Trial Outcomes & Findings for Traveler's Diarrhea (TD) Automated Process (NCT NCT00751777)
NCT ID: NCT00751777
Last Updated: 2020-01-29
Results Overview
Recruitment status
COMPLETED
Study phase
PHASE2
Target enrollment
120 participants
Primary outcome timeframe
Day 0, Day 14, Day 21, Day 28, Day 35, Day 90, Day 194
Results posted on
2020-01-29
Participant Flow
Participant milestones
| Measure |
Group 1: 37.5 µg LT Patch
heat-labile enterotoxin of E. coli (LT): Travelers' Diarrhea Vaccine System
|
Group 2: 0 µg LT Patch (Placebo)
Placebo: Travelers' Diarrhea Vaccine System
|
|---|---|---|
|
Overall Study
STARTED
|
81
|
39
|
|
Overall Study
COMPLETED
|
70
|
36
|
|
Overall Study
NOT COMPLETED
|
11
|
3
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Traveler's Diarrhea (TD) Automated Process
Baseline characteristics by cohort
| Measure |
Group 1: 37.5 µg LT Patch
n=81 Participants
heat-labile enterotoxin of E. coli (LT): Travelers' Diarrhea Vaccine System
|
Group 2: 0 µg LT Patch (Placebo)
n=39 Participants
Placebo: Travelers' Diarrhea Vaccine System
|
Total
n=120 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
34.1 years
STANDARD_DEVIATION 10.2 • n=93 Participants
|
35.3 years
STANDARD_DEVIATION 13.0 • n=4 Participants
|
34.5 years
STANDARD_DEVIATION 11.2 • n=27 Participants
|
|
Sex: Female, Male
Female
|
46 Participants
n=93 Participants
|
26 Participants
n=4 Participants
|
72 Participants
n=27 Participants
|
|
Sex: Female, Male
Male
|
35 Participants
n=93 Participants
|
13 Participants
n=4 Participants
|
48 Participants
n=27 Participants
|
PRIMARY outcome
Timeframe: Day 0, Day 14, Day 21, Day 28, Day 35, Day 90, Day 194Population: Immunogenicity Evaluable Population (IEP): all study subjects who are consented, randomized, received the assigned treatments (both vaccinations), and had blood drawn for immunogenicity testing at baseline (Day 0) and both of the following time points: Day 21 and Day 35.
Outcome measures
| Measure |
Group 1: 37.5 µg LT Patch
n=76 Participants
heat-labile enterotoxin of E. coli (LT): Travelers' Diarrhea Vaccine System
|
Group 2: 0 µg LT Patch (Placebo)
n=34 Participants
Placebo: Travelers' Diarrhea Vaccine System
|
|---|---|---|
|
Geometric Mean Titer (GMT) After First and Second Vaccination With LT Vaccine Patch and Comparison Against Placebo
GMT LT IgG - Day 90
|
6823.7 geometric mean titer
Interval 5553.1 to 8385.1
|
156.2 geometric mean titer
Interval 114.5 to 213.1
|
|
Geometric Mean Titer (GMT) After First and Second Vaccination With LT Vaccine Patch and Comparison Against Placebo
GMT LT IgG - Day 0
|
432.6 geometric mean titer
Interval 349.0 to 536.2
|
400.5 geometric mean titer
Interval 290.5 to 552.2
|
|
Geometric Mean Titer (GMT) After First and Second Vaccination With LT Vaccine Patch and Comparison Against Placebo
GMT LT IgG - Day 14
|
4477.5 geometric mean titer
Interval 3249.6 to 6169.4
|
490.6 geometric mean titer
Interval 303.8 to 792.2
|
|
Geometric Mean Titer (GMT) After First and Second Vaccination With LT Vaccine Patch and Comparison Against Placebo
GMT LT IgG - Day 21
|
9107.7 geometric mean titer
Interval 6791.9 to 12213.0
|
462.1 geometric mean titer
Interval 298.0 to 716.6
|
|
Geometric Mean Titer (GMT) After First and Second Vaccination With LT Vaccine Patch and Comparison Against Placebo
GMT LT IgG - Day 28
|
13411.9 geometric mean titer
Interval 10420.0 to 17263.5
|
372.6 geometric mean titer
Interval 255.4 to 543.4
|
|
Geometric Mean Titer (GMT) After First and Second Vaccination With LT Vaccine Patch and Comparison Against Placebo
GMT LT IgG - Day 35
|
15024.3 geometric mean titer
Interval 11893.0 to 18979.4
|
383.6 geometric mean titer
Interval 270.5 to 544.0
|
|
Geometric Mean Titer (GMT) After First and Second Vaccination With LT Vaccine Patch and Comparison Against Placebo
GMT LT IgG - Day 194
|
2489.2 geometric mean titer
Interval 1965.5 to 3152.4
|
100.2 geometric mean titer
Interval 70.7 to 142.0
|
|
Geometric Mean Titer (GMT) After First and Second Vaccination With LT Vaccine Patch and Comparison Against Placebo
GMT LT IgA - Day 0
|
49.4 geometric mean titer
Interval 37.4 to 65.1
|
58.9 geometric mean titer
Interval 38.9 to 89.1
|
|
Geometric Mean Titer (GMT) After First and Second Vaccination With LT Vaccine Patch and Comparison Against Placebo
GMT LT IgA - Day 14
|
395.6 geometric mean titer
Interval 289.9 to 539.8
|
59.1 geometric mean titer
Interval 37.2 to 94.1
|
|
Geometric Mean Titer (GMT) After First and Second Vaccination With LT Vaccine Patch and Comparison Against Placebo
GMT LT IgA - Day 21
|
619.2 geometric mean titer
Interval 466.2 to 822.4
|
60.9 geometric mean titer
Interval 39.8 to 93.0
|
|
Geometric Mean Titer (GMT) After First and Second Vaccination With LT Vaccine Patch and Comparison Against Placebo
GMT LT IgA - Day 28
|
780.0 geometric mean titer
Interval 603.8 to 1007.7
|
53.9 geometric mean titer
Interval 36.8 to 79.1
|
|
Geometric Mean Titer (GMT) After First and Second Vaccination With LT Vaccine Patch and Comparison Against Placebo
GMT LT IgA - Day 35
|
681.2 geometric mean titer
Interval 526.1 to 882.0
|
52.5 geometric mean titer
Interval 35.7 to 77.3
|
|
Geometric Mean Titer (GMT) After First and Second Vaccination With LT Vaccine Patch and Comparison Against Placebo
GMT LT IgA - Day 90
|
348.1 geometric mean titer
Interval 280.3 to 432.4
|
40.5 geometric mean titer
Interval 29.2 to 56.1
|
|
Geometric Mean Titer (GMT) After First and Second Vaccination With LT Vaccine Patch and Comparison Against Placebo
GMT LT IgA - Day 194
|
177.0 geometric mean titer
Interval 145.3 to 215.5
|
32.6 geometric mean titer
Interval 24.3 to 43.6
|
PRIMARY outcome
Timeframe: Day 14, Day 21, Day 28, Day 35, Day 90, Day 194Population: Immunogenicity Evaluable Population (IEP): all study subjects who are consented, randomized, received the assigned treatments (both vaccinations), and had blood drawn for immunogenicity testing at baseline (Day 0) and both of the following time points: Day 21 and Day 35.
GMFRs relative to the baseline titer were determined at each post-baseline time point. All GMFRs were based on log10-transformed data.
