A Comparability Study of the Phase 3 Lot and a Single Com... | NCT01375933

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

NCT01375933

Sponsor

Nabi Biopharmaceuticals

Status

Completed

Last Update Posted

May 14, 2012Estimated

Enrollment

260Actual

Phase

Phase 3

Conditions

Smoking

Interventions

NicVAX Vaccine

Countries

United States

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

May 2012

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

May 2011

Primary Completion Date

Oct 2011Actual

Completion Date

Oct 2011Actual

First Submitted Date

Jun 15, 2011

First Submission Date that Met QC Criteria

Jun 17, 2011

First Posted Date

Jun 20, 2011Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

May 10, 2012

Last Update Posted Date

May 14, 2012Estimated

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Not provided

Is FDA Regulated Device

Not provided

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

Brief 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.

Detailed Description

Not provided

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Phase 3

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

260Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
NicVAX - Phase 3 Lot	Active Comparator	NicVAX - Phase 3 Lot	Biological: NicVAX Vaccine
NicVAX - Commercial Lot	Active Comparator	NicVAX - Commercial Lot	Biological: NicVAX Vaccine

Interventions

Name	Type	Description	Arm Group Labels	Other Names
NicVAX Vaccine	Biological	NicVAX Vaccine given 6 times over 6 months	NicVAX - Commercial Lot NicVAX - Phase 3 Lot

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Immunogenicity	To compare imunogenicity of two lots by serum antibody concentration	At Week 14

Secondary Outcomes

Measure	Description	Time Frame
Safety	Assess safety by adverse events reported	Through Week 16

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

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.

Accepts Healthy Volunteers

Yes

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

55 Years

Standard Ages

Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Medical Monitor	Nabi Biopharmaceuticals	Study Director

Locations

Facility	Status	City	State	ZIP	Country	Contacts
NicVAX Investigator		Huntsville	Alabama	35802	United States
NicVAX Investigator