InfluenzaPhase 3NCT03450915
A Pivotal Trial to Assess the Safety and Clinical Efficacy of the M-001 as a Standalone Universal Flu Vaccine
A Phase 3 study testing M-001 and Saline in people with Influenza, run by BiondVax Pharmaceuticals ltd. at 2 sites in Poland.
Trial summary
The pivotal Phase 3 trial plans to enroll a total of approximately 12,460 participants aged 50+ over two years. Participants will be immunized twice with the M-001 universal influenza vaccine candidate or placebo and then followed for up to 2 seasons. Read more about this study
- Who is it for?
- Ages 50 years and olderHealthy volunteers can take part
- Conditions the study is for
- Influenza
- What is being tested?
- M-001 and Saline
- Type of treatment
- Vaccines
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 12,460 participants
- Where
- 2 sitesPoland
- Study dates
- 1 Aug 2018to 23 Oct 2020
- Phase
- Phase 3
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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 50 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Male and female subjects 50 years of age (inclusive) or older, mentally competent, willing and able to give the written informed consent prior to study entry
- Able to comply with the trial procedures and be available for all study visits.
- Medically stable. (Subjects may have underlying chronic conditions such as hypertension, diabetes, ischemic heart disease, or hypothyroidism, as long as their symptoms/signs are controlled. If they are on medication for a condition, the medication dose must have been stable for at least 3 months preceding vaccination).
- Women of childbearing potential (not surgically sterile or postmenopausal for greater than or equal to one year) and men must agree to practice adequate contraception (barrier or hormone methods or intra uterine device (IUD) for women and a condom for men) throughout the study treatment and for at least up to day 51 (for female) and day 111 (for male) of the trial (i.e. 30 (for female) and 90 (for male) days after the last dose of the IMP)
- Female subjects of childbearing potential must have a negative urine or serum pregnancy test within 24 hours prior to study vaccination.
Who cannot join
- History of neurological symptoms or signs, or anaphylactic shock following administration of any vaccine.
- Known or suspected (or have a high risk of developing) impairment/alteration of immune function (excluding that normally associated with advanced age).
- Receipt of: a) Immunosuppressive drugs: i) systemic glucocorticoids >/= 10 mg prednisone per day ii) cytotoxic drugs b) Investigational drugs within 30 days before, or planned during, the study c) Blood products within 3 months before, or planned during, the study d) Influenza vaccine within 6 months before the study) Other vaccines within 30 days before, or planned during, the study
- Any serious disease such as: cancer, autoimmune disease, advanced arteriosclerotic disease or complicated diabetes mellitus, chronic obstructive pulmonary disease (COPD) that requires oxygen therapy, acute or progressive hepatic disease, acute or progressive renal disease, or congestive heart failure, as judged by the PI.
- An acute illness, including an axillary temperature greater than 38 Celsius (38ºC), occurred within 1 week before first vaccination
- Positive positive urine pregnancy test prior to vaccination or women who are breastfeeding.
Trial locations and contacts
2 sites in 1 country.
Poland2 sites
Jagiellońskie Centrum Innowacji Sp.z o.o.
Krakow, Ul. Bobrzyńskiego 14,, 30-348
Jagiellońskie Centrum Innowacji Sp.z o.o.
Krakow, 30348
About this study
Official title: A Pivotal Multi-center, Randomized, Modified Double-blind, Placebo-controlled Phase 3 Trial to Assess the Safety and Clinical Efficacy of M-001 Influenza Vaccine Administered Intra-muscularly Twice in Older Adults and Elderly (≥50 Years).
The pivotal Phase 3 trial plans to enroll a total of approximately 12,460 participants aged 50+ over two years. Participants will be immunized twice with the M-001 universal influenza vaccine candidate or placebo and then followed for up to 2 seasons. The trial will evaluate the number of influenza cases in each group and the severity of illness during the follow up period.
Read the detailed description
The placebo-controlled pivotal clinical efficacy Phase 3 trial plans to enroll a total of approximately 12,460 participants over two years. Participants will be immunized twice with the M-001 influenza vaccine candidate or placebo. Influenza incidence and illness severity will be evaluated throughout the follow-up period of up to two years. Participants will be 50 years and older, with at least half over 65 years of age.
The trial is expected to take place in eastern European countries and begin prior to the 2018/19 Northern Hemisphere flu season.
- Conditions
- Influenza
- Being tested
- M-001, Saline
- Keywords
- Influenza, vaccine, universal, M-001, Multimeric-001, Flu
- Medical subject headings
- Influenza, Human
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
M-001Biological
Also called Multimeric-001
A recombinant protein containing 9 conserved epitopes from Influenza A and B that are common to the vast majority of influenza viruses.
