InfluenzaPhase 2NCT05284799
Immunogenicity and Safety of the Concomitant Administration of OVX836 and Quadrivalent Influenza Vaccine in Healthy Volunteers.
A Phase 2 study testing OVX836 480µg and Quadrivalent Inactivated Influenza Vaccine (Fluarix® Tetra) in people with Influenza, run by Osivax at 1 site in Australia.
Trial summary
The present study will evaluate the concomitant administration of a Quadrivalent Inactivated Influenza Vaccine with the highest dose level of OVX836 (480µg) tested in the clinic to date, for which the likelihood for interference with Quadrivalent Inactivated Influenza Vaccine is considered the highest. Read more about this study
- Who is it for?
- Ages 18 to 55 yearsHealthy volunteers can take part
- Conditions the study is for
- Influenza
- What is being tested?
- OVX836 480µg and Quadrivalent Inactivated Influenza Vaccine (Fluarix® Tetra)
- Type of treatment
- Vaccines, Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 180 participants
- Where
- 1 siteAustralia
- Study dates
- 9 May 2022to 9 Dec 2022
- Phase
- Phase 2
- 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 55 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- Written informed consent.
- Healthy male or female subjects, as determined by medical history and medical examination.
- Between the age of 18 and 55 years, inclusive.
- Subjects who have fully been vaccinated with licensed Severe Acute Respiratory Syndrome Coronavirus-2 (COVID-19) vaccine(s) according to national recommendations for the corresponding population group, in vigor at the moment the study starts.
- Reliable and willing to make themselves available for the duration of the study, and willing and able to follow study procedures.
- Ability and technical possibility for completing an e-diary and ePRO.
Who cannot join
- Subjects with a body mass index ≤19 kg/m² or ≥35 kg/m² on the day of vaccination.
- Previous influenza vaccination within 6 months before the day of vaccination or planned to receive during the study duration.
- Any known or suspected immunodeficient conditions.
- Past or current history of significant autoimmune diseases, as judged by the Investigator.
- Current history of uncontrolled medical illness such as diabetes, hypertension, heart, renal or hepatic diseases.
- Known or suspected infection with human immunodeficiency virus, hepatitis C virus, or hepatitis B virus, based upon medical history or physical examination findings.
Show all 23Show fewer
- Female subjects: pregnant, breast-feeding or of childbearing potential without appropriate contraceptive methods in place for 2 months before enrolment, or with positive pregnancy test on the day of vaccination. Appropriate contraceptive methods are to be maintained until the end of the trial. Appropriate contraceptive methods are defined by the Clinical Trial Facilitation Group as follow: "Contraceptive methods that can achieve a failure rate of less than 1% per year when used consistently and correctly are considered as highly effective birth control methods. Such methods include: combined (estrogen- and progestogen-containing) hormonal contraception associated with inhibition of ovulation (oral, intravaginal, transdermal), progestogen-only hormonal contraception associated with inhibition of ovulation (oral, injectable, implantable intrauterine device, intrauterine hormone-releasing system), bilateral tubal occlusion, vasectomized partner and/or sexual abstinence (refraining from heterosexual intercourse)."
- Having received another vaccination within 3 months prior to the day of study vaccination with live attenuated vaccines, or within 1 month prior to the day of study vaccination with inactivated vaccines, except COVID-19 vaccine.
- Planning to receive other vaccines during the first 28 days following the study vaccine administration, except COVID-19 vaccine.
- Having received a COVID-19 vaccination within 2 weeks prior to the day of study vaccination.
- Planning to receive COVID-19 vaccine during the first week (within 7 days) following the study vaccine administration. An interval of preferably 14 days is recommended. If for scheduling reasons, COVID-19 vaccine has to be given on Day 8, the vaccination should be administered after completion of the study procedures.
- Administration of any investigational or non-registered drug or vaccine within 3 months prior to the administration of study vaccines, or planned administration of any such product during the whole study period.
- History of receiving blood, blood components or immunoglobulins within 3 months prior to the day of vaccination, or planned to receive such product during the whole study period.
- Presence of an acute febrile illness on the day of vaccination (oral temperature >38.0°C, temporary exclusion criterion).
- Past or current history of any progressive or severe neurological disorder, seizure disorder or Guillain-Barré syndrome.
- Behavioral or cognitive impairment, or psychiatric disease that, in the opinion of the Investigator, may interfere with the subject's ability to participate in the study.
- Past (stopped less than 6 months before enrolment) or current history of alcohol or drug abuse, or current smoking habit above 10 cigarettes per day, or current vaping.
