Safety and Immunogenicity Study of an Inactivated Influenza Vaccine (Split Virus, Vero Cell Derived)

• Register: ClinicalTrials.gov
• Last refreshed on: 17 October 2012
• Main ID: NCT00424086
• Date of registration: 17/01/2007
• Primary sponsor: Baxter Healthcare Corporation
• Public title: Safety and Immunogenicity Study of an Inactivated Influenza Vaccine (Split Virus, Vero Cell Derived)
• Scientific title: Single Blind, Randomized, Actively Controlled Phase 1/2 Study to Compare the Safety and Immunogenicity of a Split Virus, Vero Cell Derived, Seasonal Influenza Vaccine (VCIC) With a Licensed, Egg Derived, Split Virus, Seasonal Influenza Vaccine (EIV)
• Date of first enrolment: January 2007
• Target sample size: 1000
• Recruitment status: Completed
• URL: http://clinicaltrials.gov/show/NCT00424086
• Study type: Interventional
• Study design: Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Single Blind, Primary Purpose: Prevention

Countries of recruitment

Austria, Germany, Poland

Contacts

• Name: Baxter BioScience Investigator
• Affiliation: Baxter Healthcare Corporation

Key inclusion & exclusion criteria

Inclusion Criteria:

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 Criteria:

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:

1. They do not have an oral temperature >=37.5°C at the repeat visit,

2. The repeat visit is no more than 5 calendar days after the initial Day 0 visit,

3. The repeat visit is no more than 21 calendar days after all other screening
procedures are completed,

4. Subjects are still being recruited at the study site.



Age minimum: 18 Years
Age maximum: N/A
Gender: Both

Health Condition(s) or Problem(s) studied

Influenza

Intervention(s)

Biological: Inactivated seasonal influenza vaccine (split virus, egg derived) [licensed control vaccine]

Biological: Inactivated seasonal influenza vaccine (split virus, vero cell derived)

Primary Outcome(s)

To assess the immunogenicity of Vero cell derived vaccine in comparison to egg-derived vaccine for subjects in two age strata: 18 to 49 years of age and 50 years of age and older

To assess the safety and tolerability of Vero cell derived vaccine in comparison to egg-derived vaccine in healthy subjects in two age strata: 18 to 49 years, and 50 years of age and older

Secondary ID(s)

720601

Source(s) of Monetary Support

Please refer to primary and secondary sponsors