A Study of Investigational RSV/hMPV Combination and Investigational hMPV Vaccines in Younger and Older Adults
A Phase 1/2, Randomized, Controlled, Observer-blind, Multicentre Study to Evaluate the Safety, Reactogenicity, and Immunogenicity of GSK Biologicals' Investigational Respiratory Syncytial Virus (RSV)/Human Metapneumovirus (hMPV) Combination and Investigational hMPV Vaccines When Administered Intramuscularly According to a Single Dose Schedule in Younger Adults ≥18 to ≤49 Years and Older Adults Aged ≥60 to ≤80 Years
2 other identifiers
interventional
1,808
2 countries
4
Brief Summary
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for phase_1
Started Jun 2026
Typical duration for phase_1
4 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
May 26, 2026
CompletedFirst Posted
Study publicly available on registry
June 4, 2026
CompletedStudy Start
First participant enrolled
June 5, 2026
CompletedPrimary Completion
Last participant's last visit for primary outcome
April 5, 2029
ExpectedStudy Completion
Last participant's last visit for all outcomes
April 5, 2029
July 8, 2026
July 1, 2026
2.8 years
May 26, 2026
July 7, 2026
Conditions
Keywords
Outcome Measures
Primary Outcomes (8)
Number of Participants Reporting Solicited Administration Site Events
Solicited administration site events include pain, redness (erythema) and swelling at administration site.
Day 1 to Day 7
Number of Participants Reporting Solicited Systemic Events
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).
Day 1 to Day 7
Number of Participants Reporting Unsolicited Adverse Events (AEs)
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.
Day 1 to Day 30
Number of Participants Reporting Medically Attended Adverse Events (MAAEs)
MAAE is defined as unscheduled visit to or from healthcare professional for any reason, including emergency room visits.
Day 1 to Month 12
Number of Participants Reporting Potential immune-mediated disorders (pIMDs)
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.
Day 1 to Month 12
Number of Participants Reporting Serious Adverse Events (SAEs)
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.
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)]
Number of Participants Reporting Hematological and Biochemical Laboratory Abnormalities
At Day 1 (pre-vaccination) in Phase 1 groups
Number of Participants Reporting Hematological and Biochemical Laboratory Abnormalities
At Day 8 (post-vaccination) in Phase 1 groups
Secondary Outcomes (16)
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
Seroresponse rate (SRR) against hMPV
At Day 8 and Day 31 compared to Day 1 (pre-vaccination) in Phase 1 and Phase 2 OA groups
Number of participants with RSV-A neutralization titers >= assay cut-off value
At Day 1 (pre-vaccination), Day 8 and Day 31 in Phase 1 and Phase 2 OA groups
- +11 more secondary outcomes
Study Arms (43)
RSV/hMPV_X_low dose_Ph1_Younger Adults (YA) Group
EXPERIMENTALYA 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
EXPERIMENTALYA 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
EXPERIMENTALYA 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
EXPERIMENTALYA participants receive a single dose of hMPV\_Y high dose vaccine in Phase 1, at Day 1.
hMPV_Z_low dose_Ph1_YA Group
EXPERIMENTALYA participants receive a single dose of hMPV\_Z low dose vaccine in Phase 1, at Day 1.
hMPV_Z_medium dose_Ph1_YA Group
EXPERIMENTALYA participants receive a single dose of hMPV\_Z medium dose vaccine in Phase 1, at Day 1.
hMPV_Z_high dose_Ph1_YA Group
EXPERIMENTALYA participants receive a single dose of hMPV\_Z high dose vaccine in Phase 1, at Day 1.
Control Vaccine_Ph1_YA Group
ACTIVE COMPARATORYA participants receive a single dose of control vaccine in Phase 1, at Day 1.
Placebo_Ph1_YA Group
PLACEBO COMPARATORYA participants receive a single dose of placebo in Phase 1, at Day 1.
RSV/hMPV_V_low dose_Ph1_Older Adults (OA) Group
EXPERIMENTALOA 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
EXPERIMENTALOA 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
EXPERIMENTALOA 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
EXPERIMENTALOA 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
EXPERIMENTALOA 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
EXPERIMENTALOA 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
EXPERIMENTALOA 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
EXPERIMENTALOA 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
EXPERIMENTALOA 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
EXPERIMENTALOA participants receive a single dose of hMPV\_Y low dose vaccine in Phase 1, at Day 1.
hMPV_Y_medium dose_Ph1_OA Group
EXPERIMENTALOA participants receive a single dose of hMPV\_Y medium dose vaccine in Phase 1, at Day 1.
