SARS CoV 2 InfectionPhase 2NCT06234956
Open-label, Multi-centre, Non-Inferiority Study of Safety and Immunogenicity of BIMERVAX for the Prevention of COVID-19 in Adolescents From 12 Years to Less Than 18 Years of Age.
A Phase 2 study testing BIMERVAX in people with SARS CoV 2 Infection, run by Hipra Scientific, S.L.U at 7 sites in Spain.
Trial summary
This is a Phase IIb, open-label, uncontrolled, multi-centre, non-inferiority clinical trial, to assess the safety and immunogenicity of BIMERVAX® as a heterologous booster dose in adolescents. In this study a total of 300 adolescents from 12 to less than 18 years will be enrolled and followed for 12 months. Read more about this study
- Who is it for?
- Ages 12 to 17 yearsHealthy volunteers can take part
- Conditions the study is for
- SARS CoV 2 Infection
- What is being tested?
- BIMERVAX
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 242 participants
- Where
- 7 sitesSpain
- Study dates
- 8 Jun 2023to 9 Sep 2025
- 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 12 to 17 years
- All sexes
- Healthy volunteers accepted
- Child
Who may be able to join
- Adolescents aged from 12 to less than 18 years at Screening.
- Participant's parent(s)/legal guardian(s) willing and able to sign the informed consent and can comply with all study visits and procedures. A written assent will be required for all participants in the study. Note: Participants are expected to be available for the duration of the study and whose parent(s)/legal guardian can be contacted by telephone during study participation.
- Participant must have received two previous doses of Comirnaty, last dose being at least 6 months before screening.
- Participant has a body mass index at or above the third percentile according to local Child Growth Standards at Screening Visit.
- Healthy participants and participants with pre-existing, chronic and stable diseases (non-immunocompromised), if these are stable and well-controlled according to the investigator's judgment, are eligible for inclusion in the study. Note: Healthy participants are determined by medical history, physical examination, and clinical judgment of the investigator. Healthy participants with pre-existing stable diseases, are defined as diseases not requiring significant change in the therapy or hospitalisation for worsening disease during the 6 weeks before enrolment.
- Has a negative Rapid Antigen Test (RAT) at Day 0 before BIMERVAX® vaccine administration.
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- Participants biologically able to have children may be enrolled in the study if the participant fulfils all the following criteria:
- Has a negative urine pregnancy test at Screening (Day 0), only for those participants who are biologically able to become pregnant.
- Has practiced adequate contraception or has abstained from all activities that could result in pregnancy for at least 28 days prior to the booster dose, only for those participants who are biologically able to become pregnant.
- Has agreed to continue adequate contraception or abstinence through 3 months following the booster dose.
- Participants with female reproductive system:
- Hormonal contraception (progestogen only or combined: oral, injectable or transdermal (patch)
- Intrauterine device.
- Vasectomized partner (the vasectomized partner should be the sole partner for that participant).
- Condom.
- Participants with male reproductive system:
- Vasectomized participants.
- Agree to use a condom in partners biologically able to become pregnant.
- Participant must have a body weight >50 kg at Screening visit to be eligible for the cellular immunology assays.
Who cannot join
- Acute illness with fever ≥ 38.0°C at Screening or within 24 hours prior to vaccination. Participant can be rescheduled for Screening when they have completed 24 hours without fever. Afebrile participants with minor illnesses can be enrolled at the discretion of the investigator.
- Received medications intended to prevent or treat COVID-19 before Screening, except for Comirnaty vaccines.
- Previous or current diagnosis of MIS-C.
- Other medical or psychiatric condition including recent (within the past year) or active suicidal ideation/behaviour or laboratory abnormality that may increase the risk of study participation or, in the investigator's judgment, make the participant inappropriate for the study.
- Note: This includes both conditions that may increase the risk associated with study intervention administration or a condition that may interfere with the interpretation of study results.
- 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 1 mg/kg/day of prednisone or total dose of 20mg/day 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.
- Female who is pregnant or breastfeeding.
- Receipt of blood/plasma products, immunoglobulin, monoclonal antibodies, or receipt of any passive antibody therapy, within 90 days prior to vaccination or during the study.
- Participation in other studies involving study intervention within 28 days prior to screening and/or during study participation.
- Received any non-study vaccine (including seasonal Influenza vaccine) within 14 days before or after screening. For live or attenuated vaccines, 4 weeks before or after screening.
- History of illegal substance use or alcohol abuse within the past 2 years.
- History of a diagnosis or other conditions that, in the judgment of the investigator, may affect study endpoint assessment or compromise participant safety.
- Individuals who are family members of the Investigators.
- Individuals with documented medical history of microbiologically confirmed COVID-19 will not be eligible for the immunogenicity group.
Trial locations and contacts
7 sites in 1 country.
