Approval Probability 71%
TA Base Rate26%
Adjusted LOA41%
ML RiskLOW_RISK
| NCT ID | Title | Phase | Status | Enrollment | Velocity | Design | Start | Completion | Last Updated | Sites | Countries |
|---|---|---|---|---|---|---|---|---|---|---|---|
| NCT05084508 | A Study on the Immune Response and Safety of Various Potencies of an Investigational Chickenpox Vaccine Compared With a Marketed Chickenpox Vaccine, Given to Healthy Children 12 to 15 Months of Age | PHASE2 | COMPLETED | 800 | — | — | Feb 3, 2022 | Jun 13, 2024 | Feb 28, 2025 | 51 | United States, Estonia +4 |
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...