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Study on Intradermal COVID-19 mRNA Vaccine (Tozinameran, Famtozinameran) for Elderly Patients Aged 75 and Older

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What is this study about?

This clinical trial is focused on studying the effects of a COVID-19 mRNA vaccine called Comirnaty Original/Omicron BA.4-5 in people aged 75 years and older. The vaccine is designed to help the body build protection against the virus that causes COVID-19. The study will compare two different ways of giving the vaccine: one is through a small injection into the skin using tiny needles, and the other is the usual method of injection into the muscle. The study will also compare two different doses of the vaccine: a 20 microgram dose and the standard 30 microgram dose.

The purpose of the study is to see how well the vaccine works when given in these different ways and doses. Participants will receive the vaccine and then have their blood tested to measure the levels of antibodies, which are proteins the body makes to fight infections. These tests will be done 28 days after vaccination to see how the body responds. The study will also look at any side effects that participants might experience after getting the vaccine, such as reactions at the injection site or other symptoms.

This study is important for understanding how to best protect older adults from COVID-19, especially since they are at higher risk for severe illness. By comparing different methods and doses of vaccination, researchers hope to find the most effective way to boost immunity in this age group. Participants will be monitored closely throughout the study to ensure their safety and to gather valuable information about the vaccine’s effects.

1 initial visit

Upon joining the study, you will attend an initial visit. During this visit, your medical history will be reviewed to ensure you meet the study criteria. This includes confirming that you are 75 years or older, healthy, or have a stable condition.

You will be asked to provide access to your vaccination history and agree that the study physician can access your medical records. You must also agree to postpone any regular COVID-19 vaccinations for at least four months after receiving the study vaccine.

2 informed consent

You will be required to sign an informed consent form. This form confirms that you understand the study procedures and agree to participate. It is important that you fully understand the study and agree to follow all procedures.

3 vaccination

You will receive a dose of the COVID-19 mRNA vaccine called Comirnaty Original/Omicron BA.4-5. The vaccine will be administered using a method called intradermal use, which involves injecting the vaccine just under the skin with silicon microneedles.

The dose you receive will be 20 micrograms. This is different from the standard dose, which is 30 micrograms and is usually given into the muscle.

4 monitoring and follow-up

After vaccination, you will be monitored for any immediate reactions. You will also be asked to report any side effects you experience over the next 28 days. This includes any local reactions at the injection site, reactions of regional lymph nodes, and any systemic reactions.

You will be asked to report any serious adverse events and any use of medications like antipyretics (fever reducers) and analgesics (pain relievers) for up to 14 days after vaccination.

5 blood tests

A blood sample will be taken 28 days after vaccination to measure the levels of antibodies in your blood. This will help determine how well your body has responded to the vaccine.

6 end of participation

Your participation in the study will conclude after the final blood test and follow-up. The study is expected to end by August 1, 2024.

Who Can Join the Study?

  • Must be a male or female aged 75 years or older at the time of vaccination.
  • Must agree to provide access to their vaccination history.
  • Must agree that the study doctor and their team can access their medical records.
  • Must be healthy as determined by medical history and the doctor’s judgment. If there is a pre-existing illness, it must be stable, meaning it hasn’t required significant changes in treatment or hospitalization in the last 6 weeks and isn’t expected to need any intervention during the study.
  • Must be willing and able to attend all scheduled visits, follow the vaccination plan, and complete laboratory tests and other study procedures.
  • Must be willing to delay their regular COVID-19 vaccination until at least four months after receiving the study vaccine.
  • Must have completed the initial series of COVID-19 vaccinations.
  • Must be capable and willing to provide personal signed consent to participate in the study.
  • Must have a good understanding of the study procedures and agree to follow them closely.
  • Must be fluent in the Dutch language.
  • Must agree that their general practitioner is informed about their participation in the study.

Who Cannot Join the Study?

  • Participants must be 75 years or older.
  • Participants must be healthy or have a stable disease. This means their health condition is not changing or getting worse.
  • Participants must not be part of a vulnerable population. This refers to groups of people who might be at higher risk of harm or exploitation.

Where you can join this trial?

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Verified Sites

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Other Sites

Site Name City Country Status
Soslokyki Rwhrfnx Uklkmilyud Mqnglye Cakcmc Nijmegen The Netherlands

Want to learn more about this study or check if you can participate? Contact us.

Trial status

Country Status Recruitment Start
The Netherlands The Netherlands
Not recruiting
01.08.2023

Trial locations

Investigated drugs:

Comirnaty is a COVID-19 mRNA vaccine used to help protect people from getting sick with COVID-19. In this clinical trial, the vaccine is being given to elderly people, who are 75 years and older, to see how well it works when injected into the skin using tiny silicon needles. The study is comparing this method to the usual way of giving the vaccine, which is by injecting it into the muscle. The goal is to see if the skin injection can provide a similar or better immune response compared to the muscle injection.

COVID-19 – COVID-19 is a respiratory illness caused by the SARS-CoV-2 virus. It primarily spreads through respiratory droplets when an infected person coughs, sneezes, or talks. The disease can start with mild symptoms such as fever, cough, and fatigue, but may progress to more severe respiratory issues. In some cases, it can lead to pneumonia, acute respiratory distress syndrome, and other complications. The progression of the disease varies widely among individuals, with some experiencing mild symptoms and others developing severe illness. The immune response to the virus plays a crucial role in the progression and severity of the disease.

Trial ID:
2023-503800-99-00
NCT ID:
NCT05977127
Trial Phase:
Therapeutic exploratory (Phase II)

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