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| ID | Type | Description | Link |
|---|---|---|---|
| 2024-515869-33-00 | Other Identifier | EU CT Number |
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The purpose of this study is to assess the consistency of immune response to three different lots of GSK's investigational varicella vaccine (VNS Vaccine), and to compare the safety and immune response of VNS vaccine to an already approved varicella vaccine (VV) known as Varivax. The study will be conducted in healthy children aged 12 to 15 months, who have neither contracted varicella nor received a varicella vaccination.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| VNS_Lot 1 Group | Experimental | Participants receive 1 dose of the investigational VNS vaccine of Lot 1, 1 dose of measles, mumps, and rubella (MMR) vaccine, 1 dose of hepatitis A vaccine (HAV), and 1 dose of PCV (either PCV 13 or Vaxneuvance or PCV 20) on Day 1. |
|
| VNS_Lot 2 Group | Experimental | Participants receive 1 dose of the investigational VNS vaccine of Lot 2, 1 dose of MMR vaccine, 1 dose of HAV vaccine, and 1 dose of PCV (either PCV 13 or Vaxneuvance or PCV 20) on Day 1. |
|
| VNS_Lot 3 Group | Experimental | Participants receive 1 dose of the investigational VNS vaccine of Lot 3, 1 dose of MMR vaccine, 1 dose of HAV vaccine, and 1 dose of PCV (either PCV 13 or Vaxneuvance or PCV 20) on Day 1. |
|
| VV_Lot 1 Group | Active Comparator |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Investigational varicella vaccine_Lot 1 | Biological | Investigational varicella vaccine of Lot 1 administered subcutaneously. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Percentage of participants with seroresponse to Varicella Zoster Virus (VZV) anti-glycoprotein E (gE) Immunoglobulin (IgG) for the 3 lots of VNS vaccine groups | Seroresponse is defined as post-vaccination (Day 43) anti-VZV gE IgG antibody concentration greater than or equal to (>=) 300 milli-international units per milliliter (mIU/mL) among participants who were seronegative [(antibody concentration less than (<) LLOQ (Lower limit of quantification)] before vaccination. A seronegative participant is a participant whose antibody concentration is below the LLOQ of the assay. A seropositive participant is a participant whose antibody concentration is greater than or equal to the LLOQ of the assay. | At Day 43 |
| Geometric Mean Concentration (GMC) of anti-VZV gE IgG for the 3 lots of VNS vaccine groups | Concentrations of anti-VZV gE IgG presented as GMCs and expressed in mIU/mL for each group. | At Day 43 |
| 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 groups | Seroresponse is defined as post-vaccination (Day 43) anti-VZV gE IgG concentration >= 300 mIU/mL among participants who were seronegative (antibody concentration < LLOQ) before vaccination. A seronegative participant is a participant whose antibody concentration is below the LLOQ of the assay. A seropositive participant is a participant whose antibody concentration is greater than or equal to the LLOQ of the assay. | At Day 43 |
| GMCs of anti-VZV gE IgG for the 3 pooled lots of VNS vaccine groups compared with the 2 pooled lots of VV groups | Concentrations of anti-VZV gE IgG are presented as GMCs and expressed in mIU/mL for each group. | At Day 43 |
| Measure | Description | Time Frame |
|---|---|---|
| Anti-measles antibodies GMCs for the 3 pooled lots of VNS vaccine groups compared with the 2 pooled lots of VV groups | At Day 43 | |
| Anti-mumps antibodies GMCs for the 3 pooled lots of VNS vaccine groups compared with the 2 pooled lots of VV groups | At Day 43 |
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Inclusion Criteria:
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).
Written or witnessed/thumb printed informed consent obtained from the participant's parent(s)/LAR(s) prior to performance of any study-specific procedure.
Healthy participants as established by medical history and clinical examination before entering into the study.
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.
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:
Exclusion Criteria:
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
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.
Previous vaccination against measles, mumps, and rubella.
Previous vaccination against hepatitis A virus.
Previous vaccination against varicella virus.
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.
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).
Child in care.
Any study personnel's immediate dependents, family, or household members.
