Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
Also known as MMRVNS
MMRVNS vaccine · 2 trials · 5 indications
This outcome measure evaluates immunological consistency.
This outcome measure evaluates immunological non-inferiority. Seroresponse is defined as post-vaccination IgG antibody concentrations equal to or above threshold values as follows: The seroresponse of a participant is: * zero (non-seroresponder) if the IgG concentration is below the seroresponse threshold of the assay, * One (seroresponder) if the IgG concentration is above or equal to the seroresponse threshold.
This outcome measure evaluates immunological non-inferiority.
| Arm | Type | Description |
|---|---|---|
| MMRVNS_Lot 1 group | EXPERIMENTAL | Participants will receive a single dose of the Lot 1 MMRVNS vaccine and a single dose of the DTaP-IPV vaccine on Day 1. |
| MMRVNS_Lot 2 group | EXPERIMENTAL | Participants will receive a single dose of the Lot 2 MMRVNS vaccine and a single dose of the DTaP-IPV vaccine on Day 1. |
| MMRVNS_Lot 3 group | EXPERIMENTAL | Participants will receive a single dose of the Lot 3 MMRVNS vaccine and a single dose of the DTaP-IPV vaccine on Day 1. |
| MMRV group | ACTIVE_COMPARATOR | Participants will receive a single dose of MMRV vaccine and a single dose of DTaP-IPV vaccine on Day 1. |
| MMRVNS Group | EXPERIMENTAL | Children, 15 months to 6 years old, who will receive one dose of MMRVNS on Day 1. |
| Name | Type | Description |
|---|---|---|
| MMRVNS vaccine | BIOLOGICAL | MMRVNS vaccine will be administered on Day 1. |
| MMRV vaccine | BIOLOGICAL | MMRV vaccine will be administered on Day 1. |
| DTaP-IPV vaccine | BIOLOGICAL | DTaP-IPV vaccine will be administered on Day 1. |
| MMRVNS | BIOLOGICAL | One dose of MMRVNS administered intramuscularly. |
| MMRV | BIOLOGICAL | One dose of MMRV administered intramuscularly. |
Inclusion Criteria (INC): * INC#1 Participant's parent(s)/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). * INC#2 Written or witnessed/thumb printed or digital informed consen...
The MMRVNS vaccine is an investigational combined vaccine designed to protect against measles, mumps, rubella, and varicella (chickenpox). It is being developed by GSK plc and is currently in Phase 3 clinical development. It is administered to healthy children and is not yet approved for use.
The MMRVNS vaccine is intended for immunization against measles, mumps, rubella, and varicella (chickenpox) in healthy children. Clinical trials are evaluating its use in children from 15 months to 6 years of age. It is an investigational product and has not received regulatory approval.
The MMRVNS vaccine is being developed by GSK plc, which trades under the ticker GSK. GSK is the sponsor of the two Phase 3 clinical trials evaluating the vaccine in healthy children.
The MMRVNS vaccine is in Phase 3 clinical development. Two Phase 3 trials are registered, one currently recruiting and one not yet recruiting, with a combined planned enrollment of 3,069 healthy children. The vaccine is investigational and has not been approved by the FDA.
The MMRVNS vaccine is being studied in two Phase 3 trials. NCT07742644 is a not-yet-recruiting study in healthy children aged 4 to 6 years across the United States, Argentina, Finland, Italy, Puerto Rico, and Taiwan. NCT07406360 is a recruiting study in healthy children aged 15 months to 6 years in the United States.
Yes, MMRVNS is the short name for the MMRVNS vaccine, GSK's investigational combined measles, mumps, rubella, and varicella vaccine. Both names refer to the same Phase 3 product candidate being evaluated in healthy children.