H5N1 InfluenzaPhase 2/3NCT01382329
H5N1 Vaccine Study in Japanese Adults
A Phase 2/3 study testing H5N1 (pre-)pandemic influenza vaccine (whole virion, Vero Cell derived, inactivated) in people with H5N1 Influenza, run by Alachua Government Services, Inc. at 3 sites in Japan.
Trial summary
The purpose of this study is to obtain immunogenicity and safety data of two different dose levels of an H5N1 pandemic influenza vaccine in a healthy Japanese adult population aged 18 to 59 years. Read more about this study
- Who is it for?
- Ages 18 to 59 yearsHealthy volunteers can take part
- Conditions the study is for
- H5N1 Influenza
- What is being tested?
- H5N1 (pre-)pandemic influenza vaccine (whole virion, Vero Cell derived, inactivated)
- Type of treatment
- Vaccines, Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 340 participants
- Where
- 3 sitesJapan
- Study dates
- Jun 2011to May 2012
- Phase
- Phase 2/3
- 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 to 59 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- Subject is 18 to 59 years old at the time of screening
- Subject is generally healthy, as determined by the investigator´s clinical judgement through collection of medical history and performance of a physical examination
- Subject is physically and mentally capable of participating in the study and willing to adhere to study procedures to include completion of all elements of the study diary
- If female of childbearing potential, subject presents with a negative urine pregnancy test result within 24 hours prior ot the scheduled first vaccination and agrees to employ adequate birth control measures for the duration of the study
Who cannot join
- Subject has a history of infectin with H5N1 virus or a history of vaccination with an H5N1 influenza vaccine
- Subject is at high risk of contracting H5N1 influenza infection (e.g. poultry workers)
- Subject currently has or has a history of a significant cardiovascular (including hypertension), respiratory (including asthma), metabolic, neurological (including Guillain-Barré Syndrome and acute disseminated encephalomyelitis), hepatic, rheumatic, autoimmune, hematological, gastrointestinal or renal disorder
- Subject has any inherited or acquired immunodeficiency
- Subject has a disease or is currently undergoing a form of treatment or was undergoing a form of treatment within 30 days prior to study entry that can be expected to influence immune response. Such treatment includes, but is not limited to: systemic or inhaled corticosteroids, radiation treatment, or other immunosuppressive or cytotoxic drugs
- Subject has a history of severe allergic reactions or anaphylaxis
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- Subject has a rash, dermatologic condition or tattoos which may interfere with injection site reaction rating
- Subject has received a blood transfusion or immunoglobulins within 90 days prior to study entry
- Subject has donated blood or plasma within 30 days prior to study entry
- Subject has received any influenza or any live vaccine within 4 weeks or any other inactivated vaccine within 2 weeks prior to vaccination in this study
- Subject has a functional or surgical asplenia
- Subject has a known or suspected problem with alcohol or drug abuse
- Subject was administered an investigational drug within 6 weeks prior to study entry or is concurrently participating in a clinical study that includes the administration of an investigational product
- Subject is a member of the team conducting this study or is in a dependent relationship with one of the study team members. Dependent relationships include close relatives (i.e., children, partner/spouse, siblings, parents) as well as employees of the investigator/subinvestigator or site personnel conducting the study
- If female, subject is pregnant or lactating at the time of enrollment
- Subject has any other condition that disqualifies his/her participation in the study in the opinion of the investigator
Trial locations and contacts
3 sites in 1 country.
Japan3 sites
Medical Co. LTA PS Clinic
Fukuoka, Fukuoka, 812-0025
CPC Clinic, Medipolis Medical Research Institute
Kagoshima, Kagoshima-ken, 890-0081
Osaka Pharmacology Clinical Research Hospital
Osaka, Osaka, 532-0003
About this study
Official title: A Blinded, Randomized Phase 2/3 Study to Assess Immunogenicity and Safety of Two Different Dose Levels of a Vero Cell-Derived Whole Virus H5N1 Influenza Vaccine in a Healthy Japanese Adult Population Aged 18 to 59 Years
The purpose of this study is to obtain immunogenicity and safety data of two different dose levels of an H5N1 pandemic influenza vaccine in a healthy Japanese adult population aged 18 to 59 years.