Participants with the following high-risk individuals in their household:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| US GSK Clinical Trials Call Center | Contact | 877-379-3718 | GSKClinicalSupportHD@gsk.com | |
| EU GSK Clinical Trials Call Center | Contact | +44 (0) 20 89904466 | GSKClinicalSupportHD@gsk.com |
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| GSK Investigational Site | Recruiting | Mobile | Alabama | 36608 | United States |
Study Sponsor will assess requests from qualified researchers for anonymized individual patient-level data and related study documents. Data sharing is subject to certain criteria, conditions, and exceptions. For further information, refer to https://www.gsk-studyregister.com/About\_GSK\_Patient\_Level\_Data\_Sharing\_Final\_13July2023.pdf
Anonymized IPD will be made available within 6 months of publication of primary, key secondary and safety results for studies in product with approved indication(s) or asset(s) with development terminated across all indications.
Anonymized IPD is shared with researchers whose proposals are approved by an Independent Review Panel and after a Data Sharing Agreement is in place. Access is provided for an initial period of 12 months, but an extension may be granted, when justified, for up to 6 months.
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Observer-blind study.
Participants receive 1 dose of a marketed varicella vaccine (VV) of Lot 1, 1 dose of MMR vaccine, 1 dose of HAV vaccine, and 1 dose of PCV (either PCV 13 or Vaxneuvance or PCV 20) on Day 1. |
|
| VV_Lot 2 Group | Active Comparator | Participants receive 1 dose of a marketed VV of Lot 2, 1 dose of MMR vaccine, 1 dose of HAV vaccine, and 1 dose of PCV (either PCV 13 or Vaxneuvance or PCV 20) on Day 1. |
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| Investigational varicella vaccine_Lot 2 | Biological | Investigational varicella vaccine of Lot 2 administered subcutaneously. |
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| Investigational varicella vaccine_Lot 3 | Biological | Investigational varicella vaccine of Lot 3 administered subcutaneously. |
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| Marketed varicella vaccine_Lot 1 | Biological | Marketed varicella vaccine of Lot 1 administered subcutaneously. |
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| Marketed varicella vaccine_Lot 2 | Biological | Marketed varicella vaccine of Lot 2 administered subcutaneously. |
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| MMR vaccine | Biological | MMR vaccine co-administered subcutaneously or intramuscularly. |
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| Hepatitis A vaccine | Biological | Hepatitis A vaccine co-administered intramuscularly. |
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| PCV (pneumococcal conjugate vaccine) 13 | Biological | The 13-valent pneumococcal conjugate vaccine co-administered intramuscularly. In some countries PCV will only be administered depending on the availability, country's registration status and national recommendations for pneumococcal vaccination at the time of study conduct. |
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| PCV 20 | Biological | The 20-valent pneumococcal conjugate vaccine co-administered intramuscularly. In some countries PCV will only be administered depending on the availability, country's registration status and national recommendations for pneumococcal vaccination at the time of study conduct. |
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| Vaxneuvance | Biological | The Vaxneuvance (15-valent pneumococcal conjugate vaccine) co-administered intramuscularly. In some countries PCV will only be administered depending on the availability, country's registration status and national recommendations for pneumococcal vaccination at the time of study conduct. |
|
| Anti-rubella antibodies GMCs for the 3 pooled lots of VNS vaccine groups compared with the 2 pooled lots of VV groups | At Day 43 |
| 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 groups | Seroresponse is defined as post-vaccination (Day 43) anti-measles antibody concentration >= cut-off value among participants who were seronegative (antibody concentration < cut-off value) before vaccination. The assay cut-off values for anti-measles will be defined by the laboratory before the analysis. | At Day 43 |
| 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 groups | Seroresponse is defined as post-vaccination (Day 43) anti-mumps antibody concentration >= cut-off value among participants who were seronegative (antibody concentration < cut-off value) before vaccination. The assay cut-off values for anti-mumps will be defined by the laboratory before the analysis. | At Day 43 |
| 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 groups | Seroresponse is defined as post-vaccination (Day 43) anti-rubella antibody concentration >= cut-off value among participants who were seronegative (antibody concentration < cut-off value) before vaccination. The assay cut-off values for anti-rubella will be defined by the laboratory before the analysis. | At Day 43 |