7 sites in 1 country
Spain7 sites
Hospital Vall Hebron
Barcelona, Barcelona, 08035
Hospital HM Montepríncipe
Boadilla del Monte, Madrid, 28660
CAP Centelles
Centelles, Barcelona, 08540
Hospital Josep Trueta
Girona, Girona, 17007
Hospital La Paz
Madrid, Madrid, 28046
Hospital HM Puerta del Sur
Móstoles, Madrid, 28938
CAP Peralada
Peralada, Girona, 17491
About this study
Official title: Open-label, Multi-centre, Non-Inferiority Study of Safety and Immunogenicity of BIMERVAX as Heterologous Booster for the Prevention of Coronavirus Disease 2019 (COVID-19) in Adolescents From 12 Years to Less Than 18 Years of Age.
This is a Phase IIb, open-label, uncontrolled, multi-centre, non-inferiority clinical trial, to assess the safety and immunogenicity of BIMERVAX® as a heterologous booster dose in adolescents.
In this study a total of 300 adolescents from 12 to less than 18 years will be enrolled and followed for 12 months.
- Conditions
- SARS CoV 2 Infection
- Being tested
- BIMERVAX
- Medical subject headings
- COVID-19
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
BIMERVAXBiological
BIMERVAX
| Study group | Role | What they receive |
|---|---|---|
| BIMERVAX | Experimental | Not described Receives: Biological: BIMERVAX |
What is being measured
The primary outcome is the main question the study is designed to answer.
Changes in immunogenicity against Omicron BA.1
Neutralisation titre against Omicron BA.1 measured as inhibitory concentration 50 (IC50) by PBNA and reported as log10 concentration for each individual sample at Baseline and Day 14.
Measured: 14 days
Changes in immunogenicity against Omicron BA.1
Geometric Mean Titre (GMT) for group comparison with HIPRA-HH-2 at Baseline and Day 14.
Measured: 14 days
Incidence of solicited local and systemic reactions (Safety and tolerability of PHH-1V)
Solicited local and systemic reactions through Day 7 after vaccination.
Measured: 7 days
Incidence of unsolicited local and systemic adverse events (Safety and tolerability of PHH-1V)
Unsolicited local and systemic adverse events (AEs) through Day 28 after vaccination.
Measured: 28 days
Incidence of related adverse events and serious adverse events (Safety and tolerability of PHH-1V)
Related adverse events (AEs) and all serious adverse events (SAEs) through the end of the study.
Measured: 1 year
Incidence of adverse events of special interest (Safety and tolerability of PHH-1V)
Adverse event of special interest (AESI) through the end of the study.
Measured: 1 year
Incidence of related medically attended adverse events (Safety and tolerability of PHH-1V)
Related medically attended adverse events (MAAE) through the end of the study.
Measured: 1 year
Incidence of Grade 2, Grade 3 and Grade 4 changes in safety laboratory parameters (Safety and tolerability of PHH-1V)
Grade 2, Grade 3 and Grade 4 changes from Baseline in safety laboratory parameters through Day 14 after vaccination.
Measured: 14 days
Secondary outcomes (3)
Changes in immunogenicity against VOCs
Neutralisation titre against VOCs (at least Beta and Delta) measured as IC50 by PBNA and reported as log10 concentration for each individual sample at Baseline and Days 14, 84, 168 and 336.
Measured: Days 14, 84, 168 and 336
Changes in immunogenicity against VOCs
GMT at Baseline and Days 14, 84, 168 and 336.
Measured: Days 14, 84, 168 and 336
Changes in immunogenicity against Omicron BA.1 and VOCs
GMFR in neutralising antibodies titres against Omicron BA.1 and VOCs (at least Beta and Delta) at Baseline and Day 14.
Measured: Day 14
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted31 Jan 2024
- Study start8 Jun 2023
- Primary completion9 Sep 2025
- Study completion9 Sep 2025
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
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 242 participants (actual)
Sponsor and investigators
- Lead sponsor
- Hipra Scientific, S.L.U
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Veristat, Inc., VHIR, Asphalion
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06234956
- Sponsor's protocol ID
- HIPRA-HH-3
- Status last verified
- Mar 2026
- First submitted
- 20 Oct 2023
- Last updated
- 12 Mar 2026
- Results posted
- No
- 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 12 Mar 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Open-label, Multi-centre, Non-Inferiority Study of Safety and Immunogenicity of BIMERVAX as Heterologous Booster for the Prevention of Coronavirus Disease 2019 (COVID-19) in Adolescents From 12 Years to Less Than 18 Years of Age.
