A Study of Investigational RSV/hMPV Combination and Investigational hMPV Vaccines in Younger and Older Adults

Part of paid clinical trials in Lenexa, Kansas.

Sponsor: GlaxoSmithKline
Study ID: NCT07628049
Phase: PHASE1/PHASE2
Status: Recruiting

Apply to this trial

Conditions

Respiratory Syncytial Virus Infections+Metapneumovirus

Eligibility Criteria

Sex: ALL
Age: 18 Years - 80 Years
Healthy Volunteers: Accepted

Interventions

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.

Study Details

The aim of this study is to evaluate the safety, reactogenicity, and immune response of the different formulations of the investigational RSV/hMPV combination vaccine and investigational hMPV vaccine in younger and older adults.

Key Dates

First listed: Jun 4, 2026
Start date: Jun 5, 2026
Status verified: Jul 2026
Primary completion: Apr 5, 2029
Completion: Apr 5, 2029

Study Design

Enrollment: 1,808 participants (estimated)
Allocation: RANDOMIZED
Intervention model: SEQUENTIAL
Primary purpose: PREVENTION

Arms

Experimental: RSV/hMPV_X_low dose_Ph1_Younger Adults (YA) Group
YA participants receive a single dose of RSV/hMPV\_X low dose vaccine in Phase 1, at Day 1.
Experimental: RSV/hMPV_X_medium dose_Ph1_YA Group
YA participants receive a single dose of RSV/hMPV\_X medium dose vaccine in Phase 1, at Day 1.
Experimental: RSV/hMPV_X_high dose_Ph1_YA Group
YA participants receive a single dose of RSV/hMPV\_X high dose vaccine in Phase 1, at Day 1.
Experimental: hMPV_Y_high dose_Ph1_YA Group
YA participants receive a single dose of hMPV\_Y high dose vaccine in Phase 1, at Day 1.
Experimental: hMPV_Z_low dose_Ph1_YA Group
YA participants receive a single dose of hMPV\_Z low dose vaccine in Phase 1, at Day 1.
Experimental: hMPV_Z_medium dose_Ph1_YA Group
YA participants receive a single dose of hMPV\_Z medium dose vaccine in Phase 1, at Day 1.
Experimental: hMPV_Z_high dose_Ph1_YA Group
YA participants receive a single dose of hMPV\_Z high dose vaccine in Phase 1, at Day 1.
Active Comparator: Control Vaccine_Ph1_YA Group
YA participants receive a single dose of control vaccine in Phase 1, at Day 1.
Placebo Comparator: Placebo_Ph1_YA Group
YA participants receive a single dose of placebo in Phase 1, at Day 1.
Experimental: RSV/hMPV_V_low dose_Ph1_Older Adults (OA) Group
OA participants receive a single dose of RSV/hMPV\_V low dose vaccine in Phase 1, at Day 1.
Experimental: RSV/hMPV_V_medium dose_Ph1_OA Group
OA participants receive a single dose of RSV/hMPV\_V medium dose vaccine in Phase 1, at Day 1.
Experimental: RSV/hMPV_V_high dose_Ph1_OA Group
OA participants receive a single dose of RSV/hMPV\_V high dose vaccine in Phase 1, at Day 1.
Experimental: RSV/hMPV_W_low dose_Ph1_OA Group
OA participants receive a single dose of RSV/hMPV\_W low dose vaccine in Phase 1, at Day 1.
Experimental: RSV/hMPV_W_medium dose_Ph1_OA Group
OA participants receive a single dose of RSV/hMPV\_W medium dose vaccine in Phase 1, at Day 1.
Experimental: RSV/hMPV_W_high dose_Ph1_OA Group
OA participants receive a single dose of RSV/hMPV\_W high dose vaccine in Phase 1, at Day 1.
Experimental: RSV/hMPV_X_low dose_Ph1_OA Group
OA participants receive a single dose of RSV/hMPV\_X low dose vaccine in Phase 1, at Day 1.
Experimental: RSV/hMPV_X_medium dose_Ph1_OA Group
OA participants received a single dose of RSV/hMPV\_X medium dose vaccine in Phase 1, at Day 1.
Experimental: RSV/hMPV_X_high dose_Ph1_OA Group
OA participants receive a single dose of RSV/hMPV\_X high dose vaccine in Phase 1, at Day 1.
Experimental: hMPV_Y_low dose_Ph1_OA Group
OA participants receive a single dose of hMPV\_Y low dose vaccine in Phase 1, at Day 1.
Experimental: hMPV_Y_medium dose_Ph1_OA Group
OA participants receive a single dose of hMPV\_Y medium dose vaccine in Phase 1, at Day 1.
Experimental: hMPV_Y_high dose_Ph1_OA Group
OA participants receive a single dose of hMPV\_Y high dose vaccine in Phase 1, at Day 1.
