Allergic Rhinitis
Conditions
Keywords
Vaccines, Phase 1, Allergic Rhinitis
Brief summary
The purpose of this study is to assess the safety and tolerability of different doses of PF-06444753 and PF-06444752 in subjects with allergic rhinitis.
Interventions
BIOLOGICALIGE-1
Intramuscular, multiple dose
BIOLOGICALIGE-2
Intramuscular, multiple dose
BIOLOGICALSaline
Saline (0.9% sodium chloride)
Sponsors
Pfizer
Study design
Allocation
RANDOMIZED
Primary purpose
TREATMENT
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to 55 Years
Healthy volunteers
Yes
Inclusion criteria
* Healthy, males or females of non-child bearing potential, who are between 18 and 55 years, inclusive, * Intermittent or persistent allergic rhinitis that is associated with perennial or seasonal allergen reactivity at screening as determined by a positive specific IgE level ≥1 KU/L to at least one of the following common allergens: dust mite (Dermatophagoides farinae or Dermatophagoides pteronyssinus), cat, dog, mold (Alternaria), Bermuda grass, common ragweed, oak, Timothy grass or elm.
Exclusion criteria
* Evidence or history of clinically significant hematological, renal, endocrine, pulmonary, gastrointestinal, cardiovascular, hepatic, psychiatric, or neurologic disease that may compromise their ability to safely participate in the study. * Evidence or history of clinically significant pulmonary disease (including allergic and non-allergic asthma, chronic obstructive pulmonary disease \[COPD\], cystic fibrosis, bronchiectasis, chronic bronchitis, emphysema, tuberculosis, pulmonary fibrosis, pulmonary hypertension, or others). * Evidence or history of clinically significant autoimmune disease (including rheumatoid arthritis, systemic lupus erythematosus, ulcerative colitis, or others).
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Percentages of Participants With Local Reactions By Severity Within 14 Days of Any Vaccination | Within 14 days | Local reactions consisted of any pain at the site of injection, any swelling, and any redness. Participants were issued an electronic diary (e-diary) and were asked to monitor and record (according to corresponding grading scales) any local reactions for 14 days following each vaccination. Grading details are as follows: Mild (Pain: did not interfere with activity; Redness and Swelling: 0.5-5.0 centimeters \[cm\] or 1-10 caliper units), Moderate (Pain: interfered with activity; Redness and Swelling: more than \[\>\] 5.0 to 10.0 cm or 11-20 caliper units), Severe (Pain: prevented daily activity; Redness and Swelling: \>10 cm or 21 caliper units and above). |
| Percentages of Participants With Systemic Reactions By Severity Within 14 Days of Any Vaccination | Within 14 days | Systemic reactions consisted of fever, vomiting, diarrhea, headache, fatigue, muscle pain (other than at the injection site) and joint pain (other than pain adjacent to injection site). Participants were issued an electronic diary (e-diary) and were asked to monitor and record (according to corresponding grading scales) any systemic reactions for 14 days following each vaccination. Grading details are as follows: Mild (Vomiting: 1-2 times in 24 hours; Diarrhea: 2-3 loose stools in 24 hours; Headache, Fatigue, Muscle Pain, Joint Pain: no interference with activity), Moderate (Vomiting: \>2 times in 24 hours; Diarrhea: 4-5 loose stools in 24 hours; Headache, Fatigue, Muscle and Joint Pain: some interference with activity), Severe (Vomiting: required intravenous hydration; Diarrhea: more than or equal to \[\>=\] 6 stool in 24 hours; Headache, Fatigue, Muscle and Joint Pain: Significant, prevented daily activity). |
| Number of Participants With Treatment-Emergent Adverse Events (TEAEs), Serious Adverse Events (SAEs), and Discontinuations From Treatment Due to TEAEs | Baseline up to 336 days post study administration or at Early Termination | An adverse event (AE) was any untoward medical occurrence attributed to study drug in a participant who received study drug. AEs comprised both SAEs and non-SAEs. An SAE was an AE resulting in any of the following outcomes or deemed significant for any other reason: death; initial or prolonged inpatient hospitalization; life-threatening experience (immediate risk of dying); persistent or significant disability/incapacity; congenital anomaly. Severe TEAEs were those that interfered significantly with the participant's usual function. Causality assessment was made by the investigator. |
| Number of Participants With Laboratory Test Abnormalities | Baseline up to 336 days post last study drug administration or Early Termination | Number of participants with laboratory test abnormalities without regard to baseline abnormality. Laboratory test parameters included hematology, coagulation, liver function, renal function, electrolytes, hormones, clinical chemistry, immunology urinalysis, urinalysis (dipstick and microscopy), and other tests such as human immunodeficiency virus antibody and hepatitis C antibody. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Enzyme-Linked Immunosorbent Assay (ELISA) Measured Anti-IgE Geometric Mean Titers (GMTs) at Baseline, Day 182, and Day 336 | Baseline (Day 1), Day 182 (2 weeks after last vaccination), and end of study (Day 336) | Ability of vaccine induced serum anti-immunoglobulin E (IgE) antibodies to interfere with IgE binding to recombinant alpha chain of the high affinity IgE receptor was assessed in an ELISA based assay. GMTs were calculated both as crude means (unadjusted) and by an analysis of covariance (ANCOVA) model with natural log transformed antibody titer as outcome variable, and treatment group as factor and baseline (in log scale) as covariates at each of the post dose measurement. |
Countries
Canada
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| IGE-1 6 mcg Participants received study vaccine IGE-1 (PF-06444753) 6 micrograms (mcg) on Days 1, 28, 56, and 168. Study vaccine volume was 0.5 mL and was administered intramuscularly in the upper deltoid muscle on the participant's preferred side. IGE-1 and IGE-2 contained the same antigenic material but differed in their fixed adjuvant configurations: IGE-1 was with aluminum hydroxide (alum) alone and IGE-2 with alum and CpG 24555 (CpG; a toll-like receptor 9 \[TLR9\] agonist) in combination as adjuvants. | 6 |
| IGE-1 20 mcg Participants received study vaccine IGE-1 (PF-06444753) 20 micrograms (mcg) on Days 1, 28, 56, and 168. Study vaccine volume was 0.5 mL and was administered intramuscularly in the upper deltoid muscle on the participant's preferred side. IGE-1 and IGE-2 contained the same antigenic material but differed in their fixed adjuvant configurations: IGE-1 was with aluminum hydroxide (alum) alone and IGE-2 with alum and CpG 24555 (CpG; a toll-like receptor 9 \[TLR9\] agonist) in combination as adjuvants. | 21 |
| IGE-1 60 mcg Participants received study vaccine IGE-1 (PF-06444753) 60 micrograms (mcg) on Days 1, 28, 56, and 168. Study vaccine volume was 0.5 mL and was administered intramuscularly in the upper deltoid muscle on the participant's preferred side. IGE-1 and IGE-2 contained the same antigenic material but differed in their fixed adjuvant configurations: IGE-1 was with aluminum hydroxide (alum) alone and IGE-2 with alum and CpG 24555 (CpG; a toll-like receptor 9 \[TLR9\] agonist) in combination as adjuvants. | 20 |
| IGE-1 200 mcg Participants received study vaccine IGE-1 (PF-06444753) 200 micrograms (mcg) on Days 1, 28, 56, and 168. Study vaccine volume was 0.5 mL and was administered intramuscularly in the upper deltoid muscle on the participant's preferred side. IGE-1 and IGE-2 contained the same antigenic material but differed in their fixed adjuvant configurations: IGE-1 was with aluminum hydroxide (alum) alone and IGE-2 with alum and CpG 24555 (CpG; a toll-like receptor 9 \[TLR9\] agonist) in combination as adjuvants. | 20 |
| IGE-2 20 mcg Participants received study vaccine IGE-2 (PF-06444752) 20 micrograms (mcg) on Days 1, 28, 56, and 168. Study vaccine volume was 0.5 mL and was administered intramuscularly in the upper deltoid muscle on the participant's preferred side. IGE-2 and IGE-1 contained the same antigenic material but differed in their fixed adjuvant configurations: IGE-1 was with aluminum hydroxide (alum) alone and IGE-2 with alum and CpG 24555 (CpG; a toll-like receptor 9 \[TLR9\] agonist) in combination as adjuvants. | 20 |
| IGE-2 60 mcg Participants received study vaccine IGE-2 (PF-06444752) 60 micrograms (mcg) on Days 1, 28, 56, and 168. Study vaccine volume was 0.5 mL and was administered intramuscularly in the upper deltoid muscle on the participant's preferred side. IGE-2 and IGE-1 contained the same antigenic material but differed in their fixed adjuvant configurations: IGE-1 was with aluminum hydroxide (alum) alone and IGE-2 with alum and CpG 24555 (CpG; a toll-like receptor 9 \[TLR9\] agonist) in combination as adjuvants. | 20 |
| IGE-2 200 mcg Participants received study vaccine IGE-2 (PF-06444752) 200 micrograms (mcg) on Days 1, 28, 56, and 168. Study vaccine volume was 0.5 mL and was administered intramuscularly in the upper deltoid muscle on the participant's preferred side. IGE-2 and IGE-1 contained the same antigenic material but differed in their fixed adjuvant configurations: IGE-1 was with aluminum hydroxide (alum) alone and IGE-2 with alum and CpG 24555 (CpG; a toll-like receptor 9 \[TLR9\] agonist) in combination as adjuvants. | 20 |
| Saline Placebo Participants received saline placebo matching IGE-1 or IGE-2 on Days 1, 28, 56, and 168. Placebo was also administered intramuscularly in the upper deltoid muscle on the participant's preferred side. | 63 |
| Total | 190 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 | FG002 | FG003 | FG004 | FG005 | FG006 | FG007 |
|---|---|---|---|---|---|---|---|---|---|
| Overall Study | Conflict with work schedule | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 1 |
| Overall Study | Move/Left to another country/city | 0 | 0 | 2 | 1 | 1 | 0 | 0 | 0 |
| Overall Study | No longer have time to participate | 0 | 0 | 0 | 1 | 0 | 0 | 0 | 0 |
| Overall Study | Personal issues | 0 | 0 | 0 | 0 | 0 | 1 | 0 | 0 |
| Overall Study | Protocol Violation | 0 | 1 | 0 | 0 | 0 | 0 | 0 | 0 |
| Overall Study | Withdrawal by Subject | 1 | 2 | 1 | 0 | 1 | 1 | 1 | 2 |
Baseline characteristics
| Characteristic | IGE-1 6 mcg | IGE-1 20 mcg | IGE-1 60 mcg | IGE-1 200 mcg | IGE-2 20 mcg | IGE-2 60 mcg | IGE-2 200 mcg | Saline Placebo | Total |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | 36.7 years STANDARD_DEVIATION 13.3 | 31.6 years STANDARD_DEVIATION 8.8 | 35.7 years STANDARD_DEVIATION 10 | 33.5 years STANDARD_DEVIATION 9.3 | 35.4 years STANDARD_DEVIATION 9.2 | 35.9 years STANDARD_DEVIATION 11 | 33.6 years STANDARD_DEVIATION 12 | 34.7 years STANDARD_DEVIATION 8.8 | 34.4 years STANDARD_DEVIATION 9.7 |
| Sex: Female, Male Female | 0 Participants | 0 Participants | 1 Participants | 1 Participants | 1 Participants | 2 Participants | 0 Participants | 5 Participants | 10 Participants |
| Sex: Female, Male Male | 6 Participants | 21 Participants | 19 Participants | 19 Participants | 19 Participants | 18 Participants | 20 Participants | 58 Participants | 180 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk | EG002 affected / at risk | EG003 affected / at risk | EG004 affected / at risk | EG005 affected / at risk | EG006 affected / at risk | EG007 affected / at risk |
|---|---|---|---|---|---|---|---|---|
| deaths Total, all-cause mortality | — / — | — / — | — / — | — / — | — / — | — / — | — / — | — / — |
| other Total, other adverse events | 5 / 6 | 17 / 21 | 20 / 20 | 20 / 20 | 19 / 20 | 19 / 20 | 17 / 20 | 54 / 63 |
| serious Total, serious adverse events | 0 / 6 | 0 / 21 | 0 / 20 | 0 / 20 | 0 / 20 | 1 / 20 | 0 / 20 | 1 / 63 |
Outcome results
Primary
Number of Participants With Laboratory Test Abnormalities
Number of participants with laboratory test abnormalities without regard to baseline abnormality. Laboratory test parameters included hematology, coagulation, liver function, renal function, electrolytes, hormones, clinical chemistry, immunology urinalysis, urinalysis (dipstick and microscopy), and other tests such as human immunodeficiency virus antibody and hepatitis C antibody.
