Prevention of Travelers' Diarrhea
Conditions
Brief summary
To evaluate the immune responses achieved following self-administered heat-labile enterotoxin of E. coli (LT) vaccination by transcutaneous immunization compared to the immune responses achieved by clinician-administered vaccination.
Interventions
BIOLOGICALheat-labile enterotoxin of E. coli (LT)
37.5ug patch applied on either the deltoid or the thigh
Sponsors
Intercell USA, Inc.
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 64 Years
Healthy volunteers
Yes
Inclusion criteria
Subjects must meet all of the following inclusion criteria to be eligible to participate in the study: * Healthy adult males or females 18-64 years of age with signed Informed Consent. * Women who are not post-menopausal or surgically sterile must have a negative serum or urine pregnancy test at screening and within 24 hours of each vaccination with understanding (through Informed Consent process) to not become pregnant over the duration of the study, and must agree to employ an effective form of birth control for the duration of the study. Acceptable forms of birth control are: abstinence, hormonal contraceptives (oral, injectable, implant, patch, ring), double-barrier contraceptives (condom or diaphragm, with spermicide), and IUD.
Exclusion criteria
Subjects meeting any of the following criteria are not eligible for participation in the study: * Laboratory abnormalities \[as determined by the Toxicity Grading Scale (grade 1-4)\] at laboratory screening * Abnormalities at physical examination \[as determined by the Toxicity Grading Scale (grade 1-4)\] * Known allergies to any component of the vaccine * Known allergies to adhesives * Participated in research involving investigational product within 30 days before planned date of first vaccination * Donated blood or blood products such as plasma within the past 30 days * Ever received investigational enterotoxigenic E. coli, LT, or LT (R192G) or NasalFlu, Berna Biotech, Ltd * Ever received cholera toxin or vaccine (e.g. Orochol™, Dukoral™) * History of traveler's diarrhea in the previous two years * History of abdominal surgery (excluding C-Section, hysterectomy, cosmetic surgery, liposuction, appendectomy, cholecystectomy, ventral hernia repair, and other surgeries not pertaining to gastrointestinal problems) or history of, or recent acute gastrointestinal (GI) illness * Positive serology for HIV-1, HIV-2, HBsAg, or HCV * Medical history of acute or chronic skin disease at vaccination area(s) * Active skin allergy * Signs of acute skin infection, sunburn or skin abnormalities at the vaccination area(s) including fungal infections, severe acne, or active contact dermatitis, or a history of keloid formation * Excessively hirsute at the vaccination area(s) that would interfere with patch adhesion in the opinion of the Investigator * Visible tattoos or marks (tattoos/scars) at the vaccination area(s) that would prevent appropriate dermatologic monitoring of the vaccination site(s) * Fever greater than or equal to 38.0°C (100.4°F) at the time of planned vaccination * Women who are pregnant or breastfeeding * Acute illness at screening or at baseline; or * Employee of the investigational site.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| GMTs After a Self-administered LT Vaccine Patch (In-clinic or Away From Clinic) Compared to a Clinician-administered LT Vaccine Patch. | Day 0, Day 14, Day 21, Day 28, Day 35, Day 194 | The primary endpoint of this trial was to compare the immunogenicity (i.e., GMTs, GMFRs and seroconversion rates for LT IgG and IgA) of subject self-administered \[second\] vaccination with clinician-administered \[second\] vaccination, using the deltoid/thigh (Vaccination 1/Vaccination 2) treatment regimen. GMT: geometric mean titer |
| GMFR After a Self-administered LT Vaccine Patch (In-clinic or Away From Clinic) Compared to a Clinician-administered LT Vaccine Patch. | Day 14, Day 21, Day 28, Day 35, Day 194 | The primary endpoint of this trial was to compare the immunogenicity (i.e., GMTs, GMFRs and seroconversion rates for LT IgG and IgA) of subject self-administered \[second\] vaccination with clinician-administered \[second\] vaccination, using the deltoid/thigh (Vaccination 1/Vaccination 2) treatment regimen. GMFR: geometric mean fold ratio GMFRs relative to the baseline titer were determined for LT IgG and LT IgA at each post-baseline time point. All GMFRs were based on log10-transformed data. |
| Seroconversion After a Self-administered LT Vaccine Patch (In-clinic or Away From Clinic) Compared to a Clinician-administered LT Vaccine Patch. | Day 14, Day 21, Day 28, Day 35, Day 194 | The primary endpoint of this trial was to compare the immunogenicity (i.e., GMTs, GMFRs and seroconversion rates (SCR) for LT IgG and IgA) of subject self-administered \[second\] vaccination with clinician-administered \[second\] vaccination, using the deltoid/thigh (Vaccination 1/Vaccination 2) treatment regimen. seroconversion (SC): two-fold or greater rise in titer relative to Day 0 for LT IgG and a four-fold or greater rise in titer relative to Day 0 for LT IgA |
Secondary
| Measure | Time frame |
|---|---|
| Evaluation of Immunogenicity (GMT) for Self-administration In-clinic Compared to Self-administration Away From the Clinic. | 6 months |
| Evaluation of Immunogenicity (GMFR) for Deltoid/Thigh (Prime/Boost) Versus Deltoid/Deltoid Administered LT Vaccine | 6 months |
| Number of Adverse Events for Self-administered LT Vaccine Patch and Comparison to the Clinician-administered LT Vaccine Patch | 6 months |
| Evaluation of Immunogenicity (GMFR) for Self-administration In-clinic Compared to Self-administration Away From the Clinic | 6 months |
| Evaluation of Immunogenicity (SCR) for Self-administration In-clinic Compared to Self-administration Away From the Clinic | 6 months |
| Evaluation of Immunogenicity (SCR) for Deltoid/Thigh (Prime/Boost) Versus Deltoid/Deltoid Administered LT Vaccine | 6 months |
| Evaluation of Immunogenicity (GMT) for Deltoid/Thigh (Prime/Boost) Versus Deltoid/Deltoid Administered LT Vaccine. | 6 months |
| Safety for Self-administration In-clinic Compared to Self-administration Away From the Clinic. | 6 months |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Clinician Administered (Deltoid) 40 subjects will have skin prepared using SPS:Buffer and will receive 37.5ug LT patch on the left deltoid by a Clinician on Day 0. Two weeks later will have the same treatment repeated on the right deltoid by the clinician
heat-labile enterotoxin of E. coli (LT): 37.5ug patch applied on either the deltoid or the thigh | 40 |
| Clinician Administered (Thigh) 40 subjects will be pretreated with SPS:Buffer and a patch containing 37.5ug will be applied on the left deltoid by the Clinician. Fourteen days later, the same procedure will occur on the left thigh by the clinician.
heat-labile enterotoxin of E. coli (LT): 37.5ug patch applied on either the deltoid or the thigh | 40 |
| Self Administered (In-clinic) 40 subjects will have skin prepared using SPS:Buffer and will receive 37.5ug LT on the left deltoid by the clinician. Two weeks later subject will have the same treatment repeated by self-application in the clinic on the left thigh.
heat-labile enterotoxin of E. coli (LT): 37.5ug patch applied on either the deltoid or the thigh | 40 |
| Self Administered (Non-clinic) 40 subjects will have skin prepared using SPS:Buffer and will have 37.5ug LT patch on the left deltoid by a clinician. Two weeks later subjects will have the same treatment repeated by self-application at home on the left thigh.
heat-labile enterotoxin of E. coli (LT): 37.5ug patch applied on either the deltoid or the thigh | 40 |
| Total | 160 |
Baseline characteristics
| Characteristic | Clinician Administered (Deltoid) | Clinician Administered (Thigh) | Self Administered (In-clinic) | Self Administered (Non-clinic) | Total |
|---|---|---|---|---|---|
| Age, Continuous | 36.8 years STANDARD_DEVIATION 12.21 | 35.0 years STANDARD_DEVIATION 11.1 | 38.1 years STANDARD_DEVIATION 11.18 | 34.1 years STANDARD_DEVIATION 11.18 | 36.0 years STANDARD_DEVIATION 11.02 |
| Region of Enrollment United States | 40 participants | 40 participants | 40 participants | 40 participants | 160 participants |
| Sex: Female, Male Female | 28 Participants | 21 Participants | 27 Participants | 23 Participants | 99 Participants |
| Sex: Female, Male Male | 12 Participants | 19 Participants | 13 Participants | 17 Participants | 61 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 | 40 / 40 | 40 / 40 | 40 / 40 | 40 / 40 |
| serious Total, serious adverse events | 1 / 40 | 3 / 40 | 0 / 40 | 0 / 40 |
Outcome results
Primary
GMFR After a Self-administered LT Vaccine Patch (In-clinic or Away From Clinic) Compared to a Clinician-administered LT Vaccine Patch.
The primary endpoint of this trial was to compare the immunogenicity (i.e., GMTs, GMFRs and seroconversion rates for LT IgG and IgA) of subject self-administered \[second\] vaccination with clinician-administered \[second\] vaccination, using the deltoid/thigh (Vaccination 1/Vaccination 2) treatment regimen. GMFR: geometric mean fold ratio GMFRs relative to the baseline titer were determined for LT IgG and LT IgA at each post-baseline time point. All GMFRs were based on log10-transformed data.
