> 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-various-51e7fb37-7cb5-46e7-93e7-98ba896a9d45 > Record changed: 2026-10-13 # A Study on the Immune Response and Safety of Various Potencies of an Investigational Chickenpox Vaccine Compared With a Marketed Chickenpox Vaccine, Given to Healthy Children 12 to 15 Months of Age NCT05084508 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05084508) Phase Phase 2 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05084508) Recruitment status Completed Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05084508) Participants 800 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05084508) Lead sponsor GlaxoSmithKline Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05084508) Start date 2022-02-03 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05084508) Number of sites 51 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05084508) ## Title and summary **Summary** The purpose of this study is to assess immune response and safety of various potencies of an investigational chickenpox vaccine given to healthy children 12 to 15 months of age. Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05084508) **Short title** A Study on the Immune Response and Safety of Various Potencies of an Investigational Chickenpox Vaccine Compared With a Marketed Chickenpox Vaccine, Given to Healthy Children 12 to 15 Months of Age Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05084508) **Official title** A Phase II, Observer-blind, Randomized, Controlled Study to Evaluate the Immunogenicity and Safety of a Varicella Vaccine at Various Potencies Compared With Varivax, as a First Dose, Administered in Healthy Children in Their Second Year of Life Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05084508) ## Status and phase **Control arm** Active comparator Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05084508) **Registry reports results** Yes Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05084508) **Listing at source** Listed Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05084508) **Recruitment status** Completed Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05084508) **Phase** Phase 2 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05084508) **Study type** Interventional Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05084508) ## Dates **Completion date** 2024-06-13 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05084508) **First posted** 2021-10-19 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05084508) **Registry last updated** 2025-02-28 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05084508) **Primary completion date** 2024-02-09 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05084508) **Start date** 2022-02-03 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05084508) ## Size and sites **Actual participants** 800 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05084508) **Participants** 800 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05084508) **Participant count basis** Actual Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05084508) **Protocol amendments** 4 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05084508) **Number of sites** 51 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05084508) ## Sponsor and oversight **Data monitoring committee** Yes Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05084508) **Registry sponsor category** Industry Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05084508) **Lead sponsor** GlaxoSmithKline Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05084508) **Source registry** ClinicalTrials.gov Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05084508) ## Identifiers **Registry ID** NCT05084508 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05084508) **ClinicalTrials.gov ID** NCT05084508 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05084508) **Registry record** Open registry record Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05084508) ## Study design **Allocation** Randomised **Model** Parallel groups **Purpose** Prevention **Masking** Triple masking **Masking description** Observer-blind study. Recipients and study evaluators will be unaware of vaccine administered. **Masked roles** Participants, Investigators, Outcome assessors Sources for study design Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05084508) ## Outcomes ### Primary outcomes 1. Concentrations of Anti-varicella Zoster Virus (VZV) Glycoprotein E (gE) Antibodies Timeframe: At Day 43 Concentrations of anti-VZV gE antibodies were presented as Geometric Mean Concentrations (GMCs) and expressed in milli-international units per milliliter (mIU/mL) for each group. ### Secondary outcomes 1. Percentage of Participants With Seroresponse to VZV gE Timeframe: At Day 43 Seroresponse was defined as the percentage of participants for whom the post-dose of anti VZV gE antibody concentration was greater than or equal to (\\>=) 300 mIU/mL for each group. 2. Number of Participants Reporting Each Solicited Administration Site Events Timeframe: Day 1 (post dose) to Day 4 Assessed solicited administration site events included injection site redness, pain and swelling. 3. Number of Participants Reporting Each Solicited Systemic Events Timeframe: Day 1 (post dose) to Day 43 Solicited systemic events included fever, varicella like rash (including injection site varicella-like rash), and general rash (not varicella-like) after the administration of all vaccines for each group. Fever was defined as temperature \\>= 38.0 °C (100.4°F) by any route (the preferred location for measuring temperature is the axilla). A typical varicella-like rash manifests as a rash/lesion that may appear within several weeks after the varicella vaccination. Lesions may contain spots, bumps, blisters, or crusts. Includes injection site varicella-like rash. 4. Number of Participants Reporting Each Solicited Systemic Events Timeframe: Day 1 (post dose) to Day 15 Solicited systemic events included drowsiness, loss of appetite, and irritability after the administration of all vaccines for each group. 5. Number of Participants Reporting Unsolicited Adverse Events Timeframe: Day 1 (post dose) to Day 43 Unsolicited adverse events (AEs) included 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; these were assessed for each group after the administration of all vaccines. Unsolicited AEs included both serious and non-serious AEs. 6. Number of Participants Reporting Serious Adverse Events (SAEs) Timeframe: From Day 1 to Day 181 (Study end) A SAE was defined as an AE which was life-threatening, required inpatient hospitalization or prolongation of existing hospitalization, resulted in disability/incapacity, or other situations that were considered serious per medical or scientific judgment. Sources for outcomes Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05084508) ## Eligibility **Sex** All **Age groups** Children **Minimum age** 12 Months **Maximum age** 15 Months **Healthy volunteers** Yes ### Inclusion criteria - Healthy participants as established by medical history and clinical examination before entering into the study. - A male or female between, and including, 12 and 15 months of age (i.e., from his/her 1 year birthday until the day before age of 16 months) at the time of the administration of the study interventions. - Written