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InfluenzaPhase 3NCT00462215

Phase 3 Immunogenicity and Safety Study of an Inactivated H5N1 Influenza Vaccine (Whole Virion, Vero Cell Derived)

A Phase 3 study testing Whole virion, Vero cell-derived influenza vaccine containing H5N1 HA antigen in people with Influenza, run by Alachua Government Services, Inc. at 2 sites in 2 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 objectives of this study are to assess the immune response as well as the safety and tolerability of an H5N1 influenza vaccine in an adult and elderly population. Further, the study will assess the need for a booster vaccination and whether a 6-month booster or a 12-month booster is more appropriate. 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?
Whole virion, Vero cell-derived influenza vaccine containing H5N1 HA antigen
Type of treatment
Vaccines
Could I receive a placebo?
No, everyone receives an active treatment
How many people
550 participants
Where
2 sitesin 2 countries
Study dates
Apr 2007to Feb 2010
Phase
Phase 3
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 will be eligible for participation in this study if they:
  • Are 18 to 59 years of age on the day of screening (for Stratum A only),
  • Are 60 years of age and older on the day of screening (for Stratum B only),
  • 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 vaccinating with an influenza vaccine outside the scope of a clinical study),
  • Agree to keep a daily record of symptoms,
  • If female and capable of bearing children - have a negative urine pregnancy test result at study entry and agree to employ adequate birth control measures for the duration of the study.

Who cannot join

  • Subjects will be excluded from participation in this study if they:
  • Have a history of exposure to H5N1 virus or a history of vaccination with an H5N1 influenza vaccine,
  • Are at high risk of contracting H5N1 influenza infection (e.g. poultry workers),
  • Suffer from or have a history of a significant cardiovascular, pulmonary, neurological, hepatic, rheumatic, autoimmune, hematological, metabolic or renal disorder,
  • Are unable to lead an independent life as a result of either physical or mental handicap,
  • Suffer from any kind of immunodeficiency,
Show all 17Show fewer
  • Suffer from a disease or were undergoing a treatment within 30 days prior to study entry or are currently 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 (>800µg/day of beclomethasone dipropionate or equivalent) corticosteroids, radiation treatment or other immunosuppressive or cytotoxic drugs,
  • Have a history of severe allergic reactions or anaphylaxis,
  • Have a rash, dermatologic condition or tattoos which may interfere with injection site reaction rating,
  • Have received a blood transfusion or immunoglobulins within 90 days of study entry,
  • Have donated blood or plasma within 30 days of study entry,
  • Have received any live vaccine within 4 weeks or inactivated vaccine within 2 weeks prior to vaccination in this study,
  • Have a functional or surgical asplenia,
  • Have a known or suspected problem with alcohol or drug abuse,
  • Were administered an investigational drug within six weeks prior to study entry or are concurrently participating in a clinical study that includes the administration of an investigational product,
  • Are a member of the team conducting this study or 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.

Trial locations and contacts

2 sites in 2 countries.

2 sites in 2 countries

Austria1 site

  • University Hospital, Department of Clinical Pharmacology, General Hospital Vienna

    Vienna, 1090

Other trials in Austria

Germany1 site

  • University Hospital Mainz

    Mainz, 55101

Other trials in Germany

About this study

Official title: An Open Label Phase III Study of a Vero Cell-Derived Whole Virus H5N1 Influenza Vaccine to Assess the Immunogenicity and Safety and to Investigate the Need for and Timing of a Booster Vaccination

The objectives of this study are to assess the immune response as well as the safety and tolerability of an H5N1 influenza vaccine in an adult and elderly population. Further, the study will assess the need for a booster vaccination and whether a 6-month booster or a 12-month booster is more appropriate. An independent data safety monitoring board will review and evaluate the safety data obtained in this study on an ongoing basis.

Conditions
Influenza
Being tested
Whole virion, Vero cell-derived influenza vaccine containing H5N1 HA antigen
Medical subject headings
Influenza, Human

What participants receive

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

  • Whole virion, Vero cell-derived influenza vaccine containing H5N1 HA antigenBiological

    Vaccination on Day 0 and Day 21 with the whole virion, Vero cell-derived influenza vaccine containing 7.5 µg H5N1 hemagglutinin (HA) antigen (without adjuvant) of the A/Vietnam/1203/2004 strain + 6-month booster vaccination with the H5N1 vaccine containing 3.75 mg HA antigen strain A/Vietnam/1203/2004

  • Whole virion, Vero cell-derived influenza vaccine containing H5N1 HA antigenBiological

    Vaccination on Day 0 and Day 21 with the whole virion, Vero cell-derived influenza vaccine containing 7.5 µg H5N1 hemagglutinin (HA) antigen (without adjuvant) of the A/Vietnam/1203/2004 strain + 6-month booster vaccination with the H5N1 vaccine containing 7.5 mg HA antigen strain A/Vietnam/1203/2004

  • Whole virion, Vero cell-derived influenza vaccine containing H5N1 HA antigenBiological

    Vaccination on Day 0 and Day 21 with the whole virion, Vero cell-derived influenza vaccine containing 7.5 µg H5N1 hemagglutinin (HA) antigen (without adjuvant) of the A/Vietnam/1203/2004 strain + 6-month booster vaccination with the H5N1 vaccine containing 3.75 mg HA antigen strain A/Indonesia/05/2005

  • Whole virion, Vero cell-derived influenza vaccine containing H5N1 HA antigenBiological

    Vaccination on Day 0 and Day 21 with the whole virion, Vero cell-derived influenza vaccine containing 7.5 µg H5N1 hemagglutinin (HA) antigen (without adjuvant) of the A/Vietnam/1203/2004 strain + 6-month booster vaccination with the H5N1 vaccine containing 7.5 mg HA antigen strain A/Indonesia/05/2005

  • Whole virion, Vero cell-derived influenza vaccine containing H5N1 HA antigenBiological

    Vaccination on Day 0 and Day 21 with the whole virion, Vero cell-derived influenza vaccine containing 7.5 µg H5N1 hemagglutinin (HA) antigen (without adjuvant) of the A/Vietnam/1203/2004 strain + 12-month booster vaccination with the H5N1 vaccine containing 3.75 mg HA antigen of the A/Indonesia/05/2005 strain

  • Whole virion, Vero cell-derived influenza vaccine containing H5N1 HA antigenBiological

    Vaccination on Day 0 and Day 21 with the whole virion, Vero cell-derived influenza vaccine containing 7.5 µg H5N1 hemagglutinin (HA) antigen (without adjuvant) of the A/Vietnam/1203/2004 strain + 24-month booster vaccination with the H5N1 vaccine containing 3.75 mg HA antigen of the A/Indonesia/05/2005 strain

Study groups in NCT00462215
Study groupRoleWhat they receive
1ExperimentalVaccination on Day 0 and Day 21 with the whole virion, Vero cell-derived influenza vaccine containing 7.5 µg H5N1 hemagglutinin (HA) antigen (without adjuvant) of the A/Vietnam/1203/2004 strain + 6-month booster vaccination with the H5N1 vaccine containing 3.75 mg HA antigen strain A/Vietnam/1203/2004
Receives: Biological: Whole virion, Vero cell-derived influenza vaccine containing H5N1 HA antigen
2ExperimentalVaccination on Day 0 and Day 21 with the whole virion, Vero cell-derived influenza vaccine containing 7.5 µg H5N1 hemagglutinin (HA) antigen (without adjuvant) of the A/Vietnam/1203/2004 strain + 6-month booster vaccination with the H5N1 vaccine containing 7.5 mg HA antigen strain A/Vietnam/1203/2004
Receives: Biological: Whole virion, Vero cell-derived influenza vaccine containing H5N1 HA antigen
3ExperimentalVaccination on Day 0 and Day 21 with the whole virion, Vero cell-derived influenza vaccine containing 7.5 µg H5N1 hemagglutinin (HA) antigen (without adjuvant) of the A/Vietnam/1203/2004 strain + 6-month booster vaccination with the H5N1 vaccine containing 3.75 mg HA antigen strain A/Indonesia/05/2005
Receives: Biological: Whole virion, Vero cell-derived influenza vaccine containing H5N1 HA antigen
4ExperimentalVaccination on Day 0 and Day 21 with the whole virion, Vero cell-derived influenza vaccine containing 7.5 µg H5N1 hemagglutinin (HA) antigen (without adjuvant) of the A/Vietnam/1203/2004 strain + 6-month booster vaccination with the H5N1 vaccine containing 7.5 mg HA antigen strain A/Indonesia/05/2005
Receives: Biological: Whole virion, Vero cell-derived influenza vaccine containing H5N1 HA antigen
5ExperimentalVaccination on Day 0 and Day 21 with the whole virion, Vero cell-derived influenza vaccine containing 7.5 µg H5N1 hemagglutinin (HA) antigen (without adjuvant) of the A/Vietnam/1203/2004 strain + 12-month booster vaccination with the H5N1 vaccine containing 3.75 mg HA antigen of the A/Indonesia/05/2005 strain
Receives: Biological: Whole virion, Vero cell-derived influenza vaccine containing H5N1 HA antigen
6ExperimentalVaccination on Day 0 and Day 21 with the whole virion, Vero cell-derived influenza vaccine containing 7.5 µg H5N1 hemagglutinin (HA) antigen (without adjuvant) of the A/Vietnam/1203/2004 strain + 24-month booster vaccination with the H5N1 vaccine containing 3.75 mg HA antigen of the A/Indonesia/05/2005 strain
Receives: Biological: Whole virion, Vero cell-derived influenza vaccine containing H5N1 HA antigen

What is being measured

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

  1. Number of subjects with antibody response to the vaccine strain (A/Vietnam/1203/2004) associated with protection 21 days after the second vaccination defined as titer measured by microneutralization (MN) test >= 20.

    Measured: 21 days after the second vaccination (= Day 42 in the study)

Timeline

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

  1. First posted18 Apr 2007 (estimated)
  2. Study startApr 2007
  3. Primary completionJun 2007
  4. Study completionFeb 2010

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 3
Primary purpose
Prevention
Allocation
Randomised
Intervention model
Parallel groups
Masking
None (open label)
Enrolment
550 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT00462215
Sponsor's protocol ID
810601
Status last verified
Mar 2010
First submitted
17 Apr 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 3 study testing Whole virion, Vero cell-derived influenza vaccine containing H5N1 HA antigen in people with Influenza, run by Alachua Government Services, Inc. at 2 sites in 2 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 7 inclusion and 17 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 2 sites in Austria, Germany. 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 phase mean?

Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.

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?

Number of subjects with antibody response to the vaccine strain (A/Vietnam/1203/2004) associated with protection 21 days after the second vaccination defined as titer measured by microneutralization (MN) test >= 20. (time frame: 21 days after the second vaccination (= Day 42 in the study)). 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 NCT00462215.

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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