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RSV/hMPV_V low dose vaccine

Phase 1

Respiratory Syncytial Virus Infections+Metapneumovirus | Monoclonal antibody | Respiratory |GSK plc|Last Updated: Jun 4, 2026

Success Probability
Approval Probability 71%
TA Base Rate26%
Adjusted LOA41%
ML RiskLOW_RISK
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Market & Valuation
rNPV $3.2B
Market Size $9.4B
Revenue Basis $1.6B
Competitors 6
Premium
Trial Design
RandomizedDouble-BlindPLACEBO_CONTROLLEDBiomarker
Total Trials1
Total Enrollment1,808
FDA Designations
No designations recorded
Clinical Trials (1)
NCT IDTitlePhaseStatusEnrollmentVelocityDesignStartCompletionLast UpdatedSitesCountries
NCT07628049A Study of Investigational RSV/hMPV Combination and Investigational hMPV Vaccines in Younger and Older AdultsPHASE1 NOT YET_RECRUITING 1,808Jun 3, 2026Apr 5, 2029Jun 4, 20262 Australia
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Study Endpoints
Primary Endpoints
Number of Participants Reporting Solicited Administration Site Events
Day 1 to Day 7

Solicited administration site events include pain, redness (erythema) and swelling at administration site.

Number of Participants Reporting Solicited Systemic Events
Day 1 to Day 7

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).

Number of Participants Reporting Unsolicited Adverse Events (AEs)
Day 1 to Day 30

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.

Number of Participants Reporting Medically Attended Adverse Events (MAAEs)
Day 1 to Month 12

MAAE is defined as unscheduled visit to or from healthcare professional for any reason, including emergency room visits.

Number of Participants Reporting Potential immune-mediated disorders (pIMDs)
Day 1 to Month 12

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.

Number of Participants Reporting Serious Adverse Events (SAEs)
Day 1 to study end [Month 24 for OA groups (only the selected formulation group&its comparators), Month 12 for YA groups & OA groups (all other investigational vaccine formulation groups not selected for future clinical development&other comparators)]

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.

