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A Phase I/II Trial of a Tetravalent Live Attenuated DEN Vaccine in Flavivirus Antibody Naive Children

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ClinicalTrials.gov Identifier: NCT01843621
Recruitment Status : Completed
First Posted : April 30, 2013
Results First Posted : November 26, 2018
Last Update Posted : November 26, 2018
Sponsor:
Collaborator:
GlaxoSmithKline
Information provided by (Responsible Party):
U.S. Army Medical Research and Materiel Command

Study Type Interventional
Study Design Intervention Model: Single Group Assignment;   Masking: None (Open Label);   Primary Purpose: Prevention
Condition Dengue
Intervention Biological: DEN vaccine F17
Enrollment 7
Recruitment Details Seven Thai children from the Dengue-03 study will be invited to participate
Pre-assignment Details  
Arm/Group Title Total Vaccinated
Hide Arm/Group Description

The total vaccinated cohort included all enrolled subjects who received the DEN vaccine F17 for whom data were available. These subjects were Thai children previously enrolled and vaccinated in study Dengue-003

DEN vaccine F17: The dengue booster vaccine was administered subcutaneously in the non-dominant arm (deltoid). The tetravalent, live attenuated DEN F17 vaccine was administered in this study. This pre-transfection formulation contained dengue virus types 1, 2, 3 and 4 (DEN-1, -2, -3 and -4).

Period Title: Overall Study
Started 7
Completed 7
Not Completed 0
Arm/Group Title Total Vaccinated
Hide Arm/Group Description

The total vaccinated cohort included all enrolled subjects who received the DEN vaccine F17 for whom data were available. These subjects were Thai children previously enrolled and vaccinated in study Dengue-003

DEN vaccine F17: The dengue booster vaccine was administered subcutaneously in the non-dominant arm (deltoid). The tetravalent, live attenuated DEN F17 vaccine was administered in this study. This pre-transfection formulation contained dengue virus types 1, 2, 3 and 4 (DEN-1, -2, -3 and -4).

