 vaccine at Month 14. All doses were administered intramuscularly in the non-dominant arm. Subjects received one dose of D-SUIV cH8/1N1+AS01 vaccine at Day 1, one dose of D-SUIV cH5/1N1+AS01 vaccine at Day 57 and one booster dose of D-SUIV cH11/1N1+AS01 vaccine at Month 14. All doses were administered intramuscularly in the non-dominant arm. Subjects received one dose of D-SUIV cH8/1N1 vaccine at Day 1, one dose of Placebo at Day 57 and one booster dose of D-SUIV cH5/1N1 vaccine at Month 14. All doses were administered intramuscularly in the non-dominant arm. Subjects received one dose of D-SUIV cH5/1N1 vaccine at Day 1, one dose of Placebo at Day 57 and one booster dose of D-SUIV cH8/1N1 vaccine at Month 14. All doses were administered intramuscularly in the non-dominant arm. Subjects received one dose of D-SUIV cH8/1N1 vaccine at Day 1, one dose of D-SUIV cH5/1N1 vaccine at Day 57 and one booster dose of D-SUIV cH11/1N1 vaccine at Month 14. All doses were administered intramuscularly in the non-dominant arm. Subjects received one dose of Fluarix Quadrivalent (IIV4) vaccine at Day 1, one dose of Placebo at Day 57 and one dose of Fluarix Quadrivalent vaccine at Month 14. All doses were administered intramuscularly in the non-dominant arm. Total of all reporting groups
Overall Number of Baseline Participants 45 46 47 47 48 47 47 48 46 47 468
Hide Baseline Analysis Population Description
[Not Specified]
Age, Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 45 participants 46 participants 47 participants 47 participants 48 participants 47 participants 47 participants 48 participants 46 participants 47 participants 468 participants
29.0  (6.6) 29.3  (5.7) 28.6  (6.0) 28.7  (6.4) 29.1  (6.2) 28.8  (6.1) 29.6  (5.8) 28.5  (5.9) 28.8  (5.9) 29.3  (5.8) 29.0  (6.0)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 45 participants 46 participants 47 participants 47 participants 48 participants 47 participants 47 participants 48 participants 46 participants 47 participants 468 participants
Female
26
  57.8%
27
  58.7%
28
  59.6%
28
  59.6%
27
  56.3%
27
  57.4%
27
  57.4%
26
  54.2%
25
  54.3%
27
  57.4%
268
  57.3%
Male
19
  42.2%
19
  41.3%
19
  40.4%
19
  40.4%
21
  43.8%
20
  42.6%
20
  42.6%
22
  45.8%
21
  45.7%
20
  42.6%
200
  42.7%
Race/Ethnicity, Customized  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 45 participants 46 participants 47 participants 47 participants 48 participants 47 participants 47 participants 48 participants 46 participants 47 participants 468 participants
American indian or alaska native
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
1
   2.1%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
1
   0.2%
Asian - central / south asian heritage
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
1
   2.2%
0
   0.0%
1
   0.2%
Asian - east asian heritage
0
   0.0%
1
   2.2%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
1
   0.2%
Asian - south east asian heritage
0
   0.0%
1
   2.2%
0
   0.0%
1
   2.1%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
2
   0.4%
Black or african american
11
  24.4%
9
  19.6%
10
  21.3%
8
  17.0%
5
  10.4%
7
  14.9%
10
  21.3%
13
  27.1%
6
  13.0%
9
  19.1%
88
  18.8%
Native hawaiian or other pacific islander
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
1
   2.1%
0
   0.0%
0
   0.0%
0
   0.0%
1
   0.2%
Other, Not specified
0
   0.0%
0
   0.0%
0
   0.0%
2
   4.3%
2
   4.2%
1
   2.1%
1
   2.1%
1
   2.1%
2
   4.3%
1
   2.1%
10
   2.1%
White - arabic / north african heritage
0
   0.0%
1
   2.2%
0
   0.0%
0
   0.0%
0
   0.0%
1
   2.1%
0
   0.0%
1
   2.1%
0
   0.0%
2
   4.3%
5
   1.1%
White - caucasian / european heritage
34
  75.6%
34
  73.9%
37
  78.7%
36
  76.6%
40
  83.3%
38
  80.9%
35
  74.5%
33
  68.8%
37
  80.4%
35
  74.5%
359
  76.7%
1.Primary Outcome
Title Number of Subjects With Solicited Local Adverse Events (AEs) After First Dose Administration
Hide Description Assessed solicited local symptoms are pain, erythema and swelling. Any = occurrence of the symptom regardless of intensity grade. Any erythema/swelling = erythema/swelling spreading beyond 20 millimeters (mm) of injection site.
Time Frame During the 7-day (Days 1-7) follow-up period after first vaccine dose
Hide Outcome Measure Data
Hide Analysis Population Description
Analysis was performed on the Exposed Set (ES) which included all subjects with the vaccine dose documented.
Arm/Group Title D-SUIV Adjuvanted Group 1 D-SUIV Adjuvanted Group 2 D-SUIV Adjuvanted Group 3 D-SUIV Adjuvanted Group 4 D-SUIV Adjuvanted Group 5 D-SUIV Adjuvanted Group 6 D-SUIV Unadjuvanted Group 1 D-SUIV Unadjuvanted Group 2 D-SUIV Unadjuvanted Group 3 IIV4 Group
Hide Arm/Group Description:
Subjects received one dose of D-SUIV cH8/1N1+AS03 vaccine at Day 1, one dose of Placebo at Day 57 and one booster dose of D-SUIV cH5/1N1+AS03 vaccine at Month 14. All doses were administered intramuscularly in the non-dominant arm.
Subjects received one dose of D-SUIV cH5/1N1+AS03 vaccine at Day 1, one dose of Placebo at Day 57 and one booster dose of D-SUIV cH8/1N1+AS03 vaccine at Month 14. All doses were administered intramuscularly in the non-dominant arm.
Subjects received one dose of D-SUIV cH8/1N1+AS03 vaccine at Day 1, one dose D-SUIV cH5/1N1+AS03 vaccine at Day 57 and one booster dose of D-SUIV cH11/1N1+AS03 vaccine at Month 14. All doses were administered intramuscularly in the non-dominant arm.
Subjects received one dose of D-SUIV cH8/1N1+AS01 vaccine at Day 1, one dose of Placebo at Day 57 and one booster dose of D-SUIV cH5/1N1+AS01 vaccine at Month 14. All doses were administered intramuscularly in the non-dominant arm.
Subjects received one dose of D-SUIV cH5/1N1+AS01 vaccine at Day 1, one dose of Placebo at Day 57 and one booster dose of D-SUIV cH8/1N1+AS01 vaccine at Month 14. All doses were administered intramuscularly in the non-dominant arm.
Subjects received one dose of D-SUIV cH8/1N1+AS01 vaccine at Day 1, one dose of D-SUIV cH5/1N1+AS01 vaccine at Day 57 and one booster dose of D-SUIV cH11/1N1+AS01 vaccine at Month 14. All doses were administered intramuscularly in the non-dominant arm.
Subjects received one dose of D-SUIV cH8/1N1 vaccine at Day 1, one dose of Placebo at Day 57 and one booster dose of D-SUIV cH5/1N1 vaccine at Month 14. All doses were administered intramuscularly in the non-dominant arm.
Subjects received one dose of D-SUIV cH5/1N1 vaccine at Day 1, one dose of Placebo at Day 57 and one booster dose of D-SUIV cH8/1N1 vaccine at Month 14. All doses were administered intramuscularly in the non-dominant arm.
Subjects received one dose of D-SUIV cH8/1N1 vaccine at Day 1, one dose of D-SUIV cH5/1N1 vaccine at Day 57 and one booster dose of D-SUIV cH11/1N1 vaccine at Month 14. All doses were administered intramuscularly in the non-dominant arm.
Subjects received one dose of Fluarix Quadrivalent (IIV4) vaccine at Day 1, one dose of Placebo at Day 57 and one dose of Fluarix Quadrivalent vaccine at Month 14. All doses were administered intramuscularly in the non-dominant arm.
Overall Number of Participants Analyzed 44 46 45 46 46 46 45 47 46 45
Measure Type: Count of Participants
Unit of Measure: Participants
Erythema
1
   2.3%
3
   6.5%
2
   4.4%
2
   4.3%
1
   2.2%
3
   6.5%
1
   2.2%
0
   0.0%
1
   2.2%
0
   0.0%
Pain
34
  77.3%
42
  91.3%
37
  82.2%
39
  84.8%
40
  87.0%
42
  91.3%
16
  35.6%
13
  27.7%
15
  32.6%
35
  77.8%
Swelling
4
   9.1%
2
   4.3%
2
   4.4%
4
   8.7%
3
   6.5%
2
   4.3%
0
   0.0%
0
   0.0%
1
   2.2%
0
   0.0%
2.Primary Outcome
Title Number of Subjects With Solicited Local AEs After Second Dose Administration
Hide Description Assessed solicited local symptoms are pain, erythema and swelling. Any = occurrence of the symptom regardless of intensity grade. Any erythema/swelling = erythema/swelling spreading beyond 20 millimeters (mm) of injection site.
Time Frame During the 7-day (Days 1-7) follow-up period after second vaccine dose
Hide Outcome Measure Data
Hide Analysis Population Description
Analysis was performed on the ES which included all subjects with the vaccine dose documented.
Arm/Group Title D-SUIV Adjuvanted Group 1 D-SUIV Adjuvanted Group 2 D-SUIV Adjuvanted Group 3 D-SUIV Adjuvanted Group 4 D-SUIV Adjuvanted Group 5 D-SUIV Adjuvanted Group 6 D-SUIV Unadjuvanted Group 1 D-SUIV Unadjuvanted Group 2 D-SUIV Unadjuvanted Group 3 IIV4 Group
Hide Arm/Group Description:
Subjects received one dose of D-SUIV cH8/1N1+AS03 vaccine at Day 1, one dose of Placebo at Day 57 and one booster dose of D-SUIV cH5/1N1+AS03 vaccine at Month 14. All doses were administered intramuscularly in the non-dominant arm.
Subjects received one dose of D-SUIV cH5/1N1+AS03 vaccine at Day 1, one dose of Placebo at Day 57 and one booster dose of D-SUIV cH8/1N1+AS03 vaccine at Month 14. All doses were administered intramuscularly in the non-dominant arm.
Subjects received one dose of D-SUIV cH8/1N1+AS03 vaccine at Day 1, one dose D-SUIV cH5/1N1+AS03 vaccine at Day 57 and one booster dose of D-SUIV cH11/1N1+AS03 vaccine at Month 14. All doses were administered intramuscularly in the non-dominant arm.
Subjects received one dose of D-SUIV cH8/1N1+AS01 vaccine at Day 1, one dose of Placebo at Day 57 and one booster dose of D-SUIV cH5/1N1+AS01 vaccine at Month 14. All doses were administered intramuscularly in the non-dominant arm.
Subjects received one dose of D-SUIV cH5/1N1+AS01 vaccine at Day 1, one dose of Placebo at Day 57 and one booster dose of D-SUIV cH8/1N1+AS01 vaccine at Month 14. All doses were administered intramuscularly in the non-dominant arm.
