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Also known as Investigational MMRV(H)NS vaccine
Investigational MMRVNS vaccine · 1 trial · 2 indications
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...
The investigational MMRVNS vaccine is a combined vaccine being developed to protect against measles, mumps, rubella, and chickenpox. It is a vaccine candidate in Phase 2 clinical development. It is also known as the investigational MMRV(H)NS vaccine. GSK plc, ticker GSK, is the developer.
The investigational MMRVNS vaccine is intended for immunization against measles, mumps, rubella, and chickenpox. It is being studied in healthy children 4 to 6 years of age. It is a combination vaccine candidate rather than a single-disease product, and it remains in clinical development.
GSK plc, which trades under the ticker GSK, is the developer of the investigational MMRVNS vaccine. GSK is running the clinical program for this combined measles, mumps, rubella, and chickenpox vaccine candidate. The vaccine is also referred to as the investigational MMRV(H)NS vaccine.
The investigational MMRVNS vaccine is in Phase 2 clinical development. It is not an approved product. One Phase 2 trial has been completed, and no trials are currently active. The program is evaluating the vaccine in healthy children, so it remains investigational.
The investigational MMRVNS vaccine has been studied in one Phase 2 trial, NCT05630846, titled a study on the immune response and safety of a combined measles, mumps, rubella, chickenpox vaccine compared to a marketed combined vaccine in healthy children 4 to 6 years of age. That trial is completed and enrolled 801 participants.
Yes, the investigational MMRV(H)NS vaccine is another name for the investigational MMRVNS vaccine. Both names refer to the same GSK combined vaccine candidate against measles, mumps, rubella, and chickenpox. It is in Phase 2 development and is not an approved vaccine.