GSKVX000000025896 for Varicella (chickenpox)

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)."}
• {"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 before 16 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":"- 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":"- Active untreated tuberculosis."}
• {"criterion_text":"- Any confirmed or suspected immunosuppressive or immunodeficient condition, based on medical history and physical examination (no laboratory testing required)."}
• {"criterion_text":"- Hypersensitivity to latex."}
• {"criterion_text":"- Recurrent history of uncontrolled neurological disorders or seizures."}
• {"criterion_text":"- History of varicella disease."}
• {"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."}
• {"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."}
• {"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":"- Other exclusion criteria may apply as per the study Protocol."}

Primary endpoints

• {"endpoint_text":"- Occurrence of solicited: •administration site events within 4 days (Day 1 to Day 4) post dose of VNS vaccine or VV administration. •systemic events within 15 days (Day 1 to Day 15) post-dose of study interventions administration. •systemic event (fever) within 22 days (Day 1 to Day 22) post-dose of study interventions administration. •administration site and systemic events (rash) within 43 days (Day 1 to Day 43) post-dose of study interventions administration.","definition_or_measurement_approach":"Solicited adverse events at specified time windows post-dose: administration-site events Day 1–4; systemic events Day 1–15; fever Day 1–22; administration-site and systemic rash Day 1–43. Measurement by collection of solicited AE reports (eDiaries/clinic assessment) within the defined windows."}
• {"endpoint_text":"- Occurrence of any unsolicited AEs within 43 days (Day 1 to Day 43) post-dose of study interventions administration.","definition_or_measurement_approach":"Any unsolicited adverse events reported or observed during Day 1–43 post-dose, collected via eDiary/clinic contact and recorded as AEs."}
• {"endpoint_text":"- Occurrence of any medically attended AEs post-dose of study interventions administration up to study end (Day 181).","definition_or_measurement_approach":"Medically attended adverse events captured from Day 1 post-dose through Day 181 (end of study) via medical records and investigator reports."}
• {"endpoint_text":"- Occurrence of SAEs post-dose of study interventions administration up to study end.","definition_or_measurement_approach":"Serious adverse events recorded from dose administration through study end (Day 181) via standard SAE reporting mechanisms."}

Methods

• Physician referral letters to parent/guardian (documents: Dr-to-Parent-Guardian Letter) — targeted at paediatric HCPs to refer eligible infants.
• Site-based materials (flyers, posters, brochures, participant ID cards) displayed in clinics targeting parents/guardians attending pediatric services.
• Digital waiting room advertisements and digital vaccine information brochures targeting parents in clinic digital environments.
• Digital pre-consent toolkit and digital post-consent toolkits (country-specific) including animation video storyboard and study slides to inform parents prior to consent.
• HCP fact sheets and site toolkits provided to investigators and site staff to support recruitment and informed discussions.
• Physician referral and program animation materials tailored per country (country-specific recruitment packets for BG, PL, EE, LTU, DNK).

Bulgaria

Earliest CTIS Part Ii Submission Date

28-03-2025

Latest Decision Or Authorization Date

09-05-2025

Processing Time Days

42

Number Of Sites

7

Number Of Participants

55

Poland

Earliest CTIS Part Ii Submission Date

24-04-2025

Latest Decision Or Authorization Date

12-05-2025

Processing Time Days

18

Number Of Sites

3

Number Of Participants

68

Estonia

Earliest CTIS Part Ii Submission Date

22-04-2025

Latest Decision Or Authorization Date

12-08-2025

Processing Time Days

112

Number Of Sites

2

Number Of Participants

89

Lithuania

Earliest CTIS Part Ii Submission Date

31-03-2025

Latest Decision Or Authorization Date

16-03-2026

Processing Time Days

350

Number Of Sites

2

Number Of Participants

97

Denmark

Earliest CTIS Part Ii Submission Date

23-04-2025

Latest Decision Or Authorization Date

05-03-2026

Processing Time Days

316

Number Of Sites

4

Number Of Participants

76

Primary sponsor

Full Name

GlaxoSmithKline Biologicals

Organisation Type

Pharmaceutical company

Country Of Registered Address

Belgium

Contract research organisations

Name

IQVIA Limited

Responsibilities

Sponsor duties codes: 1,11,12,15 (Drug supply co-ordination, Event adjudication IDMC, Image Transfer from subject to site for evaluation, eCOA, IPP), 2,3,4,5,6,7,8

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":"Belgium","full_name":"Akkodis Belgium","duties_or_roles":"Sponsor duties code: 11","organisation_type":"Pharmaceutical company"}
• {"country":"United Kingdom","full_name":"IQVIA Limited","duties_or_roles":"Sponsor duties codes: 1,11,12,15 (Drug supply co-ordination, Event adjudication IDMC, Image Transfer from subject to site for evaluation, eCOA, IPP), 2,3,4,5,6,7,8","organisation_type":"Pharmaceutical company"}
• {"country":"Belgium","full_name":"Keyrus Life Science","duties_or_roles":"GSK vendor for IDMC","organisation_type":"Pharmaceutical company"}