BridgeMD
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.
EU CTIS ID: 2023-504639-42-00
What this study is testing
- To determine and compare the changes in immunogenicity measured by Pseudovirus Based Neutralisation Assay (PBNA) against Omicron BA.1 variant at Baseline and Day 14, after vaccination of adolescents with a heterologous booster dose of BIMERVAX® versus post heterologous booster dose in young adults (aged 18 to 25 years) from the adult booster study (HIPRA-HH-2 EudraCT 2021-005226-26). - To assess the safety and tolerability of BIMERVAX® as a heterologous booster dose in adolescents primary vaccinated against COVID-19 with 2 doses of Comirnaty vaccine.
- Therapeutic exploratory (Phase II)
A plain-language read of the study's public EU CTIS listing. The study team confirms the details.
Who can take part
You may be able to join if
- 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.
- 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.
- Has a negative Rapid Antigen Test (RAT) at Day 0 before BIMERVAX® vaccine administration.
You likely can't join if
- 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.
- 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.
See the full eligibility criteria
Who can 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.
- 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.
- Has a negative Rapid Antigen Test (RAT) at Day 0 before BIMERVAX® vaccine administration.
- Participants biologically able to have children may be enrolled in the study if the participant fulfils all the following criteria: a. Has a negative urine pregnancy test at Screening (Day 0), only for those participants who are biologically able to become pregnant. b. 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. c. Has agreed to continue adequate contraception or abstinence through 3 months following the booster dose.
- Participant must have a body weight >50 kg at Screening visit to be eligible for the cellular immunology assays.
What rules you out
- 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.
- 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.
- 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.
- 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).
- 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.
The study team makes the final eligibility decision.
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 0-17 years. The study team makes the final eligibility decision.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from EU CTIS; the study team decides eligibility.