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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 being studied for use in measles, mumps, rubella, and chickenpox. It is a combined vaccine intended to protect against all four diseases. It is currently in Phase 2 clinical development and is not yet approved for use.
The investigational MMRVNS vaccine is being developed by GSK plc, which trades under the ticker GSK. The company is conducting clinical trials to evaluate the vaccine's immune response and safety in healthy children.
The investigational MMRVNS vaccine is in Phase 2 clinical development. It is an investigational product, meaning it has not been approved by regulatory authorities and is still undergoing clinical trials to assess its safety and efficacy.
The investigational MMRVNS vaccine has one completed Phase 2 trial, NCT05630846. This study evaluated the immune response and safety of the combined measles, mumps, rubella, and chickenpox vaccine compared to a marketed combined vaccine in healthy children aged 4 to 6 years.
The investigational MMRVNS vaccine is being compared to a marketed combined vaccine in clinical trials, but it is a distinct investigational product. It is not the same as any currently approved vaccine, as it is still in Phase 2 development and has not been licensed.