SalineBiological
0.9% sodium chloride (NaCl)
| Study group | Role | What they receive |
|---|---|---|
| M-001 | Experimental | Participants will be vaccinated with 1mg dose of M-001 twice: Once at Day 0, and once at Day 21. Receives: Biological: M-001 |
| Saline | Placebo comparator | Participants will be vaccinated with saline twice: Once at Day 0, and once at Day 21. Receives: Biological: Saline |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of Participants With qRT-PCR or Culture-confirmed Influenza-like Illness
Prevention of influenza disease by comparing the occurrence of either qRT-PCR or culture confirmed influenza in the M-001 experimental group vs. placebo caused by any influenza A or B virus in association with a protocol defined Influenza Like Illness.
Measured: From Day 14 post-second vaccination day to end of influenza season, an average of 4 months per participant per year
Number of Participants With One or More Serious Adverse Events, New Onset Chronic Illness, and Non-solicited Adverse Events
Number of participants with one or more Serious Adverse Events, New Onset Chronic illness, and Non-solicited Adverse Events assessed during one flu season per participant
Measured: From Day 0 to end of study completion by participant which coincides with end of flu season in the respective year, an average of 4 months per participant per year
Secondary outcomes (3)
Number of Participants With Culture-confirmed Influenza Incidence
Occurrence of culture confirmed influenza in the M-001 experimental group vs. placebo caused by any influenza A or B virus in association with a protocol defined Influenza Like Illness.
Measured: From Day 14 post-second vaccination day to end of influenza season, an average of 4 months per participant per year
Number of Participants With Reduction of Severity of qRT-PCR or Culture-confirmed Influenza
Assessed by reduction of severity of either qRT-PCR or culture-confirmed influenza illness by the reduction due to M-001 in the average number of days with respiratory or systemic symptoms during the first laboratory-confirmed influenza illness episode.
Measured: From Day 14 post-second vaccination day to end of influenza season, an average of 4 months per participant per year
Number of Participants With Influenza-like Illness Symptoms
Assessment of number of participants having ILI symptoms in the experimental or control group
Measured: From Day 14 post-second vaccination day to end of influenza season, an average of 4 months per participant per year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Mar 2018
- Study start1 Aug 2018
- Primary completion2 Jul 2020
- Study completion23 Oct 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- 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
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Experimental group: 2 immunizations with M-001 Control group: 2 injection of saline (placebo)
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 12,460 participants (actual)
Sponsor and investigators
- Lead sponsor
- BiondVax Pharmaceuticals ltd.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Tamar Ben-Yedidia, PhD, Study director, BiondVax Pharmaceuticals ltd.
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03450915
- Sponsor's protocol ID
- BVX-010
- Status last verified
- Sep 2021
- First submitted
- 8 Feb 2018
- Last updated
- 5 Oct 2021
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 5 Oct 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Pivotal Multi-center, Randomized, Modified Double-blind, Placebo-controlled Phase 3 Trial to Assess the Safety and Clinical Efficacy of M-001 Influenza Vaccine Administered Intra-muscularly Twice in Older Adults and Elderly (≥50 Years).
- ClinicalTrials.gov ID
- NCT03450915
- Acronym / sponsor ID
- BVX-010
- Conditions
- Influenza
- Keywords
- Influenza, vaccine, universal, M-001, Multimeric-001, Flu
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 12,460 participants (actual)
- Lead sponsor
- BiondVax Pharmaceuticals ltd.Industry (pharma, biotech, devices)
- Study start
- 1 Aug 2018 (actual)
- Primary completion
- 2 Jul 2020 (actual)
- Study completion
- 23 Oct 2020 (actual)
- First posted
- 1 Mar 2018 (actual)
- Results
- Posted 13 Sep 2021
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The pivotal Phase 3 trial plans to enroll a total of approximately 12,460 participants aged 50+ over two years. Participants will be immunized twice with the M-001 universal influenza vaccine candidate or placebo and then followed for up to 2 seasons. The trial will evaluate the number of influenza cases in each group and the severity of illness during the follow up period.
Detailed description
The placebo-controlled pivotal clinical efficacy Phase 3 trial plans to enroll a total of approximately 12,460 participants over two years. Participants will be immunized twice with the M-001 influenza vaccine candidate or placebo. Influenza incidence and illness severity will be evaluated throughout the follow-up period of up to two years. Participants will be 50 years and older, with at least half over 65 years of age.