Time frame: Baseline up to 336 days post last study drug administration or Early Termination
Population: All randomized participants who received at least one dose of study treatment.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| IGE-1 6 mcg | Number of Participants With Laboratory Test Abnormalities | 5 participants |
| IGE-1 20 mcg | Number of Participants With Laboratory Test Abnormalities | 9 participants |
| IGE-1 60 mcg | Number of Participants With Laboratory Test Abnormalities | 12 participants |
| IGE-1 200 mcg | Number of Participants With Laboratory Test Abnormalities | 13 participants |
| IGE-2 20 mcg | Number of Participants With Laboratory Test Abnormalities | 13 participants |
| IGE-2 60 mcg | Number of Participants With Laboratory Test Abnormalities | 12 participants |
| IGE-2 200 mcg | Number of Participants With Laboratory Test Abnormalities | 10 participants |
| Saline Placebo | Number of Participants With Laboratory Test Abnormalities | 36 participants |
Primary
Number of Participants With Treatment-Emergent Adverse Events (TEAEs), Serious Adverse Events (SAEs), and Discontinuations From Treatment Due to TEAEs
An adverse event (AE) was any untoward medical occurrence attributed to study drug in a participant who received study drug. AEs comprised both SAEs and non-SAEs. An SAE was an AE resulting in any of the following outcomes or deemed significant for any other reason: death; initial or prolonged inpatient hospitalization; life-threatening experience (immediate risk of dying); persistent or significant disability/incapacity; congenital anomaly. Severe TEAEs were those that interfered significantly with the participant's usual function. Causality assessment was made by the investigator.
Time frame: Baseline up to 336 days post study administration or at Early Termination
Population: All randomized participants who received at least one dose of study treatment.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| IGE-1 6 mcg | Number of Participants With Treatment-Emergent Adverse Events (TEAEs), Serious Adverse Events (SAEs), and Discontinuations From Treatment Due to TEAEs | Participants with treatment-related TEAEs | 0 participants |
| IGE-1 6 mcg | Number of Participants With Treatment-Emergent Adverse Events (TEAEs), Serious Adverse Events (SAEs), and Discontinuations From Treatment Due to TEAEs | Participants with TEAEs | 5 participants |
| IGE-1 6 mcg | Number of Participants With Treatment-Emergent Adverse Events (TEAEs), Serious Adverse Events (SAEs), and Discontinuations From Treatment Due to TEAEs | Participants with SAEs | 0 participants |
| IGE-1 6 mcg | Number of Participants With Treatment-Emergent Adverse Events (TEAEs), Serious Adverse Events (SAEs), and Discontinuations From Treatment Due to TEAEs | Participants with severe TEAEs | 0 participants |
| IGE-1 6 mcg | Number of Participants With Treatment-Emergent Adverse Events (TEAEs), Serious Adverse Events (SAEs), and Discontinuations From Treatment Due to TEAEs | Temporary discontinuations due to TEAEs | 1 participants |
| IGE-1 6 mcg | Number of Participants With Treatment-Emergent Adverse Events (TEAEs), Serious Adverse Events (SAEs), and Discontinuations From Treatment Due to TEAEs | Permanent discontinuations due to TEAEs | 0 participants |
| IGE-1 20 mcg | Number of Participants With Treatment-Emergent Adverse Events (TEAEs), Serious Adverse Events (SAEs), and Discontinuations From Treatment Due to TEAEs | Participants with severe TEAEs | 0 participants |
| IGE-1 20 mcg | Number of Participants With Treatment-Emergent Adverse Events (TEAEs), Serious Adverse Events (SAEs), and Discontinuations From Treatment Due to TEAEs | Participants with TEAEs | 18 participants |
| IGE-1 20 mcg | Number of Participants With Treatment-Emergent Adverse Events (TEAEs), Serious Adverse Events (SAEs), and Discontinuations From Treatment Due to TEAEs | Permanent discontinuations due to TEAEs | 0 participants |
| IGE-1 20 mcg | Number of Participants With Treatment-Emergent Adverse Events (TEAEs), Serious Adverse Events (SAEs), and Discontinuations From Treatment Due to TEAEs | Participants with treatment-related TEAEs | 2 participants |
| IGE-1 20 mcg | Number of Participants With Treatment-Emergent Adverse Events (TEAEs), Serious Adverse Events (SAEs), and Discontinuations From Treatment Due to TEAEs | Participants with SAEs | 0 participants |
| IGE-1 20 mcg | Number of Participants With Treatment-Emergent Adverse Events (TEAEs), Serious Adverse Events (SAEs), and Discontinuations From Treatment Due to TEAEs | Temporary discontinuations due to TEAEs | 0 participants |
| IGE-1 60 mcg | Number of Participants With Treatment-Emergent Adverse Events (TEAEs), Serious Adverse Events (SAEs), and Discontinuations From Treatment Due to TEAEs | Temporary discontinuations due to TEAEs | 0 participants |
| IGE-1 60 mcg | Number of Participants With Treatment-Emergent Adverse Events (TEAEs), Serious Adverse Events (SAEs), and Discontinuations From Treatment Due to TEAEs | Participants with severe TEAEs | 2 participants |
| IGE-1 60 mcg | Number of Participants With Treatment-Emergent Adverse Events (TEAEs), Serious Adverse Events (SAEs), and Discontinuations From Treatment Due to TEAEs | Participants with SAEs | 0 participants |
| IGE-1 60 mcg | Number of Participants With Treatment-Emergent Adverse Events (TEAEs), Serious Adverse Events (SAEs), and Discontinuations From Treatment Due to TEAEs | Permanent discontinuations due to TEAEs | 1 participants |
| IGE-1 60 mcg | Number of Participants With Treatment-Emergent Adverse Events (TEAEs), Serious Adverse Events (SAEs), and Discontinuations From Treatment Due to TEAEs | Participants with treatment-related TEAEs | 1 participants |
| IGE-1 60 mcg | Number of Participants With Treatment-Emergent Adverse Events (TEAEs), Serious Adverse Events (SAEs), and Discontinuations From Treatment Due to TEAEs | Participants with TEAEs | 20 participants |
| IGE-1 200 mcg | Number of Participants With Treatment-Emergent Adverse Events (TEAEs), Serious Adverse Events (SAEs), and Discontinuations From Treatment Due to TEAEs | Temporary discontinuations due to TEAEs | 1 participants |
| IGE-1 200 mcg | Number of Participants With Treatment-Emergent Adverse Events (TEAEs), Serious Adverse Events (SAEs), and Discontinuations From Treatment Due to TEAEs | Participants with TEAEs | 20 participants |
| IGE-1 200 mcg | Number of Participants With Treatment-Emergent Adverse Events (TEAEs), Serious Adverse Events (SAEs), and Discontinuations From Treatment Due to TEAEs | Participants with SAEs | 0 participants |
| IGE-1 200 mcg | Number of Participants With Treatment-Emergent Adverse Events (TEAEs), Serious Adverse Events (SAEs), and Discontinuations From Treatment Due to TEAEs | Participants with severe TEAEs | 0 participants |
| IGE-1 200 mcg | Number of Participants With Treatment-Emergent Adverse Events (TEAEs), Serious Adverse Events (SAEs), and Discontinuations From Treatment Due to TEAEs | Permanent discontinuations due to TEAEs | 0 participants |
| IGE-1 200 mcg | Number of Participants With Treatment-Emergent Adverse Events (TEAEs), Serious Adverse Events (SAEs), and Discontinuations From Treatment Due to TEAEs | Participants with treatment-related TEAEs | 4 participants |
| IGE-2 20 mcg | Number of Participants With Treatment-Emergent Adverse Events (TEAEs), Serious Adverse Events (SAEs), and Discontinuations From Treatment Due to TEAEs | Temporary discontinuations due to TEAEs | 0 participants |
| IGE-2 20 mcg | Number of Participants With Treatment-Emergent Adverse Events (TEAEs), Serious Adverse Events (SAEs), and Discontinuations From Treatment Due to TEAEs | Participants with SAEs | 0 participants |
| IGE-2 20 mcg | Number of Participants With Treatment-Emergent Adverse Events (TEAEs), Serious Adverse Events (SAEs), and Discontinuations From Treatment Due to TEAEs | Participants with treatment-related TEAEs | 1 participants |
| IGE-2 20 mcg | Number of Participants With Treatment-Emergent Adverse Events (TEAEs), Serious Adverse Events (SAEs), and Discontinuations From Treatment Due to TEAEs | Participants with TEAEs | 19 participants |
| IGE-2 20 mcg | Number of Participants With Treatment-Emergent Adverse Events (TEAEs), Serious Adverse Events (SAEs), and Discontinuations From Treatment Due to TEAEs | Permanent discontinuations due to TEAEs | 0 participants |
| IGE-2 20 mcg | Number of Participants With Treatment-Emergent Adverse Events (TEAEs), Serious Adverse Events (SAEs), and Discontinuations From Treatment Due to TEAEs | Participants with severe TEAEs | 1 participants |
| IGE-2 60 mcg | Number of Participants With Treatment-Emergent Adverse Events (TEAEs), Serious Adverse Events (SAEs), and Discontinuations From Treatment Due to TEAEs | Participants with severe TEAEs | 2 participants |
| IGE-2 60 mcg | Number of Participants With Treatment-Emergent Adverse Events (TEAEs), Serious Adverse Events (SAEs), and Discontinuations From Treatment Due to TEAEs | Permanent discontinuations due to TEAEs | 0 participants |
| IGE-2 60 mcg | Number of Participants With Treatment-Emergent Adverse Events (TEAEs), Serious Adverse Events (SAEs), and Discontinuations From Treatment Due to TEAEs | Participants with SAEs | 1 participants |
| IGE-2 60 mcg | Number of Participants With Treatment-Emergent Adverse Events (TEAEs), Serious Adverse Events (SAEs), and Discontinuations From Treatment Due to TEAEs | Temporary discontinuations due to TEAEs | 0 participants |
| IGE-2 60 mcg | Number of Participants With Treatment-Emergent Adverse Events (TEAEs), Serious Adverse Events (SAEs), and Discontinuations From Treatment Due to TEAEs | Participants with TEAEs | 19 participants |
| IGE-2 60 mcg | Number of Participants With Treatment-Emergent Adverse Events (TEAEs), Serious Adverse Events (SAEs), and Discontinuations From Treatment Due to TEAEs | Participants with treatment-related TEAEs | 0 participants |
| IGE-2 200 mcg | Number of Participants With Treatment-Emergent Adverse Events (TEAEs), Serious Adverse Events (SAEs), and Discontinuations From Treatment Due to TEAEs | Permanent discontinuations due to TEAEs | 0 participants |
| IGE-2 200 mcg | Number of Participants With Treatment-Emergent Adverse Events (TEAEs), Serious Adverse Events (SAEs), and Discontinuations From Treatment Due to TEAEs | Temporary discontinuations due to TEAEs | 1 participants |
| IGE-2 200 mcg | Number of Participants With Treatment-Emergent Adverse Events (TEAEs), Serious Adverse Events (SAEs), and Discontinuations From Treatment Due to TEAEs | Participants with TEAEs | 17 participants |
| IGE-2 200 mcg | Number of Participants With Treatment-Emergent Adverse Events (TEAEs), Serious Adverse Events (SAEs), and Discontinuations From Treatment Due to TEAEs | Participants with severe TEAEs | 0 participants |
| IGE-2 200 mcg | Number of Participants With Treatment-Emergent Adverse Events (TEAEs), Serious Adverse Events (SAEs), and Discontinuations From Treatment Due to TEAEs | Participants with treatment-related TEAEs | 0 participants |
| IGE-2 200 mcg | Number of Participants With Treatment-Emergent Adverse Events (TEAEs), Serious Adverse Events (SAEs), and Discontinuations From Treatment Due to TEAEs | Participants with SAEs | 0 participants |
| Saline Placebo | Number of Participants With Treatment-Emergent Adverse Events (TEAEs), Serious Adverse Events (SAEs), and Discontinuations From Treatment Due to TEAEs | Permanent discontinuations due to TEAEs | 2 participants |
| Saline Placebo | Number of Participants With Treatment-Emergent Adverse Events (TEAEs), Serious Adverse Events (SAEs), and Discontinuations From Treatment Due to TEAEs | Participants with severe TEAEs | 4 participants |
| Saline Placebo | Number of Participants With Treatment-Emergent Adverse Events (TEAEs), Serious Adverse Events (SAEs), and Discontinuations From Treatment Due to TEAEs | Participants with treatment-related TEAEs | 3 participants |
| Saline Placebo | Number of Participants With Treatment-Emergent Adverse Events (TEAEs), Serious Adverse Events (SAEs), and Discontinuations From Treatment Due to TEAEs | Temporary discontinuations due to TEAEs | 4 participants |
| Saline Placebo | Number of Participants With Treatment-Emergent Adverse Events (TEAEs), Serious Adverse Events (SAEs), and Discontinuations From Treatment Due to TEAEs | Participants with TEAEs | 55 participants |
| Saline Placebo | Number of Participants With Treatment-Emergent Adverse Events (TEAEs), Serious Adverse Events (SAEs), and Discontinuations From Treatment Due to TEAEs | Participants with SAEs | 1 participants |
Primary
Percentages of Participants With Local Reactions By Severity Within 14 Days of Any Vaccination
Local reactions consisted of any pain at the site of injection, any swelling, and any redness. Participants were issued an electronic diary (e-diary) and were asked to monitor and record (according to corresponding grading scales) any local reactions for 14 days following each vaccination. Grading details are as follows: Mild (Pain: did not interfere with activity; Redness and Swelling: 0.5-5.0 centimeters \[cm\] or 1-10 caliper units), Moderate (Pain: interfered with activity; Redness and Swelling: more than \[\>\] 5.0 to 10.0 cm or 11-20 caliper units), Severe (Pain: prevented daily activity; Redness and Swelling: \>10 cm or 21 caliper units and above).
