Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
Investigational varicella vaccine low potency · 1 trial · 1 indication
Concentrations of anti-VZV gE antibodies were presented as Geometric Mean Concentrations (GMCs) and expressed in milli-international units per milliliter (mIU/mL) for each group.
| Arm | Type | Description |
|---|---|---|
| VNS_Low Group | EXPERIMENTAL | Participants received 1 dose of an investigational varicella vaccine (VNS) of low potency, 1 dose of a measles, mumps, and rubella (MMR) vaccine, 1 dose of a hepatitis A vaccine (Havrix) and 1 dose of a13 valent pneumococcal conjugate vaccine (Prevnar 13) on Day 1. |
| VNS_Med Group | EXPERIMENTAL | Participants received 1 dose of VNS vaccine of medium potency, 1 dose of MMR vaccine, 1 dose of Havrix vaccine, and 1 dose of Prevnar 13 vaccine on Day 1. |
| VNS_High Group | EXPERIMENTAL | Participants received 1 dose of VNS vaccine of high potency, 1 dose of MMR vaccine, 1 dose of Havrix vaccine, and 1 dose of Prevnar 13 vaccine on Day 1. |
| VV_Lot1 and Lot2 Pooled Group | ACTIVE_COMPARATOR | Participants received 1 dose of a licensed varicella vaccine (VV) of Lot 1 or 1 dose of a licensed vaccine (VV) of Lot 2, 1 dose of MMR vaccine, 1 dose of Havrix vaccine, and 1 dose of Prevnar 13 vaccine on Day 1. |
| Name | Type | Description |
|---|---|---|
| Investigational varicella vaccine low potency | BIOLOGICAL | 1 dose of a low-potency investigational varicella vaccine administered subcutaneously. |
| Investigational varicella vaccine medium potency | BIOLOGICAL | 1 dose of a medium-potency investigational varicella vaccine administered subcutaneously. |
| Investigational varicella vaccine high potency | BIOLOGICAL | 1 dose of a high-potency investigational varicella vaccine administered subcutaneously. |
| Licensed varicella vaccine Lot 1 | BIOLOGICAL | 1 dose of a licensed varicella vaccine of Lot 1 administered subcutaneously. |
| Licensed varicella vaccine Lot 2 | BIOLOGICAL | 1 dose of a licensed varicella vaccine of Lot 2 administered subcutaneously. |
| Measles, mumps, and rubella vaccine | BIOLOGICAL | 1 dose of a measles, mumps, and rubella vaccine administered subcutaneously. |
| Hepatitis A vaccine | BIOLOGICAL | 1 dose of a hepatitis A vaccine administered intramuscularly. |
| 13-valent pneumococcal conjugate vaccine | BIOLOGICAL | 1 dose of a 13-valent pneumococcal conjugate vaccine administered intramuscularly. |
Inclusion Criteria: * Healthy participants as established by medical history and clinical examination before entering into the study. * A male or female between, and including, 12 and 15 months of age (i.e., from his/her 1 year birthday until the day before age of 16 months) at the time of the admi...
The investigational varicella vaccine low potency is used for chickenpox, also known as varicella. It is being studied in healthy children 12 to 15 months of age to assess the immune response and safety of various potencies of the vaccine compared with a marketed chickenpox vaccine.
The investigational varicella vaccine low potency is being developed by GSK plc, which trades under the ticker GSK. The company is conducting clinical research on this vaccine for the prevention of chickenpox in young children.
The investigational varicella vaccine low potency is in Phase 2 clinical development. It is an investigational product and has not been approved by regulatory authorities. One Phase 2 trial has been completed, involving 800 participants.
The investigational varicella vaccine low potency has been studied in one completed Phase 2 trial, NCT05084508. This randomized, double-blind, active-controlled study evaluated the immune response and safety of various potencies of the vaccine compared with a marketed chickenpox vaccine in healthy children 12 to 15 months of age.
Yes, the investigational varicella vaccine low potency is classified as a monoclonal antibody modality. It is being investigated for use in chickenpox, an infectious disease, and is currently in Phase 2 clinical development by GSK plc.