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

October 7, 2015 updated by: Ology Bioservices

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)

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Anticipated)

1000

Phase

  • Phase 2
  • Phase 1

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

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

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Prevention
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

What is the study measuring?

Primary Outcome Measures

Outcome Measure
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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Ology Bioservices

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

January 1, 2007

Study Completion (Actual)

September 1, 2007

Study Registration Dates

First Submitted

January 17, 2007

First Submitted That Met QC Criteria

January 17, 2007

First Posted (Estimate)

January 18, 2007

Study Record Updates

Last Update Posted (Estimate)

October 9, 2015

Last Update Submitted That Met QC Criteria

October 7, 2015

Last Verified

January 1, 2008

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 720601

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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