GSKVX000000025896 for Varicella

Inclusion criteria

• {"criterion_text":"- Participant’s parent(s)/Legally acceptable representative (LAR)(s), who, in the opinion of the investigator, can and will comply with the requirements of the protocol"}
• {"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 the first 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 first dose and ending 43 days after the second dose of study interventions administration* (Visit 3), 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 immunemodifying 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":"- 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 first dose of study interventions (Day -29 to Day 1), or their planned use during the study period."}
• {"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: i) Immunocompromised individuals. ii) Pregnant women without documented history of varicella. iii) Newborn infants of mothers without documented history of varicella. iv) Newborn infants born less than (<) 28 weeks of gestation."}

Primary endpoints

• {"endpoint_text":"- Percentage of participants with seroresponse to Varicella Zoster Virus (VZV) antiglycoprotein E (gE) IgG for 2 doses of VNS vaccine compared to 2 doses of VV. Time frame: At Day 133 (43 days post-dose 2)","definition_or_measurement_approach":"Seroresponse to VZV antiglycoprotein E (gE) IgG measured at Day 133 (43 days post-dose 2); comparison between 2 doses of investigational VNS vaccine and 2 doses of Varivax (VV)."}
• {"endpoint_text":"- Geometric Mean Concentration (GMC) of anti-VZV gE IgG for 2 doses of VNS vaccine compared to 2 doses of VV Time frame: At Day 133 (43 days post-dose 2)","definition_or_measurement_approach":"GMC of anti-VZV gE IgG measured at Day 133 (43 days post-dose 2); comparison between 2 doses of investigational VNS vaccine and 2 doses of Varivax (VV)."}

Secondary endpoints

• {"endpoint_text":"- Percentage of participants with seroresponse to anti-VZV gE IgG for VV-VNS group. Time frame: At Day 133 (43 days post-dose 2)","definition_or_measurement_approach":"Seroresponse rate in VV-VNS group measured at Day 133 (43 days post-dose 2)."}
• {"endpoint_text":"- GMC of anti-VZV gE IgG for VV-VNS group. Time frame: At Day 133 (43 days post-dose 2)","definition_or_measurement_approach":"GMC of anti-VZV gE IgG in VV-VNS group measured at Day 133 (43 days post-dose 2)."}
• {"endpoint_text":"- Percentage of participants reporting each solicited administration site event. Time frame: Day 1 (post-dose 1) to Day 4","definition_or_measurement_approach":"Solicited administration site events recorded Days 1–4 after Dose 1."}
• {"endpoint_text":"- Percentage of participants reporting each solicited administration site event. Time frame: Day 91 (Day 1 post-dose 2) to Day 94","definition_or_measurement_approach":"Solicited administration site events recorded Days 1–4 after Dose 2 (Day 91–94 relative to study schedule)."}
• {"endpoint_text":"- Percentage of participants reporting each solicited systemic event. Time frame: Day 1 (post-dose 1) to Day 15","definition_or_measurement_approach":"Solicited systemic events recorded Days 1–15 after Dose 1."}
• {"endpoint_text":"- Percentage of participants reporting each solicited systemic event. Time frame: Day 91 (Day 1 post-dose 2) to Day 105","definition_or_measurement_approach":"Solicited systemic events recorded Days 1–15 after Dose 2 (Day 91–105)."}
• {"endpoint_text":"- Percentage of participants reporting each solicited systemic event in terms of fever. Time frame: Day 1 (post-dose 1) to Day 22","definition_or_measurement_approach":"Fever as solicited systemic event recorded Days 1–22 after Dose 1."}
• {"endpoint_text":"- Percentage of participants reporting each solicited systemic event in terms of fever. Time frame: Day 91 (Day 1 post-dose 2) to Day 112","definition_or_measurement_approach":"Fever as solicited systemic event recorded Days 1–22 after Dose 2 (Day 91–112)."}
• {"endpoint_text":"- Percentage of participants reporting each solicited administration site event. Time frame: Day 1 (post-dose 1) to Day 43","definition_or_measurement_approach":"Solicited administration site events recorded up to Day 43 after Dose 1."}
• {"endpoint_text":"- Percentage of participants reporting each solicited administration site event. Time frame: Day 91 (Day 1 post-dose 2) to Day 133","definition_or_measurement_approach":"Solicited administration site events recorded up to Day 133 after Dose 2."}
• {"endpoint_text":"- Percentage of participants reporting each solicited systemic event. Time frame: Day 1 (post-dose 1) to Day 43","definition_or_measurement_approach":"Solicited systemic events recorded up to Day 43 after Dose 1."}
• {"endpoint_text":"- Percentage of participants reporting each solicited systemic event. Time frame: Day 91 (Day 1 post-dose 2) to Day 133","definition_or_measurement_approach":"Solicited systemic events recorded up to Day 133 after Dose 2."}
• {"endpoint_text":"- Percentage of participants reporting unsolicited adverse events (AEs). Time frame: Day 1 (post-dose 1) to Day 43","definition_or_measurement_approach":"Unsolicited AEs recorded Days 1–43 after Dose 1."}
• {"endpoint_text":"- Percentage of participants reporting unsolicited adverse events (AEs). Time frame: Day 91 (Day 1 post-dose 2) to Day 133","definition_or_measurement_approach":"Unsolicited AEs recorded Days 1–43 after Dose 2 (Day 91–133)."}
• {"endpoint_text":"- Percentage of participants reporting medically attended AEs (MAAE). Time frame: Day 1 (post-dose 1) to Day 271 (study end)","definition_or_measurement_approach":"Medically attended AEs recorded from Dose 1 to Day 271 (study end)."}
• {"endpoint_text":"- Percentage of participants reporting serious adverse events (SAEs). Time frame: Day 1 (post-dose 1) to Day 271 (study end)","definition_or_measurement_approach":"SAEs recorded from Dose 1 to Day 271 (study end)."}

Methods

• Denmark: Digital Waiting Room Ad (K2_Recruitment material_Digital Waiting Room Ad_DNK) targeted to parents/guardians.
• Denmark: Parent-Guardian Flyer (K2_Recruitment material_Parent-Guardian Flyer_DNK) for distribution to parents/guardians.
• Denmark: Parent-Guardian Poster (K2_Recruitment material_Parent-Guardian Poster_DNK).
• Denmark: Dr-to-Parent-Guardian Letter (K2_Recruitment material_Dr-to-Parent-Guardian Letter_DNK) sent via clinicians.
• Denmark: Parent-Guardian Brochure (K2_Recruitment material_Parent-Guardian Brochure_DNK).
• Denmark: Recruitment arrangement document K1_Recruitment arrangement_DNK describing local recruitment processes.
• Norway: Digital Waiting Room brochure (K2_Recruitment material Digital Waiting Room brochure_san) targeted to parents/guardians.
• Norway: Dr-to-Parent-Guardian Letter (K2_Recruitment material Dr-to-Parent-Guardian Letter_san) for clinician-mediated recruitment.
• Norway: Guardian Animation (K2_Recruitment material Guardian Animation_san) digital material for parents.
• Norway: Parent-Guardian Brochure, Flyer, Poster (K2_Recruitment material Parent-Guardian Brochure_san / Flyer_san / Poster_san) distributed to parents/guardians.
• Norway: Recruitment arrangement document K1_Recruitment arrangement_san describing local recruitment processes.

Denmark

Earliest CTIS Part Ii Submission Date

21-05-2025

Latest Decision Or Authorization Date

03-06-2025

Processing Time Days

13

Number Of Sites

4

Number Of Participants

61

Norway

Earliest CTIS Part Ii Submission Date

19-05-2025

Latest Decision Or Authorization Date

04-06-2025

Processing Time Days

16

Number Of Sites

3

Number Of Participants

18

Primary sponsor

Full Name

GlaxoSmithKline Biologicals

Organisation Type

Pharmaceutical company

Country Of Registered Address

Belgium

Contract research organisations

Name

IQVIA Limited

Responsibilities

Multiple trial operations and clinical trial services including drug supply coordination, event adjudication IDMC, image transfer, ECoA, participant payments, and other trial management duties (sponsorDuties codes: 1,2,3,5,6,7,8,11,12,15).

Name

Medidata Solutions Inc.

Responsibilities

Electronic data capture/clinical data platform services (sponsorDuties code: 7).

Third parties

• {"country":"United States","full_name":"Medidata Solutions Inc.","duties_or_roles":"sponsorDuties codes: [7]; contact: info@medidata.com","organisation_type":"Non-Pharmaceutical company"}
• {"country":"Germany","full_name":"Nexelis Marburg GmbH","duties_or_roles":"sponsorDuties codes: [4]; contact: WENDY.X.WALRAVENS@GSK.COM","organisation_type":"Pharmaceutical company"}
• {"country":"United States","full_name":"Corevitas LLC","duties_or_roles":"sponsorDuties codes: [15], value: GSK vendor for SPFQ; contact: accountspayable@evidera.com","organisation_type":"Pharmaceutical company"}
• {"country":"Belgium","full_name":"Marken Limited","duties_or_roles":"sponsorDuties codes: [15], value: GSK Samples shipment; contact: Wim.VanGoidsenhoven@marken.com","organisation_type":"Pharmaceutical company"}
• {"country":"United States","full_name":"Fisher Clinical Services Inc.","duties_or_roles":"sponsorDuties codes: [15], value: GSK vendor for Ancillary supply; contact: CustomerCare@thermofisher.com","organisation_type":"Pharmaceutical company"}
• {"country":"United Kingdom","full_name":"HCL Technologies UK Limited","duties_or_roles":"sponsorDuties codes: [15], value: GSK vendor for Lab ancillary Supply; contact: GSKMGMT@hcltech.com","organisation_type":"Non-Pharmaceutical company"}
• {"country":"Belgium","full_name":"Akkodis Belgium","duties_or_roles":"sponsorDuties codes: [11]; contact: info.be@akkodis.com","organisation_type":"Pharmaceutical company"}
• {"country":"United Kingdom","full_name":"IQVIA Limited","duties_or_roles":"sponsorDuties codes: [1,11,12,15 (Drug supply co-ordination, Event adjudication IDMC, Image Transfer from subject to site for evaluation, ECoA, IPP (IQVIA Participant Payments)),2,3,5,6,7,8]; contact: eu_clinical_trials_information@iqvia.com","organisation_type":"Pharmaceutical company"}
• {"country":"Germany","full_name":"MARKEN Germany GmbH","duties_or_roles":"sponsorDuties codes: [15], value: GSK vendor for Lab kit supply; contact: marken.ham@marken.com","organisation_type":"Pharmaceutical company"}
• {"country":"Belgium","full_name":"GlaxoSmithKline Biologicals","duties_or_roles":"sponsorDuties codes: [4]; contact: WENDY.X.WALRAVENS@GSK.COM","organisation_type":"Pharmaceutical company"}
• {"country":"United Kingdom","full_name":"Veramed Limited","duties_or_roles":"sponsorDuties codes: [15], value: GSK vendor for IDMC; contact: ben.peace@veramed.co.uk","organisation_type":"Pharmaceutical company"}
• {"country":"United Kingdom","full_name":"Medical Equipment Supplies And Management Limited","duties_or_roles":"sponsorDuties codes: [15], value: Equipment supply; contact: liz.fry@avantorsciences.com","organisation_type":"Pharmaceutical company"}