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 |
|---|---|---|---|---|---|---|---|---|---|---|---|
| NCT05630846 | A Study on the Immune Response and Safety of a Combined Measles, Mumps, Rubella, Chickenpox Vaccine Compared to a Marketed Combined Vaccine, Given to Healthy Children 4 to 6 Years of Age | PHASE2 | COMPLETED | 801 | — | — | Dec 14, 2022 | Oct 14, 2024 | Jun 22, 2025 | 47 | United States, Colombia +3 |
Anti-measles antibodies were measured with multiplex luminex based immuno assay and the results were expressed as GMC, in milli international units per milliliter (mIU/mL). Analysis was performed on per protocol set which included all eligible participants who received study intervention as per protocol, were not unblinded, had immunogenicity results pre- and post-dose for at least 1 antigen, complied with blood draw interval between study intervention and post- dose blood sample, without intercurrent medical conditions that may interfere with immunogenicity and without prohibited concomitant medication/vaccination. Only participants with data available at specified timepoint were included in the analysis.
Anti-mumps antibodies were measured with multiplex luminex based immuno assay and the results were expressed as GMC, in arbitrary units per milliliter (AU/mL). Analysis was performed on per protocol set. Only participants with data available at specified timepoint were included in the analysis.
Anti-rubella antibodies were measured with multiplex luminex based immuno assay and the results were expressed as GMC, in international units per milliliter (IU/mL). Analysis was performed on per protocol set. Only participants with data available at specified timepoint were included in the analysis.
Anti-gE antibodies were measured with enzyme linked immunosorbent assay and the results were expressed as GMC, in mIU/mL. Anti-varicella and anti-varicella zoster virus gE were used interchangeably. Analysis was performed on per protocol set. Only participants with data available at specified timepoint were included in the analysis.
| Arm | Type | Description |
|---|---|---|
| MMRV(H)NS Group | EXPERIMENTAL | Participants receive a single dose of an investigational measles, mumps, and rubella (MMR) at release potency and varicella at high (V\[H\]NS) potency vaccine on Day 1. |
| MM(H)RVNS Group | EXPERIMENTAL | Participants receive a single dose of an investigational measles, rubella (MR), and varicella (VNS) at release potency and mumps at high (M\[H\]) potency vaccine on Day 1. |
| M(L)M(L)R(L)V(L)NS Group | EXPERIMENTAL | Participants receive a single dose of an investigational measles, mumps, rubella (MMR), and varicella (VNS), all at low (L) potency vaccine on Day 1. |
| MMRV_Lot 1 and Lot 2 Pooled Group | ACTIVE_COMPARATOR | Participants receive a single dose of a marketed measles, mumps, rubella (MMR), and varicella (V) vaccine of Lot 1 or of 1 vaccine dose of a marketed MMRV vaccine of Lot 2 on Day 1. |
| Name | Type | Description |
|---|---|---|
| Investigational MMRV(H)NS vaccine | BIOLOGICAL | 1 dose of a measles, mumps, and rubella at release potency and VNS at high (H) potency vaccine administered subcutaneously. |
| Investigational MM(H)RVNS vaccine | BIOLOGICAL | 1 dose of a measles, rubella, and varicella at release potency and mumps at high (H) potency vaccine administered subcutaneously. |
| Investigational M(L)M(L)R(L)V(L)NS vaccine | BIOLOGICAL | 1 dose of measles, mumps, rubella, and varicella, all at low (L) potency vaccine administered subcutaneously. |
| Marketed MMRV_Lot 1 and Lot 2 vaccine | BIOLOGICAL | 1 dose of a marketed measles, mumps, rubella, and varicella of Lot 1 or 1 dose of a marketed measles, mumps, rubella, and varicella of Lot 2 vaccine administered subcutaneously. |
Inclusion Criteria: * Healthy participants as established by medical history and clinical examination before entering into the study. * A male or female between, and including, 4 years and 6 years of age (i.e., from 4 year birthday until the day before the 7-year birthday) at the time of study inte...