Overall Number of Baseline Participants 7
Hide Baseline Analysis Population Description
[Not Specified]
Age, Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 7 participants
8.3  (0.49)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 7 participants
Female
5
  71.4%
Male
2
  28.6%
Region of Enrollment  
Measure Type: Number
Unit of measure:  Participants
Thailand Number Analyzed 7 participants
7
1.Primary Outcome
Title Percentage of Subjects With Seropositivity Rates for Antibodies to DEN-1 - DEN-4 (ATP Cohort for Immunogenicity)
Hide Description Neutralizing antibodies as measured by plaque reduction neutralization test (seropositivity rates to each dengue virus serotype at Prebooster Year 1, 30 Days Post Booster, Year 2, and Year 3 time points.
Time Frame Prebooster Year 1, 30 Days Post Booster, Year 2, and Year 3
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
Immunogenicity data for one subject was not included in the ATP analysis due to an asymptomatic, sub-clinical, wild-type DEN-2 virus infection prior to DEN vaccine dose 1
Arm/Group Title > 10 ED50
Hide Arm/Group Description:
Seropositivity rates (% of subjects)
Overall Number of Participants Analyzed 6
Mean (95% Confidence Interval)
Unit of Measure: % of subjects
N lg to DEN-1: Prebooster Year 1
16.7
(0.4 to 64.1)
N lg to DEN-1: 30 Days Post Booster
83.3
(35.9 to 99.6)
N lg to DEN-1: Year 2
16.7
(0.4 to 64.1)
N lg to DEN-1: Year 3
66.7
(22.3 to 95.7)
N lg to DEN-2: Prebooster Year 1
50.0
(11.8 to 88.2)
N lg to DEN-2: 30 Days Post Booster
100
(54.1 to 100)
N lg to DEN-2: Year 2
66.7
(22.3 to 95.7)
N lg to DEN-2: Year 3
83.3
(35.9 to 99.6)
N lg to DEN-3: Prebooster Year 1
33.3
(4.3 to 77.7)
N lg to DEN-3: 30 Days Post Booster
100
(54.1 to 100)
N lg to DEN-3: Year 2
33.3
(4.3 to 77.7)
N lg to DEN-3: Year 3
50.0
(11.8 to 88.2)
N lg to DEN-4: Prebooster Year 1
50.0
(11.8 to 88.2)
N lg to DEN-4: 30 days Post Booster
100
(54.1 to 100)
N lg to DEN-4: Year 2
50.0
(11.8 to 88.2)
N lg to DEN-4: Year 3
100
(54.1 to 100)
2.Primary Outcome
Title Geometric Mean Titers (GMTs) on All Subjects for Antibodies to DEN-1 - DEN-4 (ATP Cohort for Immunogenicity)
Hide Description Neutralizing antibodies as measured by plaque reduction neutralization test (geometric mean titers [GMTs]) to each dengue virus serotype at Prebooster Year 1, 30 Days Post Booster, Year 2, and Year 3 time points.
Time Frame Prebooster Year 1, 30 Days Post Booster, Year 2, and Year 3
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Geometric Mean Titer (GMT)
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Geometric mean antibody titer value
Overall Number of Participants Analyzed 6
Mean (95% Confidence Interval)
Unit of Measure: GMTs
N lg to DEN-1: Pre-booster Year 1
6.0
(3.8 to 9.6)
N lg to DEN-1: 30 Days Post-booster
28.2
(6.6 to 121.3)
N lg to DEN-1: Year 2
6.8
(3.1 to 15.1)
N lg to DEN-1: Year 3
18.0
(5.2 to 63.0)
N lg to DEN-2: Pre-booster Year 1
16.8
(3.4 to 82.5)
N lg to DEN-2: 30 Day Post-booster
94.4
(24.0 to 370.3)
N lg to DEN-2: Year 2
20.8
(4.6 to 92.9)
N lg to DEN-2: Year 3
36.3
(7.0 to 186.8)
N lg to DEN-3: Pre-booster Year 1
12.8
(2.1 to 77.5)
N lg to DEN-3: 30 Days post-booster
67.2
(9.3 to 487.2)
N lg to DEN-3: Year 2
9.4
(2.8 to 31.7)
N lg to DEN-3: Year 3
12.9
(4.1 to 41.3)
N lg to DEN-4: Pre-booster Year 1
27.0
(3.6 to 200.7)
N lg to DEN-4: 30 Days Post-booster
112.0
(26.5 to 473.1)
N lg to DEN-4: Year 2
25.4
(3.5 to 182.1)
N lg to DEN-4: Year 3
70.4
(23.9 to 207.4)
3.Secondary Outcome
Title Solicited Local Adverse Events (AEs) Within 21 Day Follow-up
Hide Description Incidence of solicited local symptoms reported during the 21-day post-vaccination (total vaccination cohort).
Time Frame 21 days
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
Incidence of solicited local symptoms reported during the 21-day post-vaccination (total vaccination cohort).
Arm/Group Title Total Vaccinated
Hide Arm/Group Description:

The total vaccinated cohort included all enrolled subjects who received the DEN vaccine F17 for whom data were available. These subjects were Thai children previously enrolled and vaccinated in study Dengue-003

DEN vaccine F17: The dengue booster vaccine was administered subcutaneously in the non-dominant arm (deltoid). The tetravalent, live attenuated DEN F17 vaccine was administered in this study. This pre-transfection formulation contained dengue virus types 1, 2, 3 and 4 (DEN-1, -2, -3 and -4).

Overall Number of Participants Analyzed 7
Measure Type: Number
Unit of Measure: Adverse events
Pain: All 3
Pain: Grade 3 0
Redness: All 3
Redness: Grade 3 0
Swelling: All 4
Swelling: Grade 3 1
4.Secondary Outcome
Title Unsolicited Adverse Events (AEs) Within 31 Days Post Vaccination
Hide Description Percentage of subjects reporting unsolicited AEs within 31 days (Day 0-30) after the DEN vaccine dose (total vaccinated cohort)
Time Frame 31 days
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
Percentage of subjects reporting unsolicited AEs within 31 days (Day 0-30) after the DEN vaccine dose (total vaccinated cohort)
Arm/Group Title Total Vaccinated
Hide Arm/Group Description:

The total vaccinated cohort included all enrolled subjects who received the DEN vaccine F17 for whom data were available. These subjects were Thai children previously enrolled and vaccinated in study Dengue-003

DEN vaccine F17: The dengue booster vaccine was administered subcutaneously in the non-dominant arm (deltoid). The tetravalent, live attenuated DEN F17 vaccine was administered in this study. This pre-transfection formulation contained dengue virus types 1, 2, 3 and 4 (DEN-1, -2, -3 and -4).

