AuthorisedTherapeutic use (Phase IV)Interventional

EarLy extra Measles immunisation during a measles Outbreak (ELMO)

This study, called ELMO, is for healthy babies and aims to understand if giving the first measles vaccine (MMR-0) early during a measles outbreak helps protect them better. Researchers will measure how many protective antibodies babies have in their blood four weeks after getting this first vaccine. They will also look at how much protection babies already have from their mothers before the vaccine. The study will compare how well the vaccine works in babies who get the early MMR-0 with those who don't, checking antibody levels before and after routine vaccinations and up to a year later. They'll also carefully watch for any common side effects from the vaccines to see how babies respond.

At a glance

Status

Authorised

Phase

Therapeutic use (Phase IV)

Sponsor

Rijksinstituut voor Volksgezondheid en Milieu (RIVM)

Enrolment target

155

Start

22 Jul 2024

Healthy infants receiving a profylactic vaccine to prevent measles infection

What is this study about?

The ELMO study is looking into a way to protect babies from measles, especially when there's a measles outbreak. Normally, babies get their first measles, mumps, and rubella (MMR) vaccine a bit later. This study wants to see if giving a first dose of the measles vaccine (we'll call it MMR-0) earlier than usual works well.

Researchers will be giving healthy babies a measles vaccine. They will then test the babies' blood to see how many protective substances, called antibodies, they have against measles. These antibodies are like little soldiers that fight off infections. The goal is to see how much protection babies get from the early vaccine, four weeks after they've had it. They will also check if the babies already have some protection passed on from their mothers.

This is important because measles can be a very serious illness, especially for young babies. By understanding if an earlier vaccine dose gives good protection, doctors can make better decisions about how to keep babies safe during measles outbreaks. The study will also keep an eye on how babies react to the vaccine, making sure it's safe and well-tolerated.

Key takeaways

This study explores giving babies a measles vaccine earlier during outbreaks.
It aims to see how well this early vaccine protects against measles.
Babies' antibody levels will be measured to check their immunity.
Safety and common vaccine side effects will be carefully monitored.
The study helps improve protection for infants against measles.

Who may be eligible?

This study is open to healthy babies, no matter their age or gender. The main focus is on infants who would be getting a protective vaccine to help prevent them from catching measles.

If your baby is generally healthy and you're interested in understanding more about early measles vaccination, this study might be suitable. Your doctor will be able to help you decide if your baby can take part after a full check-up.

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.

Is my baby generally healthy?
Is my baby due for their first measles vaccine or would they be eligible due to an outbreak?
Am I comfortable with my baby having blood tests?
Can I commit to study visits over approximately one year?

Answer every question to see your result.

What does participation involve?

If your baby takes part in this study, they will receive a measles vaccine (MMR-0) earlier than the standard schedule. They might also receive a vaccine for meningitis (Nimenrix) as part of their routine care. Researchers will take small blood samples from your baby at different times: before the MMR-0 vaccine, four weeks after the MMR-0 vaccine, and then again before, four weeks after, and one year after their standard routine MMR vaccine (MMR-1).

During these visits, healthcare professionals will also check your baby for any common reactions or side effects to the vaccines. The total duration of your baby's participation in the study from the first vaccine to the final blood sample will be about one year.

Potential risks and benefits

Taking part in this study might offer your baby early protection against measles during an outbreak, potentially reducing their risk of serious illness. Researchers will also closely monitor their health and reactions to the vaccines. As with any vaccine, there's a small chance of common side effects like a fever or a sore arm. The study will carefully track these reactions. Remember, you have the right to withdraw your baby from the study at any time, for any reason, without it affecting their 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
Netherlands

Common questions

What is the MMR-0 vaccine?

MMR-0 is the standard measles, mumps, and rubella vaccine, but given earlier than usual for this study.

What are antibodies?

Antibodies are substances in your blood that fight off infections, like tiny soldiers protecting your body.

Will my baby get other vaccines?

Your baby might receive a meningitis vaccine (Nimenrix) if it's due as part of their routine healthcare, alongside the measles vaccine for the study.

How long will the study last for my baby?

Your baby's involvement in the study will last for approximately one year.

Is getting a vaccine earlier safe?

The study will closely monitor your baby for any reactions, and vaccines are generally very safe and effective.