Diarrhea
Conditions
Keywords
Prevention of Travelers' Diarrhea
Brief summary
The purpose of this study is to evaluate and compare the safety and immune responses following a two vaccination regimen by transcutaneous immunization with heat-labile enterotoxin of E. coli (LT) patches or Placebo, with or without alcohol swabbing
Interventions
BIOLOGICALHeat-Labile Enterotoxin of E. coli (LT)
Travelers' Diarrhea Vaccine System
BIOLOGICALPlacebo
Travelers' Diarrhea Vaccine System
Sponsors
Intercell USA, Inc.
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
TRIPLE (Subject, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to 64 Years
Healthy volunteers
Yes
Inclusion criteria
1. A female or male 18-64 (inclusive) years of age; 2. In good health as determined by medical history and screening exam; 3. Females who are post-menopausal, surgically sterile, or have a negative serum/urine pregnancy test at Day 0 and agree not to become pregnant for the duration of study.
Exclusion criteria
1. Abnormalities at physical exam \[as determined by the Toxicity Grading Scale (Grade 1-4)\]; 2. Laboratory abnormalities \[as determined by the Toxicity Grading Scale (Grade 1 4)\] at screening; 3. Participated in research involving investigational product within 30 days before planned date of first vaccination; 4. Ever received investigational enterotoxigenic E. coli, LT, or LT (R192G) or NasalFlu, Berna Biotech, Ltd; 5. Women who are pregnant or breastfeeding; 6. Clinically significant underlying enteric, pulmonary, cardiac or renal disease; 7. Current seizure disorder; 8. Current use of immunosuppressive therapy (inhaled steroids are allowed); 9. Known or suspected alcohol abuse or illicit drug use within the last year; 10. Positive Serology for HIV-1, HIV-2, HbsAg, or HCV; 11. Known allergies to any component of the vaccine including adhesives; 12. An employee of the study site; 13. An employee of Intercell (global) or an immediate family member; 14. Visible tattoos or marks (tattoos/scars) at the vaccination areas that would prevent appropriate dermatologic monitoring of the vaccination sites; 15. Receipt of any routine vaccinations within 7 days prior to, or following, the date of planned study vaccinations.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Characterization and Comparison of the Safety of the TD Vaccine System: (1) Solicited and Unsolicited Adverse Events (AEs) (2) Clinical Laboratory Safety (3) Serious AEs | Day 0 to Day 180 | Erythema, rash, pain, pruritus, hyperpigmentation, hypopigmentation and edema were solicited local AEs for the duration of the study. Fever, malaise, headache, and diarrhea were solicited systemic AEs for the first seven days following each vaccination; events reported outside this time frame were considered non-solicited. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Characterization and Comparison of Group LT-specific Immune Responses to the TD Vaccine System: Geometric Mean Titers | Day 0 to Day 180 | LT immunoglobulin G (IgG) and immunoglobulin A (IgA) |
| Characterization and Comparison of Group LT-specific Immune Responses to the TD Vaccine System: Geometric Mean Fold Ratios | Day 0 to Day 180 | LT immunoglobulin G (IgG) and immunoglobulin A (IgA) |
| Characterization and Comparison of Group LT-specific Immune Responses to the TD Vaccine System: Seroconversion Rates | Day 0 to Day 180 | LT immunoglobulin G (IgG) and immunoglobulin A (IgA) |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Group 1: 37.5μg LT, No Swab Two vaccination regimen with an LT patch (no swabbing)
Heat-Labile Enterotoxin of E. coli (LT): Travelers' Diarrhea Vaccine System | 203 |
| Group 2: 37.5μg LT, Swab Two vaccination regimen with an LT patch (with swabbing)
Heat-Labile Enterotoxin of E. coli (LT): Travelers' Diarrhea Vaccine System | 199 |
| Group 3: 0μg LT, No Swab Two vaccination regimen with a placebo patch (no swabbing)
Placebo: Travelers' Diarrhea Vaccine System | 97 |
| Group 4: 0μg LT, Swab Two vaccination regimen with a placebo patch (with swabbing)
Placebo: Travelers' Diarrhea Vaccine System | 101 |
| Total | 600 |
Baseline characteristics
| Characteristic | Group 1: 37.5μg LT, No Swab | Group 2: 37.5μg LT, Swab | Group 3: 0μg LT, No Swab | Group 4: 0μg LT, Swab | Total |
|---|---|---|---|---|---|
| Age, Continuous | 36.0 years STANDARD_DEVIATION 12.8 | 35.3 years STANDARD_DEVIATION 13.1 | 35.0 years STANDARD_DEVIATION 13.6 | 35.7 years STANDARD_DEVIATION 12.8 | 35.3 years STANDARD_DEVIATION 13 |
| Sex: Female, Male Female | 102 Participants | 99 Participants | 48 Participants | 51 Participants | 300 Participants |
| Sex: Female, Male Male | 101 Participants | 100 Participants | 49 Participants | 50 Participants | 300 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk | EG002 affected / at risk | EG003 affected / at risk |
|---|---|---|---|---|
| deaths Total, all-cause mortality | — / — | — / — | — / — | — / — |
| other Total, other adverse events | 197 / 203 | 192 / 199 | 90 / 97 | 92 / 101 |
| serious Total, serious adverse events | 1 / 203 | 3 / 199 | 0 / 97 | 0 / 101 |
Outcome results
Primary
Characterization and Comparison of the Safety of the TD Vaccine System: (1) Solicited and Unsolicited Adverse Events (AEs) (2) Clinical Laboratory Safety (3) Serious AEs
Erythema, rash, pain, pruritus, hyperpigmentation, hypopigmentation and edema were solicited local AEs for the duration of the study. Fever, malaise, headache, and diarrhea were solicited systemic AEs for the first seven days following each vaccination; events reported outside this time frame were considered non-solicited.
