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A Study on the Immune Response and Safety of the Second Dose of an Investigational Chickenpox Vaccine when Given to Healthy Children 3 Months after a First Dose at 12 to 15 Months of age.
EU CTIS ID: 2024-516635-27-00
What this study is testing
To evaluate non-inferiority of the immune response of 2 doses of investigational varicella (VNS) vaccine compared to 2 doses of Varicella vaccine (VV) in terms of seroresponse rate to VZV at Day 43 post Dose 2. To evaluate non-inferiority of the immune response of 2 doses of VNS vaccine compared to 2 doses of VV in terms of Geometric Mean Concentration (GMC) for Varicella zoster virus (VZV) at Day 43 post-Dose 2.
- Therapeutic confirmatory (Phase III)
A plain-language read of the study's public EU CTIS listing. The study team confirms the details.
Who can take part
You may be able to join if
- Participant’s parent(s)/Legally acceptable representative (LAR)(s), who, in the opinion of the investigator, can and will comply with the requirements of the protocol
- Written or witnessed/thumb printed informed consent obtained from the participant’s parent(s)/LAR(s) prior to performance of any study-specific procedure.
- Healthy participants as established by medical history and clinical examination before entering into the study.
- A male or female between, and including, 12 to 15 months of age (i.e., from the day of 1 year birthday until the day before 16 months of age) at the time of the administration of the first study interventions.
- Only for children in countries where PCV is recommended at 12 to 15 months of age as per national immunization schedule and provided as part of the study interventions: − Participant who previously received the primary series of PCV in the first year of life with last dose at least 60 days prior to study entry.
You likely can't join if
- History of any reaction or hypersensitivity likely to be exacerbated by any component of the study interventions.
- Hypersensitivity to latex.
- Major congenital defects, as assessed by the investigator.
- Recurrent history of uncontrolled neurological disorders or seizures.
- History of varicella disease.
- Active untreated tuberculosis.
See the full eligibility criteria
- Participant’s parent(s)/Legally acceptable representative (LAR)(s), who, in the opinion of the investigator, can and will comply with the requirements of the protocol
- Written or witnessed/thumb printed informed consent obtained from the participant’s parent(s)/LAR(s) prior to performance of any study-specific procedure.
- Healthy participants as established by medical history and clinical examination before entering into the study.
- A male or female between, and including, 12 to 15 months of age (i.e., from the day of 1 year birthday until the day before 16 months of age) at the time of the administration of the first study interventions.
- Only for children in countries where PCV is recommended at 12 to 15 months of age as per national immunization schedule and provided as part of the study interventions: − Participant who previously received the primary series of PCV in the first year of life with last dose at least 60 days prior to study entry.
- History of any reaction or hypersensitivity likely to be exacerbated by any component of the study interventions.
- Hypersensitivity to latex.
- Major congenital defects, as assessed by the investigator.
- Recurrent history of uncontrolled neurological disorders or seizures.
- History of varicella disease.
- Active untreated tuberculosis.
- Any other clinical condition that, in the opinion of the investigator, might pose additional risk to the participant due to participation in the study.
- Use of any investigational or non-registered product (drug, vaccine or invasive medical device) other than the study interventions during the period beginning 30 days before the first dose of study interventions (Day -29 to Day 1), or their planned use during the study period.
- Child in care.
- Any study personnel’s immediate dependents, family, or household members.
- Participants with the following high-risk individuals in their household: i) Immunocompromised individuals. ii) Pregnant women without documented history of varicella. iii) Newborn infants of mothers without documented history of varicella. iv) Newborn infants born less than (<) 28 weeks of gestation.
- Planned administration of a vaccine in the period starting 30 days before the first dose and ending 43 days after the second dose of study interventions administration* (Visit 3), with the exception of inactivated influenza vaccine which may be given at any time during the study and administered at a different location than the study interventions.
- Chronic administration of immune-modifying drugs (defined as more than 14 consecutive days in total) and/or planned use of long-acting immune-modifying treatments at any time up to the end of the study. - Up to 90 days prior to the study intervention administration: • For corticosteroids, this will mean prednisone equivalent ≥0.5 mg/kg/day with maximum of 20 mg/day for pediatric participants. Inhaled and topical steroids are allowed. • Administration of immunoglobulins and/or any blood products or plasma derivatives. - Up to 180 days prior to study interventions administration: long-acting immunemodifying drugs including among others immunotherapy (e.g., tumor necrosis factor-inhibitors), monoclonal antibodies (except the ones not interfering with the immune response to the study vaccines e.g., nirsevimab), antitumoral medication.
- Previous vaccination against measles, mumps, and rubella.
- Previous vaccination against hepatitis A virus.
- Previous vaccination against varicella virus.
- Only for children in countries where PCV is recommended at 12 to 15 months of age as per national immunization schedule and provided as part of the study interventions, participant who previously received a booster dose of any PCV.
- Concurrently participating in another clinical study, at any time during the study period, in which the participant has been or will be exposed to an investigational or a non-investigational intervention (drug/invasive medical device).
- Any confirmed or suspected immunosuppressive or immunodeficient condition, based on medical history and physical examination.
The study team makes the final eligibility decision.
Where it's taking place
- Dominican Republic
- Guatemala
- Honduras
- Costa Rica
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 0-17 years. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Dominican Republic; Guatemala; Honduras; Costa Rica. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from EU CTIS; the study team decides eligibility.