Outcome measures
| Measure |
Group 1: 37.5 µg LT Patch
n=76 Participants
heat-labile enterotoxin of E. coli (LT): Travelers' Diarrhea Vaccine System
|
Group 2: 0 µg LT Patch (Placebo)
n=34 Participants
Placebo: Travelers' Diarrhea Vaccine System
|
|---|---|---|
|
Geometric Mean Fold Ratio (GMFR) After First and Second Vaccination With LT Vaccine Patch and Comparison Against Placebo
GMFR LT IgG - Day 14
|
10.4 ratio
Interval 7.4 to 14.5
|
1.2 ratio
Interval 0.7 to 2.0
|
|
Geometric Mean Fold Ratio (GMFR) After First and Second Vaccination With LT Vaccine Patch and Comparison Against Placebo
GMFR LT IgG - Day 21
|
21.1 ratio
Interval 15.2 to 29.2
|
1.2 ratio
Interval 0.7 to 1.9
|
|
Geometric Mean Fold Ratio (GMFR) After First and Second Vaccination With LT Vaccine Patch and Comparison Against Placebo
GMFR LT IgG - Day 28
|
31.0 ratio
Interval 23.5 to 41.0
|
0.9 ratio
Interval 0.6 to 1.4
|
|
Geometric Mean Fold Ratio (GMFR) After First and Second Vaccination With LT Vaccine Patch and Comparison Against Placebo
GMFR LT IgG - Day 35
|
34.7 ratio
Interval 26.6 to 45.4
|
1.0 ratio
Interval 0.6 to 1.4
|
|
Geometric Mean Fold Ratio (GMFR) After First and Second Vaccination With LT Vaccine Patch and Comparison Against Placebo
GMFR LT IgG - Day 90
|
16.0 ratio
Interval 12.4 to 20.8
|
0.4 ratio
Interval 0.3 to 0.6
|
|
Geometric Mean Fold Ratio (GMFR) After First and Second Vaccination With LT Vaccine Patch and Comparison Against Placebo
GMFR LT IgG - Day 194
|
5.7 ratio
Interval 4.3 to 7.5
|
0.2 ratio
Interval 0.2 to 0.4
|
|
Geometric Mean Fold Ratio (GMFR) After First and Second Vaccination With LT Vaccine Patch and Comparison Against Placebo
GMFR LT IgA - Day 14
|
8.0 ratio
Interval 5.8 to 11.0
|
1.0 ratio
Interval 0.6 to 1.6
|
|
Geometric Mean Fold Ratio (GMFR) After First and Second Vaccination With LT Vaccine Patch and Comparison Against Placebo
GMFR LT IgA - Day 21
|
12.5 ratio
Interval 9.3 to 16.8
|
1.0 ratio
Interval 0.7 to 1.6
|
|
Geometric Mean Fold Ratio (GMFR) After First and Second Vaccination With LT Vaccine Patch and Comparison Against Placebo
GMFR LT IgA - Day 28
|
15.8 ratio
Interval 12.1 to 20.7
|
0.9 ratio
Interval 0.6 to 1.4
|
|
Geometric Mean Fold Ratio (GMFR) After First and Second Vaccination With LT Vaccine Patch and Comparison Against Placebo
GMFR LT IgA - Day 35
|
13.8 ratio
Interval 10.6 to 17.9
|
0.9 ratio
Interval 0.6 to 1.3
|
|
Geometric Mean Fold Ratio (GMFR) After First and Second Vaccination With LT Vaccine Patch and Comparison Against Placebo
GMFR LT IgA - Day 90
|
7.1 ratio
Interval 5.5 to 9.2
|
0.6 ratio
Interval 0.4 to 1.0
|
|
Geometric Mean Fold Ratio (GMFR) After First and Second Vaccination With LT Vaccine Patch and Comparison Against Placebo
GMFR LT IgA - Day 194
|
3.4 ratio
Interval 2.6 to 4.6
|
0.5 ratio
Interval 0.3 to 0.8
|
PRIMARY outcome
Timeframe: Day 14, Day 21, Day 28, Day 35, Day 90, Day 194Population: Immunogenicity Evaluable Population (IEP): all study subjects who are consented, randomized, received the assigned treatments (both vaccinations), and had blood drawn for immunogenicity testing at baseline (Day 0) and both of the following time points: Day 21 and Day 35.
