A Study to Assess the Safety and Tolerability of Different Doses of PF-05402536 and PF-06413367 in Healthy Adult Smokers.

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT01672645
Recruitment Status : Completed
First Posted : August 27, 2012
Last Update Posted : January 26, 2016
Information provided by (Responsible Party):

Brief Summary:
The purpose of this study is to determine the safety and tolerability of multiple doses of PF-05402536 and PF-06413367 in healthy adult smokers.

Condition or disease Intervention/treatment Phase
Smoking Vaccines Biological: NIC7-001 Biological: NIC7-003 Biological: Saline Phase 1

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 277 participants
Allocation: Randomized
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: A Phase 1, Randomized, Double Blind, Placebo Controlled Study To Evaluate The Safety, Tolerability, Immunogenicity, And Exploratory Efficacy Of Multiple Ascending Dose Levels Of Pf-05402536 And Pf-06413367 In Healthy Adult Smokers
Study Start Date : June 2012
Actual Primary Completion Date : December 2015
Actual Study Completion Date : December 2015

Arm Intervention/treatment
Experimental: PF-05402536 Biological: NIC7-001
Intramuscular, multiple dose

Experimental: PF-06413367
Intramuscular, multiple dose
Biological: NIC7-003
Intramuscular, multiple dose

Placebo Comparator: Placebo
Biological: Saline
Saline (0.9% sodium chloride)

Primary Outcome Measures :
  1. Frequency of solicited local reactions (erythema, induration, and pain) and severity of the local reactions as self-reported on electronic diaries (e-diaries) for 7 days following vaccination. [ Time Frame: Within 7 days after dose ]
  2. Frequency of solicited systemic events (fever, vomiting, diarrhea, headache, fatigue, new or worsening muscle pain, and new or worsening joint pain) and severity of solicited systemic events as self-reported on e-diaries for 7 days following vaccination. [ Time Frame: Within 7 days after dose ]
  3. Number of Participants With Unsolicited Treatment-Emergent Adverse Events (AEs) by Seriousness and Relationship to Treatment [ Time Frame: Baseline up to Day 364 ]
  4. Number of Participants With Abnormal Safety Laboratory Findings by Seriousness and Relationship to Treatment [ Time Frame: Baseline up to Day 364 ]

Secondary Outcome Measures :
  1. Antibody titers against nicotine. [ Time Frame: Up to Day 364 ]
  2. Avidity of antibodies against nicotine. [ Time Frame: Up to Day 364 ]
  3. 7-day point prevalence of smoking abstinence [ Time Frame: Up to Day 364 ]
  4. 4-week continuous abstinence rate from smoking [ Time Frame: Up to Day 364 ]
  5. smoking behavioral measurements (including Minnesota Nicotine Withdrawal Scale, Modified Cigarette Evaluation Questionnaire, and Brief Questionnaire of Smoking Urges) [ Time Frame: Up to Day 364 ]

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 60 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes

Inclusion Criteria:

  • Current cigarette smokers
  • Males or females of non-child bearing potential, who are between the minimum legal age for smoking (approximately 18 or 19 years, depending on local jurisdiction) and 55 years, inclusive, and who are motivated to stop smoking.
  • Subjects must have smoked an average of at least 10 cigarettes per day during the past year and during the month prior to the prescreening assessment for entry, with no period of abstinence greater than 3 months in the past year.

Exclusion Criteria:

  • Evidence or history of clinically significant hematological, renal, endocrine, pulmonary, gastrointestinal, cardiovascular, hepatic, or neurologic disease that may compromise their ability to safely participate in the study.
  • Active suicidal ideation or history of suicidal behaviors within the past 5 years prior to the screening visit.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT01672645

Canada, Ontario
INC Research Toronto Inc.
Toronto, Ontario, Canada, M5V 2T3
Canada, Quebec
Diex Research Montreal, Inc.
Montreal, Quebec, Canada, H2Y 1S1
Diex Research Sherbrooke Inc.
Sherbrooke, Quebec, Canada, J1H 1Z1
Sponsors and Collaborators
Study Director: Pfizer Call Center Pfizer

Additional Information:
Responsible Party: Pfizer Identifier: NCT01672645     History of Changes
Other Study ID Numbers: B3771001
First Posted: August 27, 2012    Key Record Dates
Last Update Posted: January 26, 2016
Last Verified: January 2016

Keywords provided by Pfizer:
Smoking cessation
Phase 1