Respiratory Syncytial Virus Infections+MetapneumovirusPhase 1/2NCT07628049
A Study of Investigational RSV/hMPV Combination and Investigational hMPV Vaccines in Younger and Older Adults
A Phase 1/2 study testing RSV/hMPV_V low dose vaccine, RSV/hMPV_V medium dose vaccine and RSV/hMPV_V high dose vaccine in people with Respiratory Syncytial Virus Infections+Metapneumovirus, run by GlaxoSmithKline at 5 sites in 2 countries.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 80 yearsHealthy volunteers can take part
- Conditions the study is for
- Respiratory Syncytial Virus Infections+Metapneumovirus
- What is being tested?
- RSV/hMPV_V low dose vaccine, RSV/hMPV_V medium dose vaccine and RSV/hMPV_V high dose vaccine
- Type of treatment
- Vaccines, Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 1,456 participants
- Where
- 5 sitesin 2 countries
- Study dates
- 5 Jun 2026to 5 Apr 2029
- Phase
- Phase 1/2
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 80 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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).
- Body Mass Index (BMI) between 18 kg/m^2 and 33 kg/m^2, inclusive.
- Specific inclusion criteria for OA
- A male or female between and including, 60 to 80 YOA at the time of the study intervention administration.
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- Healthy participants or medically stable patients as established by medical history and physical examination.
- Specific inclusion criteria for YA
- 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.
Who cannot join
- 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.
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- 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:
- For corticosteroids, this will mean prednisone equivalent >=20 mg/day for adult participants. Inhaled, topical and intra-articular steroids are allowed.
- Administration of immunoglobulins and/or any blood products or plasma derivatives.
- Up to 6 months prior to study intervention administration: long-acting immune-modifying drugs including among others immunotherapy (e.g., TNF-inhibitors), monoclonal antibodies, antitumoral medication.
- Concurrently participating in another clinical study, at any time during the study period, in which the participant has been or will be exposed to an investigational or a non-investigational intervention.
- History of chronic alcohol consumption and/or drug abuse as deemed by the investigator to render the potential participant unable/unlikely to provide accurate safety reports or comply with study procedures.
- Participation of any study personnel or their immediate dependents, family, or household members.
- Planned move during the study period that will prohibit participating in the study until study end.
- Bedridden participants.
- Specific exclusion criteria for OA population
- Planned or actual administration of a vaccine not foreseen by the study protocol in the period beginning 30 days before study intervention administration (Day - 29 to Day 1), or their planned use 30 days after study intervention administration, with the exception of inactivated, subunit and split influenza vaccines or COVID-19 vaccines which can be administered up to 14 days before or from 14 days after the study intervention administration.
- At screening (Phase 1 only), participants with:
- >=Grade 2 abnormalities for the following parameters, regardless of clinical significance, should be excluded:
- Hematologic: hemoglobin (Hb), white blood cells (WBC), platelets, absolute cell counts of lymphocytes, neutrophils, eosinophils,
- Biochemical: alanine aminotransferase (ALT), aspartate aminotransferase (AST), alkaline phosphatase (ALP), bilirubin, creatinine, blood urea nitrogen (BUN).
- Grade 1/mild hematologic and/ or biochemical laboratory abnormalities that are not clinically significant in the clinical judgment of the investigator, may be included.
- Specific exclusion criteria for YA population
- Pregnant or lactating participant.
- Female planning to become pregnant or planning to discontinue contraceptive precautions for 8 weeks after study intervention administration.
- Planned or actual administration of a vaccine not foreseen by the study protocol in the period beginning 30 days before study intervention administration (Day - 29 to Day 1), or their planned use 30 days after study intervention administration.
- At screening, participants with:
- >=Grade 2 abnormalities for the following parameters, regardless of clinical significance, should be excluded:
- Hematologic: Hb, WBC, platelets, absolute cell counts of lymphocytes, neutrophils, eosinophils,
- Biochemical: ALT, AST, ALP, bilirubin, creatinine, BUN.
- Grade 1/mild hematologic and/ or biochemical laboratory abnormalities that are not clinically significant in the clinical judgment of the investigator, may be included.
