GSKVX000000025896 for Varicella

Inclusion criteria

• {"criterion_text":"- Participant’s parent(s)/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).\n- Written or witnessed/thumb printed informed consent obtained from the participant’s parent(s)/LAR(s) prior to performance of any study-specific procedure.\n- Healthy participants as established by medical history and clinical examination before entering into the study.\n- 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.\n- 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: -\tParticipant who previously received the primary series of PCV in the first year of life with last dose at least 60 days prior to the administration of study intervention."}

Exclusion criteria

• {"criterion_text":"- History of any reaction or hypersensitivity likely to be exacerbated by any component of the study interventions including hypersensitivity to neomycin or gelatin.\n- Any other clinical condition that, in the opinion of the investigator, might pose additional risk to the participant due to participation in the study.\n- 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.\n- 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. -\tUp to 90 days prior to the study intervention administration: •\tFor 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. •\tAdministration 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.\n- Previous vaccination against measles, mumps, and rubella.\n- Previous vaccination against varicella virus.\n- Previous vaccination against hepatitis A virus.\n- 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.\n- 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)\n- Any study personnel or their immediate dependents, family, or household members.\n- Child in care. Please see DEFINITIONS OF TERMS for the definition of child in care.\n- Any confirmed or suspected immunosuppressive or immunodeficient condition, based on medical history and physical examination (no laboratory testing required).\n- 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.\n- Hypersensitivity to latex.\n- Major congenital defects, as assessed by the investigator.\n- Recurrent history of uncontrolled neurological disorders or seizures.\n- History of measles, mumps, rubella, or varicella disease.\n- Active untreated tuberculosis.\n- Participants with bleeding disorders (e.g., thrombocytopenia or any coagulation disorder).\n- Condition that in the judgment of the investigator would make intramuscular injection unsafe."}

Primary endpoints

• {"endpoint_text":"- Seroresponse to VZV gE at Day 43.","definition_or_measurement_approach":"Measured at Day 43 by serology (anti-VZV gE IgG; anti-VZV gE ELISA referenced in documents) to determine seroresponse rate."}
• {"endpoint_text":"- Anti-VZV gE IgG concentration at Day 43.","definition_or_measurement_approach":"Measured at Day 43 by quantitative anti-VZV gE IgG assay (anti-VZV gE ELISA) and reported as antibody concentration (GMC)."}
• {"endpoint_text":"- Seroresponse to MMR antigens at Day 43.","definition_or_measurement_approach":"Measured at Day 43 by serology for measles, mumps and rubella antigens using the MMR research immunological assays to determine seroresponse rate."}
• {"endpoint_text":"- Anti-measles, anti-mumps, and anti-rubella IgG concentration at Day 43.","definition_or_measurement_approach":"Measured at Day 43 by quantitative IgG assays for measles, mumps and rubella (MMR research immunological assays) and reported as antibody concentrations (GMCs)."}

Secondary endpoints

• {"endpoint_text":"- Seroresponse to MMR antigens at Day 43.","definition_or_measurement_approach":"Measured at Day 43 by serology for MMR antigens to determine seroresponse rate (same assays as primary MMR endpoints)."}
• {"endpoint_text":"- Percentage of participants reporting each solicited administration site event in terms of injection site redness, pain, and swelling within 4 days (Day 1 to Day 4) post-dose of VNS vaccine or VV administration.","definition_or_measurement_approach":"Solicited local administration-site events captured within Day 1–4 post-dose; reported as percentage of participants reporting each event (solicited reactogenicity), assessed by participant/parent eDiary and investigator as applicable."}
• {"endpoint_text":"- Percentage of participants reporting each solicited administration site event in terms of injection site redness, pain, and swelling within 4 days (Day 1 to Day 4) post-dose of MMR vaccine administration.","definition_or_measurement_approach":"Solicited local administration-site events captured within Day 1–4 post-dose for MMR; reported as percentage of participants reporting each event, assessed by parent-reported eDiary and investigator as applicable."}
• {"endpoint_text":"- Percentage of participants reporting each solicited systemic event in terms of drowsiness, loss of appetite, and irritability within 15 days (Day 1 to Day 15) post-dose of study interventions administration.","definition_or_measurement_approach":"Solicited systemic events recorded Day 1–15 post-dose; reported as percentage of participants reporting each event, using parent/guardian eDiary reporting and investigator assessment."}
• {"endpoint_text":"- Percentage of participants reporting each solicited systemic event in terms of fever within 22 days (Day 1 to Day 22) post-dose of study interventions administration.","definition_or_measurement_approach":"Fever events collected Day 1–22 post-dose; reported as percentage of participants with fever events (solicited), via parent-reported measures/eDiary and investigator."}
• {"endpoint_text":"- Percentage of participants reporting each solicited administration site and systemic event in terms of injection site varicella-like rash, varicella-like rash (non-injection site), measles/rubella-like rash, and general rash (not varicella-like and not measles/rubella like) within 43 days (Day 1 to Day 43) post dose of study interventions administration as assessed by the investigator","definition_or_measurement_approach":"Solicited rash-type events assessed by investigator within Day 1–43 post-dose; reported as percentages of participants with each rash type based on investigator assessment."}
• {"endpoint_text":"- Unsolicited adverse events (AEs) •\tPercentage of participants reporting unsolicited AEs within 43 days (Day 1 to Day 43) post-dose of study interventions administration.","definition_or_measurement_approach":"All unsolicited AEs captured Day 1–43 post-dose and presented as percentage of participants reporting unsolicited AEs."}
• {"endpoint_text":"- Medically attended AEs (MAAEs) •\tPercentage of participants reporting MAAEs from Day 1 post-dose of study interventions administration up to study end (Day 181).","definition_or_measurement_approach":"MAAEs collected from Day 1 through Day 181 (study end) and reported as percentage of participants with medically attended AEs."}
• {"endpoint_text":"- Serious adverse events (SAEs) •\tPercentage of participants reporting SAEs from Day 1 post-dose of study interventions administration up to study end (Day 181)","definition_or_measurement_approach":"SAEs collected from Day 1 through Day 181 and reported as percentage of participants with SAEs."}

Methods

• Printed materials: Parent-Guardian Flyer, Poster, Brochure, Pre-Enrollment Information Card distributed at sites and clinics targeting parents/guardians of eligible children (12–15 months).
• Digital advertising: Digital Waiting Room Ad and Digital Parent/Guardian brochures and Digital Vaccine Info brochures targeted to parents/guardians in clinic waiting rooms and online; country-specific digital assets available.
• HCP engagement and referral: Dr-to-Parent-Guardian Letter, Physician Referral Letter, HCP Fact Sheet and Study information slides provided to healthcare professionals to facilitate referrals of eligible participants.
• Multimedia: Parent-Guardian Animation Video storyboard (video) used as informational outreach for parents/guardians.
• Pre-consent and consent support: Digital pre-consent toolkit and Informed Consent Guide to support informed consent discussions prior to enrollment.
• Site-based direct recruitment: Participant ID cards, Visit Reminder Cards, Thank You cards and in-clinic study guides used at participating sites for direct parent/guardian engagement.

Bulgaria

Earliest CTIS Part Ii Submission Date

13-05-2025

Latest Decision Or Authorization Date

14-08-2025

Processing Time Days

93

Number Of Sites

2

Number Of Participants

23

Poland

Earliest CTIS Part Ii Submission Date

13-05-2025

Latest Decision Or Authorization Date

13-03-2026

Processing Time Days

304

Number Of Sites

7

Number Of Participants

90

Belgium

Earliest CTIS Part Ii Submission Date

29-07-2025

Latest Decision Or Authorization Date

09-03-2026

Processing Time Days

223

Number Of Sites

2

Number Of Participants

17

Denmark

Earliest CTIS Part Ii Submission Date

31-07-2025

Latest Decision Or Authorization Date

20-03-2026

Processing Time Days

232

Number Of Sites

6

Number Of Participants

50

Lithuania

Earliest CTIS Part Ii Submission Date

18-07-2025

Latest Decision Or Authorization Date

16-03-2026

Processing Time Days

241

Number Of Sites

1

Number Of Participants

40

Romania

Earliest CTIS Part Ii Submission Date

13-05-2025

Latest Decision Or Authorization Date

23-03-2026

Processing Time Days

314

Number Of Sites

2

Number Of Participants

20

Estonia

Earliest CTIS Part Ii Submission Date

31-07-2025

Latest Decision Or Authorization Date

12-03-2026

Processing Time Days

224

Number Of Sites

2

Number Of Participants

74

Greece

Earliest CTIS Part Ii Submission Date

28-07-2025

Latest Decision Or Authorization Date

11-03-2026

Processing Time Days

226

Number Of Sites

2

Number Of Participants

40

Primary sponsor

Full Name

GlaxoSmithKline Biologicals

Organisation Type

Pharmaceutical company

Country Of Registered Address

Belgium

Contract research organisations

Name

IQVIA Limited

Responsibilities

Drug supply co-ordination, Event adjudication IDMC, Image Transfer from subject to site for evaluation, ECoA, IPP (IQVIA Participant Payments)

Name

IQVIA RDS Hellas Single Member S.A.

Third parties

• {"country":"United Kingdom","full_name":"Medical Equipment Supplies And Management Limited","duties_or_roles":"Equipment supply","organisation_type":"Pharmaceutical company"}
• {"country":"United States","full_name":"Corevitas LLC","duties_or_roles":"GSK vendor for SPFQ","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 Kingdom","full_name":"IQVIA Limited","duties_or_roles":"Drug supply co-ordination, Event adjudication IDMC, Image Transfer from subject to site for evaluation, ECoA, IPP (IQVIA Participant Payments)","organisation_type":"Pharmaceutical company"}
• {"country":"Germany","full_name":"Nexelis Marburg GmbH","duties_or_roles":"","organisation_type":"Pharmaceutical company"}
• {"country":"Belgium","full_name":"Marken Limited","duties_or_roles":"GSK Samples shipment","organisation_type":"Pharmaceutical company"}
• {"country":"United Kingdom","full_name":"Veramed Limited","duties_or_roles":"IDMC","organisation_type":"Pharmaceutical company"}
• {"country":"Belgium","full_name":"GlaxoSmithKline Biologicals","duties_or_roles":"","organisation_type":"Pharmaceutical company"}
• {"country":"United States","full_name":"Fisher Clinical Services Inc.","duties_or_roles":"GSK vendor for Ancillary supply","organisation_type":"Pharmaceutical company"}
• {"country":"United States","full_name":"Medidata Solutions Inc.","duties_or_roles":"","organisation_type":"Non-Pharmaceutical company"}
• {"country":"Greece","full_name":"IQVIA RDS Hellas Single Member S.A.","duties_or_roles":"","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":"Belgium","full_name":"Akkodis Belgium","duties_or_roles":"GSK vendor for Medical Writing","organisation_type":"Pharmaceutical company"}