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CompletedNCT01723254Updated Jul 11, 2016Results posted

A Study To Assess The Safety And Tolerability Of Different Doses Of PF-06444753 And PF-06444752 In Subjects With Allergic Rhinitis

A Phase 1 interventional study of IGE-1 and IGE-2 in Allergic Rhinitis, sponsored by Pfizer. Completed at 4 sites in Canada. Open to participants aged 18 Years to 55 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2016-07-11.

Sponsored by Pfizer · Phase 1, Interventional, and Treatment

Phase
Phase 1
Study type
Interventional
Enrollment
190
Allocation
Randomized
Ages
18 Years to 55 Years
Sex
All
01

Study 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.

02

Conditions studied

  • Allergic Rhinitis

Keywords

  • Vaccines
  • Phase 1
  • Allergic Rhinitis
03

In context

Rhinitis

1,105 studies on the registry are indexed under Rhinitis; 65 are open to participants now.

This study's enrollment of 190 is above the median of 89 across 906 interventional studies indexed under Rhinitis.

Browse Rhinitis studies →

Lead sponsor

Pfizer is the lead sponsor of 3,244 studies on the registry; 139 are open to participants now.

Of its 582 completed or terminated interventional studies of FDA-regulated products, 381 (65%) have results posted.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years to 55 Years
Sexes eligible
All
Accepts 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

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).
05

Study design

Phase
Phase 1
Primary purpose
Treatment
Allocation
Randomized
Masking
Quadruple (Participant, Care provider, Investigator, Outcomes assessor)
Enrollment
190 participants (actual)

Study arms

  • Experimental
    PF-06444753

    Biological: IGE-1

  • Experimental
    PF-06444752

    Biological: IGE-2

  • Placebo comparator
    Placebo

    Intramuscular

    Biological: Saline

Interventions

  • BiologicalIGE-1

    Intramuscular, multiple dose

  • BiologicalIGE-2

    Intramuscular, multiple dose

  • BiologicalSaline

    Saline (0.9% sodium chloride)

06

What researchers measure

Primary outcomes

  1. 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

  2. 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

  3. 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

  4. 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

Secondary outcomes

  1. 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)

07

Results

Posted Jul 11, 2016

Participant flow

Participant flow — Overall Study
MilestoneIGE-1 6 mcgIGE-1 20 mcgIGE-1 60 mcgIGE-1 200 mcgIGE-2 20 mcgIGE-2 60 mcgIGE-2 200 mcgSaline Placebo
Started621202020202063
Completed518171818181960
Not completed13322213
Withdrew: Conflict with work schedule00000001
Withdrew: Personal issues00000100
Withdrew: No longer have time to participate00010000
Withdrew: Move/left to another country/city00211000
Withdrew: Protocol violation01000000
Withdrew: Withdrawal by subject12101112