- Conditions
- H5N1 Influenza
- Being tested
- H5N1 (pre-)pandemic influenza vaccine (whole virion, Vero Cell derived, inactivated)
- Keywords
- Prophylaxis of influenza infection caused by a pandemic influenza virus (H5N1)
- Medical subject headings
- Influenza in Birds
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
H5N1 (pre-)pandemic influenza vaccine (whole virion, Vero Cell derived, inactivated)Biological
Intramuscular injection into the musculus deltoideus or subcutaneous injection in the upper arm
| Study group | Role | What they receive |
|---|---|---|
| Treatment group I / Intramuscular | Experimental | 85 subjects to receive 2 intramuscular vaccinations at Dose A on Days 1 and 22 Receives: Biological: H5N1 (pre-)pandemic influenza vaccine (whole virion, Vero Cell derived, inactivated) |
| Treatment group II / Intramuscular | Experimental | 85 subjects to receive 2 intramuscular vaccinations at Dose B on Days 1 and 22 Receives: Biological: H5N1 (pre-)pandemic influenza vaccine (whole virion, Vero Cell derived, inactivated) |
| Treatment group III / Subcutaneous | Experimental | 85 subjects to receive 2 subcutaneous vaccinations at Dose A on Days 1 and 22 Receives: Biological: H5N1 (pre-)pandemic influenza vaccine (whole virion, Vero Cell derived, inactivated) |
| Treatment group IV / Subcutaneous | Experimental | 85 subjects to receive 2 subcutaneous vaccinations at Dose B on Days 1 and 22 Receives: Biological: H5N1 (pre-)pandemic influenza vaccine (whole virion, Vero Cell derived, inactivated) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of subjects with antibody response to the vaccine strain
Measurement by single radial hemolysis (SRH) assay
Measured: 21 days after 2nd vaccination
Number of subjects demonstrating seroconversion
Measurement by SRH assay
Measured: 21 days after 2nd vaccination
Fold increase of antibody response
Measurement by SRH assay
Measured: 21 days after 2nd vaccination
Secondary outcomes (4)
Number of subjects with antibody response to the vaccine strain
Measurement by SRH (except at 21 days after 2nd vaccination), microneutralization (MN) and hemagglutination inhibition (HI) assay
Measured: 21 days after 1st and 21+180 days after 2nd vaccination
Number of subjects demonstrating seroconversion
Measurement by SRH (except at 21 days after 2nd vaccination), MN and HI assay
Measured: 21 days after 1st and 21+180 days after 2nd vaccination
Antibody response
Measurement by SRH, MN and HI assay
Measured: 21 days after 1st and 21 + 180 days after 2nd vaccination
Fold increase of antibody response
Measurement by SRH (except at 21 days after 2nd vaccination), MN and HI assay
Measured: 21 days after 1st and 21+180 days after 2nd vaccination as compared to baseline
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Jun 2011 (estimated)
- Study startJun 2011
- Primary completionAug 2011
- Study completionMay 2012
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for H5N1 InfluenzaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
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 2/3
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 340 participants (actual)
Sponsor and investigators
- Lead sponsor
- Alachua Government Services, Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Baxter Innovations GmbH
- Responsible party
- Sponsor
- Investigators
- Alexander Geisberger, MD, Study director, Baxter Innovations GmbH
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01382329
- Sponsor's protocol ID
- 811001
- Status last verified
- Sep 2012
- First submitted
- 24 Jun 2011
- Last updated
- 9 Oct 2015
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 9 Oct 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Blinded, Randomized Phase 2/3 Study to Assess Immunogenicity and Safety of Two Different Dose Levels of a Vero Cell-Derived Whole Virus H5N1 Influenza Vaccine in a Healthy Japanese Adult Population Aged 18 to 59 Years
- ClinicalTrials.gov ID
- NCT01382329
- Acronym / sponsor ID
- 811001
- Conditions
- H5N1 Influenza
- Keywords
- Prophylaxis of influenza infection caused by a pandemic influenza virus (H5N1)
- Phase
- Phase 2/3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 340 participants (actual)
- Lead sponsor
- Alachua Government Services, Inc.Industry (pharma, biotech, devices)
- Collaborators
- Baxter Innovations GmbH
- Study start
- Jun 2011
- Primary completion
- Aug 2011 (actual)
- Study completion
- May 2012 (actual)
- First posted
- 27 Jun 2011 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The purpose of this study is to obtain immunogenicity and safety data of two different dose levels of an H5N1 pandemic influenza vaccine in a healthy Japanese adult population aged 18 to 59 years.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| Treatment group I / Intramuscular | Experimental | Biological: H5N1 (pre-)pandemic influenza vaccine (whole virion, Vero Cell derived, inactivated)85 subjects to receive 2 intramuscular vaccinations at Dose A on Days 1 and 22 |