- Use of any medication, including prescription and non-prescription drugs or herbal remedies (such as St. John's wort) beginning 14 days (or 5 half-lives) prior to study intervention administration and/or planned administration during the study period. Certain medications may be permitted (Eg: contraceptives for POCBP).
Trial locations and contacts
5 sites in 2 countries. Contact the study team or a site near you to ask about taking part.
5 sites in 2 countries
United States3 sites, 3 recruiting
- Recruiting
GSK Investigational Site
Lenexa, Kansas, 66219
US GSK Clinical Trials Call Center, 877-379-3718, GSKClinicalSupportHD@gsk.com
EU GSK Clinical Trials Call Centre, +44 (0) 20 8990 4466, GSKClinicalSupportHD@gsk.com
- Recruiting
GSK Investigational Site
Seattle, Washington, 98104-2725
US GSK Clinical Trials Call Center, 877-379-3718, GSKClinicalSupportHD@gsk.com
EU GSK Clinical Trials Call Centre, +44 (0) 20 8990 4466, GSKClinicalSupportHD@gsk.com
- Recruiting
GSK Investigational Site
Stockbridge, Georgia, 30281-9054
US GSK Clinical Trials Call Center, 877-379-3718, GSKClinicalSupportHD@gsk.com
EU GSK Clinical Trials Call Centre, +44 (0) 20 8990 4466, GSKClinicalSupportHD@gsk.com
Australia2 sites, 2 recruiting
- Recruiting
GSK Investigational Site
Botany, New South Wales, 2019
US GSK Clinical Trials Call Center, 877-379-3718, GSKClinicalSupportHD@gsk.com
EU GSK Clinical Trials Call Centre, +44 (0) 20 8990 4466, GSKClinicalSupportHD@gsk.com
- Recruiting
GSK Investigational Site
Camberwell, Victoria, 3124
US GSK Clinical Trials Call Center, 877-379-3718, GSKClinicalSupportHD@gsk.com
EU GSK Clinical Trials Call Centre, +44 (0) 20 8990 4466, GSKClinicalSupportHD@gsk.com
About this study
Official title: 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
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.
- Being tested
- RSV/hMPV_V low dose vaccine, RSV/hMPV_V medium dose vaccine, RSV/hMPV_V high dose vaccine, RSV/hMPV_W low dose vaccine, RSV/hMPV_W medium dose vaccine
- Keywords
- Safety, Reactogenicity, Immunogenicity, Respiratory syncytial virus (RSV), Human metapneumovirus (hMPV)
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
RSV/hMPV_V low dose vaccineBiological
RSV/hMPV_V low dose vaccine administered intramuscularly.
RSV/hMPV_V medium dose vaccineBiological
RSV/hMPV_V medium dose vaccine administered intramuscularly.
RSV/hMPV_V high dose vaccineBiological
RSV/hMPV_V high dose vaccine administered intramuscularly.
RSV/hMPV_W low dose vaccineBiological
RSV/hMPV_W low dose vaccine administered intramuscularly.
RSV/hMPV_W medium dose vaccineBiological
RSV/hMPV_W medium dose vaccine administered intramuscularly.
RSV/hMPV_W high dose vaccineBiological
RSV/hMPV_W high dose vaccine administered intramuscularly.
RSV/hMPV_X low dose vaccineBiological
RSV/hMPV_X low dose vaccine administered intramuscularly.
RSV/hMPV_X medium dose vaccineBiological
RSV/hMPV_X medium dose vaccine administered intramuscularly.
RSV/hMPV_X high dose vaccineBiological
RSV/hMPV_X high dose vaccine administered intramuscularly.
hMPV_Y low dose vaccineBiological
hMPV_Y low dose vaccine administered intramuscularly.
hMPV_Y medium dose vaccineBiological
hMPV_Y medium dose vaccine administered intramuscularly.
hMPV_Y high dose vaccineBiological
hMPV_Y high dose vaccine administered intramuscularly.
hMPV_Z low dose vaccineBiological
hMPV_Z low dose vaccine administered intramuscularly.
hMPV_Z medium dose vaccineBiological
hMPV_Z medium dose vaccine administered intramuscularly.
hMPV_Z high dose vaccineBiological
hMPV_Z high dose vaccine administered intramuscularly.
