Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
Candidate varicella vaccine · 1 trial · 1 indication
The seroresponse rate is defined as the percentage of participants for whom the post-vaccination Day 43 anti VZV gE IgG concentration is above the seroresponse threshold.
Concentrations of anti-VZV gE IgG are presented as GMC and expressed in milli-international units per milliliter (mIU/mL) for each group.
The seroresponse rate is defined as the percentage of participants for whom the post-vaccination Day 43 anti-measles, mumps, and rubella antibody concentrations are above the seroresponse threshold.
| Arm | Type | Description |
|---|---|---|
| VNS+ MMR Vaccine | EXPERIMENTAL | Participants receive 1 dose of the candidate varicella vaccine (VNS vaccine), 1 dose of a measles, mumps, and rubella (MMR) vaccine, 1 dose of a hepatitis A virus (HAV vaccine), and 1 dose of PCV (either PCV 13 or Vaxneuvance or PCV 20) on Day 1. |
| VV+MMR Vaccine | ACTIVE_COMPARATOR | Participants receive 1 dose of a Marketed varicella vaccine (VV), 1 dose of a MMR vaccine, 1 dose of a HAV vaccine, and 1 dose of PCV (either PCV 13 or Vaxneuvance or PCV 20) on Day 1. |
| Name | Type | Description |
|---|---|---|
| Candidate varicella vaccine | BIOLOGICAL | Investigational varicella vaccine administered intramuscularly. |
| Marketed varicella vaccine | BIOLOGICAL | Marketed varicella vaccine administered subcutaneously. |
| MMR vaccine | BIOLOGICAL | MMR vaccine 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 Vaxneuvancewill 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...
The candidate varicella vaccine is used for the prevention of chickenpox in healthy children. It is currently being investigated in a Phase 3 clinical trial for this indication. The vaccine is administered as an intramuscular injection to children aged 12 to 15 months.
The candidate varicella vaccine is being developed by GSK plc, a biopharma company listed on the stock exchange under the ticker GSK. GSK is conducting a Phase 3 clinical trial to evaluate the vaccine's immune response and safety in healthy children.
The candidate varicella vaccine 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.
The candidate varicella vaccine is being studied in a single Phase 3 clinical trial with the identifier NCT06855160. This randomized, active-controlled study is evaluating the immune response and safety of the vaccine when given alongside a marketed measles, mumps and rubella vaccine to healthy children aged 12 to 15 months. The trial is recruiting participants in the United States, Belgium, Estonia, Greece, Poland, Romania, and Thailand.
The candidate varicella vaccine targets the varicella-zoster virus, which causes chickenpox. By stimulating an immune response against this virus, the vaccine aims to protect vaccinated children from developing the disease. The vaccine is being developed as a preventive measure for this infectious disease.