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A Follow-up Study to Assess Long-term Immunogenicity and Safety of NicVAX/Placebo as an Aid to Smoking Cessation

NCT01304810 · Status: COMPLETED · Type: OBSERVATIONAL · Enrollment: 300

Last updated 2012-05-14

No results posted yet for this study

Summary

The purpose of the study is to obtain two year follow up data for subjects that received six vaccinations of NicVAX in prior phase III studies. No treatment will be administered. Anti-nicotine antibody levels and safety data will be collected.

Conditions

  • Smoking Cessation
  • Nicotine Dependence

Interventions

BIOLOGICAL

NicVAX vaccine

Prior treatment with NicVAX in Nabi-4514 or Nabi-4515. No intervention in Nabi-4522.

BIOLOGICAL

Placebo

Prior treatment with Placebo in Nabi-4514 or Nabi-4515. No intervention in Nabi-4522.

Sponsors & Collaborators

  • Nabi Biopharmaceuticals

    lead INDUSTRY

Principal Investigators

  • Medical Director · Nabi Biopharmaceuticals

Eligibility

Min Age
18 Years
Max Age
65 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2011-01-31
Primary Completion
2011-08-31
Completion
2011-08-31

Countries

  • United States

Study Locations

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Entities

Drugs

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 NCT01304810 on ClinicalTrials.gov