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 study testing IGE-1, IGE-2 and Saline in people with Allergic Rhinitis, run by Pfizer at 4 sites in Canada.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Trial 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. Read more about this study

Who is it for?: Ages 18 to 55 yearsHealthy volunteers can take part
Conditions the study is for: Allergic Rhinitis
What is being tested?: IGE-1, IGE-2 and Saline
Type of treatment: Injection or infusion
Could I receive a placebo?: Yes, some participants may receive a placebo
How many people: 190 participants
Where: 4 sitesCanada
Study dates: Dec 2012to Jun 2015
Phase: Phase 1
Are there results?: Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages 18 to 55 years
All sexes
Healthy volunteers accepted
Adult

Who may be able to join

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.

Who cannot join

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).

Trial locations and contacts

4 sites in 1 country.

Canada4 sites

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

Other trials in Canada

About this study

Official title: A Phase 1, Randomized, Double Blinded, Placebo Controlled Study To Evaluate The Safety, Tolerability, Immunogenicity, And Exploratory Pharmacodynamic Response Of Ascending Dose Levels Of An Anti-ige Vaccine With Two Different Adjuvant Formulations (Pf-06444753 And Pf-06444752) In Generally Healthy Subjects With Allergic Rhinitis

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.

Conditions: Allergic Rhinitis
Being tested: IGE-1, IGE-2, Saline
Keywords: Vaccines, Phase 1, Allergic Rhinitis
Medical subject headings: Rhinitis, Allergic

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

IGE-1Biological
Intramuscular, multiple dose
IGE-2Biological
Intramuscular, multiple dose
SalineBiological
Saline (0.9% sodium chloride)

Study groups in NCT01723254
Study group	Role	What they receive
PF-06444753	Experimental	Not described Receives: Biological: IGE-1
PF-06444752	Experimental	Not described Receives: Biological: IGE-2
Placebo	Placebo comparator	Intramuscular Receives: Biological: Saline

What is being measured

The primary outcome is the main question the study is designed to answer.

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).
Measured: 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).
Measured: 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.
Measured: 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.
Measured: 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.
Measured: Baseline (Day 1), Day 182 (2 weeks after last vaccination), and end of study (Day 336)

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

Dec 2012Jun 2015

First posted7 Nov 2012 (estimated)
Study startDec 2012
Primary completionJun 2015
Study completionJun 2015

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
Other trials for Allergic RhinitisStudies of the same condition, open and under way.
More trials run by PfizerThe sponsor's other registered studies.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Interventional
Phase: Phase 1
Primary purpose: Treatment
Allocation: Randomised
Masking: Quadruple blind
Who is masked: Participant, Care provider, Investigator, Outcomes assessor
Enrolment: 190 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT01723254
Sponsor's protocol ID: B4901001
Other IDs: ANTI- IGE VACCINE
Status last verified: May 2016
First submitted: 5 Nov 2012
Last updated: 11 Jul 2016
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: No

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

Not yet recruitingPhase 1
Safety and Tolerability of Fluticasone Propionate 10% Nasal Insert in Participants With Chronic Allergic Rhinitis
Chronic Allergic Rhinitis
RecruitingPhase 3
Specific Immunotherapy With Mannan-Conjugated Allergoids for HDM-Allergic Rhinitis/Rhinoconjunctivitis_MM09-SIT-063.
Allergic Rhinitis, Allergic Rhinoconjunctivitis
RecruitingPhase 3
Specific Immunotherapy With Mannan-Conjugated Allergoids for HDM-Allergic Rhinitis/Rhinoconjunctivitis. MM09-SIT-063.
Allergic Rhinitis, Allergic Rhinoconjunctivitis
Enrolling by invitationObservational study
Allergy, Asthma, and Atopic Eczema in Finland
Asthma, Asthma in Children
Not yet recruitingObservational study
Prevelance of Bronchial Asthma and Allergic Rhinitis Among Children With Nephrotic Syndrom at Sohag University Hospital
Allergic Diseases in Nephrotic Children, Nephrotic Syndrom

