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| ID | Type | Description | Link |
|---|---|---|---|
| ANTI- IGE VACCINE | Other Identifier | Alias Study Number |
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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| PF-06444753 | Experimental |
| |
| PF-06444752 | Experimental |
| |
| Placebo | Placebo Comparator | Intramuscular |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| IGE-1 | Biological | Intramuscular, multiple dose |
| |
| IGE-2 |
| Measure | Description | Time Frame |
|---|---|---|
| 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). | Within 14 days |
| 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). | Within 14 days |
| 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. |
| Measure | Description | Time Frame |
|---|---|---|
| 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. |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Pfizer CT.gov Call Center | Pfizer | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Ottawa Allergy Research Corporation | Ottawa | Ontario | K1Y 4G2 | Canada | ||
| Diex Research Montreal Inc. |
Not provided
| Label | URL |
|---|---|
| To obtain contact information for a study center near you, click here. | View source |
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| ID | Title | Description |
|---|---|---|
| FG000 | 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. |
| FG001 | 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. |
| FG002 | 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. |
| FG003 | 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. |
| FG004 | 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. |
| FG005 | 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. |
| FG006 | 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. |
| FG007 | 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. |
| Title | Milestones | Reasons Not Completed | ||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
|
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| ID | Title | Description |
|---|---|---|
| BG000 | 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. |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 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). | All randomized participants who received at least one dose of study treatment. | Posted | Number | 80% Confidence Interval | Percentage of participants | Within 14 days |
|
Baseline up to 336 days post study administration or at Early Termination
All treated participants were analyzed for AEs. The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and a nonserious event during the study.
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | 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. |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Appendicitis | Infections and infestations | 18.1 | Non-systematic Assessment |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Thrombocytopenia | Blood and lymphatic system disorders | 18.1 | Non-systematic Assessment |
Not provided
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Pfizer ClinicalTrials.gov Call Center | Pfizer, Inc | 18007181021 | ClinicalTrials.gov_Inquiries@pfizer.com |
Not provided
| ID | Term |
|---|---|
| D065631 | Rhinitis, Allergic |
| ID | Term |
|---|---|
| D012220 | Rhinitis |
| D009668 | Nose Diseases |
| D012140 | Respiratory Tract Diseases |
| D012130 | Respiratory Hypersensitivity |
Not provided
Not provided
| ID | Term |
|---|---|
| D012965 | Sodium Chloride |
| ID | Term |
|---|---|
| D002712 | Chlorides |
| D006851 | Hydrochloric Acid |
| D017606 | Chlorine Compounds |
| D007287 | Inorganic Chemicals |
Not provided
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| Biological |
Intramuscular, multiple dose |
|
| Saline | Biological | Saline (0.9% sodium chloride) |
|
| Baseline up to 336 days post study administration or at Early Termination |
| 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. | Baseline up to 336 days post last study drug administration or Early Termination |
| Baseline (Day 1), Day 182 (2 weeks after last vaccination), and end of study (Day 336) |
| Montreal |
| Quebec |
| H4N 3C5 |
| Canada |
| Centre de Recherche Appliquee en Allergie de Quebec | Québec | Quebec | G1V 4M6 | Canada |
| Diex Research Sherbrooke Inc. | Sherbrooke | Quebec | J1H 1Z1 | Canada |
| Personal issues |
|
| No longer have time to participate |
|