Outcome measures

PrimaryPercentages 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
Reported as:
Number · Percentage of participants
Percentages of Participants With Local Reactions By Severity Within 14 Days of Any Vaccination
Percentage of participantsIGE-1 6 mcgIGE-1 20 mcgIGE-1 60 mcgIGE-1 200 mcgIGE-2 20 mcgIGE-2 60 mcgIGE-2 200 mcgSaline Placebo
Any Redness50.0 (20.1 to 79.9)9.5 (2.6 to 23.4)30.0 (16.6 to 46.7)15.0 (5.6 to 30.4)20.0 (9.0 to 36.1)5.0 (0.5 to 18.1)10.0 (2.7 to 24.5)7.9 (3.9 to 14.2)
Mild Redness50.0 (20.1 to 79.9)9.5 (2.6 to 23.4)30.0 (16.6 to 46.7)15.0 (5.6 to 30.4)20.0 (9.0 to 36.1)5.0 (0.5 to 18.1)10.0 (2.7 to 24.5)7.9 (3.9 to 14.2)
Moderate and Severe Redness0.0 (0.0 to 0.0)0.0 (0.0 to 0.0)0.0 (0.0 to 0.0)0.0 (0.0 to 0.0)0.0 (0.0 to 0.0)0.0 (0.0 to 0.0)0.0 (0.0 to 0.0)0.0 (0.0 to 0.0)
Any Swelling16.7 (1.7 to 51.0)14.3 (5.4 to 29.1)20.0 (9.0 to 36.1)30.0 (16.6 to 46.7)15.0 (5.6 to 30.4)5.0 (0.5 to 18.1)5.0 (0.5 to 18.1)9.5 (5.1 to 16.1)
Mild Swelling16.7 (1.7 to 51.0)14.3 (5.4 to 29.1)15.0 (5.6 to 30.4)20.0 (9.0 to 36.1)10.0 (2.7 to 24.5)5.0 (0.5 to 18.1)5.0 (0.5 to 18.1)9.5 (5.1 to 16.1)
Moderate Swelling0.0 (0.0 to 31.9)0.0 (0.0 to 10.4)5.0 (0.5 to 18.1)10.0 (2.7 to 24.5)5.0 (0.5 to 18.1)0.0 (0.0 to 10.9)0.0 (0.0 to 10.9)0.0 (0.0 to 3.6)
Severe Swelling0.0 (0.0 to 31.9)0.0 (0.0 to 10.4)0.0 (0.0 to 10.9)0.0 (0.0 to 10.9)0.0 (0.0 to 10.9)0.0 (0.0 to 10.9)0.0 (0.0 to 10.9)0.0 (0.0 to 3.6)
Any Pain83.3 (49.0 to 98.3)100.0 (89.6 to 100.0)90.0 (75.5 to 97.3)100.0 (89.1 to 100.0)90.0 (75.5 to 97.3)85.0 (69.6 to 94.4)90.0 (75.5 to 97.3)15.9 (10.1 to 23.4)
Mild Pain50.0 (20.1 to 79.9)57.1 (41.0 to 72.2)50.0 (33.8 to 66.2)20.0 (9.0 to 36.1)80.0 (63.9 to 91.0)75.0 (58.5 to 87.3)60.0 (43.3 to 75.1)14.3 (8.8 to 21.6)
Moderate Pain33.3 (9.3 to 66.7)38.1 (23.6 to 54.4)40.0 (24.9 to 56.7)70.0 (53.3 to 83.4)10.0 (2.7 to 24.5)5.0 (0.5 to 18.1)30.0 (16.6 to 46.7)1.6 (0.2 to 6.0)
Severe Pain0.0 (0.0 to 31.9)4.8 (0.5 to 17.3)0.0 (0.0 to 10.9)10.0 (2.7 to 24.5)0.0 (0.0 to 10.9)5.0 (0.5 to 18.1)0.0 (0.0 to 10.9)0.0 (0.0 to 3.6)
Any Local Reaction83.3 (49.0 to 98.3)100.0 (89.6 to 100.0)90.0 (75.5 to 97.3)100.0 (89.1 to 100.0)95.0 (81.9 to 99.5)85.0 (69.6 to 94.4)90.0 (75.5 to 97.3)25.4 (18.3 to 33.8)
Any Severe Local Reaction0.0 (0.0 to 31.9)4.8 (0.5 to 17.3)0.0 (0.0 to 10.9)10.0 (2.7 to 24.5)0.0 (0.0 to 10.9)5.0 (0.5 to 18.1)0.0 (0.0 to 10.9)0.0 (0.0 to 3.6)