| Anti-Hepatitis A antibodies GMCs for the 3 pooled lots of VNS vaccine groups compared with the 2 pooled lots of VV groups in Hepatitis A virus (HAV) subset | At Day 43 |
| 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 groups in HAV subset | Seroresponse is defined as post-vaccination (Day 43) anti-HAV antibody concentration >= cut-off value among participants who were seronegative (antibody concentration < cut-off value) before vaccination. The assay cut-off values for anti-HAV antibodies will be defined by the laboratory before the analysis. | At Day 43 |
| 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 groups in PCV subset | S. pneumoniae polysaccharides to be tested: 1, 3, 4, 5, 6A, 6B, 7F, 8, 9V, 10A, 11A, 12F, 14, 15B, 18C, 19A, 19F, 22F, 23F, and 33F. | At Day 43 |
| Percentage of participants in the VNS vaccine pooled group with anti-VZV gE antibody concentrations above the adaptive seroresponse threshold | The adaptive seroresponse threshold is the anti-VZV gE IgG antibody concentration for which the response rate in the VV group is 95% or higher. | At Day 43 |
| Percentage of participants reporting each solicited administration site event | Solicited administration site events include injection site redness, pain and swelling. | Day 1 (post-dose) to Day 4 |
| Percentage of participants reporting each solicited systemic event | Solicited systemic events include drowsiness, loss of appetite and irritability. | Day 1 (post-dose) to Day 15 |
| 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 (the preferred location for measuring temperature is the axilla). | Day 1 (post-dose) to Day 22 |
| Percentage of participants reporting each solicited administration site event | Solicited administration site events include injection site varicella-like rash. | Day 1 (post-dose) to Day 43 |
| Percentage of participants reporting each solicited systemic event | Solicited systemic events include varicella-like rash (non-injection site) and general rash (not varicella-like). | Day 1 (post-dose) to Day 43 |
| Percentage of participants reporting unsolicited adverse events (AEs) | Unsolicited AEs include 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, are assessed for each group after the administration of all vaccines. | Day 1 (post-dose) to Day 43 |
| 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. | Day 1 (post-dose) to Day 181 (study end) |
| 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. | Day 1 (post-dose) to Day 181 (study end) |
| GSK Investigational Site | Recruiting | Hot Springs | Arkansas | 71913 | United States |
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| GSK Investigational Site | Recruiting | Sherwood | Arkansas | 72120 | United States |
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| GSK Investigational Site | Recruiting | Canoga Park | California | 91304 | United States |
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| GSK Investigational Site | Recruiting | Covina | California | 91723 | United States |
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| GSK Investigational Site | Withdrawn | Fullerton | California | 92835 | United States |
| GSK Investigational Site | Withdrawn | Long Beach | California | 90807 | United States |
| GSK Investigational Site | Recruiting | Los Angeles | California | 90057 | United States |
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| GSK Investigational Site | Withdrawn | Paramount | California | 90723 | United States |
| GSK Investigational Site | Recruiting | Sacramento | California | 95823 | United States |
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| GSK Investigational Site | Recruiting | Ventura | California | 93003 | United States |
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| GSK Investigational Site | Recruiting | Walnut Creek | California | 94598 | United States |
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| GSK Investigational Site | Recruiting | Winnetka | California | 91306 | United States |
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| GSK Investigational Site | Withdrawn | Miami | Florida | 33176 | United States |
| GSK Investigational Site | Recruiting | Miami | Florida | 33184 | United States |
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| GSK Investigational Site | Recruiting | Miami Lakes | Florida | 33014 | United States |
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| GSK Investigational Site | Recruiting | Spring Hill | Florida | 34609 | United States |
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| GSK Investigational Site | Recruiting | Tampa | Florida | 33613 | United States |
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| GSK Investigational Site | Recruiting | Covington | Georgia | 70433 | United States |
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| GSK Investigational Site | Recruiting | Ammon | Idaho | 83406 | United States |
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| GSK Investigational Site | Recruiting | Moline | Illinois | 61265 | United States |
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| GSK Investigational Site | Recruiting | South Bend | Indiana | 46617 | United States |
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| GSK Investigational Site | Recruiting | Topeka | Kansas | 66606 | United States |