Time frame: Day 0 to Day 180
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Group 1 & 2 Combined: 37.5µg LT Patch | Characterization and Comparison of the Safety of the TD Vaccine System: (1) Solicited and Unsolicited Adverse Events (AEs) (2) Clinical Laboratory Safety (3) Serious AEs | Non-solicited Local AEs (1st vaccination) | 20 participants |
| Group 1 & 2 Combined: 37.5µg LT Patch | Characterization and Comparison of the Safety of the TD Vaccine System: (1) Solicited and Unsolicited Adverse Events (AEs) (2) Clinical Laboratory Safety (3) Serious AEs | Solicited Systemic AEs (overall) | 134 participants |
| Group 1 & 2 Combined: 37.5µg LT Patch | Characterization and Comparison of the Safety of the TD Vaccine System: (1) Solicited and Unsolicited Adverse Events (AEs) (2) Clinical Laboratory Safety (3) Serious AEs | Solicited Local AEs (2nd vaccination) | 327 participants |
| Group 1 & 2 Combined: 37.5µg LT Patch | Characterization and Comparison of the Safety of the TD Vaccine System: (1) Solicited and Unsolicited Adverse Events (AEs) (2) Clinical Laboratory Safety (3) Serious AEs | Non-solicited Systemic AEs (overall) | 296 participants |
| Group 1 & 2 Combined: 37.5µg LT Patch | Characterization and Comparison of the Safety of the TD Vaccine System: (1) Solicited and Unsolicited Adverse Events (AEs) (2) Clinical Laboratory Safety (3) Serious AEs | Non-solicited Local AEs (2nd vaccination) | 11 participants |
| Group 1 & 2 Combined: 37.5µg LT Patch | Characterization and Comparison of the Safety of the TD Vaccine System: (1) Solicited and Unsolicited Adverse Events (AEs) (2) Clinical Laboratory Safety (3) Serious AEs | Serious AEs | 4 participants |
| Group 1 & 2 Combined: 37.5µg LT Patch | Characterization and Comparison of the Safety of the TD Vaccine System: (1) Solicited and Unsolicited Adverse Events (AEs) (2) Clinical Laboratory Safety (3) Serious AEs | Solicited Local Adverse Events (1st vaccination) | 318 participants |
| Group 3 & 4 Combined: Placebo Patch (0µg LT) | Characterization and Comparison of the Safety of the TD Vaccine System: (1) Solicited and Unsolicited Adverse Events (AEs) (2) Clinical Laboratory Safety (3) Serious AEs | Serious AEs | 0 participants |
| Group 3 & 4 Combined: Placebo Patch (0µg LT) | Characterization and Comparison of the Safety of the TD Vaccine System: (1) Solicited and Unsolicited Adverse Events (AEs) (2) Clinical Laboratory Safety (3) Serious AEs | Solicited Local Adverse Events (1st vaccination) | 93 participants |
| Group 3 & 4 Combined: Placebo Patch (0µg LT) | Characterization and Comparison of the Safety of the TD Vaccine System: (1) Solicited and Unsolicited Adverse Events (AEs) (2) Clinical Laboratory Safety (3) Serious AEs | Solicited Local AEs (2nd vaccination) | 62 participants |
| Group 3 & 4 Combined: Placebo Patch (0µg LT) | Characterization and Comparison of the Safety of the TD Vaccine System: (1) Solicited and Unsolicited Adverse Events (AEs) (2) Clinical Laboratory Safety (3) Serious AEs | Non-solicited Local AEs (1st vaccination) | 3 participants |
| Group 3 & 4 Combined: Placebo Patch (0µg LT) | Characterization and Comparison of the Safety of the TD Vaccine System: (1) Solicited and Unsolicited Adverse Events (AEs) (2) Clinical Laboratory Safety (3) Serious AEs | Non-solicited Local AEs (2nd vaccination) | 3 participants |
| Group 3 & 4 Combined: Placebo Patch (0µg LT) | Characterization and Comparison of the Safety of the TD Vaccine System: (1) Solicited and Unsolicited Adverse Events (AEs) (2) Clinical Laboratory Safety (3) Serious AEs | Solicited Systemic AEs (overall) | 59 participants |
| Group 3 & 4 Combined: Placebo Patch (0µg LT) | Characterization and Comparison of the Safety of the TD Vaccine System: (1) Solicited and Unsolicited Adverse Events (AEs) (2) Clinical Laboratory Safety (3) Serious AEs | Non-solicited Systemic AEs (overall) | 148 participants |
Secondary
Characterization and Comparison of Group LT-specific Immune Responses to the TD Vaccine System: Geometric Mean Fold Ratios
LT immunoglobulin G (IgG) and immunoglobulin A (IgA)
Time frame: Day 0 to Day 180
Population: the numbers analyzed differs from the Overall number analyzed because for this the Immunogenicity Evaluable Population (IEP) was used: includes all study subjects that were consented, randomized, received the assigned Treatments (both vaccinations) without significant protocol deviations and had blood drawn on Day 0, Day 21 and Day 35
| Arm | Measure | Group | Value (GEOMETRIC_MEAN) |
|---|---|---|---|
| Group 1 & 2 Combined: 37.5µg LT Patch | Characterization and Comparison of Group LT-specific Immune Responses to the TD Vaccine System: Geometric Mean Fold Ratios | LT IgA Day 7 | 1.02 Geometric Mean Fold Ratios (GMFRs) |
| Group 1 & 2 Combined: 37.5µg LT Patch | Characterization and Comparison of Group LT-specific Immune Responses to the TD Vaccine System: Geometric Mean Fold Ratios | LT IgG Day 180 | 6.49 Geometric Mean Fold Ratios (GMFRs) |
| Group 1 & 2 Combined: 37.5µg LT Patch | Characterization and Comparison of Group LT-specific Immune Responses to the TD Vaccine System: Geometric Mean Fold Ratios | LT IgG Day 42 | 11.72 Geometric Mean Fold Ratios (GMFRs) |
| Group 1 & 2 Combined: 37.5µg LT Patch | Characterization and Comparison of Group LT-specific Immune Responses to the TD Vaccine System: Geometric Mean Fold Ratios | LT IgA Day 180 | 1.66 Geometric Mean Fold Ratios (GMFRs) |
| Group 1 & 2 Combined: 37.5µg LT Patch | Characterization and Comparison of Group LT-specific Immune Responses to the TD Vaccine System: Geometric Mean Fold Ratios | LT IgG Day 90 | 11.18 Geometric Mean Fold Ratios (GMFRs) |
| Group 1 & 2 Combined: 37.5µg LT Patch | Characterization and Comparison of Group LT-specific Immune Responses to the TD Vaccine System: Geometric Mean Fold Ratios | LT IgG Day 56 | 11.34 Geometric Mean Fold Ratios (GMFRs) |
| Group 1 & 2 Combined: 37.5µg LT Patch | Characterization and Comparison of Group LT-specific Immune Responses to the TD Vaccine System: Geometric Mean Fold Ratios | LT IgA Day 56 | 3.16 Geometric Mean Fold Ratios (GMFRs) |
| Group 1 & 2 Combined: 37.5µg LT Patch | Characterization and Comparison of Group LT-specific Immune Responses to the TD Vaccine System: Geometric Mean Fold Ratios | LT IgA Day 42 | 3.41 Geometric Mean Fold Ratios (GMFRs) |
| Group 1 & 2 Combined: 37.5µg LT Patch | Characterization and Comparison of Group LT-specific Immune Responses to the TD Vaccine System: Geometric Mean Fold Ratios | LT IgG Day 21 | 4.61 Geometric Mean Fold Ratios (GMFRs) |
| Group 1 & 2 Combined: 37.5µg LT Patch | Characterization and Comparison of Group LT-specific Immune Responses to the TD Vaccine System: Geometric Mean Fold Ratios | LT IgG Day 7 | 1.02 Geometric Mean Fold Ratios (GMFRs) |
| Group 1 & 2 Combined: 37.5µg LT Patch | Characterization and Comparison of Group LT-specific Immune Responses to the TD Vaccine System: Geometric Mean Fold Ratios | LT IgA Day 35 | 3.91 Geometric Mean Fold Ratios (GMFRs) |
| Group 1 & 2 Combined: 37.5µg LT Patch | Characterization and Comparison of Group LT-specific Immune Responses to the TD Vaccine System: Geometric Mean Fold Ratios | LT IgA Day 28 | 4.03 Geometric Mean Fold Ratios (GMFRs) |
| Group 1 & 2 Combined: 37.5µg LT Patch | Characterization and Comparison of Group LT-specific Immune Responses to the TD Vaccine System: Geometric Mean Fold Ratios | LT IgG Day 28 | 8.91 Geometric Mean Fold Ratios (GMFRs) |
