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

This study has been completed.
Information provided by (Responsible Party):
ClinicalTrials.gov Identifier:
First received: November 5, 2012
Last updated: August 5, 2015
Last verified: August 2015
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.

Condition Intervention Phase
Allergic Rhinitis
Biological: IGE-1
Biological: IGE-2
Biological: Saline
Phase 1

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety Study
Intervention Model: Single Group Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
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

Further study details as provided by Pfizer:

Primary Outcome Measures:
  • Local reactogenicity events [ Time Frame: Within 14 days after dose ] [ Designated as safety issue: Yes ]
    Frequency of local reactogenicity events

  • Systemic reactogenicity events [ Time Frame: Within 14 days after dose ] [ Designated as safety issue: Yes ]
    Frequency of systemic reactogenicity events

  • Number of Participants With Treatment-Emergent Adverse Events (AEs) or Serious Adverse Events (SAEs) [ Time Frame: Baseline up to Day 336 ] [ Designated as safety issue: Yes ]
    An AE was any untoward medical occurrence in a participant who received study drug without regard to possibility of causal relationship. 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. Treatment-emergent are events between first dose of study drug and up to 28 days after last dose that were absent before treatment or that worsened relative to pretreatment state.

  • Number of Participants with abnormal safety laboratory findings [ Time Frame: Baseline up to Day 336 ] [ Designated as safety issue: Yes ]
    blood chemistry, hematology, coagulation, and urinalysis

Secondary Outcome Measures:
  • Antibody titers against IgE [ Time Frame: Baseline up to Day 336 ] [ Designated as safety issue: No ]
    Antibody titers against IgE

Enrollment: 190
Study Start Date: December 2012
Study Completion Date: June 2015
Primary Completion Date: June 2015 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: PF-06444753 Biological: IGE-1
Intramuscular, multiple dose
Experimental: PF-06444752 Biological: IGE-2
Intramuscular, multiple dose
Placebo Comparator: Placebo
Biological: Saline
Saline (0.9% sodium chloride)


Ages Eligible for Study:   18 Years to 55 Years
Genders Eligible for Study:   Both
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:

  • 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).
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01723254

Canada, Ontario
Ottawa Allergy Research Corporation
Ottawa, Ontario, Canada, K1Y 4G2
Canada, Quebec
Diex Research Montreal Inc.
Montreal, Quebec, Canada, H4N 3C5
Diex Research Sherbrooke Inc.
Sherbrooke, Quebec, Canada, J1H 1Z1
Centre de Recherche Appliquee en Allergie de Quebec
Quebec, Canada, G1V 4M6
Sponsors and Collaborators
Study Director: Pfizer CT.gov Call Center Pfizer
  More Information

Additional Information:
Responsible Party: Pfizer
ClinicalTrials.gov Identifier: NCT01723254     History of Changes
Other Study ID Numbers: B4901001  ANTI- IGE VACCINE 
Study First Received: November 5, 2012
Last Updated: August 5, 2015
Health Authority: Canada: Health Canada

Keywords provided by Pfizer:
Phase 1
Allergic Rhinitis

Additional relevant MeSH terms:
Rhinitis, Allergic
Hypersensitivity, Immediate
Immune System Diseases
Nose Diseases
Otorhinolaryngologic Diseases
Respiratory Hypersensitivity
Respiratory Tract Diseases
Respiratory Tract Infections

ClinicalTrials.gov processed this record on May 25, 2016