PrimaryPercentages 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
Reported as:
Number · Percentage of participants
Percentages of Participants With Systemic Reactions By Severity Within 14 Days of Any Vaccination
Percentage of participantsIGE-1 6 mcgIGE-1 20 mcgIGE-1 60 mcgIGE-1 200 mcgIGE-2 20 mcgIGE-2 60 mcgIGE-2 200 mcgSaline Placebo
Any Fever0 (0.0 to 31.9)0.0 (0.0 to 10.4)10.0 (2.7 to 24.5)20.0 (9.0 to 36.1)0.0 (0.0 to 10.9)5.0 (0.5 to 18.1)25.0 (12.7 to 41.5)1.6 (0.2 to 6.0)
Mild Fever0.0 (0.0 to 31.9)0.0 (0.0 to 10.4)10.0 (2.7 to 24.5)15.0 (5.6 to 30.4)0.0 (0.0 to 10.9)0.0 (0.0 to 10.9)10.0 (2.7 to 24.5)1.6 (0.2 to 6.0)
Moderate Fever0.0 (0.0 to 31.9)0.0 (0.0 to 10.4)0.0 (0.0 to 10.9)5.0 (0.5 to 18.1)0.0 (0.0 to 10.9)5.0 (0.5 to 18.1)10.0 (2.7 to 24.5)0.0 (0.0 to 3.6)
Severe Fever0.0 (0.0 to 31.9)0.0 (0.0 to 10.4)0.0 (0.0 to 10.9)0.0 (0.0 to 10.9)0.0 (0.0 to 10.9)0.0 (0.0 to 10.9)5.0 (0.5 to 18.1)0.0 (0.0 to 3.6)
Any Vomiting0.0 (0.0 to 31.9)0.0 (0.0 to 10.4)0.0 (0.0 to 10.9)10.0 (2.7 to 24.5)10.0 (2.7 to 24.5)15.0 (5.6 to 30.4)0.0 (0.0 to 10.9)4.8 (1.8 to 10.3)
Mild Vomiting0.0 (0.0 to 31.9)0.0 (0.0 to 10.4)0.0 (0.0 to 10.9)10.0 (2.7 to 24.5)5.0 (0.5 to 18.1)15.0 (5.6 to 30.4)0.0 (0.0 to 10.9)4.8 (1.8 to 10.3)
Moderate Vomiting0.0 (0.0 to 31.9)0.0 (0.0 to 10.4)0.0 (0.0 to 10.9)0.0 (0.0 to 10.9)5.0 (0.5 to 18.1)0.0 (0.0 to 10.9)0.0 (0.0 to 10.9)0.0 (0.0 to 3.6)
Severe Vomiting0.0 (0.0 to 31.9)0.0 (0.0 to 10.4)0.0 (0.0 to 10.9)0.0 (0.0 to 10.9)0.0 (0.0 to 10.9)0.0 (0.0 to 10.9)0.0 (0.0 to 10.9)0.0 (0.0 to 3.6)
Any Diarrhea0.0 (0.0 to 31.9)47.6 (32.1 to 63.6)35.0 (20.7 to 51.8)55.0 (38.5 to 70.7)45.0 (29.3 to 61.5)30.0 (16.6 to 46.7)40.0 (24.9 to 56.7)42.9 (34.4 to 51.7)
Mild Diarrhea0.0 (0.0 to 31.9)28.6 (15.8 to 44.8)25.0 (12.7 to 41.5)50.0 (33.8 to 66.2)30.0 (16.6 to 46.7)20.0 (9.0 to 36.1)30.0 (16.6 to 46.7)28.6 (21.1 to 37.1)
Moderate Diarrhea0.0 (0.0 to 31.9)19.0 (8.6 to 34.5)10.0 (2.7 to 24.5)5.0 (0.5 to 18.1)10.0 (2.7 to 24.5)10.0 (2.7 to 24.5)10.0 (2.7 to 24.5)14.3 (8.8 to 21.6)
Severe Diarrhea0.0 (0.0 to 31.9)0.0 (0.0 to 10.4)0.0 (0.0 to 10.9)0.0 (0.0 to 10.9)5.0 (0.5 to 18.1)0.0 (0.0 to 10.9)0.0 (0.0 to 10.9)0.0 (0.0 to 3.6)
Any Headache16.7 (1.7 to 51.0)81.0 (65.5 to 91.4)55.0 (38.5 to 70.7)70.0 (53.3 to 83.4)75.0 (58.5 to 87.3)60.0 (43.3 to 75.1)55.0 (38.5 to 70.7)65.1 (56.3 to 73.1)
