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A Study of Two Doses of WRAIR Dengue Vaccine Administered Six Months Apart to Healthy Adults and Children

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT00468858
Recruitment Status : Completed
First Posted : May 3, 2007
Results First Posted : June 6, 2017
Last Update Posted : July 2, 2017
Sponsor:
Collaborator:
GlaxoSmithKline
Information provided by (Responsible Party):
U.S. Army Medical Research and Development Command

Study Type Interventional
Study Design Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: Triple (Participant, Care Provider, Investigator);   Primary Purpose: Prevention
Conditions Dengue Fever
Dengue Hemorrhagic Fever
Dengue Shock Syndrome
Interventions Other: Placebo
Biological: T-DEN-Post-Transfection F17
Biological: T-DEN-Post-Transfection F19
Enrollment 636
Recruitment Details  
Pre-assignment Details  
Arm/Group Title T-DEN-Post-Transfection F17 T-DEN-Post-Transfection F19 Placebo
Hide Arm/Group Description

Post-Transfection F17, full dose

T-DEN-Post-Transfection F17: Lyophilized, single dose vials and sterile water for injection; 0.5 mL dose at 0 and 6 months

Post-Transfection F19, full dose

T-DEN-Post-Transfection F19: Lyophilized, single dose vials and sterile water for injection; 0.5 mL dose at 0 and 6 months

Control

Placebo: Lyophilized, single dose vials and sterile water for

> injection; 0.5 mL dose; Vaccination schedule: 0, 6 months

Period Title: Overall Study
Started 211 212 213
Completed 202 202 199
Not Completed 9 10 14
Reason Not Completed
Adverse Event             0             1             0
Withdrawal by Subject             7             4             5
Relocation             1             3             3
Lost to Follow-up             1             2             5
Other             0             0             1
Arm/Group Title T-DEN-Post-Transfection F17 T-DEN-Post-Transfection F19 Placebo Total
Hide Arm/Group Description

Post-Transfection F17, full dose

T-DEN-Post-Transfection F17: Lyophilized, single dose vials and sterile water for injection; 0.5 mL dose at 0 and 6 months

Post-Transfection F19, full dose

T-DEN-Post-Transfection F19: Lyophilized, single dose vials and sterile water for injection; 0.5 mL dose at 0 and 6 months

Control

Placebo: Lyophilized, single dose vials and sterile water for

> injection; 0.5 mL dose; Vaccination schedule: 0, 6 months

Total of all reporting groups
Overall Number of Baseline Participants 211 212 213 636
Hide Baseline Analysis Population Description
[Not Specified]
Age, Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 211 participants 212 participants 213 participants 636 participants
13.8  (14.10) 12.8  (12.51) 13.6  (13.89) 13.4  (13.50)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 211 participants 212 participants 213 participants 636 participants
Female
107
  50.7%
114
  53.8%
114
  53.5%
335
  52.7%
Male
104
  49.3%
98
  46.2%
99
  46.5%
301
  47.3%
Ethnicity (NIH/OMB)  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 211 participants 212 participants 213 participants 636 participants
Hispanic or Latino
210
  99.5%
212
 100.0%
213
 100.0%
635
  99.8%
Not Hispanic or Latino
1
   0.5%
0
   0.0%
0
   0.0%
1
   0.2%
Unknown or Not Reported
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
Race/Ethnicity, Customized  
Measure Type: Count of Participants
Unit of measure:  Participants
Race Number Analyzed 211 participants 212 participants 213 participants 636 participants
African heritage / African American
2
   0.9%
1
   0.5%
2
   0.9%
5
   0.8%
American
0
   0.0%
1
   0.5%
2
   0.9%
3
   0.5%
Dominican
2
   0.9%
2
   0.9%
1
   0.5%
5
   0.8%
Hispanic
0
   0.0%
1
   0.5%
1
   0.5%
2
   0.3%
Mixed
9
   4.3%
7
   3.3%
10
   4.7%
26
   4.1%
Peruvian
1
   0.5%
0
   0.0%
0
   0.0%
1
   0.2%
Puerto Rican
164
  77.7%
166
  78.3%
164
  77.0%
494
  77.7%
White-Arabic / North African heritage
1
   0.5%
0
   0.0%
1
   0.5%
2
   0.3%
White - Caucasian / European heritage
32
  15.2%
34
  16.0%
32
  15.0%
98
  15.4%
Region of Enrollment  
Measure Type: Count of Participants
Unit of measure:  Participants
Puerto Rico Number Analyzed 211 participants 212 participants 213 participants 636 participants
211
 100.0%
212
 100.0%
213
 100.0%
636
 100.0%
1.Primary Outcome
Title Safety: Incidence of All and Grade 3 Solicited Local Symptoms
Hide Description Incidence of all and grade 3 (prevents normal, everyday activities) solicited local and general symptoms within the 21-day follow-up period (Total vaccinated cohort)
Time Frame Within 21 days (days 0-20) f/up period after each vaccine dose
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title T-DEN-Post-Transfection F17 T-DEN-Post-Transfection F19 Placebo
Hide Arm/Group Description:

Post-Transfection F17, full dose

T-DEN-Post-Transfection F17: Lyophilized, single dose vials and sterile water for injection; 0.5 mL dose at 0 and 6 months

Post-Transfection F19, full dose

T-DEN-Post-Transfection F19: Lyophilized, single dose vials and sterile water for injection; 0.5 mL dose at 0 and 6 months

Control

Placebo: Lyophilized, single dose vials and sterile water for

> injection; 0.5 mL dose; Vaccination schedule: 0, 6 months

Overall Number of Participants Analyzed 211 212 213
Measure Type: Number
Unit of Measure: number of occurances
All Grade 3 AEs 114 98 84
Pain - All 55 60 48
Pain - Grade 3 1 0 0
Redness - All 31 22 20
Redness - Grade 3 6 2 5
Swelling - All 3 14 10
Swelling - Grade 3 3 0 1
Abdominal Pain - All 28 39 28
Abdominal Pain - Grade 3 0 1 1
Fatigue - All 28 33 32
Fatigue - Grade 3 0 1 0
Fever - All 103 100 83
Fever - Grade 3 10 13 9
Headache - All 75 73 72
Headache - Grade 3 3 1 6
Pruritus - All 25 27 19
Pruritus - Grade 3 0 0 1
Rash - All 18 20 10
Rash - Grade 3 0 0 1
Vomiting - All 24 26 21
Vomiting - Grade 3 0 1 1
2.Primary Outcome
Title Safety: Summary of Unsolicited Adverse Events Within the 31-day Post-vaccination Period
Hide Description Summary of unsolicited Adverse Events within the 31-day post-vaccination period by age group (total vaccinated cohort)
Time Frame Within the 31-day (days 0-30) follow-up period after each vaccine dose
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title T-DEN-Post-Transfection F17 T-DEN-Post-Transfection F19 Placebo
Hide Arm/Group Description:

Post-Transfection F17, full dose

T-DEN-Post-Transfection F17: Lyophilized, single dose vials and sterile water for injection; 0.5 mL dose at 0 and 6 months

Post-Transfection F19, full dose

T-DEN-Post-Transfection F19: Lyophilized, single dose vials and sterile water for injection; 0.5 mL dose at 0 and 6 months

Control

Placebo: Lyophilized, single dose vials and sterile water for

> injection; 0.5 mL dose; Vaccination schedule: 0, 6 months

Overall Number of Participants Analyzed 211 212 213
Measure Type: Count of Participants
Unit of Measure: Participants
At least one symptom - age 1 - 4 years
52
  24.6%
60
  28.3%
65
  30.5%
At least one symptom - age 5 - 50
44
  20.9%
40
  18.9%
40
  18.8%
Subject showing no unsolicited symptoms
115
  54.5%
112
  52.8%
108
  50.7%
3.Primary Outcome
Title Safety: Occurrence of Serious Adverse Events (SAEs)
Hide Description Summary of SAEs, 6 months + 30 day follow-up period after last vaccine dose
Time Frame 6 months + 30 day follow-up period after last vaccine dose
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title T-DEN-Post-Transfection F17 T-DEN-Post-Transfection F19 Placebo
Hide Arm/Group Description:

Post-Transfection F17, full dose

T-DEN-Post-Transfection F17: Lyophilized, single dose vials and sterile water for injection; 0.5 mL dose at 0 and 6 months

Post-Transfection F19, full dose

T-DEN-Post-Transfection F19: Lyophilized, single dose vials and sterile water for injection; 0.5 mL dose at 0 and 6 months

Control

Placebo: Lyophilized, single dose vials and sterile water for

> injection; 0.5 mL dose; Vaccination schedule: 0, 6 months

Overall Number of Participants Analyzed 211 212 213
Measure Type: Count of Participants
Unit of Measure: Participants
Subjects with at least 1 SAE - not related
8
   3.8%
4
   1.9%
11
   5.2%
Subject showing no SAE symptoms
203
  96.2%
208
  98.1%
202
  94.8%
Subjects with at least 1 SAE - related
0
   0.0%
0
   0.0%
0
   0.0%
4.Secondary Outcome
Title Incidence of Suspected and Laboratory Confirmed Dengue
Hide Description Incidence of suspected and confirmed dengue reported during the 31-day (Days 0-30) post-vaccination period and after the 31-day period
Time Frame 31-day (days 0-30) post-vaccination period and after 31-day period
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title During 31-Day Post Vaccination: F17 During 31-Day Post Vaccination: F19 During 31-Day Post Vaccination: Placebo After 31-Day Post Vaccination Period: F17 After 31-Day Post Vaccination Period: F19 After 31-Day Post-Vaccination Period: Placebo
Hide Arm/Group Description:

Post-Transfection F17, full dose

T-DEN-Post-Transfection F17: Lyophilized, single dose vials and sterile water for injection; 0.5 mL dose at 0 and 6 months

Post-Transfection F19, full dose

T-DEN-Post-Transfection F19: Lyophilized, single dose vials and sterile water for injection; 0.5 mL dose at 0 and 6 months

Control

Placebo: Lyophilized, single dose vials and sterile water for

> injection; 0.5 mL dose; Vaccination schedule: 0, 6 months

Post-Transfection F17, full dose

T-DEN-Post-Transfection F17: Lyophilized, single dose vials and sterile water for injection; 0.5 mL dose at 0 and 6 months

Post-Transfection F19, full dose

T-DEN-Post-Transfection F19: Lyophilized, single dose vials and sterile water for injection; 0.5 mL dose at 0 and 6 months

Control

Placebo: Lyophilized, single dose vials and sterile water for

> injection; 0.5 mL dose; Vaccination schedule: 0, 6 months

Overall Number of Participants Analyzed 211 212 213 211 212 213
Measure Type: Number
Unit of Measure: dengue fever cases
Dose 1: Suspected dengue fever 3 3 0 3 3 3
Dose 1: Suspected with med. attention 3 3 0 3 3 3
Dose 1: Confirmed dengue fever 0 0 0 0 0 0
Dose 2: Suspected dengue fever 0 1 1 1 1 0
Dose 2: Suspected with med. attention 0 1 1 1 1 0
Dose 2: Confirmed dengue fever 0 0 0 0 0 0
Overall Subject: Suspected dengue fever 3 4 1 4 4 3
Overall Subject: Suspected with med. attention 3 4 1 4 4 3
Overall Subject: Confirmed dengue fever 0 0 0 0 0 0
5.Secondary Outcome
Title GMTs for Antibody Titer Above the Assay Cut Off to Each DEN Serotype for Unprimed and Primed Subjects
Hide Description Comparison of F17 and F19 formulations in terms of GMTs at month 7 (one month post dose 2) for each DEN type, -unprimed and primed subjects
Time Frame at month 7 (one month post dose 2)
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title T-DEN-Post-Transfection F17 T-DEN-Post-Transfection F19
Hide Arm/Group Description:

Post-Transfection F17, full dose

T-DEN-Post-Transfection F17: Lyophilized, single dose vials and sterile water for injection; 0.5 mL dose at 0 and 6 months

Post-Transfection F19, full dose

T-DEN-Post-Transfection F19: Lyophilized, single dose vials and sterile water for injection; 0.5 mL dose at 0 and 6 months