hMPV_Y_high dose_Ph1_OA Group
EXPERIMENTALOA participants receive a single dose of hMPV\_Y high dose vaccine in Phase 1, at Day 1.
hMPV_Z_low dose_Ph1_OA Group
EXPERIMENTALOA participants receive a single dose of hMPV\_Z low dose vaccine in Phase 1, at Day 1.
hMPV_Z_medium dose_Ph1_OA Group
EXPERIMENTALOA participants receive a single dose of hMPV\_Z medium dose vaccine in Phase 1, at Day 1.
hMPV_Z_high dose_Ph1_OA Group
EXPERIMENTALOA participants receive a single dose of hMPV\_Z high dose vaccine in Phase 1, at Day 1.
Control Vaccine_Ph1_OA Group
ACTIVE COMPARATOROA participants receive a single dose of control vaccine in Phase 1, at Day 1.
Placebo_Ph1_OA Group
PLACEBO COMPARATOROA participants receive a single dose of placebo in Phase 1, at Day 1.
RSV/hMPV_V_low dose_Ph2_OA Group
EXPERIMENTALOA 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
EXPERIMENTALOA 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
EXPERIMENTALOA 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
EXPERIMENTALOA 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
EXPERIMENTALOA 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
EXPERIMENTALOA 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
EXPERIMENTALOA 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
EXPERIMENTALOA 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
EXPERIMENTALOA 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
EXPERIMENTALOA participants receive a single dose of hMPV\_Y low dose vaccine in Phase 2, at Day 1.
hMPV_Y_medium dose_Ph2_OA Group
EXPERIMENTALOA Participants receive a single dose of hMPV\_Y medium dose vaccine in Phase 2, at Day 1.
hMPV_Y_high dose_Ph2_OA Group
EXPERIMENTALOA participants receive a single dose of hMPV\_Y high dose vaccine in Phase 2, at Day 1.
hMPV_Z_low dose_Ph2_OA Group
EXPERIMENTALOA participants receive a single dose of hMPV\_Z low dose vaccine in Phase 2, at Day 1.
hMPV_Z_medium dose_Ph2_OA Group
EXPERIMENTALOA participants receive a single dose of hMPV\_Z medium dose vaccine in Phase 2, at Day 1.
hMPV_Z_high dose_Ph2_OA Group
EXPERIMENTALOA participants receive a single dose of hMPV\_Z high dose vaccine in Phase 2, at Day 1.
Control vaccine_Ph2_OA Group
ACTIVE COMPARATOROA participants receive a single dose of control vaccine in Phase 2, at Day 1.
Placebo_Ph2_OA Group
PLACEBO COMPARATOROA participants receive a single dose of placebo in Phase 2, at Day 1.
Interventions
RSV/hMPV\_V low dose vaccine administered intramuscularly.
RSV/hMPV\_V medium dose vaccine administered intramuscularly.
Placebo administered intramuscularly.
RSV/hMPV\_V high dose vaccine administered intramuscularly.
RSV/hMPV\_W low dose vaccine administered intramuscularly.
RSV/hMPV\_W medium dose vaccine administered intramuscularly.
RSV/hMPV\_W high dose vaccine administered intramuscularly.
RSV/hMPV\_X low dose vaccine administered intramuscularly.
RSV/hMPV\_X medium dose vaccine administered intramuscularly.
RSV/hMPV\_X high dose vaccine administered intramuscularly.
hMPV\_Y low dose vaccine administered intramuscularly.
hMPV\_Y medium dose vaccine administered intramuscularly.
hMPV\_Y high dose vaccine administered intramuscularly.
hMPV\_Z low dose vaccine administered intramuscularly.
hMPV\_Z medium dose vaccine administered intramuscularly.
hMPV\_Z high dose vaccine administered intramuscularly.
Control vaccine administered intramuscularly.
Eligibility Criteria
You may qualify if:
- 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 protocol (e.g., completion of the eDiary, return for follow-up visits, ability to access and utilize a phone or other electronic communications).
- Note: For OA participants, in case of physical incapacity that would preclude the self-completion of the eDiaries, either site staff can assist the participant (for activities performed during site visits) and/or the participant may assign a caregiver to assist him/her with this activity (for activities performed at home). However, at no time will the site staff or caregiver evaluate the participant's health status while answering eDiaries or make decisions on behalf of the participant.
- Body Mass Index (BMI) between 18 kg/m\^2 and 33 kg/m\^2, inclusive.
- A male or female between and including, 60 to 80 YOA at the time of the study intervention administration.