Mild Headache0.0 (0.0 to 31.9)47.6 (32.1 to 63.6)25.0 (12.7 to 41.5)40.0 (24.9 to 56.7)50.0 (33.8 to 66.2)30.0 (16.6 to 46.7)25.0 (12.7 to 41.5)39.7 (31.3 to 48.5)
Moderate Headache16.7 (1.7 to 51.0)33.3 (19.6 to 49.7)30.0 (16.6 to 46.7)30.0 (16.6 to 46.7)25.0 (12.7 to 41.5)30.0 (16.6 to 46.7)30.0 (16.6 to 46.7)23.8 (16.9 to 32.1)
Severe Headache.0 (0.0 to 31.9)0.0 (0.0 to 10.4)0.0 (0.0 to 10.9)0.0 (0.0 to 10.9)0.0 (0.0 to 10.9)0.0 (0.0 to 10.9)0.0 (0.0 to 10.9)1.6 (0.2 to 6.0)
Any Fatigue50.0 (20.1 to 79.9)61.9 (45.6 to 76.4)85.0 (69.6 to 94.4)85.0 (69.6 to 94.4)70.0 (53.3 to 83.4)60.0 (43.3 to 75.1)65.0 (48.2 to 79.3)66.7 (57.9 to 74.6)
Mild Fatigue16.7 (1.7 to 51.0)19.0 (8.6 to 34.5)25.0 (12.7 to 41.5)35.0 (20.7 to 51.8)30.0 (16.6 to 46.7)35.0 (20.7 to 51.8)25.0 (12.7 to 41.5)23.8 (16.9 to 32.1)
Moderate Fatigue33.3 (9.3 to 66.7)42.9 (27.8 to 59.0)55.0 (38.5 to 70.7)45.0 (29.3 to 61.5)40.0 (24.9 to 56.7)25.0 (12.7 to 41.5)40.0 (24.9 to 56.7)42.9 (34.4 to 51.7)
Severe Fatigue0.0 (0.0 to 31.9)0.0 (0.0 to 10.4)5.0 (0.5 to 18.1)5.0 (0.5 to 18.1)0.0 (0.0 to 10.9)0.0 (0.0 to 10.9)0.0 (0.0 to 10.9)0.0 (0.0 to 3.6)
Any Muscle Pain66.7 (33.3 to 90.7)71.4 (55.2 to 84.2)75.0 (58.5 to 87.3)75.0 (58.5 to 87.3)70.0 (53.3 to 83.4)50.0 (33.8 to 66.2)60.0 (43.3 to 75.1)34.9 (26.9 to 43.7)
Mild Muscle Pain33.3 (9.3 to 66.7)52.4 (36.4 to 67.9)45.0 (29.3 to 61.5)40.0 (24.9 to 56.7)45.0 (29.3 to 61.5)30.0 (16.6 to 46.7)25.0 (12.7 to 41.5)15.9 (10.1 to 23.4)
Moderate Muscle Pain16.7 (1.7 to 51.0)19.0 (8.6 to 34.5)30.0 (16.6 to 46.7)35.0 (20.7 to 51.8)25.0 (12.7 to 41.5)20.0 (9.0 to 36.1)35.0 (20.7 to 51.8)19.0 (12.8 to 26.9)
Severe Muscle Pain16.7 (1.7 to 51.0)0.0 (0.0 to 10.4)0.0 (0.0 to 10.9)0.0 (0.0 to 10.9)0.0 (0.0 to 10.9)0.0 (0.0 to 10.9)0.0 (0.0 to 10.9)0.0 (0.0 to 3.6)
Any Joint Pain50.0 (20.1 to 79.9)33.3 (19.6 to 49.7)35.0 (20.7 to 51.8)35.0 (20.7 to 51.8)45.0 (29.3 to 61.5)35.0 (20.7 to 51.8)35.0 (20.7 to 51.8)20.6 (14.1 to 28.6)
Mild Joint Pain33.3 (9.3 to 66.7)28.6 (15.8 to 44.8)20.0 (9.0 to 36.1)20.0 (9.0 to 36.1)35.0 (20.7 to 51.8)30.0 (16.6 to 46.7)25.0 (12.7 to 41.5)12.7 (7.5 to 19.8)
Moderate Joint Pain16.7 (1.7 to 51.0)4.8 (0.5 to 17.3)15.0 (5.6 to 30.4)15.0 (5.6 to 30.4)10.0 (2.7 to 24.5)5.0 (0.5 to 18.1)10.0 (2.7 to 24.5)7.9 (3.9 to 14.2)
Severe Joint Pain0.0 (0.0 to 31.9)0.0 (0.0 to 10.4)0.0 (0.0 to 10.9)0.0 (0.0 to 10.9)0.0 (0.0 to 10.9)0.0 (0.0 to 10.9)0.0 (0.0 to 10.9)0.0 (0.0 to 3.6)