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| GSK Investigational Site | Recruiting | Bardstown | Kentucky | 40004 | United States |
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| GSK Investigational Site | Recruiting | Louisville | Kentucky | 40202-1822 | United States |
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| GSK Investigational Site | Recruiting | Haughton | Louisiana | 71037 | United States |
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| GSK Investigational Site | Recruiting | Fall River | Massachusetts | 02721-1735 | United States |
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| GSK Investigational Site | Recruiting | Bingham Farms | Michigan | 48025 | United States |
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| GSK Investigational Site | Recruiting | Jefferson City | Missouri | 65109 | United States |
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| GSK Investigational Site | Recruiting | Lincoln | Nebraska | 68505 | United States |
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| GSK Investigational Site | Withdrawn | Lincoln | Nebraska | 68510 | United States |
| GSK Investigational Site | Recruiting | Lincoln | Nebraska | 68516 | United States |
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| GSK Investigational Site | Recruiting | The Bronx | New York | 10456 | United States |
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| GSK Investigational Site | Recruiting | Charlotte | North Carolina | 28203 | United States |
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| GSK Investigational Site | Withdrawn | Monroe | North Carolina | 28112 | United States |
| GSK Investigational Site | Recruiting | Cleveland | Ohio | 44121 | United States |
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| GSK Investigational Site | Recruiting | Dayton | Ohio | 45424 | United States |
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| GSK Investigational Site | Recruiting | Chickasha | Oklahoma | 73018 | United States |
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| GSK Investigational Site | Recruiting | Tulsa | Oklahoma | 74137 | United States |
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| GSK Investigational Site | Recruiting | Gresham | Oregon | 97030 | United States |
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| GSK Investigational Site | Recruiting | Charleston | South Carolina | 29407 | United States |
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| GSK Investigational Site | Recruiting | Charleston | South Carolina | 29414 | United States |
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| GSK Investigational Site | Recruiting | Greenville | South Carolina | 29607 | United States |
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| GSK Investigational Site | Recruiting | Simpsonville | South Carolina | 29681 | United States |
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| GSK Investigational Site | Recruiting | Beaumont | Texas | 77701 | United States |
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| GSK Investigational Site | Withdrawn | Burleson | Texas | 76028 | United States |
| GSK Investigational Site | Recruiting | Corpus Christi | Texas | 78404 | United States |
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| GSK Investigational Site | Recruiting | Dallas | Texas | 75230-2571 | United States |
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| GSK Investigational Site | Withdrawn | Dallas | Texas | 75251 | United States |
| GSK Investigational Site | Recruiting | Houston | Texas | 77030 | United States |
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| GSK Investigational Site | Recruiting | Houston | Texas | 77087 | United States |
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| GSK Investigational Site | Recruiting | McAllen | Texas | 78504 | United States |
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| GSK Investigational Site | Recruiting | Mesquite | Texas | 75149 | United States |
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| GSK Investigational Site | Recruiting | Layton | Utah | 84041 | United States |
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| GSK Investigational Site | Completed | Layton | Utah | 84041 | United States |
| GSK Investigational Site | Recruiting | Murray | Utah | 84107 | United States |
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| GSK Investigational Site | Recruiting | Pleasant View | Utah | 84404 | United States |
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| GSK Investigational Site | Recruiting | South Jordan | Utah | 84095 | United States |
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| GSK Investigational Site | Withdrawn | West Jordan | Utah | 84088 | United States |
| GSK Investigational Site | Recruiting | Richmond | Virginia | 23226 | United States |
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| GSK Investigational Site | Recruiting | Brussels | 1200 | Belgium |
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| GSK Investigational Site | Recruiting | Ghent | 9000 | Belgium |
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| GSK Investigational Site | Recruiting | Gozée | 6534 | Belgium |
