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InfluenzaPhase 1/2NCT00424086

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

A Phase 1/2 study testing Inactivated seasonal influenza vaccine (split virus, vero cell derived) in people with Influenza, run by Alachua Government Services, Inc. at 8 sites in 3 countries.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial 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. Read more about this study

Who is it for?
Ages 18 years and olderHealthy volunteers can take part
Conditions the study is for
Influenza
What is being tested?
Inactivated seasonal influenza vaccine (split virus, vero cell derived)
Type of treatment
Vaccines
How many people
1,000 participants
Where
8 sitesin 3 countries
Study dates
Jan 2007to Sep 2007
Phase
Phase 1/2
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • Healthy volunteers accepted
  • Adult, Older adult

Who may be able to join

  • 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
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  • 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.)

Who cannot join

  • 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)
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  • 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:
  • They do not have an oral temperature >=37.5°C at the repeat visit,
  • The repeat visit is no more than 5 calendar days after the initial Day 0 visit,
  • The repeat visit is no more than 21 calendar days after all other screening procedures are completed,
  • Subjects are still being recruited at the study site.

Trial locations and contacts

8 sites in 3 countries.

8 sites in 3 countries

Germany3 sites

  • MDS Pharma Services Germany GmbH

    Hamburg, 22769

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

    Mainz, 55116

  • Harrison Clinical Research

    Munich, 80636

Other trials in Germany

Poland3 sites

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

    Krakow, 31-135

  • PANTAMED Sp. z o.o.

    Olsztyn, 10-461

  • Niepubliczny Zaklad Opieki Zdrowotnej, Osrodek Zdrowia w Lipsku

    Zamość, 22-400

Other trials in Poland

Austria2 sites

  • Kinemed

    Graz, 8042

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

    Vienna, 1090

Other trials in Austria

About this study

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)

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
Being tested
Inactivated seasonal influenza vaccine (split virus, vero cell derived), Inactivated seasonal influenza vaccine (split virus, egg derived) [licensed control vaccine]
Medical subject headings
Influenza, Human

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

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

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

What is being measured

The primary outcome is the main question the study is designed to answer.

  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

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted18 Jan 2007 (estimated)
  2. Study startJan 2007
  3. Study completionSep 2007

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 1/2
Primary purpose
Prevention
Allocation
Randomised
Intervention model
Parallel groups
Masking
Single blind
Enrolment
1,000 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT00424086
Sponsor's protocol ID
720601
Status last verified
Jan 2008
First submitted
17 Jan 2007
Last updated
9 Oct 2015
Results posted
No
Data monitoring committee
Yes

Questions about this trial

What is this clinical trial studying?

A Phase 1/2 study testing Inactivated seasonal influenza vaccine (split virus, vero cell derived) in people with Influenza, run by Alachua Government Services, Inc. at 8 sites in 3 countries.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 10 inclusion and 31 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 9 Oct 2015. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 8 sites in Germany, Poland, Austria. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this combined phase mean?

Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary 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. The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT00424086.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 9 Oct 2015.

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