Time frame: Day 14, Day 21, Day 28, Day 35, Day 194
Population: intent to treat population = primary analysis population; defined as all study subjects who were consented, randomized, and had a baseline serology
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Clinician Administered (Deltoid/ Thigh) | GMFR After a Self-administered LT Vaccine Patch (In-clinic or Away From Clinic) Compared to a Clinician-administered LT Vaccine Patch. | LT IgG GMFR - Day 35 | 34 geometric mean fold ratio |
| Clinician Administered (Deltoid/ Thigh) | GMFR After a Self-administered LT Vaccine Patch (In-clinic or Away From Clinic) Compared to a Clinician-administered LT Vaccine Patch. | LT IgG GMFR - Day 194 | 14 geometric mean fold ratio |
| Clinician Administered (Deltoid/ Thigh) | GMFR After a Self-administered LT Vaccine Patch (In-clinic or Away From Clinic) Compared to a Clinician-administered LT Vaccine Patch. | LT IgA GMFR - Day 14 | 4 geometric mean fold ratio |
| Clinician Administered (Deltoid/ Thigh) | GMFR After a Self-administered LT Vaccine Patch (In-clinic or Away From Clinic) Compared to a Clinician-administered LT Vaccine Patch. | LT IgA GMFR - Day 21 | 8 geometric mean fold ratio |
| Clinician Administered (Deltoid/ Thigh) | GMFR After a Self-administered LT Vaccine Patch (In-clinic or Away From Clinic) Compared to a Clinician-administered LT Vaccine Patch. | LT IgA GMFR - Day 28 | 12 geometric mean fold ratio |
| Clinician Administered (Deltoid/ Thigh) | GMFR After a Self-administered LT Vaccine Patch (In-clinic or Away From Clinic) Compared to a Clinician-administered LT Vaccine Patch. | LT IgA GMFR - Day 35 | 10 geometric mean fold ratio |
| Clinician Administered (Deltoid/ Thigh) | GMFR After a Self-administered LT Vaccine Patch (In-clinic or Away From Clinic) Compared to a Clinician-administered LT Vaccine Patch. | LT IgA GMFR - Day 194 | 5 geometric mean fold ratio |
| Clinician Administered (Deltoid/ Thigh) | GMFR After a Self-administered LT Vaccine Patch (In-clinic or Away From Clinic) Compared to a Clinician-administered LT Vaccine Patch. | LT IgG GMFR - Day 14 | 6 geometric mean fold ratio |
| Clinician Administered (Deltoid/ Thigh) | GMFR After a Self-administered LT Vaccine Patch (In-clinic or Away From Clinic) Compared to a Clinician-administered LT Vaccine Patch. | LT IgG GMFR - Day 21 | 14 geometric mean fold ratio |
| Clinician Administered (Deltoid/ Thigh) | GMFR After a Self-administered LT Vaccine Patch (In-clinic or Away From Clinic) Compared to a Clinician-administered LT Vaccine Patch. | LT IgG GMFR - Day 28 | 31 geometric mean fold ratio |
| Self Administered (In-clinic & Non-clinic) | GMFR After a Self-administered LT Vaccine Patch (In-clinic or Away From Clinic) Compared to a Clinician-administered LT Vaccine Patch. | LT IgG GMFR - Day 14 | 7 geometric mean fold ratio |
| Self Administered (In-clinic & Non-clinic) | GMFR After a Self-administered LT Vaccine Patch (In-clinic or Away From Clinic) Compared to a Clinician-administered LT Vaccine Patch. | LT IgG GMFR - Day 35 | 29 geometric mean fold ratio |
| Self Administered (In-clinic & Non-clinic) | GMFR After a Self-administered LT Vaccine Patch (In-clinic or Away From Clinic) Compared to a Clinician-administered LT Vaccine Patch. | LT IgA GMFR - Day 35 | 13 geometric mean fold ratio |
| Self Administered (In-clinic & Non-clinic) | GMFR After a Self-administered LT Vaccine Patch (In-clinic or Away From Clinic) Compared to a Clinician-administered LT Vaccine Patch. | LT IgG GMFR - Day 194 | 14 geometric mean fold ratio |
| Self Administered (In-clinic & Non-clinic) | GMFR After a Self-administered LT Vaccine Patch (In-clinic or Away From Clinic) Compared to a Clinician-administered LT Vaccine Patch. | LT IgG GMFR - Day 28 | 28 geometric mean fold ratio |
| Self Administered (In-clinic & Non-clinic) | GMFR After a Self-administered LT Vaccine Patch (In-clinic or Away From Clinic) Compared to a Clinician-administered LT Vaccine Patch. | LT IgA GMFR - Day 14 | 7 geometric mean fold ratio |
| Self Administered (In-clinic & Non-clinic) | GMFR After a Self-administered LT Vaccine Patch (In-clinic or Away From Clinic) Compared to a Clinician-administered LT Vaccine Patch. | LT IgA GMFR - Day 194 | 5 geometric mean fold ratio |
| Self Administered (In-clinic & Non-clinic) | GMFR After a Self-administered LT Vaccine Patch (In-clinic or Away From Clinic) Compared to a Clinician-administered LT Vaccine Patch. | LT IgA GMFR - Day 21 | 12 geometric mean fold ratio |
| Self Administered (In-clinic & Non-clinic) | GMFR After a Self-administered LT Vaccine Patch (In-clinic or Away From Clinic) Compared to a Clinician-administered LT Vaccine Patch. | LT IgG GMFR - Day 21 | 17 geometric mean fold ratio |
| Self Administered (In-clinic & Non-clinic) | GMFR After a Self-administered LT Vaccine Patch (In-clinic or Away From Clinic) Compared to a Clinician-administered LT Vaccine Patch. | LT IgA GMFR - Day 28 | 15 geometric mean fold ratio |
Primary
GMTs After a Self-administered LT Vaccine Patch (In-clinic or Away From Clinic) Compared to a Clinician-administered LT Vaccine Patch.
The primary endpoint of this trial was to compare the immunogenicity (i.e., GMTs, GMFRs and seroconversion rates for LT IgG and IgA) of subject self-administered \[second\] vaccination with clinician-administered \[second\] vaccination, using the deltoid/thigh (Vaccination 1/Vaccination 2) treatment regimen. GMT: geometric mean titer
Time frame: Day 0, Day 14, Day 21, Day 28, Day 35, Day 194
Population: intent to treat population = primary analysis population; defined as all study subjects who were consented, randomized, and had a baseline serology
| Arm | Measure | Group | Value (GEOMETRIC_MEAN) |
|---|---|---|---|
| Clinician Administered (Deltoid/ Thigh) | GMTs After a Self-administered LT Vaccine Patch (In-clinic or Away From Clinic) Compared to a Clinician-administered LT Vaccine Patch. | LT IgA GMTs - Day 0 | 54 geometric mean titers |
| Clinician Administered (Deltoid/ Thigh) | GMTs After a Self-administered LT Vaccine Patch (In-clinic or Away From Clinic) Compared to a Clinician-administered LT Vaccine Patch. | LT IgG GMTs - Day 14 | 1974 geometric mean titers |
| Clinician Administered (Deltoid/ Thigh) | GMTs After a Self-administered LT Vaccine Patch (In-clinic or Away From Clinic) Compared to a Clinician-administered LT Vaccine Patch. | LT IgA GMTs - Day 14 | 218 geometric mean titers |
| Clinician Administered (Deltoid/ Thigh) | GMTs After a Self-administered LT Vaccine Patch (In-clinic or Away From Clinic) Compared to a Clinician-administered LT Vaccine Patch. | LT IgG GMTs - Day 28 | 11153 geometric mean titers |
| Clinician Administered (Deltoid/ Thigh) | GMTs After a Self-administered LT Vaccine Patch (In-clinic or Away From Clinic) Compared to a Clinician-administered LT Vaccine Patch. | LT IgA GMTs - Day 21 | 430 geometric mean titers |
| Clinician Administered (Deltoid/ Thigh) | GMTs After a Self-administered LT Vaccine Patch (In-clinic or Away From Clinic) Compared to a Clinician-administered LT Vaccine Patch. | LT IgG GMTs - Day 35 | 12165 geometric mean titers |
| Clinician Administered (Deltoid/ Thigh) | GMTs After a Self-administered LT Vaccine Patch (In-clinic or Away From Clinic) Compared to a Clinician-administered LT Vaccine Patch. | LT IgA GMTs - Day 28 | 632 geometric mean titers |
| Clinician Administered (Deltoid/ Thigh) | GMTs After a Self-administered LT Vaccine Patch (In-clinic or Away From Clinic) Compared to a Clinician-administered LT Vaccine Patch. | LT IgG GMTs - Day 0 | 362 geometric mean titers |
| Clinician Administered (Deltoid/ Thigh) | GMTs After a Self-administered LT Vaccine Patch (In-clinic or Away From Clinic) Compared to a Clinician-administered LT Vaccine Patch. | LT IgA GMTs - Day 35 | 548 geometric mean titers |
| Clinician Administered (Deltoid/ Thigh) | GMTs After a Self-administered LT Vaccine Patch (In-clinic or Away From Clinic) Compared to a Clinician-administered LT Vaccine Patch. | LT IgG GMTs - Day 194 | 4997 geometric mean titers |
| Clinician Administered (Deltoid/ Thigh) | GMTs After a Self-administered LT Vaccine Patch (In-clinic or Away From Clinic) Compared to a Clinician-administered LT Vaccine Patch. | LT IgA GMTs - Day 194 | 254 geometric mean titers |
| Clinician Administered (Deltoid/ Thigh) | GMTs After a Self-administered LT Vaccine Patch (In-clinic or Away From Clinic) Compared to a Clinician-administered LT Vaccine Patch. | LT IgG GMTs - Day 21 | 4747 geometric mean titers |
| Self Administered (In-clinic & Non-clinic) | GMTs After a Self-administered LT Vaccine Patch (In-clinic or Away From Clinic) Compared to a Clinician-administered LT Vaccine Patch. | LT IgA GMTs - Day 194 | 287 geometric mean titers |
| Self Administered (In-clinic & Non-clinic) | GMTs After a Self-administered LT Vaccine Patch (In-clinic or Away From Clinic) Compared to a Clinician-administered LT Vaccine Patch. | LT IgG GMTs - Day 0 | 442 geometric mean titers |
| Self Administered (In-clinic & Non-clinic) | GMTs After a Self-administered LT Vaccine Patch (In-clinic or Away From Clinic) Compared to a Clinician-administered LT Vaccine Patch. | LT IgG GMTs - Day 14 | 2896 geometric mean titers |
| Self Administered (In-clinic & Non-clinic) | GMTs After a Self-administered LT Vaccine Patch (In-clinic or Away From Clinic) Compared to a Clinician-administered LT Vaccine Patch. | LT IgG GMTs - Day 21 | 7545 geometric mean titers |
| Self Administered (In-clinic & Non-clinic) | GMTs After a Self-administered LT Vaccine Patch (In-clinic or Away From Clinic) Compared to a Clinician-administered LT Vaccine Patch. | LT IgG GMTs - Day 35 | 12745 geometric mean titers |
| Self Administered (In-clinic & Non-clinic) | GMTs After a Self-administered LT Vaccine Patch (In-clinic or Away From Clinic) Compared to a Clinician-administered LT Vaccine Patch. | LT IgG GMTs - Day 194 | 6035 geometric mean titers |
| Self Administered (In-clinic & Non-clinic) | GMTs After a Self-administered LT Vaccine Patch (In-clinic or Away From Clinic) Compared to a Clinician-administered LT Vaccine Patch. | LT IgA GMTs - Day 0 | 53 geometric mean titers |
| Self Administered (In-clinic & Non-clinic) | GMTs After a Self-administered LT Vaccine Patch (In-clinic or Away From Clinic) Compared to a Clinician-administered LT Vaccine Patch. | LT IgA GMTs - Day 14 | 365 geometric mean titers |
| Self Administered (In-clinic & Non-clinic) | GMTs After a Self-administered LT Vaccine Patch (In-clinic or Away From Clinic) Compared to a Clinician-administered LT Vaccine Patch. | LT IgA GMTs - Day 21 | 639 geometric mean titers |
| Self Administered (In-clinic & Non-clinic) | GMTs After a Self-administered LT Vaccine Patch (In-clinic or Away From Clinic) Compared to a Clinician-administered LT Vaccine Patch. | LT IgA GMTs - Day 28 | 768 geometric mean titers |
| Self Administered (In-clinic & Non-clinic) | GMTs After a Self-administered LT Vaccine Patch (In-clinic or Away From Clinic) Compared to a Clinician-administered LT Vaccine Patch. | LT IgA GMTs - Day 35 | 712 geometric mean titers |
| Self Administered (In-clinic & Non-clinic) | GMTs After a Self-administered LT Vaccine Patch (In-clinic or Away From Clinic) Compared to a Clinician-administered LT Vaccine Patch. | LT IgG GMTs - Day 28 | 12180 geometric mean titers |
Primary
Seroconversion After a Self-administered LT Vaccine Patch (In-clinic or Away From Clinic) Compared to a Clinician-administered LT Vaccine Patch.
The primary endpoint of this trial was to compare the immunogenicity (i.e., GMTs, GMFRs and seroconversion rates (SCR) for LT IgG and IgA) of subject self-administered \[second\] vaccination with clinician-administered \[second\] vaccination, using the deltoid/thigh (Vaccination 1/Vaccination 2) treatment regimen. seroconversion (SC): two-fold or greater rise in titer relative to Day 0 for LT IgG and a four-fold or greater rise in titer relative to Day 0 for LT IgA
Time frame: Day 14, Day 21, Day 28, Day 35, Day 194
Population: intent to treat population = primary analysis population; defined as all study subjects who were consented, randomized, and had a baseline serology
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Clinician Administered (Deltoid/ Thigh) | Seroconversion After a Self-administered LT Vaccine Patch (In-clinic or Away From Clinic) Compared to a Clinician-administered LT Vaccine Patch. | LT IgG SCR - Day 14 | 65 percentage of study participants |
| Clinician Administered (Deltoid/ Thigh) | Seroconversion After a Self-administered LT Vaccine Patch (In-clinic or Away From Clinic) Compared to a Clinician-administered LT Vaccine Patch. | LT IgG SCR - Day 21 | 92 percentage of study participants |
| Clinician Administered (Deltoid/ Thigh) | Seroconversion After a Self-administered LT Vaccine Patch (In-clinic or Away From Clinic) Compared to a Clinician-administered LT Vaccine Patch. | LT IgG SCR - Day 28 | 98 percentage of study participants |
| Clinician Administered (Deltoid/ Thigh) | Seroconversion After a Self-administered LT Vaccine Patch (In-clinic or Away From Clinic) Compared to a Clinician-administered LT Vaccine Patch. | LT IgG SCR - Day 35 | 100 percentage of study participants |
| Clinician Administered (Deltoid/ Thigh) | Seroconversion After a Self-administered LT Vaccine Patch (In-clinic or Away From Clinic) Compared to a Clinician-administered LT Vaccine Patch. | LT IgG SCR - Day 194 | 97 percentage of study participants |
| Clinician Administered (Deltoid/ Thigh) | Seroconversion After a Self-administered LT Vaccine Patch (In-clinic or Away From Clinic) Compared to a Clinician-administered LT Vaccine Patch. | LT IgA SCR - Day 14 | 48 percentage of study participants |
| Clinician Administered (Deltoid/ Thigh) | Seroconversion After a Self-administered LT Vaccine Patch (In-clinic or Away From Clinic) Compared to a Clinician-administered LT Vaccine Patch. | LT IgA SCR - Day 21 | 69 percentage of study participants |
| Clinician Administered (Deltoid/ Thigh) | Seroconversion After a Self-administered LT Vaccine Patch (In-clinic or Away From Clinic) Compared to a Clinician-administered LT Vaccine Patch. | LT IgA SCR - Day 28 | 83 percentage of study participants |
| Clinician Administered (Deltoid/ Thigh) | Seroconversion After a Self-administered LT Vaccine Patch (In-clinic or Away From Clinic) Compared to a Clinician-administered LT Vaccine Patch. | LT IgA SCR - Day 35 | 80 percentage of study participants |
| Clinician Administered (Deltoid/ Thigh) | Seroconversion After a Self-administered LT Vaccine Patch (In-clinic or Away From Clinic) Compared to a Clinician-administered LT Vaccine Patch. | LT IgA SCR - Day 194 | 69 percentage of study participants |
| Self Administered (In-clinic & Non-clinic) | Seroconversion After a Self-administered LT Vaccine Patch (In-clinic or Away From Clinic) Compared to a Clinician-administered LT Vaccine Patch. | LT IgA SCR - Day 28 | 90 percentage of study participants |
| Self Administered (In-clinic & Non-clinic) | Seroconversion After a Self-administered LT Vaccine Patch (In-clinic or Away From Clinic) Compared to a Clinician-administered LT Vaccine Patch. | LT IgG SCR - Day 14 | 73 percentage of study participants |
| Self Administered (In-clinic & Non-clinic) | Seroconversion After a Self-administered LT Vaccine Patch (In-clinic or Away From Clinic) Compared to a Clinician-administered LT Vaccine Patch. | LT IgA SCR - Day 14 | 59 percentage of study participants |
| Self Administered (In-clinic & Non-clinic) | Seroconversion After a Self-administered LT Vaccine Patch (In-clinic or Away From Clinic) Compared to a Clinician-administered LT Vaccine Patch. | LT IgG SCR - Day 21 | 98 percentage of study participants |
| Self Administered (In-clinic & Non-clinic) | Seroconversion After a Self-administered LT Vaccine Patch (In-clinic or Away From Clinic) Compared to a Clinician-administered LT Vaccine Patch. | LT IgA SCR - Day 194 | 62 percentage of study participants |
| Self Administered (In-clinic & Non-clinic) | Seroconversion After a Self-administered LT Vaccine Patch (In-clinic or Away From Clinic) Compared to a Clinician-administered LT Vaccine Patch. | LT IgG SCR - Day 28 | 99 percentage of study participants |
| Self Administered (In-clinic & Non-clinic) | Seroconversion After a Self-administered LT Vaccine Patch (In-clinic or Away From Clinic) Compared to a Clinician-administered LT Vaccine Patch. | LT IgA SCR - Day 21 | 85 percentage of study participants |
| Self Administered (In-clinic & Non-clinic) | Seroconversion After a Self-administered LT Vaccine Patch (In-clinic or Away From Clinic) Compared to a Clinician-administered LT Vaccine Patch. | LT IgG SCR - Day 35 | 99 percentage of study participants |
| Self Administered (In-clinic & Non-clinic) | Seroconversion After a Self-administered LT Vaccine Patch (In-clinic or Away From Clinic) Compared to a Clinician-administered LT Vaccine Patch. | LT IgA SCR - Day 35 | 87 percentage of study participants |
| Self Administered (In-clinic & Non-clinic) | Seroconversion After a Self-administered LT Vaccine Patch (In-clinic or Away From Clinic) Compared to a Clinician-administered LT Vaccine Patch. | LT IgG SCR - Day 194 | 100 percentage of study participants |
Secondary
Evaluation of Immunogenicity (GMFR) for Deltoid/Thigh (Prime/Boost) Versus Deltoid/Deltoid Administered LT Vaccine
Time frame: 6 months
Population: The Overall Number of Participants Analyzed are the number of subjects in the ITT Population in each group. The number analyzed in the Outcome Measure Data Table are the number of subjects with non-missing data at the specified time point.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Clinician Administered (Deltoid/ Thigh) | Evaluation of Immunogenicity (GMFR) for Deltoid/Thigh (Prime/Boost) Versus Deltoid/Deltoid Administered LT Vaccine | LT IgA Day 14 - GMFR | 6 fold change |
