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Comparison of the Immunogenicity, Safety and Reactogenicity of FluBlok, To a Licensed Vaccine In Elderly Adults

Primary Purpose

Influenza

Status

Completed

Phase

Phase 3

Locations

United States

Study Type

Interventional

Intervention

Influenza Vaccination

About this trial

This is an interventional prevention trial for Influenza focused on measuring Influenza

Eligibility Criteria

65 Years - undefined (Older Adult)All SexesAccepts Healthy Volunteers

Inclusion Criteria:

Ambulatory adults aged 65 and older
Medically stable, as determined by oral temperature <100.0°F, medical history, and targeted physical examination based on medical history
Able to understand and comply with planned study procedures
Provides written informed consent prior to initiation of any study procedure.

Exclusion Criteria:

Known allergy to eggs or other vaccine components.
Immunosuppression as a result of an underlying illness or treatment, or used anticancer chemotherapy or radiation therapy within the preceding 36 months.
Any malignancy (excluding nonmelanotic skin cancer or lymphoproliferative disorder), other than localized prostrate cancer, diagnosed or treated actively during the past 5 years. Subjects with any history of lymphoproliferative disorder will be excluded, while subjects with a history of localized nonmelanotic skin cancer may be eligible.
Long-term use of oral steroids, parenteral steroids, or high-dose inhaled steroids within the preceding 6 months (Nasal and topical steroids are allowed).
Major psychiatric diagnosis including schizophrenia, bipolar disease or other major depression, or any diagnosis of dementia or associated concomitant medications (e.g., Aricept) used for treating dementia
History of receiving immunoglobulin or other blood product within the 3 months prior to enrollment in this study.
Receipt of any other licensed vaccines within 2 weeks (for inactivated vaccines) or 4 weeks (for live vaccines) prior to enrollment in this study.
History of severe reactions following immunization with influenza virus vaccines.
Moderate to severe acute illness or febrile illness (oral temperature greater than 100*F) within 1 week prior to vaccination.
Receipt of an experimental agent (vaccine, drug, biologic, device, blood product or medication) within 1 month prior to enrollment in this study, or expects to receive an experimental agent during study period.
Known active human immunodeficiency virus, hepatitis B, or hepatitis C infection.
History of alcohol or drug abuse in the last 5 years.
History of Guillain-Barré Syndrome.
Any acute or chronic medical condition that, in the opinion of the investigator, would render vaccination unsafe, interfere with the evaluation of responses, or render the subject unable to meet the requirements of the protocol. These conditions include, but are not limited to: history of significant renal impairment (dialysis and treatment for kidney disease, including diabetic and hypertensive kidney disease); subjects with diabetes mellitus, well-controlled with oral agents may enroll as long there has been no dosage increase within the past 6 months; insulin-dependent diabetes is excluded; cardiac insufficiency, if heart failure is present (New York Heart Association Functional Class III or IV); an arteriosclerotic event during the 6 months prior to enrollment (e.g., history of myocardial infarction, stroke, recanalization of femoral arteries, or transient ischemic attack).

Sites / Locations

Center of Vaccine Development, Univ. of Maryland
Passport Health Maryland
Mayo Clinic College of Medicine
Passport Health New Jersey
Rochester Medical Center
Primary Physicians Research
Baylor College of Medicine

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

FluBlok

TIV (Fluzone)

Arm Description

Recombinant Trivalent Hemagglutinin Influenza Vaccine: 2005-2006 formulation containing 45μg of each hemagglutinin derived from A/New Caledonia (H1N1), A/Wisconsin (H3N2) and B/Ohio 135μg total

Licensed trivalent influenza vaccine (TIV): 2005-2006 formulation containing 15μg of each hemagglutinin derived from A/Wisconsin (H3N2), A/New Caledonia (H1N1) and B/Malaysia 45μg total (Fluzone, sanofi pasteur)

Outcomes

Primary Outcome Measures

Evaluation of safety and reactogenicity of FluBlok and TIV in medically stable adults 65 years and older.

Secondary Outcome Measures

Comparison of relative efficacy and effectiveness of FluBlok and TIV in medically stable adults 65 years and older.

Evaluation and comparison of immunogenicity of FluBlok and TIV in medically stable adults 65 years and older.

Full Information

NCT ID

NCT00395174

First Posted

October 30, 2006

Last Updated

December 16, 2009

Sponsor

Protein Sciences Corporation

1. Study Identification

Unique Protocol Identification Number

NCT00395174

Brief Title

Comparison of the Immunogenicity, Safety and Reactogenicity of FluBlok, To a Licensed Vaccine In Elderly Adults

Official Title

Comparison of the Immunogenicity, Safety and Reactogenicity of FluBlok, Trivalent Recombinant Baculovirus-Expressed Hemagglutinin Influenza Vaccine, to a Licensed Egg-Grown Influenza Vaccine In Ambulatory Elderly Adults

Study Type

Interventional

2. Study Status

Record Verification Date

December 2009

Overall Recruitment Status

Completed

Study Start Date

October 2006 (undefined)

Primary Completion Date

May 2007 (Actual)

Study Completion Date

May 2007 (Actual)

3. Sponsor/Collaborators

Name of the Sponsor

Protein Sciences Corporation

4. Oversight

Data Monitoring Committee

Yes

5. Study Description

Brief Summary

The purpose of this study were to obtain additional evidence in support of the safety and immunogenicity of a recombinant hemagglutinin (rHA) vaccine in an elderly population, and to establish non-inferiority of the immunogenicity of the rHA vaccine when compared with a licensed trivalent influenza vaccine (TIV). Another purpose was to provide a preliminary estimate of the relative efficacy of the two vaccines against culture-positive influenza-like illness during the subsequent epidemic.