Time frame: Within 14 days
Population: All randomized participants who received at least one dose of study treatment.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| IGE-1 6 mcg | Percentages of Participants With Local Reactions By Severity Within 14 Days of Any Vaccination | Any Redness | 50.0 Percentage of participants |
| IGE-1 6 mcg | Percentages of Participants With Local Reactions By Severity Within 14 Days of Any Vaccination | Severe Pain | 0.0 Percentage of participants |
| IGE-1 6 mcg | Percentages of Participants With Local Reactions By Severity Within 14 Days of Any Vaccination | Mild Swelling | 16.7 Percentage of participants |
| IGE-1 6 mcg | Percentages of Participants With Local Reactions By Severity Within 14 Days of Any Vaccination | Mild Redness | 50.0 Percentage of participants |
| IGE-1 6 mcg | Percentages of Participants With Local Reactions By Severity Within 14 Days of Any Vaccination | Mild Pain | 50.0 Percentage of participants |
| IGE-1 6 mcg | Percentages of Participants With Local Reactions By Severity Within 14 Days of Any Vaccination | Severe Swelling | 0.0 Percentage of participants |
| IGE-1 6 mcg | Percentages of Participants With Local Reactions By Severity Within 14 Days of Any Vaccination | Any Severe Local Reaction | 0.0 Percentage of participants |
| IGE-1 6 mcg | Percentages of Participants With Local Reactions By Severity Within 14 Days of Any Vaccination | Moderate Pain | 33.3 Percentage of participants |
| IGE-1 6 mcg | Percentages of Participants With Local Reactions By Severity Within 14 Days of Any Vaccination | Any Pain | 83.3 Percentage of participants |
| IGE-1 6 mcg | Percentages of Participants With Local Reactions By Severity Within 14 Days of Any Vaccination | Moderate and Severe Redness | 0.0 Percentage of participants |
| IGE-1 6 mcg | Percentages of Participants With Local Reactions By Severity Within 14 Days of Any Vaccination | Moderate Swelling | 0.0 Percentage of participants |
| IGE-1 6 mcg | Percentages of Participants With Local Reactions By Severity Within 14 Days of Any Vaccination | Any Local Reaction | 83.3 Percentage of participants |
| IGE-1 6 mcg | Percentages of Participants With Local Reactions By Severity Within 14 Days of Any Vaccination | Any Swelling | 16.7 Percentage of participants |
| IGE-1 20 mcg | Percentages of Participants With Local Reactions By Severity Within 14 Days of Any Vaccination | Moderate Swelling | 0.0 Percentage of participants |
| IGE-1 20 mcg | Percentages of Participants With Local Reactions By Severity Within 14 Days of Any Vaccination | Mild Swelling | 14.3 Percentage of participants |
| IGE-1 20 mcg | Percentages of Participants With Local Reactions By Severity Within 14 Days of Any Vaccination | Any Redness | 9.5 Percentage of participants |
| IGE-1 20 mcg | Percentages of Participants With Local Reactions By Severity Within 14 Days of Any Vaccination | Mild Pain | 57.1 Percentage of participants |
| IGE-1 20 mcg | Percentages of Participants With Local Reactions By Severity Within 14 Days of Any Vaccination | Severe Pain | 4.8 Percentage of participants |
| IGE-1 20 mcg | Percentages of Participants With Local Reactions By Severity Within 14 Days of Any Vaccination | Moderate Pain | 38.1 Percentage of participants |
| IGE-1 20 mcg | Percentages of Participants With Local Reactions By Severity Within 14 Days of Any Vaccination | Any Local Reaction | 100.0 Percentage of participants |
| IGE-1 20 mcg | Percentages of Participants With Local Reactions By Severity Within 14 Days of Any Vaccination | Any Severe Local Reaction | 4.8 Percentage of participants |
| IGE-1 20 mcg | Percentages of Participants With Local Reactions By Severity Within 14 Days of Any Vaccination | Any Swelling | 14.3 Percentage of participants |
| IGE-1 20 mcg | Percentages of Participants With Local Reactions By Severity Within 14 Days of Any Vaccination | Mild Redness | 9.5 Percentage of participants |
| IGE-1 20 mcg | Percentages of Participants With Local Reactions By Severity Within 14 Days of Any Vaccination | Moderate and Severe Redness | 0.0 Percentage of participants |
| IGE-1 20 mcg | Percentages of Participants With Local Reactions By Severity Within 14 Days of Any Vaccination | Any Pain | 100.0 Percentage of participants |
| IGE-1 20 mcg | Percentages of Participants With Local Reactions By Severity Within 14 Days of Any Vaccination | Severe Swelling | 0.0 Percentage of participants |
| IGE-1 60 mcg | Percentages of Participants With Local Reactions By Severity Within 14 Days of Any Vaccination | Any Swelling | 20.0 Percentage of participants |
| IGE-1 60 mcg | Percentages of Participants With Local Reactions By Severity Within 14 Days of Any Vaccination | Any Pain | 90.0 Percentage of participants |
| IGE-1 60 mcg | Percentages of Participants With Local Reactions By Severity Within 14 Days of Any Vaccination | Mild Redness | 30.0 Percentage of participants |
| IGE-1 60 mcg | Percentages of Participants With Local Reactions By Severity Within 14 Days of Any Vaccination | Any Redness | 30.0 Percentage of participants |
| IGE-1 60 mcg | Percentages of Participants With Local Reactions By Severity Within 14 Days of Any Vaccination | Any Local Reaction | 90.0 Percentage of participants |
| IGE-1 60 mcg | Percentages of Participants With Local Reactions By Severity Within 14 Days of Any Vaccination | Moderate and Severe Redness | 0.0 Percentage of participants |
| IGE-1 60 mcg | Percentages of Participants With Local Reactions By Severity Within 14 Days of Any Vaccination | Severe Pain | 0.0 Percentage of participants |
| IGE-1 60 mcg | Percentages of Participants With Local Reactions By Severity Within 14 Days of Any Vaccination | Mild Swelling | 15.0 Percentage of participants |
| IGE-1 60 mcg | Percentages of Participants With Local Reactions By Severity Within 14 Days of Any Vaccination | Moderate Pain | 40.0 Percentage of participants |
| IGE-1 60 mcg | Percentages of Participants With Local Reactions By Severity Within 14 Days of Any Vaccination | Moderate Swelling | 5.0 Percentage of participants |
| IGE-1 60 mcg | Percentages of Participants With Local Reactions By Severity Within 14 Days of Any Vaccination | Any Severe Local Reaction | 0.0 Percentage of participants |
| IGE-1 60 mcg | Percentages of Participants With Local Reactions By Severity Within 14 Days of Any Vaccination | Mild Pain | 50.0 Percentage of participants |
| IGE-1 60 mcg | Percentages of Participants With Local Reactions By Severity Within 14 Days of Any Vaccination | Severe Swelling | 0.0 Percentage of participants |
| IGE-1 200 mcg | Percentages of Participants With Local Reactions By Severity Within 14 Days of Any Vaccination | Severe Pain | 10.0 Percentage of participants |
| IGE-1 200 mcg | Percentages of Participants With Local Reactions By Severity Within 14 Days of Any Vaccination | Any Redness | 15.0 Percentage of participants |
| IGE-1 200 mcg | Percentages of Participants With Local Reactions By Severity Within 14 Days of Any Vaccination | Moderate and Severe Redness | 0.0 Percentage of participants |
| IGE-1 200 mcg | Percentages of Participants With Local Reactions By Severity Within 14 Days of Any Vaccination | Mild Redness | 15.0 Percentage of participants |
| IGE-1 200 mcg | Percentages of Participants With Local Reactions By Severity Within 14 Days of Any Vaccination | Moderate Swelling | 10.0 Percentage of participants |
| IGE-1 200 mcg | Percentages of Participants With Local Reactions By Severity Within 14 Days of Any Vaccination | Any Pain | 100.0 Percentage of participants |
| IGE-1 200 mcg | Percentages of Participants With Local Reactions By Severity Within 14 Days of Any Vaccination | Any Local Reaction | 100.0 Percentage of participants |
| IGE-1 200 mcg | Percentages of Participants With Local Reactions By Severity Within 14 Days of Any Vaccination | Any Swelling | 30.0 Percentage of participants |
| IGE-1 200 mcg | Percentages of Participants With Local Reactions By Severity Within 14 Days of Any Vaccination | Mild Pain | 20.0 Percentage of participants |
| IGE-1 200 mcg | Percentages of Participants With Local Reactions By Severity Within 14 Days of Any Vaccination | Mild Swelling | 20.0 Percentage of participants |
| IGE-1 200 mcg | Percentages of Participants With Local Reactions By Severity Within 14 Days of Any Vaccination | Any Severe Local Reaction | 10.0 Percentage of participants |
| IGE-1 200 mcg | Percentages of Participants With Local Reactions By Severity Within 14 Days of Any Vaccination | Moderate Pain | 70.0 Percentage of participants |
| IGE-1 200 mcg | Percentages of Participants With Local Reactions By Severity Within 14 Days of Any Vaccination | Severe Swelling | 0.0 Percentage of participants |
| IGE-2 20 mcg | Percentages of Participants With Local Reactions By Severity Within 14 Days of Any Vaccination | Severe Swelling | 0.0 Percentage of participants |
| IGE-2 20 mcg | Percentages of Participants With Local Reactions By Severity Within 14 Days of Any Vaccination | Any Redness | 20.0 Percentage of participants |
| IGE-2 20 mcg | Percentages of Participants With Local Reactions By Severity Within 14 Days of Any Vaccination | Mild Redness | 20.0 Percentage of participants |