| Clinician Administered (Deltoid/ Thigh) | Evaluation of Immunogenicity (GMFR) for Deltoid/Thigh (Prime/Boost) Versus Deltoid/Deltoid Administered LT Vaccine | LT IgG Day 21 - GMFR | 15 fold change |
| Clinician Administered (Deltoid/ Thigh) | Evaluation of Immunogenicity (GMFR) for Deltoid/Thigh (Prime/Boost) Versus Deltoid/Deltoid Administered LT Vaccine | LT IgA Day 21 - GMFR | 12 fold change |
| Clinician Administered (Deltoid/ Thigh) | Evaluation of Immunogenicity (GMFR) for Deltoid/Thigh (Prime/Boost) Versus Deltoid/Deltoid Administered LT Vaccine | LT IgG Day 14 - GMFR | 5 fold change |
| Clinician Administered (Deltoid/ Thigh) | Evaluation of Immunogenicity (GMFR) for Deltoid/Thigh (Prime/Boost) Versus Deltoid/Deltoid Administered LT Vaccine | LT IgA Day 28 - GMFR | 14 fold change |
| Clinician Administered (Deltoid/ Thigh) | Evaluation of Immunogenicity (GMFR) for Deltoid/Thigh (Prime/Boost) Versus Deltoid/Deltoid Administered LT Vaccine | LT IgG Day 28 - GMFR | 22 fold change |
| Clinician Administered (Deltoid/ Thigh) | Evaluation of Immunogenicity (GMFR) for Deltoid/Thigh (Prime/Boost) Versus Deltoid/Deltoid Administered LT Vaccine | LT IgA Day 35 - GMFR | 13 fold change |
| Clinician Administered (Deltoid/ Thigh) | Evaluation of Immunogenicity (GMFR) for Deltoid/Thigh (Prime/Boost) Versus Deltoid/Deltoid Administered LT Vaccine | LT IgG Day 194 - GMFR | 16 fold change |
| Clinician Administered (Deltoid/ Thigh) | Evaluation of Immunogenicity (GMFR) for Deltoid/Thigh (Prime/Boost) Versus Deltoid/Deltoid Administered LT Vaccine | LT IgA Day 194 - GMFR | 6 fold change |
| Clinician Administered (Deltoid/ Thigh) | Evaluation of Immunogenicity (GMFR) for Deltoid/Thigh (Prime/Boost) Versus Deltoid/Deltoid Administered LT Vaccine | LT IgG Day 35 - GMFR | 30 fold change |
| Self Administered (In-clinic & Non-clinic) | Evaluation of Immunogenicity (GMFR) for Deltoid/Thigh (Prime/Boost) Versus Deltoid/Deltoid Administered LT Vaccine | LT IgA Day 194 - GMFR | 5 fold change |
| Self Administered (In-clinic & Non-clinic) | Evaluation of Immunogenicity (GMFR) for Deltoid/Thigh (Prime/Boost) Versus Deltoid/Deltoid Administered LT Vaccine | LT IgG Day 194 - GMFR | 14 fold change |
| Self Administered (In-clinic & Non-clinic) | Evaluation of Immunogenicity (GMFR) for Deltoid/Thigh (Prime/Boost) Versus Deltoid/Deltoid Administered LT Vaccine | LT IgG Day 14 - GMFR | 6 fold change |
| Self Administered (In-clinic & Non-clinic) | Evaluation of Immunogenicity (GMFR) for Deltoid/Thigh (Prime/Boost) Versus Deltoid/Deltoid Administered LT Vaccine | LT IgG Day 21 - GMFR | 14 fold change |
| Self Administered (In-clinic & Non-clinic) | Evaluation of Immunogenicity (GMFR) for Deltoid/Thigh (Prime/Boost) Versus Deltoid/Deltoid Administered LT Vaccine | LT IgG Day 28 - GMFR | 31 fold change |
| Self Administered (In-clinic & Non-clinic) | Evaluation of Immunogenicity (GMFR) for Deltoid/Thigh (Prime/Boost) Versus Deltoid/Deltoid Administered LT Vaccine | LT IgA Day 14 - GMFR | 4 fold change |
| Self Administered (In-clinic & Non-clinic) | Evaluation of Immunogenicity (GMFR) for Deltoid/Thigh (Prime/Boost) Versus Deltoid/Deltoid Administered LT Vaccine | LT IgA Day 21 - GMFR | 8 fold change |
| Self Administered (In-clinic & Non-clinic) | Evaluation of Immunogenicity (GMFR) for Deltoid/Thigh (Prime/Boost) Versus Deltoid/Deltoid Administered LT Vaccine | LT IgA Day 28 - GMFR | 12 fold change |
| Self Administered (In-clinic & Non-clinic) | Evaluation of Immunogenicity (GMFR) for Deltoid/Thigh (Prime/Boost) Versus Deltoid/Deltoid Administered LT Vaccine | LT IgA Day 35 - GMFR | 10 fold change |
| Self Administered (In-clinic & Non-clinic) | Evaluation of Immunogenicity (GMFR) for Deltoid/Thigh (Prime/Boost) Versus Deltoid/Deltoid Administered LT Vaccine | LT IgG Day 35 - GMFR | 34 fold change |
Secondary
Evaluation of Immunogenicity (GMFR) for Self-administration In-clinic Compared to Self-administration Away From the Clinic
Time frame: 6 months
Population: Overall Number of Participants Analyzed are the number of subjects in the ITT Population in each group. The Number analyzed in the Outcome Measure Data Table are the number of subjects with non-missing data at the specified time point.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Clinician Administered (Deltoid/ Thigh) | Evaluation of Immunogenicity (GMFR) for Self-administration In-clinic Compared to Self-administration Away From the Clinic | Lt IgG Day 14 - GMFR | 5 fold change |
| Clinician Administered (Deltoid/ Thigh) | Evaluation of Immunogenicity (GMFR) for Self-administration In-clinic Compared to Self-administration Away From the Clinic | LT IgG Day 21 - GMFR | 14 fold change |
| Clinician Administered (Deltoid/ Thigh) | Evaluation of Immunogenicity (GMFR) for Self-administration In-clinic Compared to Self-administration Away From the Clinic | LT IgG Day 28 - GMFR | 22 fold change |
| Clinician Administered (Deltoid/ Thigh) | Evaluation of Immunogenicity (GMFR) for Self-administration In-clinic Compared to Self-administration Away From the Clinic | LT IgG Day 35 - GMFR | 26 fold change |
| Clinician Administered (Deltoid/ Thigh) | Evaluation of Immunogenicity (GMFR) for Self-administration In-clinic Compared to Self-administration Away From the Clinic | LT IgG Day 194 - GMFR | 12 fold change |
| Clinician Administered (Deltoid/ Thigh) | Evaluation of Immunogenicity (GMFR) for Self-administration In-clinic Compared to Self-administration Away From the Clinic | LT IgA Day 14 - GMFR | 6 fold change |
| Clinician Administered (Deltoid/ Thigh) | Evaluation of Immunogenicity (GMFR) for Self-administration In-clinic Compared to Self-administration Away From the Clinic | LT IgA Day 21 - GMFR | 10 fold change |
| Clinician Administered (Deltoid/ Thigh) | Evaluation of Immunogenicity (GMFR) for Self-administration In-clinic Compared to Self-administration Away From the Clinic | LT IgA Day 28 - GMFR | 12 fold change |
| Clinician Administered (Deltoid/ Thigh) | Evaluation of Immunogenicity (GMFR) for Self-administration In-clinic Compared to Self-administration Away From the Clinic | LT IgA Day 35 - GMFR | 11 fold change |
| Clinician Administered (Deltoid/ Thigh) | Evaluation of Immunogenicity (GMFR) for Self-administration In-clinic Compared to Self-administration Away From the Clinic | LT IgA Day 194 - GMFR | 5 fold change |
| Self Administered (In-clinic & Non-clinic) | Evaluation of Immunogenicity (GMFR) for Self-administration In-clinic Compared to Self-administration Away From the Clinic | LT IgA Day 28 - GMFR | 17 fold change |
| Self Administered (In-clinic & Non-clinic) | Evaluation of Immunogenicity (GMFR) for Self-administration In-clinic Compared to Self-administration Away From the Clinic | Lt IgG Day 14 - GMFR | 8 fold change |
| Self Administered (In-clinic & Non-clinic) | Evaluation of Immunogenicity (GMFR) for Self-administration In-clinic Compared to Self-administration Away From the Clinic | LT IgA Day 14 - GMFR | 8 fold change |
| Self Administered (In-clinic & Non-clinic) | Evaluation of Immunogenicity (GMFR) for Self-administration In-clinic Compared to Self-administration Away From the Clinic | LT IgG Day 21 - GMFR | 21 fold change |
| Self Administered (In-clinic & Non-clinic) | Evaluation of Immunogenicity (GMFR) for Self-administration In-clinic Compared to Self-administration Away From the Clinic | LT IgA Day 194 - GMFR | 6 fold change |
| Self Administered (In-clinic & Non-clinic) | Evaluation of Immunogenicity (GMFR) for Self-administration In-clinic Compared to Self-administration Away From the Clinic | LT IgG Day 28 - GMFR | 34 fold change |
| Self Administered (In-clinic & Non-clinic) | Evaluation of Immunogenicity (GMFR) for Self-administration In-clinic Compared to Self-administration Away From the Clinic | LT IgA Day 21 - GMFR | 14 fold change |
| Self Administered (In-clinic & Non-clinic) | Evaluation of Immunogenicity (GMFR) for Self-administration In-clinic Compared to Self-administration Away From the Clinic | LT IgG Day 35 - GMFR | 34 fold change |
| Self Administered (In-clinic & Non-clinic) | Evaluation of Immunogenicity (GMFR) for Self-administration In-clinic Compared to Self-administration Away From the Clinic | LT IgA Day 35 - GMFR | 16 fold change |
| Self Administered (In-clinic & Non-clinic) | Evaluation of Immunogenicity (GMFR) for Self-administration In-clinic Compared to Self-administration Away From the Clinic | LT IgG Day 194 - GMFR | 16 fold change |
Secondary
Evaluation of Immunogenicity (GMT) for Deltoid/Thigh (Prime/Boost) Versus Deltoid/Deltoid Administered LT Vaccine.