Overall Number of Participants Analyzed 211 212
Mean (95% Confidence Interval)
Unit of Measure: titers
Unprimed Subjects: DEN-1
130.9
(84.1 to 203.7)
84.4
(43.6 to 163.5)
Unprimed Subjects: DEN-2
218.6
(125.3 to 381.3)
215.2
(116.7 to 396.7)
Unprimed Subjects: DEN-3
124.5
(76.9 to 201.6)
60.3
(33.0 to 110.2)
Unprimed Subjects: DEN-4
377.7
(249.4 to 572.0)
105.9
(55.8 to 201.0)
Primed Subjects: DEN-1
1412.8
(1191.5 to 1675.3)
1324.1
(1104.1 to 1587.9)
Primed Subjects: DEN-2
1514.4
(1322.2 to 1734.6)
1338.5
(1105.6 to 1620.6)
Primed Subjects: DEN-3
1130.0
(920.0 to 1388.0)
901.4
(707.6 to 1148.3)
Primed Subjects: DEN-4
1228.4
(1014.1 to 1488.0)
1020.8
(809.5 to 1287.4)
6.Secondary Outcome
Title Percent of Subjects With Neut. Antibody Titer Above the Assay Cut-off to All Dengue Serotypes
Hide Description Monovalent, bivalent, trivalent and tetravalent response for DEN neut. antibodies for unprimed and primed subjects
Time Frame Pre-vaccination, at post dose 1, months 3 and 6 and post dose 2, month 7
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title F17: Pre-vaccination F17 PI (M3) F17 PI (M6) F17 PII (M7) F19: Pre-vaccination F19 PI (M3) F19 PI (M6) F19 PII (M7) Placebo: Pre-vaccination Placebo: PI (M3) Placebo: PI (M6) Placebo: PII (M7)
Hide Arm/Group Description:
Pre-vaccination (blood sample taken before dose 1)
Post-Transfection F-17 Post-dose 1, month 3
Post-Transfection F-17 Post-dose 1, month 6
Post-Transfection F-17 Post-dose 2, month 7
Pre-vaccination (blood sample taken before dose 1)
Post-Transfection F-19 Post-dose 1, month 3
Post-Transfection F-19 Post-dose 1, month 6
Post-Transfection F-19 Post-dose 2, month 7
Pre-vaccination (blood sample taken before dose 1)
Placebo control Post-dose 1, month 3
Placebo control Post-dose 1, month 6
Placebo control Post-dose 2, month 7
Overall Number of Participants Analyzed 86 83 82 82 61 60 59 59 74 71 69 68
Measure Type: Number
Number (95% Confidence Interval)
Unit of Measure: % of subjects
Unprimed: Valence=None
100
(95.8 to 100.0)
53
(41.7 to 64.1)
52.4
(41.1 to 63.6)
2.4
(0.3 to 8.5)
100
(94.1 to 100.0)
50
(36.8 to 63.2)
50.8
(37.5 to 64.1)
5.1
(1.1 to 14.1)
100
(95.1 to 100.0)
95.8
(88.1 to 99.1)
92.8
(83.9 to 97.6)
94.1
(85.6 to 98.4)
Unprimed: Valence=Monovalent
0
(0 to 0)
24.1
(15.4 to 34.7)
23.2
(14.6 to 33.8)
1.2
(0.0 to 6.6)
0
(0 to 0)
23.3
(13.4 to 36.0)
27.1
(16.4 to 40.3)
5.1
(1.1 to 14.1)
0
(0 to 0)
0
(0 to 0)
1.4
(0.0 to 7.8)
1.5
(0.0 to 7.9)
Unprimed: Valence=Bivalent
0
(0 to 0)
4.8
(1.3 to 11.9)
7.3
(2.7 to 15.2)
2.4
(0.3 to 8.5)
0
(0 to 0)
5
(1.0 to 13.9)
5.1
(1.1 to 14.1)
8.5
(2.8 to 18.7)
0
(0 to 0)
0
(0 to 0)
2.9
(0.4 to 10.1)
1.5
(0.0 to 7.9)
Unprimed: Valence=Trivalent
0
(0 to 0)
7.2
(2.7 to 15.1)
7.3
(2.7 to 15.2)
7.3
(2.7 to 15.2)
0
(0 to 0)
1.7
(0.0 to 8.9)
3.4
(0.4 to 11.7)
6.8
(1.9 to 16.5)
0
(0 to 0)
0
(0 to 0)
0
(0 to 0)
0
(0 to 0)
Unprimed: Valence=Tetravalent
0
(0 to 0)
10.8
(5.1 to 19.6)
9.8
(4.3 to 18.3)
86.6
(77.3 to 93.1)
0
(0 to 0)
20
(10.8 to 32.3)
13.6
(6.0 to 25.0)
74.6
(61.6 to 85.0)
0
(0 to 0)
4.2
(0.9 to 11.9)
2.9
(0.4 to 10.1)
2.9
(0.4 to 10.2)
Primed: Valence=Monovalent
3.3
(0.7 to 9.3)
1.1
(0.0 to 6.2)
1.1
(0.0 to 6.2)
0
(0 to 0)
2.1
(0.3 to 7.5)
0
(0 to 0)
0
(0 to 0)
1.1
(0.0 to 6.0)
8.9
(4.2 to 16.2)
3
(0.6 to 8.6)
3
(0.6 to 8.6)
2
(0.2 to 7.1)
Primed: Valence=Trivalent
1.1
(0.0 to 6.0)
0
(0 to 0)
0
(0 to 0)
0
(0 to 0)
2.1
(0.3 to 7.5)
0
(0 to 0)
0
(0 to 0)
0
(0 to 0)
0
(0 to 0)
0
(0 to 0)
2
(0.2 to 7.1)
1
(0.0 to 5.5)
Primed: Valence=Bivalent
0
(0 to 0)
1.1
(0.0 to 6.2)
1.1
(0.0 to 6.2)
0
(0 to 0)
3.2
(0.7 to 9.0)
0
(0 to 0)
0
(0 to 0)
0
(0 to 0)
1
(0.0 to 5.4)
2
(0.2 to 7.1)
0
(0 to 0)
1
(0.0 to 5.5)
Primed: Valence=Tetravalent
96.5
(89.1 to 98.8)
96.6
(90.4 to 99.3)
97.7
(91.9 to 99.7)