informed consent obtained from the parent(s)/legally authorized representative(s) of the participant prior to performance of any study-specific procedure. - Participants' parent(s)/legally authorized representative(s), who, in the opinion of the investigator, can and will comply, with the requirements of the protocol (e.g., completion of Electronic Diaries, return for follow-up visits). - Only for US participants and participants in countries where pneumococcal conjugate vaccine is recommended at 12-15 months of life as per national immunization schedule: Participants who previously received the primary series of pneumococcal conjugate vaccine in their first year of life with the last dose at least 60 days prior to study entry. ### Exclusion criteria Medical Conditions - History of any reaction or hypersensitivity likely to be exacerbated by any component of the study interventions including hypersensitivity to neomycin or gelatin. - Any confirmed or suspected immunosuppressive or immunodeficient condition, based on medical history and physical examination (no laboratory testing required). - Hypersensitivity to latex. - Major congenital defects, as assessed by the investigator. - History of varicella. - Recurrent history of or uncontrolled neurological disorders or seizures. - Participant with history of SARS-CoV-2 infection who is still symptomatic. - Any other clinical condition that, in the opinion of the investigator, might pose additional risk to the participant due to participation in the study. Prior and Concomitant Therapy - Use of any investigational or non-registered product (drug, vaccine or medical device) other than the study interventions during the period beginning 30 days before the dose of study interventions (Day -29 to Day 1), or planned use during the study period. - Chronic administration (defined as more than 14 days in total) of immunosuppressants, or other immune-modifying drugs during the period starting 90 days prior to the study interventions administration. For corticosteroids, this will mean prednisone equivalent ≥ 0.5 mg/kg/day or 20 mg/day whichever is the maximum dose for pediatric participants, or equivalent. Inhaled and topical steroids are allowed. - Administration of immunoglobulins and/or any blood products or plasma derivatives during the period starting 180 days before the dose of study interventions or planned administration during the study period. - Administration of long-acting immune-modifying drugs at any time during the study period (e.g., infliximab). - Previous vaccination against measles, mumps, rubella, hepatitis A, and/or varicella virus. Medical Conditions - History of any reaction or hypersensitivity likely to be exacerbated by any component of the study interventions including hypersensitivity to neomycin or gelatin. - Any confirmed or suspected immunosuppressive or immunodeficient condition, based on medical history and physical examination (no laboratory testing required). - Hypersensitivity to latex. - Major congenital defects, as assessed by the investigator. - History of varicella. - Recurrent history of or uncontrolled neurological disorders or seizures. - Participant with history of SARS-CoV-2 infection who is still symptomatic. - Any other clinical condition that, in the opinion of the investigator, might pose additional risk to the participant due to participation in the study. Prior and Concomitant Therapy - Use of any investigational or non-registered product (drug, vaccine or medical device) other than the study interventions during the period beginning 30 days before the dose of study interventions (Day -29 to Day 1), or planned use during the study period. - Chronic administration (defined as more than 14 days in total) of immunosuppressants, or other immune-modifying drugs during the period starting 90 days prior to the study interventions administration. For corticosteroids, this will mean prednisone equivalent ≥ 0.5 mg/kg/day or 20 mg/day whichever is the maximum dose for pediatric participants, or equivalent. Inhaled and topical steroids are allowed. - Administration of immunoglobulins and/or any blood products or plasma derivatives during the period starting 180 days before the dose of study interventions or planned administration during the study period. - Administration of long-acting immune-modifying drugs at any time during the study period (e.g., infliximab). - Previous vaccination against measles, mumps, rubella, hepatitis A, and/or varicella virus. - Previous administration of a booster dose of any pneumococcal conjugate vaccine. - Planned administration/administration of a vaccine not foreseen by the study protocol in the period starting 30 days before the dose and ending at 43 days after the dose of study interventions administration\* (Visit 3) with the exception of inactivated influenza (flu) 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 3 and anytime thereafter. - In case of emergency mass vaccination for an unforeseen public health threat (e.g., a pandemic) is recommended and/or organized by public health authorities outside the routine immunization program, the time period described above can be reduced if necessary for that vaccine, provided it is used according to the local governmental recommendations and that the Sponsor/designee is notified accordingly. Prior/Concurrent Clinical Study Experience • 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). Other Exclusions - 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 <28 weeks of gestation. Sources for eligibility Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05084508) ## Sites - GSK Investigational SiteBryant, United States - GSK Investigational SiteJonesboro, United States - GSK Investigational SiteLittle Rock, United States - GSK Investigational SiteBellflower, United States - GSK Investigational SiteDowney, United States - GSK Investigational SiteFoothill Ranch, United States - GSK Investigational SiteHuntington Park, United States - GSK Investigational SiteLos Angeles, United States - GSK Investigational SiteWest Covina, United States - GSK Investigational SiteTampa, United States - GSK Investigational SiteAtlanta, United States - GSK Investigational SiteIdaho Falls, United States - GSK Investigational SiteNew Orleans, United States - GSK Investigational SiteGulfport, United States - GSK Investigational SiteBridgeton, United States - GSK Investigational SiteOmaha, United States - GSK Investigational SiteOmaha, United States - GSK Investigational SiteLas Vegas, United States - GSK Investigational SiteEast Syracuse, United States - GSK Investigational SiteThe Bronx, United States - GSK Investigational SiteCharlotte, United States - GSK Investigational SiteCleveland, United States - GSK Investigational SiteDayton, United States - GSK Investigational SiteFort Washington, United States - GSK Investigational SiteBarnwell, United States And 26 more, listed on the interactive page. Sources for sites Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05084508) ## References - PubMed 41825190 Source: [pubmed.ncbi.nlm.nih.gov](https://pubmed.ncbi.nlm.nih.gov/41825190/) Related publication ### Other registry identifiers - 2022-001910-21 Sources for references Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05084508) ## 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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