Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
Investigational varicella vaccine_Lot 1 · 1 trial · 1 indication
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.
Concentrations of anti-VZV gE IgG presented as GMCs and expressed in mIU/mL for each group.
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.
Concentrations of anti-VZV gE IgG are presented as GMCs and expressed in mIU/mL for each group.
| Arm | Type | Description |
|---|---|---|
| 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 | 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. |
| Name | Type | Description |
|---|---|---|
| Investigational varicella vaccine_Lot 1 | BIOLOGICAL | Investigational varicella vaccine of Lot 1 administered subcutaneously. |
| Investigational varicella vaccine_Lot 2 | BIOLOGICAL | Investigational varicella vaccine of Lot 2 administered subcutaneously. |
| Investigational varicella vaccine_Lot 3 | BIOLOGICAL | Investigational varicella vaccine of Lot 3 administered subcutaneously. |
| Marketed varicella vaccine_Lot 1 | BIOLOGICAL | Marketed varicella vaccine of Lot 1 administered subcutaneously. |
| Marketed varicella vaccine_Lot 2 | BIOLOGICAL | Marketed varicella vaccine of Lot 2 administered subcutaneously. |
| MMR vaccine | BIOLOGICAL | MMR vaccine co-administered subcutaneously or intramuscularly. |
| Hepatitis A vaccine | BIOLOGICAL | Hepatitis A vaccine co-administered intramuscularly. |
| 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. |
| 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. |
| 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. |
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 info...
Investigational varicella vaccine_Lot 1 is a vaccine being developed for the prevention of chickenpox. It is currently in Phase 3 clinical development and is being studied in healthy children aged 12 to 15 months. The vaccine is administered to elicit an immune response against the varicella-zoster virus.
Investigational varicella vaccine_Lot 1 is being developed by GSK plc, a global biopharma company listed on the stock exchange under the ticker GSK. The company is conducting a Phase 3 clinical trial to evaluate the vaccine's immune response and safety in healthy children.
Investigational varicella vaccine_Lot 1 is in Phase 3 clinical development. It is an investigational vaccine, meaning it has not yet been approved by regulatory authorities. The ongoing Phase 3 trial is actively recruiting participants to assess the vaccine's safety and immunogenicity.
Investigational varicella vaccine_Lot 1 is being evaluated in a single Phase 3 clinical trial with the identifier NCT06740630. This randomized, double-blind, active-controlled study is recruiting 1,840 healthy children aged 12 to 15 months across multiple countries, including the United States, Belgium, Colombia, and Thailand.
Investigational varicella vaccine_Lot 1 is a vaccine designed to prevent chickenpox by stimulating the immune system to produce a protective response against the varicella-zoster virus. The vaccine is given to healthy children to help their bodies develop immunity, reducing the risk of infection.