Overall Number of Participants Analyzed 7
Measure Type: Number
Number (95% Confidence Interval)
Unit of Measure: Percentage of subjects
At Least One Symptom
85.7
(42.1 to 99.6)
Infections and Infestations
14.3
(0.4 to 57.9)
Injury, Poisoning and Procedural Complications
14.3
(0.4 to 57.9)
Nervous System Disorders
42.9
(9.9 to 81.6)
Renal and Urinary Disorders
14.3
(0.4 to 57.9)
Respiratory, Thoracic and Mediastinal Disorders
28.6
(3.7 to 71.0)
5.Secondary Outcome
Title Serious Adverse Events (SAE) Within 31 Days Post Vaccination
Hide Description Occurrence of SAEs within 31 days (Day 0-30) after vaccination
Time Frame 31 days
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
Occurrence of SAEs within 31 days (Day 0-30) after vaccination
Arm/Group Title Total Vaccinated
Hide Arm/Group Description:

The total vaccinated cohort included all enrolled subjects who received the DEN vaccine F17 for whom data were available. These subjects were Thai children previously enrolled and vaccinated in study Dengue-003

DEN vaccine F17: The dengue booster vaccine was administered subcutaneously in the non-dominant arm (deltoid). The tetravalent, live attenuated DEN F17 vaccine was administered in this study. This pre-transfection formulation contained dengue virus types 1, 2, 3 and 4 (DEN-1, -2, -3 and -4).

Overall Number of Participants Analyzed 7
Measure Type: Count of Participants
Unit of Measure: Participants
0
   0.0%
6.Secondary Outcome
Title Abnormal Findings Reported During Physical Exam 31-Days Post Vaccination
Hide Description Incidence of dengue physical examination findings reported during the 31-day post-vaccination period (total vaccinated cohort)
Time Frame 31 days
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
Incidence of dengue physical examination findings reported during the 31-day post-vaccination period (total vaccinated cohort)
Arm/Group Title Total Vaccinated
Hide Arm/Group Description:

The total vaccinated cohort included all enrolled subjects who received the DEN vaccine F17 for whom data were available. These subjects were Thai children previously enrolled and vaccinated in study Dengue-003

DEN vaccine F17: The dengue booster vaccine was administered subcutaneously in the non-dominant arm (deltoid). The tetravalent, live attenuated DEN F17 vaccine was administered in this study. This pre-transfection formulation contained dengue virus types 1, 2, 3 and 4 (DEN-1, -2, -3 and -4).

Overall Number of Participants Analyzed 7
Measure Type: Number
Number (95% Confidence Interval)
Unit of Measure: Percentage of subjects
42.9
(9.9 to 86.6)
7.Secondary Outcome
Title Monovalent, Bivalent, Trivalent and Tetravalent Response for Neutralizing Antibodies 30 Days Post Booster
Hide Description Monovalent, Bivalent, Trivalent and Tetravalent response for DEN neut. antibodies 30 days post booster dose vaccine (ATP cohort for immunogenicity)
Time Frame Prebooster year 1, 30 Days Post Booster, Year 2, Year 3
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
Monovalent, Bivalent, Trivalent and Tetravalent response for DEN neut. antibodies 30 days post booster dose vaccine (ATP cohort for immunogenicity). Immunogenicity data for one subject was not included in the ATP analysis due to an asymptomatic, sub-clinical, wild-type DEN-2 virus infection prior to DEN vaccine dose 1
Arm/Group Title Total Vaccinated
Hide Arm/Group Description:

The total vaccinated cohort included all enrolled subjects who received the DEN vaccine F17 for whom data were available. These subjects were Thai children previously enrolled and vaccinated in study Dengue-003

DEN vaccine F17: The dengue booster vaccine was administered subcutaneously in the non-dominant arm (deltoid). The tetravalent, live attenuated DEN F17 vaccine was administered in this study. This pre-transfection formulation contained dengue virus types 1, 2, 3 and 4 (DEN-1, -2, -3 and -4).