Subjects received one dose of D-SUIV cH8/1N1+AS01 vaccine at Day 1, one dose of D-SUIV cH5/1N1+AS01 vaccine at Day 57 and one booster dose of D-SUIV cH11/1N1+AS01 vaccine at Month 14. All doses were administered intramuscularly in the non-dominant arm.
Subjects received one dose of D-SUIV cH8/1N1 vaccine at Day 1, one dose of Placebo at Day 57 and one booster dose of D-SUIV cH5/1N1 vaccine at Month 14. All doses were administered intramuscularly in the non-dominant arm.
Subjects received one dose of D-SUIV cH5/1N1 vaccine at Day 1, one dose of Placebo at Day 57 and one booster dose of D-SUIV cH8/1N1 vaccine at Month 14. All doses were administered intramuscularly in the non-dominant arm.
Subjects received one dose of D-SUIV cH8/1N1 vaccine at Day 1, one dose of D-SUIV cH5/1N1 vaccine at Day 57 and one booster dose of D-SUIV cH11/1N1 vaccine at Month 14. All doses were administered intramuscularly in the non-dominant arm.
Subjects received one dose of Fluarix Quadrivalent (IIV4) vaccine at Day 1, one dose of Placebo at Day 57 and one dose of Fluarix Quadrivalent vaccine at Month 14. All doses were administered intramuscularly in the non-dominant arm.
Overall Number of Participants Analyzed 40 37 36 41 41 37 38 39 40 39
Measure Type: Count of Participants
Unit of Measure: Participants
Erythema
0
   0.0%
0
   0.0%
1
   2.8%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
Pain
5
  12.5%
2
   5.4%
29
  80.6%
2
   4.9%
8
  19.5%
32
  86.5%
4
  10.5%
5
  12.8%
12
  30.0%
10
  25.6%
Swelling
0
   0.0%
0
   0.0%
4
  11.1%
0
   0.0%
0
   0.0%
2
   5.4%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
3.Primary Outcome
Title Number of Subjects With Solicited Local AEs After Booster Dose Administration
Hide Description Assessed solicited local symptoms are pain, erythema and swelling. Any = occurrence of the symptom regardless of intensity grade. Any erythema/swelling = erythema/swelling spreading beyond 20 mm of injection site.
Time Frame During the 7-day (Days 1-7) follow-up period after booster vaccine dose
Hide Outcome Measure Data
Hide Analysis Population Description
Analysis was performed on the ES which included all subjects with the vaccine dose documented.
Arm/Group Title D-SUIV Adjuvanted Group 1 D-SUIV Adjuvanted Group 2 D-SUIV Adjuvanted Group 3 D-SUIV Adjuvanted Group 4 D-SUIV Adjuvanted Group 5 D-SUIV Adjuvanted Group 6 D-SUIV Unadjuvanted Group 1 D-SUIV Unadjuvanted Group 2 D-SUIV Unadjuvanted Group 3 IIV4 Group
Hide Arm/Group Description:
Subjects received one dose of D-SUIV cH8/1N1+AS03 vaccine at Day 1, one dose of Placebo at Day 57 and one booster dose of D-SUIV cH5/1N1+AS03 vaccine at Month 14. All doses were administered intramuscularly in the non-dominant arm.
Subjects received one dose of D-SUIV cH5/1N1+AS03 vaccine at Day 1, one dose of Placebo at Day 57 and one booster dose of D-SUIV cH8/1N1+AS03 vaccine at Month 14. All doses were administered intramuscularly in the non-dominant arm.
Subjects received one dose of D-SUIV cH8/1N1+AS03 vaccine at Day 1, one dose D-SUIV cH5/1N1+AS03 vaccine at Day 57 and one booster dose of D-SUIV cH11/1N1+AS03 vaccine at Month 14. All doses were administered intramuscularly in the non-dominant arm.
Subjects received one dose of D-SUIV cH8/1N1+AS01 vaccine at Day 1, one dose of Placebo at Day 57 and one booster dose of D-SUIV cH5/1N1+AS01 vaccine at Month 14. All doses were administered intramuscularly in the non-dominant arm.
Subjects received one dose of D-SUIV cH5/1N1+AS01 vaccine at Day 1, one dose of Placebo at Day 57 and one booster dose of D-SUIV cH8/1N1+AS01 vaccine at Month 14. All doses were administered intramuscularly in the non-dominant arm.
Subjects received one dose of D-SUIV cH8/1N1+AS01 vaccine at Day 1, one dose of D-SUIV cH5/1N1+AS01 vaccine at Day 57 and one booster dose of D-SUIV cH11/1N1+AS01 vaccine at Month 14. All doses were administered intramuscularly in the non-dominant arm.
Subjects received one dose of D-SUIV cH8/1N1 vaccine at Day 1, one dose of Placebo at Day 57 and one booster dose of D-SUIV cH5/1N1 vaccine at Month 14. All doses were administered intramuscularly in the non-dominant arm.
Subjects received one dose of D-SUIV cH5/1N1 vaccine at Day 1, one dose of Placebo at Day 57 and one booster dose of D-SUIV cH8/1N1 vaccine at Month 14. All doses were administered intramuscularly in the non-dominant arm.
Subjects received one dose of D-SUIV cH8/1N1 vaccine at Day 1, one dose of D-SUIV cH5/1N1 vaccine at Day 57 and one booster dose of D-SUIV cH11/1N1 vaccine at Month 14. All doses were administered intramuscularly in the non-dominant arm.
Subjects received one dose of Fluarix Quadrivalent (IIV4) vaccine at Day 1, one dose of Placebo at Day 57 and one dose of Fluarix Quadrivalent vaccine at Month 14. All doses were administered intramuscularly in the non-dominant arm.
Overall Number of Participants Analyzed 33 32 27 30 31 30 24 32 33 31
Measure Type: Count of Participants
Unit of Measure: Participants
Erythema
1
   3.0%
1
   3.1%
0
   0.0%
0
   0.0%
1
   3.2%
1
   3.3%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
Pain
27
  81.8%
31
  96.9%
26
  96.3%
29
  96.7%
28
  90.3%
25
  83.3%
4
  16.7%
10
  31.3%
13
  39.4%
21
  67.7%
Swelling
2
   6.1%
2
   6.3%
0
   0.0%
1
   3.3%
1
   3.2%
1
   3.3%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
4.Primary Outcome
Title Number of Subjects With Solicited General AEs After First Dose Administration
Hide Description Assessed solicited general symptoms are arthralgia, fatigue, gastrointestinal symptoms, headache, myalgia, shivering and fever [defined as oral temperature equal to or above 38.0 degrees Celsius (°C)]. Any = occurrence of the symptom regardless of intensity grade
Time Frame During the 7-day (Days 1-7) follow-up period after first vaccine dose
Hide Outcome Measure Data
Hide Analysis Population Description
Analysis was performed on the ES which included all subjects with the vaccine dose documented.
Arm/Group Title D-SUIV Adjuvanted Group 1 D-SUIV Adjuvanted Group 2 D-SUIV Adjuvanted Group 3 D-SUIV Adjuvanted Group 4 D-SUIV Adjuvanted Group 5 D-SUIV Adjuvanted Group 6 D-SUIV Unadjuvanted Group 1 D-SUIV Unadjuvanted Group 2 D-SUIV Unadjuvanted Group 3 IIV4 Group
Hide Arm/Group Description:
Subjects received one dose of D-SUIV cH8/1N1+AS03 vaccine at Day 1, one dose of Placebo at Day 57 and one booster dose of D-SUIV cH5/1N1+AS03 vaccine at Month 14. All doses were administered intramuscularly in the non-dominant arm.
Subjects received one dose of D-SUIV cH5/1N1+AS03 vaccine at Day 1, one dose of Placebo at Day 57 and one booster dose of D-SUIV cH8/1N1+AS03 vaccine at Month 14. All doses were administered intramuscularly in the non-dominant arm.
Subjects received one dose of D-SUIV cH8/1N1+AS03 vaccine at Day 1, one dose D-SUIV cH5/1N1+AS03 vaccine at Day 57 and one booster dose of D-SUIV cH11/1N1+AS03 vaccine at Month 14. All doses were administered intramuscularly in the non-dominant arm.
Subjects received one dose of D-SUIV cH8/1N1+AS01 vaccine at Day 1, one dose of Placebo at Day 57 and one booster dose of D-SUIV cH5/1N1+AS01 vaccine at Month 14. All doses were administered intramuscularly in the non-dominant arm.
Subjects received one dose of D-SUIV cH5/1N1+AS01 vaccine at Day 1, one dose of Placebo at Day 57 and one booster dose of D-SUIV cH8/1N1+AS01 vaccine at Month 14. All doses were administered intramuscularly in the non-dominant arm.
Subjects received one dose of D-SUIV cH8/1N1+AS01 vaccine at Day 1, one dose of D-SUIV cH5/1N1+AS01 vaccine at Day 57 and one booster dose of D-SUIV cH11/1N1+AS01 vaccine at Month 14. All doses were administered intramuscularly in the non-dominant arm.
Subjects received one dose of D-SUIV cH8/1N1 vaccine at Day 1, one dose of Placebo at Day 57 and one booster dose of D-SUIV cH5/1N1 vaccine at Month 14. All doses were administered intramuscularly in the non-dominant arm.
Subjects received one dose of D-SUIV cH5/1N1 vaccine at Day 1, one dose of Placebo at Day 57 and one booster dose of D-SUIV cH8/1N1 vaccine at Month 14. All doses were administered intramuscularly in the non-dominant arm.
Subjects received one dose of D-SUIV cH8/1N1 vaccine at Day 1, one dose of D-SUIV cH5/1N1 vaccine at Day 57 and one booster dose of D-SUIV cH11/1N1 vaccine at Month 14. All doses were administered intramuscularly in the non-dominant arm.
Subjects received one dose of Fluarix Quadrivalent (IIV4) vaccine at Day 1, one dose of Placebo at Day 57 and one dose of Fluarix Quadrivalent vaccine at Month 14. All doses were administered intramuscularly in the non-dominant arm.
Overall Number of Participants Analyzed 44 46 45 46 46 46 45 47 46 46
Measure Type: Count of Participants
Unit of Measure: Participants
Arthralgia
4
   9.1%
6
  13.0%
9
  20.0%
2
   4.3%
3
   6.5%
8
  17.4%
6
  13.3%
5
  10.6%
2
   4.3%
5
  10.9%
Fatigue
17
  38.6%
18
  39.1%
22
  48.9%
18
  39.1%
21
  45.7%
18
  39.1%
17
  37.8%
19
  40.4%
12
  26.1%
12
  26.1%
Gastrointestinal symptoms
6
  13.6%
7
  15.2%
10
  22.2%
6
  13.0%
8
  17.4%
8
  17.4%
6
  13.3%
8
  17.0%
10
  21.7%
8
  17.4%
Headache
18
  40.9%
18
  39.1%
19
  42.2%
23
  50.0%
16
  34.8%
26
  56.5%
16
  35.6%
19
  40.4%
15
  32.6%
14
  30.4%
Myalgia
16
  36.4%
13
  28.3%
19
  42.2%
17
  37.0%
19
  41.3%
20
  43.5%
9
  20.0%
9
  19.1%
6
  13.0%
11
  23.9%
Shivering
6
  13.6%
3
   6.5%
10
  22.2%
10
  21.7%
8
  17.4%
9
  19.6%
2
   4.4%
2
   4.3%
2
   4.3%
3
   6.5%
Temperature
1
   2.3%
1
   2.2%
0
   0.0%
2
   4.3%
2
   4.3%
1
   2.2%
1
   2.2%
1
   2.1%
0
   0.0%
0
   0.0%
5.Primary Outcome
Title Number of Subjects With Solicited General AEs After Second Dose Administration
Hide Description Assessed solicited general symptoms are arthralgia, fatigue, gastrointestinal symptoms, headache, myalgia, shivering and fever [defined as oral temperature equal to or above 38.0 degrees Celsius (°C)]. Any = occurrence of the symptom regardless of intensity grade
Time Frame During the 7-day (Days 1-7) follow-up period after second vaccine dose
Hide Outcome Measure Data
Hide Analysis Population Description
Analysis was performed on the ES which included all subjects with the vaccine dose documented.