| IGE-2 20 mcg | Percentages of Participants With Local Reactions By Severity Within 14 Days of Any Vaccination | Moderate and Severe Redness | 0.0 Percentage of participants |
| IGE-2 20 mcg | Percentages of Participants With Local Reactions By Severity Within 14 Days of Any Vaccination | Any Swelling | 15.0 Percentage of participants |
| IGE-2 20 mcg | Percentages of Participants With Local Reactions By Severity Within 14 Days of Any Vaccination | Mild Swelling | 10.0 Percentage of participants |
| IGE-2 20 mcg | Percentages of Participants With Local Reactions By Severity Within 14 Days of Any Vaccination | Moderate Swelling | 5.0 Percentage of participants |
| IGE-2 20 mcg | Percentages of Participants With Local Reactions By Severity Within 14 Days of Any Vaccination | Any Pain | 90.0 Percentage of participants |
| IGE-2 20 mcg | Percentages of Participants With Local Reactions By Severity Within 14 Days of Any Vaccination | Mild Pain | 80.0 Percentage of participants |
| IGE-2 20 mcg | Percentages of Participants With Local Reactions By Severity Within 14 Days of Any Vaccination | Moderate Pain | 10.0 Percentage of participants |
| IGE-2 20 mcg | Percentages of Participants With Local Reactions By Severity Within 14 Days of Any Vaccination | Severe Pain | 0.0 Percentage of participants |
| IGE-2 20 mcg | Percentages of Participants With Local Reactions By Severity Within 14 Days of Any Vaccination | Any Local Reaction | 95.0 Percentage of participants |
| IGE-2 20 mcg | Percentages of Participants With Local Reactions By Severity Within 14 Days of Any Vaccination | Any Severe Local Reaction | 0.0 Percentage of participants |
| IGE-2 60 mcg | Percentages of Participants With Local Reactions By Severity Within 14 Days of Any Vaccination | Severe Swelling | 0.0 Percentage of participants |
| IGE-2 60 mcg | Percentages of Participants With Local Reactions By Severity Within 14 Days of Any Vaccination | Any Redness | 5.0 Percentage of participants |
| IGE-2 60 mcg | Percentages of Participants With Local Reactions By Severity Within 14 Days of Any Vaccination | Mild Pain | 75.0 Percentage of participants |
| IGE-2 60 mcg | Percentages of Participants With Local Reactions By Severity Within 14 Days of Any Vaccination | Moderate Swelling | 0.0 Percentage of participants |
| IGE-2 60 mcg | Percentages of Participants With Local Reactions By Severity Within 14 Days of Any Vaccination | Mild Swelling | 5.0 Percentage of participants |
| IGE-2 60 mcg | Percentages of Participants With Local Reactions By Severity Within 14 Days of Any Vaccination | Moderate Pain | 5.0 Percentage of participants |
| IGE-2 60 mcg | Percentages of Participants With Local Reactions By Severity Within 14 Days of Any Vaccination | Any Swelling | 5.0 Percentage of participants |
| IGE-2 60 mcg | Percentages of Participants With Local Reactions By Severity Within 14 Days of Any Vaccination | Any Severe Local Reaction | 5.0 Percentage of participants |
| IGE-2 60 mcg | Percentages of Participants With Local Reactions By Severity Within 14 Days of Any Vaccination | Severe Pain | 5.0 Percentage of participants |
| IGE-2 60 mcg | Percentages of Participants With Local Reactions By Severity Within 14 Days of Any Vaccination | Moderate and Severe Redness | 0.0 Percentage of participants |
| IGE-2 60 mcg | Percentages of Participants With Local Reactions By Severity Within 14 Days of Any Vaccination | Any Local Reaction | 85.0 Percentage of participants |
| IGE-2 60 mcg | Percentages of Participants With Local Reactions By Severity Within 14 Days of Any Vaccination | Mild Redness | 5.0 Percentage of participants |
| IGE-2 60 mcg | Percentages of Participants With Local Reactions By Severity Within 14 Days of Any Vaccination | Any Pain | 85.0 Percentage of participants |
| IGE-2 200 mcg | Percentages of Participants With Local Reactions By Severity Within 14 Days of Any Vaccination | Moderate Pain | 30.0 Percentage of participants |
| IGE-2 200 mcg | Percentages of Participants With Local Reactions By Severity Within 14 Days of Any Vaccination | Any Swelling | 5.0 Percentage of participants |
| IGE-2 200 mcg | Percentages of Participants With Local Reactions By Severity Within 14 Days of Any Vaccination | Any Redness | 10.0 Percentage of participants |
| IGE-2 200 mcg | Percentages of Participants With Local Reactions By Severity Within 14 Days of Any Vaccination | Severe Pain | 0.0 Percentage of participants |
| IGE-2 200 mcg | Percentages of Participants With Local Reactions By Severity Within 14 Days of Any Vaccination | Moderate and Severe Redness | 0.0 Percentage of participants |
| IGE-2 200 mcg | Percentages of Participants With Local Reactions By Severity Within 14 Days of Any Vaccination | Severe Swelling | 0.0 Percentage of participants |
| IGE-2 200 mcg | Percentages of Participants With Local Reactions By Severity Within 14 Days of Any Vaccination | Mild Redness | 10.0 Percentage of participants |
| IGE-2 200 mcg | Percentages of Participants With Local Reactions By Severity Within 14 Days of Any Vaccination | Moderate Swelling | 0.0 Percentage of participants |
| IGE-2 200 mcg | Percentages of Participants With Local Reactions By Severity Within 14 Days of Any Vaccination | Any Severe Local Reaction | 0.0 Percentage of participants |
| IGE-2 200 mcg | Percentages of Participants With Local Reactions By Severity Within 14 Days of Any Vaccination | Any Pain | 90.0 Percentage of participants |
| IGE-2 200 mcg | Percentages of Participants With Local Reactions By Severity Within 14 Days of Any Vaccination | Mild Pain | 60.0 Percentage of participants |
| IGE-2 200 mcg | Percentages of Participants With Local Reactions By Severity Within 14 Days of Any Vaccination | Any Local Reaction | 90.0 Percentage of participants |
| IGE-2 200 mcg | Percentages of Participants With Local Reactions By Severity Within 14 Days of Any Vaccination | Mild Swelling | 5.0 Percentage of participants |
| Saline Placebo | Percentages of Participants With Local Reactions By Severity Within 14 Days of Any Vaccination | Mild Pain | 14.3 Percentage of participants |
| Saline Placebo | Percentages of Participants With Local Reactions By Severity Within 14 Days of Any Vaccination | Moderate Pain | 1.6 Percentage of participants |
| Saline Placebo | Percentages of Participants With Local Reactions By Severity Within 14 Days of Any Vaccination | Any Swelling | 9.5 Percentage of participants |
| Saline Placebo | Percentages of Participants With Local Reactions By Severity Within 14 Days of Any Vaccination | Moderate Swelling | 0.0 Percentage of participants |
| Saline Placebo | Percentages of Participants With Local Reactions By Severity Within 14 Days of Any Vaccination | Any Redness | 7.9 Percentage of participants |
| Saline Placebo | Percentages of Participants With Local Reactions By Severity Within 14 Days of Any Vaccination | Moderate and Severe Redness | 0.0 Percentage of participants |
| Saline Placebo | Percentages of Participants With Local Reactions By Severity Within 14 Days of Any Vaccination | Severe Swelling | 0.0 Percentage of participants |
| Saline Placebo | Percentages of Participants With Local Reactions By Severity Within 14 Days of Any Vaccination | Any Severe Local Reaction | 0.0 Percentage of participants |
| Saline Placebo | Percentages of Participants With Local Reactions By Severity Within 14 Days of Any Vaccination | Mild Swelling | 9.5 Percentage of participants |
| Saline Placebo | Percentages of Participants With Local Reactions By Severity Within 14 Days of Any Vaccination | Severe Pain | 0.0 Percentage of participants |
| Saline Placebo | Percentages of Participants With Local Reactions By Severity Within 14 Days of Any Vaccination | Any Pain | 15.9 Percentage of participants |
| Saline Placebo | Percentages of Participants With Local Reactions By Severity Within 14 Days of Any Vaccination | Any Local Reaction | 25.4 Percentage of participants |
| Saline Placebo | Percentages of Participants With Local Reactions By Severity Within 14 Days of Any Vaccination | Mild Redness | 7.9 Percentage of participants |
Primary
Percentages of Participants With Systemic Reactions By Severity Within 14 Days of Any Vaccination
Systemic reactions consisted of fever, vomiting, diarrhea, headache, fatigue, muscle pain (other than at the injection site) and joint pain (other than pain adjacent to injection site). Participants were issued an electronic diary (e-diary) and were asked to monitor and record (according to corresponding grading scales) any systemic reactions for 14 days following each vaccination. Grading details are as follows: Mild (Vomiting: 1-2 times in 24 hours; Diarrhea: 2-3 loose stools in 24 hours; Headache, Fatigue, Muscle Pain, Joint Pain: no interference with activity), Moderate (Vomiting: \>2 times in 24 hours; Diarrhea: 4-5 loose stools in 24 hours; Headache, Fatigue, Muscle and Joint Pain: some interference with activity), Severe (Vomiting: required intravenous hydration; Diarrhea: more than or equal to \[\>=\] 6 stool in 24 hours; Headache, Fatigue, Muscle and Joint Pain: Significant, prevented daily activity).
