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| ID | Type | Description | Link |
|---|---|---|---|
| 2024-515868-31-00 | Other Identifier | Eu CT number |
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The purpose of this study is to assess how well-tolerated GSK's investigational varicella vaccine (VNS Vaccine) is, in comparison to an already approved varicella vaccine (VV) known as Varivax. The study will be conducted on healthy children aged 12 to 15 months, and who have neither contracted varicella nor received a varicella vaccination.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| VNS Group | Experimental | Participants receive 1 dose of a VNS vaccine, 1 dose of measles, mumps, and rubella (MMR) vaccine, 1 dose of hepatitis A (HAV) vaccine, and 1 dose of PCV (either PCV 13 or Vaxneuvance or PCV 20) on Day 1. |
|
| VV Group | Active Comparator | Participants receive 1 dose of a marketed VV, 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. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Investigational varicella vaccine | Biological | 1 dose of investigational varicella vaccine administered subcutaneously. |
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| Measure | Description | Time Frame |
|---|---|---|
| Percentage of participants reporting each solicited administration site events | 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°C (100.4°F) 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 events | Solicited administration site include injection site varicella-like rash. | Day 1 (post-dose) to Day 43 |
| Percentage of participants reporting solicited systemic events | Solicited systemic events includes 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) | An unsolicited AE is an AE that was either not included in the list of solicited events or could be included in the list of solicited events but with an onset outside the specified period of follow-up for solicited events. | Day 1 (post-dose) to Day 43 |
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Inclusion Criteria:
Exclusion Criteria:
History of any reaction or hypersensitivity likely to be exacerbated by any component of the study interventions.
Any confirmed or suspected immunosuppressive or immunodeficient condition, based on medical history and physical examination (no laboratory testing required).
Hypersensitivity to latex.
Recurrent history of uncontrolled neurological disorders or seizures.
History of varicella disease.
Active untreated tuberculosis
Any other clinical condition that, in the opinion of the investigator, might pose additional risk to the participant due to participation in the study.
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.
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.
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:
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.
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 | Withdrawn | Phoenix | Arizona | 85006 | United States | |
| GSK Investigational Site |
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.
| Marketed varicella vaccine | Biological | 1 dose of marketed varicella vaccine administered subcutaneously. |
|
| Measles, mumps, and rubella vaccine | Biological | 1 dose of measles, mumps, and rubella vaccine co-administered subcutaneously or intramuscularly. |
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| Hepatitis A vaccine | Biological | 1 dose of hepatitis A vaccine co-administered intramuscularly. |
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| PCV (pneumococcal conjugate vaccine) 13 | Biological | 1 dose of 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 | 1 dose of 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 | 1 dose of 15-valent pneumococcal conjugate (Vaxneuvance) 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. |
|
| 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) |
| Withdrawn |
| Tucson |
| Arizona |
| 85741 |
| United States |
| GSK Investigational Site | Recruiting | Huntington Park | California | 90057 | United States |
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| GSK Investigational Site | Recruiting | National City | California | 91950 | United States |
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| GSK Investigational Site | Recruiting | West Covina | California | 91790 | United States |
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| GSK Investigational Site | Recruiting | Hialeah | Florida | 33012 | United States |
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| GSK Investigational Site | Recruiting | Miami | Florida | 33142 | United States |
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| GSK Investigational Site | Recruiting | Chicago | Illinois | 60621 | United States |
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| GSK Investigational Site | Withdrawn | El Dorado | Kansas | 67042 | United States |
| GSK Investigational Site | Recruiting | Lafayette | Louisiana | 70508 | United States |
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| GSK Investigational Site | Recruiting | Mankato | Minnesota | 56002 | United States |
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| GSK Investigational Site | Recruiting | Lincoln | Nebraska | 68516 | United States |
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| GSK Investigational Site | Recruiting | Cincinnati | Ohio | 45245 | 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 | 75235 | United States |
| GSK Investigational Site | Recruiting | Houston | Texas | 77065 | United States |
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| GSK Investigational Site | Recruiting | Richmond | Texas | 77469 | United States |
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| GSK Investigational Site | Recruiting | Richmond | Texas | 77469 | United States |
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| GSK Investigational Site | Withdrawn | San Antonio | Texas | 78244 | United States |
| GSK Investigational Site | Completed | Roy | Utah | 84067 | United States |
| GSK Investigational Site | Recruiting | Syracuse | Utah | 84075 | United States |
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| GSK Investigational Site | Recruiting | Richmond | Virginia | 23294 | United States |
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| GSK Investigational Site | Withdrawn | Vienna | Virginia | 22180 | United States |
| GSK Investigational Site | Withdrawn | Burgas | 8008 | Bulgaria |
| GSK Investigational Site | Recruiting | Gabrovo | 5300 | Bulgaria |
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| GSK Investigational Site | Recruiting | Kyustendil | 2500 | Bulgaria |
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| GSK Investigational Site | Recruiting | Plovdiv | 4002 | Bulgaria |
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| GSK Investigational Site | Recruiting | Rousse | 7000 | Bulgaria |
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| GSK Investigational Site | Recruiting | Sevlievo | 5400 | Bulgaria |
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| GSK Investigational Site | Withdrawn | Yambol | 8600 | Bulgaria |
| GSK Investigational Site | Recruiting | Aarhus N | 8200 | Denmark |
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| GSK Investigational Site | Recruiting | Copenhagen | DK-2100 | Denmark |
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| GSK Investigational Site | Recruiting | Hvidovre | 2650 | Denmark |
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| GSK Investigational Site | Recruiting | Odense C | DK-5000 | Denmark |
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| GSK Investigational Site | Recruiting | Tallinn | 10615 | Estonia |
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| GSK Investigational Site | Recruiting | Tallinn | 10617 | Estonia |
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| GSK Investigational Site | Recruiting | Hong Kong | 00852 | Hong Kong |
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| GSK Investigational Site | Recruiting | Shatin | Hong Kong |
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| GSK Investigational Site | Recruiting | Kaunas | 47116 | Lithuania |
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| GSK Investigational Site | Recruiting | Kaunas | LT-48259 | Lithuania |
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| GSK Investigational Site | Recruiting | Durango | 34000 | Mexico |
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| GSK Investigational Site | Recruiting | Tlalpan | 14340 | Mexico |
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| GSK Investigational Site | Recruiting | Tlalpan | 14340 | Mexico |
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| GSK Investigational Site | Recruiting | Bydgoszcz | 85-796 | Poland |
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| GSK Investigational Site | Recruiting | Trzebnica | 55-100 | Poland |
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| GSK Investigational Site | Recruiting | Warsaw | 02-172 | Poland |
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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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