GSKVX000000025896 for Varicella

Inclusion criteria

• {"criterion_text":"- 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)."}
• {"criterion_text":"- Written or witnessed/thumb printed informed consent obtained from the participant’s parent(s)/LAR(s) prior to performance of any study-specific procedure."}
• {"criterion_text":"- Healthy participants as established by medical history and clinical examination before entering into the study."}
• {"criterion_text":"- 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 before16 months of age) at the time of the administration of study interventions."}
• {"criterion_text":"- 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

• {"criterion_text":"- History of any reaction or hypersensitivity likely to be exacerbated by any component of the study interventions."}
• {"criterion_text":"- 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"}
• {"criterion_text":"- 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."}
• {"criterion_text":"- Previous vaccination against measles, mumps, and rubella."}
• {"criterion_text":"- Previous vaccination against hepatitis A virus."}
• {"criterion_text":"- Previous vaccination against varicella virus."}
• {"criterion_text":"- 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."}
• {"criterion_text":"- 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)."}
• {"criterion_text":"- Child in care"}
• {"criterion_text":"- Any study personnel’s immediate dependents, family, or household members."}
• {"criterion_text":"- Participants with the following high-risk individuals in their household: -\tImmunocompromised individuals. -\tPregnant women without documented history of varicella. -\tNewborn infants of mothers without documented history of varicella. -\tNewborn infants born less than (<) 28 weeks of gestation."}
• {"criterion_text":"- Any confirmed or suspected immunosuppressive or immunodeficient condition, based on medical history and physical examination."}
• {"criterion_text":"- Hypersensitivity to latex."}
• {"criterion_text":"- Major congenital defects, as assessed by the investigator."}
• {"criterion_text":"- Recurrent history of uncontrolled neurological disorders or seizures."}
• {"criterion_text":"- History of varicella disease."}
• {"criterion_text":"- Active untreated tuberculosis"}
• {"criterion_text":"- Any other clinical condition that, in the opinion of the investigator, might pose additional risk to the participant due to participation in the study."}
• {"criterion_text":"- 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."}

Primary endpoints

• {"endpoint_text":"- Percentage of participants with seroresponse to Varicella Zoster Virus (VZV) anti- glycoprotein E (gE) Immunoglobulin (IgG) for the 3 lots of VNS vaccine groups. Time frame: At Day 43","definition_or_measurement_approach":"Seroresponse to anti-VZV gE IgG measured by anti-VZV gE IgG assay at Day 43; time frame specified as Day 43."}
• {"endpoint_text":"- Geometric Mean Concentration (GMC) of anti-VZV gE IgG for the 3 lots of VNS vaccine groups. Time time frame: At Day 43","definition_or_measurement_approach":"GMC of anti-VZV gE IgG measured by quantitative immunoassay at Day 43; time frame specified as Day 43."}
• {"endpoint_text":"- 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 group. Time frame: At day 43.","definition_or_measurement_approach":"Comparative seroresponse rate (VNS pooled 3 lots vs VV pooled 2 lots) measured by anti-VZV gE IgG assay at Day 43."}
• {"endpoint_text":"- GMCs of anti-VZV gE IgG for the 3 pooled lots of VNS vaccine groups compared with the 2 pooled lots of VV group. Fime frame: At Day 43.","definition_or_measurement_approach":"Comparative GMC of anti-VZV gE IgG (VNS pooled vs VV pooled) measured at Day 43."}

Secondary endpoints

• {"endpoint_text":"- Anti-measles antibodies GMCs for the 3 pooled lots of VNS vaccine groups compared with the 2 pooled lots of VV group. Time frame: At Day 43","definition_or_measurement_approach":"GMCs of anti-measles antibodies measured at Day 43 in pooled-group comparison."}
• {"endpoint_text":"- Anti-mumps antibodies GMCs for the 3 pooled lots of VNS vaccine groups compared with the 2 pooled lots of VV group. TIme frame: At Day 43","definition_or_measurement_approach":"GMCs of anti-mumps antibodies measured at Day 43 in pooled-group comparison."}
• {"endpoint_text":"- Anti-rubella antibodies GMCs for the 3 pooled lots of VNS vaccine groups compared with the 2 pooled lots of VV group. Time frame: At Day 43","definition_or_measurement_approach":"GMCs of anti-rubella antibodies measured at Day 43 in pooled-group comparison."}
• {"endpoint_text":"- 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 group. Time frame: At Day 43.","definition_or_measurement_approach":"Seroresponse rate to anti-measles at Day 43 compared between pooled groups."}
• {"endpoint_text":"- 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 group. Time frame: At Day 43","definition_or_measurement_approach":"Seroresponse rate to anti-mumps at Day 43 compared between pooled groups."}
• {"endpoint_text":"- 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 group. Time frame: At Day 43.","definition_or_measurement_approach":"Seroresponse rate to anti-rubella at Day 43 compared between pooled groups."}
• {"endpoint_text":"- Anti-Hepatitis A antibodies GMCs for the 3 pooled lots of VNS vaccine groups compared with the 2 pooled lots of VV group in HAV subset. Time frame: At Day 43.","definition_or_measurement_approach":"GMCs of anti-HAV antibodies measured at Day 43 in the HAV subset, pooled-group comparison."}
• {"endpoint_text":"- 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 group in HAV subset. Time frame: At day 43.","definition_or_measurement_approach":"Seroresponse rate to anti-HAV at Day 43 in the HAV subset, pooled-group comparison."}
• {"endpoint_text":"- 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 group in PCV subset. Time frame: At Day 43.","definition_or_measurement_approach":"Serotype-specific polysaccharide IgG concentrations for S. pneumoniae measured at Day 43 in the PCV subset; pooled-group comparison."}
• {"endpoint_text":"- Percentage of participants in the VNS vaccine pooled group with anti-VZV gE antibody concentrations above the adaptive seroresponse threshold. Time frame: At Day 43.","definition_or_measurement_approach":"Proportion of participants exceeding the predefined adaptive seroresponse threshold for anti-VZV gE IgG at Day 43."}
• {"endpoint_text":"- Percentage of participants reporting each solicited administration site events (injection site redness, pain and swelling). Time frame: Day 1 (post-dose) to Day 4.","definition_or_measurement_approach":"Solicited injection-site events (redness, pain, swelling) reported by participants/parents from Day 1 to Day 4 post-dose."}
• {"endpoint_text":"- Percentage of participants reporting each solicited systemic event (drowsiness, loss of appetite and irritability). Time frame: Day 1 (post-dose) to Day 15.","definition_or_measurement_approach":"Solicited systemic events (drowsiness, loss of appetite, irritability) reported from Day 1 to Day 15 post-dose."}
• {"endpoint_text":"- Percentage of participants reporting each solicited systemic event in terms of fever (Fever is defined as temperature greater than or equal to [>=)] 38.0 degrees Celsius [°C] by any route). Time frame: Day 1 (post-dose) to Day 22.","definition_or_measurement_approach":"Solicited systemic event of fever (defined as ≥38.0°C by any route) collected Day 1 to Day 22 post-dose."}
• {"endpoint_text":"- Percentage of participants reporting each solicited administration site events (injection site varicella-like rash). Time frame: Day 1 (post-dose) to Day 43.","definition_or_measurement_approach":"Solicited injection-site varicella-like rash reports collected Day 1 to Day 43 post-dose."}
• {"endpoint_text":"- Percentage of participants reporting each solicited systemic events (varicella-like rash [non-injection site] and general rash [not varicella like]). Time frame: Day 1 (post-dose) to Day 43.","definition_or_measurement_approach":"Solicited systemic rash events (varicella-like non-injection-site and general rash) collected Day 1 to Day 43 post-dose."}
• {"endpoint_text":"- Percentage of participants reporting unsolicited adverse events (AEs) (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). Time frame: Day 1 (post-dose) to Day 43.","definition_or_measurement_approach":"Unsolicited AEs reported from Day 1 to Day 43 post-dose; includes any AE outside solicited windows."}
• {"endpoint_text":"- Percentage of participants reporting medically attended AEs (MAAE) (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.). Time frame: Day 1 (post-dose) to Day 181 (study end).","definition_or_measurement_approach":"MAAEs (requiring medical attention/hospitalization/ER/healthcare professional visit) collected Day 1 to Day 181."}
• {"endpoint_text":"- Percentage of participants reporting serious adverse events (SAEs). (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.). Time frame: Day 1 (post-dose) to Day 181 (study end).","definition_or_measurement_approach":"SAEs (as per standard definition) collected Day 1 to Day 181 (study end)."}

Methods

• Digital Waiting Room Ad – digital advertisement displayed in waiting rooms targeting parents/guardians of age-eligible children (documents available in English/French/Dutch/Polish/Czech/Estonian as per country versions).
• Parent-Guardian brochures, flyers, posters and vaccine information brochures – paper and digital materials for parents/guardians describing the study and eligibility (country-specific language versions and formats).
• Dr-to-Parent-Guardian Letter and Physician Referral Letter – letters sent from clinicians to parents/guardians to inform and refer eligible children; used in country-specific implementations.
• Parent-Guardian Study Guide, Pre-consent and Post-consent toolkits – informational materials to support informed decision-making for parents/guardians (digital and printed).
• Parent-Guardian animation video storyboard – multimedia educational content for parents/guardians to explain the study.
• Participant ID cards and Visit Reminder Cards – materials to support retention and visit attendance.
• Informed Consent Guide and country-specific parental ICF documents – materials provided to parents/guardians during recruitment and consent process.
• Country-targeted recruitment packs and translations – recruitment materials are prepared for Belgium (EN/FR/NL), Poland (PL), Czechia (CS/CZ) and Estonia (EST) reflecting country-specific approaches and languages.

Estonia

Earliest CTIS Part Ii Submission Date

06-05-2025

Latest Decision Or Authorization Date

09-04-2026

Processing Time Days

338

Number Of Sites

2

Number Of Participants

75

Belgium

Earliest CTIS Part Ii Submission Date

17-04-2025

Latest Decision Or Authorization Date

18-03-2026

Processing Time Days

335

Number Of Sites

5

Number Of Participants

25

Poland

Earliest CTIS Part Ii Submission Date

16-04-2025

Latest Decision Or Authorization Date

23-03-2026

Processing Time Days

341

Number Of Sites

5

Number Of Participants

35

Czechia

Earliest CTIS Part Ii Submission Date

02-09-2024

Latest Decision Or Authorization Date

23-02-2026

Processing Time Days

539

Number Of Sites

5

Number Of Participants

64

Primary sponsor

Full Name

GlaxoSmithKline Biologicals

Organisation Type

Pharmaceutical company

Country Of Registered Address

Belgium

Contract research organisations

Name

IQVIA Limited

Responsibilities

Multiple responsibilities including study management roles: drug supply coordination, event adjudication (IDMC), image transfer from subject to site for evaluation, eCoA, IPP, and other operational functions (as listed under sponsor duties). Contact: eu_clinical_trials_information@iqvia.com

Third parties

• {"country":"Belgium","full_name":"GlaxoSmithKline Biologicals (Wavre address)","duties_or_roles":"Sponsor duties code: 4","organisation_type":"Pharmaceutical company"}
• {"country":"United Kingdom","full_name":"HCL Technologies UK Limited","duties_or_roles":"GSK vendor for Lab ancillary Supply","organisation_type":"Non-Pharmaceutical company"}
• {"country":"United States","full_name":"Fisher Clinical Services Inc.","duties_or_roles":"GSK vendor for Ancillary supply","organisation_type":"Pharmaceutical company"}
• {"country":"Germany","full_name":"Azenta Germany GmbH","duties_or_roles":"Sponsor duties code: 4","organisation_type":"Pharmaceutical company"}
• {"country":"Belgium","full_name":"Akkodis Belgium","duties_or_roles":"Sponsor duties code: 11","organisation_type":"Pharmaceutical company"}
• {"country":"United States","full_name":"Azenta US Inc.","duties_or_roles":"Sponsor duties code: 4","organisation_type":"Pharmaceutical company"}
• {"country":"Belgium","full_name":"Marken Limited","duties_or_roles":"GSK Samples shipment","organisation_type":"Pharmaceutical company"}
• {"country":"United States","full_name":"Corevitas LLC","duties_or_roles":"SPFQ questionnaire","organisation_type":"Pharmaceutical company"}
• {"country":"Canada","full_name":"Iqvia Laboratories Canada Inc.","duties_or_roles":"Sponsor duties code: 4","organisation_type":"Laboratory/Research/Testing facility"}
• {"country":"United Kingdom","full_name":"Veramed Limited","duties_or_roles":"GSK vendor for IDMC Charter","organisation_type":"Pharmaceutical company"}
• {"country":"United States","full_name":"Medidata Solutions Inc.","duties_or_roles":"Sponsor duties code: 7","organisation_type":"Non-Pharmaceutical company"}
• {"country":"United Kingdom","full_name":"Medical Equipment Supplies And Management Limited","duties_or_roles":"Equipment supply","organisation_type":"Pharmaceutical company"}
• {"country":"Germany","full_name":"MARKEN Germany GmbH","duties_or_roles":"GSK vendor for Lab kit supply","organisation_type":"Pharmaceutical company"}
• {"country":"United Kingdom","full_name":"IQVIA Limited","duties_or_roles":"Multiple operational roles including drug supply co-ordination, event adjudication (IDMC), image transfer, eCoA, IPP, and other study operational responsibilities","organisation_type":"Pharmaceutical company"}
• {"country":"Belgium","full_name":"GlaxoSmithKline Biologicals (Rixensart address)","duties_or_roles":"Sponsor duties code: 4 (local sponsor contact)","organisation_type":"Pharmaceutical company"}