- Treatment that can affect immune response such as systemic or high dose inhaled corticosteroids (>800μg/day beclomethasone or equivalent; occasional inhaled corticosteroids for asthma therapy are allowed), radiation treatment, cytotoxic drugs, or current or recent (within 30 days before study entry) chronic or prolonged (>10 days) use of systemic non-steroidal anti-inflammatory drugs, interferon, immunomodulators, allergy shots, as judged by the Investigator.
- History of severe allergic reactions and/or anaphylaxis, or serious adverse reactions to vaccines or allergy to any component of either of the study vaccines, including to egg protein or to kanamycin.
- Any contraindication to IM administration, as judged by the Investigator, including bleeding disorders such as hemophilia or anticoagulant therapy.
- Individuals with history of any illness that, in the opinion of the Investigator, might interfere with the results of the study or pose additional risk to the subjects due to participation in the study.
- Subjects with tattoos in the deltoid region bilaterally, which might interfere with observation of local signs and symptoms or other adverse events at the injection sites. In case of tattoos on one side, injections of study vaccines should be performed in the contralateral arm.
- Sponsor employees or Investigator site personnel directly affiliated with this study, and their immediate families. Immediate family is defined as a spouse, parent, child or sibling, whether biological or legally adopted, including children of newly composed families.
Trial locations and contacts
1 site in 1 country.
Australia1 site
Northern Beaches Clinical Research
Brookvale, New South Wales, 2100
About this study
Official title: Phase 2a, Randomized, Double-blind (Double-dummy), Controlled, Parallel-group Study to Evaluate the Immunogenicity and the Safety of the Concomitant Administration of OVX836 Influenza Vaccine and a Quadrivalent Inactivated Influenza Vaccine Given Intramuscularly as 2 Separate Injections in the Same Arm, in Comparison to Co-administration of Quadrivalent Inactivated Influenza Vaccine and Placebo and to Co-administration of OVX836 and Placebo Given Intramuscularly in Healthy Subjects.
The present study will evaluate the concomitant administration of a Quadrivalent Inactivated Influenza Vaccine with the highest dose level of OVX836 (480µg) tested in the clinic to date, for which the likelihood for interference with Quadrivalent Inactivated Influenza Vaccine is considered the highest.
Read the detailed description
This trial is a Phase 2a, randomized, double-blind, controlled study in 180 adult subjects to compare the immunogenicity and the safety of the concomitant administration (given intramuscularly, in healthy subjects, as 2 separate injections in the same arm) of:
- OVX836 influenza vaccine and a Quadrivalent Inactivated Influenza Vaccine
- Quadrivalent Inactivated Influenza Vaccine and placebo
- OVX836 influenza vaccine and placebo
- Conditions
- Influenza
- Being tested
- OVX836 480µg, Quadrivalent Inactivated Influenza Vaccine (Fluarix® Tetra), Placebo
- Medical subject headings
- Influenza, Human
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
OVX836 480µgBiological
One single administration intramuscularly at Day 1
Quadrivalent Inactivated Influenza Vaccine (Fluarix® Tetra)Biological
One single administration intramuscularly at Day 1
PlaceboBiological
One single administration intramuscularly at Day 1
| Study group | Role | What they receive |
|---|---|---|
| OVX836 480µg + Quadrivalent Inactivated Influenza Vaccine (Fluarix® Tetra) at commercial dose | Experimental | OVX836: Adjuvant-free recombinant influenza candidate vaccine based on Nucleoprotein of the incluenza virus. One single administration intramuscularly of 480µg dose on Day 1
AND
Fluarix® Tetra (GlaxoSmithKline Biologicals): Inactivated and purified split influenza vaccine. Receives: Biological: OVX836 480µg; Biological: Quadrivalent Inactivated Influenza Vaccine (Fluarix® Tetra) |
| Quadrivalent Inactivated Influenza Vaccine (Fluarix® Tetra) at commercial dose + Placebo | Active comparator | Fluarix® Tetra (GlaxoSmithKline Biologicals): Inactivated and purified split influenza vaccine.
AND
Placebo Comparator: Saline solution (B. Braun Ecoflac Plus) Saline solution (NaCl 0,9%), B. Braun Ecoflac Plus 50mL. One single administration intrumuscularly of a 0.8mL dose on Day 1 Receives: Biological: Quadrivalent Inactivated Influenza Vaccine (Fluarix® Tetra); Biological: Placebo |
| OVX836 480µg + Placebo | Placebo comparator | OVX836: Adjuvant-free recombinant influenza candidate vaccine based on Nucleoprotein of the incluenza virus. One single administration intramuscularly of 480µg dose on Day 1
AND
Placebo Comparator: Saline solution (B. Braun Ecoflac Plus) Saline solution (NaCl 0,9%), B. Braun Ecoflac Plus 50mL. One single administration intrumuscularly of a 0.8mL dose on Day 1 Receives: Biological: OVX836 480µg; Biological: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of seroconversion determined using Hemagglutination-Inhibition assay, for the four influenza strains contained in the Quadrivalent Influenza Vaccine.