Arm/Group Title D-SUIV Adjuvanted Group 1 D-SUIV Adjuvanted Group 2 D-SUIV Adjuvanted Group 3 D-SUIV Adjuvanted Group 4 D-SUIV Adjuvanted Group 5 D-SUIV Adjuvanted Group 6 D-SUIV Unadjuvanted Group 1 D-SUIV Unadjuvanted Group 2 D-SUIV Unadjuvanted Group 3 IIV4 Group
Hide Arm/Group Description:
Subjects received one dose of D-SUIV cH8/1N1+AS03 vaccine at Day 1, one dose of Placebo at Day 57 and one booster dose of D-SUIV cH5/1N1+AS03 vaccine at Month 14. All doses were administered intramuscularly in the non-dominant arm.
Subjects received one dose of D-SUIV cH5/1N1+AS03 vaccine at Day 1, one dose of Placebo at Day 57 and one booster dose of D-SUIV cH8/1N1+AS03 vaccine at Month 14. All doses were administered intramuscularly in the non-dominant arm.
Subjects received one dose of D-SUIV cH8/1N1+AS03 vaccine at Day 1, one dose D-SUIV cH5/1N1+AS03 vaccine at Day 57 and one booster dose of D-SUIV cH11/1N1+AS03 vaccine at Month 14. All doses were administered intramuscularly in the non-dominant arm.
Subjects received one dose of D-SUIV cH8/1N1+AS01 vaccine at Day 1, one dose of Placebo at Day 57 and one booster dose of D-SUIV cH5/1N1+AS01 vaccine at Month 14. All doses were administered intramuscularly in the non-dominant arm.
Subjects received one dose of D-SUIV cH5/1N1+AS01 vaccine at Day 1, one dose of Placebo at Day 57 and one booster dose of D-SUIV cH8/1N1+AS01 vaccine at Month 14. All doses were administered intramuscularly in the non-dominant arm.
Subjects received one dose of D-SUIV cH8/1N1+AS01 vaccine at Day 1, one dose of D-SUIV cH5/1N1+AS01 vaccine at Day 57 and one booster dose of D-SUIV cH11/1N1+AS01 vaccine at Month 14. All doses were administered intramuscularly in the non-dominant arm.
Subjects received one dose of D-SUIV cH8/1N1 vaccine at Day 1, one dose of Placebo at Day 57 and one booster dose of D-SUIV cH5/1N1 vaccine at Month 14. All doses were administered intramuscularly in the non-dominant arm.
Subjects received one dose of D-SUIV cH5/1N1 vaccine at Day 1, one dose of Placebo at Day 57 and one booster dose of D-SUIV cH8/1N1 vaccine at Month 14. All doses were administered intramuscularly in the non-dominant arm.
Subjects received one dose of D-SUIV cH8/1N1 vaccine at Day 1, one dose of D-SUIV cH5/1N1 vaccine at Day 57 and one booster dose of D-SUIV cH11/1N1 vaccine at Month 14. All doses were administered intramuscularly in the non-dominant arm.
Subjects received one dose of Fluarix Quadrivalent (IIV4) vaccine at Day 1, one dose of Placebo at Day 57 and one dose of Fluarix Quadrivalent vaccine at Month 14. All doses were administered intramuscularly in the non-dominant arm.
Overall Number of Participants Analyzed 40 37 36 41 41 39 38 39 40 40
Measure Type: Count of Participants
Unit of Measure: Participants
Arthralgia
3
   7.5%
4
  10.8%
4
  11.1%
0
   0.0%
4
   9.8%
4
  10.3%
0
   0.0%
0
   0.0%
2
   5.0%
2
   5.0%
Fatigue
7
  17.5%
7
  18.9%
10
  27.8%
6
  14.6%
7
  17.1%
8
  20.5%
5
  13.2%
5
  12.8%
10
  25.0%
5
  12.5%
Gastrointestinal symptoms
3
   7.5%
4
  10.8%
4
  11.1%
3
   7.3%
3
   7.3%
6
  15.4%
1
   2.6%
4
  10.3%
2
   5.0%
2
   5.0%
Headache
8
  20.0%
12
  32.4%
13
  36.1%
7
  17.1%
9
  22.0%
12
  30.8%
5
  13.2%
12
  30.8%
8
  20.0%
7
  17.5%
Myalgia
5
  12.5%
6
  16.2%
12
  33.3%
1
   2.4%
4
   9.8%
16
  41.0%
3
   7.9%
2
   5.1%
6
  15.0%
3
   7.5%
Shivering
2
   5.0%
4
  10.8%
4
  11.1%
0
   0.0%
3
   7.3%
5
  12.8%
1
   2.6%
0
   0.0%
2
   5.0%
1
   2.5%
Temperature
1
   2.5%
2
   5.4%
0
   0.0%
0
   0.0%
1
   2.4%
2
   5.1%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
6.Primary Outcome
Title Number of Subjects With Solicited General AEs After Booster Dose Administration
Hide Description Assessed solicited general symptoms are arthralgia, fatigue, gastrointestinal symptoms, headache, myalgia, shivering and fever [defined as oral temperature equal to or above 38.0 degrees Celsius (°C)]. Any = occurrence of the symptom regardless of intensity grade.
Time Frame During the 7-day (Days 1-7) follow-up period after booster vaccine dose
Hide Outcome Measure Data
Hide Analysis Population Description
Analysis was performed on the ES which included all subjects with the vaccine dose documented.
Arm/Group Title D-SUIV Adjuvanted Group 1 D-SUIV Adjuvanted Group 2 D-SUIV Adjuvanted Group 3 D-SUIV Adjuvanted Group 4 D-SUIV Adjuvanted Group 5 D-SUIV Adjuvanted Group 6 D-SUIV Unadjuvanted Group 1 D-SUIV Unadjuvanted Group 2 D-SUIV Unadjuvanted Group 3 IIV4 Group
Hide Arm/Group Description:
Subjects received one dose of D-SUIV cH8/1N1+AS03 vaccine at Day 1, one dose of Placebo at Day 57 and one booster dose of D-SUIV cH5/1N1+AS03 vaccine at Month 14. All doses were administered intramuscularly in the non-dominant arm.
Subjects received one dose of D-SUIV cH5/1N1+AS03 vaccine at Day 1, one dose of Placebo at Day 57 and one booster dose of D-SUIV cH8/1N1+AS03 vaccine at Month 14. All doses were administered intramuscularly in the non-dominant arm.
Subjects received one dose of D-SUIV cH8/1N1+AS03 vaccine at Day 1, one dose D-SUIV cH5/1N1+AS03 vaccine at Day 57 and one booster dose of D-SUIV cH11/1N1+AS03 vaccine at Month 14. All doses were administered intramuscularly in the non-dominant arm.
Subjects received one dose of D-SUIV cH8/1N1+AS01 vaccine at Day 1, one dose of Placebo at Day 57 and one booster dose of D-SUIV cH5/1N1+AS01 vaccine at Month 14. All doses were administered intramuscularly in the non-dominant arm.
Subjects received one dose of D-SUIV cH5/1N1+AS01 vaccine at Day 1, one dose of Placebo at Day 57 and one booster dose of D-SUIV cH8/1N1+AS01 vaccine at Month 14. All doses were administered intramuscularly in the non-dominant arm.
Subjects received one dose of D-SUIV cH8/1N1+AS01 vaccine at Day 1, one dose of D-SUIV cH5/1N1+AS01 vaccine at Day 57 and one booster dose of D-SUIV cH11/1N1+AS01 vaccine at Month 14. All doses were administered intramuscularly in the non-dominant arm.
Subjects received one dose of D-SUIV cH8/1N1 vaccine at Day 1, one dose of Placebo at Day 57 and one booster dose of D-SUIV cH5/1N1 vaccine at Month 14. All doses were administered intramuscularly in the non-dominant arm.
Subjects received one dose of D-SUIV cH5/1N1 vaccine at Day 1, one dose of Placebo at Day 57 and one booster dose of D-SUIV cH8/1N1 vaccine at Month 14. All doses were administered intramuscularly in the non-dominant arm.
Subjects received one dose of D-SUIV cH8/1N1 vaccine at Day 1, one dose of D-SUIV cH5/1N1 vaccine at Day 57 and one booster dose of D-SUIV cH11/1N1 vaccine at Month 14. All doses were administered intramuscularly in the non-dominant arm.
Subjects received one dose of Fluarix Quadrivalent (IIV4) vaccine at Day 1, one dose of Placebo at Day 57 and one dose of Fluarix Quadrivalent vaccine at Month 14. All doses were administered intramuscularly in the non-dominant arm.
Overall Number of Participants Analyzed 33 32 27 30 31 30 24 32 33 31
Measure Type: Count of Participants
Unit of Measure: Participants
Arthralgia
6
  18.2%
8
  25.0%
4
  14.8%
4
  13.3%
9
  29.0%
4
  13.3%
1
   4.2%
1
   3.1%
2
   6.1%
1
   3.2%
Fatigue
15
  45.5%
19
  59.4%
17
  63.0%
16
  53.3%
20
  64.5%
9
  30.0%
2
   8.3%
6
  18.8%
6
  18.2%
3
   9.7%
Gastrointestinal symptoms
3
   9.1%
8
  25.0%
8
  29.6%
5
  16.7%
6
  19.4%
5
  16.7%
1
   4.2%
2
   6.3%
4
  12.1%
0
   0.0%
Headache
9
  27.3%
13
  40.6%
14
  51.9%
15
  50.0%
16
  51.6%
15
  50.0%
3
  12.5%
7
  21.9%
6
  18.2%
4
  12.9%
Myalgia
15
  45.5%
17
  53.1%
15
  55.6%
15
  50.0%
13
  41.9%
10
  33.3%
0
   0.0%
4
  12.5%
5
  15.2%
3
   9.7%
Shivering
5
  15.2%
13
  40.6%
6
  22.2%
6
  20.0%
14
  45.2%
9
  30.0%
0
   0.0%
1
   3.1%
2
   6.1%
1
   3.2%
Temperature
2
   6.1%
3
   9.4%
1
   3.7%
4
  13.3%
2
   6.5%
1
   3.3%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
7.Primary Outcome
Title Number of Subjects With Any Unsolicited AEs Post-vaccination Period
Hide Description An unsolicited AE covers any untoward medical occurrence in a clinical investigation subject temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product and reported in addition to those solicited during the clinical study and any solicited symptom with onset outside the specified period of follow-up for solicited symptoms. Any is defined as the occurrence of any unsolicited AE regardless of intensity grade or relation to vaccination
Time Frame During the 28-day (Days 1-28) follow-up period accross doses
Hide Outcome Measure Data
Hide Analysis Population Description
Analysis was performed on the ES which included all subjects with at least one vaccine administration documented.