| Group 1 & 2 Combined: 37.5µg LT Patch | Characterization and Comparison of Group LT-specific Immune Responses to the TD Vaccine System: Geometric Mean Fold Ratios | LT IgA Day 90 | 2.32 Geometric Mean Fold Ratios (GMFRs) |
| Group 1 & 2 Combined: 37.5µg LT Patch | Characterization and Comparison of Group LT-specific Immune Responses to the TD Vaccine System: Geometric Mean Fold Ratios | LT IgA Day 21 | 2.52 Geometric Mean Fold Ratios (GMFRs) |
| Group 1 & 2 Combined: 37.5µg LT Patch | Characterization and Comparison of Group LT-specific Immune Responses to the TD Vaccine System: Geometric Mean Fold Ratios | LT IgA Day 14 | 1.81 Geometric Mean Fold Ratios (GMFRs) |
| Group 1 & 2 Combined: 37.5µg LT Patch | Characterization and Comparison of Group LT-specific Immune Responses to the TD Vaccine System: Geometric Mean Fold Ratios | LT IgG Day 35 | 10.90 Geometric Mean Fold Ratios (GMFRs) |
| Group 1 & 2 Combined: 37.5µg LT Patch | Characterization and Comparison of Group LT-specific Immune Responses to the TD Vaccine System: Geometric Mean Fold Ratios | LT IgG Day 14 | 2.37 Geometric Mean Fold Ratios (GMFRs) |
| Group 3 & 4 Combined: Placebo Patch (0µg LT) | Characterization and Comparison of Group LT-specific Immune Responses to the TD Vaccine System: Geometric Mean Fold Ratios | LT IgG Day 21 | 6.03 Geometric Mean Fold Ratios (GMFRs) |
| Group 3 & 4 Combined: Placebo Patch (0µg LT) | Characterization and Comparison of Group LT-specific Immune Responses to the TD Vaccine System: Geometric Mean Fold Ratios | LT IgG Day 7 | 1.04 Geometric Mean Fold Ratios (GMFRs) |
| Group 3 & 4 Combined: Placebo Patch (0µg LT) | Characterization and Comparison of Group LT-specific Immune Responses to the TD Vaccine System: Geometric Mean Fold Ratios | LT IgG Day 14 | 2.73 Geometric Mean Fold Ratios (GMFRs) |
| Group 3 & 4 Combined: Placebo Patch (0µg LT) | Characterization and Comparison of Group LT-specific Immune Responses to the TD Vaccine System: Geometric Mean Fold Ratios | LT IgG Day 28 | 11.39 Geometric Mean Fold Ratios (GMFRs) |
| Group 3 & 4 Combined: Placebo Patch (0µg LT) | Characterization and Comparison of Group LT-specific Immune Responses to the TD Vaccine System: Geometric Mean Fold Ratios | LT IgG Day 35 | 14.26 Geometric Mean Fold Ratios (GMFRs) |
| Group 3 & 4 Combined: Placebo Patch (0µg LT) | Characterization and Comparison of Group LT-specific Immune Responses to the TD Vaccine System: Geometric Mean Fold Ratios | LT IgG Day 42 | 13.65 Geometric Mean Fold Ratios (GMFRs) |
| Group 3 & 4 Combined: Placebo Patch (0µg LT) | Characterization and Comparison of Group LT-specific Immune Responses to the TD Vaccine System: Geometric Mean Fold Ratios | LT IgG Day 56 | 13.47 Geometric Mean Fold Ratios (GMFRs) |
| Group 3 & 4 Combined: Placebo Patch (0µg LT) | Characterization and Comparison of Group LT-specific Immune Responses to the TD Vaccine System: Geometric Mean Fold Ratios | LT IgG Day 90 | 11.04 Geometric Mean Fold Ratios (GMFRs) |
| Group 3 & 4 Combined: Placebo Patch (0µg LT) | Characterization and Comparison of Group LT-specific Immune Responses to the TD Vaccine System: Geometric Mean Fold Ratios | LT IgG Day 180 | 6.58 Geometric Mean Fold Ratios (GMFRs) |
| Group 3 & 4 Combined: Placebo Patch (0µg LT) | Characterization and Comparison of Group LT-specific Immune Responses to the TD Vaccine System: Geometric Mean Fold Ratios | LT IgA Day 7 | 0.98 Geometric Mean Fold Ratios (GMFRs) |
| Group 3 & 4 Combined: Placebo Patch (0µg LT) | Characterization and Comparison of Group LT-specific Immune Responses to the TD Vaccine System: Geometric Mean Fold Ratios | LT IgA Day 14 | 1.99 Geometric Mean Fold Ratios (GMFRs) |
| Group 3 & 4 Combined: Placebo Patch (0µg LT) | Characterization and Comparison of Group LT-specific Immune Responses to the TD Vaccine System: Geometric Mean Fold Ratios | LT IgA Day 21 | 2.61 Geometric Mean Fold Ratios (GMFRs) |
| Group 3 & 4 Combined: Placebo Patch (0µg LT) | Characterization and Comparison of Group LT-specific Immune Responses to the TD Vaccine System: Geometric Mean Fold Ratios | LT IgA Day 28 | 4.38 Geometric Mean Fold Ratios (GMFRs) |
| Group 3 & 4 Combined: Placebo Patch (0µg LT) | Characterization and Comparison of Group LT-specific Immune Responses to the TD Vaccine System: Geometric Mean Fold Ratios | LT IgA Day 35 | 4.28 Geometric Mean Fold Ratios (GMFRs) |
| Group 3 & 4 Combined: Placebo Patch (0µg LT) | Characterization and Comparison of Group LT-specific Immune Responses to the TD Vaccine System: Geometric Mean Fold Ratios | LT IgA Day 42 | 3.92 Geometric Mean Fold Ratios (GMFRs) |
| Group 3 & 4 Combined: Placebo Patch (0µg LT) | Characterization and Comparison of Group LT-specific Immune Responses to the TD Vaccine System: Geometric Mean Fold Ratios | LT IgA Day 56 | 3.53 Geometric Mean Fold Ratios (GMFRs) |
| Group 3 & 4 Combined: Placebo Patch (0µg LT) | Characterization and Comparison of Group LT-specific Immune Responses to the TD Vaccine System: Geometric Mean Fold Ratios | LT IgA Day 90 | 2.58 Geometric Mean Fold Ratios (GMFRs) |
| Group 3 & 4 Combined: Placebo Patch (0µg LT) | Characterization and Comparison of Group LT-specific Immune Responses to the TD Vaccine System: Geometric Mean Fold Ratios | LT IgA Day 180 | 1.89 Geometric Mean Fold Ratios (GMFRs) |
| Placebo Patch Without Swabbing | Characterization and Comparison of Group LT-specific Immune Responses to the TD Vaccine System: Geometric Mean Fold Ratios | LT IgG Day 35 | 1.32 Geometric Mean Fold Ratios (GMFRs) |
| Placebo Patch Without Swabbing | Characterization and Comparison of Group LT-specific Immune Responses to the TD Vaccine System: Geometric Mean Fold Ratios | LT IgA Day 7 | 1.00 Geometric Mean Fold Ratios (GMFRs) |
| Placebo Patch Without Swabbing | Characterization and Comparison of Group LT-specific Immune Responses to the TD Vaccine System: Geometric Mean Fold Ratios | LT IgA Day 14 | 0.95 Geometric Mean Fold Ratios (GMFRs) |
| Placebo Patch Without Swabbing | Characterization and Comparison of Group LT-specific Immune Responses to the TD Vaccine System: Geometric Mean Fold Ratios | LT IgG Day 28 | 1.31 Geometric Mean Fold Ratios (GMFRs) |
| Placebo Patch Without Swabbing | Characterization and Comparison of Group LT-specific Immune Responses to the TD Vaccine System: Geometric Mean Fold Ratios | LT IgA Day 180 | 0.92 Geometric Mean Fold Ratios (GMFRs) |
| Placebo Patch Without Swabbing | Characterization and Comparison of Group LT-specific Immune Responses to the TD Vaccine System: Geometric Mean Fold Ratios | LT IgA Day 21 | 1.04 Geometric Mean Fold Ratios (GMFRs) |
| Placebo Patch Without Swabbing | Characterization and Comparison of Group LT-specific Immune Responses to the TD Vaccine System: Geometric Mean Fold Ratios | LT IgA Day 90 | 0.98 Geometric Mean Fold Ratios (GMFRs) |
| Placebo Patch Without Swabbing | Characterization and Comparison of Group LT-specific Immune Responses to the TD Vaccine System: Geometric Mean Fold Ratios | LT IgA Day 28 | 1.07 Geometric Mean Fold Ratios (GMFRs) |
| Placebo Patch Without Swabbing | Characterization and Comparison of Group LT-specific Immune Responses to the TD Vaccine System: Geometric Mean Fold Ratios | LT IgG Day 21 | 1.03 Geometric Mean Fold Ratios (GMFRs) |
