Ongoing, recruitingTherapeutic exploratory (Phase II)Interventional

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 research study is investigating a new COVID-19 booster vaccine named BIMERVAX. It’s for young people aged 12 to 17 who have already been vaccinated against COVID-19. The main goal is to check how well BIMERVAX works in boosting their immune system against the Omicron variant of COVID-19, and to see if it's as good as another vaccine called HIPRA-HH-2. Researchers are also carefully monitoring for any side effects or reactions to the vaccine. This is an important step to make sure any new vaccines are safe and help protect people effectively.

At a glance

Status

Ongoing, recruiting

Phase

Therapeutic exploratory (Phase II)

Sponsor

Hipra Scientific S.L.

Enrolment target

300

Start

26 May 2023

SARS-CoV-2 infection

What is this study about?

This study is focused on a new COVID-19 booster vaccine called BIMERVAX. If you're a young person aged 12 to 17 and have already had your initial COVID-19 vaccines, this study is looking into whether BIMERVAX can provide an effective boost to your protection against the virus. Specifically, it's interested in how well your body creates protective antibodies against the Omicron variant of COVID-19 after getting the BIMERVAX booster.

The main idea behind this study, known as a 'non-inferiority' study, is to see if the BIMERVAX vaccine is at least as good as, but not worse than, an existing vaccine called HIPRA-HH-2. This comparison helps scientists understand if BIMERVAX could be a valuable new option for boosting immunity. They're also keeping a close eye on any side effects, both common ones like a sore arm, and any more unexpected reactions, to make sure the vaccine is safe. Understanding how different vaccines work and their safety profiles is crucial. This study helps gather the necessary information to potentially make more vaccination options available in the future, ultimately contributing to better protection against COVID-19 for younger people.

Key takeaways

Tests a new COVID-19 booster vaccine called BIMERVAX.
Aimed at teenagers aged 12 to 17 who have had previous COVID-19 vaccines.
Compares BIMERVAX's effectiveness and safety to another vaccine.
Closely monitors immune response and any side effects.
Helps develop more options for COVID-19 protection.

Who may be eligible?

This study is specifically looking for young people who are aged between 12 and 17 years old. Both boys and girls can take part in this research.

To be eligible, participants will need to have already received their initial COVID-19 vaccinations. The study is particularly interested in how a booster shot works in those who have already had their primary doses.

There might be other specific health requirements or conditions that would make someone suitable or unsuitable for the study. These would be discussed in detail by the study team if you express interest.

Could this study suit you?

Answer these quick questions to see if you may be eligible. This is a guide only — the research team makes the final call.

Are you between 12 and 17 years old?
Have you already received your initial COVID-19 vaccinations?
Are you generally in good health?
Are you willing to attend study appointments and provide blood samples?

Answer every question to see your result.

What does participation involve?

If you join this study, you would receive the BIMERVAX COVID-19 booster vaccine. After the vaccination, the research team would carefully monitor your health. You would need to report any reactions you experience, such as a sore arm or feeling unwell, for seven days after the shot. For a longer period, up to 28 days, the team would continue to check for any unexpected health changes. They will also collect blood samples at specific times, including at the start (baseline) and again after 14 days, to measure your body's immune response to the vaccine. The study team will keep track of any serious health issues or medical visits related to the vaccine right through to the end of the study. The total duration of your participation would be explained fully by the study team.

Potential risks and benefits

Participating in this study might offer the potential benefit of receiving a new COVID-19 booster vaccine that could strengthen your protection against the virus. However, like all vaccines, BIMERVAX may have side effects, which could include common reactions like soreness at the injection site, tiredness, or headache, or, in very rare cases, more serious reactions. You have the right to withdraw from the study at any time, for any reason, without it affecting your medical care.

Locations (1)

Some site locations are approximate. We're improving this — please verify with the trial team before travelling.

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Unverified
Spain

Common questions

What is BIMERVAX?

BIMERVAX is a new type of COVID-19 vaccine that this study is testing as a booster shot.

Who can take part in this study?

This study is for young people aged 12 to 17 who have already had their first COVID-19 vaccines.

Will I get COVID-19 from the vaccine?

No, the vaccine does not contain the live virus, so it cannot give you COVID-19.

What kind of side effects might I experience?

You might have common vaccine side effects like a sore arm, tiredness, or a mild headache. The study team will monitor you closely for these and any other reactions.

Is this vaccine approved for general use?

No, BIMERVAX is still being studied in clinical trials like this one to ensure it is safe and effective before it can be widely used.