100
(95.8 to 100.0)
92.6
(85.3 to 97.0)
98.9
(94.2 to 100.0)
100
(96.0 to 100.0)
98.9
(94.0 to 100.0)
90.1
(82.5 to 95.1)
91.9
(84.7 to 96.4)
89.9
(82.2 to 95.0)
90.9
(84.4 to 95.8)
Primed: Valence=None
0
(0 to 0)
1.1
(0.0 to 6.2)
1.1
(0.0 to 6.2)
0
(0 to 0)
0
(0 to 0)
1.1
(0.0 to 5.8)
0
(0 to 0)
0
(0 to 0)
0
(0 to 0)
3
(0.6 to 8.6)
5.1
(1.7 to 11.4)
5.1
(1.7 to 11.4)
7.Secondary Outcome
Title Percent of Subjects With Neut. Sero-response to Each DEN Serotype
Hide Description Seropositivity rates for DEN neut. antibodies for unprimed and primed subjects
Time Frame Pre-accination, at post dose 1, months 3 and 6 and post dose 2, month 7
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title F17: Pre-vaccination F17 PI (M3) F17 PI (M6) F17 PII (M7) F19: Pre-vaccination F19 PI (M3) F19 PI (M6) F19 PII (M7) Placebo: Pre-vaccination Placebo: PI (M3) Placebo: PI (M6) Placebo: PII (M7)
Hide Arm/Group Description:
Pre-vaccination (blood sample taken before dose 1)
Post-Transfection F-17 Post-dose 1, month 3
Post-Transfection F-17 Post-dose 1, month 6
Post-Transfection F-17 Post-dose 2, month 7
Pre-vaccination (blood sample taken before dose 1)
Post-Transfection F-19 Post-dose 1, month 3
Post-Transfection F-19 Post-dose 1, month 6
Post-Transfection F-19 Post-dose 2, month 7
Pre-vaccination (blood sample taken before dose 1)
Placebo control Post-dose 1, month 3
Placebo control Post-dose 1, month 6
Placebo control Post-dose 2, month 7
Overall Number of Participants Analyzed 86 83 82 82 61 60 59 59 74 71 69 68
Measure Type: Number
Number (95% Confidence Interval)
Unit of Measure: percent of subject with attribute
Unprimed: DEN-1, >10 ED50
0.0
(0.0 to 4.2)
20.5
(12.4 to 30.8)
22.0
(13.6 to 32.5)
95.1
(88.0 to 98.7)
0.0
(0.0 to 5.9)
26.7
(16.1 to 39.7)
18.6
(9.7 to 30.9)
83.1
(71.0 to 91.6)
0.0
(0.0 to 4.9)
4.2
(0.9 to 11.9)
4.3
(0.9 to 12.2)
4.4
(0.9 to 12.4)
Unprimed: DEN-2, >10 ED50
0
(0.0 to 0.0)
26.5
(17.4 to 37.3)
28.0
(18.7 to 39.1)
89.0
(80.2 to 94.9)
0.0
(0.0 to 5.9)
43.3
(30.6 to 56.8)
40.7
(28.1 to 54.3)
93.2
(83.5 to 98.1)
0.0
(0.0 to 4.9)
4.2
(0.9 to 11.9)
4.3
(0.9 to 12.2)
2.9
(0.4 to 10.2)
Unprimed: DEN-3, >10 ED50
0.0
(0.0 to 4.2)
14.5
(7.7 to 23.9)
15.9
(8.7 to 25.6)
92.7
(84.8 to 97.3)
0.0
(0.0 to 5.9)
21.7
(12.1 to 34.2)
16.9
(8.4 to 29.0)
78.0
(65.3 to 87.7)
0.0
(0.0 to 4.9)
4.2
(0.9 to 11.9)
7.2
(2.4 to 16.1)
4.4
(0.9 to 12.4)
Unprimed: DEN-4, >10 ED50
0.0
(0.0 to 4.2)
37.3
(27.0 to 48.7)
32.9
(22.9 to 44.2)
97.6
(91.5 to 99.7)
0.0
(0.0 to 5.9)
26.7
(16.1 to 39.7)
25.4
(15.0 to 38.4)
86.4
(75.0 to 94.0)
0.0
(0.0 to 4.9)
4.2
(0.9 to 11.9)
2.9
(0.4 to 10.1)
4.4
(0.9 to 12.4)
Primed: DEN-1, >10 ED50
97.8
(92.3 to 99.7)
97.7
(92.0 to 99.7)
98.9
(93.8 to 100)
100
(95.8 to 100)
96.8
(91.0 to 99.3)
98.9
(94.2 to 100)
100
(96.0 to 100)
100
(96.0 to 100)
94.1
(87.5 to 97.8)
94.9
(88.6 to 98.3)
92.9
(86.0 to 97.1)
90.9
(83.4 to 95.8)
Primed: DEN-2, >10 ED50
97.8
(92.3 to 99.7)
96.6
(90.4 to 99.3)
97.7
(91.9 to 99.7)
100
(95.8 to 100)
96.8
(91.0 to 99.3)
98.9
(94.2 to 100)
100
(96.0 to 100)
98.9
(94.0 to 100)
95.0
(88.8 to 98.4)
93.9
(87.3 to 97.7)
92.9
(86.0 to 97.1)
93.9
(87.3 to 97.7)
Primed: DEN-3, >10 ED50
96.7
(90.7 to 99.3)
96.6
(90.4 to 99.3)
97.7
(91.9 to 99.7)
100
(95.8 to 100)
92.6
(85.3 to 97.0)
98.9
(94.2 to 100)
100
(96.0 to 100)
98.9
(94.0 to 100)
90.1
(82.5 to 95.1)
91.9
(84.7 to 96.4)
90.9
(83.4 to 95.8)
92.9
(86.0 to 97.1)
Primed: DEN-4, >10 ED50
96.7
(90.7 to 99.3)
98.9
(93.8 to 100)
98.9
(93.8 to 100)
100
(95.8 to 100)
98.9
(94.2 to 100)
98.9
(94.2 to 100)
100
(96.0 to 100)
98.9
(94.0 to 100)
92.1
(85.0 to 96.5)
93.9
(87.3 to 97.7)
91.9
(84.7 to 96.4)
92.9
(86.0 to 97.1)
8.Secondary Outcome
Title Vaccine Response to DEN Antibody at Post Dose 1, Month 3
Hide Description