Arm/Group Title D-SUIV Adjuvanted Group 1 D-SUIV Adjuvanted Group 2 D-SUIV Adjuvanted Group 3 D-SUIV Adjuvanted Group 4 D-SUIV Adjuvanted Group 5 D-SUIV Adjuvanted Group 6 D-SUIV Unadjuvanted Group 1 D-SUIV Unadjuvanted Group 2 D-SUIV Unadjuvanted Group 3 IIV4 Group
Hide Arm/Group Description:
Subjects received one dose of D-SUIV cH8/1N1+AS03 vaccine at Day 1, one dose of Placebo at Day 57 and one booster dose of D-SUIV cH5/1N1+AS03 vaccine at Month 14. All doses were administered intramuscularly in the non-dominant arm.
Subjects received one dose of D-SUIV cH5/1N1+AS03 vaccine at Day 1, one dose of Placebo at Day 57 and one booster dose of D-SUIV cH8/1N1+AS03 vaccine at Month 14. All doses were administered intramuscularly in the non-dominant arm.
Subjects received one dose of D-SUIV cH8/1N1+AS03 vaccine at Day 1, one dose D-SUIV cH5/1N1+AS03 vaccine at Day 57 and one booster dose of D-SUIV cH11/1N1+AS03 vaccine at Month 14. All doses were administered intramuscularly in the non-dominant arm.
Subjects received one dose of D-SUIV cH8/1N1+AS01 vaccine at Day 1, one dose of Placebo at Day 57 and one booster dose of D-SUIV cH5/1N1+AS01 vaccine at Month 14. All doses were administered intramuscularly in the non-dominant arm.
Subjects received one dose of D-SUIV cH5/1N1+AS01 vaccine at Day 1, one dose of Placebo at Day 57 and one booster dose of D-SUIV cH8/1N1+AS01 vaccine at Month 14. All doses were administered intramuscularly in the non-dominant arm.
Subjects received one dose of D-SUIV cH8/1N1+AS01 vaccine at Day 1, one dose of D-SUIV cH5/1N1+AS01 vaccine at Day 57 and one booster dose of D-SUIV cH11/1N1+AS01 vaccine at Month 14. All doses were administered intramuscularly in the non-dominant arm.
Subjects received one dose of D-SUIV cH8/1N1 vaccine at Day 1, one dose of Placebo at Day 57 and one booster dose of D-SUIV cH5/1N1 vaccine at Month 14. All doses were administered intramuscularly in the non-dominant arm.
Subjects received one dose of D-SUIV cH5/1N1 vaccine at Day 1, one dose of Placebo at Day 57 and one booster dose of D-SUIV cH8/1N1 vaccine at Month 14. All doses were administered intramuscularly in the non-dominant arm.
Subjects received one dose of D-SUIV cH8/1N1 vaccine at Day 1, one dose of D-SUIV cH5/1N1 vaccine at Day 57 and one booster dose of D-SUIV cH11/1N1 vaccine at Month 14. All doses were administered intramuscularly in the non-dominant arm.
Subjects received one dose of Fluarix Quadrivalent (IIV4) vaccine at Day 1, one dose of Placebo at Day 57 and one dose of Fluarix Quadrivalent vaccine at Month 14. All doses were administered intramuscularly in the non-dominant arm.
Overall Number of Participants Analyzed 45 46 47 47 48 47 47 48 46 47
Measure Type: Count of Participants
Unit of Measure: Participants
27
  60.0%
23
  50.0%
23
  48.9%
24
  51.1%
24
  50.0%
17
  36.2%
22
  46.8%
23
  47.9%
22
  47.8%
21
  44.7%
8.Primary Outcome
Title Number of Subjects With Change From Baseline in Hematological and Biochemical Laboratory Results at Day 8 by Toxicity Grading
Hide Description Hematological parameters assessed are: Eosinophils increase [EOSi], hemoglobin decrease [HEMd] , lymphocytes decrease [LYMd], Neutrophils decrease [NEUd], platelets decrease [PLTCd], white blood cells decrease [WBCd], WBC increase [WBCi]. Biochemical parameters assessed are: alanine aminotransferase increase [ALTi], aspartate aminotransferase increase [ASTi], blood urea nitrogen [BUN], creatinine [CRE].Toxicity grading is according to the Food and Drug Administration (FDA) guidance for industry: Toxicity grading scale for healthy adult and adolescent volunteers enrolled in preventive vaccine clinical Trials (September 2007). The grading scale is defined as follows: mild (Grade 1), moderate (Grade 2), severe (Grade 3) and potentially life threatening (Grade 4). Category naming has been defined as follows: Parameter- grading at Baseline- grading at Timing: e.g.: "ALT-Grade 0-Grade 1".
Time Frame At Day 8
Hide Outcome Measure Data
Hide Analysis Population Description
Analysis was performed on the ES which included all subjects with at least one vaccine administration documented.
Arm/Group Title D-SUIV Adjuvanted Group 1 D-SUIV Adjuvanted Group 2 D-SUIV Adjuvanted Group 3 D-SUIV Adjuvanted Group 4 D-SUIV Adjuvanted Group 5 D-SUIV Adjuvanted Group 6 D-SUIV Unadjuvanted Group 1 D-SUIV Unadjuvanted Group 2 D-SUIV Unadjuvanted Group 3 IIV4 Group
Hide Arm/Group Description:
Subjects received one dose of D-SUIV cH8/1N1+AS03 vaccine at Day 1, one dose of Placebo at Day 57 and one booster dose of D-SUIV cH5/1N1+AS03 vaccine at Month 14. All doses were administered intramuscularly in the non-dominant arm.
Subjects received one dose of D-SUIV cH5/1N1+AS03 vaccine at Day 1, one dose of Placebo at Day 57 and one booster dose of D-SUIV cH8/1N1+AS03 vaccine at Month 14. All doses were administered intramuscularly in the non-dominant arm.
Subjects received one dose of D-SUIV cH8/1N1+AS03 vaccine at Day 1, one dose D-SUIV cH5/1N1+AS03 vaccine at Day 57 and one booster dose of D-SUIV cH11/1N1+AS03 vaccine at Month 14. All doses were administered intramuscularly in the non-dominant arm.
Subjects received one dose of D-SUIV cH8/1N1+AS01 vaccine at Day 1, one dose of Placebo at Day 57 and one booster dose of D-SUIV cH5/1N1+AS01 vaccine at Month 14. All doses were administered intramuscularly in the non-dominant arm.
Subjects received one dose of D-SUIV cH5/1N1+AS01 vaccine at Day 1, one dose of Placebo at Day 57 and one booster dose of D-SUIV cH8/1N1+AS01 vaccine at Month 14. All doses were administered intramuscularly in the non-dominant arm.
Subjects received one dose of D-SUIV cH8/1N1+AS01 vaccine at Day 1, one dose of D-SUIV cH5/1N1+AS01 vaccine at Day 57 and one booster dose of D-SUIV cH11/1N1+AS01 vaccine at Month 14. All doses were administered intramuscularly in the non-dominant arm.
Subjects received one dose of D-SUIV cH8/1N1 vaccine at Day 1, one dose of Placebo at Day 57 and one booster dose of D-SUIV cH5/1N1 vaccine at Month 14. All doses were administered intramuscularly in the non-dominant arm.
Subjects received one dose of D-SUIV cH5/1N1 vaccine at Day 1, one dose of Placebo at Day 57 and one booster dose of D-SUIV cH8/1N1 vaccine at Month 14. All doses were administered intramuscularly in the non-dominant arm.
Subjects received one dose of D-SUIV cH8/1N1 vaccine at Day 1, one dose of D-SUIV cH5/1N1 vaccine at Day 57 and one booster dose of D-SUIV cH11/1N1 vaccine at Month 14. All doses were administered intramuscularly in the non-dominant arm.
Subjects received one dose of Fluarix Quadrivalent (IIV4) vaccine at Day 1, one dose of Placebo at Day 57 and one dose of Fluarix Quadrivalent vaccine at Month 14. All doses were administered intramuscularly in the non-dominant arm.
