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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT00424086
Recruitment Status : Completed
First Posted : January 18, 2007
Last Update Posted : October 9, 2015
Information provided by:
Nanotherapeutics, Inc.

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, Split Virus, Seasonal Influenza Vaccine (EIV) in healthy subjects 18 years of age and older.

Approximately 1000 subjects will be randomly assigned in a 3:1 ratio to receive a single injection of VCIV or EIV. Subjects will be monitored for 180 days following vaccination for occurrence of adverse reactions and for antibody response to the vaccine.

Condition or disease Intervention/treatment Phase
Influenza Biological: Inactivated seasonal influenza vaccine (split virus, vero cell derived) Biological: Inactivated seasonal influenza vaccine (split virus, egg derived) [licensed control vaccine] Phase 1 Phase 2

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 1000 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single
Primary Purpose: Prevention
Official 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)
Study Start Date : January 2007
Study Completion Date : September 2007

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Flu Flu Shot
U.S. FDA Resources

Primary Outcome Measures :
  1. 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
  2. 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

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes

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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00424086

Graz, Austria, 8042
Universitaetsklinik f. Klinische Pharmakologie, Allgemeines Krankenhaus Wien (University Hospital for Clinical Pharmacology, General Hospital of Vienna)
Vienna, Austria, 1090
MDS Pharma Services Germany GmbH
Hamburg, Germany, 22769
Internistische Gemeinschaftspraxis Dr. Regner & Dr. Schmitt (Group practice for internal medicine)
Mainz, Germany, 55116
Harrison Clinical Research
Munich, Germany, 80636
Zespol Przychodni Specjalistycznych "DIAB-END-COR" Sp. z o.o.
Krakow, Poland, 31-135
PANTAMED Sp. z o.o.
Olsztyn, Poland, 10-461
Niepubliczny Zaklad Opieki Zdrowotnej, Osrodek Zdrowia w Lipsku
Zamosc, Poland, 22-400
Sponsors and Collaborators
Nanotherapeutics, Inc.
Principal Investigator: Baxter BioScience Investigator Baxter Healthcare Corporation

ClinicalTrials.gov Identifier: NCT00424086     History of Changes
Other Study ID Numbers: 720601
First Posted: January 18, 2007    Key Record Dates
Last Update Posted: October 9, 2015
Last Verified: January 2008

Additional relevant MeSH terms:
Influenza, Human
Orthomyxoviridae Infections
RNA Virus Infections
Virus Diseases
Respiratory Tract Infections
Respiratory Tract Diseases
Immunologic Factors
Physiological Effects of Drugs