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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| PF-05402536 | Experimental |
| |
| PF-06413367 | Experimental | Intramuscular, multiple dose |
|
| Placebo | Placebo Comparator | Intramuscular |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| NIC7-001 | Biological | Intramuscular, multiple dose |
| |
| NIC7-003 |
| Measure | Description | Time Frame |
|---|---|---|
| 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. | Within 7 days after dose | |
| 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. | Within 7 days after dose | |
| Number of Participants With Unsolicited Treatment-Emergent Adverse Events (AEs) by Seriousness and Relationship to Treatment | Baseline up to Day 364 | |
| Number of Participants With Abnormal Safety Laboratory Findings by Seriousness and Relationship to Treatment | Baseline up to Day 364 |
| Measure | Description | Time Frame |
|---|---|---|
| Antibody titers against nicotine. | Up to Day 364 | |
| Avidity of antibodies against nicotine. | Up to Day 364 | |
| 7-day point prevalence of smoking abstinence |
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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 |
|---|---|---|---|---|---|---|
| INC Research Toronto Inc. | Toronto | Ontario | M5V 2T3 | Canada | ||
| Diex Research Montreal, Inc. |
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| Label | URL |
|---|---|
| To obtain contact information for a study center near you, click here. | View source |
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| ID | Term |
|---|---|
| D012907 | Smoking |
| D016540 | Smoking Cessation |
| ID | Term |
|---|---|
| D001519 | Behavior |
| D015438 | Health Behavior |
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| ID | Term |
|---|---|
| D012965 | Sodium Chloride |
| ID | Term |
|---|---|
| D002712 | Chlorides |
| D006851 | Hydrochloric Acid |
| D017606 | Chlorine Compounds |
| D007287 | Inorganic Chemicals |
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| Biological |
Intramuscular, multiple dose |
|
| Saline | Biological | Saline (0.9% sodium chloride) |
|
| Up to Day 364 |
| 4-week continuous abstinence rate from smoking | Up to Day 364 |
| smoking behavioral measurements (including Minnesota Nicotine Withdrawal Scale, Modified Cigarette Evaluation Questionnaire, and Brief Questionnaire of Smoking Urges) | Up to Day 364 |
| Montreal |
| Quebec |
| H2Y 1S1 |
| Canada |
| Diex Research Sherbrooke Inc. | Sherbrooke | Quebec | J1H 1Z1 | Canada |
| D017670 |
| Sodium Compounds |