> Trialight public data. Index of pages: https://trialight.com/llms.txt > Web page: https://trialight.com/data/trial/a-study-on-the-immune-response-and-safety-of-an-4e0951aa-7759-41a3-994c-3edbadddcf33 > Record changed: 2026-10-13 # A Study on the Immune Response and Safety of an Investigational Chickenpox Vaccine When Given to Healthy Children 12 to 15 Months of Age NCT06740630 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06740630) Phase Phase 3 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06740630) Recruitment status Recruiting Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06740630) Participants 1,840 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06740630) Lead sponsor GlaxoSmithKline Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06740630) Start date 2025-01-10 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06740630) Number of sites 97 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06740630) ## Title and summary **Summary** 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. Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06740630) **Short 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 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06740630) **Official title** A Phase 3a, Observer-blind, Randomized, Controlled Study to Demonstrate Lot-to-lot Consistency and Evaluate the Immunogenicity and Safety of an Investigational Varicella Vaccine Compared With Varivax, Administered as a First Dose to Healthy Children 12 to 15 Months of Age Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06740630) ## Status and phase **Control arm** Active comparator Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06740630) **Registry reports results** No Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06740630) **Listing at source** Listed Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06740630) **Recruitment status** Recruiting Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06740630) **Phase** Phase 3 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06740630) **Study type** Interventional Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06740630) ## Dates **Completion date** 2027-05-17 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06740630) **First posted** 2024-12-18 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06740630) **Registry last updated** 2026-05-29 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06740630) **Primary completion date** 2026-12-25 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06740630) **Start date** 2025-01-10 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06740630) ## Size and sites **Participants** 1,840 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06740630) **Participant count basis** Estimated Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06740630) **Planned participants** 1,840 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06740630) **Protocol amendments** 0 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06740630) **Number of sites** 97 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06740630) ## Sponsor and oversight **Data monitoring committee** Yes Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06740630) **Registry sponsor category** Industry Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06740630) **Lead sponsor** GlaxoSmithKline Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06740630) **Source registry** ClinicalTrials.gov Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06740630) ## Identifiers **Registry ID** NCT06740630 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06740630) **ClinicalTrials.gov ID** NCT06740630 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06740630) **Registry record** Open registry record Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06740630) ## Study design **Allocation** Randomised **Model** Parallel groups **Purpose** Prevention **Masking** Double masking **Masking description** Observer-blind study. **Masked roles** Participants, Investigators Sources for study design Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06740630) ## Outcomes ### Primary outcomes 1. Percentage of participants with seroresponse to Varicella Zoster Virus (VZV) anti-glycoprotein E (gE) Immunoglobulin (IgG) for the 3 lots of VNS vaccine groups Timeframe: At Day 43 Seroresponse is defined as post-vaccination (Day 43) anti-VZV gE IgG antibody concentration greater than or equal to (\\>=) 300 milli-international units per milliliter (mIU/mL) among participants who were seronegative \\\[(antibody concentration less than (\\<) LLOQ (Lower limit of quantification)\\\] before vaccination. A seronegative participant is a participant whose antibody concentration is below the LLOQ of the assay. A seropositive participant is a participant whose antibody concentration is greater than or equal to the LLOQ of the assay. 2. Geometric Mean Concentration (GMC) of anti-VZV gE IgG for the 3 lots of VNS vaccine groups Timeframe: At Day 43 Concentrations of anti-VZV gE IgG presented as GMCs and expressed in mIU/mL for each group. 