Seroconversion is defined as a negative pre-vaccination Hemagglutination-Inhibition assay titer and post-vaccination Hemagglutination-Inhibition assay titer ≥1:40, or a fourfold increase in Hemagglutination-Inhibition assay titer between pre- and post-vaccination timepoints.
Measured: At Day 29 versus pre-injection baseline (Day 1)
Proportion of subjects achieving a titer ≥1:40 at Day 29 determined using Hemagglutination-Inhibition assay, for the four influenza strains contained in the Quadrivalent Influenza Vaccine.
Measured: At Day 29
Number of Hemagglutination-Inhibition assay titers geometric mean ratios >2.5 for the four influenza strains contained in the Quadrivalent Influenza Vaccine.
Measured: At Day 29 versus pre-injection baseline (Day 1)
Proportion of subjects reporting solicited local (Injection site redness, Injection site swelling, Injection site pain) and systemic signs and symptoms (Fatigue, Headache, Arthralgia, Malaise, Myalgia, Fever)
Measured: During 7 days after vaccine administration
Proportion of subjects reporting unsolicited AEs
Measured: During 29 days after vaccine administration
Proportion of subjects with Influenza-Like-Illness cases
Measured: During the whole study duration, 180 days
Severity scores of Influenza-Like-Illness cases (as per Flu-PRO questionnaire)
Measured: During the whole study duration, 180 days
Proportion of subjects reporting Serious Adverse Events
Measured: During the whole study duration, 180 days
Secondary outcomes (4)
Hemagglutination-Inhibition assay geometric mean titers for each of the four strains contained in the Quadrivalent Influenza Vaccine.
Measured: At Day 1 (pre-injection baseline) and Day 29
Cell-mediated immune response in terms of change of Nucleoprotein-specific T-cell frequencies in Peripheral Blood Mononuclear Cells, measured by Interferon Gamma Enzyme-Linked Immunospot Assay.
Measured: At Day 8 versus pre-injection baseline (Day 1)
Geometric Mean Titer of anti-Nucleoprotein immunoglobulin G (Enzyme-Linked Immunosorbent Assay, serum).
Measured: At Day 1, Day 8 and Day 29
Proportion of subjects with an increase (four-fold) in anti-Nucleoprotein Immunoglobulin G (Enzyme-Linked Immunosorbent Assay, serum) titer.
Measured: At Day 29 with respect to pre-injection baseline (Day 1)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Mar 2022
- Study start9 May 2022
- Primary completion19 Jul 2022
- Study completion9 Dec 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- 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 2
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Randomized assignment (1:1:1) into 3 groups of 60 subjects to receive: * First group: OVX836 480µg and Quadrivalent Inactivated Influenza Vaccine at commercial dose administered * Second group: Quadrivalent Inactivated Influenza Vaccine at commercial dose, concomitantly administered with placebo * Third group: OVX836 480µg, concomitantly administered with placebo
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 180 participants (actual)
Sponsor and investigators
- Lead sponsor
- Osivax
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Northern Beaches Clinical Research, Novotech (Australia) Pty Limited, Harmony Clinical Research BVBA
- Responsible party
- Sponsor
- Investigators
- Ross Aldrich, MBBS, Principal investigator, Northern Beaches Clinical Research
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05284799
- Sponsor's protocol ID
- OVX836-004
- Status last verified
- Dec 2022
- First submitted
- 10 Mar 2022
- Last updated
- 31 Oct 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Groth N, Bruhwyler J, Tourneur J, Piat E, Moris P, Le Vert A, Nicolas F. Safety and Immunogenicity of OVX836, a Nucleoprotein-Based Universal Influenza Vaccine, Co-Administered with Fluarix(R) Tetra, a Seasonal Hemagglutinin-Based Vaccine. Vaccines (Basel). 2025 May 23;13(6):558. doi: 10.3390/vaccines13060558.
PubMed 40573889
Study at a glance
From the registry record, last updated by the sponsor on 31 Oct 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Phase 2a, Randomized, Double-blind (Double-dummy), Controlled, Parallel-group Study to Evaluate the Immunogenicity and the Safety of the Concomitant Administration of OVX836 Influenza Vaccine and a Quadrivalent Inactivated Influenza Vaccine Given Intramuscularly as 2 Separate Injections in the Same Arm, in Comparison to Co-administration of Quadrivalent Inactivated Influenza Vaccine and Placebo and to Co-administration of OVX836 and Placebo Given Intramuscularly in Healthy Subjects.
- ClinicalTrials.gov ID
- NCT05284799
- Acronym / sponsor ID
- OVX836-004
- Conditions
- Influenza
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 180 participants (actual)
- Lead sponsor
- OsivaxIndustry (pharma, biotech, devices)
- Collaborators
- Northern Beaches Clinical Research, Novotech (Australia) Pty Limited, Harmony Clinical Research BVBA
- Study start
- 9 May 2022 (actual)
- Primary completion
- 19 Jul 2022 (actual)
- Study completion
- 9 Dec 2022 (actual)
- First posted
- 17 Mar 2022 (actual)
- 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 present study will evaluate the concomitant administration of a Quadrivalent Inactivated Influenza Vaccine with the highest dose level of OVX836 (480µg) tested in the clinic to date, for which the likelihood for interference with Quadrivalent Inactivated Influenza Vaccine is considered the highest.
Detailed description
This trial is a Phase 2a, randomized, double-blind, controlled study in 180 adult subjects to compare the immunogenicity and the safety of the concomitant administration (given intramuscularly, in healthy subjects, as 2 separate injections in the same arm) of:
- OVX836 influenza vaccine and a Quadrivalent Inactivated Influenza Vaccine
- Quadrivalent Inactivated Influenza Vaccine and placebo
- OVX836 influenza vaccine and placebo
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 3
- Model description
- Randomized assignment (1:1:1) into 3 groups of 60 subjects to receive: * First group: OVX836 480µg and Quadrivalent Inactivated Influenza Vaccine at commercial dose administered * Second group: Quadrivalent Inactivated Influenza Vaccine at commercial dose, concomitantly administered with placebo * Third group: OVX836 480µg, concomitantly administered with placebo
| Arm | Type | Receives |
|---|---|---|
| OVX836 480µg + Quadrivalent Inactivated Influenza Vaccine (Fluarix® Tetra) at commercial dose | Experimental | Biological: OVX836 480µg, Biological: Quadrivalent Inactivated Influenza Vaccine (Fluarix® Tetra)OVX836: Adjuvant-free recombinant influenza candidate vaccine based on Nucleoprotein of the incluenza virus. One single administration intramuscularly of 480µg dose on Day 1 AND Fluarix® Tetra (GlaxoSmithKline Biologicals): Inactivated and purified split influenza vaccine. |
| Quadrivalent Inactivated Influenza Vaccine (Fluarix® Tetra) at commercial dose + Placebo | Active comparator | Biological: Quadrivalent Inactivated Influenza Vaccine (Fluarix® Tetra), Biological: PlaceboFluarix® Tetra (GlaxoSmithKline Biologicals): Inactivated and purified split influenza vaccine. AND Placebo Comparator: Saline solution (B. Braun Ecoflac Plus) Saline solution (NaCl 0,9%), B. Braun Ecoflac Plus 50mL. One single administration intrumuscularly of a 0.8mL dose on Day 1 |
| OVX836 480µg + Placebo | Placebo comparator | Biological: OVX836 480µg, Biological: PlaceboOVX836: Adjuvant-free recombinant influenza candidate vaccine based on Nucleoprotein of the incluenza virus. One single administration intramuscularly of 480µg dose on Day 1 AND Placebo Comparator: Saline solution (B. Braun Ecoflac Plus) Saline solution (NaCl 0,9%), B. Braun Ecoflac Plus 50mL. One single administration intrumuscularly of a 0.8mL dose on Day 1 |
Who may qualify
- Ages
- 18 to 55 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (6 listed)
- Written informed consent.
- Healthy male or female subjects, as determined by medical history and medical examination.
- Between the age of 18 and 55 years, inclusive.
- Subjects who have fully been vaccinated with licensed Severe Acute Respiratory Syndrome Coronavirus-2 (COVID-19) vaccine(s) according to national recommendations for the corresponding population group, in vigor at the moment the study starts.
- Reliable and willing to make themselves available for the duration of the study, and willing and able to follow study procedures.
Key exclusion criteria (23 listed)
- Subjects with a body mass index ≤19 kg/m² or ≥35 kg/m² on the day of vaccination.
- Previous influenza vaccination within 6 months before the day of vaccination or planned to receive during the study duration.
- Any known or suspected immunodeficient conditions.
- Past or current history of significant autoimmune diseases, as judged by the Investigator.
- Current history of uncontrolled medical illness such as diabetes, hypertension, heart, renal or hepatic diseases.
