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OpenTrials
Completed

NCT Number: NCT01375933

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

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.

Completed

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Key information

Conditions

Smoking Behavior

Age range

18 year–55 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 3

Primary location

NicVAX Investigator, Huntsville, Alabama, United States

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Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

NicVAX Vaccine

Biological

NicVAX Vaccine given 6 times over 6 months

Primary outcomes

  1. Immunogenicity

    Time frame: At Week 14

    To compare imunogenicity of two lots by serum antibody concentration

Secondary outcomes

  1. Safety

    Time frame: Through Week 16

    Assess safety by adverse events reported

Sponsors and collaborators

Lead sponsor

Nabi Biopharmaceuticals

Industry

Registry information

Official study title

A Phase 3, Multicenter, Double-Blinded, Randomized, Study to Assess Comparability of a Single Phase 3 Lot and a Single Commercial Lot of 3'-Aminomethylnicotine-P. Aeruginosa r-Exoprotein A Conjugate Vaccine (NicVAX) in Healthy Adult Smokers

Important dates

Study start
2011
Primary completion
2011
Study completion
2011
First posted
Jun 20, 2011
Registry last updated
May 14, 2012

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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