SARS CoV 2 InfectionPhase 2NCT05981846
A Phase II Trial to Evaluate the Safety and Immunogenicity of BIMERVAX® When Coadministered With Seasonal Influenza Vaccine (SIIV) in Adults Older Than 65 Years of Age Fully Vaccinated Against COVID-19
A Phase 2 study testing BIMERVAX and SIIV in people with SARS CoV 2 Infection and Influenza, Human, run by Hipra Scientific, S.L.U at 8 sites in Spain.
Trial summary
This is a Phase II, randomized, double-blind, multi-centre trial to evaluate the safety and immunogenicity of BIMERVAX® when coadministered with seasonal surface antigen inactivated adjuvanted influenza vaccine (SIIV) in adults older than 65 years of age fully vaccinated against COVID-19. Read more about this study
- Who is it for?
- Ages 65 years and olderHealthy volunteers can take part
- Conditions the study is for
- SARS CoV 2 Infection, Influenza, Human
- What is being tested?
- BIMERVAX and SIIV
- Type of treatment
- Vaccines
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 279 participants
- Where
- 8 sitesSpain
- Study dates
- 4 Sep 2023to 6 Nov 2023
- 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 65 years and older
- All sexes
- Healthy volunteers accepted
- Older adult
Who may be able to join
- Adults aged 65 or older at Day 0.
- Are willing and able to sign the informed consent and can comply with all study visits and procedures.
- Participant must have received at least a primary scheme of an mRNA vaccine (2 doses). Booster doses or previous COVID-19 infections are allowed. Last dose must have been administered at least 6 months before Day 0. History of COVID-19 infection is allowed if occurred at least >30 days before Day 0.
- Have a negative Rapid Antigen Test (RAT) at Day 0 before vaccinations.
- Adults determined by clinical assessment, including medical history and clinical judgement, to be eligible for the study, including adults with pre-existing chronic and stable diseases (non-immunocompromised), if these are stable and well-controlled according to the investigator's judgment.
Who cannot join
- Acute illness with fever ≥ 38.0°C at Day 0 or within 24 hours prior to vaccination. Afebrile participants with minor illnesses can be enrolled at the discretion of the investigator.
- Allergy to egg proteins (egg or egg products) or chicken proteins.
- History of Guillain-Barré syndrome (GBS)
- History of COVID-19 infection (described as a positive RAT or PCR), in the previous 30 days before Day 0.
- Other medical or psychiatric condition including recent (within the past year) or active suicidal ideation/behaviour that may increase the risk of study participation or, in the investigator's judgment, make the participant inappropriate for the study.
- History of severe adverse reaction associated with a vaccine and/or severe allergic reaction (e.g. anaphylaxis) to any component of the study intervention(s).
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- Immunocompromised individuals defined as those with primary and secondary immune deficiencies and those receiving chemotherapy or immunosuppressant drugs other than steroids and glucocorticoids (maximum 30mg/day of prednisone, or equivalent, by any administration route for a maximum of 30 consecutive days), within 90 days prior to vaccination or during the study.
- Bleeding diathesis or condition associated with prolonged bleeding that would, in the opinion of the investigator, contraindicate intramuscular injection.
- Receipt of blood-derived immune globulins, blood, or blood-derived products in the past 3 months.
- Participation in other studies involving study intervention within 28 days prior to screening and/or during study participation.
- Received any non-study vaccine within 14 days before or after screening. For live or attenuated vaccines, 4 weeks before or after screening.
- History of a diagnosis or other conditions that, in the judgment of the investigator, may affect study endpoint assessment or compromise participant safety.
Trial locations and contacts
8 sites in 1 country.
8 sites in 1 country
Spain8 sites
Hospital HM Modelo
A Coruña, 15011
Hospital Germans Trias i Pujol
Badalona, Barcelona, 08916
Hospital Clínic de Barcelona
Barcelona, 08036
CAP Centelles
Centelles, Barcelona, 08540
Hospital Josep Trueta
Girona, 17001
Hospital Regional de Málaga
Málaga, 29010
Hospital Clínico Universitario de Santiago
Santiago de Compostela, A Coruña, 15706
Hospital Clínico de Valladolid
Valladolid, 47003
About this study
Official title: A Phase II, Randomized, Double-blind, Multi-centre Trial to Evaluate the Safety and Immunogenicity of BIMERVAX® When Coadministered With Seasonal Surface Antigen, Inactivated, Adjuvanted Influenza Vaccine (SIIV) in Adults Older Than 65 Years of Age Fully Vaccinated Against COVID-19
This is a Phase II, randomized, double-blind, multi-centre trial to evaluate the safety and immunogenicity of BIMERVAX® when coadministered with seasonal surface antigen inactivated adjuvanted influenza vaccine (SIIV) in adults older than 65 years of age fully vaccinated against COVID-19.
In this study approximately 300 adults aged 65 or older will be enrolled and followed for 1 month after study treatment. Safety and immunogenicity of all participants will be assessed.
- Conditions
- SARS CoV 2 Infection, Influenza, Human
- Being tested
- BIMERVAX, SIIV
- Medical subject headings
- COVID-19, Influenza, Human
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
BIMERVAXBiological
One dose of booster vaccine
SIIVBiological
One dose
| Study group | Role | What they receive |
|---|---|---|
| BIMERVAX + SIIV | Experimental | Not described Receives: Biological: BIMERVAX; Biological: SIIV |
| BIMERVAX + PLACEBO | Active comparator | Not described Receives: Biological: BIMERVAX |
| SIIV + PLACEBO | Active comparator | Not described Receives: Biological: SIIV |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number, percentage, and characteristics of solicited local and systemic reactions through Day 7 after vaccination.