| Treatment group II / Intramuscular | Experimental | Biological: H5N1 (pre-)pandemic influenza vaccine (whole virion, Vero Cell derived, inactivated)85 subjects to receive 2 intramuscular vaccinations at Dose B on Days 1 and 22 |
| Treatment group III / Subcutaneous | Experimental | Biological: H5N1 (pre-)pandemic influenza vaccine (whole virion, Vero Cell derived, inactivated)85 subjects to receive 2 subcutaneous vaccinations at Dose A on Days 1 and 22 |
| Treatment group IV / Subcutaneous | Experimental | Biological: H5N1 (pre-)pandemic influenza vaccine (whole virion, Vero Cell derived, inactivated)85 subjects to receive 2 subcutaneous vaccinations at Dose B on Days 1 and 22 |
Who may qualify
- Ages
- 18 to 59 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (4 listed)
- Subject is 18 to 59 years old at the time of screening
- Subject is generally healthy, as determined by the investigator´s clinical judgement through collection of medical history and performance of a physical examination
- Subject is physically and mentally capable of participating in the study and willing to adhere to study procedures to include completion of all elements of the study diary
- If female of childbearing potential, subject presents with a negative urine pregnancy test result within 24 hours prior ot the scheduled first vaccination and agrees to employ adequate birth control measures for the duration of the study
Key exclusion criteria (16 listed)
- Subject has a history of infectin with H5N1 virus or a history of vaccination with an H5N1 influenza vaccine
- Subject is at high risk of contracting H5N1 influenza infection (e.g. poultry workers)
- Subject currently has or has a history of a significant cardiovascular (including hypertension), respiratory (including asthma), metabolic, neurological (including Guillain-Barré Syndrome and acute disseminated encephalomyelitis), hepatic, rheumatic, autoimmune, hematological, gastrointestinal or renal disorder
- Subject has any inherited or acquired immunodeficiency
- Subject has a disease or is currently undergoing a form of treatment or was undergoing a form of treatment within 30 days prior to study entry that can be expected to influence immune response. Such treatment includes, but is not limited to: systemic or inhaled corticosteroids, radiation treatment, or other immunosuppressive or cytotoxic drugs
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| H5N1 (pre-)pandemic influenza vaccine (whole virion, Vero Cell derived, inactivated)Intramuscular injection into the musculus deltoideus or subcutaneous injection in the upper arm | Biological | Treatment group I / Intramuscular, Treatment group II / Intramuscular, Treatment group III / Subcutaneous, Treatment group IV / Subcutaneous |
Primary outcome
Number of subjects with antibody response to the vaccine strain
Time frame: 21 days after 2nd vaccination
Measurement by single radial hemolysis (SRH) assay
Number of subjects demonstrating seroconversion
Time frame: 21 days after 2nd vaccination
Measurement by SRH assay
Fold increase of antibody response
Time frame: 21 days after 2nd vaccination
Measurement by SRH assay
4 secondary outcomes
Number of subjects with antibody response to the vaccine strain
Time frame: 21 days after 1st and 21+180 days after 2nd vaccination
Number of subjects demonstrating seroconversion
Time frame: 21 days after 1st and 21+180 days after 2nd vaccination
Antibody response
Time frame: 21 days after 1st and 21 + 180 days after 2nd vaccination
Fold increase of antibody response
Time frame: 21 days after 1st and 21+180 days after 2nd vaccination as compared to baseline
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Oct 2015.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Alexander Geisberger, MD study director
Baxter Innovations GmbH
3 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2/3 study testing H5N1 (pre-)pandemic influenza vaccine (whole virion, Vero Cell derived, inactivated) in people with H5N1 Influenza, run by Alachua Government Services, Inc. at 3 sites in Japan.
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 4 inclusion and 16 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 3 sites in Japan. 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 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
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 (time frame: 21 days after 2nd vaccination). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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.