- Healthy participants or medically stable patients as established by medical history, physical examination (and normal screening laboratory tests including Grade 1 laboratory abnormalities that are not-clinically significant in Phase 1 only).
- A male or female participant between and including 18 to 49 YOA at the time of the study intervention administration.
- Healthy participants as established by medical history, clinical examination and laboratory assessment at screening.
- Participants of non-childbearing potential may be enrolled in the clinical study.
- Participant of childbearing potential may be enrolled in the study if the participant:
- has used two methods of contraception, at-least one of which must be a highly effective method, and the other being male condom for male sexual partners of POCBP to be used during sexual intercourse (with the exception of sexual abstinence, vasectomized partner and male partner who has been sterilized, in which case contraception is not required), at-least 30 days prior to study intervention administration, and has agreed to continue using above contraception requirements for 8 weeks after study intervention administration.
- has a negative serum pregnancy test at screening and negative urine pregnancy test prior to study intervention administration on Day 1.
You may not qualify if:
- Participants are excluded from participating in the study if any of the following criteria apply:
- History of any reaction or hypersensitivity likely to be exacerbated by any component of the study intervention(s).
- Any medical condition that in the judgment of the investigator would make IM injection unsafe.
- Any confirmed or suspected immunosuppressive or immunodeficient condition resulting from disease (e.g., current malignancy, HIV) or immunosuppressive/cytotoxic therapy (e.g., medication used during cancer chemotherapy, organ transplantation, or to treat autoimmune disorders), based on medical history and physical examination (no laboratory testing required).
- Acute or unstable chronic pulmonary, cardiovascular, hepatic, or renal functional abnormality, as determined by physical examination and medical history.
- Documented history of HIV, HBV, HCV infection.
- History of RSV and /or hMPV-associated illness, diagnosed serologically or microbiologically in the last 12 months.
- Recurrent history or uncontrolled neurological disorders or seizures, or history of demyelinating conditions (including GBS).
- Any history of dementia or any medical condition that moderately or severely impairs cognition.
- Any other clinical condition that, in the opinion of the investigator, might pose additional risk to the participant due to participation in the clinical study.
- Significant underlying illness that in the opinion of the investigator would be expected to prevent completion of the study (e.g., life-threatening disease).
- Use of any investigational or non-registered product (drug, vaccine, or invasive medical device) other than the study intervention during the period beginning 30 days before study intervention administration (Day -29 to Day 1), or within 5 half-lives, whichever is longer, or their planned use during the study period.
- Has previously received an investigational or approved vaccine or antibody for prevention of hMPV and/or RSV-associated diseases.
- Chronic administration of immune-modifying drugs (defined as more than 14 consecutive days in total) and/or planned use of long-acting immune-modifying treatments at any time up to the end of the study.
- Up to 3 months prior to the study intervention administration:
- +16 more criteria
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- GlaxoSmithKlinelead
Study Sites (4)
GSK Investigational Site
Lenexa, Kansas, 66219, United States
GSK Investigational Site
Seattle, Washington, 98104, United States
GSK Investigational Site
Botany, New South Wales, 2019, Australia
GSK Investigational Site
Camberwell, Victoria, 3124, Australia
MeSH Terms
Interventions
Intervention Hierarchy (Ancestors)
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- phase 1
- Allocation
- RANDOMIZED
- Masking
- QUADRUPLE
- Who Masked
- PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
- Masking Details
- This is an observer-blind study.
- Purpose
- PREVENTION
- Intervention Model
- SEQUENTIAL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
May 26, 2026
First Posted
June 4, 2026
Study Start
June 5, 2026
Primary Completion (Estimated)
April 5, 2029
Study Completion (Estimated)
April 5, 2029
Last Updated
July 8, 2026
Record last verified: 2026-07
Data Sharing
- IPD Sharing
- Will share
- Shared Documents
- STUDY PROTOCOL, SAP, ICF, CSR
- Time Frame
- Anonymized IPD will be made available within 6 months of publication of primary, key secondary and safety results for studies in product with approved indication(s) or asset(s) with development terminated across all indications.
- Access Criteria
- Anonymized IPD is shared with researchers whose proposals are approved by an Independent Review Panel and after a Data Sharing Agreement is in place. Access is provided for an initial period of 12 months, but an extension may be granted, when justified, for up to 6 months.
Study Sponsor will assess requests from qualified researchers for anonymized individual patient-level data and related study documents. Data sharing is subject to certain criteria, conditions, and exceptions. For further information, refer to https://www.gsk-studyregister.com/gsk-patient-level-data-sharing-july2025.pdf