| Placebo Patch Without Swabbing | Characterization and Comparison of Group LT-specific Immune Responses to the TD Vaccine System: Geometric Mean Fold Ratios | LT IgA Day 35 | 1.11 Geometric Mean Fold Ratios (GMFRs) |
| Placebo Patch Without Swabbing | Characterization and Comparison of Group LT-specific Immune Responses to the TD Vaccine System: Geometric Mean Fold Ratios | LT IgG Day 7 | 0.96 Geometric Mean Fold Ratios (GMFRs) |
| Placebo Patch Without Swabbing | Characterization and Comparison of Group LT-specific Immune Responses to the TD Vaccine System: Geometric Mean Fold Ratios | LT IgA Day 42 | 1.07 Geometric Mean Fold Ratios (GMFRs) |
| Placebo Patch Without Swabbing | Characterization and Comparison of Group LT-specific Immune Responses to the TD Vaccine System: Geometric Mean Fold Ratios | LT IgG Day 14 | 0.99 Geometric Mean Fold Ratios (GMFRs) |
| Placebo Patch Without Swabbing | Characterization and Comparison of Group LT-specific Immune Responses to the TD Vaccine System: Geometric Mean Fold Ratios | LT IgG Day 56 | 1.36 Geometric Mean Fold Ratios (GMFRs) |
| Placebo Patch Without Swabbing | Characterization and Comparison of Group LT-specific Immune Responses to the TD Vaccine System: Geometric Mean Fold Ratios | LT IgG Day 42 | 1.36 Geometric Mean Fold Ratios (GMFRs) |
| Placebo Patch Without Swabbing | Characterization and Comparison of Group LT-specific Immune Responses to the TD Vaccine System: Geometric Mean Fold Ratios | LT IgG Day 90 | 1.23 Geometric Mean Fold Ratios (GMFRs) |
| Placebo Patch Without Swabbing | Characterization and Comparison of Group LT-specific Immune Responses to the TD Vaccine System: Geometric Mean Fold Ratios | LT IgA Day 56 | 1.13 Geometric Mean Fold Ratios (GMFRs) |
| Placebo Patch Without Swabbing | Characterization and Comparison of Group LT-specific Immune Responses to the TD Vaccine System: Geometric Mean Fold Ratios | LT IgG Day 180 | 1.15 Geometric Mean Fold Ratios (GMFRs) |
| Placebo Patch With Swabbing | Characterization and Comparison of Group LT-specific Immune Responses to the TD Vaccine System: Geometric Mean Fold Ratios | LT IgG Day 56 | 1.19 Geometric Mean Fold Ratios (GMFRs) |
| Placebo Patch With Swabbing | Characterization and Comparison of Group LT-specific Immune Responses to the TD Vaccine System: Geometric Mean Fold Ratios | LT IgA Day 56 | 1.13 Geometric Mean Fold Ratios (GMFRs) |
| Placebo Patch With Swabbing | Characterization and Comparison of Group LT-specific Immune Responses to the TD Vaccine System: Geometric Mean Fold Ratios | LT IgA Day 35 | 1.08 Geometric Mean Fold Ratios (GMFRs) |
| Placebo Patch With Swabbing | Characterization and Comparison of Group LT-specific Immune Responses to the TD Vaccine System: Geometric Mean Fold Ratios | LT IgA Day 7 | 1.02 Geometric Mean Fold Ratios (GMFRs) |
| Placebo Patch With Swabbing | Characterization and Comparison of Group LT-specific Immune Responses to the TD Vaccine System: Geometric Mean Fold Ratios | LT IgG Day 28 | 1.22 Geometric Mean Fold Ratios (GMFRs) |
| Placebo Patch With Swabbing | Characterization and Comparison of Group LT-specific Immune Responses to the TD Vaccine System: Geometric Mean Fold Ratios | LT IgG Day 7 | 1.02 Geometric Mean Fold Ratios (GMFRs) |
| Placebo Patch With Swabbing | Characterization and Comparison of Group LT-specific Immune Responses to the TD Vaccine System: Geometric Mean Fold Ratios | LT IgG Day 14 | 0.98 Geometric Mean Fold Ratios (GMFRs) |
| Placebo Patch With Swabbing | Characterization and Comparison of Group LT-specific Immune Responses to the TD Vaccine System: Geometric Mean Fold Ratios | LT IgA Day 14 | 1.00 Geometric Mean Fold Ratios (GMFRs) |
| Placebo Patch With Swabbing | Characterization and Comparison of Group LT-specific Immune Responses to the TD Vaccine System: Geometric Mean Fold Ratios | LT IgG Day 35 | 1.22 Geometric Mean Fold Ratios (GMFRs) |
| Placebo Patch With Swabbing | Characterization and Comparison of Group LT-specific Immune Responses to the TD Vaccine System: Geometric Mean Fold Ratios | LT IgA Day 180 | 0.90 Geometric Mean Fold Ratios (GMFRs) |
| Placebo Patch With Swabbing | Characterization and Comparison of Group LT-specific Immune Responses to the TD Vaccine System: Geometric Mean Fold Ratios | LT IgA Day 42 | 1.04 Geometric Mean Fold Ratios (GMFRs) |
| Placebo Patch With Swabbing | Characterization and Comparison of Group LT-specific Immune Responses to the TD Vaccine System: Geometric Mean Fold Ratios | LT IgA Day 21 | 1.01 Geometric Mean Fold Ratios (GMFRs) |
| Placebo Patch With Swabbing | Characterization and Comparison of Group LT-specific Immune Responses to the TD Vaccine System: Geometric Mean Fold Ratios | LT IgG Day 21 | 1.17 Geometric Mean Fold Ratios (GMFRs) |
| Placebo Patch With Swabbing | Characterization and Comparison of Group LT-specific Immune Responses to the TD Vaccine System: Geometric Mean Fold Ratios | LT IgG Day 42 | 1.24 Geometric Mean Fold Ratios (GMFRs) |
| Placebo Patch With Swabbing | Characterization and Comparison of Group LT-specific Immune Responses to the TD Vaccine System: Geometric Mean Fold Ratios | LT IgG Day 180 | 1.23 Geometric Mean Fold Ratios (GMFRs) |
| Placebo Patch With Swabbing | Characterization and Comparison of Group LT-specific Immune Responses to the TD Vaccine System: Geometric Mean Fold Ratios | LT IgA Day 28 | 1.09 Geometric Mean Fold Ratios (GMFRs) |
| Placebo Patch With Swabbing | Characterization and Comparison of Group LT-specific Immune Responses to the TD Vaccine System: Geometric Mean Fold Ratios | LT IgG Day 90 | 1.36 Geometric Mean Fold Ratios (GMFRs) |
| Placebo Patch With Swabbing | Characterization and Comparison of Group LT-specific Immune Responses to the TD Vaccine System: Geometric Mean Fold Ratios | LT IgA Day 90 | 1.02 Geometric Mean Fold Ratios (GMFRs) |
Secondary
Characterization and Comparison of Group LT-specific Immune Responses to the TD Vaccine System: Geometric Mean Titers
LT immunoglobulin G (IgG) and immunoglobulin A (IgA)
Time frame: Day 0 to Day 180
Population: the numbers analyzed differs from the Overall number analyzed because for this the Immunogenicity Evaluable Population (IEP) was used: includes all study subjects that were consented, randomized, received the assigned Treatments (both vaccinations) without significant protocol deviations and had blood drawn on Day 0, Day 21 and Day 35
| Arm | Measure | Group | Value (GEOMETRIC_MEAN) |
|---|---|---|---|
| Group 1 & 2 Combined: 37.5µg LT Patch | Characterization and Comparison of Group LT-specific Immune Responses to the TD Vaccine System: Geometric Mean Titers | IgA Day 35 | 284.26 titers |
| Group 1 & 2 Combined: 37.5µg LT Patch | Characterization and Comparison of Group LT-specific Immune Responses to the TD Vaccine System: Geometric Mean Titers | IgA Day 7 | 74.30 titers |
| Group 1 & 2 Combined: 37.5µg LT Patch | Characterization and Comparison of Group LT-specific Immune Responses to the TD Vaccine System: Geometric Mean Titers | IgG Day 21 | 2036.77 titers |
| Group 1 & 2 Combined: 37.5µg LT Patch | Characterization and Comparison of Group LT-specific Immune Responses to the TD Vaccine System: Geometric Mean Titers | IgA Day 28 | 290.95 titers |
| Group 1 & 2 Combined: 37.5µg LT Patch | Characterization and Comparison of Group LT-specific Immune Responses to the TD Vaccine System: Geometric Mean Titers | IgA Day 14 | 130.89 titers |
| Group 1 & 2 Combined: 37.5µg LT Patch | Characterization and Comparison of Group LT-specific Immune Responses to the TD Vaccine System: Geometric Mean Titers | IgG Day 0 | 442.21 titers |
| Group 1 & 2 Combined: 37.5µg LT Patch | Characterization and Comparison of Group LT-specific Immune Responses to the TD Vaccine System: Geometric Mean Titers | IgA Day 21 | 183.42 titers |
| Group 1 & 2 Combined: 37.5µg LT Patch | Characterization and Comparison of Group LT-specific Immune Responses to the TD Vaccine System: Geometric Mean Titers | IgG Day 7 | 455.68 titers |
| Group 1 & 2 Combined: 37.5µg LT Patch | Characterization and Comparison of Group LT-specific Immune Responses to the TD Vaccine System: Geometric Mean Titers | IgA Day 90 | 168.18 titers |
| Group 1 & 2 Combined: 37.5µg LT Patch | Characterization and Comparison of Group LT-specific Immune Responses to the TD Vaccine System: Geometric Mean Titers | IgG Day 28 | 4010.55 titers |
| Group 1 & 2 Combined: 37.5µg LT Patch | Characterization and Comparison of Group LT-specific Immune Responses to the TD Vaccine System: Geometric Mean Titers | IgG Day 35 | 4820.85 titers |
| Group 1 & 2 Combined: 37.5µg LT Patch | Characterization and Comparison of Group LT-specific Immune Responses to the TD Vaccine System: Geometric Mean Titers | IgA Day 56 | 229.76 titers |
| Group 1 & 2 Combined: 37.5µg LT Patch | Characterization and Comparison of Group LT-specific Immune Responses to the TD Vaccine System: Geometric Mean Titers | IgG Day 42 | 5229.02 titers |
| Group 1 & 2 Combined: 37.5µg LT Patch | Characterization and Comparison of Group LT-specific Immune Responses to the TD Vaccine System: Geometric Mean Titers | IgA Day 180 | 120.12 titers |
| Group 1 & 2 Combined: 37.5µg LT Patch | Characterization and Comparison of Group LT-specific Immune Responses to the TD Vaccine System: Geometric Mean Titers | IgG Day 56 | 5056.13 titers |
| Group 1 & 2 Combined: 37.5µg LT Patch | Characterization and Comparison of Group LT-specific Immune Responses to the TD Vaccine System: Geometric Mean Titers | IgG Day 14 | 1042.41 titers |
| Group 1 & 2 Combined: 37.5µg LT Patch | Characterization and Comparison of Group LT-specific Immune Responses to the TD Vaccine System: Geometric Mean Titers | IgA Day 42 | 248.33 titers |
| Group 1 & 2 Combined: 37.5µg LT Patch | Characterization and Comparison of Group LT-specific Immune Responses to the TD Vaccine System: Geometric Mean Titers | IgG Day 90 | 4833.84 titers |
| Group 1 & 2 Combined: 37.5µg LT Patch | Characterization and Comparison of Group LT-specific Immune Responses to the TD Vaccine System: Geometric Mean Titers | IgG Day 180 | 2809.18 titers |
| Group 1 & 2 Combined: 37.5µg LT Patch | Characterization and Comparison of Group LT-specific Immune Responses to the TD Vaccine System: Geometric Mean Titers | IgA Day 0 | 72.71 titers |
| Group 3 & 4 Combined: Placebo Patch (0µg LT) | Characterization and Comparison of Group LT-specific Immune Responses to the TD Vaccine System: Geometric Mean Titers | IgA Day 35 | 286.88 titers |
| Group 3 & 4 Combined: Placebo Patch (0µg LT) | Characterization and Comparison of Group LT-specific Immune Responses to the TD Vaccine System: Geometric Mean Titers | IgA Day 0 | 67.06 titers |
| Group 3 & 4 Combined: Placebo Patch (0µg LT) | Characterization and Comparison of Group LT-specific Immune Responses to the TD Vaccine System: Geometric Mean Titers | IgA Day 90 | 166.85 titers |
| Group 3 & 4 Combined: Placebo Patch (0µg LT) | Characterization and Comparison of Group LT-specific Immune Responses to the TD Vaccine System: Geometric Mean Titers | IgA Day 28 | 294.68 titers |
| Group 3 & 4 Combined: Placebo Patch (0µg LT) | Characterization and Comparison of Group LT-specific Immune Responses to the TD Vaccine System: Geometric Mean Titers | IgG Day 35 | 6005.34 titers |
| Group 3 & 4 Combined: Placebo Patch (0µg LT) | Characterization and Comparison of Group LT-specific Immune Responses to the TD Vaccine System: Geometric Mean Titers | IgA Day 7 | 65.29 titers |
| Group 3 & 4 Combined: Placebo Patch (0µg LT) | Characterization and Comparison of Group LT-specific Immune Responses to the TD Vaccine System: Geometric Mean Titers | IgG Day 0 | 421.20 titers |
| Group 3 & 4 Combined: Placebo Patch (0µg LT) | Characterization and Comparison of Group LT-specific Immune Responses to the TD Vaccine System: Geometric Mean Titers | IgA Day 180 | 124.50 titers |
| Group 3 & 4 Combined: Placebo Patch (0µg LT) | Characterization and Comparison of Group LT-specific Immune Responses to the TD Vaccine System: Geometric Mean Titers | IgG Day 180 | 2843.59 titers |
| Group 3 & 4 Combined: Placebo Patch (0µg LT) | Characterization and Comparison of Group LT-specific Immune Responses to the TD Vaccine System: Geometric Mean Titers | IgA Day 14 | 132.33 titers |
| Group 3 & 4 Combined: Placebo Patch (0µg LT) | Characterization and Comparison of Group LT-specific Immune Responses to the TD Vaccine System: Geometric Mean Titers | IgG Day 42 | 5757.21 titers |
| Group 3 & 4 Combined: Placebo Patch (0µg LT) | Characterization and Comparison of Group LT-specific Immune Responses to the TD Vaccine System: Geometric Mean Titers | IgA Day 21 | 175.05 titers |
| Group 3 & 4 Combined: Placebo Patch (0µg LT) | Characterization and Comparison of Group LT-specific Immune Responses to the TD Vaccine System: Geometric Mean Titers | IgG Day 90 | 4695.02 titers |
| Group 3 & 4 Combined: Placebo Patch (0µg LT) | Characterization and Comparison of Group LT-specific Immune Responses to the TD Vaccine System: Geometric Mean Titers | IgG Day 21 | 2537.89 titers |
| Group 3 & 4 Combined: Placebo Patch (0µg LT) | Characterization and Comparison of Group LT-specific Immune Responses to the TD Vaccine System: Geometric Mean Titers | IgA Day 42 | 261.53 titers |
| Group 3 & 4 Combined: Placebo Patch (0µg LT) | Characterization and Comparison of Group LT-specific Immune Responses to the TD Vaccine System: Geometric Mean Titers | IgG Day 14 | 1148.98 titers |
| Group 3 & 4 Combined: Placebo Patch (0µg LT) | Characterization and Comparison of Group LT-specific Immune Responses to the TD Vaccine System: Geometric Mean Titers | IgG Day 56 | 5633.07 titers |
| Group 3 & 4 Combined: Placebo Patch (0µg LT) | Characterization and Comparison of Group LT-specific Immune Responses to the TD Vaccine System: Geometric Mean Titers | IgG Day 28 | 4806.53 titers |
| Group 3 & 4 Combined: Placebo Patch (0µg LT) | Characterization and Comparison of Group LT-specific Immune Responses to the TD Vaccine System: Geometric Mean Titers | IgG Day 7 | 437.80 titers |
| Group 3 & 4 Combined: Placebo Patch (0µg LT) | Characterization and Comparison of Group LT-specific Immune Responses to the TD Vaccine System: Geometric Mean Titers | IgA Day 56 | 232.70 titers |
| Placebo Patch Without Swabbing | Characterization and Comparison of Group LT-specific Immune Responses to the TD Vaccine System: Geometric Mean Titers | IgA Day 14 | 59.70 titers |
| Placebo Patch Without Swabbing | Characterization and Comparison of Group LT-specific Immune Responses to the TD Vaccine System: Geometric Mean Titers | IgG Day 0 | 435.64 titers |
| Placebo Patch Without Swabbing | Characterization and Comparison of Group LT-specific Immune Responses to the TD Vaccine System: Geometric Mean Titers | IgG Day 7 | 426.28 titers |
| Placebo Patch Without Swabbing | Characterization and Comparison of Group LT-specific Immune Responses to the TD Vaccine System: Geometric Mean Titers | IgG Day 14 | 433.13 titers |