| Move/Left to another country/city |
|
| Protocol Violation |
|
| Withdrawal by Subject |
|
| BG001 | 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. |
| BG002 | 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. |
| BG003 | 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. |
| BG004 | 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. |
| BG005 | 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. |
| BG006 | 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. |
| BG007 | 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. |
| BG008 | Total | Total of all reporting groups |
| years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
Participants received study vaccine IGE-1 (PF-06444753) 6 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 TLR9 agonist) in combination as adjuvants. |
| OG001 | IGE-1 20 mcg | Participants received study vaccine IGE-1 (PF-06444753) 20 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 TLR9 agonist) in combination as adjuvants. |
| OG002 | IGE-1 60 mcg | Participants received study vaccine IGE-1 (PF-06444753) 60 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 TLR9 agonist) in combination as adjuvants. |
| OG003 | IGE-1 200 mcg | Participants received study vaccine IGE-1 (PF-06444753) 200 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 TLR9 agonist) in combination as adjuvants. |
| OG004 | IGE-2 20 mcg | Participants received study vaccine IGE-2 (PF-06444752) 20 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 TLR9 agonist) in combination as adjuvants. |
| OG005 | IGE-2 60 mcg | Participants received study vaccine IGE-2 (PF-06444752) 60 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 TLR9 agonist) in combination as adjuvants. |
| OG006 | IGE-2 200 mcg | Participants received study vaccine IGE-2 (PF-06444752) 200 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 TLR9 agonist) in combination as adjuvants. |
| OG007 | 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. |
|
|
| 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). | All randomized participants who received at least one dose of study treatment. | Posted | Number | 80% Confidence Interval | Percentage of participants | Within 14 days |
|
|
|
| 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. | All randomized participants who received at least one dose of study treatment. | Posted | Number | participants | Baseline up to 336 days post study administration or at Early Termination |
|
|
|
| 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. | All randomized participants who received at least one dose of study treatment. | Posted | Number | participants | Baseline up to 336 days post last study drug administration or Early Termination |
|
|
|
| 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. | All randomized participants who received at least 1 dose of randomized treatment, n=number of evaluable participants at the specified time point. | Posted | Number | 80% Confidence Interval | units/milliliter (u/mL) | Baseline (Day 1), Day 182 (2 weeks after last vaccination), and end of study (Day 336) |
|
|
|
| 0 |
| 6 |
| 5 |
| 6 |
| EG001 | 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. | 0 | 21 | 17 | 21 |
| EG002 | 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. | 0 | 20 | 20 | 20 |
| EG003 | 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. | 0 | 20 | 20 | 20 |
| EG004 | 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. | 0 | 20 | 19 | 20 |
| EG005 | 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. | 1 | 20 | 19 | 20 |
| EG006 | 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. | 0 | 20 | 17 | 20 |
| EG007 | 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. | 1 | 63 | 54 | 63 |
| Peritonsillar abscess | Infections and infestations | 18.1 | Non-systematic Assessment |
|
| Palpitations | Cardiac disorders | 18.1 | Non-systematic Assessment |
|
| Ear pain | Ear and labyrinth disorders | 18.1 | Non-systematic Assessment |
|
| Tinnitus | Ear and labyrinth disorders | 18.1 | Non-systematic Assessment |
|
| Conjunctivitis allergic | Eye disorders | 18.1 | Non-systematic Assessment |
|
| Dry eye | Eye disorders | 18.1 | Non-systematic Assessment |
|
| Eye pain | Eye disorders | 18.1 | Non-systematic Assessment |
|
| Eyelid oedema | Eye disorders | 18.1 | Non-systematic Assessment |
|
| Ocular hyperaemia | Eye disorders | 18.1 | Non-systematic Assessment |
|
