Status:
COMPLETED
Safety and Immunogenicity Study of an Inactivated Influenza Vaccine (Split Virus, Vero Cell Derived)
Lead Sponsor:
Alachua Government Services, Inc.
Conditions:
Influenza
Eligibility:
All Genders
18+ years
Phase:
PHASE1
PHASE2
Brief Summary
The objective of this study is to assess the safety, tolerability and immunogenicity of a Split Virus, Vero Cell derived, Seasonal Influenza Vaccine (VCIV) in comparison to a Licensed Egg Derived, Spl...
Eligibility Criteria
Inclusion
- Male and female subjects who
- Are 18 to 49 years of age (inclusive) on the day of screening (Stratum A)
- Are 50 years of age or older on the day of screening (Stratum B)
- Have an understanding of the study, agree to its provisions, and give written informed consent prior to study entry
- Are clinically healthy (in a physical condition such that the physician would have no reservations administering influenza vaccine outside the scope of a clinical study)
- Are physically and mentally capable of participating in the study
- Agree to keep a daily record of symptoms
- If female and capable of bearing children, have a negative urine pregnancy test result within 24 hours of the vaccination on Study Day 0 and agree to employ adequate birth control measures. For the purposes of this study adequate birth control measures incorporate 2 types of the following FDA approved birth control measures through 60 days after vaccination:
- Hormonal types of birth control (such as implants, birth control pills, patches or other methods) or an intrauterine device, AND
- An additional barrier type of birth control measure (i.e., condoms, diaphragms, cervical caps, etc.)
Exclusion
- Subjects who
- Have previously been vaccinated against influenza with vaccine formulated for the 2006/2007 influenza season
- Have an oral temperature \>=37.5°C at the time of vaccination on Day 0 (see note below)
- Have Type I diabetes
- Have a Body Mass Index \>35
- Have hypertension at screening (with or without medication) that is graded as greater than Stage 1 defined as a systolic pressure \>159 or diastolic pressure \>99 while seated and at rest (measurement may be repeated twice before subject is absolutely excluded)
- Have clinically significant abnormal clinical laboratory values at screening
- Have clinically significant electrocardiographic abnormalities at screening
- Test positive for Human Immunodeficiency Virus(HIV), Hepatitis B Surface Antigen (HbsAg) or Hepatitis C Virus (HCV)
- Have a history of cardiovascular disease that required hospitalization
- Have a history of immunodeficiency or autoimmune diseases
- Have a history of arthritis (joint swelling, tenderness, warmth or erythema) on more than one occasion, not related to trauma (including running) or any episode of non-trauma related arthritis within the previous 6 months
- Suffer from active neoplastic disease or have a history of hematologic malignancy
- Suffer from a disease or are 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 (\>800 μg/day of beclomethasone dipropionate or equivalent) corticosteroids, radiation treatment or other immunosuppressive or cytotoxic drugs
- Have a history of inflammatory or degenerative neurological disease (e.g. Guillain Barré, multiple sclerosis)
- Have received any vaccination within 2 weeks prior to vaccination in this study
- Have received a blood transfusion or immunoglobulins within 30 days prior to vaccination in this study
- Have donated blood or plasma within 30 days prior to vaccination in this study
- Have a history of any vaccine related contraindicating event (e.g., anaphylaxis, allergy to eggs, allergy to components of the test or comparator vaccine, other known contraindications)
- Have a rash, dermatologic condition or tattoos which may interfere with injection site reaction rating
- Have a positive urine drug screen (unless the detected drug is currently prescribed by a licensed health care provider and the continued administration of the drug would not otherwise exclude the subject from participation)
- Were administered an investigational drug within 6 weeks prior to study entry
- Are concurrently participating in a clinical study that Inactivated Influenza Vaccine (Split Virus, Vero Cell Derived)includes the administration of an investigational product
- Are a member of the team conducting this study
- Are in a dependent relationship with the study investigator. Dependent relationships include close relatives (i.e., children, partner/spouse, siblings, parents) as well as employees of the investigator
- If female, are pregnant or lactating.
- NOTE: If all other inclusion/exclusion criteria are met, a subject with a temperature \>=37.5°C on Day 0 may be included in the study at a repeat visit provided:
- They do not have an oral temperature \>=37.5°C at the repeat visit,
- The repeat visit is no more than 5 calendar days after the initial Day 0 visit,
- The repeat visit is no more than 21 calendar days after all other screening procedures are completed,
- Subjects are still being recruited at the study site.
Key Trial Info
Start Date :
January 1 2007
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
September 1 2007
Estimated Enrollment :
1000 Patients enrolled
Trial Details
Trial ID
NCT00424086
Start Date
January 1 2007
End Date
September 1 2007
Last Update
October 9 2015
Active Locations (8)
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1
Kinemed
Graz, Austria, 8042
2
Universitaetsklinik f. Klinische Pharmakologie, Allgemeines Krankenhaus Wien (University Hospital for Clinical Pharmacology, General Hospital of Vienna)
Vienna, Austria, 1090
3
MDS Pharma Services Germany GmbH
Hamburg, Germany, 22769
4
Internistische Gemeinschaftspraxis Dr. Regner & Dr. Schmitt (Group practice for internal medicine)
Mainz, Germany, 55116