Experimental: hMPV_Z_low dose_Ph1_OA Group
OA participants receive a single dose of hMPV\_Z low dose vaccine in Phase 1, at Day 1.
Experimental: hMPV_Z_medium dose_Ph1_OA Group
OA participants receive a single dose of hMPV\_Z medium dose vaccine in Phase 1, at Day 1.
Experimental: hMPV_Z_high dose_Ph1_OA Group
OA participants receive a single dose of hMPV\_Z high dose vaccine in Phase 1, at Day 1.
Active Comparator: Control Vaccine_Ph1_OA Group
OA participants receive a single dose of control vaccine in Phase 1, at Day 1.
Placebo Comparator: Placebo_Ph1_OA Group
OA participants receive a single dose of placebo in Phase 1, at Day 1.
Experimental: RSV/hMPV_V_low dose_Ph2_OA Group
OA participants receive a single dose of RSV/hMPV\_V low dose vaccine in Phase 2, at Day 1.
Experimental: RSV/hMPV_V_medium dose_Ph2_OA Group
OA participants receive a single dose of RSV/hMPV\_V medium dose vaccine in Phase 2, at Day 1.
Experimental: RSV/hMPV_V_high dose_Ph2_OA Group
OA participants receive a single dose of RSV/hMPV\_V high dose vaccine in Phase 2, at Day 1.
Experimental: RSV/hMPV_W_low dose_Ph2_OA Group
OA participants receive a single dose of RSV/hMPV\_W low dose vaccine in Phase 2, at Day 1.
Experimental: RSV/hMPV_W_medium dose_Ph2_OA Group
OA participants receive a single dose of RSV/hMPV\_W medium dose vaccine in Phase 2, at Day 1.
Experimental: RSV/hMPV_W_high dose_Ph2_OA Group
OA participants receive a single dose of RSV/hMPV\_W high dose vaccine in Phase 2, at Day 1.
Experimental: RSV/hMPV_X_low dose_Ph2_OA Group
OA participants receive a single dose of RSV/hMPV\_X low dose vaccine in Phase 2, at Day 1.
Experimental: RSV/hMPV_X_medium dose_Ph2_OA Group
OA participants receive a single dose of RSV/hMPV\_X medium dose vaccine in Phase 2, at Day 1.
Experimental: RSV/hMPV_X_high dose_Ph2_OA Group
OA participants receive a single dose of RSV/hMPV\_X high dose vaccine in Phase 2, at Day 1.
Experimental: hMPV_Y_low dose_Ph2_OA Group
OA participants receive a single dose of hMPV\_Y low dose vaccine in Phase 2, at Day 1.
Experimental: hMPV_Y_medium dose_Ph2_OA Group
OA Participants receive a single dose of hMPV\_Y medium dose vaccine in Phase 2, at Day 1.
Experimental: hMPV_Y_high dose_Ph2_OA Group
OA participants receive a single dose of hMPV\_Y high dose vaccine in Phase 2, at Day 1.
Experimental: hMPV_Z_low dose_Ph2_OA Group
OA participants receive a single dose of hMPV\_Z low dose vaccine in Phase 2, at Day 1.
Experimental: hMPV_Z_medium dose_Ph2_OA Group
OA participants receive a single dose of hMPV\_Z medium dose vaccine in Phase 2, at Day 1.
Experimental: hMPV_Z_high dose_Ph2_OA Group
OA participants receive a single dose of hMPV\_Z high dose vaccine in Phase 2, at Day 1.
Active Comparator: Control vaccine_Ph2_OA Group
OA participants receive a single dose of control vaccine in Phase 2, at Day 1.
Placebo Comparator: Placebo_Ph2_OA Group
OA participants receive a single dose of placebo in Phase 2, at Day 1.

Primary Outcome Measure

Number of Participants Reporting Solicited Administration Site Events [ Time Frame: Day 1 to Day 7 ]

Central Contacts

US GSK Clinical Trials Call Center
877-379-3718
[email protected]
EU GSK Clinical Trials Call Center
+44 (0) 20 89904466
[email protected]

Locations (2)

Facility	City	State	ZIP	Site coordinators
GSK Investigational Site	Lenexa	Kansas	66219	US GSK Clinical Trials Call Center [email protected] 877-379-3718 EU GSK Clinical Trials Call Centre [email protected] +44 (0) 20 8990 4466 Thomas Kreamer (PRINCIPAL_INVESTIGATOR)
GSK Investigational Site	Seattle	Washington	98104	US GSK Clinical Trials Call Center [email protected] 877-379-3718 EU GSK Clinical Trials Call Centre [email protected] +44 (0) 20 8990 4466 Nicole Ehrhardt (PRINCIPAL_INVESTIGATOR)

Find similar trials in Lenexa, KS

By research site

GSK Investigational Site· Lenexa, KS GSK Investigational Site· Seattle, WA