| Abdominal pain | Gastrointestinal disorders | 18.1 | Non-systematic Assessment |
|
| Abdominal pain upper | Gastrointestinal disorders | 18.1 | Non-systematic Assessment |
|
| Constipation | Gastrointestinal disorders | 18.1 | Non-systematic Assessment |
|
| Diarrhoea | Gastrointestinal disorders | 18.1 | Non-systematic Assessment |
|
| Dry mouth | Gastrointestinal disorders | 18.1 | Non-systematic Assessment |
|
| Dysphagia | Gastrointestinal disorders | 18.1 | Non-systematic Assessment |
|
| Food poisoning | Gastrointestinal disorders | 18.1 | Non-systematic Assessment |
|
| Gastrooesophageal reflux disease | Gastrointestinal disorders | 18.1 | Non-systematic Assessment |
|
| Gingival pain | Gastrointestinal disorders | 18.1 | Non-systematic Assessment |
|
| Haematochezia | Gastrointestinal disorders | 18.1 | Non-systematic Assessment |
|
| Inguinal hernia | Gastrointestinal disorders | 18.1 | Non-systematic Assessment |
|
| Intestinal polyp | Gastrointestinal disorders | 18.1 | Non-systematic Assessment |
|
| Nausea | Gastrointestinal disorders | 18.1 | Non-systematic Assessment |
|
| Toothache | Gastrointestinal disorders | 18.1 | Non-systematic Assessment |
|
| Vomiting | Gastrointestinal disorders | 18.1 | Non-systematic Assessment |
|
| Chills | General disorders | 18.1 | Non-systematic Assessment |
|
| Facial pain | General disorders | 18.1 | Non-systematic Assessment |
|
| Fatigue | General disorders | 18.1 | Non-systematic Assessment |
|
| Injection site haemorrhage | General disorders | 18.1 | Non-systematic Assessment |
|
| Local swelling | General disorders | 18.1 | Non-systematic Assessment |
|
| Oedema peripheral | General disorders | 18.1 | Non-systematic Assessment |
|
| Pyrexia | General disorders | 18.1 | Non-systematic Assessment |
|
| Hypersensitivity | Immune system disorders | 18.1 | Non-systematic Assessment |
|
| Bacterial infection | Infections and infestations | 18.1 | Non-systematic Assessment |
|
| Blister infected | Infections and infestations | 18.1 | Non-systematic Assessment |
|
| Bronchitis | Infections and infestations | 18.1 | Non-systematic Assessment |
|
| Cellulitis | Infections and infestations | 18.1 | Non-systematic Assessment |
|
| Conjunctivitis | Infections and infestations | 18.1 | Non-systematic Assessment |
|
| Ear infection | Infections and infestations | 18.1 | Non-systematic Assessment |
|
| Fungal skin infection | Infections and infestations | 18.1 | Non-systematic Assessment |
|
| Gastric infection | Infections and infestations | 18.1 | Non-systematic Assessment |
|
| Gastroenteritis | Infections and infestations | 18.1 | Non-systematic Assessment |
|
| Gastrointestinal viral infection | Infections and infestations | 18.1 | Non-systematic Assessment |
|
| Influenza | Infections and infestations | 18.1 | Non-systematic Assessment |
|
| Laryngitis | Infections and infestations | 18.1 | Non-systematic Assessment |
|
| Localised infection | Infections and infestations | 18.1 | Non-systematic Assessment |
|
| Lyme disease | Infections and infestations | 18.1 | Non-systematic Assessment |
|
| Malaria | Infections and infestations | 18.1 | Non-systematic Assessment |
|
| Nasopharyngitis | Infections and infestations | 18.1 | Non-systematic Assessment |
|
| Oral candidiasis | Infections and infestations | 18.1 | Non-systematic Assessment |
|
| Oral herpes | Infections and infestations | 18.1 | Non-systematic Assessment |
|
| Oropharyngeal candidiasis | Infections and infestations | 18.1 | Non-systematic Assessment |
|
| Pharyngitis | Infections and infestations | 18.1 | Non-systematic Assessment |
|
| Pneumonia | Infections and infestations | 18.1 | Non-systematic Assessment |
|
| Sinusitis | Infections and infestations | 18.1 | Non-systematic Assessment |
|
| Streptococcal infection | Infections and infestations | 18.1 | Non-systematic Assessment |
|
| Tinea pedis | Infections and infestations | 18.1 | Non-systematic Assessment |
|
| Tinea versicolour | Infections and infestations | 18.1 | Non-systematic Assessment |
|
| Tooth abscess | Infections and infestations | 18.1 | Non-systematic Assessment |
|
| Tooth infection | Infections and infestations | 18.1 | Non-systematic Assessment |
|
| Upper respiratory tract infection | Infections and infestations | 18.1 | Non-systematic Assessment |
|
| Vaginal infection | Infections and infestations | 18.1 | Non-systematic Assessment | Gender-specific event. |
|
| Vulvovaginitis | Infections and infestations | 18.1 | Non-systematic Assessment | Gender-specific event. |