Detailed Description

Annual influenza epidemics are associated with serious excess morbidity and mortality, particularly among the elderly. Licensed trivalent inactivated influenza vaccines (TIVs) have been shown to reduce hospitalization and death following influenza in this vulnerable population, but their efficacy is lower than that observed in younger, healthy populations. In addition, recent studies have questioned the level of effectiveness of TIV in the elderly, suggesting that cohort studies have overestimated the benefits of immunization with current TIV formulations in this age group. In view of these considerations, it is widely accepted that improved and alternative vaccines are needed for control of seasonal and pandemic influenza. Currently available TIVs are prepared from viruses that are grown in embryonated hens' eggs. Alternative substrates for vaccine production are desirable in order to reduce the vulnerability of and to expand influenza vaccine supply. Recombinant DNA techniques allow for expression of the influenza hemagglutinin (rHA) by baculovirus vectors in insect cell cultures. Advantages of this technique include speed of production, absence of egg protein, and a highly purified product. Previous studies among healthy younger and older adults have confirmed that rHA vaccines are safe, well tolerated and immunogenic at dosages up to nine times higher than those contained in TIV. Dose-related increases in serum antibody levels after immunization also were observed.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Influenza

Keywords

Influenza

7. Study Design

Primary Purpose

Prevention

Study Phase

Phase 3

Interventional Study Model

Factorial Assignment

Masking

ParticipantInvestigator

Allocation

Randomized

Enrollment

870 (Actual)

8. Arms, Groups, and Interventions

Arm Title

FluBlok

Arm Type

Experimental

Arm Description

Recombinant Trivalent Hemagglutinin Influenza Vaccine: 2005-2006 formulation containing 45μg of each hemagglutinin derived from A/New Caledonia (H1N1), A/Wisconsin (H3N2) and B/Ohio 135μg total

Arm Title

TIV (Fluzone)

Arm Type

Active Comparator

Arm Description

Intervention Type

Biological

Intervention Name(s)

Influenza Vaccination

Other Intervention Name(s)

FluBlok, Fluzone, rHA, rHA0, recombinant hemagglutinin, TIV

Intervention Description

0.5mL dose for intramuscular injection

Primary Outcome Measure Information:

Title

Evaluation of safety and reactogenicity of FluBlok and TIV in medically stable adults 65 years and older.

Time Frame

influenza season

Secondary Outcome Measure Information:

Title

Comparison of relative efficacy and effectiveness of FluBlok and TIV in medically stable adults 65 years and older.

Time Frame

influenza season

Title

Evaluation and comparison of immunogenicity of FluBlok and TIV in medically stable adults 65 years and older.

Time Frame

influenza season

10. Eligibility

Sex

All

Minimum Age & Unit of Time

65 Years

Accepts Healthy Volunteers

Eligibility Criteria

Inclusion Criteria: Ambulatory adults aged 65 and older Medically stable, as determined by oral temperature <100.0°F, medical history, and targeted physical examination based on medical history Able to understand and comply with planned study procedures Provides written informed consent prior to initiation of any study procedure. Exclusion Criteria: Known allergy to eggs or other vaccine components. Immunosuppression as a result of an underlying illness or treatment, or used anticancer chemotherapy or radiation therapy within the preceding 36 months. Any malignancy (excluding nonmelanotic skin cancer or lymphoproliferative disorder), other than localized prostrate cancer, diagnosed or treated actively during the past 5 years. Subjects with any history of lymphoproliferative disorder will be excluded, while subjects with a history of localized nonmelanotic skin cancer may be eligible. Long-term use of oral steroids, parenteral steroids, or high-dose inhaled steroids within the preceding 6 months (Nasal and topical steroids are allowed). Major psychiatric diagnosis including schizophrenia, bipolar disease or other major depression, or any diagnosis of dementia or associated concomitant medications (e.g., Aricept) used for treating dementia History of receiving immunoglobulin or other blood product within the 3 months prior to enrollment in this study. Receipt of any other licensed vaccines within 2 weeks (for inactivated vaccines) or 4 weeks (for live vaccines) prior to enrollment in this study. History of severe reactions following immunization with influenza virus vaccines. Moderate to severe acute illness or febrile illness (oral temperature greater than 100*F) within 1 week prior to vaccination. Receipt of an experimental agent (vaccine, drug, biologic, device, blood product or medication) within 1 month prior to enrollment in this study, or expects to receive an experimental agent during study period. Known active human immunodeficiency virus, hepatitis B, or hepatitis C infection. History of alcohol or drug abuse in the last 5 years. History of Guillain-Barré Syndrome. Any acute or chronic medical condition that, in the opinion of the investigator, would render vaccination unsafe, interfere with the evaluation of responses, or render the subject unable to meet the requirements of the protocol. These conditions include, but are not limited to: history of significant renal impairment (dialysis and treatment for kidney disease, including diabetic and hypertensive kidney disease); subjects with diabetes mellitus, well-controlled with oral agents may enroll as long there has been no dosage increase within the past 6 months; insulin-dependent diabetes is excluded; cardiac insufficiency, if heart failure is present (New York Heart Association Functional Class III or IV); an arteriosclerotic event during the 6 months prior to enrollment (e.g., history of myocardial infarction, stroke, recanalization of femoral arteries, or transient ischemic attack).

Overall Study Officials: