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AzTrials

InfluenzaPhase 3NCT01774032

H5N1 Vaccine Study in Japanese Elderly Population Aged 65 Years and Older

A Phase 3 study testing H5N1 Influenza Vaccine (Whole Virion, Vero Cell-Derived, Inactivated), non-adjuvanted formulation in people with Influenza, run by Alachua Government Services, Inc. at 2 sites in Japan.

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 purpose of this study is to obtain immunogenicity and safety data of an H5N1 pandemic influenza vaccine in a Japanese elderly population aged 65 years and older. Read more about this study

Who is it for?
Ages 65 years and olderHealthy volunteers can take part
Conditions the study is for
Influenza
What is being tested?
H5N1 Influenza Vaccine (Whole Virion, Vero Cell-Derived, Inactivated), non-adjuvanted formulation
Could I receive a placebo?
No, everyone receives an active treatment
How many people
91 participants
Where
2 sitesJapan
Study dates
Mar 2013to Oct 2013
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 65 years and older
  • All sexes
  • Healthy volunteers accepted
  • Older adult

Who may be able to join

  • Participant is 65 years or older at the time of screening.
  • Participant is generally healthy, as determined by the investigator's clinical judgment through collection of medical history and performance of a physical examination.
  • Participant is physically and mentally capable of participating in the study.
  • Participant is willing and able to comply with the requirements of the protocol.

Who cannot join

  • Participant has a history of infection with H5N1 virus or a history of vaccination with an H5N1 influenza vaccine.
  • Participant is at high risk of contracting H5N1 influenza infection (e.g., poultry workers).
  • Participant 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.
  • Participant has any inherited or acquired immunodeficiency.
  • Participant 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.
  • Participant has a history of severe allergic reactions or anaphylaxis.
Show all 15Show fewer
  • Participant has a rash, dermatologic condition or tattoos which may interfere with injection site reaction rating.
  • Participant has received a blood transfusion or immunoglobulins within 90 days prior to study entry.
  • Participant has donated blood or plasma within 30 days prior to study entry.
  • Participant 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.
  • Participant has a functional or surgical asplenia.
  • Participant has a known or suspected problem with alcohol or drug abuse.
  • Participant has been exposed to an investigational product (IP) within 30 days prior to enrollment or is scheduled to participate in another clinical study involving an IP or investigational device during the course of this study.
  • Participant is a family member or employee of the investigator.
  • Participant has any other condition that disqualifies his/her participation in the study in the opinion of the investigator.

Trial locations and contacts

2 sites in 1 country.

Japan2 sites

  • PS Clinic

    Fukuoka, 812-0025

  • Osaka Pharmacology Clinical Research Hospital (OPHAC Hospital)

    Osaka, 532-0003

Other trials in Japan

About this study

Official title: An Open-Label Phase 3 Study to Assess Immunogenicity and Safety of a Vero Cell-Derived Whole Virus H5N1 Influenza Vaccine in a Japanese Elderly Population Aged 65 Years and Older

The purpose of this study is to obtain immunogenicity and safety data of an H5N1 pandemic influenza vaccine in a Japanese elderly population aged 65 years and older.

Conditions
Influenza
Being tested
H5N1 Influenza Vaccine (Whole Virion, Vero Cell-Derived, Inactivated), non-adjuvanted formulation
Medical subject headings
Influenza, Human

What participants receive

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

  • H5N1 Influenza Vaccine (Whole Virion, Vero Cell-Derived, Inactivated), non-adjuvanted formulationBiological

Study groups in NCT01774032
Study groupRoleWhat they receive
Influenza VaccineExperimentalOne dose of the vaccine will be administered at a volume of 0.5 mL by intramuscular injection into the musculus deltoideus in the upper arm on Day 1 and 22.
Receives: Biological: H5N1 Influenza Vaccine (Whole Virion, Vero Cell-Derived, Inactivated), non-adjuvanted formulation

What is being measured

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

  1. Co-Primary Evaluation of Immunogenicity by Single Radial Hemolysis (SRH) Assay: Number of participants with antibody response to vaccine strain (A/Indonesia/05/2005)

    Associated with protection 21 days after second vaccination defined as hemolysis area measured by SRH assay ≥25mm^2

    Measured: Day 43 (42 days after first vaccination, 21 days after second vaccination)

  2. Co-Primary Evaluation of Immunogenicity by SRH Assay: Number of participants demonstrating seroconversion 21 days after the second vaccination

    'Seroconversion' is defined as either a ≥25mm^2 hemolysis area after the vaccination in case of a negative prevaccination sample (≤4mm^2) or a ≥50% increase in hemolysis area if the prevaccination sample is >4mm^2.