All Allergic Rhinitis trials

Study at a glance

From the registry record, last updated by the sponsor on 11 Jul 2016. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: A Phase 1, Randomized, Double Blinded, Placebo Controlled Study To Evaluate The Safety, Tolerability, Immunogenicity, And Exploratory Pharmacodynamic Response Of Ascending Dose Levels Of An Anti-ige Vaccine With Two Different Adjuvant Formulations (Pf-06444753 And Pf-06444752) In Generally Healthy Subjects With Allergic Rhinitis
ClinicalTrials.gov ID: NCT01723254
Acronym / sponsor ID: B4901001
Conditions: Allergic Rhinitis
Keywords: Vaccines, Phase 1, Allergic Rhinitis
Phase: Phase 1
Study type: Interventional
Recruitment status: Completed
Enrolment: 190 participants (actual)
Lead sponsor: PfizerIndustry (pharma, biotech, devices)
Study start: Dec 2012
Primary completion: Jun 2015 (actual)
Study completion: Jun 2015 (actual)
First posted: 7 Nov 2012 (estimated)
Results: Posted 11 Jul 2016

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

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.

Study design

Primary purpose: Treatment
Allocation: Randomised
Masking: Quadruple blind (participant, care provider, investigator, outcomes assessor)
Number of arms: 3

Arm	Type	Receives
PF-06444753	Experimental	Biological: IGE-1
PF-06444752	Experimental	Biological: IGE-2
Placebo	Placebo comparator	Biological: SalineIntramuscular

Who may qualify

Ages: 18 to 55 years
Sex: All
Healthy volunteers: Accepted
Age groups: Adult

Key inclusion criteria (2 listed)

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.

Key exclusion criteria (3 listed)

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).

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
IGE-1Intramuscular, multiple dose	Biological	PF-06444753
IGE-2Intramuscular, multiple dose	Biological	PF-06444752
SalineSaline (0.9% sodium chloride)	Biological	Placebo

Primary outcome

Percentages of Participants With Local Reactions By Severity Within 14 Days of Any Vaccination
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: 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.

1 secondary outcome

Enzyme-Linked Immunosorbent Assay (ELISA) Measured Anti-IgE Geometric Mean Titers (GMTs) at Baseline, Day 182, and Day 336
Time frame: Baseline (Day 1), Day 182 (2 weeks after last vaccination), and end of study (Day 336)

Results and safety

Results posted to the registry on 11 Jul 2016, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
IGE-1 6 mcg	6	5
IGE-1 20 mcg	21	18
IGE-1 60 mcg	20	17
IGE-1 200 mcg	20	18
IGE-2 20 mcg	20	18
IGE-2 60 mcg	20	18
IGE-2 200 mcg	20	19
Saline Placebo	63	60

Primary outcome: Percentages of Participants With Local Reactions By Severity Within 14 Days of Any Vaccination

Time frame: Within 14 days. Number (80% Confidence Interval). Unit: Percentage of participants

Measure	IGE-1 6 mcg n = 6	IGE-1 20 mcg n = 21	IGE-1 60 mcg n = 20	IGE-1 200 mcg n = 20	IGE-2 20 mcg n = 20	IGE-2 60 mcg n = 20	IGE-2 200 mcg n = 20	Saline Placebo n = 63
Any Redness	50.0 (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 Redness	50.0 (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 Redness	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)	0.0 (0.0 to 0.0)
Any Swelling	16.7 (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 Swelling	16.7 (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 Swelling	0.0 (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 Swelling	0.0 (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 Pain	83.3 (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)

Population analysed: All randomized participants who received at least one dose of study treatment.