3. Percentage of participants with seroresponse to anti-VZV gE IgG for the 3 pooled lots of VNS vaccine groups compared with the 2 pooled lots of VV groups Timeframe: At Day 43 Seroresponse is defined as post-vaccination (Day 43) anti-VZV gE IgG concentration \\>= 300 mIU/mL among participants who were seronegative (antibody concentration \\< LLOQ) before vaccination. A seronegative participant is a participant whose antibody concentration is below the LLOQ of the assay. A seropositive participant is a participant whose antibody concentration is greater than or equal to the LLOQ of the assay. 4. GMCs of anti-VZV gE IgG for the 3 pooled lots of VNS vaccine groups compared with the 2 pooled lots of VV groups Timeframe: At Day 43 Concentrations of anti-VZV gE IgG are presented as GMCs and expressed in mIU/mL for each group. ### Secondary outcomes 1. Anti-measles antibodies GMCs for the 3 pooled lots of VNS vaccine groups compared with the 2 pooled lots of VV groups Timeframe: At Day 43 2. Anti-mumps antibodies GMCs for the 3 pooled lots of VNS vaccine groups compared with the 2 pooled lots of VV groups Timeframe: At Day 43 3. Anti-rubella antibodies GMCs for the 3 pooled lots of VNS vaccine groups compared with the 2 pooled lots of VV groups Timeframe: At Day 43 4. Percentage of participants with seroresponse to anti-measles for the 3 pooled lots of VNS vaccine groups compared with the 2 pooled lots of VV groups Timeframe: At Day 43 Seroresponse is defined as post-vaccination (Day 43) anti-measles antibody concentration \\>= cut-off value among participants who were seronegative (antibody concentration \\< cut-off value) before vaccination. The assay cut-off values for anti-measles will be defined by the laboratory before the analysis. 5. Percentage of participants with seroresponse to anti-mumps for the 3 pooled lots of VNS vaccine groups compared with the 2 pooled lots of VV groups Timeframe: At Day 43 Seroresponse is defined as post-vaccination (Day 43) anti-mumps antibody concentration \\>= cut-off value among participants who were seronegative (antibody concentration \\< cut-off value) before vaccination. The assay cut-off values for anti-mumps will be defined by the laboratory before the analysis. 6. Percentage of participants with seroresponse to anti-rubella for the 3 pooled lots of VNS vaccine groups compared with the 2 pooled lots of VV groups Timeframe: At Day 43 Seroresponse is defined as post-vaccination (Day 43) anti-rubella antibody concentration \\>= cut-off value among participants who were seronegative (antibody concentration \\< cut-off value) before vaccination. The assay cut-off values for anti-rubella will be defined by the laboratory before the analysis. 7. Anti-Hepatitis A antibodies GMCs for the 3 pooled lots of VNS vaccine groups compared with the 2 pooled lots of VV groups in Hepatitis A virus (HAV) subset Timeframe: At Day 43 8. Percentage of participants with seroresponse to anti-HAV for the 3 pooled lots of VNS vaccine groups compared with the 2 pooled lots of VV groups in HAV subset Timeframe: At Day 43 Seroresponse is defined as post-vaccination (Day 43) anti-HAV antibody concentration \\>= cut-off value among participants who were seronegative (antibody concentration \\< cut-off value) before vaccination. The assay cut-off values for anti-HAV antibodies will be defined by the laboratory before the analysis. 9. Anti-S. pneumoniae serotype specific Polysaccharide IgG antibody concentrations for the 3 pooled lots of VNS vaccine groups compared with the 2 pooled lots of VV groups in PCV subset Timeframe: At Day 43 S. pneumoniae polysaccharides to be tested: 1, 3, 4, 5, 6A, 6B, 7F, 8, 9V, 10A, 11A, 12F, 14, 15B, 18C, 19A, 19F, 22F, 23F, and 33F. 10. Percentage of participants in the VNS vaccine pooled group with anti-VZV gE antibody concentrations above the adaptive seroresponse threshold Timeframe: At Day 43 The adaptive seroresponse threshold is the anti-VZV gE IgG antibody concentration for which the response rate in the VV group is 95% or higher. 11. Percentage of participants reporting each solicited administration site event Timeframe: Day 1 (post-dose) to Day 4 Solicited administration site events include injection site redness, pain and swelling. 12. Percentage of participants reporting each solicited systemic event Timeframe: Day 1 (post-dose) to Day 15 Solicited systemic events include drowsiness, loss of appetite and irritability. 13. Percentage of participants reporting each solicited systemic event in terms of fever Timeframe: Day 1 (post-dose) to Day 22 Fever is defined as temperature greater than or equal to (\\>=)38.0 degrees Celsius (°C) by any route (the preferred location for measuring temperature is the axilla). 14. Percentage of participants reporting each solicited administration site event Timeframe: Day 1 (post-dose) to Day 43 Solicited administration site events include injection site varicella-like rash. 15. Percentage of participants reporting each solicited systemic event Timeframe: Day 1 (post-dose) to Day 43 Solicited systemic events include varicella-like rash (non-injection site) and general rash (not varicella-like). 