Time frame: 6 months
Population: The Overall Number of Participants Analyzed are the number of subjects in the ITT Population in each group. The number analyzed in the Outcome Measure Data Table are the number of subjects with non-missing data at the specified time point.
| Arm | Measure | Group | Value (GEOMETRIC_MEAN) |
|---|---|---|---|
| Clinician Administered (Deltoid/ Thigh) | Evaluation of Immunogenicity (GMT) for Deltoid/Thigh (Prime/Boost) Versus Deltoid/Deltoid Administered LT Vaccine. | LT IgG Day 0 - GMT | 411 titers |
| Clinician Administered (Deltoid/ Thigh) | Evaluation of Immunogenicity (GMT) for Deltoid/Thigh (Prime/Boost) Versus Deltoid/Deltoid Administered LT Vaccine. | LT IgG Day 14 - GMT | 2176 titers |
| Clinician Administered (Deltoid/ Thigh) | Evaluation of Immunogenicity (GMT) for Deltoid/Thigh (Prime/Boost) Versus Deltoid/Deltoid Administered LT Vaccine. | LT IgG Day 21 - GMT | 6292 titers |
| Clinician Administered (Deltoid/ Thigh) | Evaluation of Immunogenicity (GMT) for Deltoid/Thigh (Prime/Boost) Versus Deltoid/Deltoid Administered LT Vaccine. | LT IgG Day 28 - GMT | 8895 titers |
| Clinician Administered (Deltoid/ Thigh) | Evaluation of Immunogenicity (GMT) for Deltoid/Thigh (Prime/Boost) Versus Deltoid/Deltoid Administered LT Vaccine. | LT IgG Day 35 - GMT | 12460 titers |
| Clinician Administered (Deltoid/ Thigh) | Evaluation of Immunogenicity (GMT) for Deltoid/Thigh (Prime/Boost) Versus Deltoid/Deltoid Administered LT Vaccine. | LT IgG Day 194 - GMT | 6694 titers |
| Clinician Administered (Deltoid/ Thigh) | Evaluation of Immunogenicity (GMT) for Deltoid/Thigh (Prime/Boost) Versus Deltoid/Deltoid Administered LT Vaccine. | LT IgA Day 0 - GMT | 43 titers |
| Clinician Administered (Deltoid/ Thigh) | Evaluation of Immunogenicity (GMT) for Deltoid/Thigh (Prime/Boost) Versus Deltoid/Deltoid Administered LT Vaccine. | LT IgA Day 14 - GMT | 239 titers |
| Clinician Administered (Deltoid/ Thigh) | Evaluation of Immunogenicity (GMT) for Deltoid/Thigh (Prime/Boost) Versus Deltoid/Deltoid Administered LT Vaccine. | LT IgA Day 21 - GMT | 502 titers |
| Clinician Administered (Deltoid/ Thigh) | Evaluation of Immunogenicity (GMT) for Deltoid/Thigh (Prime/Boost) Versus Deltoid/Deltoid Administered LT Vaccine. | LT IgA Day 28 - GMT | 610 titers |
| Clinician Administered (Deltoid/ Thigh) | Evaluation of Immunogenicity (GMT) for Deltoid/Thigh (Prime/Boost) Versus Deltoid/Deltoid Administered LT Vaccine. | LT IgA Day 35 - GMT | 567 titers |
| Clinician Administered (Deltoid/ Thigh) | Evaluation of Immunogenicity (GMT) for Deltoid/Thigh (Prime/Boost) Versus Deltoid/Deltoid Administered LT Vaccine. | LT IgA Day 194 - GMT | 272 titers |
| Self Administered (In-clinic & Non-clinic) | Evaluation of Immunogenicity (GMT) for Deltoid/Thigh (Prime/Boost) Versus Deltoid/Deltoid Administered LT Vaccine. | LT IgA Day 35 - GMT | 548 titers |
| Self Administered (In-clinic & Non-clinic) | Evaluation of Immunogenicity (GMT) for Deltoid/Thigh (Prime/Boost) Versus Deltoid/Deltoid Administered LT Vaccine. | LT IgG Day 0 - GMT | 362 titers |
| Self Administered (In-clinic & Non-clinic) | Evaluation of Immunogenicity (GMT) for Deltoid/Thigh (Prime/Boost) Versus Deltoid/Deltoid Administered LT Vaccine. | LT IgA Day 0 - GMT | 54 titers |
| Self Administered (In-clinic & Non-clinic) | Evaluation of Immunogenicity (GMT) for Deltoid/Thigh (Prime/Boost) Versus Deltoid/Deltoid Administered LT Vaccine. | LT IgG Day 14 - GMT | 1974 titers |
| Self Administered (In-clinic & Non-clinic) | Evaluation of Immunogenicity (GMT) for Deltoid/Thigh (Prime/Boost) Versus Deltoid/Deltoid Administered LT Vaccine. | LT IgA Day 28 - GMT | 632 titers |
| Self Administered (In-clinic & Non-clinic) | Evaluation of Immunogenicity (GMT) for Deltoid/Thigh (Prime/Boost) Versus Deltoid/Deltoid Administered LT Vaccine. | LT IgG Day 21 - GMT | 4747 titers |
| Self Administered (In-clinic & Non-clinic) | Evaluation of Immunogenicity (GMT) for Deltoid/Thigh (Prime/Boost) Versus Deltoid/Deltoid Administered LT Vaccine. | LT IgA Day 14 - GMT | 218 titers |
| Self Administered (In-clinic & Non-clinic) | Evaluation of Immunogenicity (GMT) for Deltoid/Thigh (Prime/Boost) Versus Deltoid/Deltoid Administered LT Vaccine. | LT IgG Day 28 - GMT | 11153 titers |
| Self Administered (In-clinic & Non-clinic) | Evaluation of Immunogenicity (GMT) for Deltoid/Thigh (Prime/Boost) Versus Deltoid/Deltoid Administered LT Vaccine. | LT IgA Day 194 - GMT | 254 titers |
| Self Administered (In-clinic & Non-clinic) | Evaluation of Immunogenicity (GMT) for Deltoid/Thigh (Prime/Boost) Versus Deltoid/Deltoid Administered LT Vaccine. | LT IgG Day 35 - GMT | 12165 titers |
| Self Administered (In-clinic & Non-clinic) | Evaluation of Immunogenicity (GMT) for Deltoid/Thigh (Prime/Boost) Versus Deltoid/Deltoid Administered LT Vaccine. | LT IgA Day 21 - GMT | 430 titers |
| Self Administered (In-clinic & Non-clinic) | Evaluation of Immunogenicity (GMT) for Deltoid/Thigh (Prime/Boost) Versus Deltoid/Deltoid Administered LT Vaccine. | LT IgG Day 194 - GMT | 4997 titers |
Secondary
Evaluation of Immunogenicity (GMT) for Self-administration In-clinic Compared to Self-administration Away From the Clinic.
Time frame: 6 months
Population: Overall Number of Participants Analyzed are the number of subjects in the ITT Population in each group. The Number analyzed in the Outcome Measure Data Table are the number of subjects with non-missing data at the specified time point.