Overall Number of Participants Analyzed 6
Measure Type: Number
Number (95% Confidence Interval)
Unit of Measure: percentage of subjects
Pre-Booster Year 1: Monovalent
16.67
(0.42 to 64.12)
Pre-Booster Year 1: Bivalent
33.33
(4.33 to 77.72)
Pre-Booster Year 1: Trivalent
0.00
(0.00 to 45.93)
Pre-Booster Year 1: Tetravalent
16.67
(0.42 to 64.12)
30 Days Post Booster: Monovalent
0.00
(0.00 to 45.93)
30 Days Post Booster: Bivalent
0.00
(0.00 to 45.93)
30 Days post Booster: Trivalent
16.67
(0.42 to 64.12)
30 Days Post Booster: Tetravalent
83.33
(35.88 to 99.58)
Year 2: Monovalent
33.33
(4.33 to 77.72)
Year 2: Bivalent
33.33
(4.33 to 77.72)
Year 2: Trivalent
0.00
(0.00 to 45.93)
Year 2: Tetravalent
16.67
(0.42 to 64.12)
Year 3: Monovalent
0.00
(0.00 to 45.93)
Year 3: Bivalent
33.33
(4.33 to 77.72)
Year 3: Trivalent
33.33
(4.33 to 77.72)
Year 3: Tetravalent
33.33
(4.33 to 77.72)
8.Secondary Outcome
Title Presence of Dengue Viremia 10 Days After the Dengue Vaccine Dose
Hide Description Nested Polymerase Chain Reaction (PCR) for DEN was conducted on day 10 after DEN booster vaccination to evaluate the presence of Dengue viremia 10 days after vaccination
Time Frame 10 days
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
Nested PCR for DEN was conducted on day 10 after DEN booster vaccination to evaluate the presence of Dengue viremia 10 days after vaccination
Arm/Group Title Total Vaccinated
Hide Arm/Group Description:

The total vaccinated cohort included all enrolled subjects who received the DEN vaccine F17 for whom data were available. These subjects were Thai children previously enrolled and vaccinated in study Dengue-003

DEN vaccine F17: The dengue booster vaccine was administered subcutaneously in the non-dominant arm (deltoid). The tetravalent, live attenuated DEN F17 vaccine was administered in this study. This pre-transfection formulation contained dengue virus types 1, 2, 3 and 4 (DEN-1, -2, -3 and -4).

Overall Number of Participants Analyzed 7
Measure Type: Count of Participants
Unit of Measure: Participants
1
  14.3%
9.Secondary Outcome
Title Flavivirus Infection in Terms of Dengue Immunoglobulin M and Immunoglobulin G Per Subject (ATP Cohort for Immunogenicity)
Hide Description

The ratio of DEN Immunoglobulin type M and G (IgM:IgG) measured at the time of booster vaccination and 30 days following was used to assess intercurrent flavivirus infection. Flavivirus infection in terms of dengue IgM and IgG and Japanese encephalitis virus (JEV) IgM and IgG is summarized.

Flavivirus immunity= ratio IgM on IgG <1.8 with either IgM or IgM >1:40

If the antibody response is detectable by isotype capture enzyme immunoassay (either the IgM or IgG component ≥40 U), its anamnestic character can be inferred from detection of a DEN IgM to IgG ratio of <1.8.

