Study of new chickenpox vaccine and measles-mumps-rubella vaccine given by intramuscular injection in healthy children aged 12 to 15 months

3 1 1 1

What is this study about?

This clinical trial evaluates a new investigational varicella vaccine (chickenpox vaccine) and Priorix (a combination vaccine against measles, mumps, and rubella) when given as injections to healthy children aged 12 to 15 months. The study compares giving these vaccines through different injection methods – either into the muscle (intramuscular injection) or under the skin (subcutaneous injection).

The study aims to determine if the new chickenpox vaccine and Priorix work equally well when given as muscle injections compared to the standard under-the-skin method. The effectiveness will be measured by testing the body’s immune response to the vaccines through blood tests taken 43 days after vaccination.

During the study, participants will be monitored for common vaccination reactions like redness, pain, and swelling at the injection site, as well as general symptoms such as drowsiness, decreased appetite, irritability, and fever. They will also be checked for any rashes that may develop after vaccination. The total study duration will be 181 days, during which participants will have regular check-ups to monitor their health and any side effects.

1 Initial vaccination visit

You will receive two vaccinations during your first visit. Your child must be between 12 and 15 months of age.

The first vaccine is for chickenpox (varicella), given by injection into the muscle or under the skin.

The second vaccine is Priorix, which protects against measles, mumps, and rubella, given by injection into the muscle or under the skin.

Medical staff will examine your child to confirm they are healthy before administering the vaccines.

2 Initial monitoring period

For the first 4 days after vaccination, monitor and record any injection site reactions (redness, pain, swelling).

For 15 days after vaccination, monitor and record if your child experiences drowsiness, loss of appetite, or irritability.

Monitor your child’s temperature for 22 days after vaccination.

Watch for any rashes for 43 days after vaccination.

3 Follow-up blood test

Return to the clinic on Day 43 after vaccination for a blood test.

This test will check how well your child’s immune system has responded to the vaccines.

4 Extended monitoring period

Continue to monitor your child’s health for a total of 181 days (approximately 6 months) after vaccination.

Report any medical visits or serious health issues that occur during this period.

5 Final visit

Return to the clinic on Day 181 for the final study visit.

Medical staff will review your child’s health and complete the study documentation.

Who Can Join the Study?

  • Child must be between 12 and 15 months old (from their first birthday until the day before they turn 16 months)
  • Child must be in good health, as confirmed by medical history and examination
  • Parents or legal guardians must provide written consent (or witnessed thumbprint) before any study procedures begin
  • Parents or legal guardians must be able to follow study requirements, including:
    • Completing electronic diaries
    • Attending follow-up visits
  • For children in countries where PCV (Pneumococcal Conjugate Vaccine) is recommended at 12-15 months:
    • Must have received the primary PCV series in first year of life
    • Last PCV dose must have been given at least 60 days before starting the study
  • Both male and female children can participate

Who Cannot Join the Study?

  • History of allergic reactions to any vaccine components, especially to neomycin (an antibiotic)
  • Previous severe reaction to any measles, mumps, rubella, or varicella vaccines
  • Active, untreated tuberculosis (a bacterial infection primarily affecting the lungs)
  • Currently taking medications that suppress the immune system
  • Blood disorders or recent blood transfusions within the past 3 months
  • Current fever or active infection
  • Pregnancy or planning to become pregnant within 3 months of vaccination
  • History of immunodeficiency disorders (conditions that weaken the body’s ability to fight infections)
  • Receipt of any other vaccines within 30 days before the study
  • Participation in another clinical trial within the past 3 months
  • Any serious chronic medical condition that could interfere with study procedures
  • Known or suspected cancer
  • History of seizures or neurological disorders

Where you can join this trial?

Verified and Recommended Sites

No sites found in this category

Verified Sites

Site Name City Country Status
Med Fam Apolo S.R.L. Călărași Romania
Al Mare Perearstikeskus OU Tallin Estonia