Time frame: Within 14 days
Population: All randomized participants who received at least one dose of study treatment.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| IGE-1 6 mcg | Percentages of Participants With Systemic Reactions By Severity Within 14 Days of Any Vaccination | Moderate Joint Pain | 16.7 Percentage of participants |
| IGE-1 6 mcg | Percentages of Participants With Systemic Reactions By Severity Within 14 Days of Any Vaccination | Mild Fatigue | 16.7 Percentage of participants |
| IGE-1 6 mcg | Percentages of Participants With Systemic Reactions By Severity Within 14 Days of Any Vaccination | Severe Muscle Pain | 16.7 Percentage of participants |
| IGE-1 6 mcg | Percentages of Participants With Systemic Reactions By Severity Within 14 Days of Any Vaccination | Any Fatigue | 50.0 Percentage of participants |
| IGE-1 6 mcg | Percentages of Participants With Systemic Reactions By Severity Within 14 Days of Any Vaccination | Mild Muscle Pain | 33.3 Percentage of participants |
| IGE-1 6 mcg | Percentages of Participants With Systemic Reactions By Severity Within 14 Days of Any Vaccination | Severe Headache | .0 Percentage of participants |
| IGE-1 6 mcg | Percentages of Participants With Systemic Reactions By Severity Within 14 Days of Any Vaccination | Severe Vomiting | 0.0 Percentage of participants |
| IGE-1 6 mcg | Percentages of Participants With Systemic Reactions By Severity Within 14 Days of Any Vaccination | Any Muscle Pain | 66.7 Percentage of participants |
| IGE-1 6 mcg | Percentages of Participants With Systemic Reactions By Severity Within 14 Days of Any Vaccination | Any Severe Systemic Reaction | 16.7 Percentage of participants |
| IGE-1 6 mcg | Percentages of Participants With Systemic Reactions By Severity Within 14 Days of Any Vaccination | Moderate Headache | 16.7 Percentage of participants |
| IGE-1 6 mcg | Percentages of Participants With Systemic Reactions By Severity Within 14 Days of Any Vaccination | Mild Vomiting | 0.0 Percentage of participants |
| IGE-1 6 mcg | Percentages of Participants With Systemic Reactions By Severity Within 14 Days of Any Vaccination | Mild Headache | 0.0 Percentage of participants |
| IGE-1 6 mcg | Percentages of Participants With Systemic Reactions By Severity Within 14 Days of Any Vaccination | Moderate Fever | 0.0 Percentage of participants |
| IGE-1 6 mcg | Percentages of Participants With Systemic Reactions By Severity Within 14 Days of Any Vaccination | Severe Fatigue | 0.0 Percentage of participants |
| IGE-1 6 mcg | Percentages of Participants With Systemic Reactions By Severity Within 14 Days of Any Vaccination | Any Systemic Reaction | 66.7 Percentage of participants |
| IGE-1 6 mcg | Percentages of Participants With Systemic Reactions By Severity Within 14 Days of Any Vaccination | Severe Joint Pain | 0.0 Percentage of participants |
| IGE-1 6 mcg | Percentages of Participants With Systemic Reactions By Severity Within 14 Days of Any Vaccination | Any Headache | 16.7 Percentage of participants |
| IGE-1 6 mcg | Percentages of Participants With Systemic Reactions By Severity Within 14 Days of Any Vaccination | Moderate Fatigue | 33.3 Percentage of participants |
| IGE-1 6 mcg | Percentages of Participants With Systemic Reactions By Severity Within 14 Days of Any Vaccination | Severe Diarrhea | 0.0 Percentage of participants |
| IGE-1 6 mcg | Percentages of Participants With Systemic Reactions By Severity Within 14 Days of Any Vaccination | Mild Joint Pain | 33.3 Percentage of participants |
| IGE-1 6 mcg | Percentages of Participants With Systemic Reactions By Severity Within 14 Days of Any Vaccination | Severe Fever | 0.0 Percentage of participants |
| IGE-1 6 mcg | Percentages of Participants With Systemic Reactions By Severity Within 14 Days of Any Vaccination | Moderate Muscle Pain | 16.7 Percentage of participants |
| IGE-1 6 mcg | Percentages of Participants With Systemic Reactions By Severity Within 14 Days of Any Vaccination | Moderate Vomiting | 0.0 Percentage of participants |
| IGE-1 6 mcg | Percentages of Participants With Systemic Reactions By Severity Within 14 Days of Any Vaccination | Moderate Diarrhea | 0.0 Percentage of participants |
| IGE-1 6 mcg | Percentages of Participants With Systemic Reactions By Severity Within 14 Days of Any Vaccination | Any Fever | 0 Percentage of participants |
| IGE-1 6 mcg | Percentages of Participants With Systemic Reactions By Severity Within 14 Days of Any Vaccination | Mild Diarrhea | 0.0 Percentage of participants |
| IGE-1 6 mcg | Percentages of Participants With Systemic Reactions By Severity Within 14 Days of Any Vaccination | Any Joint Pain | 50.0 Percentage of participants |
| IGE-1 6 mcg | Percentages of Participants With Systemic Reactions By Severity Within 14 Days of Any Vaccination | Any Diarrhea | 0.0 Percentage of participants |
| IGE-1 6 mcg | Percentages of Participants With Systemic Reactions By Severity Within 14 Days of Any Vaccination | Any Vomiting | 0.0 Percentage of participants |
| IGE-1 6 mcg | Percentages of Participants With Systemic Reactions By Severity Within 14 Days of Any Vaccination | Mild Fever | 0.0 Percentage of participants |
| IGE-1 20 mcg | Percentages of Participants With Systemic Reactions By Severity Within 14 Days of Any Vaccination | Any Vomiting | 0.0 Percentage of participants |
| IGE-1 20 mcg | Percentages of Participants With Systemic Reactions By Severity Within 14 Days of Any Vaccination | Severe Vomiting | 0.0 Percentage of participants |
| IGE-1 20 mcg | Percentages of Participants With Systemic Reactions By Severity Within 14 Days of Any Vaccination | Moderate Vomiting | 0.0 Percentage of participants |
| IGE-1 20 mcg | Percentages of Participants With Systemic Reactions By Severity Within 14 Days of Any Vaccination | Mild Vomiting | 0.0 Percentage of participants |
| IGE-1 20 mcg | Percentages of Participants With Systemic Reactions By Severity Within 14 Days of Any Vaccination | Moderate Joint Pain | 4.8 Percentage of participants |
| IGE-1 20 mcg | Percentages of Participants With Systemic Reactions By Severity Within 14 Days of Any Vaccination | Mild Joint Pain | 28.6 Percentage of participants |
| IGE-1 20 mcg | Percentages of Participants With Systemic Reactions By Severity Within 14 Days of Any Vaccination | Any Muscle Pain | 71.4 Percentage of participants |
| IGE-1 20 mcg | Percentages of Participants With Systemic Reactions By Severity Within 14 Days of Any Vaccination | Any Severe Systemic Reaction | 0.0 Percentage of participants |
| IGE-1 20 mcg | Percentages of Participants With Systemic Reactions By Severity Within 14 Days of Any Vaccination | Any Joint Pain | 33.3 Percentage of participants |
| IGE-1 20 mcg | Percentages of Participants With Systemic Reactions By Severity Within 14 Days of Any Vaccination | Severe Muscle Pain | 0.0 Percentage of participants |
| IGE-1 20 mcg | Percentages of Participants With Systemic Reactions By Severity Within 14 Days of Any Vaccination | Mild Muscle Pain | 52.4 Percentage of participants |
| IGE-1 20 mcg | Percentages of Participants With Systemic Reactions By Severity Within 14 Days of Any Vaccination | Severe Fatigue | 0.0 Percentage of participants |
| IGE-1 20 mcg | Percentages of Participants With Systemic Reactions By Severity Within 14 Days of Any Vaccination | Moderate Fatigue | 42.9 Percentage of participants |
| IGE-1 20 mcg | Percentages of Participants With Systemic Reactions By Severity Within 14 Days of Any Vaccination | Mild Fatigue | 19.0 Percentage of participants |
| IGE-1 20 mcg | Percentages of Participants With Systemic Reactions By Severity Within 14 Days of Any Vaccination | Moderate Muscle Pain | 19.0 Percentage of participants |
| IGE-1 20 mcg | Percentages of Participants With Systemic Reactions By Severity Within 14 Days of Any Vaccination | Any Fever | 0.0 Percentage of participants |
| IGE-1 20 mcg | Percentages of Participants With Systemic Reactions By Severity Within 14 Days of Any Vaccination | Any Systemic Reaction | 100.0 Percentage of participants |
| IGE-1 20 mcg | Percentages of Participants With Systemic Reactions By Severity Within 14 Days of Any Vaccination | Any Fatigue | 61.9 Percentage of participants |
| IGE-1 20 mcg | Percentages of Participants With Systemic Reactions By Severity Within 14 Days of Any Vaccination | Severe Headache | 0.0 Percentage of participants |
| IGE-1 20 mcg | Percentages of Participants With Systemic Reactions By Severity Within 14 Days of Any Vaccination | Mild Fever | 0.0 Percentage of participants |
| IGE-1 20 mcg | Percentages of Participants With Systemic Reactions By Severity Within 14 Days of Any Vaccination | Moderate Headache | 33.3 Percentage of participants |
| IGE-1 20 mcg | Percentages of Participants With Systemic Reactions By Severity Within 14 Days of Any Vaccination | Mild Headache | 47.6 Percentage of participants |
| IGE-1 20 mcg | Percentages of Participants With Systemic Reactions By Severity Within 14 Days of Any Vaccination | Moderate Fever | 0.0 Percentage of participants |
| IGE-1 20 mcg | Percentages of Participants With Systemic Reactions By Severity Within 14 Days of Any Vaccination | Any Headache | 81.0 Percentage of participants |
| IGE-1 20 mcg | Percentages of Participants With Systemic Reactions By Severity Within 14 Days of Any Vaccination | Severe Diarrhea | 0.0 Percentage of participants |
| IGE-1 20 mcg | Percentages of Participants With Systemic Reactions By Severity Within 14 Days of Any Vaccination | Moderate Diarrhea | 19.0 Percentage of participants |
| IGE-1 20 mcg | Percentages of Participants With Systemic Reactions By Severity Within 14 Days of Any Vaccination | Severe Fever | 0.0 Percentage of participants |
| IGE-1 20 mcg | Percentages of Participants With Systemic Reactions By Severity Within 14 Days of Any Vaccination | Severe Joint Pain | 0.0 Percentage of participants |
| IGE-1 20 mcg | Percentages of Participants With Systemic Reactions By Severity Within 14 Days of Any Vaccination | Mild Diarrhea | 28.6 Percentage of participants |
| IGE-1 20 mcg | Percentages of Participants With Systemic Reactions By Severity Within 14 Days of Any Vaccination | Any Diarrhea | 47.6 Percentage of participants |
| IGE-1 60 mcg | Percentages of Participants With Systemic Reactions By Severity Within 14 Days of Any Vaccination | Any Vomiting | 0.0 Percentage of participants |
| IGE-1 60 mcg | Percentages of Participants With Systemic Reactions By Severity Within 14 Days of Any Vaccination | Any Muscle Pain | 75.0 Percentage of participants |
| IGE-1 60 mcg | Percentages of Participants With Systemic Reactions By Severity Within 14 Days of Any Vaccination | Mild Muscle Pain | 45.0 Percentage of participants |
| IGE-1 60 mcg | Percentages of Participants With Systemic Reactions By Severity Within 14 Days of Any Vaccination | Any Fever | 10.0 Percentage of participants |
| IGE-1 60 mcg | Percentages of Participants With Systemic Reactions By Severity Within 14 Days of Any Vaccination | Mild Fever | 10.0 Percentage of participants |
| IGE-1 60 mcg | Percentages of Participants With Systemic Reactions By Severity Within 14 Days of Any Vaccination | Moderate Fever | 0.0 Percentage of participants |
| IGE-1 60 mcg | Percentages of Participants With Systemic Reactions By Severity Within 14 Days of Any Vaccination | Severe Fever | 0.0 Percentage of participants |
| IGE-1 60 mcg | Percentages of Participants With Systemic Reactions By Severity Within 14 Days of Any Vaccination | Mild Vomiting | 0.0 Percentage of participants |
| IGE-1 60 mcg | Percentages of Participants With Systemic Reactions By Severity Within 14 Days of Any Vaccination | Moderate Vomiting | 0.0 Percentage of participants |
| IGE-1 60 mcg | Percentages of Participants With Systemic Reactions By Severity Within 14 Days of Any Vaccination | Severe Vomiting | 0.0 Percentage of participants |
| IGE-1 60 mcg | Percentages of Participants With Systemic Reactions By Severity Within 14 Days of Any Vaccination | Any Diarrhea | 35.0 Percentage of participants |
| IGE-1 60 mcg | Percentages of Participants With Systemic Reactions By Severity Within 14 Days of Any Vaccination | Mild Diarrhea | 25.0 Percentage of participants |
| IGE-1 60 mcg | Percentages of Participants With Systemic Reactions By Severity Within 14 Days of Any Vaccination | Moderate Diarrhea | 10.0 Percentage of participants |
| IGE-1 60 mcg | Percentages of Participants With Systemic Reactions By Severity Within 14 Days of Any Vaccination | Severe Diarrhea | 0.0 Percentage of participants |
| IGE-1 60 mcg | Percentages of Participants With Systemic Reactions By Severity Within 14 Days of Any Vaccination | Any Headache | 55.0 Percentage of participants |
| IGE-1 60 mcg | Percentages of Participants With Systemic Reactions By Severity Within 14 Days of Any Vaccination | Mild Headache | 25.0 Percentage of participants |
| IGE-1 60 mcg | Percentages of Participants With Systemic Reactions By Severity Within 14 Days of Any Vaccination | Moderate Headache | 30.0 Percentage of participants |
| IGE-1 60 mcg | Percentages of Participants With Systemic Reactions By Severity Within 14 Days of Any Vaccination | Severe Headache | 0.0 Percentage of participants |
| IGE-1 60 mcg | Percentages of Participants With Systemic Reactions By Severity Within 14 Days of Any Vaccination | Any Fatigue | 85.0 Percentage of participants |
| IGE-1 60 mcg | Percentages of Participants With Systemic Reactions By Severity Within 14 Days of Any Vaccination | Mild Fatigue | 25.0 Percentage of participants |
| IGE-1 60 mcg | Percentages of Participants With Systemic Reactions By Severity Within 14 Days of Any Vaccination | Moderate Fatigue | 55.0 Percentage of participants |
| IGE-1 60 mcg | Percentages of Participants With Systemic Reactions By Severity Within 14 Days of Any Vaccination | Severe Fatigue | 5.0 Percentage of participants |
| IGE-1 60 mcg | Percentages of Participants With Systemic Reactions By Severity Within 14 Days of Any Vaccination | Moderate Muscle Pain | 30.0 Percentage of participants |
| IGE-1 60 mcg | Percentages of Participants With Systemic Reactions By Severity Within 14 Days of Any Vaccination | Severe Muscle Pain | 0.0 Percentage of participants |
| IGE-1 60 mcg | Percentages of Participants With Systemic Reactions By Severity Within 14 Days of Any Vaccination | Any Joint Pain | 35.0 Percentage of participants |
| IGE-1 60 mcg | Percentages of Participants With Systemic Reactions By Severity Within 14 Days of Any Vaccination | Mild Joint Pain | 20.0 Percentage of participants |
| IGE-1 60 mcg | Percentages of Participants With Systemic Reactions By Severity Within 14 Days of Any Vaccination | Moderate Joint Pain | 15.0 Percentage of participants |
| IGE-1 60 mcg | Percentages of Participants With Systemic Reactions By Severity Within 14 Days of Any Vaccination | Severe Joint Pain | 0.0 Percentage of participants |
| IGE-1 60 mcg | Percentages of Participants With Systemic Reactions By Severity Within 14 Days of Any Vaccination | Any Systemic Reaction | 90.0 Percentage of participants |
| IGE-1 60 mcg | Percentages of Participants With Systemic Reactions By Severity Within 14 Days of Any Vaccination | Any Severe Systemic Reaction | 5.0 Percentage of participants |
| IGE-1 200 mcg | Percentages of Participants With Systemic Reactions By Severity Within 14 Days of Any Vaccination | Any Vomiting | 10.0 Percentage of participants |
| IGE-1 200 mcg | Percentages of Participants With Systemic Reactions By Severity Within 14 Days of Any Vaccination | Moderate Fatigue | 45.0 Percentage of participants |
| IGE-1 200 mcg | Percentages of Participants With Systemic Reactions By Severity Within 14 Days of Any Vaccination | Moderate Fever | 5.0 Percentage of participants |
| IGE-1 200 mcg | Percentages of Participants With Systemic Reactions By Severity Within 14 Days of Any Vaccination | Mild Muscle Pain | 40.0 Percentage of participants |
| IGE-1 200 mcg | Percentages of Participants With Systemic Reactions By Severity Within 14 Days of Any Vaccination | Any Headache | 70.0 Percentage of participants |
| IGE-1 200 mcg | Percentages of Participants With Systemic Reactions By Severity Within 14 Days of Any Vaccination | Moderate Diarrhea | 5.0 Percentage of participants |
| IGE-1 200 mcg | Percentages of Participants With Systemic Reactions By Severity Within 14 Days of Any Vaccination | Severe Joint Pain | 0.0 Percentage of participants |
| IGE-1 200 mcg | Percentages of Participants With Systemic Reactions By Severity Within 14 Days of Any Vaccination | Moderate Joint Pain | 15.0 Percentage of participants |
| IGE-1 200 mcg | Percentages of Participants With Systemic Reactions By Severity Within 14 Days of Any Vaccination | Any Fever | 20.0 Percentage of participants |
| IGE-1 200 mcg | Percentages of Participants With Systemic Reactions By Severity Within 14 Days of Any Vaccination | Moderate Vomiting | 0.0 Percentage of participants |
| IGE-1 200 mcg | Percentages of Participants With Systemic Reactions By Severity Within 14 Days of Any Vaccination | Mild Joint Pain | 20.0 Percentage of participants |
| IGE-1 200 mcg | Percentages of Participants With Systemic Reactions By Severity Within 14 Days of Any Vaccination | Severe Headache | 0.0 Percentage of participants |
| IGE-1 200 mcg | Percentages of Participants With Systemic Reactions By Severity Within 14 Days of Any Vaccination | Mild Headache | 40.0 Percentage of participants |
| IGE-1 200 mcg | Percentages of Participants With Systemic Reactions By Severity Within 14 Days of Any Vaccination | Any Fatigue | 85.0 Percentage of participants |
| IGE-1 200 mcg | Percentages of Participants With Systemic Reactions By Severity Within 14 Days of Any Vaccination | Any Diarrhea | 55.0 Percentage of participants |
| IGE-1 200 mcg | Percentages of Participants With Systemic Reactions By Severity Within 14 Days of Any Vaccination | Any Severe Systemic Reaction | 5.0 Percentage of participants |
| IGE-1 200 mcg | Percentages of Participants With Systemic Reactions By Severity Within 14 Days of Any Vaccination | Any Muscle Pain | 75.0 Percentage of participants |
| IGE-1 200 mcg | Percentages of Participants With Systemic Reactions By Severity Within 14 Days of Any Vaccination | Mild Diarrhea | 50.0 Percentage of participants |
| IGE-1 200 mcg | Percentages of Participants With Systemic Reactions By Severity Within 14 Days of Any Vaccination | Mild Vomiting | 10.0 Percentage of participants |
| IGE-1 200 mcg | Percentages of Participants With Systemic Reactions By Severity Within 14 Days of Any Vaccination | Severe Vomiting | 0.0 Percentage of participants |
| IGE-1 200 mcg | Percentages of Participants With Systemic Reactions By Severity Within 14 Days of Any Vaccination | Moderate Headache | 30.0 Percentage of participants |
| IGE-1 200 mcg | Percentages of Participants With Systemic Reactions By Severity Within 14 Days of Any Vaccination | Severe Fatigue | 5.0 Percentage of participants |
| IGE-1 200 mcg | Percentages of Participants With Systemic Reactions By Severity Within 14 Days of Any Vaccination | Severe Diarrhea | 0.0 Percentage of participants |
| IGE-1 200 mcg | Percentages of Participants With Systemic Reactions By Severity Within 14 Days of Any Vaccination | Any Joint Pain | 35.0 Percentage of participants |
| IGE-1 200 mcg | Percentages of Participants With Systemic Reactions By Severity Within 14 Days of Any Vaccination | Severe Fever | 0.0 Percentage of participants |
| IGE-1 200 mcg | Percentages of Participants With Systemic Reactions By Severity Within 14 Days of Any Vaccination | Severe Muscle Pain | 0.0 Percentage of participants |
| IGE-1 200 mcg | Percentages of Participants With Systemic Reactions By Severity Within 14 Days of Any Vaccination | Mild Fever | 15.0 Percentage of participants |
| IGE-1 200 mcg | Percentages of Participants With Systemic Reactions By Severity Within 14 Days of Any Vaccination | Any Systemic Reaction | 100.0 Percentage of participants |
| IGE-1 200 mcg | Percentages of Participants With Systemic Reactions By Severity Within 14 Days of Any Vaccination | Mild Fatigue | 35.0 Percentage of participants |
| IGE-1 200 mcg | Percentages of Participants With Systemic Reactions By Severity Within 14 Days of Any Vaccination | Moderate Muscle Pain | 35.0 Percentage of participants |
| IGE-2 20 mcg | Percentages of Participants With Systemic Reactions By Severity Within 14 Days of Any Vaccination | Any Diarrhea | 45.0 Percentage of participants |
| IGE-2 20 mcg | Percentages of Participants With Systemic Reactions By Severity Within 14 Days of Any Vaccination | Any Fever | 0.0 Percentage of participants |
| IGE-2 20 mcg | Percentages of Participants With Systemic Reactions By Severity Within 14 Days of Any Vaccination | Any Systemic Reaction | 95.0 Percentage of participants |
| IGE-2 20 mcg | Percentages of Participants With Systemic Reactions By Severity Within 14 Days of Any Vaccination | Any Fatigue | 70.0 Percentage of participants |
| IGE-2 20 mcg | Percentages of Participants With Systemic Reactions By Severity Within 14 Days of Any Vaccination | Mild Muscle Pain | 45.0 Percentage of participants |
| IGE-2 20 mcg | Percentages of Participants With Systemic Reactions By Severity Within 14 Days of Any Vaccination | Moderate Fatigue | 40.0 Percentage of participants |
| IGE-2 20 mcg | Percentages of Participants With Systemic Reactions By Severity Within 14 Days of Any Vaccination | Mild Fatigue | 30.0 Percentage of participants |
| IGE-2 20 mcg | Percentages of Participants With Systemic Reactions By Severity Within 14 Days of Any Vaccination | Any Vomiting | 10.0 Percentage of participants |
| IGE-2 20 mcg | Percentages of Participants With Systemic Reactions By Severity Within 14 Days of Any Vaccination | Moderate Vomiting | 5.0 Percentage of participants |
| IGE-2 20 mcg | Percentages of Participants With Systemic Reactions By Severity Within 14 Days of Any Vaccination | Moderate Diarrhea | 10.0 Percentage of participants |
| IGE-2 20 mcg | Percentages of Participants With Systemic Reactions By Severity Within 14 Days of Any Vaccination | Severe Vomiting | 0.0 Percentage of participants |
| IGE-2 20 mcg | Percentages of Participants With Systemic Reactions By Severity Within 14 Days of Any Vaccination | Mild Vomiting | 5.0 Percentage of participants |
| IGE-2 20 mcg | Percentages of Participants With Systemic Reactions By Severity Within 14 Days of Any Vaccination | Severe Diarrhea | 5.0 Percentage of participants |
| IGE-2 20 mcg | Percentages of Participants With Systemic Reactions By Severity Within 14 Days of Any Vaccination | Severe Joint Pain | 0.0 Percentage of participants |
| IGE-2 20 mcg | Percentages of Participants With Systemic Reactions By Severity Within 14 Days of Any Vaccination | Severe Fatigue | 0.0 Percentage of participants |
| IGE-2 20 mcg | Percentages of Participants With Systemic Reactions By Severity Within 14 Days of Any Vaccination | Moderate Joint Pain | 10.0 Percentage of participants |
| IGE-2 20 mcg | Percentages of Participants With Systemic Reactions By Severity Within 14 Days of Any Vaccination | Moderate Fever | 0.0 Percentage of participants |
| IGE-2 20 mcg | Percentages of Participants With Systemic Reactions By Severity Within 14 Days of Any Vaccination | Severe Muscle Pain | 0.0 Percentage of participants |
