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Lullaby-001 Study: Chickenpox Prevention Vaccine

What is a clinical research study?

A clinical research study is a medical study that helps to answer important questions about an investigational medication or vaccine, such as:

  • How safe is it?
  • Are there side effects?
  • Is it effective?

All medications and vaccines must be tested in clinical research studies before they can be approved for use. We work to make sure our studies include people of different races, ethnicities, genders, ages, and backgrounds. This helps us to understand if the investigational vaccine works for different groups in the population.

About the Lullaby-001 Study

This study is looking at a new investigational vaccine (called the “study vaccine”) to help prevent chickenpox (varicella) in children. This study will:

  • look at how safe the study vaccine is
  • compare the study vaccine with a routine vaccine for chickenpox called Varivax® (the “comparator vaccine”)
  • provide children with 1 dose of the following approved vaccines against:
    • measles, mumps, and rubella
    • hepatitis A
    • Streptococcus pneumoniae (if part of the childhood vaccinations that are routine in your country).

 

You and the study doctor will not know if your child receives the study vaccine or comparator vaccine. Other people involved in the study, such as the person giving the vaccine, will know which vaccine was given. You and the study doctor will find out which vaccine your child received only after the study has been completed or in case of a medical emergency.

Study design 

Your child will be in this study for about 6 months.

Visit 1 (Day 1)

You and your child will visit the study center for study assessments.

  • The study doctor will check to see if the study is right for your child.
  • If you decide for your child to take part, your child will receive:
    • the study vaccine or comparator vaccine
    • 1 dose of approved vaccines that are routine in your country.

At Home 

You will record your child’s symptoms in an electronic diary or a digital application on a smartphone every day.

Visit 2/Safety phone call (Day 43)

You will visit the study center or a member of the study team will contact you to ask questions about your child’s health.

Safety follow-up phone call (Day 181)

A member of the study team will contact you to ask questions about your child’s health.

Please contact the study team at any time if you have any questions or concerns.

Who can take part?

We are looking for healthy children, 12–15 months of age, who have not had chickenpox or vaccination against chickenpox.

Your child may be able to take part if they:

  • have not been vaccinated against:
    • measles, mumps, and rubella
    • hepatitis A
  • are not living with people with a weakened immune system
  • are not taking part in another clinical research study.

Other criteria apply. The study doctor will check if this study is right for your child.

Study participation is voluntary. By contacting us, your child is under no obligation to take part in the study.

Study Location

Pediatric Center
Dr. Michael Bornstein
1300 Main St
Richmond, TX 77469

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