| Placebo Patch Without Swabbing | Characterization and Comparison of Group LT-specific Immune Responses to the TD Vaccine System: Geometric Mean Titers | IgG Day 21 | 447.47 titers |
| Placebo Patch Without Swabbing | Characterization and Comparison of Group LT-specific Immune Responses to the TD Vaccine System: Geometric Mean Titers | IgG Day 28 | 571.09 titers |
| Placebo Patch Without Swabbing | Characterization and Comparison of Group LT-specific Immune Responses to the TD Vaccine System: Geometric Mean Titers | IgG Day 35 | 573.03 titers |
| Placebo Patch Without Swabbing | Characterization and Comparison of Group LT-specific Immune Responses to the TD Vaccine System: Geometric Mean Titers | IgG Day 42 | 582.72 titers |
| Placebo Patch Without Swabbing | Characterization and Comparison of Group LT-specific Immune Responses to the TD Vaccine System: Geometric Mean Titers | IgG Day 56 | 588.69 titers |
| Placebo Patch Without Swabbing | Characterization and Comparison of Group LT-specific Immune Responses to the TD Vaccine System: Geometric Mean Titers | IgG Day 90 | 537.23 titers |
| Placebo Patch Without Swabbing | Characterization and Comparison of Group LT-specific Immune Responses to the TD Vaccine System: Geometric Mean Titers | IgG Day 180 | 498.20 titers |
| Placebo Patch Without Swabbing | Characterization and Comparison of Group LT-specific Immune Responses to the TD Vaccine System: Geometric Mean Titers | IgA Day 0 | 63.00 titers |
| Placebo Patch Without Swabbing | Characterization and Comparison of Group LT-specific Immune Responses to the TD Vaccine System: Geometric Mean Titers | IgA Day 7 | 62.26 titers |
| Placebo Patch Without Swabbing | Characterization and Comparison of Group LT-specific Immune Responses to the TD Vaccine System: Geometric Mean Titers | IgA Day 21 | 65.82 titers |
| Placebo Patch Without Swabbing | Characterization and Comparison of Group LT-specific Immune Responses to the TD Vaccine System: Geometric Mean Titers | IgA Day 28 | 67.52 titers |
| Placebo Patch Without Swabbing | Characterization and Comparison of Group LT-specific Immune Responses to the TD Vaccine System: Geometric Mean Titers | IgA Day 35 | 69.84 titers |
| Placebo Patch Without Swabbing | Characterization and Comparison of Group LT-specific Immune Responses to the TD Vaccine System: Geometric Mean Titers | IgA Day 42 | 67.45 titers |
| Placebo Patch Without Swabbing | Characterization and Comparison of Group LT-specific Immune Responses to the TD Vaccine System: Geometric Mean Titers | IgA Day 56 | 70.11 titers |
| Placebo Patch Without Swabbing | Characterization and Comparison of Group LT-specific Immune Responses to the TD Vaccine System: Geometric Mean Titers | IgA Day 90 | 61.79 titers |
| Placebo Patch Without Swabbing | Characterization and Comparison of Group LT-specific Immune Responses to the TD Vaccine System: Geometric Mean Titers | IgA Day 180 | 56.00 titers |
| Placebo Patch With Swabbing | Characterization and Comparison of Group LT-specific Immune Responses to the TD Vaccine System: Geometric Mean Titers | IgG Day 180 | 419.89 titers |
| Placebo Patch With Swabbing | Characterization and Comparison of Group LT-specific Immune Responses to the TD Vaccine System: Geometric Mean Titers | IgG Day 90 | 464.11 titers |
| Placebo Patch With Swabbing | Characterization and Comparison of Group LT-specific Immune Responses to the TD Vaccine System: Geometric Mean Titers | IgA Day 90 | 70.93 titers |
| Placebo Patch With Swabbing | Characterization and Comparison of Group LT-specific Immune Responses to the TD Vaccine System: Geometric Mean Titers | IgA Day 35 | 74.91 titers |
| Placebo Patch With Swabbing | Characterization and Comparison of Group LT-specific Immune Responses to the TD Vaccine System: Geometric Mean Titers | IgG Day 56 | 411.26 titers |
| Placebo Patch With Swabbing | Characterization and Comparison of Group LT-specific Immune Responses to the TD Vaccine System: Geometric Mean Titers | IgG Day 42 | 427.64 titers |
| Placebo Patch With Swabbing | Characterization and Comparison of Group LT-specific Immune Responses to the TD Vaccine System: Geometric Mean Titers | IgG Day 7 | 348.13 titers |
| Placebo Patch With Swabbing | Characterization and Comparison of Group LT-specific Immune Responses to the TD Vaccine System: Geometric Mean Titers | IgA Day 42 | 71.97 titers |
| Placebo Patch With Swabbing | Characterization and Comparison of Group LT-specific Immune Responses to the TD Vaccine System: Geometric Mean Titers | IgG Day 35 | 421.34 titers |
| Placebo Patch With Swabbing | Characterization and Comparison of Group LT-specific Immune Responses to the TD Vaccine System: Geometric Mean Titers | IgG Day 28 | 418.78 titers |
| Placebo Patch With Swabbing | Characterization and Comparison of Group LT-specific Immune Responses to the TD Vaccine System: Geometric Mean Titers | IgG Day 0 | 344.40 titers |
| Placebo Patch With Swabbing | Characterization and Comparison of Group LT-specific Immune Responses to the TD Vaccine System: Geometric Mean Titers | IgA Day 56 | 78.60 titers |
| Placebo Patch With Swabbing | Characterization and Comparison of Group LT-specific Immune Responses to the TD Vaccine System: Geometric Mean Titers | IgG Day 21 | 404.66 titers |
| Placebo Patch With Swabbing | Characterization and Comparison of Group LT-specific Immune Responses to the TD Vaccine System: Geometric Mean Titers | IgA Day 14 | 69.79 titers |
| Placebo Patch With Swabbing | Characterization and Comparison of Group LT-specific Immune Responses to the TD Vaccine System: Geometric Mean Titers | IgG Day 14 | 336.41 titers |
| Placebo Patch With Swabbing | Characterization and Comparison of Group LT-specific Immune Responses to the TD Vaccine System: Geometric Mean Titers | IgA Day 21 | 69.91 titers |
| Placebo Patch With Swabbing | Characterization and Comparison of Group LT-specific Immune Responses to the TD Vaccine System: Geometric Mean Titers | IgA Day 7 | 70.77 titers |
| Placebo Patch With Swabbing | Characterization and Comparison of Group LT-specific Immune Responses to the TD Vaccine System: Geometric Mean Titers | IgA Day 0 | 69.52 titers |
| Placebo Patch With Swabbing | Characterization and Comparison of Group LT-specific Immune Responses to the TD Vaccine System: Geometric Mean Titers | IgA Day 180 | 61.30 titers |
| Placebo Patch With Swabbing | Characterization and Comparison of Group LT-specific Immune Responses to the TD Vaccine System: Geometric Mean Titers | IgA Day 28 | 76.00 titers |
Secondary
Characterization and Comparison of Group LT-specific Immune Responses to the TD Vaccine System: Seroconversion Rates
LT immunoglobulin G (IgG) and immunoglobulin A (IgA)
Time frame: Day 0 to Day 180
Population: the numbers analyzed differs from the Overall number analyzed because for this the Immunogenicity Evaluable Population (IEP) was used: includes all study subjects that were consented, randomized, received the assigned Treatments (both vaccinations) without significant protocol deviations and had blood drawn on Day 0, Day 21 and Day 35
| Arm | Measure | Group | Value (GEOMETRIC_MEAN) |
|---|---|---|---|
| Group 1 & 2 Combined: 37.5µg LT Patch | Characterization and Comparison of Group LT-specific Immune Responses to the TD Vaccine System: Seroconversion Rates | LT IgA Day 7 | 1.66 percentage of participants |