    Measured: Day 43 (42 days after first vaccination, 21 days after second vaccination)

  3. Co-Primary Evaluation of Immunogenicity by SRH Assay: Fold increase of antibody response 21 days after the second vaccination as compared to baseline

    Measured: Day 43 (42 days after first vaccination, 21 days after second vaccination)

Secondary outcomes (16)

  1. Evaluation of Immunogenicity by SRH Assay: Number of participants with antibody response to the vaccine strain (A/Indonesia/05/2005)

    Associated with protection 21 days after the first and 180 days after the second vaccination defined as SRH area ≥25mm^2

    Measured: Days 22 and 202

  2. Evaluation of Immunogenicity by SRH Assay: Number of participants demonstrating seroconversion 21 days after the first and 180 days after the second vaccination

    'Seroconversion' is defined as either a ≥25mm^2 hemolysis area after the vaccination in case of a negative prevaccination sample [≤4mm^2] or a ≥50% increase in hemolysis area if the prevaccination sample is >4mm^2.

    Measured: Days 22 and 202

  3. Evaluation of Immunogenicity by SRH Assay: Antibody response 21 days after the first and 21 and 180 days after the second vaccination

    Measured: Days 22, 43 and 202

  4. Evaluation of Immunogenicity by SRH Assay: Fold increase of antibody response 21 days after the first and 180 days after the second vaccination as compared to baseline

    Measured: Days 22 and 202

  5. Evaluation of Immunogenicity by Microneutralization (MN) Assay: Number of participants with antibody response to the vaccine strain (A/Indonesia/05/2005)

    Associated with protection 21 days after the first and 21 and 180 days after the second vaccination defined as MN titer ≥ 1:20

    Measured: Days 22, 43 and 202

  6. Evaluation of Immunogenicity by MN Assay: Number of participants demonstrating seroconversion 21 days after the first and 21 and 180 days after the second vaccination

    'Seroconversion' is defined as a four-fold or greater increase in titer as compared to baseline.

    Measured: Days 22, 43 and 202

  7. Evaluation of Immunogenicity by MN Assay: Number of participants demonstrating either ≥4-fold titer increase compared to baseline if above detection limit OR ≥ 20 titer after vaccination if baseline titer is below detection limit

    Measured: Days 22, 43 and 202

  8. Evaluation of Immunogenicity by MN Assay: Antibody response 21 days after the first and 21 and 180 days after the second vaccination

    Measured: Days 22, 43 and 202

  9. Evaluation of Immunogenicity by MN Assay: Fold increase of antibody response 21 days after the first and 21 and 180 days after the second vaccination as compared to baseline

    Measured: Days 22, 43 and 202

  10. Evaluation of Immunogenicity by Hemagglutination Inhibition (HI) Assay: Number of participants with antibody response to the vaccine strain (A/Indonesia/05/2005)

    Associated with protection 21 days after the first and 21 and 180 days after second vaccination defined as HI titer ≥ 1:40

    Measured: Days 22, 43 and 202

  11. Evaluation of Immunogenicity by HI Assay: Number of participants demonstrating seroconversion 21 days after the first and 21 and 180 days after the second vaccination

    'Seroconversion' is defined as a 4-fold or greater increase in HI titer as compared to baseline

    Measured: Days 22, 43 and 202

  12. Evaluation of Immunogenicity by HI Assay: Antibody response 21 days after the first and 21 and 180 days after the second vaccination

    Measured: Days 22, 43 and 202

  13. Evaluation of Immunogenicity by HI Assay: Fold increase of antibody response 21 days after the first and 21 and 180 days after the second vaccination as compared to baseline

    Measured: Days 22, 43 and 202

  14. Frequency and severity of injection site and systemic reactions until 21 days after the first and second vaccinations

    Measured: Through study day 43

  15. Number of participants with fever, malaise or shivering with onset within 7 days after the first and second vaccinations

    Measured: Days 1-8 and days 22-29

  16. Frequency and severity of all adverse events (AEs) observed during the entire study period

    Measured: Throughout the study period- 8 months

Timeline

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

  1. First posted23 Jan 2013 (estimated)
  2. Study startMar 2013
  3. Primary completionJun 2013
  4. Study completionOct 2013

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
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrolment
91 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT01774032
Sponsor's protocol ID
811201
Status last verified
Apr 2014
First submitted
17 Jan 2013
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 H5N1 Influenza Vaccine (Whole Virion, Vero Cell-Derived, Inactivated), non-adjuvanted formulation in people with Influenza, run by Alachua Government Services, Inc. at 2 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 15 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 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 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?

Co-Primary Evaluation of Immunogenicity by Single Radial Hemolysis (SRH) Assay: Number of participants with antibody response to vaccine strain (A/Indonesia/05/2005) (time frame: Day 43 (42 days after first vaccination, 21 days after second 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?

On the ClinicalTrials.gov record for NCT01774032.

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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