Number of Participants Reporting Hematological and Biochemical Laboratory Abnormalities
At Day 1 (pre-vaccination) in Phase 1 groups
Secondary Endpoints
Number of participants with hMPV neutralization titers equal to or above (>=) the assay cut-off value
At Day 1 (pre-vaccination), Day 8 and Day 31 in Phase 1 and Phase 2 OA groups
Geometric mean titers (GMTs) of hMPV neutralization titers
At Day 1 (pre-vaccination), Day 8 and Day 31 in Phase 1 and Phase 2 OA groups
Mean geometric increase (MGI) of hMPV neutralization titers
At Day 8 and Day 31 compared to Day 1 (pre-vaccination) in Phase 1 and Phase 2 OA groups
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Study Design & Arms
AllocationRANDOMIZED
MaskingQUADRUPLE
ModelSEQUENTIAL
PurposePREVENTION
Treatment Arms
ArmTypeDescription
RSV/hMPV_X_low dose_Ph1_Younger Adults (YA) GroupEXPERIMENTALYA 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 GroupEXPERIMENTALYA 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 GroupEXPERIMENTALYA participants receive a single dose of RSV/hMPV\_X high dose vaccine in Phase 1, at Day 1.
hMPV_Y_high dose_Ph1_YA GroupEXPERIMENTALYA participants receive a single dose of hMPV\_Y high dose vaccine in Phase 1, at Day 1.
hMPV_Z_low dose_Ph1_YA GroupEXPERIMENTALYA participants receive a single dose of hMPV\_Z low dose vaccine in Phase 1, at Day 1.
hMPV_Z_medium dose_Ph1_YA GroupEXPERIMENTALYA participants receive a single dose of hMPV\_Z medium dose vaccine in Phase 1, at Day 1.
hMPV_Z_high dose_Ph1_YA GroupEXPERIMENTALYA participants receive a single dose of hMPV\_Z high dose vaccine in Phase 1, at Day 1.
Control Vaccine_Ph1_YA GroupACTIVE_COMPARATORYA participants receive a single dose of control vaccine in Phase 1, at Day 1.
Placebo_Ph1_YA GroupPLACEBO_COMPARATORYA participants receive a single dose of placebo in Phase 1, at Day 1.
RSV/hMPV_V_low dose_Ph1_Older Adults (OA) GroupEXPERIMENTALOA 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 GroupEXPERIMENTALOA 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 GroupEXPERIMENTALOA 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 GroupEXPERIMENTALOA 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 GroupEXPERIMENTALOA 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 GroupEXPERIMENTALOA 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 GroupEXPERIMENTALOA 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 GroupEXPERIMENTALOA 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 GroupEXPERIMENTALOA participants receive a single dose of RSV/hMPV\_X high dose vaccine in Phase 1, at Day 1.
hMPV_Y_low dose_Ph1_OA GroupEXPERIMENTALOA participants receive a single dose of hMPV\_Y low dose vaccine in Phase 1, at Day 1.
hMPV_Y_medium dose_Ph1_OA GroupEXPERIMENTALOA participants receive a single dose of hMPV\_Y medium dose vaccine in Phase 1, at Day 1.
hMPV_Y_high dose_Ph1_OA GroupEXPERIMENTALOA participants receive a single dose of hMPV\_Y high dose vaccine in Phase 1, at Day 1.
hMPV_Z_low dose_Ph1_OA GroupEXPERIMENTALOA participants receive a single dose of hMPV\_Z low dose vaccine in Phase 1, at Day 1.
hMPV_Z_medium dose_Ph1_OA GroupEXPERIMENTALOA participants receive a single dose of hMPV\_Z medium dose vaccine in Phase 1, at Day 1.
hMPV_Z_high dose_Ph1_OA GroupEXPERIMENTALOA participants receive a single dose of hMPV\_Z high dose vaccine in Phase 1, at Day 1.
Control Vaccine_Ph1_OA GroupACTIVE_COMPARATOROA participants receive a single dose of control vaccine in Phase 1, at Day 1.
Placebo_Ph1_OA GroupPLACEBO_COMPARATOROA participants receive a single dose of placebo in Phase 1, at Day 1.
RSV/hMPV_V_low dose_Ph2_OA GroupEXPERIMENTALOA 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 GroupEXPERIMENTALOA 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 GroupEXPERIMENTALOA 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 GroupEXPERIMENTALOA 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 GroupEXPERIMENTALOA 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 GroupEXPERIMENTALOA 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 GroupEXPERIMENTALOA 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 GroupEXPERIMENTALOA 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 GroupEXPERIMENTALOA participants receive a single dose of RSV/hMPV\_X high dose vaccine in Phase 2, at Day 1.
hMPV_Y_low dose_Ph2_OA GroupEXPERIMENTALOA participants receive a single dose of hMPV\_Y low dose vaccine in Phase 2, at Day 1.
hMPV_Y_medium dose_Ph2_OA GroupEXPERIMENTALOA Participants receive a single dose of hMPV\_Y medium dose vaccine in Phase 2, at Day 1.
hMPV_Y_high dose_Ph2_OA GroupEXPERIMENTALOA participants receive a single dose of hMPV\_Y high dose vaccine in Phase 2, at Day 1.
hMPV_Z_low dose_Ph2_OA GroupEXPERIMENTALOA participants receive a single dose of hMPV\_Z low dose vaccine in Phase 2, at Day 1.
hMPV_Z_medium dose_Ph2_OA GroupEXPERIMENTALOA participants receive a single dose of hMPV\_Z medium dose vaccine in Phase 2, at Day 1.
hMPV_Z_high dose_Ph2_OA GroupEXPERIMENTALOA participants receive a single dose of hMPV\_Z high dose vaccine in Phase 2, at Day 1.
Control vaccine_Ph2_OA GroupACTIVE_COMPARATOROA participants receive a single dose of control vaccine in Phase 2, at Day 1.
Placebo_Ph2_OA GroupPLACEBO_COMPARATOROA participants receive a single dose of placebo in Phase 2, at Day 1.
Interventions
NameTypeDescription
RSV/hMPV_V low dose vaccineBIOLOGICALRSV/hMPV\_V low dose vaccine administered intramuscularly.
RSV/hMPV_V medium dose vaccineBIOLOGICALRSV/hMPV\_V medium dose vaccine administered intramuscularly.
RSV/hMPV_V high dose vaccineBIOLOGICALRSV/hMPV\_V high dose vaccine administered intramuscularly.
RSV/hMPV_W low dose vaccineBIOLOGICALRSV/hMPV\_W low dose vaccine administered intramuscularly.
RSV/hMPV_W medium dose vaccineBIOLOGICALRSV/hMPV\_W medium dose vaccine administered intramuscularly.
RSV/hMPV_W high dose vaccineBIOLOGICALRSV/hMPV\_W high dose vaccine administered intramuscularly.
RSV/hMPV_X low dose vaccineBIOLOGICALRSV/hMPV\_X low dose vaccine administered intramuscularly.
RSV/hMPV_X medium dose vaccineBIOLOGICALRSV/hMPV\_X medium dose vaccine administered intramuscularly.
RSV/hMPV_X high dose vaccineBIOLOGICALRSV/hMPV\_X high dose vaccine administered intramuscularly.
hMPV_Y low dose vaccineBIOLOGICALhMPV\_Y low dose vaccine administered intramuscularly.
hMPV_Y medium dose vaccineBIOLOGICALhMPV\_Y medium dose vaccine administered intramuscularly.
hMPV_Y high dose vaccineBIOLOGICALhMPV\_Y high dose vaccine administered intramuscularly.
hMPV_Z low dose vaccineBIOLOGICALhMPV\_Z low dose vaccine administered intramuscularly.
hMPV_Z medium dose vaccineBIOLOGICALhMPV\_Z medium dose vaccine administered intramuscularly.
hMPV_Z high dose vaccineBIOLOGICALhMPV\_Z high dose vaccine administered intramuscularly.
Control vaccineBIOLOGICALControl vaccine administered intramuscularly.
PlaceboCOMBINATION_PRODUCTPlacebo administered intramuscularly.
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Eligibility Criteria
Age Range18 Years — 80 Years
SexALL
Healthy VolunteersYes
Study Sites2

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 ...

Countries:Australia
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Recent Changes (Last 90 Days)
LOWJun 4, 2026NCT07628049NEW_TRIAL: changed
LOWJun 4, 2026NCT07628049NEW_TRIAL: changed
LOWJun 4, 2026NCT07628049NEW_TRIAL: changed
LOWJun 4, 2026NCT07628049NEW_TRIAL: changed