| Arm | Measure | Group | Value (GEOMETRIC_MEAN) |
|---|---|---|---|
| Clinician Administered (Deltoid/ Thigh) | Evaluation of Immunogenicity (GMT) for Self-administration In-clinic Compared to Self-administration Away From the Clinic. | LT IgG Day 28 - GMT | 10496 titers |
| Clinician Administered (Deltoid/ Thigh) | Evaluation of Immunogenicity (GMT) for Self-administration In-clinic Compared to Self-administration Away From the Clinic. | LT IgA Day 0 - GMT | 54 titers |
| Clinician Administered (Deltoid/ Thigh) | Evaluation of Immunogenicity (GMT) for Self-administration In-clinic Compared to Self-administration Away From the Clinic. | LT IgG Day 21 - GMT | 6511 titers |
| Clinician Administered (Deltoid/ Thigh) | Evaluation of Immunogenicity (GMT) for Self-administration In-clinic Compared to Self-administration Away From the Clinic. | LT IgA Day 21 - GMT | 549 titers |
| Clinician Administered (Deltoid/ Thigh) | Evaluation of Immunogenicity (GMT) for Self-administration In-clinic Compared to Self-administration Away From the Clinic. | LT IgG Day 35 - GMT | 11995 titers |
| Clinician Administered (Deltoid/ Thigh) | Evaluation of Immunogenicity (GMT) for Self-administration In-clinic Compared to Self-administration Away From the Clinic. | LT IgA Day 28 - GMT | 660 titers |
| Clinician Administered (Deltoid/ Thigh) | Evaluation of Immunogenicity (GMT) for Self-administration In-clinic Compared to Self-administration Away From the Clinic. | LT IgG Day 14 - GMT | 2539 titers |
| Clinician Administered (Deltoid/ Thigh) | Evaluation of Immunogenicity (GMT) for Self-administration In-clinic Compared to Self-administration Away From the Clinic. | LT IgA Day 35 - GMT | 605 titers |
| Clinician Administered (Deltoid/ Thigh) | Evaluation of Immunogenicity (GMT) for Self-administration In-clinic Compared to Self-administration Away From the Clinic. | LT IgG Day 194 - GMT | 5712 titers |
| Clinician Administered (Deltoid/ Thigh) | Evaluation of Immunogenicity (GMT) for Self-administration In-clinic Compared to Self-administration Away From the Clinic. | LT IgA Day 194 - GMT | 246 titers |
| Clinician Administered (Deltoid/ Thigh) | Evaluation of Immunogenicity (GMT) for Self-administration In-clinic Compared to Self-administration Away From the Clinic. | LT IgG Day 0 - GMT | 473 titers |
| Self Administered (In-clinic & Non-clinic) | Evaluation of Immunogenicity (GMT) for Self-administration In-clinic Compared to Self-administration Away From the Clinic. | LT IgA Day 194 - GMT | 338 titers |
| Self Administered (In-clinic & Non-clinic) | Evaluation of Immunogenicity (GMT) for Self-administration In-clinic Compared to Self-administration Away From the Clinic. | LT IgG Day 0 - GMT | 413 titers |
| Self Administered (In-clinic & Non-clinic) | Evaluation of Immunogenicity (GMT) for Self-administration In-clinic Compared to Self-administration Away From the Clinic. | LT IgG Day 14 - GMT | 3304 titers |
| Self Administered (In-clinic & Non-clinic) | Evaluation of Immunogenicity (GMT) for Self-administration In-clinic Compared to Self-administration Away From the Clinic. | LT IgG Day 21 - GMT | 8712 titers |
| Self Administered (In-clinic & Non-clinic) | Evaluation of Immunogenicity (GMT) for Self-administration In-clinic Compared to Self-administration Away From the Clinic. | LT IgG Day 28 - GMT | 14083 titers |
| Self Administered (In-clinic & Non-clinic) | Evaluation of Immunogenicity (GMT) for Self-administration In-clinic Compared to Self-administration Away From the Clinic. | LT IgG Day 35 - GMT | 13564 titers |
| Self Administered (In-clinic & Non-clinic) | Evaluation of Immunogenicity (GMT) for Self-administration In-clinic Compared to Self-administration Away From the Clinic. | LT IgG Day 194 - GMT | 6396 titers |
| Self Administered (In-clinic & Non-clinic) | Evaluation of Immunogenicity (GMT) for Self-administration In-clinic Compared to Self-administration Away From the Clinic. | LT IgA Day 0 - GMT | 52 titers |
| Self Administered (In-clinic & Non-clinic) | Evaluation of Immunogenicity (GMT) for Self-administration In-clinic Compared to Self-administration Away From the Clinic. | LT IgA Day 21 - GMT | 742 titers |
| Self Administered (In-clinic & Non-clinic) | Evaluation of Immunogenicity (GMT) for Self-administration In-clinic Compared to Self-administration Away From the Clinic. | LT IgA Day 28 - GMT | 891 titers |
| Self Administered (In-clinic & Non-clinic) | Evaluation of Immunogenicity (GMT) for Self-administration In-clinic Compared to Self-administration Away From the Clinic. | LT IgA Day 35 - GMT | 842 titers |
Secondary
Evaluation of Immunogenicity (SCR) for Deltoid/Thigh (Prime/Boost) Versus Deltoid/Deltoid Administered LT Vaccine
Time frame: 6 months
Population: The Overall Number of Participants Analyzed are the number of subjects in the ITT Population in each group. The number analyzed in the Outcome Measure Data Table are the number of subjects with non-missing data at the specified time point.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Clinician Administered (Deltoid/ Thigh) | Evaluation of Immunogenicity (SCR) for Deltoid/Thigh (Prime/Boost) Versus Deltoid/Deltoid Administered LT Vaccine | LT IgG Day 35 - SCR | 95 Percent of Participants |
| Clinician Administered (Deltoid/ Thigh) | Evaluation of Immunogenicity (SCR) for Deltoid/Thigh (Prime/Boost) Versus Deltoid/Deltoid Administered LT Vaccine | LT IgG Day 21 - SCR | 90 Percent of Participants |
| Clinician Administered (Deltoid/ Thigh) | Evaluation of Immunogenicity (SCR) for Deltoid/Thigh (Prime/Boost) Versus Deltoid/Deltoid Administered LT Vaccine | LT IgG Day 194 - SCR | 98 Percent of Participants |
| Clinician Administered (Deltoid/ Thigh) | Evaluation of Immunogenicity (SCR) for Deltoid/Thigh (Prime/Boost) Versus Deltoid/Deltoid Administered LT Vaccine | LT IgA Day 28 - SCR | 88 Percent of Participants |
| Clinician Administered (Deltoid/ Thigh) | Evaluation of Immunogenicity (SCR) for Deltoid/Thigh (Prime/Boost) Versus Deltoid/Deltoid Administered LT Vaccine | LT IgA Day 14 - SCR | 50 Percent of Participants |
| Clinician Administered (Deltoid/ Thigh) | Evaluation of Immunogenicity (SCR) for Deltoid/Thigh (Prime/Boost) Versus Deltoid/Deltoid Administered LT Vaccine | LT IgG Day 14 - SCR | 70 Percent of Participants |
| Clinician Administered (Deltoid/ Thigh) | Evaluation of Immunogenicity (SCR) for Deltoid/Thigh (Prime/Boost) Versus Deltoid/Deltoid Administered LT Vaccine | LT IgA Day 21 - SCR | 80 Percent of Participants |
| Clinician Administered (Deltoid/ Thigh) | Evaluation of Immunogenicity (SCR) for Deltoid/Thigh (Prime/Boost) Versus Deltoid/Deltoid Administered LT Vaccine | LT IgG Day 28 - SCR | 98 Percent of Participants |
| Clinician Administered (Deltoid/ Thigh) | Evaluation of Immunogenicity (SCR) for Deltoid/Thigh (Prime/Boost) Versus Deltoid/Deltoid Administered LT Vaccine | LT IgA Day 194 - SCR | 70 Percent of Participants |
| Clinician Administered (Deltoid/ Thigh) | Evaluation of Immunogenicity (SCR) for Deltoid/Thigh (Prime/Boost) Versus Deltoid/Deltoid Administered LT Vaccine | LT IgA Day 35 - SCR | 90 Percent of Participants |
| Self Administered (In-clinic & Non-clinic) | Evaluation of Immunogenicity (SCR) for Deltoid/Thigh (Prime/Boost) Versus Deltoid/Deltoid Administered LT Vaccine | LT IgA Day 194 - SCR | 69 Percent of Participants |
| Self Administered (In-clinic & Non-clinic) | Evaluation of Immunogenicity (SCR) for Deltoid/Thigh (Prime/Boost) Versus Deltoid/Deltoid Administered LT Vaccine | LT IgA Day 35 - SCR | 80 Percent of Participants |
| Self Administered (In-clinic & Non-clinic) | Evaluation of Immunogenicity (SCR) for Deltoid/Thigh (Prime/Boost) Versus Deltoid/Deltoid Administered LT Vaccine | LT IgG Day 14 - SCR | 65 Percent of Participants |
| Self Administered (In-clinic & Non-clinic) | Evaluation of Immunogenicity (SCR) for Deltoid/Thigh (Prime/Boost) Versus Deltoid/Deltoid Administered LT Vaccine | LT IgG Day 21 - SCR | 92 Percent of Participants |
| Self Administered (In-clinic & Non-clinic) | Evaluation of Immunogenicity (SCR) for Deltoid/Thigh (Prime/Boost) Versus Deltoid/Deltoid Administered LT Vaccine | LT IgG Day 28 - SCR | 97 Percent of Participants |
| Self Administered (In-clinic & Non-clinic) | Evaluation of Immunogenicity (SCR) for Deltoid/Thigh (Prime/Boost) Versus Deltoid/Deltoid Administered LT Vaccine | LT IgG Day 35 - SCR | 100 Percent of Participants |
| Self Administered (In-clinic & Non-clinic) | Evaluation of Immunogenicity (SCR) for Deltoid/Thigh (Prime/Boost) Versus Deltoid/Deltoid Administered LT Vaccine | LT IgG Day 194 - SCR | 97 Percent of Participants |
| Self Administered (In-clinic & Non-clinic) | Evaluation of Immunogenicity (SCR) for Deltoid/Thigh (Prime/Boost) Versus Deltoid/Deltoid Administered LT Vaccine | LT IgA Day 14 - SCR | 48 Percent of Participants |
| Self Administered (In-clinic & Non-clinic) | Evaluation of Immunogenicity (SCR) for Deltoid/Thigh (Prime/Boost) Versus Deltoid/Deltoid Administered LT Vaccine | LT IgA Day 21 - SCR | 69 Percent of Participants |
| Self Administered (In-clinic & Non-clinic) | Evaluation of Immunogenicity (SCR) for Deltoid/Thigh (Prime/Boost) Versus Deltoid/Deltoid Administered LT Vaccine | LT IgA Day 28 - SCR | 83 Percent of Participants |
Secondary
Evaluation of Immunogenicity (SCR) for Self-administration In-clinic Compared to Self-administration Away From the Clinic
Time frame: 6 months
Population: Overall Number of Participants Analyzed are the number of subjects in the ITT Population in each group. The Number analyzed in the Outcome Measure Data Table are the number of subjects with non-missing data at the specified time point.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Clinician Administered (Deltoid/ Thigh) | Evaluation of Immunogenicity (SCR) for Self-administration In-clinic Compared to Self-administration Away From the Clinic | LT IgA Day 14 - SCR | 58 Percent of Participants |
| Clinician Administered (Deltoid/ Thigh) | Evaluation of Immunogenicity (SCR) for Self-administration In-clinic Compared to Self-administration Away From the Clinic | LT IgG Day 21 - SCR | 97 Percent of Participants |
| Clinician Administered (Deltoid/ Thigh) | Evaluation of Immunogenicity (SCR) for Self-administration In-clinic Compared to Self-administration Away From the Clinic | LT IgA Day 21 - SCR | 84 Percent of Participants |
| Clinician Administered (Deltoid/ Thigh) | Evaluation of Immunogenicity (SCR) for Self-administration In-clinic Compared to Self-administration Away From the Clinic | LT IgG Day 35 - SCR | 100 Percent of Participants |