Vaccine response for DEN-1, DEN-2, DEN-3 and DEN-4 antibody

S- = seronegative subjects (antibody titer <10 ED50 for DEN-1, 2, 3, and 4 prior to vaccination; S+ = Seropositive subjects (antibody titer >10 ED50 for DEN-1, 2, 3 and 4 prior to vaccination; Total = subjects either seropositive or seronegative at pre-vaccination

Vaccine response defined as: For initially seronegative subjects, antibody titer >10 ED50 at PI(M3) and for initially seropositive subjects: antibody titer at PI(m3) >4 fold the pre-vaccination antibody titer

Time Frame at month 3, post dose 1
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title DEN-1, F17, S- DEN-1, F17, S+ DEN-1, F17, Total DEN-1, F19, S- DEN-1, F19, S+ DEN-1, F19, Total DEN-1, Placebo, S- DEN-1, Placebo, S+ DEN-1, Placebo, Total DEN-2, F17, S- DEN-2, F17, S+ DEN-2, F17, Total DEN-2, F19, S- DEN-2, F19, S+ DEN-2, F19, Total DEN-2, Placebo, S- DEN-2, Placebo, S+ DEN-2, Placebo, Total DEN-3, F17, S- DEN-3, F17, S+ DEN-3, F17, Total DEN-3, F19, S- DEN-3, F19, S+ DEN-3, F19, Total DEN-3, Placebo, S- DEN-3, Placebo, S+ DEN-3, Placebo, Total DEN-4, F17, S- DEN-4, F17, S+ DEN-4, F17, Total DEN-4, F19, S- DEN-4, F19, S+ DEN-4, F19, Total DEN-4, Placebo, S- DEN-4, Placebo, S+ DEN-4, Placebo, Total
Hide Arm/Group Description:
Antibody DEN-1, Group F17, Pre-vaccination status = S-
Antibody DEN-1, Group F17, Pre-vaccination status = S+
Antibody DEN-1, Group F17, Pre-vaccination status = Total
Antibody DEN-1, Group F19, Pre-vaccination status = S-
Antibody DEN-1, Group F19, Pre-vaccination group = S+
Antibody DEN-1, Group F19, Pre-vaccination status = Total
Antibody DEN-1, Placebo group, Pre-vaccination status = S-
Antibody DEN-1, Placebo group, Pre-vaccination status = S+
Antibody DEN-1, Placebo group, Pre-vaccination status = Total
Antibody DEN-2, Group F17, Pre-vaccination status = S-
Antibody DEN-2, Group F17, Pre-vaccination status = S+
Antibody DEN-2,. Group F17, Pre-vaccination status = Total
Antibody DEN-2, Group F19, Pre-vaccination status = S-
Antibody DEN-2, Group F19, Pre-vaccination status = S+
Antibody DEN-2, Group F19, Pre-vaccination status = Total
Antibody DEN-2, Placebo group, Pre-vaccination status = S-
Antibody DEN-2, Placebo group, Pre-vaccination status = S+
Antibody DEN-2, Placebo group, Pre-vaccination status = Total
Antibody DEN-3, Group F17, Pre-vaccination status = S-
Antibody DEN-3, Group F17, Pre-vaccination status = S+
Antibody DEN-3, Group F17, Pre-vaccination status = Total
Antibody DEN-3, Group F19, Pre-vaccination status = S-
Antibody DEN-3, Group F19, Pre-vaccination status = S+
Antibody DEN-3, Group F19, Pre-vaccination status = Total
Antibody DEN-3, Placebo group, Pre-vaccination status = S-
Antibody DEN-3, Placebo group, Pre-vaccination status = S+
Antibody DEN-3, Placebo group, Pre-vaccination status = Total
Antibody DEN-4, Group F17, Pre-vaccination status = S-
Antibody DEN-4, Group F17, Pre-vaccination status = S+
Antibody DEN-4, Group F17, Pre-vaccination status = Total
Antibody DEN-4, Group F19, Pre-vaccination status = S-
Antibody DEN-4, Group F19, Pre-vaccination status = S+
Antibody DEN-4, Group F19, Pre-vaccination status = Total
Antibody DEN-4, Placebo group, Pre-vaccination status = S-
Antibody DEN-4, Placebo group, Pre-vaccination status = S+
Antibody DEN-4, Placebo group, Pre-vaccination status = Total
Overall Number of Participants Analyzed 84 37 121 63 38 101 77 43 120 85 33 118 63 45 108 76 43 119 85 36 121 66 45 111 81 39 120 85 42 127 61 49 110 79 45 124
Measure Type: Number
Number (95% Confidence Interval)
Unit of Measure: % of subjects
20.2
(12.3 to 30.4)
54.1
(36.9 to 70.5)
30.6
(22.5 to 39.6)
30.2
(19.2 to 43.0)
73.7
(56.9 to 86.6)
46.5
(36.5 to 56.7)
7.8
(2.9 to 16.2)
7.0
(1.5 to 19.1)
7.5
(3.5 to 13.8)
25.9
(17.0 to 36.5)
63.6
(45.1 to 79.6)
36.4
(27.8 to 45.8)
46.0
(33.4 to 59.1)
64.4
(48.8 to 78.1)
53.7
(43.8 to 63.3)
3.9
(0.8 to 11.1)
14.0
(5.3 to 27.9)
7.6
(3.5 to 13.9)
15.3
(8.4 to 24.7)
61.1
(43.5 to 76.9)
28.9
(21.0 to 37.9)
28.8
(18.3 to 41.3)
62.2
(46.5 to 76.2)
42.3
(33.0 to 52.1)
6.2
(2.0 to 13.8)
5.1
(0.6 to 17.3)
5.8
(2.4 to 11.6)
38.8
(28.4 to 50.0)
52.4
(36.4 to 68.0)
43.3
(34.5 to 52.4)
27.9
(17.1 to 40.8)
65.3
(50.4 to 78.3)
44.5
(35.1 to 54.3)
7.6
(2.8 to 15.8)
11.1
(3.7 to 24.1)
8.9
(4.5 to 15.3)
9.Secondary Outcome
Title Vaccine Response to DEN Antibody at Post Dose 2, Month 7
Hide Description Vaccine response for DEN-1, DEN2, DEN-3, DEN-4 antibody at post dose 2, month 7
Time Frame at month 7, post dose 2
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title DEN-1, F17, S- DEN-1, F17, S+ DEN-1, F17, Total DEN-1, F19, S- DEN-1, F19, S+ DEN-1, F19, Total DEN-1, Placebo, S- DEN-1, Placebo, S+ DEN-1, Placebo, Total DEN-2, F17, S- DEN-2, F17, S+ DEN-2, F17, Total DEN-2, F19, S- DEN-2, F19, S+ DEN-2, F19, Total DEN-2, Placebo, S- DEN-2, Placebo, S+ DEN-2, Placebo, Total DEN-3, F17, S- DEN-3, F17, S+ DEN-3, F17, Total DEN-3, F19, S- DEN-3, F19, S+ DEN-3, F19, Total DEN-3, Placebo, S- DEN-3, Placebo, S+ DEN-3, Placebo, Total DEN-4, F17, S- DEN-4, F17, S+ DEN-4, F17, Total DEN-4, F19, S- DEN-4, F19, S+ DEN-4, F19, Total DEN-4, Placebo, S- DEN-4, Placebo, S+ DEN-4, Placebo, Total
Hide Arm/Group Description:
Antibody DEN-1, Group F17, Pre-vaccination status = S-
Antibody DEN-1, Group F17, Pre-vaccination status = S+
Antibody DEN-1, Group F17, Pre-vaccination status = Total
Antibody DEN-1, Group F19, Pre-vaccination status = S-
Antibody DEN-1, Group F19, Pre-vaccination group = S+
Antibody DEN-1, Group F19, Pre-vaccination status = Total
Antibody DEN-1, Placebo group, Pre-vaccination status = S-
Antibody DEN-1, Placebo group, Pre-vaccination status = S+
Antibody DEN-1, Placebo group, Pre-vaccination status = Total
Antibody DEN-2, Group F17, Pre-vaccination status = S-
Antibody DEN-2, Group F17, Pre-vaccination status = S+
Antibody DEN-2,. Group F17, Pre-vaccination status = Total
Antibody DEN-2, Group F19, Pre-vaccination status = S-
Antibody DEN-2, Group F19, Pre-vaccination status = S+
Antibody DEN-2, Group F19, Pre-vaccination status = Total
Antibody DEN-2, Placebo group, Pre-vaccination status = S-
Antibody DEN-2, Placebo group, Pre-vaccination status = S+
Antibody DEN-2, Placebo group, Pre-vaccination status = Total
Antibody DEN-3, Group F17, Pre-vaccination status = S-
Antibody DEN-3, Group F17, Pre-vaccination status = S+
Antibody DEN-3, Group F17, Pre-vaccination status = Total
Antibody DEN-3, Group F19, Pre-vaccination status = S-
Antibody DEN-3, Group F19, Pre-vaccination status = S+
Antibody DEN-3, Group F19, Pre-vaccination status = Total
Antibody DEN-3, Placebo group, Pre-vaccination status = S-
Antibody DEN-3, Placebo group, Pre-vaccination status = S+
Antibody DEN-3, Placebo group, Pre-vaccination status = Total
Antibody DEN-4, Group F17, Pre-vaccination status = S-
Antibody DEN-4, Group F17, Pre-vaccination status = S+
Antibody DEN-4, Group F17, Pre-vaccination status = Total
Antibody DEN-4, Group F19, Pre-vaccination status = S-
Antibody DEN-4, Group F19, Pre-vaccination status = S+
Antibody DEN-4, Group F19, Pre-vaccination status = Total
Antibody DEN-4, Placebo group, Pre-vaccination status = S-
Antibody DEN-4, Placebo group, Pre-vaccination status = S+
Antibody DEN-4, Placebo group, Pre-vaccination status = Total
Overall Number of Participants Analyzed 83 35 118 61 37 98 74 43 117 84 32 116 62 42 104 73 43 116 84 34 118 64 43 107 78 39 117 84 40 124 60 48 108 76 45 121
Measure Type: Number
Number (95% Confidence Interval)
Unit of Measure: % of subjects
95.2
(88.1 to 98.7)
60.0
(42.1 to 76.1)
84.7
(77.0 to 90.7)
83.6
(71.9 to 91.8)
75.7
(58.8 to 88.2)
80.6
(71.4 to 87.9)
6.8
(2.2 to 15.1)
11.6
(3.9 to 25.1)
8.5
(4.2 to 15.2)
89.3
(80.6 to 95.0)
71.9
(53.3 to 86.3)
84.5
(76.6 to 90.5)
93.5
(84.3 to 98.2)
64.3
(48.0 to 78.4)
81.7
(72.9 to 88.6)
4.1
(0.9 to 11.5)
14.0
(5.3 to 27.9)
7.8
(3.6 to 14.2)
92.9
(85.1 to 97.3)
47.1
(29.8 to 64.9)
79.7
(71.3 to 86.5)
79.7
(67.8 to 88.7)
48.8
(33.3 to 64.5)
67.3
(57.5 to 76.0)
9.0
(3.7 to 17.6)
15.4
(5.9 to 30.5)
11.1
(6.1 to 18.3)
97.6
(91.7 to 99.7)
57.5
(40.9 to 73.0)
84.7
(77.1 to 90.5)
86.7
(75.4 to 94.1)
68.8
(53.7 to 81.3)
78.7
(69.8 to 86.0)
7.9
(3.0 to 16.4)
6.7
(1.4 to 18.3)
7.4
(3.5 to 13.7)
Time Frame 12 months
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title T-DEN-Post-Transfection F17 T-DEN-Post-Transfection F19 Placebo
Hide Arm/Group Description