Time Frame 1 year, 30 Days Post Booster, 2 years
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Ratio IgM and IgG
Hide Arm/Group Description:
Ratio of Dengue (DEN) IgM and IgG and Japanese encephalitis virus (JEV) IgM and IgG (ATP cohort for immunogenicity)
Overall Number of Participants Analyzed 6
Measure Type: Number
Unit of Measure: Flavivirus immunity ratio
DEN Subject 2: 1 Year Ratio 0
DEN Subject 2: 30 Days Post Booster Ratio 0.3
DEN Subject 2: Year 2 Ratio 0
JEV Subject 2: Year 1 Ratio 0
JEV Subject 2: 30 Days Post Booster Ratio 0.4
JEV Subject 2: Year 2 Ratio 0
DEN Subject 3: Year 1 Ratio 0
DEN Subject 3: 30 Days Post Booster Ratio 0
DEN Subject 3: Year 2 Ratio 0
JEV Subject 3: Year 1 Ratio 0
JEV Subject 3: 30 Days Post Booster Ratio 0
JEV Subject 3: Year 2 Ratio 0
DEN Subject 4: Year 1 Ratio 0
DEN Subject 4: 30 Days Post Booster Ratio 0
DEN Subject 4: Year 2 Ratio 0
JEV Subject 4: Year 1 Ratio 0
JEV Subject 4: Year 2 Ratio 0
DEN Subject 5: Year 1 Ratio 0
DEN Subject 5: 30 Days Post Booster Ratio 0
DEN Subject 5: Year 2 Ratio 0
JEV Subject 5: Year 1 Ratio 0
JEV Subject 5: 30 Days Post Booster Ratio 0
JEV Subject 5: Year 2 Ratio 0
DEN Subject 6: Year 1 Ratio 0
DEN Subject 6: 30 Days Post Booster Ratio 0
DEN Subject 6: Year 2 Ratio 0
JEV Subject 6: Year 1 Ratio 0
JEV Subject 6: 30 Days Post Booster Ratio 0
JEV Subject 6: Year 2 Ratio 0
DEN Subject 7: Year 1 Ratio 0
DEN Subject 7: 30 Days Post Booster Ratio 0
DEN Subject 7: Year 2 Ratio 0
JEV Subject 7: Year 1 Ratio 0
JEV Subject 7: 30 Days Post Ratio 0
JEV Subject 7: Year 2 Ratio 0
10.Secondary Outcome
Title Subject Biochemistry and Hematology Parameters Monitored for Alert Levels
Hide Description

Clinical safety laboratory test were monitored for alert levels. Tests were performed by Laser scattering using Cell Dyn 3500 and Serum chemistry conducted by Kinetic method using Hitachi 717.

Normal Ranges:

Alanine Aminotransferases (ALT): LNL=0 and UNL=30 Aspartate Aminotransferases (AST): LNL=0 and UNL=40 Platelet (PLA): LNL=150000 and UNL=350000 Hematocrit (HC): LNL=35 and UNL=45 Neutrophil (NEU): LNL=1500 and UNL=8000

Time Frame Year 1 (day 0); Year 1 (day 30); Year 2
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
Tests were performed by Laser scattering using Cell Dyn 3500 and Serum chemistry conducted by Kinetic method using Hitachi 717. Tests included ALT, AST, PLA, HC, and NEU levels.
Arm/Group Title ALT Level AST Level PLA Level HC Level NEU Level
Hide Arm/Group Description:
Normal Range = 0-30
Normal Range = 0-40
Normal Range = 150000-350000
Normal Range = 35-45
Normal Range = 1500-8000
Overall Number of Participants Analyzed 7 7 7 7 7
Measure Type: Number
Unit of Measure: U/L
Subject 1: Year 1, Day 0 15 28 494000 37 2820
Subject 1: Year 1, Day 10 15 34 369000 37.1 3020
Subject 1: Year 1, Day 30 12 32 411000 39.3 3000
Subject 1: Year 2 12 23 502000 38.9 4790
Subject 2: Year 1, Day 0 10 29 293000 36.1 3210
Subject 2: Year 1, Day 10 13 30 248000 36.9 2770
Subject 2: Year 1, Day 30 12 31 296000 35.9 3070
Subject 2: Year 2 11 28 323000 38.4 2400
Subject 3: Year 1, Day 0 51 28 270000 39.3 2580
Subject 3: Year 1, Day 10 68 44 272000 41.8 3750
Subject 3: Year 1, Day 30 68 36 303000 42.3 4380
Subject 3: Year 2 46 33 306000 40.4 5170
Subject 4: Year 1, Day 0 11 24 280000 38.8 3320
Subject 4: Year 1, Day 10 12 23 253000 39.9 3460
Subject 4: Year 1, Day 30 13 34 297000 41.8 3320
Subject 4: Year 2 16 34 231000 43.1 3900
Subject 5: Year 1, Day 0 49 45 403000 39 3950
Subject 5: Year 1, Day 10 28 36 415000 40.2 4580
Subject 5: Year 1, Day 30 41 49 329000 38.8 2970
Subject 5: Year 2 26 29 346000 36.6 5920
Subject 6: Year 1, Day 0 10 27 440000 36.6 3020
Subject 6, Year 1, Day 10 13 28 434000 38 3390
Subject 6, Year 1, Day 30 12 28 417000 35.4 2690
Subject 6, Year 2 16 35 461000 39.7 3840
Subject 7: Year 1, Day 0 11 27 244000 38.6 3460
Subject 7: Year 1, Day 10 12 26 238000 37.1 3050
Subject 7: Year 1, Day 30 10 29 270000 38.4 2940
Subject 7, Year 2 13 27 311000 41.4 4240
Time Frame 21 days post vaccination period following each dose
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title Total Vaccinated
Hide Arm/Group Description