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| GSK Investigational Site | Recruiting | Leuven | 3000 | Belgium |
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| GSK Investigational Site | Recruiting | Liège | 4000 | Belgium |
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| GSK Investigational Site | Recruiting | Cali | 760042 | Colombia |
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| GSK Investigational Site | Recruiting | Medellín | 050021 | Colombia |
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| GSK Investigational Site | Recruiting | Jindřichův Hradec | 377 01 | Czechia |
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| GSK Investigational Site | Recruiting | Jindřichův Hradec | 37701 | Czechia |
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| GSK Investigational Site | Recruiting | Jinočany | 530 12 | Czechia |
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| GSK Investigational Site | Recruiting | Ostrava | 708 00 | Czechia |
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| GSK Investigational Site | Recruiting | Prague | 160 00 | Czechia |
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| GSK Investigational Site | Recruiting | Santo Domingo | 10201 | Dominican Republic |
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| GSK Investigational Site | Recruiting | Santo Domingo | 10205 | Dominican Republic |
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| GSK Investigational Site | Recruiting | Santo Domingo Oeste | 11114 | Dominican Republic |
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| GSK Investigational Site | Recruiting | Paide | 72713 | Estonia |
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| GSK Investigational Site | Recruiting | Tartu | 50106 | Estonia |
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| GSK Investigational Site | Recruiting | Acapulco | 39670 | Mexico |
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| GSK Investigational Site | Recruiting | Hidalgo | 42000 | Mexico |
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| GSK Investigational Site | Recruiting | Mexico City | 6750 | Mexico |
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| GSK Investigational Site | Recruiting | Mexico City | Mexico |
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| GSK Investigational Site | Recruiting | Veracruz | 91900 | Mexico |
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| GSK Investigational Site | Recruiting | Bydgoszcz | 85-048 | Poland |
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| GSK Investigational Site | Recruiting | Częstochowa | 42-217 | Poland |
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| GSK Investigational Site | Recruiting | Krakow | 30-363 | Poland |
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| GSK Investigational Site | Recruiting | Siemianowice Śląskie | 41103 | Poland |
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| GSK Investigational Site | Recruiting | Torun | 87-100 | Poland |
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| GSK Investigational Site | Recruiting | Caguas | 00725 | Puerto Rico |
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| GSK Investigational Site | Recruiting | Ponce | 00716 | Puerto Rico |
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| GSK Investigational Site | Recruiting | San Juan | 00918 | Puerto Rico |
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| GSK Investigational Site | Recruiting | San Juan | 907 | Puerto Rico |
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| GSK Investigational Site | Recruiting | Bangkok | 10700 | Thailand |
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| GSK Investigational Site | Recruiting | Rajathevee | 10400 | Thailand |
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| GSK Investigational Site | Recruiting | Abu Dhabi | United Arab Emirates |
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| GSK Investigational Site | Recruiting | Abu Dhabi | United Arab Emirates |
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| GSK Investigational Site | Recruiting | Abu Dhabi | United Arab Emirates |
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| GSK Investigational Site | Recruiting | Al Ain City | United Arab Emirates |
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| ID | Term |
|---|---|
| D002644 | Chickenpox |
| ID | Term |
|---|---|
| D000073618 | Varicella Zoster Virus Infection |
| D006566 | Herpesviridae Infections |
| D004266 | DNA Virus Infections |
| D014777 | Virus Diseases |
| D007239 | Infections |
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| ID | Term |
|---|---|
| D022542 | Measles-Mumps-Rubella Vaccine |
| D022362 | Hepatitis A Vaccines |
| D022242 | Pneumococcal Vaccines |
| ID | Term |
|---|---|
| D017778 | Vaccines, Combined |
| D014612 | Vaccines |
| D001688 | Biological Products |
| D045424 | Complex Mixtures |
| D008458 | Measles Vaccine |
| D014765 | Viral Vaccines |
| D009108 | Mumps Vaccine |
| D012411 | Rubella Vaccine |
| D014761 | Viral Hepatitis Vaccines |
| D022541 | Streptococcal Vaccines |
| D001428 | Bacterial Vaccines |
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