InfluenzaPhase 3NCT01767896
Phase-3 Study of ASP7374, Cell-culture-derived Influenza Vaccine
A Phase 3 study testing ASP7374 and approved egg-derived TIV in people with Influenza, run by UMN Pharma Inc. at 3 sites in Japan.
Trial summary
The purpose of this study is to compare immunogenicity and safety of ASP7374 (cell-culture derived influenza vaccine) with those of approved egg-derived trivalent inactivated vaccine (TIV) in elderly subjects. 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?
- ASP7374 and approved egg-derived TIV
- Type of treatment
- Vaccines, Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 1,020 participants
- Where
- 3 sitesJapan
- Study dates
- Oct 2012to Mar 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
- Medically stable, as judged on the basis of history and concurrent diseases
- Subject understands procedure of the protocol and is willing to comply with the protocol
Who cannot join
- Scheduled to receive another vaccine during the study
- Received influenza HA vaccine within 180 days prior to screening
- Received or scheduled to receive a live vaccine within 28 days prior to vaccination with the study vaccine, and received or scheduled to receive an inactivated vaccine or a toxoid within 7 days prior to vaccination with the study vaccine
- Diagnosis of immune deficit in the past, has a family member (within the third degree of kinship) with a diagnosis of congenital immunodeficiency syndrome
- Received one of the following medications or treatment prior to vaccination with the study vaccine: Interferon formulation, drugs which affect the immune system, corticosteroids, G-CSF, M-CSF, human immunoglobulin products, blood products
- History of anaphylactic shock or an allergic reaction such as generalized eruption due to food or drug (including vaccines) allergies, fever ≥39.0°C within 2 days after the previous vaccination (influenza vaccine and others)
Show all 11Show fewer
- History of seizures
- History of Guillain-Barre syndrome or acute disseminated encephalomyelitis (ADEM)
- Confirmed diagnosis of influenza within 84 days prior to screening test
- Body temperature of ≥37.5°C on Day 1 (before vaccination)
- Immunological tests reveal positive HBs antigen, HCV antibody, and HIV antigen and/or antibody
Trial locations and contacts
3 sites in 1 country.
About this study
Official title: Phase III Study of ASP7374 -Approved Egg-derived Vaccine Controlled, Double-blind, Parallel Group Study in Elderly Subjects
The purpose of this study is to compare immunogenicity and safety of ASP7374 (cell-culture derived influenza vaccine) with those of approved egg-derived trivalent inactivated vaccine (TIV) in elderly subjects.
- Conditions
- Influenza
- Being tested
- ASP7374, approved egg-derived TIV
- Keywords
- Influenza 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.
ASP7374Biological
subcutaneous (sc)
approved egg-derived TIVBiological
Also called Influenza HA vaccine "SEIKEN"
subcutaneous (sc)
| Study group | Role | What they receive |
|---|---|---|
| ASP7374 group | Experimental | cell-culture-derived vaccine group Receives: Biological: ASP7374 |
| TIV group | Active comparator | approved egg-derived TIV group Receives: Biological: approved egg-derived TIV |
What is being measured
The primary outcome is the main question the study is designed to answer.
