Single blind, randomized, active controlled Phase 1/2 study to compare the safety and immunogenicity of a Split Virus, Vero cell-derived, seasonal influenza vaccine (VCIV) with a licensed egg-derived, Split Virus, seasonal influenza vaccine (EIV) - Phase 1/2 Split Virus Influenza Vaccine Trial
- Conditions
- Influenza Vaccination in healthy subjects
- Registration Number
- EUCTR2006-005191-41-AT
- Lead Sponsor
- Baxter Healthcare Corporation, Baxter BioScience
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ot Recruiting
- Sex
- All
- Target Recruitment
- 1000
Male and female subjects will be eligible for participation in this study if they:
- 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 two types of the following FDA approved birth control measures through 60 days after the 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.).
Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range
Subjects will be excluded from this study if they:
- Have previously been vaccinated against influenza with vaccine formulated for the 2006/2007 influenza season
- Have an oral temperature of ?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) cortico-steroids, 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 six weeks prior to study entry
- Are concurrently participating in a clinical study that includes the administration of an investigational product
- Are a member of the team conducting this study
- re 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.
Study & Design
- Study Type
- Interventional clinical trial of medicinal product
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Secondary Objective: ;Main Objective: To assess the safety and tolerability of a Split Virus Vero Cell Derived, Seasonal Influenza Vaccine in comparison to an egg derived vaccine in two age strata 18 to 49 years of age and 50 years of age and older.<br><br>To assess the immunogenicity of a Split Virus Vero Cell Derived, Seasonal Influenza Vaccine in comparison to an egg derived vaccine in two age strata 18 to 49 years of age and 50 years of age and older.;Primary end point(s): The primary end point is the number of subjects in each vaccine group with oral temperatures greater or equal to 38°C and onset within 2 days after vaccination.
- Secondary Outcome Measures
Name Time Method