Definition of SCR: * Seroconversion IgG: ≥ 2-fold rise of LT IgG titer relative to baseline * Seroconversion IgA: ≥ 4-fold rise of LT IgA titer relative to baseline
Outcome measures
| Measure |
Group 1: 37.5 µg LT Patch
n=76 Participants
heat-labile enterotoxin of E. coli (LT): Travelers' Diarrhea Vaccine System
|
Group 2: 0 µg LT Patch (Placebo)
n=34 Participants
Placebo: Travelers' Diarrhea Vaccine System
|
|---|---|---|
|
Seroconversion (SCR) After First and Second Vaccination With LT Vaccine Patch and Comparison Against Placebo
SCR LT IgG - Day 14
|
77.6 percentage of participants
Interval 66.6 to 86.4
|
8.8 percentage of participants
Interval 1.9 to 23.7
|
|
Seroconversion (SCR) After First and Second Vaccination With LT Vaccine Patch and Comparison Against Placebo
SCR LT IgG - Day 21
|
89.5 percentage of participants
Interval 80.3 to 95.3
|
8.8 percentage of participants
Interval 1.9 to 23.7
|
|
Seroconversion (SCR) After First and Second Vaccination With LT Vaccine Patch and Comparison Against Placebo
SCR LT IgG - Day 28
|
97.4 percentage of participants
Interval 90.8 to 99.7
|
2.9 percentage of participants
Interval 0.1 to 15.3
|
|
Seroconversion (SCR) After First and Second Vaccination With LT Vaccine Patch and Comparison Against Placebo
SCR LT IgG - Day 35
|
97.4 percentage of participants
Interval 90.8 to 99.7
|
5.9 percentage of participants
Interval 0.7 to 19.7
|
|
Seroconversion (SCR) After First and Second Vaccination With LT Vaccine Patch and Comparison Against Placebo
SCR LT IgG - Day 90
|
98.7 percentage of participants
Interval 92.8 to 100.0
|
9.1 percentage of participants
Interval 1.9 to 24.3
|
|
Seroconversion (SCR) After First and Second Vaccination With LT Vaccine Patch and Comparison Against Placebo
SCR LT IgG - Day 194
|
83.3 percentage of participants
Interval 72.7 to 91.1
|
0 percentage of participants
Interval 0.0 to 10.6
|
|
Seroconversion (SCR) After First and Second Vaccination With LT Vaccine Patch and Comparison Against Placebo
SCR LT IgA - Day 14
|
57.9 percentage of participants
Interval 46.0 to 69.1
|
0.0 percentage of participants
Interval 0.0 to 10.3
|
|
Seroconversion (SCR) After First and Second Vaccination With LT Vaccine Patch and Comparison Against Placebo
SCR LT IgA - Day 21
|
71.1 percentage of participants
Interval 59.5 to 80.9
|
0.0 percentage of participants
Interval 0.0 to 10.3
|
|
Seroconversion (SCR) After First and Second Vaccination With LT Vaccine Patch and Comparison Against Placebo
SCR LT IgA - Day 28
|
82.9 percentage of participants
Interval 72.5 to 90.6
|
0.0 percentage of participants
Interval 0.0 to 10.3
|
|
Seroconversion (SCR) After First and Second Vaccination With LT Vaccine Patch and Comparison Against Placebo
SCR LT IgA - Day 35
|
81.6 percentage of participants
Interval 71.0 to 89.5
|
2.9 percentage of participants
Interval 0.1 to 15.3
|
|
Seroconversion (SCR) After First and Second Vaccination With LT Vaccine Patch and Comparison Against Placebo
SCR LT IgA - Day 90
|
68.0 percentage of participants
Interval 56.2 to 78.3
|
3.0 percentage of participants
Interval 0.1 to 15.8
|
|
Seroconversion (SCR) After First and Second Vaccination With LT Vaccine Patch and Comparison Against Placebo
SCR LT IgA - Day 194
|
50.0 percentage of participants
Interval 38.0 to 62.0
|
0.0 percentage of participants
Interval 0.0 to 10.6
|
SECONDARY outcome
Timeframe: 13 monthsLT subjects (Group 1) were followed for six months longer (until Day 380) than Placebo subjects (Group 2) (until Day 194)
Outcome measures
| Measure |
Group 1: 37.5 µg LT Patch