|
| Contusion | Injury, poisoning and procedural complications | 18.1 | Non-systematic Assessment |
|
| Facial bones fracture | Injury, poisoning and procedural complications | 18.1 | Non-systematic Assessment |
|
| Fall | Injury, poisoning and procedural complications | 18.1 | Non-systematic Assessment |
|
| Intervertebral disc injury | Injury, poisoning and procedural complications | 18.1 | Non-systematic Assessment |
|
| Laceration | Injury, poisoning and procedural complications | 18.1 | Non-systematic Assessment |
|
| Ligament sprain | Injury, poisoning and procedural complications | 18.1 | Non-systematic Assessment |
|
| Limb injury | Injury, poisoning and procedural complications | 18.1 | Non-systematic Assessment |
|
| Meniscus injury | Injury, poisoning and procedural complications | 18.1 | Non-systematic Assessment |
|
| Muscle strain | Injury, poisoning and procedural complications | 18.1 | Non-systematic Assessment |
|
| Post procedural oedema | Injury, poisoning and procedural complications | 18.1 | Non-systematic Assessment |
|
| Procedural pain | Injury, poisoning and procedural complications | 18.1 | Non-systematic Assessment |
|
| Road traffic accident | Injury, poisoning and procedural complications | 18.1 | Non-systematic Assessment |
|
| Thermal burn | Injury, poisoning and procedural complications | 18.1 | Non-systematic Assessment |
|
| Alanine aminotransferase increased | Investigations | 18.1 | Non-systematic Assessment |
|
| Aspartate aminotransferase increased | Investigations | 18.1 | Non-systematic Assessment |
|
| Blood creatinine increased | Investigations | 18.1 | Non-systematic Assessment |
|
| Blood lactate dehydrogenase increased | Investigations | 18.1 | Non-systematic Assessment |
|
| Blood pressure increased | Investigations | 18.1 | Non-systematic Assessment |
|
| Lymphocyte count decreased | Investigations | 18.1 | Non-systematic Assessment |
|
| Platelet count decreased | Investigations | 18.1 | Non-systematic Assessment |
|
| Weight decreased | Investigations | 18.1 | Non-systematic Assessment |
|
| Weight increased | Investigations | 18.1 | Non-systematic Assessment |
|
| Decreased appetite | Metabolism and nutrition disorders | 18.1 | Non-systematic Assessment |
|
| Food intolerance | Metabolism and nutrition disorders | 18.1 | Non-systematic Assessment |
|
| Increased appetite | Metabolism and nutrition disorders | 18.1 | Non-systematic Assessment |
|
| Arthralgia | Musculoskeletal and connective tissue disorders | 18.1 | Non-systematic Assessment |
|
| Back pain | Musculoskeletal and connective tissue disorders | 18.1 | Non-systematic Assessment |
|
| Bursitis | Musculoskeletal and connective tissue disorders | 18.1 | Non-systematic Assessment |
|
| Chondrolysis | Musculoskeletal and connective tissue disorders | 18.1 | Non-systematic Assessment |
|
| Groin pain | Musculoskeletal and connective tissue disorders | 18.1 | Non-systematic Assessment |
|
| Joint swelling | Musculoskeletal and connective tissue disorders | 18.1 | Non-systematic Assessment |
|
| Muscle mass | Musculoskeletal and connective tissue disorders | 18.1 | Non-systematic Assessment |
|
| Muscle spasms | Musculoskeletal and connective tissue disorders | 18.1 | Non-systematic Assessment |
|
| Musculoskeletal pain | Musculoskeletal and connective tissue disorders | 18.1 | Non-systematic Assessment |
|
| Myalgia | Musculoskeletal and connective tissue disorders | 18.1 | Non-systematic Assessment |
|
| Neck pain | Musculoskeletal and connective tissue disorders | 18.1 | Non-systematic Assessment |
|
| Pain in extremity | Musculoskeletal and connective tissue disorders | 18.1 | Non-systematic Assessment |
|
| Plantar fasciitis | Musculoskeletal and connective tissue disorders | 18.1 | Non-systematic Assessment |
|
| Tendonitis | Musculoskeletal and connective tissue disorders | 18.1 | Non-systematic Assessment |
|
| Burning sensation | Nervous system disorders | 18.1 | Non-systematic Assessment |
|
| Dizziness | Nervous system disorders | 18.1 | Non-systematic Assessment |
|
| Headache | Nervous system disorders | 18.1 | Non-systematic Assessment |
|
| Hypoaesthesia | Nervous system disorders | 18.1 | Non-systematic Assessment |
|
| Migraine | Nervous system disorders | 18.1 | Non-systematic Assessment |
|
| Muscle contractions involuntary | Nervous system disorders | 18.1 | Non-systematic Assessment |
|
| Syncope | Nervous system disorders | 18.1 | Non-systematic Assessment |