Post-Transfection F17, full dose

T-DEN-Post-Transfection F17: Lyophilized, single dose vials and sterile water for injection; 0.5 mL dose at 0 and 6 months

Post-Transfection F19, full dose

T-DEN-Post-Transfection F19: Lyophilized, single dose vials and sterile water for injection; 0.5 mL dose at 0 and 6 months

Control

Placebo: Lyophilized, single dose vials and sterile water for

> injection; 0.5 mL dose; Vaccination schedule: 0, 6 months

All-Cause Mortality
T-DEN-Post-Transfection F17 T-DEN-Post-Transfection F19 Placebo
Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%)
Total   0/211 (0.00%)      0/212 (0.00%)      0/213 (0.00%)    
Show Serious Adverse Events Hide Serious Adverse Events
T-DEN-Post-Transfection F17 T-DEN-Post-Transfection F19 Placebo
Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   8/211 (3.79%)      4/212 (1.89%)      11/213 (5.16%)    
Eye disorders       
Conjunctivitis * 1  1/211 (0.47%)  1 0/212 (0.00%)  0 0/213 (0.00%)  0
Gastrointestinal disorders       
Acute gastroenteritis * 1  2/211 (0.95%)  2 0/212 (0.00%)  0 1/213 (0.47%)  1
Acute viral gastroenteritis * 1  1/211 (0.47%)  1 0/212 (0.00%)  0 0/213 (0.00%)  0
Gastroenteritis * 1  0/211 (0.00%)  0 1/212 (0.47%)  1 1/213 (0.47%)  1
Diarrhea * 1  0/211 (0.00%)  0 0/212 (0.00%)  0 1/213 (0.47%)  1
Infections and infestations       
Cellulitis (face) * 1  1/211 (0.47%)  1 0/212 (0.00%)  0 0/213 (0.00%)  0
Cellulitis orbital * 1  1/211 (0.47%)  1 0/212 (0.00%)  0 0/213 (0.00%)  0
Dengue fever * 1  1/211 (0.47%)  1 0/212 (0.00%)  0 0/213 (0.00%)  0
Tonsillitis * 1  1/211 (0.47%)  1 0/212 (0.00%)  0 0/213 (0.00%)  0
Sinusitis * 1  1/211 (0.47%)  1 0/212 (0.00%)  0 0/213 (0.00%)  0
Upper respiratory tract infection * 1  1/211 (0.47%)  1 0/212 (0.00%)  0 1/213 (0.47%)  1
Pneumonia * 1  0/211 (0.00%)  0 2/212 (0.94%)  2 2/213 (0.94%)  2
Presumptive viral syndrome * 1  0/211 (0.00%)  0 0/212 (0.00%)  0 1/213 (0.47%)  1
Acute bronchitis * 1  0/211 (0.00%)  0 0/212 (0.00%)  0 1/213 (0.47%)  1
Bronchitis * 1  0/211 (0.00%)  0 0/212 (0.00%)  0 1/213 (0.47%)  1
Viral infection * 1  0/211 (0.00%)  0 0/212 (0.00%)  0 1/213 (0.47%)  1
Metabolism and nutrition disorders       
Dehydration * 1  0/211 (0.00%)  0 1/212 (0.47%)  1 0/213 (0.00%)  0
Renal and urinary disorders       
Ureteral calculus * 1  0/211 (0.00%)  0 0/212 (0.00%)  0 1/213 (0.47%)  1
Renal failure acute * 1  0/211 (0.00%)  0 0/212 (0.00%)  0 1/213 (0.47%)  1
Respiratory, thoracic and mediastinal disorders       
Tonsillitis * 1  0/211 (0.00%)  0 1/212 (0.47%)  1 0/213 (0.00%)  0
Bronchial asthma * 1  0/211 (0.00%)  0 0/212 (0.00%)  0 1/213 (0.47%)  1
1
Term from vocabulary, MedDRA (Unspecified)
*
Indicates events were collected by non-systematic assessment
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 0%
T-DEN-Post-Transfection F17 T-DEN-Post-Transfection F19 Placebo
Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   90/211 (42.65%)      93/212 (43.87%)      93./213 (43.66%)    
Cardiac disorders       
Tachycardia * 1 [1]  1/211 (0.47%)  1 0/212 (0.00%)  0 0/213 (0.00%)  0
Ear and labyrinth disorders       
Ear congestion * 1 [2]  0/211 (0.00%)  0 0/212 (0.00%)  0 1/213 (0.47%)  1
Ear pain * 1 [2]  1/211 (0.47%)  1 1/212 (0.47%)  1 2/213 (0.94%)  2
Eye disorders       
Photophobia * 1 [2]  0/211 (0.00%)  0 1/212 (0.47%)  1 0/213 (0.00%)  0
Eye pain * 1 [1]  0/211 (0.00%)  0 0/212 (0.00%)  0 1/213 (0.47%)  1
Ocular hyperaemia * 1 [1]  0/211 (0.00%)  0 1/212 (0.47%)  1 0/213 (0.00%)  0
Gastrointestinal disorders       
Abdominal pain  1 [3]  18/211 (8.53%)  18 26/212 (12.26%)  26 17/213 (7.98%)  17
Vomiting  1 [3]  13/211 (6.16%)  13 15/212 (7.08%)  15 14/213 (6.57%)  14
Abdominal pain  1 [4]  10/211 (4.74%)  10 13/212 (6.13%)  13 11/213 (5.16%)  11
Vomiting  1 [4]  11/211 (5.21%)  11 11/212 (5.19%)  11 7/213 (3.29%)  7
Abdominal pain * 1 [2]  0/211 (0.00%)  0 1/212 (0.47%)  1 1/213 (0.47%)  1
Abdominal pain (upper) * 1 [2]  0/211 (0.00%)  0 1/212 (0.47%)  1 0/213 (0.00%)  0
Constipation * 1 [2]  0/211 (0.00%)  0 1/212 (0.47%)  1 1/213 (0.47%)  1
Diarrhea * 1 [2]  8/211 (3.79%)  8 6/212 (2.83%)  6 5/213 (2.35%)  5
Enteritis * 1 [2]  0/211 (0.00%)  0 0/212 (0.00%)  0 1/213 (0.47%)  1
Vomiting * 1 [2]  2/211 (0.95%)  2 1/212 (0.47%)  1 1/213 (0.47%)  1
Gastroenteritis * 1 [2]  2/211 (0.95%)  2 2/212 (0.94%)  2 3/213 (1.41%)  3
Gastroenteritis viral * 1 [2]  0/211 (0.00%)  0 1/212 (0.47%)  1 0/213 (0.00%)  0
Abdominal pain * 1 [1]  2/211 (0.95%)  2 0/212 (0.00%)  0 0/213 (0.00%)  0
Anal pruritus * 1 [1]  0/211 (0.00%)  0 1/212 (0.47%)  1 0/213 (0.00%)  0
Diarrhea * 1 [1]  1/211 (0.47%)  1 2/212 (0.94%)  2 2/213 (0.94%)  2
Dry mouth * 1 [1]  1/211 (0.47%)  1 0/212 (0.00%)  0 0/213 (0.00%)  0
Dyspepsia * 1 [1]  0/211 (0.00%)  0 0/212 (0.00%)  0 1/213 (0.47%)  1
Gastritis * 1 [1]  1/211 (0.47%)  1 2/212 (0.94%)  2 1/213 (0.47%)  1
Gastroesophageal reflux desease * 1 [1]  0/211 (0.00%)  0 1/212 (0.47%)  1 0/213 (0.00%)  0
Sensitivity of teeth * 1 [1]  0/211 (0.00%)  0 0/212 (0.00%)  0 1/213 (0.47%)  1
Tooth development disorder * 1 [1]  0/211 (0.00%)  0 1/212 (0.47%)  1 0/213 (0.00%)  0
Vomiting * 1 [1]  0/211 (0.00%)  0 1/212 (0.47%)  1 0/213 (0.00%)  0
Gastroenteritis * 1 [1]  1/211 (0.47%)  1 2/212 (0.94%)  2 0/213 (0.00%)  0
Gastroenteritis viral * 1 [1]  0/211 (0.00%)  0 1/212 (0.47%)  1 0/213 (0.00%)  0
General disorders       
Pain  1 [3]  25/211 (11.85%)  25 34/212 (16.04%)  34 31/213 (14.55%)  31
Swelling  1 [3]  8/211 (3.79%)  8 7/212 (3.30%)  7 6/213 (2.82%)  6
Pain  1 [4]  30/211 (14.22%)  30 26/212 (12.26%)  26 17/213 (7.98%)  17
Fatigue  1 [3]  17/211 (8.06%)  17 26/212 (12.26%)  26 18/213 (8.45%)  18
Fever (axillary)  1 [3]  52/211 (24.64%)  52 54/212 (25.47%)  54 47/213 (22.07%)  47