Any Systemic Reaction66.7 (33.3 to 90.7)100.0 (89.6 to 100.0)90.0 (75.5 to 97.3)100.0 (89.1 to 100.0)95.0 (81.9 to 99.5)85.0 (69.6 to 94.4)85.0 (69.6 to 94.4)82.5 (74.8 to 88.6)
Any Severe Systemic Reaction16.7 (1.7 to 51.0)0.0 (0.0 to 10.4)5.0 (0.5 to 18.1)5.0 (0.5 to 18.1)5.0 (0.5 to 18.1)0.0 (0.0 to 10.9)5.0 (0.5 to 18.1)1.6 (0.2 to 6.0)
PrimaryNumber 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
Reported as:
Number · participants
Number of Participants With Treatment-Emergent Adverse Events (TEAEs), Serious Adverse Events (SAEs), and Discontinuations From Treatment Due to TEAEs
participantsIGE-1 6 mcgIGE-1 20 mcgIGE-1 60 mcgIGE-1 200 mcgIGE-2 20 mcgIGE-2 60 mcgIGE-2 200 mcgSaline Placebo
Participants with TEAEs518202019191755
Participants with SAEs00000101
Participants with severe TEAEs00201204
Permanent discontinuations due to TEAEs00100002
Temporary discontinuations due to TEAEs10010014
Participants with treatment-related TEAEs02141003
PrimaryNumber 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
Reported as:
Number · participants
Number of Participants With Laboratory Test Abnormalities
participantsIGE-1 6 mcgIGE-1 20 mcgIGE-1 60 mcgIGE-1 200 mcgIGE-2 20 mcgIGE-2 60 mcgIGE-2 200 mcgSaline Placebo
Number of Participants With Laboratory Test Abnormalities59121313121036
SecondaryEnzyme-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)
Reported as:
Number · units/milliliter (u/mL)
Enzyme-Linked Immunosorbent Assay (ELISA) Measured Anti-IgE Geometric Mean Titers (GMTs) at Baseline, Day 182, and Day 336
units/milliliter (u/mL)IGE-1 6 mcgIGE-1 20 mcgIGE-1 60 mcgIGE-1 200 mcgIGE-2 20 mcgIGE-2 60 mcgIGE-2 200 mcgSaline Placebo
Day 1 (n=6,21,20,20,20,20,20,62)2002.8 (2002.8 to 2002.8)2002.8 (2002.8 to 2002.8)2002.8 (2002.8 to 2002.8)2002.8 (2002.8 to 2002.8)2002.8 (2002.8 to 2002.8)2002.8 (2002.8 to 2002.8)2002.8 (2002.8 to 2002.8)2002.8 (2002.8 to 2002.8)
Day 182 (n=5,18,16,19,19,18,19,57)11310.6 (5642.0 to 22674.9)44480.1 (30845.9 to 64141.0)72925.4 (49484.3 to 107470.7)126981.7 (88942.3 to 181290.0)35833.4 (25031.3 to 51296.9)41947.5 (29086.0 to 60496.1)106036.8 (73954.8 to 152036.2)2147.9 (1745.8 to 2642.7)
Day 336 (n=5,18,16,17,18,16,6,52)1896.7 (846.6 to 4248.9)17836.4 (11665.8 to 27271.1)22611.2 (14425.4 to 35442.0)42772.1 (27643.3 to 66180.7)9642.9 (6298.5 to 14763.1)12490.1 (7966.5 to 19582.1)43979.2 (20992.0 to 92138.2)2265.3 (1761.5 to 2913.2)

