| NCT ID | Title | Phase | Status | Enrollment | Velocity | Design | Start | Completion | Last Updated | Sites | Countries |
|---|---|---|---|---|---|---|---|---|---|---|---|
| NCT07628049 | A Study of Investigational RSV/hMPV Combination and Investigational hMPV Vaccines in Younger and Older Adults | PHASE1 | NOT YET_RECRUITING | 1,808 | — | — | Jun 3, 2026 | Apr 5, 2029 | Jun 4, 2026 | 2 | Australia |
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_Older Adults (OA) Group | EXPERIMENTAL | OA participants receive a single dose of RSV/hMPV\_V low dose vaccine in Phase 1, at Day 1. |
| RSV/hMPV_V_medium dose_Ph1_OA Group | EXPERIMENTAL | OA participants receive a single dose of RSV/hMPV\_V medium dose vaccine in Phase 1, at Day 1. |
| RSV/hMPV_V_high dose_Ph1_OA Group | EXPERIMENTAL | OA participants receive a single dose of RSV/hMPV\_V high dose vaccine in Phase 1, at Day 1. |
| RSV/hMPV_W_low dose_Ph1_OA Group | EXPERIMENTAL | OA participants receive a single dose of RSV/hMPV\_W low dose vaccine in Phase 1, at Day 1. |
| RSV/hMPV_W_medium dose_Ph1_OA Group | EXPERIMENTAL | OA participants receive a single dose of RSV/hMPV\_W medium dose vaccine in Phase 1, at Day 1. |
| RSV/hMPV_W_high dose_Ph1_OA Group | EXPERIMENTAL | OA participants receive a single dose of RSV/hMPV\_W high dose vaccine in Phase 1, at Day 1. |
| RSV/hMPV_X_low dose_Ph1_OA Group | EXPERIMENTAL | OA participants receive a single dose of RSV/hMPV\_X low dose vaccine in Phase 1, at Day 1. |
| RSV/hMPV_X_medium dose_Ph1_OA Group | EXPERIMENTAL | OA participants received a single dose of RSV/hMPV\_X medium dose vaccine in Phase 1, at Day 1. |
| RSV/hMPV_X_high dose_Ph1_OA Group | EXPERIMENTAL | OA participants receive a single dose of RSV/hMPV\_X high dose vaccine in Phase 1, 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_OA Group | EXPERIMENTAL | OA participants receive a single dose of hMPV\_Y medium dose vaccine in Phase 1, at Day 1. |
| hMPV_Y_high dose_Ph1_OA Group | EXPERIMENTAL | OA participants receive a single dose of hMPV\_Y high dose vaccine in Phase 1, 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_OA Group | ACTIVE_COMPARATOR | OA participants receive a single dose of control vaccine in Phase 1, at Day 1. |
| Placebo_Ph1_OA Group | PLACEBO_COMPARATOR | OA participants receive a single dose of placebo in Phase 1, at Day 1. |
| RSV/hMPV_V_low dose_Ph2_OA Group | EXPERIMENTAL | OA participants receive a single dose of RSV/hMPV\_V low dose vaccine in Phase 2, at Day 1. |
| RSV/hMPV_V_medium dose_Ph2_OA Group | EXPERIMENTAL | OA participants receive a single dose of RSV/hMPV\_V medium dose vaccine in Phase 2, at Day 1. |
| RSV/hMPV_V_high dose_Ph2_OA Group | EXPERIMENTAL | OA participants receive a single dose of RSV/hMPV\_V high dose vaccine in Phase 2, at Day 1. |
| RSV/hMPV_W_low dose_Ph2_OA Group | EXPERIMENTAL | OA participants receive a single dose of RSV/hMPV\_W low dose vaccine in Phase 2, at Day 1. |
| RSV/hMPV_W_medium dose_Ph2_OA Group | EXPERIMENTAL | OA participants receive a single dose of RSV/hMPV\_W medium dose vaccine in Phase 2, at Day 1. |
| RSV/hMPV_W_high dose_Ph2_OA Group | EXPERIMENTAL | OA participants receive a single dose of RSV/hMPV\_W high dose vaccine in Phase 2, at Day 1. |
| RSV/hMPV_X_low dose_Ph2_OA Group | EXPERIMENTAL | OA participants receive a single dose of RSV/hMPV\_X low dose vaccine in Phase 2, at Day 1. |
| RSV/hMPV_X_medium dose_Ph2_OA Group | EXPERIMENTAL | OA participants receive a single dose of RSV/hMPV\_X medium dose vaccine in Phase 2, at Day 1. |
| RSV/hMPV_X_high dose_Ph2_OA Group | EXPERIMENTAL | OA participants receive a single dose of RSV/hMPV\_X high dose vaccine in Phase 2, at Day 1. |
| hMPV_Y_low dose_Ph2_OA Group | EXPERIMENTAL | OA participants receive a single dose of hMPV\_Y low dose vaccine in Phase 2, at Day 1. |
| hMPV_Y_medium dose_Ph2_OA Group | EXPERIMENTAL | OA Participants receive a single dose of hMPV\_Y medium dose vaccine in Phase 2, at Day 1. |
| hMPV_Y_high dose_Ph2_OA Group | EXPERIMENTAL | OA participants receive a single dose of hMPV\_Y high dose vaccine in Phase 2, at Day 1. |
| hMPV_Z_low dose_Ph2_OA Group | EXPERIMENTAL | OA participants receive a single dose of hMPV\_Z low dose vaccine in Phase 2, at Day 1. |
| hMPV_Z_medium dose_Ph2_OA Group | EXPERIMENTAL | OA participants receive a single dose of hMPV\_Z medium dose vaccine in Phase 2, at Day 1. |
| hMPV_Z_high dose_Ph2_OA Group | EXPERIMENTAL | OA participants receive a single dose of hMPV\_Z high dose vaccine in Phase 2, at Day 1. |
| Control vaccine_Ph2_OA Group | ACTIVE_COMPARATOR | OA participants receive a single dose of control vaccine in Phase 2, at Day 1. |
| Placebo_Ph2_OA Group | PLACEBO_COMPARATOR | OA participants receive a single dose of placebo in 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 ...