| Clinician Administered (Deltoid/ Thigh) | Evaluation of Immunogenicity (SCR) for Self-administration In-clinic Compared to Self-administration Away From the Clinic | LT IgA Day 28 - SCR | 92 Percent of Participants |
| Clinician Administered (Deltoid/ Thigh) | Evaluation of Immunogenicity (SCR) for Self-administration In-clinic Compared to Self-administration Away From the Clinic | LT IgG Day 14 - SCR | 68 Percent of Participants |
| Clinician Administered (Deltoid/ Thigh) | Evaluation of Immunogenicity (SCR) for Self-administration In-clinic Compared to Self-administration Away From the Clinic | LT IgA Day 35 - SCR | 85 Percent of Participants |
| Clinician Administered (Deltoid/ Thigh) | Evaluation of Immunogenicity (SCR) for Self-administration In-clinic Compared to Self-administration Away From the Clinic | LT IgG Day 194 - SCR | 100 Percent of Participants |
| Clinician Administered (Deltoid/ Thigh) | Evaluation of Immunogenicity (SCR) for Self-administration In-clinic Compared to Self-administration Away From the Clinic | LT IgA Day 194 - SCR | 56 Percent of Participants |
| Clinician Administered (Deltoid/ Thigh) | Evaluation of Immunogenicity (SCR) for Self-administration In-clinic Compared to Self-administration Away From the Clinic | LT IgG Day 28 - SCR | 100 Percent of Participants |
| Self Administered (In-clinic & Non-clinic) | Evaluation of Immunogenicity (SCR) for Self-administration In-clinic Compared to Self-administration Away From the Clinic | LT IgA Day 194 - SCR | 68 Percent of Participants |
| Self Administered (In-clinic & Non-clinic) | Evaluation of Immunogenicity (SCR) for Self-administration In-clinic Compared to Self-administration Away From the Clinic | LT IgG Day 21 - SCR | 98 Percent of Participants |
| Self Administered (In-clinic & Non-clinic) | Evaluation of Immunogenicity (SCR) for Self-administration In-clinic Compared to Self-administration Away From the Clinic | LT IgG Day 28 - SCR | 98 Percent of Participants |
| Self Administered (In-clinic & Non-clinic) | Evaluation of Immunogenicity (SCR) for Self-administration In-clinic Compared to Self-administration Away From the Clinic | LT IgG Day 35 - SCR | 97 Percent of Participants |
| Self Administered (In-clinic & Non-clinic) | Evaluation of Immunogenicity (SCR) for Self-administration In-clinic Compared to Self-administration Away From the Clinic | LT IgG Day 194 - SCR | 100 Percent of Participants |
| Self Administered (In-clinic & Non-clinic) | Evaluation of Immunogenicity (SCR) for Self-administration In-clinic Compared to Self-administration Away From the Clinic | LT IgA Day 14 - SCR | 60 Percent of Participants |
| Self Administered (In-clinic & Non-clinic) | Evaluation of Immunogenicity (SCR) for Self-administration In-clinic Compared to Self-administration Away From the Clinic | LT IgA Day 21 - SCR | 85 Percent of Participants |
| Self Administered (In-clinic & Non-clinic) | Evaluation of Immunogenicity (SCR) for Self-administration In-clinic Compared to Self-administration Away From the Clinic | LT IgA Day 28 - SCR | 88 Percent of Participants |
| Self Administered (In-clinic & Non-clinic) | Evaluation of Immunogenicity (SCR) for Self-administration In-clinic Compared to Self-administration Away From the Clinic | LT IgA Day 35 - SCR | 90 Percent of Participants |
| Self Administered (In-clinic & Non-clinic) | Evaluation of Immunogenicity (SCR) for Self-administration In-clinic Compared to Self-administration Away From the Clinic | LT IgG Day 14 - SCR | 78 Percent of Participants |
Secondary
Number of Adverse Events for Self-administered LT Vaccine Patch and Comparison to the Clinician-administered LT Vaccine Patch
Time frame: 6 months
Population: Number analyzed in the Outcome Measure Data Teble are the number of subjects with events
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Clinician Administered (Deltoid/ Thigh) | Number of Adverse Events for Self-administered LT Vaccine Patch and Comparison to the Clinician-administered LT Vaccine Patch | Related Local AEs | 284 Events |
| Clinician Administered (Deltoid/ Thigh) | Number of Adverse Events for Self-administered LT Vaccine Patch and Comparison to the Clinician-administered LT Vaccine Patch | All Related AEs | 299 Events |
| Clinician Administered (Deltoid/ Thigh) | Number of Adverse Events for Self-administered LT Vaccine Patch and Comparison to the Clinician-administered LT Vaccine Patch | All Severe AEs | 3 Events |
| Clinician Administered (Deltoid/ Thigh) | Number of Adverse Events for Self-administered LT Vaccine Patch and Comparison to the Clinician-administered LT Vaccine Patch | Local AEs | 284 Events |
| Clinician Administered (Deltoid/ Thigh) | Number of Adverse Events for Self-administered LT Vaccine Patch and Comparison to the Clinician-administered LT Vaccine Patch | Severe Systemic AEs | 3 Events |
| Clinician Administered (Deltoid/ Thigh) | Number of Adverse Events for Self-administered LT Vaccine Patch and Comparison to the Clinician-administered LT Vaccine Patch | All AEs | 347 Events |
| Clinician Administered (Deltoid/ Thigh) | Number of Adverse Events for Self-administered LT Vaccine Patch and Comparison to the Clinician-administered LT Vaccine Patch | All Serious AEs | 2 Events |
| Clinician Administered (Deltoid/ Thigh) | Number of Adverse Events for Self-administered LT Vaccine Patch and Comparison to the Clinician-administered LT Vaccine Patch | Related Systemic AEs | 15 Events |
| Clinician Administered (Deltoid/ Thigh) | Number of Adverse Events for Self-administered LT Vaccine Patch and Comparison to the Clinician-administered LT Vaccine Patch | Systemic AEs | 63 Events |
| Clinician Administered (Deltoid/ Thigh) | Number of Adverse Events for Self-administered LT Vaccine Patch and Comparison to the Clinician-administered LT Vaccine Patch | Serious Systemic AEs | 2 Events |
| Self Administered (In-clinic & Non-clinic) | Number of Adverse Events for Self-administered LT Vaccine Patch and Comparison to the Clinician-administered LT Vaccine Patch | Serious Systemic AEs | 3 Events |
| Self Administered (In-clinic & Non-clinic) | Number of Adverse Events for Self-administered LT Vaccine Patch and Comparison to the Clinician-administered LT Vaccine Patch | All AEs | 358 Events |
| Self Administered (In-clinic & Non-clinic) | Number of Adverse Events for Self-administered LT Vaccine Patch and Comparison to the Clinician-administered LT Vaccine Patch | Local AEs | 283 Events |
| Self Administered (In-clinic & Non-clinic) | Number of Adverse Events for Self-administered LT Vaccine Patch and Comparison to the Clinician-administered LT Vaccine Patch | Systemic AEs | 75 Events |
| Self Administered (In-clinic & Non-clinic) | Number of Adverse Events for Self-administered LT Vaccine Patch and Comparison to the Clinician-administered LT Vaccine Patch | All Severe AEs | 9 Events |
| Self Administered (In-clinic & Non-clinic) | Number of Adverse Events for Self-administered LT Vaccine Patch and Comparison to the Clinician-administered LT Vaccine Patch | Severe Systemic AEs | 9 Events |
| Self Administered (In-clinic & Non-clinic) | Number of Adverse Events for Self-administered LT Vaccine Patch and Comparison to the Clinician-administered LT Vaccine Patch | All Related AEs | 297 Events |
| Self Administered (In-clinic & Non-clinic) | Number of Adverse Events for Self-administered LT Vaccine Patch and Comparison to the Clinician-administered LT Vaccine Patch | Related Local AEs | 283 Events |
| Self Administered (In-clinic & Non-clinic) | Number of Adverse Events for Self-administered LT Vaccine Patch and Comparison to the Clinician-administered LT Vaccine Patch | Related Systemic AEs | 14 Events |
| Self Administered (In-clinic & Non-clinic) | Number of Adverse Events for Self-administered LT Vaccine Patch and Comparison to the Clinician-administered LT Vaccine Patch | All Serious AEs | 3 Events |
| Group 3 | Number of Adverse Events for Self-administered LT Vaccine Patch and Comparison to the Clinician-administered LT Vaccine Patch | Local AEs | 268 Events |
| Group 3 | Number of Adverse Events for Self-administered LT Vaccine Patch and Comparison to the Clinician-administered LT Vaccine Patch | Systemic AEs | 90 Events |
| Group 3 | Number of Adverse Events for Self-administered LT Vaccine Patch and Comparison to the Clinician-administered LT Vaccine Patch | Related Systemic AEs | 17 Events |
| Group 3 | Number of Adverse Events for Self-administered LT Vaccine Patch and Comparison to the Clinician-administered LT Vaccine Patch | All AEs | 358 Events |
| Group 3 | Number of Adverse Events for Self-administered LT Vaccine Patch and Comparison to the Clinician-administered LT Vaccine Patch | All Severe AEs | 2 Events |
| Group 3 | Number of Adverse Events for Self-administered LT Vaccine Patch and Comparison to the Clinician-administered LT Vaccine Patch | Related Local AEs | 268 Events |
| Group 3 | Number of Adverse Events for Self-administered LT Vaccine Patch and Comparison to the Clinician-administered LT Vaccine Patch | Severe Systemic AEs | 2 Events |
| Group 3 | Number of Adverse Events for Self-administered LT Vaccine Patch and Comparison to the Clinician-administered LT Vaccine Patch | All Related AEs | 285 Events |
| Group 4 | Number of Adverse Events for Self-administered LT Vaccine Patch and Comparison to the Clinician-administered LT Vaccine Patch | Severe Systemic AEs | 7 Events |
| Group 4 | Number of Adverse Events for Self-administered LT Vaccine Patch and Comparison to the Clinician-administered LT Vaccine Patch | All Related AEs | 334 Events |
| Group 4 | Number of Adverse Events for Self-administered LT Vaccine Patch and Comparison to the Clinician-administered LT Vaccine Patch | Related Local AEs | 304 Events |
| Group 4 | Number of Adverse Events for Self-administered LT Vaccine Patch and Comparison to the Clinician-administered LT Vaccine Patch | Local AEs | 304 Events |
| Group 4 | Number of Adverse Events for Self-administered LT Vaccine Patch and Comparison to the Clinician-administered LT Vaccine Patch | All AEs | 387 Events |
| Group 4 | Number of Adverse Events for Self-administered LT Vaccine Patch and Comparison to the Clinician-administered LT Vaccine Patch | All Severe AEs | 7 Events |
| Group 4 | Number of Adverse Events for Self-administered LT Vaccine Patch and Comparison to the Clinician-administered LT Vaccine Patch | Related Systemic AEs | 30 Events |
| Group 4 | Number of Adverse Events for Self-administered LT Vaccine Patch and Comparison to the Clinician-administered LT Vaccine Patch | Systemic AEs | 83 Events |
Secondary
Safety for Self-administration In-clinic Compared to Self-administration Away From the Clinic.
