A Comparability Study of the Phase 3 Lot and a Single Commercial Lot of NicVAX in Healthy Adult Smokers

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE3

Total Enrollment

260 participants

Study Classification

INTERVENTIONAL

Study Start Date

2011-05-31

Study Completion Date

2011-10-31

Brief Summary

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The purpose of this study is to assess the comparability of the phase 3 lot and a single commercial lot of NicVAX in healthy smokers.

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Detailed Description

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Conditions

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Smoking

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

QUADRUPLE

Participants Caregivers Investigators Outcome Assessors

Study Groups

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NicVAX - Phase 3 Lot

Group Type ACTIVE_COMPARATOR

NicVAX Vaccine

Intervention Type BIOLOGICAL

NicVAX Vaccine given 6 times over 6 months

NicVAX - Commercial Lot

Group Type ACTIVE_COMPARATOR

NicVAX Vaccine

Intervention Type BIOLOGICAL

NicVAX Vaccine given 6 times over 6 months

Interventions

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NicVAX Vaccine

NicVAX Vaccine given 6 times over 6 months

Intervention Type BIOLOGICAL

Eligibility Criteria

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Inclusion Criteria

* Healthy male or female smokers, age 18-55, who are currently smoking at least 10 cigarettes per day.

Exclusion Criteria

* Prior exposure to NicVAX or any other nicotine vaccine.
* History of clinically significant allergic reactions.
* Use of systemic steroids.
* Cancer or cancer treatment within 5 years.
* HIV infection.
* History of drug or alcohol abuse or dependence.
* Required treatment for depression within the past 12 months.
* Body mass index ≥ 30 \[calculated as weight (kg)/height2 (m)\].
* Significant cardiovascular, hepatic, renal, psychiatric and/or respiratory disease.
* Inability to fulfill all visits for approximately 30 weeks.

Minimum Eligible Age

18 Years

Maximum Eligible Age

55 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes