Hello! I’m Carol, the doctor in charge of this research project.

Thanks for showing interest in our work.

My team and I will take care of you throughout this process. We’ll try to make you feel as comfortable as possible.

And remember! We’ll be by your side to answer any of your questions.

SO LET’S GO!

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We are working to achieve these goals:

  • To analyse and compare the body’s ability to generate antibodies against this disease with the new vaccine (MenACWY)  and the old one (MVaccine).
  • To investigate whether the new meningococcal vaccine is safe.

VACCINE

Vaccines are preparations that teach our body to defend itself against certain diseases.

WHAT ARE ANTIBODIES?

Antibodies are substances created by the body that help protect us against viruses and infectious bacteria.

THE TRIAL

A phase II clinical trial study.

A study that complies with current regulations in clinical research.

A study that has also been approved by an ethics committee specialised in this field.

GLOSSARY

CURRENT REGULATIONS

European Regulation (EU) No. 536/2014 of the European Parliament and of the Council, of April 16, 2014, on clinical trials of medicinal products for human use.

You can consult Regulation 2014/536 for more information.

ETHICS COMMITTEE

This is an independent review body that studies and approves/disapproves biomedical research in humans.

The approval of the Ethics Committee is required for each clinical study protocol and main researcher before the start of the study.

WHAT IS A CLINICAL TRIAL?

Clinical trials are medical research studies in which volunteers are enrolled to test out treatments that can prevent, detect or cure diseases.

Depending on the kind of study, people participating have to present specific characteristics. For example: they may be healthy, have a specific disease, or present a specific age range.

Clinical trials for vaccines are conducted before they the vaccine can be marketed. The vaccine under study is first assayed in the laboratory and then tested in clinical trials to ensure its safety and efficacy.

Finally, the national health authorities review the study results and decide on approval.

PHASES OF A CLINICAL TRIAL

Clinical trials are performed in a series of steps called “phases.” Each phase has a different aim and helps researchers answer different questions.

Phase I trials: researchers study a medication or treatment in a small group of people (20–80) for the first time. The purpose is to study the medication or treatment to find out if it is safe and identify possible side effects.

Phase II trials. This is ours! The new drug or treatment is administered to a larger group of people (100–300) to determine its effectiveness and make further safety studies.

Phase III trials: The new drug or treatment is given to large groups of people (1,000–3,000) to confirm effectiveness, control side effects, compare it with standard or similar treatments, and gather further information allowing the new drug or treatment be used safely.

Phase IV trials: After regulatory agencies approve a drug and make it available to the public, researchers track its safety in the general population, seeking more information about its benefits and optimal use.

What vaccines will we work with in this study?

We want to compare the effectiveness of the new vaccine (MenACWY) with the old one (MVaccine). Both of them are designed to protect against the disease caused by meningococci, known as meningitis.

CURRENT PROCEDURE FOR THE MVACCINE.

This vaccine is currently administered in two vials.

1

One contains a liquid with the components C, W and Y (MenCWY)

2

The second one contains the lyophilised component A (MenA)

The fact that the vaccine comes in two vials makes administration more difficult, because these two vials have to be mixed before being given.

In addition, the two vials take up more cold storage space.

Our study aims to compare the traditional way of presenting the MVaccine with a new vaccine format.

The MenACWY vaccine has the advantage of having all the components in one single vial.

THE PROCEDURE

WHAT’S THE PROCEDURE?

 

In this study we will form 2 groups.

You will be part of one group, and you’ll only go through one of the phases.

The new MenACWY vaccine, stored under appropriate conditions for 24 months

The known MVaccine as marketed, stored under appropriate conditions for 24 months

 

Your participation in this study is expected to last 6 months.

During this time, we will ask you to come to your health centre on the scheduled dates.

We’ll run some tests.

I will also ask you to keep me informed of any changes you observe in your health status.

Let me explain which group you’ll be in.

Your group will be randomly assigned. It can be the group MenACWY or the group MVaccine. 

Neither you nor I will know which group you are in. We won’t know what vaccine you get, either.

WHAT IS RANDOM ASSIGNMENT?

Randomisation is the process by which treatments are assigned to participants by chance rather than by choice.

This is done to avoid any bias (inequality) in the assignment of volunteers receiving one kind of treatment or another.

If you’ve received the new MenACWY study vaccine and it hasn’t produced an adequate immune response in your body, we’ll give you the MenACWY vaccine already available on the market to keep you suitably protected. Preferably, the MVaccine. We’ll give this to you after the study has been completed, provided your doctor considers it appropriate

You won’t know which group you are in, and neither will we.

But don’t worry, in an emergency, I will be the one who can access this information.

During your participation you’ll come to two visits.

First, I check that you’re OK, and if so, our nurse gives you your first vaccine. I’ll also run a blood test and some laboratory tests.

We’ll also give you a study diary. You should keep a diary for 7 days after receiving your vaccine.

LABORATORY TESTS

Laboratory tests may include a sample of blood, urine or body tissues. 

A technician or I myself will analyse the test samples to see if your results are within the normal values.

Your diary will help you to explain possible symptoms or side effects that may appear after vaccination.

DON’T WORRY. IT’S SIMPLE. WE’LL SHOW YOU HOW TO USE IT.

On day 29 after vaccination, I’ll give you another check-up and confirm that everything’s going well. Then our nurse will give you another blood test.

We’ll also ask you to hand in the diary you’ve been keeping since visit 1.

In addition to ensuring everything’s going OK, we need to collect information to comply with the aims of this study.

That’s why I’ll be asking you questions about your health status during your visits.

In addition to these two visits to the health centre, the nurse and I will call you on 3 occasions to ask after your health. 

RISKS

Yes, you may be concerned about the adverse events you might experience. 

It’s completely natural that you might be concerned, so let me try and explain everything clearly.

All drugs are studied carefully before they are given to people. But adverse events may occur during the study. That’s why we’ll be watching over you, so don’t worry.

Let me explain what adverse events might occur.

The following adverse events may occur:

After vaccination, in adolescents and adults, with both the MVaccine and the MenACWY vaccine.

 VERY FREQUENT

Headache, nausea, muscle pain, pain at the injection site, redness at the injection site, hardening at the injection site and/or general malaise.

FREQUENT

Skin rash, joint pain, redness at the injection site, hardening at the injection site, fever ≥38°C and chills.

LESS FREQUENT

As with all vaccines and medical products, strong or unforeseen allergic reactions may occur, manifesting as a rash on the hands and feet causing itching, swelling of the eyes and face, and difficulty breathing and swallowing.

POSSIBLE EFFECTS AFTER A BLOOD SAMPLE

Blood sampling may cause minor discomfort such as dizziness, pain, bruising, redness, irritation, and very rarely, infection at the extraction site.

REMEMBER YOU CAN ASK QUESTIONS AT ALL TIMES

Above all, remember to tell us about any adverse events you have experienced, whether they are the ones described above or any others.

How do I avoid them?

Some reactions usually occur before you leave the study centre.

This is why it’s important that you stay at the centre for at least 30 minutes after vaccination. This will help us to prevent problems, and act more effectively in case you experience any adverse symptoms.

For more information on other risks related to the use of this vaccine, ask me for a copy of the vaccine data sheet.

You can also ask your regular doctor.

Call me immediately if you experience a side effect you think is serious.

YOU CANNOT PARTICIPATE IN OUR STUDY IF YOU HAVE ANY OF THESE CONDITIONS:

If you are pregnant or breastfeeding your baby

you will not be able to participate in our study

If you plan to get pregnant in the near future

This is because we do not know the impact this vaccine may have on the foetus. This measure is being taken because it is very important for us to minimise all risks and ensure that you stay healthy.

Tell the study doctor if you are pregnant. If you do get pregnant during the study, you may stay in the study for follow-up purposes. In this case, we will be supervising you until delivery.

LEARN MORE ABOUT PREGNANCY AND BREASTFEEDING HERE

If you are a woman of childbearing age, please be aware that you will have to use a contraceptive method for 30 days before vaccination and during the entire treatment period (approximately one month after vaccination). You can get a pregnancy test before receiving the vaccine if you want. Talk to your study doctor about the type of contraceptive methods you can use and the time period you will have to continue using them. Please note that the use of certain methods may not be allowed in this study.

If you plan to receive the MVaccine or another meningococcal vaccine

Talk to your regular doctor about the indications for these vaccines, as well as their availability in your country.

The MenACWY vaccine may not be included in the universal vaccination scheme in your country, although it may be recommended in certain situations, such as in the case of a scheduled trip to a high-risk area.

BENEFITS OF PARTICIPATING

  • You will receive the known meningococcal vaccine (MVaccine) or the study meningococcal vaccine (MenACWY) for free. 
  • This may be beneficial in reducing the risk of contracting the disease known as meningitis.

Remember that, whenever you want,  you will be able to ask for information on the development of the study and its results.

CONTRIBUTION TO MEDICAL KNOWLEDGE

Participating in a clinical study contributes to medical knowledge.

IMPROVED CARE TO FUTURE PATIENTS

The results of these studies can make a difference in the care given to future patients by providing information on the benefits and risks of the new study vaccine (MenACWY).

SAFER, MORE EFFECTIVE MEDICINES

Clinical trials provide the basis for the development and commercialisation of new medicines, biological products and medical devices. Sometimes, the safety and efficacy of the experimental approach or actual treatment may not be fully known at the time of the trial.

WHO PAYS FOR THIS STUDY?

Medical studies are usually conducted by a promoting company, which develops, manufactures and markets vaccines, medicines and other health products. They are also the sponsors of this study.

The hospital and our research team will receive financial compensation from the sponsor for conducting this study.

WHAT ARE YOUR RIGHTS?

Your blood samples may be sent to the sponsor or to other laboratories working with the sponsor, including some located outside your country, in order to:

  • Measure your body’s ability to produce antibodies against the vaccines used in this study.
  • Guarantee the quality of tests performed with vaccines and/or to study diseases over time.
  • Improve tests and develop new tests related to vaccines and/or to study diseases. These tests will never include tests related to the hereditary characteristics of your genes.

You can tell us if you agree or not with the use described above

Your samples will receive a code so they cannot be identified directly.

All samples of the study will be managed following the provisions of the Biomedical Research Law 14/2007.

HOW ARE BLOOD SAMPLES MANAGED?

They will be labelled with the same code as the rest of the study information and stored in a safe place.

 

Everyone who works with your samples will keep the information and the results strictly confidential.

The promoter may use your samples or share them with other companies or research institutes to better understand this disease, other related diseases or for the future development of study medication or other related medications.

Your samples will be kept for a maximum of 20 years after the end of the study (the last visit of the last participant). At that time, all remaining samples will be destroyed.

This will allow for further scientific research in the future as new discoveries are made.

You can request the destruction of your samples at any time by contacting the study doctor.

Your medical and personal information will be kept confidential and secure.

The promoting company will protect your information in accordance with applicable laws.

Your participation in our study is voluntary. You can decide not to continue in the study without having to give us any reason. In case of withdrawal, we will tell you the best way to quit the study.

There are two important things to remember:

  • We would like you to notify me or any of our team members if you decide to withdraw.
  • We will ask you if your withdrawal is related to any adverse effects. This is very important for us and for you.
Even so, it is NOT mandatory that you give us a reason for quitting.

The study promoter has an insurance policy pursuant to current legislation.

We will provide you with compensation in case of injury or deterioration of your health occurring as a result of your participation in this study.

Your participation in the study will not involve any expense for you.

Study staff will provide you with a telephone number of a taxi service so you can come to the centre for your visits free of charge.

Futhermore, for the inconvenience and the time you dedicate to your participation in this study, you can receive, if you wish, a financial compensation of €30 for each visit to the centre where the study is being conducted. The corresponding taxes will be applied to this amount.

If you decide to withdraw your consent, it will mean:

  • You won’t continue with the study procedures.
  • You won’t come to any more study visits.
  • We will stop collecting information about your health related to your participation. Find out more in the section on the right.

Whatever the case, the same as before: you can quit if you want; it’s your right.

Talk to your study doctor if you have any questions about this.

AND THAT’S IT!

Thank you for your interest in our study.

I hope you have understood everything. If not, just ask us.

My team and I hope you’ll have a great participation!

SEE YOU SOON!

+1 123 45 67

If you call this number, a member of our team will answer your questions.



If you decide to participate in this study, please sign on the last page of this document, and we'll give you your copy. Start survey
This project has received funding from the European Union’s Horizon 2020 research and innovation programme under Grant Agreement No 741856