- ClinicalTrials.gov ID
- NCT06234956
- Acronym / sponsor ID
- HIPRA-HH-3
- Conditions
- SARS CoV 2 Infection
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 242 participants (actual)
- Lead sponsor
- Hipra Scientific, S.L.UIndustry (pharma, biotech, devices)
- Collaborators
- Veristat, Inc., VHIR, Asphalion
- Study start
- 8 Jun 2023 (actual)
- Primary completion
- 9 Sep 2025 (actual)
- Study completion
- 9 Sep 2025 (actual)
- First posted
- 31 Jan 2024 (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 IIb, open-label, uncontrolled, multi-centre, non-inferiority clinical trial, to assess the safety and immunogenicity of BIMERVAX® as a heterologous booster dose in adolescents.
In this study a total of 300 adolescents from 12 to less than 18 years will be enrolled and followed for 12 months.
Study design
- Primary purpose
- Prevention
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| BIMERVAX | Experimental | Biological: BIMERVAX |
Who may qualify
- Ages
- 12 to 17 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
Key inclusion criteria (19 listed)
- Adolescents aged from 12 to less than 18 years at Screening.
- Participant's parent(s)/legal guardian(s) willing and able to sign the informed consent and can comply with all study visits and procedures. A written assent will be required for all participants in the study. Note: Participants are expected to be available for the duration of the study and whose parent(s)/legal guardian can be contacted by telephone during study participation.
- Participant must have received two previous doses of Comirnaty, last dose being at least 6 months before screening.
- Participant has a body mass index at or above the third percentile according to local Child Growth Standards at Screening Visit.
- Healthy participants and participants with pre-existing, chronic and stable diseases (non-immunocompromised), if these are stable and well-controlled according to the investigator's judgment, are eligible for inclusion in the study. Note: Healthy participants are determined by medical history, physical examination, and clinical judgment of the investigator. Healthy participants with pre-existing stable diseases, are defined as diseases not requiring significant change in the therapy or hospitalisation for worsening disease during the 6 weeks before enrolment.
Key exclusion criteria (16 listed)
- Acute illness with fever ≥ 38.0°C at Screening or within 24 hours prior to vaccination. Participant can be rescheduled for Screening when they have completed 24 hours without fever. Afebrile participants with minor illnesses can be enrolled at the discretion of the investigator.
- Received medications intended to prevent or treat COVID-19 before Screening, except for Comirnaty vaccines.
- Previous or current diagnosis of MIS-C.
- Other medical or psychiatric condition including recent (within the past year) or active suicidal ideation/behaviour or laboratory abnormality that may increase the risk of study participation or, in the investigator's judgment, make the participant inappropriate for the study.
- Note: This includes both conditions that may increase the risk associated with study intervention administration or a condition that may interfere with the interpretation of study results.
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 |
|---|---|---|
| BIMERVAXBIMERVAX | Biological | BIMERVAX |
Primary outcome
Changes in immunogenicity against Omicron BA.1
Time frame: 14 days
Neutralisation titre against Omicron BA.1 measured as inhibitory concentration 50 (IC50) by PBNA and reported as log10 concentration for each individual sample at Baseline and Day 14.
Changes in immunogenicity against Omicron BA.1
Time frame: 14 days
Geometric Mean Titre (GMT) for group comparison with HIPRA-HH-2 at Baseline and Day 14.
Incidence of solicited local and systemic reactions (Safety and tolerability of PHH-1V)
Time frame: 7 days
Solicited local and systemic reactions through Day 7 after vaccination.
Incidence of unsolicited local and systemic adverse events (Safety and tolerability of PHH-1V)
Time frame: 28 days
Unsolicited local and systemic adverse events (AEs) through Day 28 after vaccination.
Incidence of related adverse events and serious adverse events (Safety and tolerability of PHH-1V)
Time frame: 1 year
Related adverse events (AEs) and all serious adverse events (SAEs) through the end of the study.
Incidence of adverse events of special interest (Safety and tolerability of PHH-1V)
Time frame: 1 year
Adverse event of special interest (AESI) through the end of the study.
Incidence of related medically attended adverse events (Safety and tolerability of PHH-1V)
Time frame: 1 year
Related medically attended adverse events (MAAE) through the end of the study.
Incidence of Grade 2, Grade 3 and Grade 4 changes in safety laboratory parameters (Safety and tolerability of PHH-1V)
Time frame: 14 days
Grade 2, Grade 3 and Grade 4 changes from Baseline in safety laboratory parameters through Day 14 after vaccination.
3 secondary outcomes
Changes in immunogenicity against VOCs
Time frame: Days 14, 84, 168 and 336
Changes in immunogenicity against VOCs
Time frame: Days 14, 84, 168 and 336
Changes in immunogenicity against Omicron BA.1 and VOCs
Time frame: Day 14
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 12 Mar 2026.
- 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.
The record lists no contact. Use the official record to reach the sponsor.
7 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 in people with SARS CoV 2 Infection, run by Hipra Scientific, S.L.U at 7 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 19 inclusion and 16 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 12 Mar 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 7 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?
Changes in immunogenicity against Omicron BA.1 (time frame: 14 days). 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?
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 12 Mar 2026.