| IGE-2 20 mcg | Percentages of Participants With Systemic Reactions By Severity Within 14 Days of Any Vaccination | Any Headache | 75.0 Percentage of participants |
| IGE-2 20 mcg | Percentages of Participants With Systemic Reactions By Severity Within 14 Days of Any Vaccination | Severe Fever | 0.0 Percentage of participants |
| IGE-2 20 mcg | Percentages of Participants With Systemic Reactions By Severity Within 14 Days of Any Vaccination | Any Severe Systemic Reaction | 5.0 Percentage of participants |
| IGE-2 20 mcg | Percentages of Participants With Systemic Reactions By Severity Within 14 Days of Any Vaccination | Mild Joint Pain | 35.0 Percentage of participants |
| IGE-2 20 mcg | Percentages of Participants With Systemic Reactions By Severity Within 14 Days of Any Vaccination | Mild Headache | 50.0 Percentage of participants |
| IGE-2 20 mcg | Percentages of Participants With Systemic Reactions By Severity Within 14 Days of Any Vaccination | Mild Fever | 0.0 Percentage of participants |
| IGE-2 20 mcg | Percentages of Participants With Systemic Reactions By Severity Within 14 Days of Any Vaccination | Any Joint Pain | 45.0 Percentage of participants |
| IGE-2 20 mcg | Percentages of Participants With Systemic Reactions By Severity Within 14 Days of Any Vaccination | Moderate Headache | 25.0 Percentage of participants |
| IGE-2 20 mcg | Percentages of Participants With Systemic Reactions By Severity Within 14 Days of Any Vaccination | Mild Diarrhea | 30.0 Percentage of participants |
| IGE-2 20 mcg | Percentages of Participants With Systemic Reactions By Severity Within 14 Days of Any Vaccination | Any Muscle Pain | 70.0 Percentage of participants |
| IGE-2 20 mcg | Percentages of Participants With Systemic Reactions By Severity Within 14 Days of Any Vaccination | Severe Headache | 0.0 Percentage of participants |
| IGE-2 20 mcg | Percentages of Participants With Systemic Reactions By Severity Within 14 Days of Any Vaccination | Moderate Muscle Pain | 25.0 Percentage of participants |
| IGE-2 60 mcg | Percentages of Participants With Systemic Reactions By Severity Within 14 Days of Any Vaccination | Mild Vomiting | 15.0 Percentage of participants |
| IGE-2 60 mcg | Percentages of Participants With Systemic Reactions By Severity Within 14 Days of Any Vaccination | Any Diarrhea | 30.0 Percentage of participants |
| IGE-2 60 mcg | Percentages of Participants With Systemic Reactions By Severity Within 14 Days of Any Vaccination | Severe Fever | 0.0 Percentage of participants |
| IGE-2 60 mcg | Percentages of Participants With Systemic Reactions By Severity Within 14 Days of Any Vaccination | Severe Joint Pain | 0.0 Percentage of participants |
| IGE-2 60 mcg | Percentages of Participants With Systemic Reactions By Severity Within 14 Days of Any Vaccination | Mild Diarrhea | 20.0 Percentage of participants |
| IGE-2 60 mcg | Percentages of Participants With Systemic Reactions By Severity Within 14 Days of Any Vaccination | Moderate Diarrhea | 10.0 Percentage of participants |
| IGE-2 60 mcg | Percentages of Participants With Systemic Reactions By Severity Within 14 Days of Any Vaccination | Moderate Fever | 5.0 Percentage of participants |
| IGE-2 60 mcg | Percentages of Participants With Systemic Reactions By Severity Within 14 Days of Any Vaccination | Severe Diarrhea | 0.0 Percentage of participants |
| IGE-2 60 mcg | Percentages of Participants With Systemic Reactions By Severity Within 14 Days of Any Vaccination | Any Headache | 60.0 Percentage of participants |
| IGE-2 60 mcg | Percentages of Participants With Systemic Reactions By Severity Within 14 Days of Any Vaccination | Mild Headache | 30.0 Percentage of participants |
| IGE-2 60 mcg | Percentages of Participants With Systemic Reactions By Severity Within 14 Days of Any Vaccination | Mild Fever | 0.0 Percentage of participants |
| IGE-2 60 mcg | Percentages of Participants With Systemic Reactions By Severity Within 14 Days of Any Vaccination | Moderate Headache | 30.0 Percentage of participants |
| IGE-2 60 mcg | Percentages of Participants With Systemic Reactions By Severity Within 14 Days of Any Vaccination | Severe Headache | 0.0 Percentage of participants |
| IGE-2 60 mcg | Percentages of Participants With Systemic Reactions By Severity Within 14 Days of Any Vaccination | Any Fever | 5.0 Percentage of participants |
| IGE-2 60 mcg | Percentages of Participants With Systemic Reactions By Severity Within 14 Days of Any Vaccination | Any Fatigue | 60.0 Percentage of participants |
| IGE-2 60 mcg | Percentages of Participants With Systemic Reactions By Severity Within 14 Days of Any Vaccination | Any Systemic Reaction | 85.0 Percentage of participants |
| IGE-2 60 mcg | Percentages of Participants With Systemic Reactions By Severity Within 14 Days of Any Vaccination | Mild Fatigue | 35.0 Percentage of participants |
| IGE-2 60 mcg | Percentages of Participants With Systemic Reactions By Severity Within 14 Days of Any Vaccination | Mild Muscle Pain | 30.0 Percentage of participants |
| IGE-2 60 mcg | Percentages of Participants With Systemic Reactions By Severity Within 14 Days of Any Vaccination | Moderate Fatigue | 25.0 Percentage of participants |
| IGE-2 60 mcg | Percentages of Participants With Systemic Reactions By Severity Within 14 Days of Any Vaccination | Moderate Muscle Pain | 20.0 Percentage of participants |
| IGE-2 60 mcg | Percentages of Participants With Systemic Reactions By Severity Within 14 Days of Any Vaccination | Severe Muscle Pain | 0.0 Percentage of participants |
| IGE-2 60 mcg | Percentages of Participants With Systemic Reactions By Severity Within 14 Days of Any Vaccination | Any Muscle Pain | 50.0 Percentage of participants |
| IGE-2 60 mcg | Percentages of Participants With Systemic Reactions By Severity Within 14 Days of Any Vaccination | Any Joint Pain | 35.0 Percentage of participants |
| IGE-2 60 mcg | Percentages of Participants With Systemic Reactions By Severity Within 14 Days of Any Vaccination | Mild Joint Pain | 30.0 Percentage of participants |
| IGE-2 60 mcg | Percentages of Participants With Systemic Reactions By Severity Within 14 Days of Any Vaccination | Severe Fatigue | 0.0 Percentage of participants |
| IGE-2 60 mcg | Percentages of Participants With Systemic Reactions By Severity Within 14 Days of Any Vaccination | Moderate Joint Pain | 5.0 Percentage of participants |
| IGE-2 60 mcg | Percentages of Participants With Systemic Reactions By Severity Within 14 Days of Any Vaccination | Any Vomiting | 15.0 Percentage of participants |
| IGE-2 60 mcg | Percentages of Participants With Systemic Reactions By Severity Within 14 Days of Any Vaccination | Any Severe Systemic Reaction | 0.0 Percentage of participants |
| IGE-2 60 mcg | Percentages of Participants With Systemic Reactions By Severity Within 14 Days of Any Vaccination | Moderate Vomiting | 0.0 Percentage of participants |
| IGE-2 60 mcg | Percentages of Participants With Systemic Reactions By Severity Within 14 Days of Any Vaccination | Severe Vomiting | 0.0 Percentage of participants |
| IGE-2 200 mcg | Percentages of Participants With Systemic Reactions By Severity Within 14 Days of Any Vaccination | Moderate Headache | 30.0 Percentage of participants |
| IGE-2 200 mcg | Percentages of Participants With Systemic Reactions By Severity Within 14 Days of Any Vaccination | Any Headache | 55.0 Percentage of participants |
| IGE-2 200 mcg | Percentages of Participants With Systemic Reactions By Severity Within 14 Days of Any Vaccination | Any Severe Systemic Reaction | 5.0 Percentage of participants |
| IGE-2 200 mcg | Percentages of Participants With Systemic Reactions By Severity Within 14 Days of Any Vaccination | Any Diarrhea | 40.0 Percentage of participants |
| IGE-2 200 mcg | Percentages of Participants With Systemic Reactions By Severity Within 14 Days of Any Vaccination | Moderate Joint Pain | 10.0 Percentage of participants |
| IGE-2 200 mcg | Percentages of Participants With Systemic Reactions By Severity Within 14 Days of Any Vaccination | Moderate Muscle Pain | 35.0 Percentage of participants |
| IGE-2 200 mcg | Percentages of Participants With Systemic Reactions By Severity Within 14 Days of Any Vaccination | Severe Diarrhea | 0.0 Percentage of participants |
| IGE-2 200 mcg | Percentages of Participants With Systemic Reactions By Severity Within 14 Days of Any Vaccination | Any Joint Pain | 35.0 Percentage of participants |
| IGE-2 200 mcg | Percentages of Participants With Systemic Reactions By Severity Within 14 Days of Any Vaccination | Moderate Vomiting | 0.0 Percentage of participants |
| IGE-2 200 mcg | Percentages of Participants With Systemic Reactions By Severity Within 14 Days of Any Vaccination | Moderate Fever | 10.0 Percentage of participants |
| IGE-2 200 mcg | Percentages of Participants With Systemic Reactions By Severity Within 14 Days of Any Vaccination | Severe Muscle Pain | 0.0 Percentage of participants |
| IGE-2 200 mcg | Percentages of Participants With Systemic Reactions By Severity Within 14 Days of Any Vaccination | Severe Headache | 0.0 Percentage of participants |
| IGE-2 200 mcg | Percentages of Participants With Systemic Reactions By Severity Within 14 Days of Any Vaccination | Mild Vomiting | 0.0 Percentage of participants |
| IGE-2 200 mcg | Percentages of Participants With Systemic Reactions By Severity Within 14 Days of Any Vaccination | Mild Headache | 25.0 Percentage of participants |
| IGE-2 200 mcg | Percentages of Participants With Systemic Reactions By Severity Within 14 Days of Any Vaccination | Any Vomiting | 0.0 Percentage of participants |
| IGE-2 200 mcg | Percentages of Participants With Systemic Reactions By Severity Within 14 Days of Any Vaccination | Severe Fever | 5.0 Percentage of participants |
| IGE-2 200 mcg | Percentages of Participants With Systemic Reactions By Severity Within 14 Days of Any Vaccination | Mild Fever | 10.0 Percentage of participants |
| IGE-2 200 mcg | Percentages of Participants With Systemic Reactions By Severity Within 14 Days of Any Vaccination | Severe Vomiting | 0.0 Percentage of participants |
| IGE-2 200 mcg | Percentages of Participants With Systemic Reactions By Severity Within 14 Days of Any Vaccination | Mild Muscle Pain | 25.0 Percentage of participants |
| IGE-2 200 mcg | Percentages of Participants With Systemic Reactions By Severity Within 14 Days of Any Vaccination | Moderate Diarrhea | 10.0 Percentage of participants |
| IGE-2 200 mcg | Percentages of Participants With Systemic Reactions By Severity Within 14 Days of Any Vaccination | Any Systemic Reaction | 85.0 Percentage of participants |
| IGE-2 200 mcg | Percentages of Participants With Systemic Reactions By Severity Within 14 Days of Any Vaccination | Mild Fatigue | 25.0 Percentage of participants |
| IGE-2 200 mcg | Percentages of Participants With Systemic Reactions By Severity Within 14 Days of Any Vaccination | Any Muscle Pain | 60.0 Percentage of participants |
| IGE-2 200 mcg | Percentages of Participants With Systemic Reactions By Severity Within 14 Days of Any Vaccination | Severe Joint Pain | 0.0 Percentage of participants |
| IGE-2 200 mcg | Percentages of Participants With Systemic Reactions By Severity Within 14 Days of Any Vaccination | Moderate Fatigue | 40.0 Percentage of participants |
| IGE-2 200 mcg | Percentages of Participants With Systemic Reactions By Severity Within 14 Days of Any Vaccination | Mild Joint Pain | 25.0 Percentage of participants |
| IGE-2 200 mcg | Percentages of Participants With Systemic Reactions By Severity Within 14 Days of Any Vaccination | Any Fever | 25.0 Percentage of participants |