|
| Anxiety | Psychiatric disorders | 18.1 | Non-systematic Assessment |
|
| Bruxism | Psychiatric disorders | 18.1 | Non-systematic Assessment |
|
| Depressed mood | Psychiatric disorders | 18.1 | Non-systematic Assessment |
|
| Insomnia | Psychiatric disorders | 18.1 | Non-systematic Assessment |
|
| Stress | Psychiatric disorders | 18.1 | Non-systematic Assessment |
|
| Dysuria | Renal and urinary disorders | 18.1 | Non-systematic Assessment |
|
| Haematuria | Renal and urinary disorders | 18.1 | Non-systematic Assessment |
|
| Proteinuria | Renal and urinary disorders | 18.1 | Non-systematic Assessment |
|
| Urethral discharge | Renal and urinary disorders | 18.1 | Non-systematic Assessment |
|
| Penile blister | Reproductive system and breast disorders | 18.1 | Non-systematic Assessment | Gender-specific disorder |
|
| Postmenopausal haemorrhage | Reproductive system and breast disorders | 18.1 | Non-systematic Assessment | Gender-specific disorder |
|
| Bronchial hyperreactivity | Respiratory, thoracic and mediastinal disorders | 18.1 | Non-systematic Assessment |
|
| Cough | Respiratory, thoracic and mediastinal disorders | 18.1 | Non-systematic Assessment |
|
| Epistaxis | Respiratory, thoracic and mediastinal disorders | 18.1 | Non-systematic Assessment |
|
| Nasal congestion | Respiratory, thoracic and mediastinal disorders | 18.1 | Non-systematic Assessment |
|
| Nasal dryness | Respiratory, thoracic and mediastinal disorders | 18.1 | Non-systematic Assessment |
|
| Nasal polyps | Respiratory, thoracic and mediastinal disorders | 18.1 | Non-systematic Assessment |
|
| Nasal septum deviation | Respiratory, thoracic and mediastinal disorders | 18.1 | Non-systematic Assessment |
|
| Oropharyngeal pain | Respiratory, thoracic and mediastinal disorders | 18.1 | Non-systematic Assessment |
|
| Productive cough | Respiratory, thoracic and mediastinal disorders | 18.1 | Non-systematic Assessment |
|
| Wheezing | Respiratory, thoracic and mediastinal disorders | 18.1 | Non-systematic Assessment |
|
| Dermatitis contact | Skin and subcutaneous tissue disorders | 18.1 | Non-systematic Assessment |
|
| Dry skin | Skin and subcutaneous tissue disorders | 18.1 | Non-systematic Assessment |
|
| Ecchymosis | Skin and subcutaneous tissue disorders | 18.1 | Non-systematic Assessment |
|
| Eczema | Skin and subcutaneous tissue disorders | 18.1 | Non-systematic Assessment |
|
| Erythema | Skin and subcutaneous tissue disorders | 18.1 | Non-systematic Assessment |
|
| Pruritus | Skin and subcutaneous tissue disorders | 18.1 | Non-systematic Assessment |
|
| Rash | Skin and subcutaneous tissue disorders | 18.1 | Non-systematic Assessment |
|
| Rash papular | Skin and subcutaneous tissue disorders | 18.1 | Non-systematic Assessment |
|
| Skin lesion | Skin and subcutaneous tissue disorders | 18.1 | Non-systematic Assessment |
|
| Haematoma | Vascular disorders | 18.1 | Non-systematic Assessment |
|
Pfizer has the right to review disclosures, requesting a delay of less than 60 days. Investigator will postpone single center publications until after disclosure of pooled data (all sites), less than 12 months from study completion/termination at all participating sites. Investigator may not disclose previously undisclosed confidential information other than study results.
| D010038 |
| Otorhinolaryngologic Diseases |
| D006969 | Hypersensitivity, Immediate |
| D006967 | Hypersensitivity |
| D007154 | Immune System Diseases |
| D017670 |
| Sodium Compounds |
| Mild Fever |
|
| Moderate Fever |
|
| Severe Fever |
|
| Any Vomiting |
|
| Mild Vomiting |
|
| Moderate Vomiting |
|
| Severe Vomiting |
|
| Any Diarrhea |
|
| Mild Diarrhea |
|
| Moderate Diarrhea |
|
| Severe Diarrhea |
|
| Any Headache |
|
| Mild Headache |
|
| Moderate Headache |
|
| Severe Headache |
|
| Any Fatigue |
|
| Mild Fatigue |
|
| Moderate Fatigue |
|
| Severe Fatigue |
|
| Any Muscle Pain |
|
| Mild Muscle Pain |
|
| Moderate Muscle Pain |
|
| Severe Muscle Pain |
|
| Any Joint Pain |
|
| Mild Joint Pain |
|
| Moderate Joint Pain |
|
| Severe Joint Pain |
|
| Any Systemic Reaction |
|
| Any Severe Systemic Reaction |
|
| Participants with SAEs |
|
| Participants with severe TEAEs |
|
| Permanent discontinuations due to TEAEs |
|
| Temporary discontinuations due to TEAEs |
|
| Participants with treatment-related TEAEs |
|
| Day 182 (n=5,18,16,19,19,18,19,57) |
|
| Day 336 (n=5,18,16,17,18,16,6,52) |
|