| Group 1 & 2 Combined: 37.5µg LT Patch | Characterization and Comparison of Group LT-specific Immune Responses to the TD Vaccine System: Seroconversion Rates | LT IgG Day 180 | 85.09 percentage of participants |
| Group 1 & 2 Combined: 37.5µg LT Patch | Characterization and Comparison of Group LT-specific Immune Responses to the TD Vaccine System: Seroconversion Rates | LT IgG Day 90 | 93.49 percentage of participants |
| Group 1 & 2 Combined: 37.5µg LT Patch | Characterization and Comparison of Group LT-specific Immune Responses to the TD Vaccine System: Seroconversion Rates | LT IgG Day 42 | 90.61 percentage of participants |
| Group 1 & 2 Combined: 37.5µg LT Patch | Characterization and Comparison of Group LT-specific Immune Responses to the TD Vaccine System: Seroconversion Rates | LT IgG Day 14 | 47.51 percentage of participants |
| Group 1 & 2 Combined: 37.5µg LT Patch | Characterization and Comparison of Group LT-specific Immune Responses to the TD Vaccine System: Seroconversion Rates | LT IgG Day 56 | 92.09 percentage of participants |
| Group 1 & 2 Combined: 37.5µg LT Patch | Characterization and Comparison of Group LT-specific Immune Responses to the TD Vaccine System: Seroconversion Rates | LT IgG Day 7 | 7.18 percentage of participants |
| Group 1 & 2 Combined: 37.5µg LT Patch | Characterization and Comparison of Group LT-specific Immune Responses to the TD Vaccine System: Seroconversion Rates | LT IgA Day 56 | 40.68 percentage of participants |
| Group 1 & 2 Combined: 37.5µg LT Patch | Characterization and Comparison of Group LT-specific Immune Responses to the TD Vaccine System: Seroconversion Rates | LT IgA Day 42 | 46.96 percentage of participants |
| Group 1 & 2 Combined: 37.5µg LT Patch | Characterization and Comparison of Group LT-specific Immune Responses to the TD Vaccine System: Seroconversion Rates | LT IgG Day 21 | 67.03 percentage of participants |
| Group 1 & 2 Combined: 37.5µg LT Patch | Characterization and Comparison of Group LT-specific Immune Responses to the TD Vaccine System: Seroconversion Rates | LT IgA Day 180 | 14.91 percentage of participants |
| Group 1 & 2 Combined: 37.5µg LT Patch | Characterization and Comparison of Group LT-specific Immune Responses to the TD Vaccine System: Seroconversion Rates | LT IgA Day 35 | 51.10 percentage of participants |
| Group 1 & 2 Combined: 37.5µg LT Patch | Characterization and Comparison of Group LT-specific Immune Responses to the TD Vaccine System: Seroconversion Rates | LT IgA Day 28 | 50.56 percentage of participants |
| Group 1 & 2 Combined: 37.5µg LT Patch | Characterization and Comparison of Group LT-specific Immune Responses to the TD Vaccine System: Seroconversion Rates | LT IgG Day 28 | 86.67 percentage of participants |
| Group 1 & 2 Combined: 37.5µg LT Patch | Characterization and Comparison of Group LT-specific Immune Responses to the TD Vaccine System: Seroconversion Rates | LT IgA Day 90 | 26.63 percentage of participants |
| Group 1 & 2 Combined: 37.5µg LT Patch | Characterization and Comparison of Group LT-specific Immune Responses to the TD Vaccine System: Seroconversion Rates | LT IgA Day 21 | 32.42 percentage of participants |
| Group 1 & 2 Combined: 37.5µg LT Patch | Characterization and Comparison of Group LT-specific Immune Responses to the TD Vaccine System: Seroconversion Rates | LT IgA Day 14 | 17.68 percentage of participants |
| Group 1 & 2 Combined: 37.5µg LT Patch | Characterization and Comparison of Group LT-specific Immune Responses to the TD Vaccine System: Seroconversion Rates | LT IgG Day 35 | 90.11 percentage of participants |
| Group 3 & 4 Combined: Placebo Patch (0µg LT) | Characterization and Comparison of Group LT-specific Immune Responses to the TD Vaccine System: Seroconversion Rates | LT IgG Day 35 | 93.06 percentage of participants |
| Group 3 & 4 Combined: Placebo Patch (0µg LT) | Characterization and Comparison of Group LT-specific Immune Responses to the TD Vaccine System: Seroconversion Rates | LT IgG Day 7 | 7.56 percentage of participants |
| Group 3 & 4 Combined: Placebo Patch (0µg LT) | Characterization and Comparison of Group LT-specific Immune Responses to the TD Vaccine System: Seroconversion Rates | LT IgG Day 14 | 49.42 percentage of participants |
| Group 3 & 4 Combined: Placebo Patch (0µg LT) | Characterization and Comparison of Group LT-specific Immune Responses to the TD Vaccine System: Seroconversion Rates | LT IgG Day 21 | 74.57 percentage of participants |
| Group 3 & 4 Combined: Placebo Patch (0µg LT) | Characterization and Comparison of Group LT-specific Immune Responses to the TD Vaccine System: Seroconversion Rates | LT IgG Day 28 | 89.53 percentage of participants |
| Group 3 & 4 Combined: Placebo Patch (0µg LT) | Characterization and Comparison of Group LT-specific Immune Responses to the TD Vaccine System: Seroconversion Rates | LT IgG Day 42 | 94.71 percentage of participants |
| Group 3 & 4 Combined: Placebo Patch (0µg LT) | Characterization and Comparison of Group LT-specific Immune Responses to the TD Vaccine System: Seroconversion Rates | LT IgG Day 56 | 95.81 percentage of participants |
| Group 3 & 4 Combined: Placebo Patch (0µg LT) | Characterization and Comparison of Group LT-specific Immune Responses to the TD Vaccine System: Seroconversion Rates | LT IgG Day 90 | 93.79 percentage of participants |
| Group 3 & 4 Combined: Placebo Patch (0µg LT) | Characterization and Comparison of Group LT-specific Immune Responses to the TD Vaccine System: Seroconversion Rates | LT IgG Day 180 | 90.26 percentage of participants |
| Group 3 & 4 Combined: Placebo Patch (0µg LT) | Characterization and Comparison of Group LT-specific Immune Responses to the TD Vaccine System: Seroconversion Rates | LT IgA Day 7 | 1.74 percentage of participants |
| Group 3 & 4 Combined: Placebo Patch (0µg LT) | Characterization and Comparison of Group LT-specific Immune Responses to the TD Vaccine System: Seroconversion Rates | LT IgA Day 14 | 23.84 percentage of participants |
| Group 3 & 4 Combined: Placebo Patch (0µg LT) | Characterization and Comparison of Group LT-specific Immune Responses to the TD Vaccine System: Seroconversion Rates | LT IgA Day 21 | 36.42 percentage of participants |
| Group 3 & 4 Combined: Placebo Patch (0µg LT) | Characterization and Comparison of Group LT-specific Immune Responses to the TD Vaccine System: Seroconversion Rates | LT IgA Day 28 | 54.65 percentage of participants |
| Group 3 & 4 Combined: Placebo Patch (0µg LT) | Characterization and Comparison of Group LT-specific Immune Responses to the TD Vaccine System: Seroconversion Rates | LT IgA Day 35 | 54.91 percentage of participants |
| Group 3 & 4 Combined: Placebo Patch (0µg LT) | Characterization and Comparison of Group LT-specific Immune Responses to the TD Vaccine System: Seroconversion Rates | LT IgA Day 42 | 51.76 percentage of participants |
| Group 3 & 4 Combined: Placebo Patch (0µg LT) | Characterization and Comparison of Group LT-specific Immune Responses to the TD Vaccine System: Seroconversion Rates | LT IgA Day 56 | 49.70 percentage of participants |
| Group 3 & 4 Combined: Placebo Patch (0µg LT) | Characterization and Comparison of Group LT-specific Immune Responses to the TD Vaccine System: Seroconversion Rates | LT IgA Day 90 | 37.27 percentage of participants |
