A/H1N1 Immunogenicity and Safety in Adults

This study has been completed.

Sponsor:

Information provided by:

Baxter Healthcare Corporation

ClinicalTrials.gov Identifier:

NCT00959465

First received: August 13, 2009

Last updated: July 8, 2010

Last verified: July 2010

History of Changes

Tracking Information

First Received Date ^ICMJE

August 13, 2009

Last Updated Date

July 8, 2010

Start Date ^ICMJE

August 2009

Primary Completion Date

November 2009 (final data collection date for primary outcome measure)

Current Primary Outcome Measures ^ICMJE

Number of subjects achieving antibody levels to A/H1N1/California/07/2009 virus that meet the definition of seroprotection and seroconversion at 21 days after the second vaccination [ Time Frame: 42 days ] [ Designated as safety issue: Yes ]

Original Primary Outcome Measures ^ICMJE

Same as current

Change History

Complete list of historical versions of study NCT00959465 on ClinicalTrials.gov Archive Site

Current Secondary Outcome Measures ^ICMJE

Not Provided

Original Secondary Outcome Measures ^ICMJE

Not Provided

Current Other Outcome Measures ^ICMJE

Not Provided

Original Other Outcome Measures ^ICMJE

Not Provided

Descriptive Information

Brief Title ^ICMJE

A/H1N1 Immunogenicity and Safety in Adults

Official Title ^ICMJE

An Open Label Phase 1/2 Study to Assess Immunogenicity and Safety of Different Dose Levels of H1N1 Pandemic Influenza Vaccine in Healthy Adults Aged 18 Years and Older

Brief Summary

The purpose of the study is to obtain immunogenicity and safety data at different dose levels of an investigational H1N1 pandemic influenza vaccine in healthy adults 18 years of age and older.

Detailed Description

Not Provided

Study Type ^ICMJE

Interventional

Study Phase

Phase 1
Phase 2

Study Design ^ICMJE

Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Prevention

Condition ^ICMJE

Influenza
Pandemic Influenza

Intervention ^ICMJE

Biological: H1N1 pandemic influenza vaccine (whole virion, Vero Cell-derived, inactivated)

Two injections at a 21-day interval (Days 1 and 22)

Study Arm (s)

Experimental: Cohort 1/Dose Level A
Subjects in Cohort 1 will be randomized 1:1 to receive two vaccinations of Dose A or Dose B of H1N1 pandemic influenza vaccine at a 21-day interval.

Intervention: Biological: H1N1 pandemic influenza vaccine (whole virion, Vero Cell-derived, inactivated)
Experimental: Cohort 1/Dose B
Subjects in Cohort 1 will be randomized 1:1 to receive two vaccinations of Dose A or Dose B of H1N1 pandemic influenza vaccine at a 21-day interval.

Intervention: Biological: H1N1 pandemic influenza vaccine (whole virion, Vero Cell-derived, inactivated)
Experimental: Cohort 2/Dose C
A second cohort may be enrolled with all subjects in this cohort receiving two vaccinations of Dose C of H1N1 pandemic influenza vaccine at a 21-day interval.

Intervention: Biological: H1N1 pandemic influenza vaccine (whole virion, Vero Cell-derived, inactivated)

Publications *

Not Provided

* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.

Recruitment Information

Recruitment Status ^ICMJE

Completed

Enrollment ^ICMJE

408

Completion Date

April 2010

Primary Completion Date

November 2009 (final data collection date for primary outcome measure)

Eligibility Criteria ^ICMJE

Inclusion Criteria:

Subject is 18 to 59 years old (age stratum A) or 60 years of age or older (age stratum B) at the time of screening
Subject has an understanding of the study, agrees to its provisions, and gives written informed consent prior to study entry
Subject is generally healthy, as determined by the investigator's clinical judgment through collection of medical history and the performance of a physical examination
Subject is physically and mentally capable of participating in the study and willing to adhere to study procedures to include completion of all elements of the study diary
If female of childbearing potential, subject has a negative urine pregnancy test result within 24 hours prior to the scheduled first vaccination and agrees to employ adequate birth control measures for the duration of the study

Exclusion Criteria:

Subject has participated in another clinical study involving an investigational drug, biological product or device within 30 days prior to study enrollment or is scheduled to participate in another clinical study involving an investigational drug, biological or device during the course of this study
Subject has a history of exposure to A/H1N1/California/07/2009 virus or a history of vaccination with A/H1N1/California/07/2009 antigen or a closely related influenza virus antigen
Subject has inherited or acquired immune deficiency
Subject currently has or has a recent history of significant neurological, cardiovascular or pulmonary (including asthma), hepatic, metabolic, rheumatic, autoimmune, hematological or renal disorder

Gender

Both

Ages

18 Years and older

Accepts Healthy Volunteers

Yes

Contacts ^ICMJE

Contact information is only displayed when the study is recruiting subjects

Location Countries ^ICMJE

Austria, Germany

Administrative Information

NCT Number ^ICMJE

NCT00959465

Other Study ID Numbers ^ICMJE

820902, EUDRACT Number 2009-013394-17

Has Data Monitoring Committee

Yes

Responsible Party

Gerald Aichinger, MD; Study Medical Director, Baxter Healthcare Corporation

Study Sponsor ^ICMJE

Baxter Healthcare Corporation

Collaborators ^ICMJE

Not Provided

Investigators ^ICMJE

Study Director:

Gerald Aichinger, MD

Baxter Healthcare Corporation

Information Provided By

Baxter Healthcare Corporation

Verification Date

July 2010

^ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP

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