Control vaccineBiological
Control vaccine administered intramuscularly.
PlaceboCombination product
Placebo administered intramuscularly.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Biological: RSV/hMPV_X low dose vaccine |
| 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. Receives: Biological: RSV/hMPV_X medium dose vaccine |
| 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. Receives: Biological: RSV/hMPV_X high dose vaccine |
| 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. Receives: Biological: hMPV_Y high dose vaccine |
| 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. Receives: Biological: hMPV_Z low dose vaccine |
| 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. Receives: Biological: hMPV_Z medium dose vaccine |
| 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. Receives: Biological: hMPV_Z high dose vaccine |
| Control Vaccine_Ph1_YA Group | Active comparator | YA participants receive a single dose of control vaccine in Phase 1, at Day 1. Receives: Biological: Control vaccine |
| Placebo_Ph1_YA Group | Placebo comparator | YA participants receive a single dose of placebo in Phase 1, at Day 1. Receives: Combination Product: Placebo |
| 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. Receives: Biological: RSV/hMPV_V low dose vaccine |
| 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. Receives: Biological: RSV/hMPV_V medium dose vaccine |
| 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. Receives: Biological: RSV/hMPV_V high dose vaccine |
| 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. Receives: Biological: RSV/hMPV_W low dose vaccine |
| 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. Receives: Biological: RSV/hMPV_W medium dose vaccine |
| 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. Receives: Biological: RSV/hMPV_W high dose vaccine |
| 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. Receives: Biological: RSV/hMPV_X low dose vaccine |
| 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. Receives: Biological: RSV/hMPV_X medium dose vaccine |
| 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. Receives: Biological: RSV/hMPV_X high dose vaccine |
| 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. Receives: Biological: hMPV_Y low dose vaccine |
| 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. Receives: Biological: hMPV_Y medium dose vaccine |
| 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. Receives: Biological: hMPV_Y high dose vaccine |
| 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. Receives: Biological: hMPV_Z low dose vaccine |
| 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. Receives: Biological: hMPV_Z medium dose vaccine |
| 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. Receives: Biological: hMPV_Z high dose vaccine |
| 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. Receives: Biological: Control vaccine |
| 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. Receives: Combination Product: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of Participants Reporting Solicited Administration Site Events
Solicited administration site events include pain, redness (erythema) and swelling at administration site.
Measured: 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).
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: Day 1 to study end [Month 24 for OA groups (only the selected formulation group & its comparators) and Month 12 for all other YA groups & OA groups]
Number of Participants Reporting Hematological and Biochemical Laboratory Abnormalities
Measured: At Day 1 (pre-vaccination) in Phase 1 groups
Number of Participants Reporting Hematological and Biochemical Laboratory Abnormalities
Measured: At Day 8 (post-vaccination) in Phase 1 groups
Secondary outcomes (12)
Number of participants with hMPV neutralization titers equal to or above (>=) the assay cut-off value
Measured: At Day 1 (pre-vaccination), Day 8 and Day 31 in OA groups included in both Phase 1 and Phase 2
Geometric mean titers (GMTs) of hMPV neutralization titers
Measured: At Day 1 (pre-vaccination), Day 8 and Day 31 in OA groups included in both Phase 1 and Phase 2
Mean geometric increase (MGI) of hMPV neutralization titers
Measured: At Day 8 and Day 31 compared to Day 1 (pre-vaccination) in OA groups included in both Phase 1 and Phase 2
Seroresponse rate (SRR) against hMPV
SRR is defined as the number of participants having >=4-fold increase post-vaccination in neutralization titers against hMPV.
Measured: At Day 8 and Day 31 compared to Day 1 (pre-vaccination) in OA groups included in both Phase 1 and Phase 2
Number of participants with RSV-A neutralization titers >= assay cut-off value
Measured: At Day 1 (pre-vaccination), Day 8 and Day 31 in OA groups included in both Phase 1 and Phase 2
GMTs of RSV-A neutralization titers
Measured: At Day 1 (pre-vaccination), Day 8 and Day 31 in OA groups included in both Phase 1 and Phase 2
MGI of RSV-A neutralization titers
Measured: At Day 8 and Day 31 compared to Day 1 (pre-vaccination) in OA groups included in both Phase 1 and Phase 2
SRR against RSV-A
SRR is defined as number of participants having >=4-fold-increase post-vaccination in neutralization titers against RSV-A.
Measured: At Day 8 and Day 31 compared to Day 1 (pre-vaccination) in OA groups included in both Phase 1 and Phase 2
Number of participants with RSV-B neutralization titers >= assay cut-off value
Measured: At Day 1 (pre-vaccination), Day 8 and Day 31 in OA groups included in both Phase 1 and Phase 2
GMTs of RSV-B neutralization titers
Measured: At Day 1 (pre-vaccination), Day 8 and Day 31 in OA groups included in both Phase 1 and Phase 2
MGI of RSV-B neutralization titers
Measured: At Day 8 and Day 31 compared to Day 1 (pre-vaccination) in OA groups included in both Phase 1 and Phase 2
SRR against RSV-B
SRR is defined as number of participants having >=4-fold-increase post-vaccination in neutralization titers against RSV-B.
Measured: At Day 8 and Day 31 compared to Day 1 (pre-vaccination) in OA groups included in both Phase 1 and Phase 2
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Jun 2026
- Study start5 Jun 2026
- Primary completion5 Apr 2029 (estimated)
- Study completion5 Apr 2029 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Respiratory Syncytial Virus Infections+MetapneumovirusStudies of the same condition, open and under way.
- More trials run by GlaxoSmithKlineThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1/2
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Sequential
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 1,456 participants (estimated)
Sponsor and investigators
- Lead sponsor
- GlaxoSmithKline
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07628049
- Sponsor's protocol ID
- 223960
- Other IDs
- 2025-524456-58, 2025
- Status last verified
- Sep 2026
- First submitted
- 26 May 2026
- Last updated
- 1 Oct 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- Yes: 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
Study at a glance
From the registry record, last updated by the sponsor on 1 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- 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
- ClinicalTrials.gov ID
- NCT07628049
- Acronym / sponsor ID
- 223960
- Keywords
- Safety, Reactogenicity, Immunogenicity, Respiratory syncytial virus (RSV), Human metapneumovirus (hMPV)
- Phase
- Phase 1/2
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 1,456 participants (estimated)
- Lead sponsor
- GlaxoSmithKlineIndustry (pharma, biotech, devices)
- Study start
- 5 Jun 2026 (actual)
- Primary completion
- 5 Apr 2029 (estimated)
- Study completion
- 5 Apr 2029 (estimated)
- First posted
- 4 Jun 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Sequential
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 26
| Arm | Type | Receives |
|---|---|---|
| RSV/hMPV_X_low dose_Ph1_Younger Adults (YA) Group | Experimental | Biological: RSV/hMPV_X low dose vaccineYA 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 | Biological: RSV/hMPV_X medium dose vaccineYA 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 | Biological: RSV/hMPV_X high dose vaccineYA 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 | Biological: hMPV_Y high dose vaccineYA 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 | Biological: hMPV_Z low dose vaccineYA 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 | Biological: hMPV_Z medium dose vaccineYA 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 | Biological: hMPV_Z high dose vaccineYA participants receive a single dose of hMPV_Z high dose vaccine in Phase 1, at Day 1. |
| Control Vaccine_Ph1_YA Group | Active comparator | Biological: Control vaccineYA participants receive a single dose of control vaccine in Phase 1, at Day 1. |
| Placebo_Ph1_YA Group | Placebo comparator | Combination Product: PlaceboYA 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 | Biological: RSV/hMPV_V low dose vaccineOA 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 | Biological: RSV/hMPV_V medium dose vaccineOA 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 | Biological: RSV/hMPV_V high dose vaccineOA 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 | Biological: RSV/hMPV_W low dose vaccineOA 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 | Biological: RSV/hMPV_W medium dose vaccineOA 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 | Biological: RSV/hMPV_W high dose vaccineOA 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 | Biological: RSV/hMPV_X low dose vaccineOA 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 | Biological: RSV/hMPV_X medium dose vaccineOA 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 | Biological: RSV/hMPV_X high dose vaccineOA 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 | Biological: hMPV_Y low dose vaccineOA 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 | Biological: hMPV_Y medium dose vaccineOA 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 | Biological: hMPV_Y high dose vaccineOA 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 | Biological: hMPV_Z low dose vaccineOA 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 | Biological: hMPV_Z medium dose vaccineOA 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 | Biological: hMPV_Z high dose vaccineOA 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 | Biological: Control vaccineOA 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 | Combination Product: PlaceboOA participants receive a single dose of placebo in both Phase 1 and Phase 2, at Day 1. |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (14 listed)
- 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).