Overall Number of Participants Analyzed 44 46 45 46 46 46 44 47 45 46
Measure Type: Count of Participants
Unit of Measure: Participants
ALTi, UNKNOWN, GRADE 0 Number Analyzed 0 participants 0 participants 0 participants 0 participants 0 participants 0 participants 1 participants 0 participants 1 participants 0 participants
0 0 0 0 0 0
0
   0.0%
0
1
 100.0%
0
ALTi, UNKNOWN, GRADE 1 Number Analyzed 0 participants 0 participants 0 participants 0 participants 0 participants 0 participants 1 participants 0 participants 1 participants 0 participants
0 0 0 0 0 0
1
 100.0%
0
0
   0.0%
0
ALTi, GRADE 0, UNKNOWN Number Analyzed 40 participants 46 participants 43 participants 45 participants 45 participants 45 participants 44 participants 44 participants 43 participants 46 participants
0
   0.0%
0
   0.0%
0
   0.0%
3
   6.7%
0
   0.0%
0
   0.0%
1
   2.3%
0
   0.0%
0
   0.0%
1
   2.2%
ALTi, GRADE 0, GRADE 0 Number Analyzed 40 participants 46 participants 43 participants 45 participants 45 participants 45 participants 44 participants 44 participants 43 participants 46 participants
40
 100.0%
45
  97.8%
42
  97.7%
41
  91.1%
45
 100.0%
45
 100.0%
43
  97.7%
44
 100.0%
41
  95.3%
44
  95.7%
ALTi, GRADE 0, GRADE 1 Number Analyzed 40 participants 46 participants 43 participants 45 participants 45 participants 45 participants 44 participants 44 participants 43 participants 46 participants
0
   0.0%
1
   2.2%
1
   2.3%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
2
   4.7%
1
   2.2%
ALTi, GRADE 0, GRADE 3 Number Analyzed 40 participants 46 participants 43 participants 45 participants 45 participants 45 participants 44 participants 44 participants 43 participants 46 participants
0
   0.0%
0
   0.0%
0
   0.0%
1
   2.2%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
ALTi, GRADE 1, GRADE 0 Number Analyzed 4 participants 0 participants 2 participants 1 participants 1 participants 1 participants 0 participants 3 participants 2 participants 0 participants
3
  75.0%
0
1
  50.0%
1
 100.0%
1
 100.0%
0
   0.0%
0
2
  66.7%
2
 100.0%
0
ALTi, GRADE 1, GRADE 1 Number Analyzed 4 participants 0 participants 2 participants 1 participants 1 participants 1 participants 0 participants 3 participants 2 participants 0 participants
1
  25.0%
0
1
  50.0%
0
   0.0%
0
   0.0%
1
 100.0%
0
1
  33.3%
0
   0.0%
0
ASTi, UNKNOWN, GRADE 0 Number Analyzed 0 participants 0 participants 0 participants 0 participants 0 participants 0 participants 1 participants 0 participants 1 participants 0 participants
0 0 0 0 0 0
1
 100.0%
0
1
 100.0%
0
ASTi, GRADE 0, UNKNOWN Number Analyzed 44 participants 46 participants 45 participants 46 participants 46 participants 45 participants 43 participants 46 participants 45 participants 46 participants
0
   0.0%
0
   0.0%
0
   0.0%
3
   6.5%
0
   0.0%
0
   0.0%
1
   2.3%
0
   0.0%
0
   0.0%
1
   2.2%
ASTi, GRADE 0, GRADE 0 Number Analyzed 44 participants 46 participants 45 participants 46 participants 46 participants 45 participants 43 participants 46 participants 45 participants 46 participants
44
 100.0%
46
 100.0%
44
  97.8%
42
  91.3%
46
 100.0%
45
 100.0%
42
  97.7%
44
  95.7%
44
  97.8%
44
  95.7%
ASTi, GRADE 0, GRADE 1 Number Analyzed 44 participants 46 participants 45 participants 46 participants 46 participants 45 participants 43 participants 46 participants 45 participants 46 participants
0
   0.0%
0
   0.0%
1
   2.2%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
2
   4.3%
0
   0.0%
0
   0.0%
ASTi, GRADE 0, GRADE 2 Number Analyzed 44 participants 46 participants 45 participants 46 participants 46 participants 45 participants 43 participants 46 participants 45 participants 46 participants
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
1
   2.2%
1
   2.2%
ASTi, GRADE 0, GRADE 4 Number Analyzed 44 participants 46 participants 45 participants 46 participants 46 participants 45 participants 43 participants 46 participants 45 participants 46 participants
0
   0.0%
0
   0.0%
0
   0.0%
1
   2.2%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
ASTi, GRADE 1, GRADE 0 Number Analyzed 0 participants 0 participants 0 participants 0 participants 0 participants 1 participants 1 participants 0 participants 0 participants 0 participants
0 0 0 0 0
1
 100.0%
1
 100.0%
0 0 0
ASTi, GRADE 2, GRADE 0 Number Analyzed 0 participants 0 participants 0 participants 0 participants 0 participants 0 participants 0 participants 1 participants 0 participants 0 participants
0 0 0 0 0 0 0
1
 100.0%
0 0
BUN, UNKNOWN, GRADE 0 Number Analyzed 0 participants 0 participants 0 participants 0 participants 0 participants 0 participants 1 participants 0 participants 1 participants 0 participants
0 0 0 0 0 0
1
 100.0%
0
1
 100.0%
0
BUN, GRADE 0, UNKNOWN Number Analyzed 43 participants 46 participants 45 participants 46 participants 46 participants 46 participants 44 participants 47 participants 43 participants 46 participants
0
   0.0%
0
   0.0%
0
   0.0%
3
   6.5%
0
   0.0%
0
   0.0%
1
   2.3%
0
   0.0%
0
   0.0%
1
   2.2%
BUN, GRADE 0, GRADE 0 Number Analyzed 43 participants 46 participants 45 participants 46 participants 46 participants 46 participants 44 participants 47 participants 43 participants 46 participants
43
 100.0%
46
 100.0%
45
 100.0%
43
  93.5%
46
 100.0%
46
 100.0%
43
  97.7%
47
 100.0%
43
 100.0%
45
  97.8%
BUN, GRADE 1, GRADE 0 Number Analyzed 1 participants 0 participants 0 participants 0 participants 0 participants 0 participants 0 participants 0 participants 1 participants 0 participants
1
 100.0%
0 0 0 0 0 0 0
1
 100.0%
0
BUN, GRADE 2, GRADE 0 Number Analyzed 0 participants 0 participants 0 participants 0 participants 0 participants 0 participants 0 participants 0 participants 1 participants 0 participants
0 0 0 0 0 0 0 0
1
 100.0%
0
CRE, UNKNOWN, GRADE 0 Number Analyzed 0 participants 0 participants 0 participants 0 participants 0 participants 0 participants 1 participants 0 participants 1 participants 0 participants
0 0 0 0 0 0
1
 100.0%
0
1
 100.0%
0
CRE, GRADE 0, UNKNOWN Number Analyzed 44 participants 46 participants 45 participants 46 participants 46 participants 46 participants 44 participants 47 participants 45 participants 46 participants
0
   0.0%
0
   0.0%
0
   0.0%
3
   6.5%
0
   0.0%
0
   0.0%
1
   2.3%
0
   0.0%
0
   0.0%
1
   2.2%
CRE, GRADE 0, GRADE 0 Number Analyzed 44 participants 46 participants 45 participants 46 participants 46 participants 46 participants 44 participants 47 participants 45 participants 46 participants
44
 100.0%
46
 100.0%
45
 100.0%
43
  93.5%
46
 100.0%
46
 100.0%
43
  97.7%
47
 100.0%
45
 100.0%
45
  97.8%
EOSi, UNKNOWN, GRADE 0 Number Analyzed 1 participants 1 participants 3 participants 1 participants 1 participants 1 participants 1 participants 2 participants 5 participants 2 participants
1
 100.0%
1
 100.0%
3
 100.0%
1
 100.0%
1
 100.0%
1
 100.0%
1
 100.0%
2
 100.0%
5
 100.0%
2
 100.0%
EOSi, GRADE 0, UNKNOWN Number Analyzed 43 participants 44 participants 41 participants 44 participants 45 participants 45 participants 44 participants 45 participants 40 participants 43 participants
2
   4.7%
0
   0.0%
2
   4.9%
1
   2.3%
0
   0.0%
0
   0.0%
2
   4.5%
2
   4.4%
1
   2.5%
2
   4.7%
EOSi, GRADE 0, GRADE 0 Number Analyzed 43 participants 44 participants 41 participants 44 participants 45 participants 45 participants 44 participants 45 participants 40 participants 43 participants
41
  95.3%
43
  97.7%
38
  92.7%
43
  97.7%
45
 100.0%
44
  97.8%
40
  90.9%
43
  95.6%
38
  95.0%
41
  95.3%
EOSi, GRADE 0, GRADE 1 Number Analyzed 43 participants 44 participants 41 participants 44 participants 45 participants 45 participants 44 participants 45 participants 40 participants 43 participants
0
   0.0%
1
   2.3%
1
   2.4%
0
   0.0%
0
   0.0%
1
   2.2%
2
   4.5%
0
   0.0%
1
   2.5%
0
   0.0%
EOSi, GRADE 1, GRADE 0 Number Analyzed 0 participants 1 participants 1 participants 1 participants 0 participants 0 participants 0 participants 0 participants 1 participants 1 participants
0
1
 100.0%
1
 100.0%
1
 100.0%
0 0 0 0
0
   0.0%
0
   0.0%
EOSi, GRADE 1, GRADE 1 Number Analyzed 0 participants 1 participants 1 participants 1 participants 0 participants 0 participants 0 participants 0 participants 1 participants 1 participants
0
0
   0.0%
0
   0.0%
0
   0.0%
0 0 0 0
1
 100.0%
1
 100.0%
HEMd, UNKNOWN, GRADE 0 Number Analyzed 0 participants 1 participants 0 participants 0 participants 0 participants 0 participants 1 participants 0 participants 0 participants 1 participants
0
1
 100.0%
0 0 0 0
1
 100.0%
0 0
1
 100.0%
HEMd, GRADE 0, UNKNOWN Number Analyzed 39 participants 41 participants 42 participants 42 participants 44 participants 43 participants 39 participants 42 participants 43 participants 43 participants
1
   2.6%
0
   0.0%
1
   2.4%
1
   2.4%
0
   0.0%
0
   0.0%
1
   2.6%
1
   2.4%
1
   2.3%
2
   4.7%
HEMd, GRADE 0, GRADE 0 Number Analyzed 39 participants 41 participants 42 participants 42 participants 44 participants 43 participants 39 participants 42 participants 43 participants 43 participants
37
  94.9%
37
  90.2%
40
  95.2%
39
  92.9%
43
  97.7%
40
  93.0%
37
  94.9%
40
  95.2%
40
  93.0%
40
  93.0%
HEMd, GRADE 0, GRADE 1 Number Analyzed 39 participants 41 participants 42 participants 42 participants 44 participants 43 participants 39 participants 42 participants 43 participants 43 participants
1
   2.6%
4
   9.8%
1
   2.4%
1
   2.4%
1
   2.3%
3
   7.0%
1
   2.6%
1
   2.4%
2
   4.7%
1
   2.3%
HEMd, GRADE 0, GRADE 2 Number Analyzed 39 participants 41 participants 42 participants 42 participants 44 participants 43 participants 39 participants 42 participants 43 participants 43 participants
0
   0.0%
0
   0.0%
0
   0.0%
1
   2.4%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
HEMd, GRADE 1, UNKNOWN Number Analyzed 3 participants 3 participants 2 participants 4 participants 0 participants 2 participants 4 participants 2 participants 1 participants 2 participants
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
0
   0.0%
1
  25.0%
0
   0.0%
0
   0.0%
0
   0.0%
HEMd, GRADE 1, GRADE 0 Number Analyzed 3 participants 3 participants 2 participants 4 participants 0 participants 2 participants 4 participants 2 participants 1 participants 2 participants
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
0
   0.0%
1
  25.0%
2
 100.0%
0
   0.0%
1
  50.0%
HEMd, GRADE 1, GRADE 1 Number Analyzed 3 participants 3 participants 2 participants 4 participants 0 participants 2 participants 4 participants 2 participants 1 participants 2 participants
3
 100.0%
1
  33.3%
2
 100.0%
4
 100.0%
0
1
  50.0%
2
  50.0%
0
   0.0%
0
   0.0%
0
   0.0%
HEMd, GRADE 1, GRADE 2 Number Analyzed 3 participants 3 participants 2 participants 4 participants 0 participants 2 participants 4 participants 2 participants 1 participants 2 participants
0
   0.0%
2
  66.7%
0
   0.0%
0
   0.0%
0
1
  50.0%
0
   0.0%
0
   0.0%
1
 100.0%
1
  50.0%
HEMd, GRADE 2, GRADE 1 Number Analyzed 2 participants 0 participants 1 participants 0 participants 2 participants 1 participants 1 participants 2 participants 2 participants 0 participants
0
   0.0%
0
0
   0.0%
0
0
   0.0%
0
   0.0%
1
 100.0%
0
   0.0%
0
   0.0%
0
HEMd, GRADE 2, GRADE 2 Number Analyzed 2 participants 0 participants 1 participants 0 participants 2 participants 1 participants 1 participants 2 participants 2 participants 0 participants
2
 100.0%
0
1
 100.0%
0
2
 100.0%
1
 100.0%
0
   0.0%
0
   0.0%
2
 100.0%
0
HEMd, GRADE 2, GRADE 3 Number Analyzed 2 participants 0 participants 1 participants 0 participants 2 participants 1 participants 1 participants 2 participants 2 participants 0 participants
0
   0.0%
0
0
   0.0%
0
0
   0.0%
0
   0.0%
0
   0.0%
2
 100.0%
0
   0.0%
0
HEMd, GRADE 3, UNKNOWN Number Analyzed 0 participants 1 participants 0 participants 0 participants 0 participants 0 participants 0 participants 1 participants 0 participants 0 participants
0
0
   0.0%
0 0 0 0 0
1
 100.0%
0 0
HEMd, GRADE 3, GRADE 3 Number Analyzed 0 participants 1 participants 0 participants 0 participants 0 participants 0 participants 0 participants 1 participants 0 participants 0 participants
