Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
RSV/hMPV_V low dose vaccine · 1 trial · 1 indication
Solicited administration site events include pain, redness (erythema) and swelling at administration site.
Solicited systemic events include fever \[defined as oral or axillary temperature greater than or equal to (\>=) 38.0°C/100.4°F\], headache, myalgia (muscle pain), arthralgia (joint pain) and fatigue (tiredness).
An unsolicited AE is defined as an AE that was either not included in the list of solicited events or could be included in the list of solicited events but with an onset outside the specified period of follow up for solicited events. Unsolicited AEs include both serious and non-serious AEs.
MAAE is defined as unscheduled visit to or from healthcare professional for any reason, including emergency room visits.
pIMDs are a subset of AEs of Special Interest (AESIs) that include autoimmune disorders and other inflammatory and/or neurologic disorders of interest which may or may not have an autoimmune etiology.
An SAE is any untoward medical occurrence that results in death, is life-threatening, requires hospitalization or prolongation of existing hospitalization, results in persistent or significant disability/incapacity, is a congenital anomaly/birth defect in the offspring of a study participant, is an abnormal pregnancy outcome, or is a suspected transmission of any infectious agent via an authorized medicinal product.
| Arm | Type | Description |
|---|---|---|
| RSV/hMPV_X_low dose_Ph1_Younger Adults (YA) Group | EXPERIMENTAL | YA participants receive a single dose of RSV/hMPV\_X low dose vaccine in Phase 1, at Day 1. |
| RSV/hMPV_X_medium dose_Ph1_YA Group | EXPERIMENTAL | YA participants receive a single dose of RSV/hMPV\_X medium dose vaccine in Phase 1, at Day 1. |
| RSV/hMPV_X_high dose_Ph1_YA Group | EXPERIMENTAL | YA participants receive a single dose of RSV/hMPV\_X high dose vaccine in Phase 1, at Day 1. |
| hMPV_Y_high dose_Ph1_YA Group | EXPERIMENTAL | YA participants receive a single dose of hMPV\_Y high dose vaccine in Phase 1, at Day 1. |
| hMPV_Z_low dose_Ph1_YA Group | EXPERIMENTAL | YA participants receive a single dose of hMPV\_Z low dose vaccine in Phase 1, at Day 1. |
| hMPV_Z_medium dose_Ph1_YA Group | EXPERIMENTAL | YA participants receive a single dose of hMPV\_Z medium dose vaccine in Phase 1, at Day 1. |
| hMPV_Z_high dose_Ph1_YA Group | EXPERIMENTAL | YA participants receive a single dose of hMPV\_Z high dose vaccine in Phase 1, at Day 1. |
| Control Vaccine_Ph1_YA Group | ACTIVE_COMPARATOR | YA participants receive a single dose of control vaccine in Phase 1, at Day 1. |
| Placebo_Ph1_YA Group | PLACEBO_COMPARATOR | YA participants receive a single dose of placebo in Phase 1, at Day 1. |
| RSV/hMPV_V_low dose_Ph1 and Ph2_Older Adults (OA) Group | EXPERIMENTAL | OA participants receive a single dose of RSV/hMPV\_V low dose vaccine in both Phase 1 and Phase 2, at Day 1. |
| RSV/hMPV_V_medium dose_Ph1 and Ph2_OA Group | EXPERIMENTAL | OA participants receive a single dose of RSV/hMPV\_V medium dose vaccine in both Phase 1 and Phase 2, at Day 1. |
| RSV/hMPV_V_high dose_Ph1 and Ph2_OA Group | EXPERIMENTAL | OA participants receive a single dose of RSV/hMPV\_V high dose vaccine in both Phase 1 and Phase 2, at Day 1. |
| RSV/hMPV_W_low dose_Ph1 and Ph2_OA Group | EXPERIMENTAL | OA participants receive a single dose of RSV/hMPV\_W low dose vaccine in both Phase 1 and Phase 2, at Day 1. |
| RSV/hMPV_W_medium dose_Ph1 and Ph2_OA Group | EXPERIMENTAL | OA participants receive a single dose of RSV/hMPV\_W medium dose vaccine in both Phase 1 and Phase 2, at Day 1. |
| RSV/hMPV_W_high dose_Ph1 and Ph2_OA Group | EXPERIMENTAL | OA participants receive a single dose of RSV/hMPV\_W high dose vaccine in both Phase 1 and Phase 2, at Day 1. |
| RSV/hMPV_X_low dose_Ph1 and Ph2_OA Group | EXPERIMENTAL | OA participants receive a single dose of RSV/hMPV\_X low dose vaccine in both Phase 1 and Phase 2, at Day 1. |
| RSV/hMPV_X_medium dose_Ph1 and Ph2_OA Group | EXPERIMENTAL | OA participants received a single dose of RSV/hMPV\_X medium dose vaccine in both Phase 1 and Phase 2, at Day 1. |
| RSV/hMPV_X_high dose_Ph1 and Ph2_OA Group | EXPERIMENTAL | OA participants receive a single dose of RSV/hMPV\_X high dose vaccine in both Phase 1 and Phase 2, at Day 1. |
| hMPV_Y_low dose_Ph1_OA Group | EXPERIMENTAL | OA participants receive a single dose of hMPV\_Y low dose vaccine in Phase 1, at Day 1. |
| hMPV_Y_medium dose_Ph1 and Ph2_OA Group | EXPERIMENTAL | OA participants receive a single dose of hMPV\_Y medium dose vaccine in both Phase 1 and Phase 2, at Day 1. |
