Clinical trial NCT06806137: 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
Official title: A Phase 3a, Observer-blind, Randomized, Controlled, Study to Evaluate the Immunogenicity and Safety of an Investigational Varicella Vaccine Compared With Varivax, When Given as a Second Dose to Healthy Children, 3 Months After the Administration of a First Dose at 12 to 15 Months of Age
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: PHASE3
Conditions: Chickenpox
Keywords: Chicken pox
Investigational varicella vaccine (VNS) Varicella
Varivax (VV)
Healthy Children
Lead sponsor: GlaxoSmithKline
Sponsor class: INDUSTRY
First posted: 2025-02-03
Enrollment: 600
Sex: ALL
Minimum age (years): 12
Maximum age (years): 15
Standard ages: CHILD
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief summary: The purpose of this study is to evaluate the immune response and safety of GSKs investigational varicella vaccine (VNS Vaccine) compared to an already approved varicella vaccine, Varivax (VV), when administered as second dose to healthy children. 3 months after first dose at 12 to 15 months. The study will be conducted in children who have not previously contracted varicella or received a varicella vaccination.


Eligibility criteria: Inclusion 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.

Exclusion Criteria:

* 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 first dose of study interventions (Day -29 to Day 1), or their planned use during the study period.
* 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:

    i) 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.

ii) 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 interfering with the immune response to the study vaccinese.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).
* 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.

Primary outcomes:
measure: Percentage of participants with seroresponse to Varicella Zoster Virus (VZV) anti- glycoprotein E (gE) IgG for 2 doses of VNS vaccine compared to 2 doses of VV
timeFrame: At Day 133 (43 days post-dose 2)
measure: Geometric Mean Concentration (GMC) of anti-VZV gE IgG for 2 doses of VNS vaccine compared to 2 doses of VV
timeFrame: At Day 133 (within 43 days post-dose 2)
Secondary outcomes:
measure: Percentage of participants with seroresponse to anti-VZV gE IgG for VV-VNS group
timeFrame: At Day 133 (within 43 days post-dose 2)
measure: GMC of anti-VZV gE IgG for VV-VNS group
timeFrame: At Day 133 (within 43 days post-dose 2)
measure: Percentage of participants reporting each solicited administration site event
timeFrame: Day 1 (post-dose 1) to Day 4
measure: Percentage of participants reporting each solicited administration site event
timeFrame: Day 91 (post-dose 2) to Day 94
measure: Percentage of participants reporting each solicited systemic event
timeFrame: Day 1 (post-dose 1) to Day 15
measure: Percentage of participants reporting each solicited systemic event
timeFrame: Day 91 (post-dose 2) to Day 105
measure: Percentage of participants reporting each solicited systemic event in terms of fever
timeFrame: Day 1 (post-dose 1) to Day 22
measure: Percentage of participants reporting each solicited systemic event in terms of fever
timeFrame: Day 91 (post-dose 2) to Day 112
measure: Percentage of participants reporting each solicited administration site event
timeFrame: Day 1 (post-dose 1) to Day 43
measure: Percentage of participants reporting each solicited administration site event
timeFrame: Day 91 (post-dose 2) to Day 133
measure: Percentage of participants reporting each solicited systemic event
timeFrame: Day 1 (post-dose 1) to Day 43
measure: Percentage of participants reporting each solicited systemic event
timeFrame: Day 91 (post-dose 2) to Day 133
measure: Percentage of participants reporting unsolicited adverse events (AEs)
timeFrame: Day 1 (post-dose 1) to Day 43
measure: Percentage of participants reporting unsolicited adverse events (AEs)
timeFrame: Day 91 (post-dose 2) to Day 133
measure: Percentage of participants reporting medically attended AEs (MAAE)
timeFrame: Day 1 (post-dose 1) to Day 271 (study end)
measure: Percentage of participants reporting serious adverse events (SAEs)
timeFrame: Day 1 (post-dose 1) to Day 271 (study end)
Other outcomes:
Locations:
Study officials:
References: