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

NCT00424086 | Completed Phase 1 DMC

• 1 other identifier: 720601
• Study Type: interventional
• Target: 1,000
• Locations: 3 countries
• Sites: 8

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.

Conditions

Influenza

Outcome Measures

Primary Outcomes (2)

• 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

• 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

Interventions

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

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

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.)

You may not qualify if:

• 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)

Sponsors & Collaborators

• Alachua Government Services, Inc.: lead

Study Sites (8)

Kinemed

Graz, 8042, Austria

Location

Universitaetsklinik f. Klinische Pharmakologie, Allgemeines Krankenhaus Wien (University Hospital for Clinical Pharmacology, General Hospital of Vienna)

Vienna, 1090, Austria

Location

MDS Pharma Services Germany GmbH

Hamburg, 22769, Germany

Location

Internistische Gemeinschaftspraxis Dr. Regner & Dr. Schmitt (Group practice for internal medicine)

Mainz, 55116, Germany

Location

Harrison Clinical Research

Munich, 80636, Germany

Location

Zespol Przychodni Specjalistycznych "DIAB-END-COR" Sp. z o.o.

Krakow, 31-135, Poland

Location

PANTAMED Sp. z o.o.

Olsztyn, 10-461, Poland

Location

Niepubliczny Zaklad Opieki Zdrowotnej, Osrodek Zdrowia w Lipsku

Zamość, 22-400, Poland

Location

MeSH Terms

Conditions

Influenza, Human

Condition Hierarchy (Ancestors)

Respiratory Tract Infections; Infections; Orthomyxoviridae Infections; RNA Virus Infections; Virus Diseases; Respiratory Tract Diseases

Study Officials

• Baxter BioScience Investigator

  Baxter Healthcare Corporation

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: SINGLE
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY

Study Record Dates

• First Submitted: January 17, 2007
• First Posted: January 18, 2007
• Study Start: January 1, 2007
• Study Completion: September 1, 2007
• Last Updated: October 9, 2015

Record last verified: 2008-01

Locations

DE (3); PL (3); AU (2)