n=81 Participants
heat-labile enterotoxin of E. coli (LT): Travelers' Diarrhea Vaccine System
|
Group 2: 0 µg LT Patch (Placebo)
n=39 Participants
Placebo: Travelers' Diarrhea Vaccine System
|
|---|---|---|
|
Evaluation of Safety of LT Vaccine Patch After First and Second Vaccination Compared to Placebo Patch
AEs : All AEs - vaccination 1
|
75 Participants
|
26 Participants
|
|
Evaluation of Safety of LT Vaccine Patch After First and Second Vaccination Compared to Placebo Patch
AEs : All AEs - vaccination 2
|
76 Participants
|
24 Participants
|
|
Evaluation of Safety of LT Vaccine Patch After First and Second Vaccination Compared to Placebo Patch
AEs : Local AEs - vaccination 1
|
73 Participants
|
19 Participants
|
|
Evaluation of Safety of LT Vaccine Patch After First and Second Vaccination Compared to Placebo Patch
AEs : Systemic AEs - vaccination 1
|
43 Participants
|
18 Participants
|
|
Evaluation of Safety of LT Vaccine Patch After First and Second Vaccination Compared to Placebo Patch
AEs : Local AEs - vaccination 2
|
73 Participants
|
13 Participants
|
|
Evaluation of Safety of LT Vaccine Patch After First and Second Vaccination Compared to Placebo Patch
AEs : Systemic AEs - vaccination 2
|
44 Participants
|
18 Participants
|
|
Evaluation of Safety of LT Vaccine Patch After First and Second Vaccination Compared to Placebo Patch
Severe AEs : All AEs - vaccination 1
|
2 Participants
|
2 Participants
|
|
Evaluation of Safety of LT Vaccine Patch After First and Second Vaccination Compared to Placebo Patch
Severe AEs : All AEs - vaccination 2
|
2 Participants
|
0 Participants
|
|
Evaluation of Safety of LT Vaccine Patch After First and Second Vaccination Compared to Placebo Patch
Severe AEs : Local AEs - vaccination 1
|
0 Participants
|
0 Participants
|
|
Evaluation of Safety of LT Vaccine Patch After First and Second Vaccination Compared to Placebo Patch
Severe AEs : Systemic AEs - vaccination 1
|
2 Participants
|
2 Participants
|
|
Evaluation of Safety of LT Vaccine Patch After First and Second Vaccination Compared to Placebo Patch
Severe AEs : Local AEs - vaccination 2
|
0 Participants
|
0 Participants
|
|
Evaluation of Safety of LT Vaccine Patch After First and Second Vaccination Compared to Placebo Patch
Severe AEs : Systemic AEs - vaccination 2
|
2 Participants
|
0 Participants
|
|
Evaluation of Safety of LT Vaccine Patch After First and Second Vaccination Compared to Placebo Patch
AEs requiring Treatment : All AEs - vaccination 1
|
24 Participants
|
6 Participants
|
|
Evaluation of Safety of LT Vaccine Patch After First and Second Vaccination Compared to Placebo Patch
AEs requiring Treatment : All AEs - vaccination 2
|
33 Participants
|
10 Participants
|
|
Evaluation of Safety of LT Vaccine Patch After First and Second Vaccination Compared to Placebo Patch
AEs requiring Treatment : Local AEs - vacc. 1
|
10 Participants
|
0 Participants
|
|
Evaluation of Safety of LT Vaccine Patch After First and Second Vaccination Compared to Placebo Patch
AEs requiring Treatment : Systemic AEs - vacc. 1
|
16 Participants
|
6 Participants
|
|
Evaluation of Safety of LT Vaccine Patch After First and Second Vaccination Compared to Placebo Patch
AEs requiring Treatment : Local AEs - vacc. 2
|
4 Participants
|
0 Participants
|
|
Evaluation of Safety of LT Vaccine Patch After First and Second Vaccination Compared to Placebo Patch
AEs requiring Treatment : Systemic AEs - vacc. 2
|
31 Participants
|
10 Participants
|
|
Evaluation of Safety of LT Vaccine Patch After First and Second Vaccination Compared to Placebo Patch
related AEs : All AEs - vaccination 1
|
74 Participants
|
20 Participants
|
|
Evaluation of Safety of LT Vaccine Patch After First and Second Vaccination Compared to Placebo Patch
related AEs : All AEs - vaccination 2
|
74 Participants
|
13 Participants
|
|
Evaluation of Safety of LT Vaccine Patch After First and Second Vaccination Compared to Placebo Patch
related AEs : Local AEs - vaccination 1
|
73 Participants
|
19 Participants
|
|
Evaluation of Safety of LT Vaccine Patch After First and Second Vaccination Compared to Placebo Patch
related AEs : Systemic AEs - vaccination 1
|
17 Participants
|
5 Participants
|
|
Evaluation of Safety of LT Vaccine Patch After First and Second Vaccination Compared to Placebo Patch
related AEs : Local AEs - vaccination 2
|
73 Participants
|
13 Participants
|
|
Evaluation of Safety of LT Vaccine Patch After First and Second Vaccination Compared to Placebo Patch
related AEs : Systemic AEs - vaccination 2
|
6 Participants
|
3 Participants
|
|
Evaluation of Safety of LT Vaccine Patch After First and Second Vaccination Compared to Placebo Patch
Serious AEs : All AEs - vaccination 1
|
0 Participants
|
1 Participants
|
|
Evaluation of Safety of LT Vaccine Patch After First and Second Vaccination Compared to Placebo Patch
Serious AEs : All AEs - vaccination 2
|
1 Participants
|
1 Participants
|
|
Evaluation of Safety of LT Vaccine Patch After First and Second Vaccination Compared to Placebo Patch
Serious AEs : Local AEs - vaccination 1
|
0 Participants
|
0 Participants
|
|
Evaluation of Safety of LT Vaccine Patch After First and Second Vaccination Compared to Placebo Patch
Serious AEs : Systemic AEs - vaccination 1
|
0 Participants
|
1 Participants
|
|
Evaluation of Safety of LT Vaccine Patch After First and Second Vaccination Compared to Placebo Patch
Serious AEs : Local AEs - vaccination 2
|
0 Participants
|
0 Participants
|
|
Evaluation of Safety of LT Vaccine Patch After First and Second Vaccination Compared to Placebo Patch
Serious AEs : Systemic AEs - vaccination 2
|
1 Participants
|
1 Participants
|
SECONDARY outcome
Timeframe: 1 monthPopulation: Summary statistics are only shown for the LT Group in a protocol pre-defined subset of subjects, results for the Placebo Group were below the Limit of detection in all cases
Outcome measures
| Measure |
Group 1: 37.5 µg LT Patch
n=22 Participants
heat-labile enterotoxin of E. coli (LT): Travelers' Diarrhea Vaccine System
|
Group 2: 0 µg LT Patch (Placebo)
Placebo: Travelers' Diarrhea Vaccine System
|
|---|---|---|
|
Evaluation of Residual LT in the Patch and on the Skin at the Patch Site Post-wear
Residual LT in the Swab (ng LT)
|
7231 nanograms (ng)
Standard Deviation 2939
|
—
|
|
Evaluation of Residual LT in the Patch and on the Skin at the Patch Site Post-wear
Residual LT in the Patch (ng LT)
|
15893 nanograms (ng)
Standard Deviation 6980
|
—
|
|
Evaluation of Residual LT in the Patch and on the Skin at the Patch Site Post-wear
Estimate of LT Delivered (ng LT)
|
14376 nanograms (ng)
Standard Deviation 7609
|
—
|
SECONDARY outcome
Timeframe: 13 monthsGMT
Outcome measures
| Measure |
Group 1: 37.5 µg LT Patch
n=76 Participants
heat-labile enterotoxin of E. coli (LT): Travelers' Diarrhea Vaccine System
|
Group 2: 0 µg LT Patch (Placebo)
Placebo: Travelers' Diarrhea Vaccine System
|
|---|---|---|
|
Evaluation of LT-specific Immune Responses One-year After Original Treatment Regimen in LT Patch Group
GMT LT IgG - Day 380
|
1653.7 GMT
Interval 1377.9 to 1984.8
|
—
|
|
Evaluation of LT-specific Immune Responses One-year After Original Treatment Regimen in LT Patch Group
GMT LT IgA - Day 380
|
122.3 GMT
Interval 98.3 to 152.1
|
—
|
SECONDARY outcome
Timeframe: 13 monthsGMFR
Outcome measures
| Measure |
Group 1: 37.5 µg LT Patch
n=76 Participants
heat-labile enterotoxin of E. coli (LT): Travelers' Diarrhea Vaccine System
|
Group 2: 0 µg LT Patch (Placebo)
Placebo: Travelers' Diarrhea Vaccine System
|
|---|---|---|
|
Evaluation of LT-specific Immune Responses One Year After Original Treatment Regimen in LT Patch Group
GMFR LT IgG - Day 380
|
3.8 ratio
Interval 3.0 to 4.9
|
—
|
|
Evaluation of LT-specific Immune Responses One Year After Original Treatment Regimen in LT Patch Group
GMFR LT IgA - Day 380
|
2.4 ratio
Interval 1.8 to 3.3
|
—
|
SECONDARY outcome
Timeframe: 13 monthsSCR
Outcome measures
| Measure |
Group 1: 37.5 µg LT Patch
n=76 Participants
heat-labile enterotoxin of E. coli (LT): Travelers' Diarrhea Vaccine System
|
Group 2: 0 µg LT Patch (Placebo)
Placebo: Travelers' Diarrhea Vaccine System
|
|---|---|---|
|
Evaluation of LT-specific Immune Responses One Year After Original Treatment Regimen in LT Patch Group
SCR LT IgG - Day 380
|
67.1 percentage of participants
Interval 54.9 to 77.9
|
—
|
|
Evaluation of LT-specific Immune Responses One Year After Original Treatment Regimen in LT Patch Group
SCR LT IgA - Day 380
|
38.6 percentage of participants
Interval 27.2 to 51.0
|
—
|
Adverse Events
Group 1: 37.5 µg LT Patch
Serious events: 1 serious events
Other events: 79 other events
Deaths: 0 deaths
Group 2: 0 µg LT Patch (Placebo)
Serious events: 2 serious events
Other events: 32 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Group 1: 37.5 µg LT Patch
n=81 participants at risk
heat-labile enterotoxin of E. coli (LT): Travelers' Diarrhea Vaccine System
|
Group 2: 0 µg LT Patch (Placebo)
n=39 participants at risk
Placebo: Travelers' Diarrhea Vaccine System
|
|---|---|---|
|
Gastrointestinal disorders
Haemorrhoidal haemorrhage
|
0.00%
0/81
|
2.6%
1/39
|
|
General disorders
Non-cardiac chest pain
|
1.2%
1/81
|
0.00%
0/39
|
|
Infections and infestations
Gastroenteritis
|
0.00%
0/81
|
2.6%
1/39
|
Other adverse events
| Measure |
Group 1: 37.5 µg LT Patch
n=81 participants at risk
heat-labile enterotoxin of E. coli (LT): Travelers' Diarrhea Vaccine System
|
Group 2: 0 µg LT Patch (Placebo)
n=39 participants at risk
Placebo: Travelers' Diarrhea Vaccine System
|
|---|---|---|
|
Gastrointestinal disorders
Diarrhoea
|
13.6%
11/81
|
10.3%
4/39
|
|
Infections and infestations
Upper respiratory tract infection
|
8.6%
7/81
|
10.3%
4/39
|
|
Investigations
Blood glucose increased
|
7.4%
6/81
|
7.7%
3/39
|
|
Investigations
Haemoglobin decreased
|
3.7%
3/81
|
5.1%
2/39
|
|
Investigations
Protein urine present
|
4.9%
4/81
|
7.7%
3/39
|
|
Injury, poisoning and procedural complications
Application site discolouration
|
76.5%
62/81
|
12.8%
5/39
|
|
Injury, poisoning and procedural complications
Application site erythema
|
88.9%
72/81
|
35.9%
14/39
|
|
Injury, poisoning and procedural complications
Application site oedema
|
13.6%
11/81
|
0.00%
0/39
|
|
Injury, poisoning and procedural complications
Application site pain
|
27.2%
22/81
|
7.7%
3/39
|
|
Injury, poisoning and procedural complications
Application site pruritus
|
88.9%
72/81
|
20.5%
8/39
|
|
Injury, poisoning and procedural complications
Application site rash
|
95.1%
77/81
|
12.8%
5/39
|
|
General disorders
Malaise
|
6.2%
5/81
|
0.00%
0/39
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place
Restriction type: OTHER