| hMPV_Y_high dose_Ph1 and Ph2_OA Group | EXPERIMENTAL | OA participants receive a single dose of hMPV\_Y high dose vaccine in both Phase 1 and Phase 2, at Day 1. |
| hMPV_Z_low dose_Ph1_OA Group | EXPERIMENTAL | OA participants receive a single dose of hMPV\_Z low dose vaccine in Phase 1, at Day 1. |
| hMPV_Z_medium dose_Ph1_OA Group | EXPERIMENTAL | OA participants receive a single dose of hMPV\_Z medium dose vaccine in Phase 1, at Day 1. |
| hMPV_Z_high dose_Ph1_OA Group | EXPERIMENTAL | OA participants receive a single dose of hMPV\_Z high dose vaccine in Phase 1, at Day 1. |
| Control Vaccine_Ph1 and Ph2_OA Group | ACTIVE_COMPARATOR | OA participants receive a single dose of control vaccine in both Phase 1 and Phase 2, at Day 1. |
| Placebo_Ph1 and Ph2_OA Group | PLACEBO_COMPARATOR | OA participants receive a single dose of placebo in both Phase 1 and Phase 2, at Day 1. |
| Name | Type | Description |
|---|---|---|
| RSV/hMPV_V low dose vaccine | BIOLOGICAL | RSV/hMPV\_V low dose vaccine administered intramuscularly. |
| RSV/hMPV_V medium dose vaccine | BIOLOGICAL | RSV/hMPV\_V medium dose vaccine administered intramuscularly. |
| RSV/hMPV_V high dose vaccine | BIOLOGICAL | RSV/hMPV\_V high dose vaccine administered intramuscularly. |
| RSV/hMPV_W low dose vaccine | BIOLOGICAL | RSV/hMPV\_W low dose vaccine administered intramuscularly. |
| RSV/hMPV_W medium dose vaccine | BIOLOGICAL | RSV/hMPV\_W medium dose vaccine administered intramuscularly. |
| RSV/hMPV_W high dose vaccine | BIOLOGICAL | RSV/hMPV\_W high dose vaccine administered intramuscularly. |
| RSV/hMPV_X low dose vaccine | BIOLOGICAL | RSV/hMPV\_X low dose vaccine administered intramuscularly. |
| RSV/hMPV_X medium dose vaccine | BIOLOGICAL | RSV/hMPV\_X medium dose vaccine administered intramuscularly. |
| RSV/hMPV_X high dose vaccine | BIOLOGICAL | RSV/hMPV\_X high dose vaccine administered intramuscularly. |
| hMPV_Y low dose vaccine | BIOLOGICAL | hMPV\_Y low dose vaccine administered intramuscularly. |
| hMPV_Y medium dose vaccine | BIOLOGICAL | hMPV\_Y medium dose vaccine administered intramuscularly. |
| hMPV_Y high dose vaccine | BIOLOGICAL | hMPV\_Y high dose vaccine administered intramuscularly. |
| hMPV_Z low dose vaccine | BIOLOGICAL | hMPV\_Z low dose vaccine administered intramuscularly. |
| hMPV_Z medium dose vaccine | BIOLOGICAL | hMPV\_Z medium dose vaccine administered intramuscularly. |
| hMPV_Z high dose vaccine | BIOLOGICAL | hMPV\_Z high dose vaccine administered intramuscularly. |
| Control vaccine | BIOLOGICAL | Control vaccine administered intramuscularly. |
| Placebo | COMBINATION_PRODUCT | Placebo administered intramuscularly. |
Inclusion criteria: Participants are eligible to be included in the study only if all of the following criteria apply: * Written informed consent obtained from the participant prior to performance of any study-specific procedure. * Participants who can and will comply with the requirements of the ...
RSV low dose formulation vaccine is an investigational vaccine being developed for Respiratory Syncytial Virus Infections and for Respiratory Syncytial Virus Infections combined with Metapneumovirus. It is being studied in infants, younger adults, and older adults. The vaccine is currently in Phase 1 clinical development.
RSV low dose formulation vaccine is being developed by GSK plc, a biopharma company traded on the New York Stock Exchange under the ticker GSK. GSK is conducting clinical trials of this investigational vaccine in multiple countries including the United States, Canada, and Australia.
RSV low dose formulation vaccine is in Phase 1 clinical development. It is an investigational vaccine and has not been approved by regulatory authorities. GSK is currently recruiting participants for a Phase 1 trial in younger and older adults, while two earlier Phase 1 trials in infants have been completed.
RSV low dose formulation vaccine has been studied in three Phase 1 trials. NCT02927873 and NCT03636906 evaluated the vaccine in infants and are completed. NCT07628049 is an ongoing recruiting trial studying the vaccine in younger and older adults, with an enrollment of 1456 participants.
Yes, RSV low dose formulation vaccine is also known as RSV/hMPV_V low dose vaccine. The ongoing Phase 1 trial NCT07628049 uses this alternative name to describe the investigational vaccine being studied in combination with a human metapneumovirus vaccine.
RSV low dose formulation vaccine is a monoclonal antibody modality designed to target respiratory syncytial virus and metapneumovirus infections. As a vaccine, it is intended to stimulate an immune response against these respiratory viruses, though the specific molecular target has not been disclosed in available information.