- Body Mass Index (BMI) between 18 kg/m^2 and 33 kg/m^2, inclusive.
- Specific inclusion criteria for OA
Key exclusion criteria (40 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| RSV/hMPV_V low dose vaccineRSV/hMPV_V low dose vaccine administered intramuscularly. | Biological | RSV/hMPV_V_low dose_Ph1 and Ph2_Older Adults (OA) Group |
| RSV/hMPV_V medium dose vaccineRSV/hMPV_V medium dose vaccine administered intramuscularly. | Biological | RSV/hMPV_V_medium dose_Ph1 and Ph2_OA Group |
| RSV/hMPV_V high dose vaccineRSV/hMPV_V high dose vaccine administered intramuscularly. | Biological | RSV/hMPV_V_high dose_Ph1 and Ph2_OA Group |
| RSV/hMPV_W low dose vaccineRSV/hMPV_W low dose vaccine administered intramuscularly. | Biological | RSV/hMPV_W_low dose_Ph1 and Ph2_OA Group |
| RSV/hMPV_W medium dose vaccineRSV/hMPV_W medium dose vaccine administered intramuscularly. | Biological | RSV/hMPV_W_medium dose_Ph1 and Ph2_OA Group |
| RSV/hMPV_W high dose vaccineRSV/hMPV_W high dose vaccine administered intramuscularly. | Biological | RSV/hMPV_W_high dose_Ph1 and Ph2_OA Group |
| RSV/hMPV_X low dose vaccineRSV/hMPV_X low dose vaccine administered intramuscularly. | Biological | RSV/hMPV_X_low dose_Ph1 and Ph2_OA Group, RSV/hMPV_X_low dose_Ph1_Younger Adults (YA) Group |
| RSV/hMPV_X medium dose vaccineRSV/hMPV_X medium dose vaccine administered intramuscularly. | Biological | RSV/hMPV_X_medium dose_Ph1 and Ph2_OA Group, RSV/hMPV_X_medium dose_Ph1_YA Group |
| RSV/hMPV_X high dose vaccineRSV/hMPV_X high dose vaccine administered intramuscularly. | Biological | RSV/hMPV_X_high dose_Ph1 and Ph2_OA Group, RSV/hMPV_X_high dose_Ph1_YA Group |
| hMPV_Y low dose vaccinehMPV_Y low dose vaccine administered intramuscularly. | Biological | hMPV_Y_low dose_Ph1_OA Group |
| hMPV_Y medium dose vaccinehMPV_Y medium dose vaccine administered intramuscularly. | Biological | hMPV_Y_medium dose_Ph1 and Ph2_OA Group |
| hMPV_Y high dose vaccinehMPV_Y high dose vaccine administered intramuscularly. | Biological | hMPV_Y_high dose_Ph1 and Ph2_OA Group, hMPV_Y_high dose_Ph1_YA Group |
| hMPV_Z low dose vaccinehMPV_Z low dose vaccine administered intramuscularly. | Biological | hMPV_Z_low dose_Ph1_OA Group, hMPV_Z_low dose_Ph1_YA Group |
| hMPV_Z medium dose vaccinehMPV_Z medium dose vaccine administered intramuscularly. | Biological | hMPV_Z_medium dose_Ph1_OA Group, hMPV_Z_medium dose_Ph1_YA Group |
| hMPV_Z high dose vaccinehMPV_Z high dose vaccine administered intramuscularly. | Biological | hMPV_Z_high dose_Ph1_OA Group, hMPV_Z_high dose_Ph1_YA Group |
| Control vaccineControl vaccine administered intramuscularly. | Biological | Control Vaccine_Ph1 and Ph2_OA Group, Control Vaccine_Ph1_YA Group |
| PlaceboPlacebo administered intramuscularly. | Combination product | Placebo_Ph1 and Ph2_OA Group, Placebo_Ph1_YA Group |
Primary outcome
Number of Participants Reporting Solicited Administration Site Events
Time frame: 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
Time frame: 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)
Time frame: 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)
Time frame: 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)
Time frame: 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)
Time frame: Day 1 to study end [Month 24 for OA groups (only the selected formulation group & its comparators) and Month 12 for all other YA groups & OA groups]
