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Study on Early Measles Immunization with MMR-0 Vaccine for Infants Under 12 Months During a Measles Outbreak

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What is this trial about?

A plain-language summary of the goals, design and what participants do

This clinical trial is focused on studying the effects of early vaccination against measles during an outbreak. The study involves healthy infants who will receive a vaccine called M-M-RvaxPro, which is designed to protect against measles, mumps, and rubella. This vaccine contains live, weakened forms of the viruses that cause these diseases. Another vaccine, Nimenrix, which protects against certain types of meningococcal infections, is also part of the study.

The purpose of the study is to assess how well infants' immune systems respond to the early administration of the measles vaccine, known as MMR-0, when given to children younger than 12 months during a measles outbreak. The study will compare the immune response of infants who receive the MMR-0 vaccine with those who receive the standard measles vaccine, MMR-1, at 14 months of age. The study will monitor the levels of antibodies, which are proteins the body makes to fight infections, in the infants' blood at different times after vaccination.

Participants in the study will receive the vaccines through an injection into the muscle. The study will track the infants' immune responses over time, including four weeks after the MMR-0 vaccination and up to one year after the MMR-1 vaccination. The study aims to provide valuable information on the effectiveness and safety of early measles vaccination in young children during an outbreak.

The research process

The trial runs in 7 steps – from screening to follow-up. Each step says what happens and what the team monitors.

  1. Step 1

    Joining the study

    Upon joining the study, the infant must be eligible for the MMR-0 immunisation and the parents or legal representatives must provide signed informed consent after receiving both oral and written information about the study.

  2. Step 2

    Initial immunisation

    The infant will receive the MMR-0 immunisation, which is a vaccine to prevent measles, mumps, and rubella. This is administered as an intramuscular injection using the M-M-RvaxPro vaccine.

  3. Step 3

    First follow-up

    Four weeks after the MMR-0 immunisation, the infant's blood will be tested to measure the concentration of measles-specific virus-neutralising antibodies. This helps assess the immune response to the vaccine.

  4. Step 4

    Control group immunisation

    At 14 months of age, infants in the control group will receive the MMR-1 immunisation. This is also an intramuscular injection using the same M-M-RvaxPro vaccine.

  5. Step 5

    Second follow-up

    Before the MMR-1 immunisation, blood samples will be taken to measure measles-specific maternal antibody concentrations. This is to understand the level of antibodies present before the second dose.

  6. Step 6

    Third follow-up

    Four weeks after the MMR-1 immunisation, another blood test will be conducted to measure the concentration of measles-specific virus-neutralising antibodies. This helps evaluate the immune response to the second dose.

  7. Step 7

    Final follow-up

    One year after the MMR-1 immunisation, a final blood test will be performed to assess the long-term immune response by measuring the concentration of measles-specific virus-neutralising antibodies.

Who can join the trial?

5 criteria

  • Infants must be eligible for an MMR-0 immunisation (a vaccine to protect against measles, mumps, and rubella) and willing to receive it, or have received it less than 4 weeks ago.
  • Infants must be willing to receive the MMR-1 immunisation at 14 months of age.
  • Infants must be healthy according to the health criteria used in a well-baby clinic. This means even if they have a slight fever or a cold, they are still considered healthy.
  • The parents or legal representatives must agree to the infant's participation in the study according to the described procedures.
  • There must be a signed informed consent from the parents or legal representatives, meaning they have given written permission after receiving both oral and written information about the study.

Who cannot join the trial?

4 criteria

  • Infants who are not healthy cannot participate.
  • Infants who are not receiving a **prophylactic vaccine** (a vaccine given to prevent disease) to prevent measles infection cannot participate.
  • Infants older than 12 months cannot participate.
  • Infants who are not in a **measles outbreak setting** (an area where there is a sudden increase in measles cases) cannot participate.
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Investigated drugs

MMR-0 is a vaccine used to protect against three diseases: measles, mumps, and rubella. In this clinical trial, the focus is on how well this vaccine works when given to infants who are younger than 12 months old during a measles outbreak. The goal is to see how the immune system of these young infants responds to the vaccine, which is important because they are usually too young to receive the standard measles vaccination. By giving the vaccine earlier, researchers hope to provide protection against measles during an outbreak, which can be very serious for young children.

What is already known about the treatment

MMR-0 vaccine – The MMR-0 vaccine is administered as an injection to healthy infants, specifically those younger than 12 months, to prevent measles infection during an outbreak. Currently, this vaccine is being studied in clinical trials to understand its effectiveness in generating an immune response in this age group. The main therapeutic indication is to provide early protection against measles, a highly contagious viral disease. At the molecular level, the vaccine works by stimulating the body's immune system to recognize and fight the measles virus, should the individual be exposed to it in the future. It is classified pharmacologically as a vaccine, which is a type of biological preparation that provides active acquired immunity to a particular infectious disease.

Investigated diseases

Measles – Measles is a highly contagious viral infection caused by the measles virus. It begins with symptoms such as fever, cough, runny nose, and red eyes. A few days later, a red rash appears, typically starting on the face and spreading to the rest of the body. The disease progresses with the rash lasting for about a week, and other symptoms gradually improving. Complications can occur, especially in young children and those with weakened immune systems. The virus spreads through respiratory droplets from coughs and sneezes.
Trial detailsLast updated 2 Oct 2026
Age0-17PhasePhase IIITrial ID2024-513395-18-00Protocol codeIIV-671Estimated enrolment155 patientsSponsorRijksinstituut voor Volksgezondheid en Milieu (RIVM)

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