The total vaccinated cohort included all enrolled subjects who received the DEN vaccine F17 for whom data were available. These subjects were Thai children previously enrolled and vaccinated in study Dengue-003

DEN vaccine F17: The dengue booster vaccine was administered subcutaneously in the non-dominant arm (deltoid). The tetravalent, live attenuated DEN F17 vaccine was administered in this study. This pre-transfection formulation contained dengue virus types 1, 2, 3 and 4 (DEN-1, -2, -3 and -4).

All-Cause Mortality
Total Vaccinated
Affected / at Risk (%)
Total   --/--    
Show Serious Adverse Events Hide Serious Adverse Events
Total Vaccinated
Affected / at Risk (%) # Events
Total   0/7 (0.00%)    
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 0%
Total Vaccinated
Affected / at Risk (%) # Events
Total   7/7 (100.00%)    
Eye disorders   
Pain behind eyes  1 [1]  1/7 (14.29%)  1
Pain behind eyes  1 [2]  1/7 (14.29%)  1
Photophobia  1 [1]  1/7 (14.29%)  1
Photophobia  1 [2]  1/7 (14.29%)  1
Gastrointestinal disorders   
Abdominal pain  1 [1]  1/7 (14.29%)  1
Abdominial Pain  1 [2]  0/7 (0.00%)  0
Nausea  1 [1]  0/7 (0.00%)  0
Nausea  1 [2]  0/7 (0.00%)  0
Vomiting  1 [1]  0/7 (0.00%)  0
Vomiting  1 [2]  0/7 (0.00%)  0
General disorders   
Fatigue  1 [1]  4/7 (57.14%)  4
Fatigue  1 [2]  0/7 (0.00%)  0
Fever (Axillary)  1 [1]  1/7 (14.29%)  1
Fever (Axillary)  1 [2]  0/7 (0.00%)  0
Musculoskeletal and connective tissue disorders   
Arthralgia  1 [1]  0/7 (0.00%)  0
Arthralgia  1 [2]  1/7 (14.29%)  1
Muscle aches  1 [1]  3/7 (42.86%)  3
Muscle aches  1 [2]  1/7 (14.29%)  1
Nervous system disorders   
Headache  1 [1]  1/7 (14.29%)  1
Headache  1 [2]  1/7 (14.29%)  1
Skin and subcutaneous tissue disorders   
Pruritus  1 [1]  1/7 (14.29%)  1
Pruritus  1 [2]  0/7 (0.00%)  0
Rash  1 [1]  1/7 (14.29%)  1
Rash  1 [2]  0/7 (0.00%)  0
Indicates events were collected by systematic assessment
1
Term from vocabulary, MedDRA (Unspecified)
[1]
< 2 days
[2]
> 2 days
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
Name/Title: Sriluck Simasathien, MD
Organization: Dept of Pediatrics, Pharmongkutklao Hospital, Bankok, Thailand
Phone: 66-2-644-8971
Responsible Party: U.S. Army Medical Research and Materiel Command
ClinicalTrials.gov Identifier: NCT01843621     History of Changes
Obsolete Identifiers: NCT00318916
Other Study ID Numbers: A-13227
GSK 103795 ( Other Identifier: GSK )
WRAIR 1159 ( Other Identifier: WRAIR )
First Submitted: April 22, 2013
First Posted: April 30, 2013
Results First Submitted: December 29, 2016
Results First Posted: November 26, 2018
Last Update Posted: November 26, 2018