0
1
 100.0%
0 0 0 0 0
0
   0.0%
0 0
LYMd, UNKNOWN, GRADE 0 Number Analyzed 1 participants 1 participants 3 participants 1 participants 1 participants 1 participants 1 participants 2 participants 5 participants 2 participants
1
 100.0%
1
 100.0%
3
 100.0%
1
 100.0%
1
 100.0%
1
 100.0%
1
 100.0%
2
 100.0%
5
 100.0%
2
 100.0%
LYMd, GRADE 0, UNKNOWN Number Analyzed 43 participants 45 participants 39 participants 45 participants 44 participants 45 participants 44 participants 45 participants 39 participants 44 participants
2
   4.7%
0
   0.0%
2
   5.1%
1
   2.2%
0
   0.0%
0
   0.0%
2
   4.5%
2
   4.4%
1
   2.6%
2
   4.5%
LYMd, GRADE 0, GRADE 0 Number Analyzed 43 participants 45 participants 39 participants 45 participants 44 participants 45 participants 44 participants 45 participants 39 participants 44 participants
39
  90.7%
45
 100.0%
37
  94.9%
44
  97.8%
43
  97.7%
45
 100.0%
42
  95.5%
42
  93.3%
38
  97.4%
41
  93.2%
LYMd, GRADE 0, GRADE 1 Number Analyzed 43 participants 45 participants 39 participants 45 participants 44 participants 45 participants 44 participants 45 participants 39 participants 44 participants
2
   4.7%
0
   0.0%
0
   0.0%
0
   0.0%
1
   2.3%
0
   0.0%
0
   0.0%
1
   2.2%
0
   0.0%
1
   2.3%
LYMd, GRADE 1, GRADE 0 Number Analyzed 0 participants 0 participants 3 participants 0 participants 0 participants 0 participants 0 participants 0 participants 2 participants 0 participants
0 0
2
  66.7%
0 0 0 0 0
2
 100.0%
0
LYMd, GRADE 1, GRADE 2 Number Analyzed 0 participants 0 participants 3 participants 0 participants 0 participants 0 participants 0 participants 0 participants 2 participants 0 participants
0 0
1
  33.3%
0 0 0 0 0
0
   0.0%
0
LYMd, GRADE 2, GRADE 0 Number Analyzed 0 participants 0 participants 0 participants 0 participants 1 participants 0 participants 0 participants 0 participants 0 participants 0 participants
0 0 0 0
1
 100.0%
0 0 0 0 0
NEUd, UNKNOWN, GRADE 0 Number Analyzed 1 participants 1 participants 3 participants 1 participants 1 participants 1 participants 1 participants 2 participants 5 participants 2 participants
1
 100.0%
1
 100.0%
3
 100.0%
1
 100.0%
1
 100.0%
1
 100.0%
1
 100.0%
2
 100.0%
2
  40.0%
1
  50.0%
NEUd, UNKNOWN, GRADE 1 Number Analyzed 1 participants 1 participants 3 participants 1 participants 1 participants 1 participants 1 participants 2 participants 5 participants 2 participants
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
2
  40.0%
1
  50.0%
NEUd, UNKNOWN, GRADE 2 Number Analyzed 1 participants 1 participants 3 participants 1 participants 1 participants 1 participants 1 participants 2 participants 5 participants 2 participants
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
1
  20.0%
0
   0.0%
NEUd, GRADE 0, UNKNOWN Number Analyzed 41 participants 41 participants 41 participants 44 participants 41 participants 44 participants 43 participants 41 participants 39 participants 41 participants
2
   4.9%
0
   0.0%
2
   4.9%
1
   2.3%
0
   0.0%
0
   0.0%
2
   4.7%
2
   4.9%
1
   2.6%
2
   4.9%
NEUd, GRADE 0, GRADE 0 Number Analyzed 41 participants 41 participants 41 participants 44 participants 41 participants 44 participants 43 participants 41 participants 39 participants 41 participants
37
  90.2%
40
  97.6%
39
  95.1%
41
  93.2%
41
 100.0%
43
  97.7%
39
  90.7%
38
  92.7%
37
  94.9%
37
  90.2%
NEUd, GRADE 0, GRADE 1 Number Analyzed 41 participants 41 participants 41 participants 44 participants 41 participants 44 participants 43 participants 41 participants 39 participants 41 participants
2
   4.9%
1
   2.4%
0
   0.0%
1
   2.3%
0
   0.0%
0
   0.0%
1
   2.3%
1
   2.4%
0
   0.0%
2
   4.9%
NEUd, GRADE 0, GRADE 2 Number Analyzed 41 participants 41 participants 41 participants 44 participants 41 participants 44 participants 43 participants 41 participants 39 participants 41 participants
0
   0.0%
0
   0.0%
0
   0.0%
1
   2.3%
0
   0.0%
1
   2.3%
1
   2.3%
0
   0.0%
1
   2.6%
0
   0.0%
NEUd, GRADE 1, GRADE 0 Number Analyzed 2 participants 4 participants 0 participants 1 participants 2 participants 1 participants 1 participants 2 participants 1 participants 1 participants
1
  50.0%
4
 100.0%
0
0
   0.0%
0
   0.0%
1
 100.0%
0
   0.0%
0
   0.0%
1
 100.0%
1
 100.0%
NEUd, GRADE 1, GRADE 1 Number Analyzed 2 participants 4 participants 0 participants 1 participants 2 participants 1 participants 1 participants 2 participants 1 participants 1 participants
1
  50.0%
0
   0.0%
0
0
   0.0%
2
 100.0%
0
   0.0%
1
 100.0%
2
 100.0%
0
   0.0%
0
   0.0%
NEUd, GRADE 1, GRADE 2 Number Analyzed 2 participants 4 participants 0 participants 1 participants 2 participants 1 participants 1 participants 2 participants 1 participants 1 participants
0
   0.0%
0
   0.0%
0
1
 100.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
NEUd, GRADE 2, GRADE 0 Number Analyzed 0 participants 0 participants 1 participants 0 participants 1 participants 0 participants 0 participants 2 participants 1 participants 2 participants
0 0
1
 100.0%
0
1
 100.0%
0 0
2
 100.0%
1
 100.0%
2
 100.0%
NEUd, GRADE 3, GRADE 0 Number Analyzed 0 participants 0 participants 0 participants 0 participants 1 participants 0 participants 0 participants 0 participants 0 participants 0 participants
0 0 0 0
1
 100.0%
0 0 0 0 0
PLTCd, UNKNOWN, GRADE 0 Number Analyzed 0 participants 1 participants 0 participants 0 participants 0 participants 0 participants 1 participants 0 participants 1 participants 1 participants
0
1
 100.0%
0 0 0 0
1
 100.0%
0
1
 100.0%
1
 100.0%
PLTCd, GRADE 0, UNKNOWN Number Analyzed 44 participants 45 participants 45 participants 44 participants 46 participants 46 participants 44 participants 46 participants 44 participants 45 participants
1
   2.3%
0
   0.0%
2
   4.4%
1
   2.3%
0
   0.0%
0
   0.0%
2
   4.5%
2
   4.3%
1
   2.3%
2
   4.4%
PLTCd, GRADE 0, GRADE 0 Number Analyzed 44 participants 45 participants 45 participants 44 participants 46 participants 46 participants 44 participants 46 participants 44 participants 45 participants
43
  97.7%
45
 100.0%
42
  93.3%
43
  97.7%
46
 100.0%
45
  97.8%
42
  95.5%
44
  95.7%
43
  97.7%
43
  95.6%
PLTCd, GRADE 0, GRADE 1 Number Analyzed 44 participants 45 participants 45 participants 44 participants 46 participants 46 participants 44 participants 46 participants 44 participants 45 participants
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
1
   2.2%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
PLTCd, GRADE 0, GRADE 2 Number Analyzed 44 participants 45 participants 45 participants 44 participants 46 participants 46 participants 44 participants 46 participants 44 participants 45 participants
0
   0.0%
0
   0.0%
1
   2.2%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
PLTCd, GRADE 1, GRADE 0 Number Analyzed 0 participants 0 participants 0 participants 2 participants 0 participants 0 participants 0 participants 1 participants 0 participants 0 participants
0 0 0
1
  50.0%
0 0 0
1
 100.0%
0 0
PLTCd, GRADE 1, GRADE 1 Number Analyzed 0 participants 0 participants 0 participants 2 participants 0 participants 0 participants 0 participants 1 participants 0 participants 0 participants
0 0 0
1
  50.0%
0 0 0
0
   0.0%
0 0
PLTCd, GRADE 2, GRADE 1 Number Analyzed 0 participants 0 participants 0 participants 0 participants 0 participants 0 participants 0 participants 0 participants 1 participants 0 participants
0 0 0 0 0 0 0 0
1
 100.0%
0
WBCd, UNKNOWN, GRADE 0 Number Analyzed 0 participants 1 participants 0 participants 0 participants 0 participants 0 participants 1 participants 0 participants 2 participants 1 participants
0
1
 100.0%
0 0 0 0
1
 100.0%
0
2
 100.0%
1
 100.0%
WBCd, GRADE 0, UNKNOWN Number Analyzed 43 participants 45 participants 44 participants 46 participants 44 participants 46 participants 44 participants 44 participants 42 participants 45 participants
1
   2.3%
0
   0.0%
2
   4.5%
1
   2.2%
0
   0.0%
0
   0.0%
2
   4.5%
2
   4.5%
1
   2.4%
2
   4.4%
WBCd, GRADE 0, GRADE 0 Number Analyzed 43 participants 45 participants 44 participants 46 participants 44 participants 46 participants 44 participants 44 participants 42 participants 45 participants
41
  95.3%
45
 100.0%
42
  95.5%
44
  95.7%
44
 100.0%
46
 100.0%
41
  93.2%
42
  95.5%
41
  97.6%
43
  95.6%
WBCd, GRADE 0, GRADE 1 Number Analyzed 43 participants 45 participants 44 participants 46 participants 44 participants 46 participants 44 participants 44 participants 42 participants 45 participants
1
   2.3%
0
   0.0%
0
   0.0%
1
   2.2%
0
   0.0%
0
   0.0%
1
   2.3%
0
   0.0%
0
   0.0%
0
   0.0%
WBCd, GRADE 1, GRADE 0 Number Analyzed 1 participants 0 participants 1 participants 0 participants 1 participants 0 participants 0 participants 3 participants 2 participants 0 participants
1
 100.0%
0
1
 100.0%
0
1
 100.0%
0 0
3
 100.0%
2
 100.0%
0
WBCd, GRADE 2, GRADE 0 Number Analyzed 0 participants 0 participants 0 participants 0 participants 1 participants 0 participants 0 participants 0 participants 0 participants 0 participants
0 0 0 0
1
 100.0%
0 0 0 0 0
WBCi, UNKNOWN, GRADE 0 Number Analyzed 0 participants 1 participants 0 participants 0 participants 0 participants 0 participants 1 participants 0 participants 2 participants 1 participants
0
1
 100.0%
0 0 0 0
1
 100.0%
0
2
 100.0%
1
 100.0%
WBCi, GRADE 0, UNKNOWN Number Analyzed 42 participants 43 participants 44 participants 44 participants 45 participants 46 participants 42 participants 44 participants 40 participants 44 participants
1
   2.4%
0
   0.0%
2
   4.5%
1
   2.3%
0
   0.0%
0
   0.0%
2
   4.8%
2
   4.5%
1
   2.5%
2
   4.5%
WBCi, GRADE 0, GRADE 0 Number Analyzed 42 participants 43 participants 44 participants 44 participants 45 participants 46 participants 42 participants 44 participants 40 participants 44 participants
41
  97.6%
43
 100.0%
42
  95.5%
42
  95.5%
45
 100.0%
45
  97.8%
39
  92.9%
39
  88.6%
38
  95.0%
39
  88.6%
WBCi, GRADE 0, GRADE 1 Number Analyzed 42 participants 43 participants 44 participants 44 participants 45 participants 46 participants 42 participants 44 participants 40 participants 44 participants
0
   0.0%
0
   0.0%
0
   0.0%
1
   2.3%
0
   0.0%
1
   2.2%
1
   2.4%
3
   6.8%
1
   2.5%
3
   6.8%
WBCi, GRADE 1, GRADE 0 Number Analyzed 2 participants 2 participants 1 participants 2 participants 1 participants 0 participants 2 participants 3 participants 3 participants 1 participants
1
  50.0%
2
 100.0%
0
   0.0%
1
  50.0%
1
 100.0%
0
1
  50.0%
1
  33.3%
2
  66.7%
0
   0.0%
WBCi, GRADE 1, GRADE 1 Number Analyzed 2 participants 2 participants 1 participants 2 participants 1 participants 0 participants 2 participants 3 participants 3 participants 1 participants
1
  50.0%
0
   0.0%
1
 100.0%
1
  50.0%
0
   0.0%
0
1
  50.0%
2
  66.7%
1
  33.3%
1
 100.0%
WBCi, GRADE 2, GRADE 1 Number Analyzed 0 participants 0 participants 0 participants 0 participants 0 participants 0 participants 0 participants 0 participants 1 participants 0 participants
0 0 0 0 0 0 0 0
1
 100.0%
0
9.Primary Outcome
Title Number of Subjects With Change in Hematological and Biochemical Laboratory Results From Day 8 to Day 29 Versus Baseline by Toxicity Grading
Hide Description Hematological parameters assessed are: EOSi, HEMd, LYMd, NEUd, PLTCd, WBCd, WBCi. Biochemical parameters assessed are: ALTi, ASTi, BUN, CRE. Toxicity grading is according to the FDA guidance for industry: Toxicity grading scale for healthy adult and adolescent volunteers enrolled in preventive vaccine clinical Trials (September 2007). The grading scale is defined as following: mild (Grade 1), moderate (Grade 2), severe (Grade 3) and potentially life threatening (Grade 4). Category naming has been defined as: Parameter-grading at Baseline-grading at Timing: e.g.: "ALT-Grade 0-Grade 1". The reported results consider any change that occurred during the defined time frame: i.e. any abnormality occurring at an intermediate visit leading to a maximum change from baseline, during the period covered, is the reported result for the outcome.