Fatigue  1 [4]  11/211 (5.21%)  11 7/212 (3.30%)  7 14/213 (6.57%)  14
Fever (axillary)  1 [4]  51/211 (24.17%)  51 46/212 (21.70%)  46 36/213 (16.90%)  36
Injection site reaction * 1 [2]  1/211 (0.47%)  1 0/212 (0.00%)  0 0/213 (0.00%)  0
Irritability * 1 [2]  0/211 (0.00%)  0 1/212 (0.47%)  1 0/213 (0.00%)  0
Pyrexia * 1 [2]  2/211 (0.95%)  2 4/212 (1.89%)  4 1/213 (0.47%)  1
Thirst * 1 [2]  0/211 (0.00%)  0 0/212 (0.00%)  0 1/213 (0.47%)  1
Chills * 1 [1]  1/211 (0.47%)  1 0/212 (0.00%)  0 0/213 (0.00%)  0
Exercise tolerance decreased * 1 [1]  1/211 (0.47%)  1 0/212 (0.00%)  0 0/213 (0.00%)  0
Influenza like symptoms * 1 [1]  0/211 (0.00%)  0 0/212 (0.00%)  0 1/213 (0.47%)  1
Injection site haematoma * 1 [1]  0/211 (0.00%)  0 0/212 (0.00%)  0 1/213 (0.47%)  1
Injection site pruritus * 1 [1]  0/211 (0.00%)  0 0/212 (0.00%)  0 1/213 (0.47%)  1
Pyrexia * 1 [1]  0/211 (0.00%)  0 1/212 (0.47%)  1 0/213 (0.00%)  0
Immune system disorders       
Food allergy * 1 [2]  0/211 (0.00%)  0 0/212 (0.00%)  0 1/213 (0.47%)  1
Drug hypersensitivity * 1 [1]  0/211 (0.00%)  0 1/212 (0.47%)  1 0/213 (0.00%)  0
Hypersensitivity * 1 [1]  0/211 (0.00%)  0 1/212 (0.47%)  1 0/213 (0.00%)  0
Seasonal allergy * 1 [1]  0/211 (0.00%)  0 1/212 (0.47%)  1 0/213 (0.00%)  0
Infections and infestations       
Conjunctivitis * 1 [2]  2/211 (0.95%)  2 4/212 (1.89%)  4 2/213 (0.94%)  2
Abscess * 1 [2]  1/211 (0.47%)  1 0/212 (0.00%)  0 0/213 (0.00%)  0
Bronchiolitis * 1 [2]  0/211 (0.00%)  0 1/212 (0.47%)  1 0/213 (0.00%)  0
Bronchitis * 1 [2]  0/211 (0.00%)  0 1/212 (0.47%)  1 1/213 (0.47%)  1
Conjunctivitis * 1 [2]  0/211 (0.00%)  0 1/212 (0.47%)  1 0/213 (0.00%)  0
Croup infectious * 1 [2]  0/211 (0.00%)  0 2/212 (0.94%)  2 1/213 (0.47%)  1
Ear infection * 1 [2]  0/211 (0.00%)  0 2/212 (0.94%)  2 2/213 (0.94%)  2
Genital candidiasis * 1 [2]  0/211 (0.00%)  0 1/212 (0.47%)  1 0/213 (0.00%)  0
Impetigo * 1 [2]  1/211 (0.47%)  1 4/212 (1.89%)  4 3/213 (1.41%)  3
Infected bites * 1 [2]  0/211 (0.00%)  0 1/212 (0.47%)  1 0/213 (0.00%)  0
Infection parasitic * 1 [2]  1/211 (0.47%)  1 0/212 (0.00%)  0 0/213 (0.00%)  0
Nasopharyngitis * 1 [2]  13/211 (6.16%)  13 6/212 (2.83%)  6 16/213 (7.51%)  16
Otitis externa * 1 [2]  1/211 (0.47%)  1 0/212 (0.00%)  0 0/213 (0.00%)  0
Otitis media * 1 [2]  3/211 (1.42%)  3 3/212 (1.42%)  3 4/213 (1.88%)  4
Otitis media acute * 1 [2]  0/211 (0.00%)  0 0/212 (0.00%)  0 1/213 (0.47%)  1
Parasitic gastroenteritis * 1 [2]  1/211 (0.47%)  1 0/212 (0.00%)  0 0/213 (0.00%)  0
Pharyngitis * 1 [2]  1/211 (0.47%)  1 0/212 (0.00%)  0 0/213 (0.00%)  0
Pneumonia * 1 [2]  0/211 (0.00%)  0 2/212 (0.94%)  2 1/213 (0.47%)  1
Rhinitis * 1 [2]  0/211 (0.00%)  0 0/212 (0.00%)  0 1/213 (0.47%)  1
Sinusitis * 1 [2]  1/211 (0.47%)  1 4/212 (1.89%)  4 2/213 (0.94%)  2
Subcutaneous abscess * 1 [2]  0/211 (0.00%)  0 1/212 (0.47%)  1 0/213 (0.00%)  0
Tonsillitis * 1 [2]  1/211 (0.47%)  1 2/212 (0.94%)  2 1/213 (0.47%)  1
Upper respiratory tract infection * 1 [2]  12/211 (5.69%)  12 21/212 (9.91%)  21 21/213 (9.86%)  21
Urinary tract infection * 1 [2]  0/211 (0.00%)  0 0/212 (0.00%)  0 1/213 (0.47%)  1
Viral infection * 1 [2]  3/211 (1.42%)  3 1/212 (0.47%)  1 2/213 (0.94%)  2
Conuunctivitis * 1 [1]  2/211 (0.95%)  2 0/212 (0.00%)  0 0/213 (0.00%)  0
Conjunctivitis allergic * 1 [1]  0/211 (0.00%)  0 0/212 (0.00%)  0 1/213 (0.47%)  1
Abscess * 1 [1]  0/211 (0.00%)  0 1/212 (0.47%)  1 0/213 (0.00%)  0
Acute sinusitis * 1 [1]  0/211 (0.00%)  0 1/212 (0.47%)  1 0/213 (0.00%)  0
Bronchitis * 1 [1]  1/211 (0.47%)  1 0/212 (0.00%)  0 0/213 (0.00%)  0
Cellulitis * 1 [1]  0/211 (0.00%)  0 1/212 (0.47%)  1 0/213 (0.00%)  0
Enterobiasis * 1 [1]  0/211 (0.00%)  0 1/212 (0.47%)  1 0/213 (0.00%)  0
Fungal skin infection * 1 [1]  0/211 (0.00%)  0 0/212 (0.00%)  0 1/213 (0.47%)  1
Gingival abscess * 1 [1]  1/211 (0.47%)  1 0/212 (0.00%)  0 0/213 (0.00%)  0
Impetigo * 1 [1]  0/211 (0.00%)  0 1/212 (0.47%)  1 1/213 (0.47%)  1
Influenza * 1 [1]  1/211 (0.47%)  1 0/212 (0.00%)  0 0/213 (0.00%)  0
Nasopharyngitis * 1 [1]  0/211 (0.00%)  0 0/212 (0.00%)  0 3/213 (1.41%)  3
Otitis media * 1 [1]  1/211 (0.47%)  1 0/212 (0.00%)  0 1/213 (0.47%)  1
Pharyngitis * 1 [1]  3/211 (1.42%)  3 3/212 (1.42%)  3 5/213 (2.35%)  5
Rhinitis * 1 [1]  1/211 (0.47%)  1 0/212 (0.00%)  0 1/213 (0.47%)  1
Sinusitis * 1 [1]  1/211 (0.47%)  1 2/212 (0.94%)  2 3/213 (1.41%)  3
Tinea versicolour * 1 [1]  1/211 (0.47%)  1 1/212 (0.47%)  1 0/213 (0.00%)  0
Tonsillitis * 1 [1]  0/211 (0.00%)  0 0/212 (0.00%)  0 2/213 (0.94%)  2
Upper respiratory tract infection * 1 [1]  7/211 (3.32%)  7 8/212 (3.77%)  8 7/213 (3.29%)  7
Viral infection * 1 [1]  2/211 (0.95%)  2 0/212 (0.00%)  0 1/213 (0.47%)  1
Viral pharyngitis * 1 [1]  1/211 (0.47%)  1 0/212 (0.00%)  0 0/213 (0.00%)  0
Injury, poisoning and procedural complications       
Arthropod bite * 1 [2]  1/211 (0.47%)  1 1/212 (0.47%)  1 1/213 (0.47%)  1
Bruns first degree * 1 [2]  1/211 (0.47%)  1 0/212 (0.00%)  0 0/213 (0.00%)  0
Excoriation * 1 [2]  0/211 (0.00%)  0 1/212 (0.47%)  1 1/213 (0.47%)  1
Head injury * 1 [2]  0/211 (0.00%)  0 1/212 (0.47%)  1 0/213 (0.00%)  0
Limb injury * 1 [2]  1/211 (0.47%)  1 1/212 (0.47%)  1 0/213 (0.00%)  0
Scratch * 1 [2]  1/211 (0.47%)  1 0/212 (0.00%)  0 0/213 (0.00%)  0
Skin laceration * 1 [2]  0/211 (0.00%)  0 1/212 (0.47%)  1 0/213 (0.00%)  0
Tooth injury * 1 [2]  0/211 (0.00%)  0 1/212 (0.47%)  1 0/213 (0.00%)  0
Humerus fracture * 1 [1]  0/211 (0.00%)  0 0/212 (0.00%)  0 1/213 (0.47%)  1
Joint injury * 1 [1]  0/211 (0.00%)  0 0/212 (0.00%)  0 1/213 (0.47%)  1
Joint sprain * 1 [1]  0/211 (0.00%)  0 0/212 (0.00%)  0 1/213 (0.47%)  1
Metabolism and nutrition disorders       
Swelling  1 [4]  10/211 (4.74%)  10 7/212 (3.30%)  7 4/213 (1.88%)  4
