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

NCT01375933 · Status: COMPLETED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 260

Last updated 2012-05-14

No results posted yet for this study

Summary

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.

Conditions

  • Smoking

Interventions

BIOLOGICAL

NicVAX Vaccine

NicVAX Vaccine given 6 times over 6 months

Sponsors & Collaborators

  • Nabi Biopharmaceuticals

    lead INDUSTRY

Principal Investigators

  • Medical Monitor · Nabi Biopharmaceuticals

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
55 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2011-05-31
Primary Completion
2011-10-31
Completion
2011-10-31

Countries

  • United States

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01375933 on ClinicalTrials.gov