Time Frame From Day 8 to Day 29
Hide Outcome Measure Data
Hide Analysis Population Description
Analysis was performed on the ES which included all subjects with at least one vaccine administration documented.
Arm/Group Title D-SUIV Adjuvanted Group 1 D-SUIV Adjuvanted Group 2 D-SUIV Adjuvanted Group 3 D-SUIV Adjuvanted Group 4 D-SUIV Adjuvanted Group 5 D-SUIV Adjuvanted Group 6 D-SUIV Unadjuvanted Group 1 D-SUIV Unadjuvanted Group 2 D-SUIV Unadjuvanted Group 3 IIV4 Group
Hide Arm/Group Description:
Subjects received one dose of D-SUIV cH8/1N1+AS03 vaccine at Day 1, one dose of Placebo at Day 57 and one booster dose of D-SUIV cH5/1N1+AS03 vaccine at Month 14. All doses were administered intramuscularly in the non-dominant arm.
Subjects received one dose of D-SUIV cH5/1N1+AS03 vaccine at Day 1, one dose of Placebo at Day 57 and one booster dose of D-SUIV cH8/1N1+AS03 vaccine at Month 14. All doses were administered intramuscularly in the non-dominant arm.
Subjects received one dose of D-SUIV cH8/1N1+AS03 vaccine at Day 1, one dose D-SUIV cH5/1N1+AS03 vaccine at Day 57 and one booster dose of D-SUIV cH11/1N1+AS03 vaccine at Month 14. All doses were administered intramuscularly in the non-dominant arm.
Subjects received one dose of D-SUIV cH8/1N1+AS01 vaccine at Day 1, one dose of Placebo at Day 57 and one booster dose of D-SUIV cH5/1N1+AS01 vaccine at Month 14. All doses were administered intramuscularly in the non-dominant arm.
Subjects received one dose of D-SUIV cH5/1N1+AS01 vaccine at Day 1, one dose of Placebo at Day 57 and one booster dose of D-SUIV cH8/1N1+AS01 vaccine at Month 14. All doses were administered intramuscularly in the non-dominant arm.
Subjects received one dose of D-SUIV cH8/1N1+AS01 vaccine at Day 1, one dose of D-SUIV cH5/1N1+AS01 vaccine at Day 57 and one booster dose of D-SUIV cH11/1N1+AS01 vaccine at Month 14. All doses were administered intramuscularly in the non-dominant arm.
Subjects received one dose of D-SUIV cH8/1N1 vaccine at Day 1, one dose of Placebo at Day 57 and one booster dose of D-SUIV cH5/1N1 vaccine at Month 14. All doses were administered intramuscularly in the non-dominant arm.
Subjects received one dose of D-SUIV cH5/1N1 vaccine at Day 1, one dose of Placebo at Day 57 and one booster dose of D-SUIV cH8/1N1 vaccine at Month 14. All doses were administered intramuscularly in the non-dominant arm.
Subjects received one dose of D-SUIV cH8/1N1 vaccine at Day 1, one dose of D-SUIV cH5/1N1 vaccine at Day 57 and one booster dose of D-SUIV cH11/1N1 vaccine at Month 14. All doses were administered intramuscularly in the non-dominant arm.
Subjects received one dose of Fluarix Quadrivalent (IIV4) vaccine at Day 1, one dose of Placebo at Day 57 and one dose of Fluarix Quadrivalent vaccine at Month 14. All doses were administered intramuscularly in the non-dominant arm.
Overall Number of Participants Analyzed 44 46 45 46 46 46 44 47 45 46
Measure Type: Count of Participants
Unit of Measure: Participants
ALTi, UNKNOWN, GRADE 0 Number Analyzed 0 participants 0 participants 0 participants 0 participants 0 participants 0 participants 1 participants 0 participants 1 participants 0 participants
0 0 0 0 0 0
0
   0.0%
0
1
 100.0%
0
ALTi, UNKNOWN, GRADE 1 Number Analyzed 0 participants 0 participants 0 participants 0 participants 0 participants 0 participants 1 participants 0 participants 1 participants 0 participants
0 0 0 0 0 0
1
 100.0%
0
0
   0.0%
0
ALTi, GRADE 0, UNKNOWN Number Analyzed 40 participants 46 participants 43 participants 45 participants 45 participants 45 participants 44 participants 44 participants 43 participants 46 participants
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
1
   2.3%
0
   0.0%
0
   0.0%
0
   0.0%
ALTi, GRADE 0, GRADE 0 Number Analyzed 40 participants 46 participants 43 participants 45 participants 45 participants 45 participants 44 participants 44 participants 43 participants 46 participants
40
 100.0%
45
  97.8%
41
  95.3%
44
  97.8%
45
 100.0%
44
  97.8%
41
  93.2%
43
  97.7%
40
  93.0%
44
  95.7%
ALTi, GRADE 0, GRADE 1 Number Analyzed 40 participants 46 participants 43 participants 45 participants 45 participants 45 participants 44 participants 44 participants 43 participants 46 participants
0
   0.0%
1
   2.2%
2
   4.7%
0
   0.0%
0
   0.0%
1
   2.2%
2
   4.5%
0
   0.0%
3
   7.0%
2
   4.3%
ALTi, GRADE 0, GRADE 2 Number Analyzed 40 participants 46 participants 43 participants 45 participants 45 participants 45 participants 44 participants 44 participants 43 participants 46 participants
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
1
   2.3%
0
   0.0%
0
   0.0%
ALTi, GRADE 0, GRADE 3 Number Analyzed 40 participants 46 participants 43 participants 45 participants 45 participants 45 participants 44 participants 44 participants 43 participants 46 participants
0
   0.0%
0
   0.0%
0
   0.0%
1
   2.2%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
ALTi, GRADE 1, GRADE 0 Number Analyzed 4 participants 0 participants 2 participants 1 participants 1 participants 1 participants 0 participants 3 participants 2 participants 0 participants
3
  75.0%
0
1
  50.0%
1
 100.0%
1
 100.0%
0
   0.0%
0
2
  66.7%
2
 100.0%
0
ALTi, GRADE 1, GRADE 1 Number Analyzed 4 participants 0 participants 2 participants 1 participants 1 participants 1 participants 0 participants 3 participants 2 participants 0 participants
1
  25.0%
0
1
  50.0%
0
   0.0%
0
   0.0%
1
 100.0%
0
1
  33.3%
0
   0.0%
0
ASTi, UNKNOWN, GRADE 0 Number Analyzed 0 participants 0 participants 0 participants 0 participants 0 participants 0 participants 1 participants 0 participants 1 participants 0 participants
0 0 0 0 0 0
1
 100.0%
0
1
 100.0%
0
ASTi, GRADE 0, UNKNOWN Number Analyzed 44 participants 46 participants 45 participants 46 participants 46 participants 45 participants 43 participants 46 participants 45 participants 46 participants
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
1
   2.3%
0
   0.0%
0
   0.0%
0
   0.0%
ASTi, GRADE 0, GRADE 0 Number Analyzed 44 participants 46 participants 45 participants 46 participants 46 participants 45 participants 43 participants 46 participants 45 participants 46 participants
44
 100.0%
46
 100.0%
44
  97.8%
45
  97.8%
46
 100.0%
44
  97.8%
42
  97.7%
43
  93.5%
42
  93.3%
45
  97.8%
ASTi, GRADE 0, GRADE 1 Number Analyzed 44 participants 46 participants 45 participants 46 participants 46 participants 45 participants 43 participants 46 participants 45 participants 46 participants
0
   0.0%
0
   0.0%
1
   2.2%
0
   0.0%
0
   0.0%
1
   2.2%
0
   0.0%
3
   6.5%
2
   4.4%
0
   0.0%
ASTi, GRADE 0, GRADE 2 Number Analyzed 44 participants 46 participants 45 participants 46 participants 46 participants 45 participants 43 participants 46 participants 45 participants 46 participants
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
1
   2.2%
1
   2.2%
ASTi, GRADE 0, GRADE 4 Number Analyzed 44 participants 46 participants 45 participants 46 participants 46 participants 45 participants 43 participants 46 participants 45 participants 46 participants
0
   0.0%
0
   0.0%
0
   0.0%
1
   2.2%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
ASTi, GRADE 1, GRADE 0 Number Analyzed 0 participants 0 participants 0 participants 0 participants 0 participants 1 participants 1 participants 0 participants 0 participants 0 participants
0 0 0 0 0
0
   0.0%
1
 100.0%
0 0 0
ASTi, GRADE 1, GRADE 1 Number Analyzed 0 participants 0 participants 0 participants 0 participants 0 participants 1 participants 1 participants 0 participants 0 participants 0 participants
0 0 0 0 0
1
 100.0%
0
   0.0%
0 0 0
ASTi, GRADE 2, GRADE 0 Number Analyzed 0 participants 0 participants 0 participants 0 participants 0 participants 0 participants 0 participants 1 participants 0 participants 0 participants
0 0 0 0 0 0 0
1
 100.0%
0 0
BUN, UNKNOWN, GRADE 0 Number Analyzed 0 participants 0 participants 0 participants 0 participants 0 participants 0 participants 1 participants 0 participants 1 participants 0 participants
0 0 0 0 0 0
1
 100.0%
0
1
 100.0%
0
BUN, GRADE 0, UNKNOWN Number Analyzed 43 participants 46 participants 45 participants 46 participants 46 participants 46 participants 44 participants 47 participants 43 participants 46 participants
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
1
   2.3%
0
   0.0%
0
   0.0%
0
   0.0%
BUN, GRADE 0, GRADE 0 Number Analyzed 43 participants 46 participants 45 participants 46 participants 46 participants 46 participants 44 participants 47 participants 43 participants 46 participants