| Group 3 & 4 Combined: Placebo Patch (0µg LT) | Characterization and Comparison of Group LT-specific Immune Responses to the TD Vaccine System: Seroconversion Rates | LT IgA Day 180 | 17.53 percentage of participants |
| Placebo Patch Without Swabbing | Characterization and Comparison of Group LT-specific Immune Responses to the TD Vaccine System: Seroconversion Rates | LT IgG Day 180 | 9.41 percentage of participants |
| Placebo Patch Without Swabbing | Characterization and Comparison of Group LT-specific Immune Responses to the TD Vaccine System: Seroconversion Rates | LT IgA Day 180 | 1.18 percentage of participants |
| Placebo Patch Without Swabbing | Characterization and Comparison of Group LT-specific Immune Responses to the TD Vaccine System: Seroconversion Rates | LT IgA Day 56 | 3.33 percentage of participants |
| Placebo Patch Without Swabbing | Characterization and Comparison of Group LT-specific Immune Responses to the TD Vaccine System: Seroconversion Rates | LT IgA Day 7 | 0.00 percentage of participants |
| Placebo Patch Without Swabbing | Characterization and Comparison of Group LT-specific Immune Responses to the TD Vaccine System: Seroconversion Rates | LT IgA Day 14 | 0.00 percentage of participants |
| Placebo Patch Without Swabbing | Characterization and Comparison of Group LT-specific Immune Responses to the TD Vaccine System: Seroconversion Rates | LT IgG Day 28 | 14.13 percentage of participants |
| Placebo Patch Without Swabbing | Characterization and Comparison of Group LT-specific Immune Responses to the TD Vaccine System: Seroconversion Rates | LT IgA Day 21 | 1.09 percentage of participants |
| Placebo Patch Without Swabbing | Characterization and Comparison of Group LT-specific Immune Responses to the TD Vaccine System: Seroconversion Rates | LT IgA Day 28 | 2.17 percentage of participants |
| Placebo Patch Without Swabbing | Characterization and Comparison of Group LT-specific Immune Responses to the TD Vaccine System: Seroconversion Rates | LT IgG Day 21 | 5.43 percentage of participants |
| Placebo Patch Without Swabbing | Characterization and Comparison of Group LT-specific Immune Responses to the TD Vaccine System: Seroconversion Rates | LT IgA Day 90 | 0.00 percentage of participants |
| Placebo Patch Without Swabbing | Characterization and Comparison of Group LT-specific Immune Responses to the TD Vaccine System: Seroconversion Rates | LT IgA Day 35 | 2.17 percentage of participants |
| Placebo Patch Without Swabbing | Characterization and Comparison of Group LT-specific Immune Responses to the TD Vaccine System: Seroconversion Rates | LT IgA Day 42 | 1.11 percentage of participants |
| Placebo Patch Without Swabbing | Characterization and Comparison of Group LT-specific Immune Responses to the TD Vaccine System: Seroconversion Rates | LT IgG Day 42 | 17.78 percentage of participants |
| Placebo Patch Without Swabbing | Characterization and Comparison of Group LT-specific Immune Responses to the TD Vaccine System: Seroconversion Rates | LT IgG Day 56 | 16.67 percentage of participants |
| Placebo Patch Without Swabbing | Characterization and Comparison of Group LT-specific Immune Responses to the TD Vaccine System: Seroconversion Rates | LT IgG Day 14 | 2.17 percentage of participants |
| Placebo Patch Without Swabbing | Characterization and Comparison of Group LT-specific Immune Responses to the TD Vaccine System: Seroconversion Rates | LT IgG Day 90 | 11.24 percentage of participants |
| Placebo Patch Without Swabbing | Characterization and Comparison of Group LT-specific Immune Responses to the TD Vaccine System: Seroconversion Rates | LT IgG Day 35 | 15.22 percentage of participants |
| Placebo Patch Without Swabbing | Characterization and Comparison of Group LT-specific Immune Responses to the TD Vaccine System: Seroconversion Rates | LT IgG Day 7 | 3.33 percentage of participants |
| Placebo Patch With Swabbing | Characterization and Comparison of Group LT-specific Immune Responses to the TD Vaccine System: Seroconversion Rates | LT IgG Day 180 | 20.93 percentage of participants |
| Placebo Patch With Swabbing | Characterization and Comparison of Group LT-specific Immune Responses to the TD Vaccine System: Seroconversion Rates | LT IgG Day 56 | 16.67 percentage of participants |
| Placebo Patch With Swabbing | Characterization and Comparison of Group LT-specific Immune Responses to the TD Vaccine System: Seroconversion Rates | LT IgA Day 35 | 2.22 percentage of participants |
| Placebo Patch With Swabbing | Characterization and Comparison of Group LT-specific Immune Responses to the TD Vaccine System: Seroconversion Rates | LT IgG Day 14 | 3.33 percentage of participants |
| Placebo Patch With Swabbing | Characterization and Comparison of Group LT-specific Immune Responses to the TD Vaccine System: Seroconversion Rates | LT IgA Day 7 | 0.00 percentage of participants |
| Placebo Patch With Swabbing | Characterization and Comparison of Group LT-specific Immune Responses to the TD Vaccine System: Seroconversion Rates | LT IgG Day 28 | 16.67 percentage of participants |
| Placebo Patch With Swabbing | Characterization and Comparison of Group LT-specific Immune Responses to the TD Vaccine System: Seroconversion Rates | LT IgA Day 56 | 3.33 percentage of participants |
| Placebo Patch With Swabbing | Characterization and Comparison of Group LT-specific Immune Responses to the TD Vaccine System: Seroconversion Rates | LT IgA Day 90 | 1.12 percentage of participants |
| Placebo Patch With Swabbing | Characterization and Comparison of Group LT-specific Immune Responses to the TD Vaccine System: Seroconversion Rates | LT IgA Day 14 | 1.11 percentage of participants |
| Placebo Patch With Swabbing | Characterization and Comparison of Group LT-specific Immune Responses to the TD Vaccine System: Seroconversion Rates | LT IgG Day 35 | 17.78 percentage of participants |
| Placebo Patch With Swabbing | Characterization and Comparison of Group LT-specific Immune Responses to the TD Vaccine System: Seroconversion Rates | LT IgG Day 7 | 6.74 percentage of participants |
| Placebo Patch With Swabbing | Characterization and Comparison of Group LT-specific Immune Responses to the TD Vaccine System: Seroconversion Rates | LT IgG Day 42 | 20.00 percentage of participants |
| Placebo Patch With Swabbing | Characterization and Comparison of Group LT-specific Immune Responses to the TD Vaccine System: Seroconversion Rates | LT IgA Day 21 | 1.11 percentage of participants |
| Placebo Patch With Swabbing | Characterization and Comparison of Group LT-specific Immune Responses to the TD Vaccine System: Seroconversion Rates | LT IgG Day 21 | 16.67 percentage of participants |
| Placebo Patch With Swabbing | Characterization and Comparison of Group LT-specific Immune Responses to the TD Vaccine System: Seroconversion Rates | LT IgA Day 180 | 0.00 percentage of participants |
| Placebo Patch With Swabbing | Characterization and Comparison of Group LT-specific Immune Responses to the TD Vaccine System: Seroconversion Rates | LT IgG Day 90 | 24.72 percentage of participants |
| Placebo Patch With Swabbing | Characterization and Comparison of Group LT-specific Immune Responses to the TD Vaccine System: Seroconversion Rates | LT IgA Day 28 | 2.22 percentage of participants |
| Placebo Patch With Swabbing | Characterization and Comparison of Group LT-specific Immune Responses to the TD Vaccine System: Seroconversion Rates | LT IgA Day 42 | 2.22 percentage of participants |