Adverse events

Collected over Baseline up to 336 days post study administration or at Early Termination. Non-serious events are listed at a 5% frequency threshold.

Adverse event summary by group
GroupDeathsSeriousOther
IGE-1 6 mcg—0/6 (0%)5/6 (83.3%)
IGE-1 20 mcg—0/21 (0%)17/21 (81%)
IGE-1 60 mcg—0/20 (0%)20/20 (100%)
IGE-1 200 mcg—0/20 (0%)20/20 (100%)
IGE-2 20 mcg—0/20 (0%)19/20 (95%)
IGE-2 60 mcg—1/20 (5%)19/20 (95%)
IGE-2 200 mcg—0/20 (0%)17/20 (85%)
Saline Placebo—1/63 (1.6%)54/63 (85.7%)
Most frequent serious events
Most frequent serious events
EventIGE-1 6 mcgIGE-1 20 mcgIGE-1 60 mcgIGE-1 200 mcgIGE-2 20 mcgIGE-2 60 mcgIGE-2 200 mcgSaline Placebo
AppendicitisInfections and infestations0/60/210/200/200/201/200/200/63
Peritonsillar abscessInfections and infestations0/60/210/200/200/200/200/201/63
Most frequent other events
Showing 10 of 139
Most frequent other events
EventIGE-1 6 mcgIGE-1 20 mcgIGE-1 60 mcgIGE-1 200 mcgIGE-2 20 mcgIGE-2 60 mcgIGE-2 200 mcgSaline Placebo
Upper respiratory tract infectionInfections and infestations2/67/2110/2011/208/2011/206/2026/63
Back painMusculoskeletal and connective tissue disorders0/62/213/204/202/200/207/206/63
NasopharyngitisInfections and infestations1/64/214/202/204/202/206/2010/63
Weight increasedInvestigations0/65/216/202/201/204/202/2011/63
NauseaGastrointestinal disorders0/61/213/202/205/201/200/205/63
DiarrhoeaGastrointestinal disorders0/61/212/200/204/201/201/206/63
FatigueGeneral disorders0/60/210/202/204/200/200/203/63
Vaginal infectionInfections and infestations——0/10/10/10/2—1/5
VulvovaginitisInfections and infestations——0/10/10/10/2—1/5
Weight decreasedInvestigations0/60/212/204/202/201/202/2011/63

Baseline characteristics

Age, Continuous
Age, Continuous(years)IGE-1 6 mcgIGE-1 20 mcgIGE-1 60 mcgIGE-1 200 mcgIGE-2 20 mcgIGE-2 60 mcgIGE-2 200 mcgSaline PlaceboTotal
Mean36.7 ± 13.331.6 ± 8.835.7 ± 10.033.5 ± 9.335.4 ± 9.235.9 ± 11.033.6 ± 12.034.7 ± 8.834.4 ± 9.7
Sex: Female, Male
Sex: Female, Male(Participants)IGE-1 6 mcgIGE-1 20 mcgIGE-1 60 mcgIGE-1 200 mcgIGE-2 20 mcgIGE-2 60 mcgIGE-2 200 mcgSaline PlaceboTotal
Female0011120510
Male621191919182058180
08

Study locations

4 sites
  • Ottawa Allergy Research Corporation
    Ottawa, Ontario K1Y 4G2, Canada
  • Diex Research Montreal Inc.
    Montreal, Quebec H4N 3C5, Canada
  • Diex Research Sherbrooke Inc.
    Sherbrooke, Quebec J1H 1Z1, Canada
  • Centre de Recherche Appliquee en Allergie de Quebec
    Quebec, G1V 4M6, Canada
09

References and documents

10

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Jul 11, 2016, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
11

Registry details

Key details

Study ID
NCT01723254
Lead sponsor
Pfizer
Responsible party
Sponsor
First posted
Nov 7, 2012
Start date
Dec 2012
Primary completion
Jun 2015
Completion
Jun 2015
Results posted
Jul 11, 2016
Last update
Jul 11, 2016

Study contacts

Pfizer CT.gov Call Center
study director · Pfizer

Oversight

Data monitoring committee
No
View the source record on ClinicalTrials.gov ↗

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