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 |
|---|---|---|
| OVX836 480µgOne single administration intramuscularly at Day 1 | Biological | OVX836 480µg + Placebo, OVX836 480µg + Quadrivalent Inactivated Influenza Vaccine (Fluarix® Tetra) at commercial dose |
| Quadrivalent Inactivated Influenza Vaccine (Fluarix® Tetra)One single administration intramuscularly at Day 1 | Biological | OVX836 480µg + Quadrivalent Inactivated Influenza Vaccine (Fluarix® Tetra) at commercial dose, Quadrivalent Inactivated Influenza Vaccine (Fluarix® Tetra) at commercial dose + Placebo |
| PlaceboOne single administration intramuscularly at Day 1 | Biological | OVX836 480µg + Placebo, Quadrivalent Inactivated Influenza Vaccine (Fluarix® Tetra) at commercial dose + Placebo |
Primary outcome
Number of seroconversion determined using Hemagglutination-Inhibition assay, for the four influenza strains contained in the Quadrivalent Influenza Vaccine.
Time frame: At Day 29 versus pre-injection baseline (Day 1)
Seroconversion is defined as a negative pre-vaccination Hemagglutination-Inhibition assay titer and post-vaccination Hemagglutination-Inhibition assay titer ≥1:40, or a fourfold increase in Hemagglutination-Inhibition assay titer between pre- and post-vaccination timepoints.
Proportion of subjects achieving a titer ≥1:40 at Day 29 determined using Hemagglutination-Inhibition assay, for the four influenza strains contained in the Quadrivalent Influenza Vaccine.
Time frame: At Day 29
Number of Hemagglutination-Inhibition assay titers geometric mean ratios >2.5 for the four influenza strains contained in the Quadrivalent Influenza Vaccine.
Time frame: At Day 29 versus pre-injection baseline (Day 1)
Proportion of subjects reporting solicited local (Injection site redness, Injection site swelling, Injection site pain) and systemic signs and symptoms (Fatigue, Headache, Arthralgia, Malaise, Myalgia, Fever)
Time frame: During 7 days after vaccine administration
Proportion of subjects reporting unsolicited AEs
Time frame: During 29 days after vaccine administration
Proportion of subjects with Influenza-Like-Illness cases
Time frame: During the whole study duration, 180 days
Severity scores of Influenza-Like-Illness cases (as per Flu-PRO questionnaire)
Time frame: During the whole study duration, 180 days
Proportion of subjects reporting Serious Adverse Events
Time frame: During the whole study duration, 180 days
4 secondary outcomes
Hemagglutination-Inhibition assay geometric mean titers for each of the four strains contained in the Quadrivalent Influenza Vaccine.
Time frame: At Day 1 (pre-injection baseline) and Day 29
Cell-mediated immune response in terms of change of Nucleoprotein-specific T-cell frequencies in Peripheral Blood Mononuclear Cells, measured by Interferon Gamma Enzyme-Linked Immunospot Assay.
Time frame: At Day 8 versus pre-injection baseline (Day 1)
Geometric Mean Titer of anti-Nucleoprotein immunoglobulin G (Enzyme-Linked Immunosorbent Assay, serum).
Time frame: At Day 1, Day 8 and Day 29
Proportion of subjects with an increase (four-fold) in anti-Nucleoprotein Immunoglobulin G (Enzyme-Linked Immunosorbent Assay, serum) titer.
Time frame: At Day 29 with respect to pre-injection baseline (Day 1)
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 31 Oct 2024.
- Derived from this study: PubMed 40573889Groth N, Bruhwyler J, Tourneur J, Piat E, Moris P, Le Vert A, Nicolas F. Safety and Immunogenicity of OVX836, a Nucleoprotein-Based Universal Influenza Vaccine, Co-Administered with Fluarix(R) Tetra, a Seasonal Hemagglutinin-Based Vaccine. Vaccines (Basel). 2025 May 23;13(6):558. doi: 10.3390/vaccines13060558.
- 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.
Ross Aldrich, MBBS principal investigator
Northern Beaches Clinical Research
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing OVX836 480µg and Quadrivalent Inactivated Influenza Vaccine (Fluarix® Tetra) in people with Influenza, run by Osivax at 1 site in Australia.
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 6 inclusion and 23 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 31 Oct 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Australia. 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 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
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 seroconversion determined using Hemagglutination-Inhibition assay, for the four influenza strains contained in the Quadrivalent Influenza Vaccine. (time frame: At Day 29 versus pre-injection baseline (Day 1)). The study lists 8 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 NCT05284799, which also lists 1 linked publication.
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 31 Oct 2024.