43
 100.0%
45
  97.8%
45
 100.0%
46
 100.0%
46
 100.0%
46
 100.0%
43
  97.7%
47
 100.0%
43
 100.0%
46
 100.0%
BUN, GRADE 0, GRADE 1 Number Analyzed 43 participants 46 participants 45 participants 46 participants 46 participants 46 participants 44 participants 47 participants 43 participants 46 participants
0
   0.0%
1
   2.2%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
BUN, GRADE 1, GRADE 0 Number Analyzed 1 participants 0 participants 0 participants 0 participants 0 participants 0 participants 0 participants 0 participants 1 participants 0 participants
1
 100.0%
0 0 0 0 0 0 0
1
 100.0%
0
BUN, GRADE 2, GRADE 0 Number Analyzed 0 participants 0 participants 0 participants 0 participants 0 participants 0 participants 0 participants 0 participants 1 participants 0 participants
0 0 0 0 0 0 0 0
1
 100.0%
0
CRE, UNKNOWN, GRADE 0 Number Analyzed 0 participants 0 participants 0 participants 0 participants 0 participants 0 participants 1 participants 0 participants 1 participants 0 participants
0 0 0 0 0 0
1
 100.0%
0
1
 100.0%
0
CRE, GRADE 0, UNKNOWN Number Analyzed 44 participants 46 participants 45 participants 46 participants 46 participants 46 participants 44 participants 47 participants 45 participants 46 participants
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
1
   2.3%
0
   0.0%
0
   0.0%
0
   0.0%
CRE, GRADE 0, GRADE 0 Number Analyzed 44 participants 46 participants 45 participants 46 participants 46 participants 46 participants 44 participants 47 participants 45 participants 46 participants
44
 100.0%
46
 100.0%
45
 100.0%
46
 100.0%
46
 100.0%
46
 100.0%
43
  97.7%
47
 100.0%
45
 100.0%
46
 100.0%
EOSi, UNKNOWN, GRADE 0 Number Analyzed 1 participants 1 participants 3 participants 1 participants 1 participants 1 participants 1 participants 2 participants 5 participants 2 participants
1
 100.0%
1
 100.0%
3
 100.0%
1
 100.0%
1
 100.0%
1
 100.0%
0
   0.0%
2
 100.0%
5
 100.0%
2
 100.0%
EOSi, UNKNOWN, GRADE 1 Number Analyzed 1 participants 1 participants 3 participants 1 participants 1 participants 1 participants 1 participants 2 participants 5 participants 2 participants
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
1
 100.0%
0
   0.0%
0
   0.0%
0
   0.0%
EOSi, GRADE 0, UNKNOWN Number Analyzed 43 participants 44 participants 41 participants 44 participants 45 participants 45 participants 44 participants 45 participants 40 participants 43 participants
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
1
   2.3%
0
   0.0%
0
   0.0%
0
   0.0%
EOSi, GRADE 0, GRADE 0 Number Analyzed 43 participants 44 participants 41 participants 44 participants 45 participants 45 participants 44 participants 45 participants 40 participants 43 participants
43
 100.0%
43
  97.7%
40
  97.6%
44
 100.0%
45
 100.0%
44
  97.8%
40
  90.9%
45
 100.0%
39
  97.5%
43
 100.0%
EOSi, GRADE 0, GRADE 1 Number Analyzed 43 participants 44 participants 41 participants 44 participants 45 participants 45 participants 44 participants 45 participants 40 participants 43 participants
0
   0.0%
1
   2.3%
1
   2.4%
0
   0.0%
0
   0.0%
1
   2.2%
3
   6.8%
0
   0.0%
1
   2.5%
0
   0.0%
EOSi, GRADE 1, GRADE 0 Number Analyzed 0 participants 1 participants 1 participants 1 participants 0 participants 0 participants 0 participants 0 participants 1 participants 1 participants
0
0
   0.0%
1
 100.0%
1
 100.0%
0 0 0 0
0
   0.0%
0
   0.0%
EOSi, GRADE 1, GRADE 1 Number Analyzed 0 participants 1 participants 1 participants 1 participants 0 participants 0 participants 0 participants 0 participants 1 participants 1 participants
0
1
 100.0%
0
   0.0%
0
   0.0%
0 0 0 0
1
 100.0%
1
 100.0%
HEMd, UNKNOWN, GRADE 0 Number Analyzed 0 participants 1 participants 0 participants 0 participants 0 participants 0 participants 1 participants 0 participants 0 participants 1 participants
0
1
 100.0%
0 0 0 0
1
 100.0%
0 0
1
 100.0%
HEMd, GRADE 0, GRADE 0 Number Analyzed 39 participants 41 participants 42 participants 42 participants 44 participants 43 participants 39 participants 42 participants 43 participants 43 participants
37
  94.9%
37
  90.2%
41
  97.6%
38
  90.5%
43
  97.7%
40
  93.0%
37
  94.9%
39
  92.9%
39
  90.7%
42
  97.7%
HEMd, GRADE 0, GRADE 1 Number Analyzed 39 participants 41 participants 42 participants 42 participants 44 participants 43 participants 39 participants 42 participants 43 participants 43 participants
2
   5.1%
4
   9.8%
1
   2.4%
3
   7.1%
1
   2.3%
3
   7.0%
2
   5.1%
3
   7.1%
4
   9.3%
1
   2.3%
HEMd, GRADE 0, GRADE 2 Number Analyzed 39 participants 41 participants 42 participants 42 participants 44 participants 43 participants 39 participants 42 participants 43 participants 43 participants
0
   0.0%
0
   0.0%
0
   0.0%
1
   2.4%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
HEMd, GRADE 1, UNKNOWN Number Analyzed 3 participants 3 participants 2 participants 4 participants 0 participants 2 participants 4 participants 2 participants 1 participants 2 participants
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
0
   0.0%
1
  25.0%
0
   0.0%
0
   0.0%
0
   0.0%
HEMd, GRADE 1, GRADE 0 Number Analyzed 3 participants 3 participants 2 participants 4 participants 0 participants 2 participants 4 participants 2 participants 1 participants 2 participants
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
0
   0.0%
1
  25.0%
2
 100.0%
0
   0.0%
1
  50.0%
HEMd, GRADE 1, GRADE 1 Number Analyzed 3 participants 3 participants 2 participants 4 participants 0 participants 2 participants 4 participants 2 participants 1 participants 2 participants
3
 100.0%
1
  33.3%
2
 100.0%
4
 100.0%
0
1
  50.0%
2
  50.0%
0
   0.0%
0
   0.0%
0
   0.0%
HEMd, GRADE 1, GRADE 2 Number Analyzed 3 participants 3 participants 2 participants 4 participants 0 participants 2 participants 4 participants 2 participants 1 participants 2 participants
0
   0.0%
2
  66.7%
0
   0.0%
0
   0.0%
0
1
  50.0%
0
   0.0%
0
   0.0%
1
 100.0%
1
  50.0%
HEMd, GRADE 2, GRADE 2 Number Analyzed 2 participants 0 participants 1 participants 0 participants 2 participants 1 participants 1 participants 2 participants 2 participants 0 participants
2
 100.0%
0
1
 100.0%
0
2
 100.0%
1
 100.0%
1
 100.0%
0
   0.0%
2
 100.0%
0
HEMd, GRADE 2, GRADE 3 Number Analyzed 2 participants 0 participants 1 participants 0 participants 2 participants 1 participants 1 participants 2 participants 2 participants 0 participants
0
   0.0%
0
0
   0.0%
0
0
   0.0%
0
   0.0%
0
   0.0%
2
 100.0%
0
   0.0%
0
HEMd, GRADE 3, GRADE 3 Number Analyzed 0 participants 1 participants 0 participants 0 participants 0 participants 0 participants 0 participants 1 participants 0 participants 0 participants
0
1
 100.0%
0 0 0 0 0
1
 100.0%
0 0
LYMd, UNKNOWN, GRADE 0 Number Analyzed 1 participants 1 participants 3 participants 1 participants 1 participants 1 participants 1 participants 2 participants 5 participants 2 participants
0
   0.0%
1
 100.0%
3
 100.0%
1
 100.0%
1
 100.0%
1
 100.0%
1
 100.0%
2
 100.0%
5
 100.0%
2
 100.0%
LYMd, UNKNOWN, GRADE 1 Number Analyzed 1 participants 1 participants 3 participants 1 participants 1 participants 1 participants 1 participants 2 participants 5 participants 2 participants
1
 100.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
LYMd, GRADE 0, UNKNOWN Number Analyzed 43 participants 45 participants 39 participants 45 participants 44 participants 45 participants 44 participants 45 participants 39 participants 44 participants
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
1
   2.3%
0
   0.0%
0
   0.0%
0
   0.0%
LYMd, GRADE 0, GRADE 0 Number Analyzed 43 participants 45 participants 39 participants 45 participants 44 participants 45 participants 44 participants 45 participants 39 participants 44 participants
41
  95.3%
45
 100.0%
39
 100.0%
45
 100.0%
42
  95.5%
45
 100.0%
43
  97.7%
43
  95.6%
39
 100.0%
41
  93.2%
LYMd, GRADE 0, GRADE 1 Number Analyzed 43 participants 45 participants 39 participants 45 participants 44 participants 45 participants 44 participants 45 participants 39 participants 44 participants
2
   4.7%
0
   0.0%
0
   0.0%
0
   0.0%
1
   2.3%
0
   0.0%
0
   0.0%
2
   4.4%
0
   0.0%
3
   6.8%
LYMd, GRADE 0, GRADE 2 Number Analyzed 43 participants 45 participants 39 participants 45 participants 44 participants 45 participants 44 participants 45 participants 39 participants 44 participants
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
1