seroconversion rate of hemoagglutination inhibition (HI) antibody titer
evaluated for A/H1N1, A/H3N2, and B
Measured: Day 29
geometric mean titer (GMT) of HI antibody titer
evaluated for A/H1N1, A/H3N2, and B
Measured: Day 29
Secondary outcomes (6)
seroprotection rate of HI antibody titer
evaluated for A/H1N1, A/H3N2, and B
Measured: Day 29
GMT ratio of HI antibody titer
evaluated for A/H1N1, A/H3N2, and B
Measured: Day 1 and Day 29
seroconversion rate of neutralizing antibody titer
evaluated for A/H1N1, A/H3N2, and B
Measured: Day 29
seroprotection rate of neutralizing antibody titer
evaluated for A/H1N1, A/H3N2, and B
Measured: Day 29
GMT of neutralizing antibody
evaluated for A/H1N1, A/H3N2, and B
Measured: Day 29
GMT ratio of neutralizing antibody
evaluated for A/H1N1, A/H3N2, and B
Measured: Day 1 and Day 29
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Jan 2013 (estimated)
- Study startOct 2012
- Primary completionMar 2013
- Study completionMar 2013
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for 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 3
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 1,020 participants (actual)
Sponsor and investigators
- Lead sponsor
- UMN Pharma Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Medical Director, Study director, Astellas Pharma Inc
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01767896
- Sponsor's protocol ID
- 7374-CL-0103
- Status last verified
- Sep 2017
- First submitted
- 11 Jan 2013
- Last updated
- 29 Sep 2017
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 29 Sep 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Phase III Study of ASP7374 -Approved Egg-derived Vaccine Controlled, Double-blind, Parallel Group Study in Elderly Subjects
- ClinicalTrials.gov ID
- NCT01767896
- Acronym / sponsor ID
- 7374-CL-0103
- Conditions
- Influenza
- Keywords
- Influenza vaccine
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 1,020 participants (actual)
- Lead sponsor
- UMN Pharma Inc.Industry (pharma, biotech, devices)
- Study start
- Oct 2012
- Primary completion
- Mar 2013 (actual)
- Study completion
- Mar 2013 (actual)
- First posted
- 15 Jan 2013 (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 compare immunogenicity and safety of ASP7374 (cell-culture derived influenza vaccine) with those of approved egg-derived trivalent inactivated vaccine (TIV) in elderly subjects.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| ASP7374 group | Experimental | Biological: ASP7374cell-culture-derived vaccine group |
| TIV group | Active comparator | Biological: approved egg-derived TIVapproved egg-derived TIV group |
Who may qualify
- Ages
- 65 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Older adult
Key inclusion criteria (2 listed)
- Medically stable, as judged on the basis of history and concurrent diseases
- Subject understands procedure of the protocol and is willing to comply with the protocol
Key exclusion criteria (11 listed)
- Scheduled to receive another vaccine during the study
- Received influenza HA vaccine within 180 days prior to screening
- Received or scheduled to receive a live vaccine within 28 days prior to vaccination with the study vaccine, and received or scheduled to receive an inactivated vaccine or a toxoid within 7 days prior to vaccination with the study vaccine
- Diagnosis of immune deficit in the past, has a family member (within the third degree of kinship) with a diagnosis of congenital immunodeficiency syndrome
- Received one of the following medications or treatment prior to vaccination with the study vaccine: Interferon formulation, drugs which affect the immune system, corticosteroids, G-CSF, M-CSF, human immunoglobulin products, blood products
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 |
|---|---|---|
| ASP7374subcutaneous (sc) | Biological | ASP7374 group |
| approved egg-derived TIVAlso: Influenza HA vaccine "SEIKEN"subcutaneous (sc) | Biological | TIV group |
Primary outcome
seroconversion rate of hemoagglutination inhibition (HI) antibody titer
Time frame: Day 29
evaluated for A/H1N1, A/H3N2, and B
geometric mean titer (GMT) of HI antibody titer
Time frame: Day 29
evaluated for A/H1N1, A/H3N2, and B
6 secondary outcomes
seroprotection rate of HI antibody titer
Time frame: Day 29
GMT ratio of HI antibody titer
Time frame: Day 1 and Day 29
seroconversion rate of neutralizing antibody titer
Time frame: Day 29
seroprotection rate of neutralizing antibody titer
Time frame: Day 29
GMT of neutralizing antibody
Time frame: Day 29
GMT ratio of neutralizing antibody
Time frame: Day 1 and Day 29
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 29 Sep 2017.
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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.
Medical Director study director
Astellas Pharma Inc
3 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing ASP7374 and approved egg-derived TIV in people with Influenza, run by UMN Pharma 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 2 inclusion and 11 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 29 Sep 2017. 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 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?
seroconversion rate of hemoagglutination inhibition (HI) antibody titer (time frame: Day 29). 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?
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 29 Sep 2017.