Measured: Day 0, Day 7
Number, percentage, and characteristics of unsolicited local and systemic adverse events (AEs) through the end of the study.
Measured: Day 0, Day 7, Day 28
Number and percentage of serious adverse events (SAEs) through the end of the study.
Measured: Day 0, Day 7, Day 28
Number and percentage of adverse events of special interest (AESI) through the end of the study
Measured: Day 0, Day 7, Day 28
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Aug 2023
- Study start4 Sep 2023
- Primary completion9 Oct 2023
- Study completion6 Nov 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for SARS CoV 2 InfectionStudies 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
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 279 participants (actual)
Sponsor and investigators
- Lead sponsor
- Hipra Scientific, S.L.U
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05981846
- Sponsor's protocol ID
- HIPRA-HH-11
- Status last verified
- Feb 2024
- First submitted
- 7 Aug 2023
- Last updated
- 26 Feb 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 26 Feb 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase II, Randomized, Double-blind, Multi-centre Trial to Evaluate the Safety and Immunogenicity of BIMERVAX® When Coadministered With Seasonal Surface Antigen, Inactivated, Adjuvanted Influenza Vaccine (SIIV) in Adults Older Than 65 Years of Age Fully Vaccinated Against COVID-19
- ClinicalTrials.gov ID
- NCT05981846
- Acronym / sponsor ID
- HIPRA-HH-11
- Conditions
- SARS CoV 2 Infection, Influenza, Human
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 279 participants (actual)
- Lead sponsor
- Hipra Scientific, S.L.UIndustry (pharma, biotech, devices)
- Study start
- 4 Sep 2023 (actual)
- Primary completion
- 9 Oct 2023 (actual)
- Study completion
- 6 Nov 2023 (actual)
- First posted
- 8 Aug 2023 (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.
This is a Phase II, randomized, double-blind, multi-centre trial to evaluate the safety and immunogenicity of BIMERVAX® when coadministered with seasonal surface antigen inactivated adjuvanted influenza vaccine (SIIV) in adults older than 65 years of age fully vaccinated against COVID-19.
In this study approximately 300 adults aged 65 or older will be enrolled and followed for 1 month after study treatment. Safety and immunogenicity of all participants will be assessed.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| BIMERVAX + SIIV | Experimental | Biological: BIMERVAX, Biological: SIIV |
| BIMERVAX + PLACEBO | Active comparator | Biological: BIMERVAX |
| SIIV + PLACEBO | Active comparator | Biological: SIIV |
Who may qualify
- Ages
- 65 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Older adult
Key inclusion criteria (5 listed)
- Adults aged 65 or older at Day 0.
- Are willing and able to sign the informed consent and can comply with all study visits and procedures.
- Participant must have received at least a primary scheme of an mRNA vaccine (2 doses). Booster doses or previous COVID-19 infections are allowed. Last dose must have been administered at least 6 months before Day 0. History of COVID-19 infection is allowed if occurred at least >30 days before Day 0.
- Have a negative Rapid Antigen Test (RAT) at Day 0 before vaccinations.
- Adults determined by clinical assessment, including medical history and clinical judgement, to be eligible for the study, including adults with pre-existing chronic and stable diseases (non-immunocompromised), if these are stable and well-controlled according to the investigator's judgment.
Key exclusion criteria (12 listed)
- Acute illness with fever ≥ 38.0°C at Day 0 or within 24 hours prior to vaccination. Afebrile participants with minor illnesses can be enrolled at the discretion of the investigator.
- Allergy to egg proteins (egg or egg products) or chicken proteins.
- History of Guillain-Barré syndrome (GBS)
- History of COVID-19 infection (described as a positive RAT or PCR), in the previous 30 days before Day 0.
- Other medical or psychiatric condition including recent (within the past year) or active suicidal ideation/behaviour that may increase the risk of study participation or, in the investigator's judgment, make the participant inappropriate for the study.
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 |
|---|---|---|
| BIMERVAXOne dose of booster vaccine | Biological | BIMERVAX + PLACEBO, BIMERVAX + SIIV |
| SIIVOne dose | Biological | BIMERVAX + SIIV, SIIV + PLACEBO |
Primary outcome
Number, percentage, and characteristics of solicited local and systemic reactions through Day 7 after vaccination.
Time frame: Day 0, Day 7
Number, percentage, and characteristics of unsolicited local and systemic adverse events (AEs) through the end of the study.
Time frame: Day 0, Day 7, Day 28
Number and percentage of serious adverse events (SAEs) through the end of the study.
Time frame: Day 0, Day 7, Day 28
Number and percentage of adverse events of special interest (AESI) through the end of the study
Time frame: Day 0, Day 7, Day 28
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 26 Feb 2024.
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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.
The record lists no contact. Use the official record to reach the sponsor.
8 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing BIMERVAX and SIIV in people with SARS CoV 2 Infection and Influenza, Human, run by Hipra Scientific, S.L.U at 8 sites in Spain.
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 12 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 26 Feb 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 8 sites in Spain. 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 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, percentage, and characteristics of solicited local and systemic reactions through Day 7 after vaccination. (time frame: Day 0, Day 7). The study lists 4 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 26 Feb 2024.