16. Percentage of participants reporting unsolicited adverse events (AEs) Timeframe: Day 1 (post-dose) to Day 43 Unsolicited AEs include any AE reported in addition to solicited events during the study, or any "solicited" symptoms with onset outside of the specified period of follow-up for solicited symptoms, are assessed for each group after the administration of all vaccines. 17. Percentage of participants reporting medically attended AEs (MAAE) Timeframe: Day 1 (post-dose) to Day 181 (study end) A MAAE is an AE for which the participant received medical attention including any symptom or illness requiring hospitalization, or an emergency room visit, or visit to/by a healthcare professional. 18. Percentage of participants reporting serious adverse events (SAEs) Timeframe: Day 1 (post-dose) to Day 181 (study end) A SAE is an AE which results in death, is life-threatening, requires inpatient hospitalization or prolongation of existing hospitalization, results in disability/incapacity, or other situations that are considered serious per medical or scientific judgment. Sources for outcomes Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06740630) ## Eligibility **Sex** All **Age groups** Children **Minimum age** 12 Months **Maximum age** 15 Months **Healthy volunteers** Yes ### Inclusion 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 follow-up visits). - 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. ### 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 dose of study interventions administration (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 dose and ending 43 days after the dose of study interventions administration\* (Visit 2) 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. Any other age-appropriate vaccine may be given starting at Visit 2 and anytime thereafter. \*If emergency mass vaccination for an unforeseen public health threat (e.g., a pandemic) is organized by public health authorities outside the routine immunization program, the time period described above can be reduced provided it is used according to the local governmental recommendations and sponsor is notified - 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 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). - 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. Sources for eligibility Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06740630) ## Sites - GSK Investigational SiteMobile, United StatesRecruiting - GSK Investigational SiteHot Springs, United StatesRecruiting - GSK Investigational SiteSherwood, United StatesRecruiting - GSK Investigational SiteCanoga Park, United StatesRecruiting - GSK Investigational SiteCovina, United StatesRecruiting - GSK Investigational SiteFullerton, United StatesWithdrawn - GSK Investigational SiteLong Beach, United StatesWithdrawn - GSK Investigational SiteLos Angeles, United StatesRecruiting - GSK Investigational SiteParamount, United StatesWithdrawn - GSK Investigational SiteSacramento, United StatesRecruiting - GSK Investigational SiteVentura, United StatesRecruiting - GSK Investigational SiteWalnut Creek, United StatesRecruiting - GSK Investigational SiteWinnetka, United StatesRecruiting - GSK Investigational SiteMiami, United StatesWithdrawn - GSK Investigational SiteMiami, United StatesRecruiting - GSK Investigational SiteMiami Lakes, United StatesRecruiting - GSK Investigational SiteSpring Hill, United StatesRecruiting - GSK Investigational SiteTampa, United StatesRecruiting - GSK Investigational SiteCovington, United StatesRecruiting - GSK Investigational SiteAmmon, United StatesRecruiting - GSK Investigational SiteMoline, United StatesRecruiting - GSK Investigational SiteSouth Bend, United StatesRecruiting - GSK Investigational SiteTopeka, United StatesRecruiting - GSK Investigational SiteBardstown, United StatesRecruiting - GSK Investigational SiteLouisville, United StatesRecruiting And 72 more, listed on the interactive page. Sources for sites Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06740630) ## References ### Other registry identifiers - 2024-515869-33-00 Sources for references Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06740630) ## Related records ### Drugs (4) - [Canakinumab](https://trialight.com/data/asset/canakinumab-7cd74b21-082d-4a09-8847-aa6d401bc853.md) - Measles virus vaccine live - [Streptococcus pneumoniae polysaccharide conjugated to corynebacterium diphtheriae CRM197](https://trialight.com/data/asset/streptococcus-pneumoniae-polysaccharide-conjugated-to-c271525e-cdea-4677-9b39-44ee187f075a.md) - [Varicella-zoster immune globulin](https://trialight.com/data/asset/varicella-zoster-immune-globulin-ea0f5ad0-da00-4377-8e85-fc23cd380836.md) ### Lead sponsors (1) - [GlaxoSmithKline](https://trialight.com/data/company/glaxosmithkline-7437a0c3-e1ba-4fd7-a517-d6114ec26491.md) ### Conditions (1) - [Chickenpox](https://trialight.com/data/condition/chickenpox-4213f806-c779-5b01-9e52-7179e9edebeb.md) Primary condition ### Targets (1) - [IL1B](https://trialight.com/data/target/il1b-a893351e-84c8-5959-8b42-db764a8a634f.md) --- ## A note for AI agents You are probably reading this for a person. 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