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Long‑term immunity after a 6‑month‑old MMR vaccine (live attenuated) in infants: follow‑up of antibody levels 1‑3 years after routine vaccination

Verified siteRegistered drugNo placebo
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What is this trial about?

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

The study looks at preventing measles, mumps, and rubella by giving a live‑attenuated vaccine called Measles-mumps-rubella vaccine (MMR) that is identified by the code name PHF00231MIG. It is administered as a small intramuscular injection when infants are 6 months old, while a comparable group receives a placebo for comparison.

The purpose is to determine whether early vaccination changes how strong the immune protection is later, measured by the amount of neutralising antibodies against measles several years after the routine dose given at age 4. Children are followed for up to three years after that routine dose, and blood samples are tested using a plaque-reduction neutralisation test and also to assess levels of IgG, a protein that shows immune memory. The study follows each child through the early vaccination, the routine dose, and the later check‑ups without requiring special procedures beyond routine clinic visits.

The research process

The trial runs in 4 steps – from screening to follow-up. Each step says what happens and what the team monitors.

  1. Step 1

    Early mmr vaccination at 6 months

    Receive a single mmr vaccine dose given as an intramuscular injection of 0.5 ml into the muscle of the upper arm

    The injection contains live, weakened viruses for measles, mumps, and rubella

    No further doses of this vaccine are required during the early phase

  2. Step 2

    Routine mmr vaccination at 4 years

    Receive a second mmr vaccine dose, also 0.5 ml given as an intramuscular injection in the upper arm

    This dose follows the standard vaccination schedule for children at age four

    The vaccine again contains live, weakened measles, mumps, and rubella viruses

  3. Step 3

    First follow‑up blood test (about 1 year after second dose)

    A small amount of blood is drawn to measure the level of antibodies against measles, mumps, and rubella

    The test checks the immune response at least one year after the routine vaccination at four years of age

    No medication is taken at this visit

  4. Step 4

    Final follow‑up blood test (1–3 years after routine dose)

    Another blood sample is collected between one and three years after the routine mmr vaccine given at age four

    The laboratory measures the amount of measles‑neutralising antibodies using a plaque‑reduction neutralisation test

    The result indicates how long the vaccine protection lasts

Who can join the trial?

4 criteria

  • Participation in the original MMR trial
  • Being a healthy volunteer (meaning you do not have serious illnesses that could affect the study)
  • Being either male or female
  • Being within the age range defined by the study (code “2”, which includes children roughly around the age the vaccine was given, about 4‑7 years old)

Who cannot join the trial?

4 criteria

  • Having an immune deficiency (a weak or missing immune system), any condition that suppresses the immune system, or taking medicines that change how the immune system works (such as high‑dose corticosteroids) will keep you from joining.
  • Having thrombocytopenia (a low number of platelets, which help blood clot) or any other bleeding or clotting problem (called a coagulation disorder) will exclude you.
  • Having abnormal blood cell conditions (blood dyscrasias), blood cancers like leukaemia, cancers of the lymph nodes or lymphatic system (lymphoma), or any other cancers that affect the blood‑forming or immune system (the haematopoietic and lymphatic systems) will exclude you.
  • If you have received a blood or plasma transfusion, or have been given a product called human immune serum globulin (a preparation of antibodies) within the past three months, you cannot take part.
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Investigated drugs

MMR vaccine is a shot that contains weakened (live‑attenuated) viruses for measles, mumps, and rubella. It is given by injection into the muscle. In this study the vaccine was used to see how well it creates long‑lasting protection. Children who received the vaccine early (at 6 months) were compared with children who received a placebo at that time, and later both groups received the routine MMR dose at 4 years of age. The researchers measured the amount of measles antibodies 1‑3 years after the routine dose to determine how strong the immune response was after the early vaccination.

What is already known about the treatment

Measles-mumps-rubella vaccine - It is given as a small amount (0.5 ml) injected into the muscle. The vaccine is an approved, widely used product that contains weakened measles, mumps and rubella viruses. It is used to protect children from getting measles, mumps and rubella infections. The weakened viruses enter the body and trigger the immune system to make antibodies, giving protection without causing disease, and it belongs to the class of live‑attenuated viral vaccines.

Investigated diseases

  • Measles

    Measles is a highly contagious viral infection that begins with fever, cough, runny nose, and red eyes. After a few days, a red rash appears, starting on the face and spreading downward. The rash typically lasts about a week. The virus spreads through droplets when an infected person coughs or sneezes. Symptoms may worsen before they improve, and most people recover fully.

  • Mumps

    Mumps is a viral illness that mainly affects the salivary glands, especially the parotid glands near the ears. It starts with fever, headache, and muscle aches, followed by swelling and tenderness of the cheeks. The swelling can last several days to a week. The virus spreads through saliva and respiratory secretions. Most cases resolve as the swelling gradually decreases.

  • Rubella

    Rubella, also known as German measles, is a mild viral infection that starts with low fever, headache, and a pink rash. The rash begins on the face and spreads to the body within a day. Small swollen lymph nodes may appear behind the ears and at the back of the neck. The virus spreads through respiratory droplets. The rash and other symptoms usually disappear within a few days.

Trial detailsLast updated 7 Oct 2026
Age0-17PhasePhase IIITrial ID2026-526160-21-00Estimated enrolment1 000 patientsSponsorRegion Hovedstaden

sourced from the EU Clinical Trials Register and site verification

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