| IGE-2 200 mcg | Percentages of Participants With Systemic Reactions By Severity Within 14 Days of Any Vaccination | Any Fatigue | 65.0 Percentage of participants |
| IGE-2 200 mcg | Percentages of Participants With Systemic Reactions By Severity Within 14 Days of Any Vaccination | Severe Fatigue | 0.0 Percentage of participants |
| IGE-2 200 mcg | Percentages of Participants With Systemic Reactions By Severity Within 14 Days of Any Vaccination | Mild Diarrhea | 30.0 Percentage of participants |
| Saline Placebo | Percentages of Participants With Systemic Reactions By Severity Within 14 Days of Any Vaccination | Any Diarrhea | 42.9 Percentage of participants |
| Saline Placebo | Percentages of Participants With Systemic Reactions By Severity Within 14 Days of Any Vaccination | Moderate Muscle Pain | 19.0 Percentage of participants |
| Saline Placebo | Percentages of Participants With Systemic Reactions By Severity Within 14 Days of Any Vaccination | Any Muscle Pain | 34.9 Percentage of participants |
| Saline Placebo | Percentages of Participants With Systemic Reactions By Severity Within 14 Days of Any Vaccination | Any Fever | 1.6 Percentage of participants |
| Saline Placebo | Percentages of Participants With Systemic Reactions By Severity Within 14 Days of Any Vaccination | Severe Muscle Pain | 0.0 Percentage of participants |
| Saline Placebo | Percentages of Participants With Systemic Reactions By Severity Within 14 Days of Any Vaccination | Moderate Vomiting | 0.0 Percentage of participants |
| Saline Placebo | Percentages of Participants With Systemic Reactions By Severity Within 14 Days of Any Vaccination | Moderate Headache | 23.8 Percentage of participants |
| Saline Placebo | Percentages of Participants With Systemic Reactions By Severity Within 14 Days of Any Vaccination | Any Severe Systemic Reaction | 1.6 Percentage of participants |
| Saline Placebo | Percentages of Participants With Systemic Reactions By Severity Within 14 Days of Any Vaccination | Moderate Fever | 0.0 Percentage of participants |
| Saline Placebo | Percentages of Participants With Systemic Reactions By Severity Within 14 Days of Any Vaccination | Any Joint Pain | 20.6 Percentage of participants |
| Saline Placebo | Percentages of Participants With Systemic Reactions By Severity Within 14 Days of Any Vaccination | Mild Headache | 39.7 Percentage of participants |
| Saline Placebo | Percentages of Participants With Systemic Reactions By Severity Within 14 Days of Any Vaccination | Severe Fatigue | 0.0 Percentage of participants |
| Saline Placebo | Percentages of Participants With Systemic Reactions By Severity Within 14 Days of Any Vaccination | Mild Fever | 1.6 Percentage of participants |
| Saline Placebo | Percentages of Participants With Systemic Reactions By Severity Within 14 Days of Any Vaccination | Mild Diarrhea | 28.6 Percentage of participants |
| Saline Placebo | Percentages of Participants With Systemic Reactions By Severity Within 14 Days of Any Vaccination | Mild Joint Pain | 12.7 Percentage of participants |
| Saline Placebo | Percentages of Participants With Systemic Reactions By Severity Within 14 Days of Any Vaccination | Any Headache | 65.1 Percentage of participants |
| Saline Placebo | Percentages of Participants With Systemic Reactions By Severity Within 14 Days of Any Vaccination | Severe Diarrhea | 0.0 Percentage of participants |
| Saline Placebo | Percentages of Participants With Systemic Reactions By Severity Within 14 Days of Any Vaccination | Moderate Joint Pain | 7.9 Percentage of participants |
| Saline Placebo | Percentages of Participants With Systemic Reactions By Severity Within 14 Days of Any Vaccination | Any Vomiting | 4.8 Percentage of participants |
| Saline Placebo | Percentages of Participants With Systemic Reactions By Severity Within 14 Days of Any Vaccination | Severe Joint Pain | 0.0 Percentage of participants |
| Saline Placebo | Percentages of Participants With Systemic Reactions By Severity Within 14 Days of Any Vaccination | Moderate Diarrhea | 14.3 Percentage of participants |
| Saline Placebo | Percentages of Participants With Systemic Reactions By Severity Within 14 Days of Any Vaccination | Severe Fever | 0.0 Percentage of participants |
| Saline Placebo | Percentages of Participants With Systemic Reactions By Severity Within 14 Days of Any Vaccination | Mild Vomiting | 4.8 Percentage of participants |
| Saline Placebo | Percentages of Participants With Systemic Reactions By Severity Within 14 Days of Any Vaccination | Severe Vomiting | 0.0 Percentage of participants |
| Saline Placebo | Percentages of Participants With Systemic Reactions By Severity Within 14 Days of Any Vaccination | Mild Fatigue | 23.8 Percentage of participants |
| Saline Placebo | Percentages of Participants With Systemic Reactions By Severity Within 14 Days of Any Vaccination | Mild Muscle Pain | 15.9 Percentage of participants |
| Saline Placebo | Percentages of Participants With Systemic Reactions By Severity Within 14 Days of Any Vaccination | Moderate Fatigue | 42.9 Percentage of participants |
| Saline Placebo | Percentages of Participants With Systemic Reactions By Severity Within 14 Days of Any Vaccination | Any Fatigue | 66.7 Percentage of participants |
| Saline Placebo | Percentages of Participants With Systemic Reactions By Severity Within 14 Days of Any Vaccination | Any Systemic Reaction | 82.5 Percentage of participants |
| Saline Placebo | Percentages of Participants With Systemic Reactions By Severity Within 14 Days of Any Vaccination | Severe Headache | 1.6 Percentage of participants |
Secondary
Enzyme-Linked Immunosorbent Assay (ELISA) Measured Anti-IgE Geometric Mean Titers (GMTs) at Baseline, Day 182, and Day 336
Ability of vaccine induced serum anti-immunoglobulin E (IgE) antibodies to interfere with IgE binding to recombinant alpha chain of the high affinity IgE receptor was assessed in an ELISA based assay. GMTs were calculated both as crude means (unadjusted) and by an analysis of covariance (ANCOVA) model with natural log transformed antibody titer as outcome variable, and treatment group as factor and baseline (in log scale) as covariates at each of the post dose measurement.
Time frame: Baseline (Day 1), Day 182 (2 weeks after last vaccination), and end of study (Day 336)
Population: All randomized participants who received at least 1 dose of randomized treatment, n=number of evaluable participants at the specified time point.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| IGE-1 6 mcg | Enzyme-Linked Immunosorbent Assay (ELISA) Measured Anti-IgE Geometric Mean Titers (GMTs) at Baseline, Day 182, and Day 336 | Day 1 (n=6,21,20,20,20,20,20,62) | 2002.8 units/milliliter (u/mL) |
| IGE-1 6 mcg | Enzyme-Linked Immunosorbent Assay (ELISA) Measured Anti-IgE Geometric Mean Titers (GMTs) at Baseline, Day 182, and Day 336 | Day 336 (n=5,18,16,17,18,16,6,52) | 1896.7 units/milliliter (u/mL) |
| IGE-1 6 mcg | Enzyme-Linked Immunosorbent Assay (ELISA) Measured Anti-IgE Geometric Mean Titers (GMTs) at Baseline, Day 182, and Day 336 | Day 182 (n=5,18,16,19,19,18,19,57) | 11310.6 units/milliliter (u/mL) |
| IGE-1 20 mcg | Enzyme-Linked Immunosorbent Assay (ELISA) Measured Anti-IgE Geometric Mean Titers (GMTs) at Baseline, Day 182, and Day 336 | Day 336 (n=5,18,16,17,18,16,6,52) | 17836.4 units/milliliter (u/mL) |
| IGE-1 20 mcg | Enzyme-Linked Immunosorbent Assay (ELISA) Measured Anti-IgE Geometric Mean Titers (GMTs) at Baseline, Day 182, and Day 336 | Day 182 (n=5,18,16,19,19,18,19,57) | 44480.1 units/milliliter (u/mL) |
| IGE-1 20 mcg | Enzyme-Linked Immunosorbent Assay (ELISA) Measured Anti-IgE Geometric Mean Titers (GMTs) at Baseline, Day 182, and Day 336 | Day 1 (n=6,21,20,20,20,20,20,62) | 2002.8 units/milliliter (u/mL) |
| IGE-1 60 mcg | Enzyme-Linked Immunosorbent Assay (ELISA) Measured Anti-IgE Geometric Mean Titers (GMTs) at Baseline, Day 182, and Day 336 | Day 336 (n=5,18,16,17,18,16,6,52) | 22611.2 units/milliliter (u/mL) |
| IGE-1 60 mcg | Enzyme-Linked Immunosorbent Assay (ELISA) Measured Anti-IgE Geometric Mean Titers (GMTs) at Baseline, Day 182, and Day 336 | Day 1 (n=6,21,20,20,20,20,20,62) | 2002.8 units/milliliter (u/mL) |
| IGE-1 60 mcg | Enzyme-Linked Immunosorbent Assay (ELISA) Measured Anti-IgE Geometric Mean Titers (GMTs) at Baseline, Day 182, and Day 336 | Day 182 (n=5,18,16,19,19,18,19,57) | 72925.4 units/milliliter (u/mL) |
| IGE-1 200 mcg | Enzyme-Linked Immunosorbent Assay (ELISA) Measured Anti-IgE Geometric Mean Titers (GMTs) at Baseline, Day 182, and Day 336 | Day 1 (n=6,21,20,20,20,20,20,62) | 2002.8 units/milliliter (u/mL) |
| IGE-1 200 mcg | Enzyme-Linked Immunosorbent Assay (ELISA) Measured Anti-IgE Geometric Mean Titers (GMTs) at Baseline, Day 182, and Day 336 | Day 182 (n=5,18,16,19,19,18,19,57) | 126981.7 units/milliliter (u/mL) |
| IGE-1 200 mcg | Enzyme-Linked Immunosorbent Assay (ELISA) Measured Anti-IgE Geometric Mean Titers (GMTs) at Baseline, Day 182, and Day 336 | Day 336 (n=5,18,16,17,18,16,6,52) | 42772.1 units/milliliter (u/mL) |
| IGE-2 20 mcg | Enzyme-Linked Immunosorbent Assay (ELISA) Measured Anti-IgE Geometric Mean Titers (GMTs) at Baseline, Day 182, and Day 336 | Day 182 (n=5,18,16,19,19,18,19,57) | 35833.4 units/milliliter (u/mL) |
| IGE-2 20 mcg | Enzyme-Linked Immunosorbent Assay (ELISA) Measured Anti-IgE Geometric Mean Titers (GMTs) at Baseline, Day 182, and Day 336 | Day 1 (n=6,21,20,20,20,20,20,62) | 2002.8 units/milliliter (u/mL) |
| IGE-2 20 mcg | Enzyme-Linked Immunosorbent Assay (ELISA) Measured Anti-IgE Geometric Mean Titers (GMTs) at Baseline, Day 182, and Day 336 | Day 336 (n=5,18,16,17,18,16,6,52) | 9642.9 units/milliliter (u/mL) |
| IGE-2 60 mcg | Enzyme-Linked Immunosorbent Assay (ELISA) Measured Anti-IgE Geometric Mean Titers (GMTs) at Baseline, Day 182, and Day 336 | Day 182 (n=5,18,16,19,19,18,19,57) | 41947.5 units/milliliter (u/mL) |
| IGE-2 60 mcg | Enzyme-Linked Immunosorbent Assay (ELISA) Measured Anti-IgE Geometric Mean Titers (GMTs) at Baseline, Day 182, and Day 336 | Day 1 (n=6,21,20,20,20,20,20,62) | 2002.8 units/milliliter (u/mL) |
| IGE-2 60 mcg | Enzyme-Linked Immunosorbent Assay (ELISA) Measured Anti-IgE Geometric Mean Titers (GMTs) at Baseline, Day 182, and Day 336 | Day 336 (n=5,18,16,17,18,16,6,52) | 12490.1 units/milliliter (u/mL) |
| IGE-2 200 mcg | Enzyme-Linked Immunosorbent Assay (ELISA) Measured Anti-IgE Geometric Mean Titers (GMTs) at Baseline, Day 182, and Day 336 | Day 182 (n=5,18,16,19,19,18,19,57) | 106036.8 units/milliliter (u/mL) |
| IGE-2 200 mcg | Enzyme-Linked Immunosorbent Assay (ELISA) Measured Anti-IgE Geometric Mean Titers (GMTs) at Baseline, Day 182, and Day 336 | Day 1 (n=6,21,20,20,20,20,20,62) | 2002.8 units/milliliter (u/mL) |
| IGE-2 200 mcg | Enzyme-Linked Immunosorbent Assay (ELISA) Measured Anti-IgE Geometric Mean Titers (GMTs) at Baseline, Day 182, and Day 336 | Day 336 (n=5,18,16,17,18,16,6,52) | 43979.2 units/milliliter (u/mL) |
| Saline Placebo | Enzyme-Linked Immunosorbent Assay (ELISA) Measured Anti-IgE Geometric Mean Titers (GMTs) at Baseline, Day 182, and Day 336 | Day 1 (n=6,21,20,20,20,20,20,62) | 2002.8 units/milliliter (u/mL) |
| Saline Placebo | Enzyme-Linked Immunosorbent Assay (ELISA) Measured Anti-IgE Geometric Mean Titers (GMTs) at Baseline, Day 182, and Day 336 | Day 182 (n=5,18,16,19,19,18,19,57) | 2147.9 units/milliliter (u/mL) |
| Saline Placebo | Enzyme-Linked Immunosorbent Assay (ELISA) Measured Anti-IgE Geometric Mean Titers (GMTs) at Baseline, Day 182, and Day 336 | Day 336 (n=5,18,16,17,18,16,6,52) | 2265.3 units/milliliter (u/mL) |