Trials Sponsors Conditions Drugs Pricing

Conditions

Influenza Pandemic Influenza

Outcome Measures

Primary Outcomes (1)

Number of subjects with an antibody response to the vaccine strain associated with protection 21 days after the second vaccination
42 days

Secondary Outcomes (1)

Frequency and severity of systemic reactions and injection site reactions after the first and second vaccinations
180 days

Study Arms (2)

Cohort 1

EXPERIMENTAL

60 subjects randomized in an equal number to six different vaccine doses

Biological: H5N1 Influenza Vaccine, Whole virion, Vero cell-derived, Inactivated Influenza Vaccine, non-adjuvanted (reverse genetic reassortant/H5N1 hemagglutinin antigen)

Cohort 2

EXPERIMENTAL

Following review of safety data of Cohort 1, approximately 360 additional subjects randomized in an equal number to the six different vaccine doses

Biological: H5N1 Influenza Vaccine, Whole virion, Vero cell-derived, Inactivated Influenza Vaccine, non-adjuvanted (reverse genetic reassortant/H5N1 hemagglutinin antigen)

Interventions

H5N1 Influenza Vaccine, Whole virion, Vero cell-derived, Inactivated Influenza Vaccine, non-adjuvanted (reverse genetic reassortant/H5N1 hemagglutinin antigen)Biological

2 x 0.5 mL intramuscular injections 21 days apart (one of six different doses of hemagglutinin antigen without adjuvant)

Cohort 1Cohort 2

Registry-reported names are shown in full. Names without a link have not yet been matched to a Syfrah profile.

Eligibility Criteria

Age18 Years - 45 Years

Sexall

Healthy VolunteersYes

Age GroupsAdult (18-64)

You may qualify if:

Subjects who
Have an understanding of the study, agree to its provisions, and give written informed consent prior to study entry

Sponsors & Collaborators

Alachua Government Services, Inc.
Industrylead

Study Sites (6)

Heartland Research Associates, LLC

Wichita, Kansas, 67207, United States

Central Kentucky Research Associates, Inc.

Lexington, Kentucky, 40509, United States

The Center for Pharmaceutical Research

Kansas City, Missouri, 64114, United States

Rochester Clinical Research

Rochester, New York, 14609, United States

Omega Medical Research

Warwick, Rhode Island, 02886, United States

Research Across America

Dallas, Texas, 75234, United States

MeSH Terms

Conditions

Influenza, Human

Condition Hierarchy (Ancestors)

Respiratory Tract InfectionsInfectionsOrthomyxoviridae InfectionsRNA Virus InfectionsVirus DiseasesRespiratory Tract Diseases

Study Officials

Baxter BioScience Investigator, MD
Baxter Healthcare Corporation
STUDY DIRECTOR

Enrollment

422 participants (actual enrollment reported by the registry).

Study Design

Study Type: interventional
Phase: phase 1
Allocation: RANDOMIZED
Masking: DOUBLE
Who Masked: PARTICIPANT, INVESTIGATOR
Purpose: PREVENTION
Intervention Model: PARALLEL
Sponsor Type: INDUSTRY

Study Record Dates

First Submitted

October 31, 2008

First Posted

November 3, 2008

Study Start

July 2008

Date type not reported

This date has not been verified as actual or estimated.

You may not qualify if:

Subjects will be excluded from participation in this study if they:
Have a history of exposure to H5N1 influenza virus or a history of vaccination with an H5N1 influenza vaccine
Are at potential occupational risk of contracting H5N1 influenza infection (e.g., poultry workers)
Suffer from or have a history of a significant neurological, cardiovascular, pulmonary (including asthma), hepatic, rheumatic, autoimmune, hematological, metabolic or renal disorder
Have a Body Mass Index \> 35
Have hypertension at screening that is graded as greater than Stage 1 (defined as a systolic pressure \> 159 or diastolic pressure \> 99) while seated and at rest (measurement shall be repeated twice before subject is excluded)
Have clinically significant abnormal clinical laboratory values at screening as determined by the Investigator
Have clinically significant electrocardiographic abnormalities at screening
Test positive for HIV, HBcAb or HCV
Suffer from any kind of immunodeficiency
Suffer from a disease or were undergoing a form of treatment within 30 days of study entry or are currently undergoing a form of treatment that can be expected to influence immune response. Such treatment includes, but is not limited to, systemic or high dose inhaled (\>800µg/day of beclomethasone dipropionate or equivalent) corticosteroids, radiation treatment or other immunosuppressive or cytotoxic drugs
Have a history of severe allergic reactions (e.g. clinically severe urticaria, allergic rhinitis, asthma) or anaphylaxis (a medical emergency caused by an acute hypersensitivity reaction involving several organ systems including, but not limited to, cardio-respiratory signs with mucosal and/or skin changes (e.g. angioedema, etc) that presents as or rapidly progresses to a severe life-threatening reaction.
Have a rash, dermatologic condition or tattoos which may interfere with injection site reaction rating
Have received any blood products (e.g. a blood transfusion or immunoglobulins within 90 days of vaccination in this study
Have donated one or more units of blood (approximately 450 mL) or plasma within 30 days of vaccination in this study
+9 more criteria

Phase 1 Study of a H5N1 Influenza Vaccine (Reverse Genetic Reassortant)

Brief Summary

Registry Overview

Trial Relationships

Study Timeline

Study Start

First Submitted

First Posted

Primary Completion

Study Completion

Conditions

Outcome Measures

Primary Outcomes (1)

Secondary Outcomes (1)

Study Arms (2)

Cohort 1

Cohort 2

Interventions

Eligibility Criteria

You may qualify if:

Sponsors & Collaborators

Study Sites (6)

MeSH Terms

Conditions

Condition Hierarchy (Ancestors)

Study Officials

Enrollment

Study Design

Study Record Dates

You may not qualify if:

Source record

Locations

Brief Summary

Registry Overview

Trial Relationships

Related Scientific Literature

Study Timeline

Study Start

First Submitted

First Posted

Primary Completion

Study Completion

Conditions

Outcome Measures

Primary Outcomes (1)

Secondary Outcomes (1)

Study Arms (2)

Cohort 1

Cohort 2

Interventions

Eligibility Criteria

You may qualify if:

Sponsors & Collaborators

Study Sites (6)

MeSH Terms

Conditions

Condition Hierarchy (Ancestors)

Study Officials

Enrollment

Study Design

Study Record Dates

You may not qualify if:

Source record

Locations