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 being developed for the prevention of chickenpox, also known as varicella. It is a vaccine candidate studied in healthy children 12 to 15 months of age. The Phase 2 trial compared different potencies of the vaccine with a marketed chickenpox vaccine.
The investigational varicella vaccine low potency is being developed by GSK plc, which trades under the ticker GSK. GSK conducted a Phase 2 study of the vaccine in healthy children. The company is a global healthcare and pharmaceutical developer.
The investigational varicella vaccine low potency is in Phase 2 clinical development. A Phase 2 trial has been completed, and the vaccine is not yet approved for use. It remains an investigational candidate for chickenpox prevention.
The investigational varicella vaccine low potency was evaluated in a completed Phase 2 trial, NCT05084508. The study enrolled 800 healthy children aged 12 to 15 months and compared various potencies of the vaccine with a marketed chickenpox vaccine. It was randomized, double-blind, and active-controlled, conducted in multiple countries.