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Tests treatment safety and results for Chickenpox
Official title A Study on the Immune Response and Safety of an Investigational Chickenpox Vaccine When Given to Healthy Children 12 to 15 Months of Age
ClinicalTrials.gov ID: NCT06740630
What this study is testing
What is Investigational varicella vaccine_Lot 1?
Investigational varicella vaccine_Lot 1 is an investigational medicine, given as an injection under the skin, being studied as a potential treatment for chickenpox.
Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- The purpose of this study is to assess the consistency of immune response to three different lots of GSK's investigational varicella vaccine (VNS Vaccine), and to compare the safety and immune response of VNS vaccine to an already approved varicella vaccine (VV) known as Varivax. The study will be conducted in healthy children aged 12 to 15 months, who have neither contracted varicella nor received a varicella vaccination.
- Phase 3: a large, late-stage study
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 12 to 15. Healthy volunteers may be eligible.
You may be able to join if
- Participant's parent(s) Legally acceptable representatives /(LAR(s)), who, in the opinion of the investigator, can and will comply with the...
- Written or witnessed/thumb printed informed consent obtained from the participant's parent(s)/LAR(s) prior to performance of any study-specific...
- 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...
- 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...
You likely can't join if
- History of any reaction or hypersensitivity likely to be exacerbated by any component of the study interventions.
- Any confirmed or suspected immunosuppressive or immunodeficient condition, based on medical history and physical examination.
- Hypersensitivity to latex.
- Major congenital defects, as assessed by the investigator.
- Recurrent history of uncontrolled neurological disorders or seizures.
- History of varicella disease.
See the full eligibility criteria
- Participant's parent(s) Legally acceptable representatives /(LAR(s)), who, in the opinion of the investigator, can and will comply with the requirements of the protocol (e.g., completion of the eDiaries, return for...
- 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 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.
- Any confirmed or suspected immunosuppressive or immunodeficient condition, based on medical history and physical examination.
- 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 dose of study interventions...
- Planned administration of a vaccine in the period starting 30 days before the dose and ending 43 days after the dose of study interventions administration\ (Visit 2) with the exception of inactivated influenza vaccine...
- 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 immune-modifying drugs including among others immunotherapy (e.g., tumor necrosis factor-inhibitors), monoclonal antibodies (except the ones not...
- 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...
- 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...
- Child in care.
- Any study personnel's immediate dependents, family, or household members.
- Participants with the following high-risk individuals in their household:
- Immunocompromised individuals.
- Pregnant women without documented history of varicella.
- Newborn infants of mothers without documented history of varicella.
- Newborn infants born less than (\<) 28 weeks of gestation.
The study team makes the final eligibility decision.
Where it's taking place
- Mobile, Alabama, United States
- Hot Springs, Arkansas, United States
- Sherwood, Arkansas, United States
- Canoga Park, California, United States
- Covina, California, United States
- Fullerton, California, United States
- Long Beach, California, United States
- Los Angeles, California, United States
- Paramount, California, United States
- Sacramento, California, United States
- Ventura, California, United States
- Walnut Creek, California, United States
- Winnetka, California, United States
- Miami, Florida, United States
- Miami Lakes, Florida, United States
- Spring Hill, Florida, United States
- Tampa, Florida, United States
- Covington, Georgia, United States
- Ammon, Idaho, United States
- Moline, Illinois, United States
+ 64 more site(s).
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, 12 months to 15 months. Healthy volunteers may be eligible. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Mobile, Alabama, United States; Hot Springs, Arkansas, United States; Sherwood, Arkansas, United States; Canoga Park, California, United States; Covina, California, United States; Fullerton, California, United States and 78 more location(s). 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 ClinicalTrials.gov; the study team decides eligibility.