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 |
|---|---|---|---|---|---|---|---|---|---|---|---|
| NCT06855160 | A Study on the Immune Response and Safety of an Investigational Chickenpox Vaccine and a Marketed Measles, Mumps and Rubella Vaccine When Administered as Intramuscular Injection to Healthy Children 12 to 15 Months of Age | PHASE3 | RECRUITING | 911 | — | — | Apr 17, 2025 | Feb 2, 2027 | May 29, 2026 | 22 | United States, Belgium +5 |
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...