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...
MMRVNS vaccine is an investigational combined measles, mumps, rubella and varicella vaccine being studied for use in healthy children to protect against measles, mumps, rubella and varicella (chickenpox). It is currently in Phase 3 clinical development and has not been approved by regulatory authorities.
MMRVNS vaccine is being developed by GSK plc, a biopharma company listed on the stock exchange under the ticker GSK. The company is conducting Phase 3 clinical trials to evaluate the vaccine's immune response and safety in healthy children.
MMRVNS vaccine is currently in Phase 3 clinical development. It is an investigational vaccine, meaning it has not yet been approved by regulatory authorities. Two Phase 3 trials are ongoing or planned to assess its safety and immune response in children.
MMRVNS vaccine is being studied in two Phase 3 trials. NCT07406360 is recruiting 1,209 children aged 15 months to 6 years in the United States. NCT07742644, not yet recruiting, plans to enroll 1,860 children aged 4 to 6 years across the US, Argentina, Finland, Italy, Puerto Rico and Taiwan.
Yes, MMRVNS vaccine is also known as MMRVNS. Both names refer to the same investigational combined measles, mumps, rubella and varicella vaccine being developed by GSK plc for use in healthy children.