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 |
|---|---|---|---|---|---|---|---|---|---|---|---|
| NCT06740630 | A Study on the Immune Response and Safety of an Investigational Chickenpox Vaccine When Given to Healthy Children 12 to 15 Months of Age | PHASE3 | RECRUITING | 1,840 | — | — | Jan 10, 2025 | May 17, 2027 | May 29, 2026 | 97 | United States, Belgium +9 |
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...