Primary outcome: Percentages of Participants With Systemic Reactions By Severity Within 14 Days of Any Vaccination

Time frame: Within 14 days. Number (80% Confidence Interval). Unit: Percentage of participants

Measure	IGE-1 6 mcg n = 6	IGE-1 20 mcg n = 21	IGE-1 60 mcg n = 20	IGE-1 200 mcg n = 20	IGE-2 20 mcg n = 20	IGE-2 60 mcg n = 20	IGE-2 200 mcg n = 20	Saline Placebo n = 63
Any Fever	0 (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 Fever	0.0 (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 Fever	0.0 (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 Fever	0.0 (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 Vomiting	0.0 (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 Vomiting	0.0 (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 Vomiting	0.0 (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)

Primary outcome: Number of Participants With Treatment-Emergent Adverse Events (TEAEs), Serious Adverse Events (SAEs), and Discontinuations From Treatment Due to TEAEs

Time frame: Baseline up to 336 days post study administration or at Early Termination. Number. Unit: participants

Measure	IGE-1 6 mcg n = 6	IGE-1 20 mcg n = 21	IGE-1 60 mcg n = 20	IGE-1 200 mcg n = 20	IGE-2 20 mcg n = 20	IGE-2 60 mcg n = 20	IGE-2 200 mcg n = 20	Saline Placebo n = 63
Participants with TEAEs	5	18	20	20	19	19	17	55
Participants with SAEs	0	0	0	0	0	1	0	1
Participants with severe TEAEs	0	0	2	0	1	2	0	4
Permanent discontinuations due to TEAEs	0	0	1	0	0	0	0	2
Temporary discontinuations due to TEAEs	1	0	0	1	0	0	1	4
Participants with treatment-related TEAEs	0	2	1	4	1	0	0	3

Population analysed: All randomized participants who received at least one dose of study treatment.

Primary outcome: Number of Participants With Laboratory Test Abnormalities

Time frame: Baseline up to 336 days post last study drug administration or Early Termination. Number. Unit: participants

Measure	IGE-1 6 mcg n = 6	IGE-1 20 mcg n = 21	IGE-1 60 mcg n = 20	IGE-1 200 mcg n = 20	IGE-2 20 mcg n = 20	IGE-2 60 mcg n = 20	IGE-2 200 mcg n = 20	Saline Placebo n = 63
Value	5	9	12	13	13	12	10	36

Population analysed: All randomized participants who received at least one dose of study treatment.

1 secondary outcome is reported in the full results.

Adverse events

Time frame: Baseline up to 336 days post study administration or at Early Termination. Other adverse events reported at 5% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
IGE-1 6 mcg	0 of 6 (0%)	5 of 6 (83.3%)	Not reported
IGE-1 20 mcg	0 of 21 (0%)	17 of 21 (81%)	Not reported
IGE-1 60 mcg	0 of 20 (0%)	20 of 20 (100%)	Not reported
IGE-1 200 mcg	0 of 20 (0%)	20 of 20 (100%)	Not reported
IGE-2 20 mcg	0 of 20 (0%)	19 of 20 (95%)	Not reported
IGE-2 60 mcg	1 of 20 (5%)	19 of 20 (95%)	Not reported
IGE-2 200 mcg	0 of 20 (0%)	17 of 20 (85%)	Not reported
Saline Placebo	1 of 63 (1.6%)	54 of 63 (85.7%)	Not reported

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 11 Jul 2016.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
To obtain contact information for a study center near you, click here.Link provided by the sponsor.

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Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

Pfizer CT.gov Call Center study director

Pfizer

4 sites in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

A Phase 1 study testing IGE-1, IGE-2 and Saline in people with Allergic Rhinitis, run by Pfizer at 4 sites in Canada.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 2 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 11 Jul 2016. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 4 sites in Canada. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Yes. Results are posted in the registry (first posted 11 Jul 2016). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Percentages of Participants With Local Reactions By Severity Within 14 Days of Any Vaccination (time frame: Within 14 days). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT01723254.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 11 Jul 2016.