Other Sites

Site Name City Country Status
Mtz Clinical Research Powered By Pratia Warsaw Poland
Niepubliczny Zaklad Lecznictwa Ambulatoryjnego Michalkowice Rybarczyk I Partnerzy Spolka Lekarska sp.p. Siemianowice Slaskie Poland
University Multiprofile Hospital For Active Treatment Saint Georgi EAD Plovdiv Bulgaria
Athens General Children’s Hospital Panagioti And Aglaia Kyriakou Athens Greece
Hippokration Hospital Athens Greece
Medical Center Doctor Staykov EOOD Burgas Bulgaria
Kliiniliste Uuringute Keskus OÜ Tartu Estonia
Aalborg University Hospital Aalborg Denmark
Pratia S.A. Skorzewo Poland
In Vivo Sp. z o.o. Bydgoszcz Poland
Region Midtjylland Aarhus Denmark
Anima Alken Belgium
Regionshospital Nordjylland Hjørring Denmark
Coyenar Msnquxq Dc Dgxllhbbav Si Tgqwmyyxi Avmhxzuwb Negugl Sjyuru Brasov Romania
Spcbntb Iud Sjq Jsskldp Sekupeyb W Tiounkwqa Sovuwanqwfy Poumzpmyn Zyxkoe Olrcdx Zqpiefqefn Trzebnica Poland
Mnxgioxsf Iipbixuest Ceardbld Schyzosn Sjp z oglh Warsaw Poland
Hlriwa Hioklvwg Herlev Denmark
Ahaydu Usadeljacw Hxzvnkfx Aarhus Denmark
Ucoxpcdydz Ok Awmuqsa Edegem Belgium
Iilxlnic Umr Kaunas Lithuania

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

Trial status

Country Status Recruitment Start
Belgium Belgium
Not yet recruiting
01.09.2025
Bulgaria Bulgaria
Not recruiting
01.09.2025
Denmark Denmark
Not yet recruiting
01.09.2025
Estonia Estonia
Recruiting
01.09.2025
Greece Greece
Not yet recruiting
01.09.2025
Lithuania Lithuania
Not yet recruiting
01.09.2025
Poland Poland
Recruiting
01.09.2025
Romania Romania
Recruiting
01.09.2025

Trial locations

Varicella vaccine (VNS)
This is an investigational vaccine designed to protect against chickenpox (varicella). It is being tested for intramuscular administration, which means it is injected into a muscle.

Varivax (VV)
This is an approved vaccine that protects against chickenpox. It is administered subcutaneously, which means it is injected under the skin.

Priorix (MMR vaccine)
This is a combination vaccine that protects against three different diseases: measles, mumps, and rubella. In this trial, it is being tested for both intramuscular and subcutaneous administration.

Investigated diseases:

Varicella – A highly contagious viral infection caused by the varicella-zoster virus that primarily affects children. The disease typically begins with a fever and general feeling of unwellness, followed by the appearance of a characteristic itchy rash. The rash progresses from small red bumps to fluid-filled blisters that eventually crust over. The condition usually spreads across the entire body in waves, with new spots appearing while others are healing. Symptoms typically last between 5-10 days, during which time the virus is most contagious.

Measles – A viral infection that begins with cold-like symptoms including fever, runny nose, and cough. A distinctive red-brown rash appears a few days later, typically starting on the face and spreading downward across the body. The infection also causes characteristic white spots inside the mouth called Koplik’s spots. The disease is highly contagious and can spread through airborne particles.

Mumps – A viral infection that primarily affects the salivary glands, causing them to become swollen and tender. The most noticeable symptom is swelling of the parotid glands, which causes the cheeks to puff out. Initial symptoms include fever, headache, muscle aches, and fatigue. The swelling typically appears first on one side before affecting both sides of the face.

Rubella – A viral infection characterized by a distinctive red rash that first appears on the face before spreading to the rest of the body. The condition often begins with mild fever and swollen lymph nodes, particularly behind the ears. The rash typically lasts about three days and may be accompanied by mild joint pain and cold-like symptoms.

Trial ID:
2024-518840-18-00
Protocol code:
223105
NCT ID:
NCT06855160
Trial Phase:
Therapeutic confirmatory (Phase III)

Other Trials to Consider

  • Study on the Safety of a New Chickenpox Vaccine (GSKVX000000025896) Compared to Varicella Virus Oka/Merck Strain in Healthy Children Aged 12-15 Months

    Recruiting

    3 1 1 1
    Investigated diseases:
    Bulgaria Denmark Estonia Lithuania Poland
  • Study on the Immune Response and Safety of a New Varicella Vaccine (GSKVX000000025896) Compared to Varicella Virus Oka/Merck Strain in Healthy Children Aged 12-15 Months

    Recruiting

    3 1 1 1
    Investigated diseases:
    Belgium Czechia Estonia Poland