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
Time frame: At Day 1 (pre-vaccination) in Phase 1 groups
Number of Participants Reporting Hematological and Biochemical Laboratory Abnormalities
Time frame: At Day 8 (post-vaccination) in Phase 1 groups
12 secondary outcomes
Number of participants with hMPV neutralization titers equal to or above (>=) the assay cut-off value
Time frame: At Day 1 (pre-vaccination), Day 8 and Day 31 in OA groups included in both Phase 1 and Phase 2
Geometric mean titers (GMTs) of hMPV neutralization titers
Time frame: At Day 1 (pre-vaccination), Day 8 and Day 31 in OA groups included in both Phase 1 and Phase 2
Mean geometric increase (MGI) of hMPV neutralization titers
Time frame: At Day 8 and Day 31 compared to Day 1 (pre-vaccination) in OA groups included in both Phase 1 and Phase 2
Seroresponse rate (SRR) against hMPV
Time frame: At Day 8 and Day 31 compared to Day 1 (pre-vaccination) in OA groups included in both Phase 1 and Phase 2
Number of participants with RSV-A neutralization titers >= assay cut-off value
Time frame: At Day 1 (pre-vaccination), Day 8 and Day 31 in OA groups included in both Phase 1 and Phase 2
GMTs of RSV-A neutralization titers
Time frame: At Day 1 (pre-vaccination), Day 8 and Day 31 in OA groups included in both Phase 1 and Phase 2
MGI of RSV-A neutralization titers
Time frame: At Day 8 and Day 31 compared to Day 1 (pre-vaccination) in OA groups included in both Phase 1 and Phase 2
SRR against RSV-A
Time frame: At Day 8 and Day 31 compared to Day 1 (pre-vaccination) in OA groups included in both Phase 1 and Phase 2
Number of participants with RSV-B neutralization titers >= assay cut-off value
Time frame: At Day 1 (pre-vaccination), Day 8 and Day 31 in OA groups included in both Phase 1 and Phase 2
GMTs of RSV-B neutralization titers
Time frame: At Day 1 (pre-vaccination), Day 8 and Day 31 in OA groups included in both Phase 1 and Phase 2
MGI of RSV-B neutralization titers
Time frame: At Day 8 and Day 31 compared to Day 1 (pre-vaccination) in OA groups included in both Phase 1 and Phase 2
SRR against RSV-B
Time frame: At Day 8 and Day 31 compared to Day 1 (pre-vaccination) in OA groups included in both Phase 1 and Phase 2
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 1 Oct 2026.
- Individual participant dataSharing planned: Yes. 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
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
5 sites in 2 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1/2 study testing RSV/hMPV_V low dose vaccine, RSV/hMPV_V medium dose vaccine and RSV/hMPV_V high dose vaccine in people with Respiratory Syncytial Virus Infections+Metapneumovirus, run by GlaxoSmithKline at 5 sites in 2 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 14 inclusion and 40 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 1 Oct 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 5 sites in United States, Australia. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this combined phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact US GSK Clinical Trials Call Center (877-379-3718, GSKClinicalSupportHD@gsk.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Number of Participants Reporting Solicited Administration Site Events (time frame: Day 1 to Day 7). The study lists 8 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 1 Oct 2026.