Decreased appetite * 1 [2]  0/211 (0.00%)  0 0/212 (0.00%)  0 1/213 (0.47%)  1
Musculoskeletal and connective tissue disorders       
Muscle spasms * 1 [2]  0/211 (0.00%)  0 1/212 (0.47%)  1 0/213 (0.00%)  0
Neck pain * 1 [2]  0/211 (0.00%)  0 1/212 (0.47%)  1 0/213 (0.00%)  0
Pain in extremity * 1 [2]  0/211 (0.00%)  0 1/212 (0.47%)  1 0/213 (0.00%)  0
Back pain * 1 [1]  4/211 (1.90%)  4 3/212 (1.42%)  3 1/213 (0.47%)  1
Costochondritis * 1 [1]  1/211 (0.47%)  1 0/212 (0.00%)  0 0/213 (0.00%)  0
Muscle spasms * 1 [1]  1/211 (0.47%)  1 0/212 (0.00%)  0 0/213 (0.00%)  0
Muscular weakness * 1 [1]  0/211 (0.00%)  0 1/212 (0.47%)  1 0/213 (0.00%)  0
Myalgia * 1 [1]  0/211 (0.00%)  0 0/212 (0.00%)  0 4/213 (1.88%)  4
Neck pain * 1 [1]  0/211 (0.00%)  0 0/212 (0.00%)  0 1/213 (0.47%)  1
Nervous system disorders       
Headache  1 [3]  41/211 (19.43%)  41 49/212 (23.11%)  49 45/213 (21.13%)  45
Headache  1 [4]  34/211 (16.11%)  34 24/212 (11.32%)  24 27/213 (12.68%)  27
Crying * 1 [2]  0/211 (0.00%)  0 1/212 (0.47%)  1 0/213 (0.00%)  0
Psychomotor hyperactivity * 1 [2]  1/211 (0.47%)  1 0/212 (0.00%)  0 0/213 (0.00%)  0
Dizziness * 1 [1]  0/211 (0.00%)  0 1/212 (0.47%)  1 2/213 (0.94%)  2
Dysgeusia * 1 [1]  2/211 (0.95%)  2 1/212 (0.47%)  1 3/213 (1.41%)  3
Headache * 1 [1]  1/211 (0.47%)  1 0/212 (0.00%)  0 2/213 (0.94%)  2
Paraesthesia * 1 [1]  1/211 (0.47%)  1 0/212 (0.00%)  0 0/213 (0.00%)  0
Psychomotor hyperactivity * 1 [1]  0/211 (0.00%)  0 1/212 (0.47%)  1 0/213 (0.00%)  0
Insomnia * 1 [1]  1/211 (0.47%)  1 0/212 (0.00%)  0 1/213 (0.47%)  1
Psychiatric disorders       
Aggression * 1 [2]  0/211 (0.00%)  0 1/212 (0.47%)  1 0/213 (0.00%)  0
Renal and urinary disorders       
Bladder pain * 1 [1]  0/211 (0.00%)  0 0/212 (0.00%)  0 1/213 (0.47%)  1
Reproductive system and breast disorders       
Vulvovaginal pruritus * 1 [2]  0/211 (0.00%)  0 0/212 (0.00%)  0 1/213 (0.47%)  1
Breast tenderness * 1 [1]  0/211 (0.00%)  0 0/212 (0.00%)  0 1/213 (0.47%)  1
Ovarian disorder * 1 [1]  0/211 (0.00%)  0 0/212 (0.00%)  0 1/213 (0.47%)  1
Penis disorder * 1 [1]  0/211 (0.00%)  0 0/212 (0.00%)  0 1/213 (0.47%)  1
Vulvovaginal pruritus * 1 [1]  0/211 (0.00%)  0 1/212 (0.47%)  1 0/213 (0.00%)  0
Respiratory, thoracic and mediastinal disorders       
Asthma * 1 [2]  2/211 (0.95%)  2 3/212 (1.42%)  3 4/213 (1.88%)  4
Bronchospasm * 1 [2]  2/211 (0.95%)  2 2/212 (0.94%)  2 0/213 (0.00%)  0
Cough * 1 [2]  4/211 (1.90%)  4 8/212 (3.77%)  8 5/213 (2.35%)  5
Nasal congestion * 1 [2]  3/211 (1.42%)  3 3/212 (1.42%)  3 4/213 (1.88%)  4
Oropharyngeal pain * 1 [2]  1/211 (0.47%)  1 1/212 (0.47%)  1 2/213 (0.94%)  2
Pulmonary congestion * 1 [2]  0/211 (0.00%)  0 1/212 (0.47%)  1 0/213 (0.00%)  0
Rhinitis allergic * 1 [2]  2/211 (0.95%)  2 2/212 (0.94%)  2 1/213 (0.47%)  1
Rhinorrhoea * 1 [2]  1/211 (0.47%)  1 0/212 (0.00%)  0 0/213 (0.00%)  0
Asthma * 1 [1]  1/211 (0.47%)  1 3/212 (1.42%)  3 1/213 (0.47%)  1
Bronchospasm * 1 [1]  1/211 (0.47%)  1 1/212 (0.47%)  1 2/213 (0.94%)  2
Cough * 1 [1]  4/211 (1.90%)  4 2/212 (0.94%)  2 0/213 (0.00%)  0
Nasal congestion * 1 [1]  4/211 (1.90%)  4 4/212 (1.89%)  4 2/213 (0.94%)  2
Oropharyngeal pain * 1 [1]  5/211 (2.37%)  5 2/212 (0.94%)  2 2/213 (0.94%)  2
Postnasal drip * 1 [1]  0/211 (0.00%)  0 1/212 (0.47%)  1 0/213 (0.00%)  0
Rhinitis allergic * 1 [1]  2/211 (0.95%)  2 2/212 (0.94%)  2 3/213 (1.41%)  3
Skin and subcutaneous tissue disorders       
Redness  1 [3]  15/211 (7.11%)  15 15/212 (7.08%)  15 12/213 (5.63%)  12
Redness  1 [4]  16/211 (7.58%)  16 7/212 (3.30%)  7 8/213 (3.76%)  8
Pruritus  1 [3]  20/211 (9.48%)  20 19/212 (8.96%)  19 13/213 (6.10%)  13
Rash  1 [3]  13/211 (6.16%)  13 16/212 (7.55%)  16 9/213 (4.23%)  9
Pruritus  1 [4]  5/211 (2.37%)  5 8/212 (3.77%)  8 6/213 (2.82%)  6
Rash  1 [4]  5/211 (2.37%)  5 4/212 (1.89%)  4 1/213 (0.47%)  1
Dermatitis allergic * 1 [2]  1/211 (0.47%)  1 0/212 (0.00%)  0 0/213 (0.00%)  0
Dermatitis atopic * 1 [2]  1/211 (0.47%)  1 0/212 (0.00%)  0 2/213 (0.94%)  2
Rash * 1 [2]  1/211 (0.47%)  1 1/212 (0.47%)  1 0/213 (0.00%)  0
Rash generalized * 1 [2]  0/211 (0.00%)  0 0/212 (0.00%)  0 1/213 (0.47%)  1
Rash macular * 1 [2]  0/211 (0.00%)  0 1/212 (0.47%)  1 0/213 (0.00%)  0
Skin lesion * 1 [2]  0/211 (0.00%)  0 0/212 (0.00%)  0 1/213 (0.47%)  1
Urticaria * 1 [2]  1/211 (0.47%)  1 0/212 (0.00%)  0 0/213 (0.00%)  0
Dermititis allergic * 1 [1]  2/211 (0.95%)  2 0/212 (0.00%)  0 0/213 (0.00%)  0
Dermatitis atopic * 1 [1]  1/211 (0.47%)  1 0/212 (0.00%)  0 0/213 (0.00%)  0
Dermatitis contact * 1 [1]  0/211 (0.00%)  0 0/212 (0.00%)  0 1/213 (0.47%)  1
Petechiae * 1 [1]  0/211 (0.00%)  0 1/212 (0.47%)  1 0/213 (0.00%)  0
Rash * 1 [1]  0/211 (0.00%)  0 2/212 (0.94%)  2 0/213 (0.00%)  0
Rash papular * 1 [1]  1/211 (0.47%)  1 0/212 (0.00%)  0 0/213 (0.00%)  0
1
Term from vocabulary, MedDRA (Unspecified)
*
Indicates events were collected by non-systematic assessment
[1]
Ages 5 - 50
[2]
Ages 1 to 4
Indicates events were collected by systematic assessment
[3]
Dose 1
[4]
Dose 2
Certain Agreements
Principal Investigators are NOT employed by the organization sponsoring the study.
There is NOT 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: Faina Rose, PhD
Organization: GSK
Phone: 610-664-8986
EMail: faina.v.rose@gsk.com
Layout table for additonal information
Responsible Party: U.S. Army Medical Research and Development Command
ClinicalTrials.gov Identifier: NCT00468858     History of Changes
Other Study ID Numbers: A-14040
WIRB number 20070071 ( Other Identifier: Western Institutional Review Boards (WIRB) )
106405 ( Other Identifier: GSK )
T-DEN-003 ( Other Identifier: MRMC/WRAIR )
First Submitted: May 1, 2007
First Posted: May 3, 2007
Results First Submitted: February 8, 2017
Results First Posted: June 6, 2017
Last Update Posted: July 2, 2017