Time frame: 6 months
Population: Number Analyzed in Outcome Measure Data Table: in Group 3 only 39 subjects received the second vaccination.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Clinician Administered (Deltoid/ Thigh) | Safety for Self-administration In-clinic Compared to Self-administration Away From the Clinic. | Erythema - 1st vaccination | 37 Events |
| Clinician Administered (Deltoid/ Thigh) | Safety for Self-administration In-clinic Compared to Self-administration Away From the Clinic. | Erythema - 2nd vaccination | 33 Events |
| Clinician Administered (Deltoid/ Thigh) | Safety for Self-administration In-clinic Compared to Self-administration Away From the Clinic. | Rash - 1st vaccination | 35 Events |
| Clinician Administered (Deltoid/ Thigh) | Safety for Self-administration In-clinic Compared to Self-administration Away From the Clinic. | Rash - 2nd vaccination | 20 Events |
| Clinician Administered (Deltoid/ Thigh) | Safety for Self-administration In-clinic Compared to Self-administration Away From the Clinic. | Pruritus - 1st vaccination | 37 Events |
| Clinician Administered (Deltoid/ Thigh) | Safety for Self-administration In-clinic Compared to Self-administration Away From the Clinic. | Pruiruts - 2nd vaccination | 23 Events |
| Clinician Administered (Deltoid/ Thigh) | Safety for Self-administration In-clinic Compared to Self-administration Away From the Clinic. | Hyperpigmentation - 1st vaccination | 16 Events |
| Clinician Administered (Deltoid/ Thigh) | Safety for Self-administration In-clinic Compared to Self-administration Away From the Clinic. | Hyperpigmentation - 2nd vaccination | 7 Events |
| Clinician Administered (Deltoid/ Thigh) | Safety for Self-administration In-clinic Compared to Self-administration Away From the Clinic. | Edema - 1st vaccination | 5 Events |
| Clinician Administered (Deltoid/ Thigh) | Safety for Self-administration In-clinic Compared to Self-administration Away From the Clinic. | Edema - 2nd vaccination | 7 Events |
| Clinician Administered (Deltoid/ Thigh) | Safety for Self-administration In-clinic Compared to Self-administration Away From the Clinic. | Pain - 1st vaccination | 6 Events |
| Clinician Administered (Deltoid/ Thigh) | Safety for Self-administration In-clinic Compared to Self-administration Away From the Clinic. | Pain - 2nd vaccination | 5 Events |
| Clinician Administered (Deltoid/ Thigh) | Safety for Self-administration In-clinic Compared to Self-administration Away From the Clinic. | Fever - 1st vaccination | 1 Events |
| Clinician Administered (Deltoid/ Thigh) | Safety for Self-administration In-clinic Compared to Self-administration Away From the Clinic. | Fever - 2nd vaccination | 0 Events |
| Clinician Administered (Deltoid/ Thigh) | Safety for Self-administration In-clinic Compared to Self-administration Away From the Clinic. | Malaise - 1st vaccination | 3 Events |
| Clinician Administered (Deltoid/ Thigh) | Safety for Self-administration In-clinic Compared to Self-administration Away From the Clinic. | Malaise - 2nd vaccination | 3 Events |
| Clinician Administered (Deltoid/ Thigh) | Safety for Self-administration In-clinic Compared to Self-administration Away From the Clinic. | Headache - 1st vaccination | 7 Events |
| Clinician Administered (Deltoid/ Thigh) | Safety for Self-administration In-clinic Compared to Self-administration Away From the Clinic. | Headache - 2nd vaccination | 9 Events |
| Clinician Administered (Deltoid/ Thigh) | Safety for Self-administration In-clinic Compared to Self-administration Away From the Clinic. | Diarrhea - 1st vaccination | 6 Events |
| Clinician Administered (Deltoid/ Thigh) | Safety for Self-administration In-clinic Compared to Self-administration Away From the Clinic. | Diarrhea - 2nd vaccination | 3 Events |
| Self Administered (In-clinic & Non-clinic) | Safety for Self-administration In-clinic Compared to Self-administration Away From the Clinic. | Headache - 2nd vaccination | 4 Events |
| Self Administered (In-clinic & Non-clinic) | Safety for Self-administration In-clinic Compared to Self-administration Away From the Clinic. | Erythema - 1st vaccination | 38 Events |
| Self Administered (In-clinic & Non-clinic) | Safety for Self-administration In-clinic Compared to Self-administration Away From the Clinic. | Pain - 1st vaccination | 8 Events |
| Self Administered (In-clinic & Non-clinic) | Safety for Self-administration In-clinic Compared to Self-administration Away From the Clinic. | Erythema - 2nd vaccination | 36 Events |
| Self Administered (In-clinic & Non-clinic) | Safety for Self-administration In-clinic Compared to Self-administration Away From the Clinic. | Malaise - 2nd vaccination | 3 Events |
| Self Administered (In-clinic & Non-clinic) | Safety for Self-administration In-clinic Compared to Self-administration Away From the Clinic. | Rash - 1st vaccination | 38 Events |
| Self Administered (In-clinic & Non-clinic) | Safety for Self-administration In-clinic Compared to Self-administration Away From the Clinic. | Pain - 2nd vaccination | 4 Events |
| Self Administered (In-clinic & Non-clinic) | Safety for Self-administration In-clinic Compared to Self-administration Away From the Clinic. | Rash - 2nd vaccination | 23 Events |
| Self Administered (In-clinic & Non-clinic) | Safety for Self-administration In-clinic Compared to Self-administration Away From the Clinic. | Diarrhea - 2nd vaccination | 4 Events |
| Self Administered (In-clinic & Non-clinic) | Safety for Self-administration In-clinic Compared to Self-administration Away From the Clinic. | Pruritus - 1st vaccination | 31 Events |
| Self Administered (In-clinic & Non-clinic) | Safety for Self-administration In-clinic Compared to Self-administration Away From the Clinic. | Fever - 1st vaccination | 0 Events |
| Self Administered (In-clinic & Non-clinic) | Safety for Self-administration In-clinic Compared to Self-administration Away From the Clinic. | Pruiruts - 2nd vaccination | 29 Events |
| Self Administered (In-clinic & Non-clinic) | Safety for Self-administration In-clinic Compared to Self-administration Away From the Clinic. | Headache - 1st vaccination | 5 Events |
| Self Administered (In-clinic & Non-clinic) | Safety for Self-administration In-clinic Compared to Self-administration Away From the Clinic. | Hyperpigmentation - 1st vaccination | 23 Events |
| Self Administered (In-clinic & Non-clinic) | Safety for Self-administration In-clinic Compared to Self-administration Away From the Clinic. | Fever - 2nd vaccination | 1 Events |
| Self Administered (In-clinic & Non-clinic) | Safety for Self-administration In-clinic Compared to Self-administration Away From the Clinic. | Hyperpigmentation - 2nd vaccination | 14 Events |
| Self Administered (In-clinic & Non-clinic) | Safety for Self-administration In-clinic Compared to Self-administration Away From the Clinic. | Diarrhea - 1st vaccination | 4 Events |
| Self Administered (In-clinic & Non-clinic) | Safety for Self-administration In-clinic Compared to Self-administration Away From the Clinic. | Edema - 1st vaccination | 5 Events |
| Self Administered (In-clinic & Non-clinic) | Safety for Self-administration In-clinic Compared to Self-administration Away From the Clinic. | Malaise - 1st vaccination | 4 Events |
| Self Administered (In-clinic & Non-clinic) | Safety for Self-administration In-clinic Compared to Self-administration Away From the Clinic. | Edema - 2nd vaccination | 5 Events |