The trial is expected to take place in eastern European countries and begin prior to the 2018/19 Northern Hemisphere flu season.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
- Model description
- Experimental group: 2 immunizations with M-001 Control group: 2 injection of saline (placebo)
| Arm | Type | Receives |
|---|---|---|
| M-001 | Experimental | Biological: M-001Participants will be vaccinated with 1mg dose of M-001 twice: Once at Day 0, and once at Day 21. |
| Saline | Placebo comparator | Biological: SalineParticipants will be vaccinated with saline twice: Once at Day 0, and once at Day 21. |
Who may qualify
- Ages
- 50 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Male and female subjects 50 years of age (inclusive) or older, mentally competent, willing and able to give the written informed consent prior to study entry
- Able to comply with the trial procedures and be available for all study visits.
- Medically stable. (Subjects may have underlying chronic conditions such as hypertension, diabetes, ischemic heart disease, or hypothyroidism, as long as their symptoms/signs are controlled. If they are on medication for a condition, the medication dose must have been stable for at least 3 months preceding vaccination).
- Women of childbearing potential (not surgically sterile or postmenopausal for greater than or equal to one year) and men must agree to practice adequate contraception (barrier or hormone methods or intra uterine device (IUD) for women and a condom for men) throughout the study treatment and for at least up to day 51 (for female) and day 111 (for male) of the trial (i.e. 30 (for female) and 90 (for male) days after the last dose of the IMP)
- Female subjects of childbearing potential must have a negative urine or serum pregnancy test within 24 hours prior to study vaccination.
Key exclusion criteria (6 listed)
- History of neurological symptoms or signs, or anaphylactic shock following administration of any vaccine.
- Known or suspected (or have a high risk of developing) impairment/alteration of immune function (excluding that normally associated with advanced age).
- Receipt of: a) Immunosuppressive drugs: i) systemic glucocorticoids >/= 10 mg prednisone per day ii) cytotoxic drugs b) Investigational drugs within 30 days before, or planned during, the study c) Blood products within 3 months before, or planned during, the study d) Influenza vaccine within 6 months before the study) Other vaccines within 30 days before, or planned during, the study
- Any serious disease such as: cancer, autoimmune disease, advanced arteriosclerotic disease or complicated diabetes mellitus, chronic obstructive pulmonary disease (COPD) that requires oxygen therapy, acute or progressive hepatic disease, acute or progressive renal disease, or congestive heart failure, as judged by the PI.
- An acute illness, including an axillary temperature greater than 38 Celsius (38ºC), occurred within 1 week before first vaccination
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 |
|---|---|---|
| M-001Also: Multimeric-001A recombinant protein containing 9 conserved epitopes from Influenza A and B that are common to the vast majority of influenza viruses. | Biological | M-001 |
| Saline0.9% sodium chloride (NaCl) | Biological | Saline |
Primary outcome
Number of Participants With qRT-PCR or Culture-confirmed Influenza-like Illness
Time frame: From Day 14 post-second vaccination day to end of influenza season, an average of 4 months per participant per year
Prevention of influenza disease by comparing the occurrence of either qRT-PCR or culture confirmed influenza in the M-001 experimental group vs. placebo caused by any influenza A or B virus in association with a protocol defined Influenza Like Illness.
Number of Participants With One or More Serious Adverse Events, New Onset Chronic Illness, and Non-solicited Adverse Events
Time frame: From Day 0 to end of study completion by participant which coincides with end of flu season in the respective year, an average of 4 months per participant per year
Number of participants with one or more Serious Adverse Events, New Onset Chronic illness, and Non-solicited Adverse Events assessed during one flu season per participant
3 secondary outcomes
Number of Participants With Culture-confirmed Influenza Incidence
Time frame: From Day 14 post-second vaccination day to end of influenza season, an average of 4 months per participant per year
Number of Participants With Reduction of Severity of qRT-PCR or Culture-confirmed Influenza
Time frame: From Day 14 post-second vaccination day to end of influenza season, an average of 4 months per participant per year
Number of Participants With Influenza-like Illness Symptoms
Time frame: From Day 14 post-second vaccination day to end of influenza season, an average of 4 months per participant per year
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Oct 2021.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Individual participant dataSharing planned: No
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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.
Tamar Ben-Yedidia, PhD study director
BiondVax Pharmaceuticals ltd.
2 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 M-001 and Saline in people with Influenza, run by BiondVax Pharmaceuticals ltd. at 2 sites in Poland.
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 5 inclusion and 6 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 5 Oct 2021. 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 Poland. 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. Some participants in this study may receive a placebo. 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?
Yes. Results are posted in the registry (first posted 13 Sep 2021). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
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 Participants With qRT-PCR or Culture-confirmed Influenza-like Illness (time frame: From Day 14 post-second vaccination day to end of influenza season, an average of 4 months per participant per year). 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 5 Oct 2021; AzTrials last refreshed its copy on 8 Nov 2026.