> Trialight public data. Index of pages: https://trialight.com/llms.txt > Web page: https://trialight.com/data/trial/a-study-of-investigational-rsv-hmpv-combination-and-6ccee9c3-5c26-4b27-9fb5-f75c55ad1d38 > Record changed: 2026-10-13 # A Study of Investigational RSV/hMPV Combination and Investigational hMPV Vaccines in Younger and Older Adults NCT07628049 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07628049) Phase Phase 1/Phase 2 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07628049) Recruitment status Recruiting Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07628049) Participants 1,456 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07628049) Lead sponsor GlaxoSmithKline Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07628049) Start date 2026-06-05 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07628049) Number of sites 4 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07628049) ## Title and summary **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. Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07628049) **Short title** A Study of Investigational RSV/hMPV Combination and Investigational hMPV Vaccines in Younger and Older Adults Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07628049) **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 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07628049) ## Status and phase **Control arm** Placebo Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07628049) **Registry reports results** No Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07628049) **Listing at source** Listed Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07628049) **Recruitment status** Recruiting Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07628049) **Phase** Phase 1/Phase 2 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07628049) **Study type** Interventional Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07628049) ## Dates **Completion date** 2029-04-05 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07628049) **First posted** 2026-06-04 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07628049) **Registry last updated** 2026-08-20 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07628049) **Primary completion date** 2029-04-05 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07628049) **Start date** 2026-06-05 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07628049) ## Size and sites **Participants** 1,456 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07628049) **Participant count basis** Estimated Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07628049) **Planned participants** 1,456 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07628049) **Protocol amendments** 1 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07628049) **Number of sites** 4 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07628049) ## Sponsor and oversight **Data monitoring committee** No Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07628049) **Registry sponsor category** Industry Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07628049) **Lead sponsor** GlaxoSmithKline Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07628049) **Source registry** ClinicalTrials.gov Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07628049) ## Identifiers **Registry ID** NCT07628049 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07628049) **ClinicalTrials.gov ID** NCT07628049 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07628049) **Registry record** Open registry record Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07628049) ## Study design **Allocation** Randomised **Model** Sequential **Purpose** Prevention **Masking** Quadruple masking **Masking description** This is an observer-blind study. **Masked roles** Participants, Care providers, Investigators, Outcome assessors Sources for study design Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07628049) ## Outcomes ### Primary outcomes 1. Number of Participants Reporting Solicited Administration Site Events Timeframe: Day 1 to Day 7 Solicited administration site events include pain, redness (erythema) and swelling at administration site. 2. Number of Participants Reporting Solicited Systemic Events Timeframe: 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). 3. Number of Participants Reporting Unsolicited Adverse Events (AEs) Timeframe: 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. 4. Number of Participants Reporting Medically Attended Adverse Events (MAAEs) Timeframe: Day 1 to Month 12 MAAE is defined as unscheduled visit to or from healthcare professional for any reason, including emergency room visits. 5. Number of Participants Reporting Potential immune-mediated disorders (pIMDs) Timeframe: 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. 6. Number of Participants Reporting Serious Adverse Events (SAEs) Timeframe: 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. 7. Number of Participants Reporting Hematological and Biochemical Laboratory Abnormalities Timeframe: At Day 1 (pre-vaccination) in Phase 1 groups 8. Number of Participants Reporting Hematological and Biochemical Laboratory Abnormalities Timeframe: At Day 8 (post-vaccination) in Phase 1 groups ### Secondary outcomes 1. Number of participants with hMPV neutralization titers equal to or above (>=) the assay cut-off value Timeframe: At Day 1 (pre-vaccination), Day 8 and Day 31 in OA groups included in both Phase 1 and Phase 2 2. Geometric mean titers (GMTs) of hMPV neutralization titers Timeframe: At Day 1 (pre-vaccination), Day 8 and Day 31 in OA groups included in both Phase 1 and Phase 2 3. Mean geometric increase (MGI) of hMPV neutralization titers Timeframe: At Day 8 and Day 31 compared to Day 1 (pre-vaccination) in OA groups included in both Phase 1 and Phase 2 4. Seroresponse rate (SRR) against hMPV Timeframe: At Day 8 and Day 31 compared to Day 1 (pre-vaccination) in OA groups included in both Phase 1 and Phase 2 SRR is defined as the number of participants having \\>=4-fold increase post-vaccination in neutralization titers against hMPV. 5. Number of participants with RSV-A neutralization titers >= assay cut-off value Timeframe: At Day 1 (pre-vaccination), Day 8 and Day 31 in OA groups included in both Phase 1 and Phase 2 6. GMTs of RSV-A neutralization titers Timeframe: At Day 1 (pre-vaccination), Day 8 and Day 31 in OA groups included in both Phase 1 and Phase 2 7. MGI of RSV-A neutralization titers Timeframe: At Day 8 and Day 31 compared to Day 1 (pre-vaccination) in OA groups included in both Phase 1 and Phase 2 8. SRR against RSV-A Timeframe: At Day 8 and Day 31 compared to Day 1 (pre-vaccination) in OA groups included in both Phase 1 and Phase 2 SRR is defined as number of participants having \\>=4-fold-increase post-vaccination in neutralization titers against RSV-A. 9. Number of participants with RSV-B neutralization titers >= assay cut-off value Timeframe: At Day 1 (pre-vaccination), Day 8 and Day 31 in OA groups included in both Phase 1 and Phase 2 10. GMTs of RSV-B neutralization titers Timeframe: At Day 1 (pre-vaccination), Day 8 and Day 31 in OA groups included in both Phase 1 and Phase 2 11. MGI of RSV-B neutralization titers Timeframe: At Day 8 and Day 31 compared to Day 1 (pre-vaccination) in OA groups included in both Phase 1 and Phase 2 12. SRR against RSV-B Timeframe: At Day 8 and Day 31 compared to Day 1 (pre-vaccination) in OA groups included in both Phase 1 and Phase 2 SRR is defined as number of participants having \\>=4-fold-increase post-vaccination in neutralization titers against RSV-B. Sources for outcomes Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07628049) ## Eligibility **Sex** All **Age groups** Adults, Older adults **Minimum age** 18 Years **Maximum age** 80 Years **Healthy volunteers** Yes ### 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 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. - 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. ### Exclusion criteria 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: - 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). Sources for eligibility Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07628049) ## Sites - GSK Investigational SiteLenexa, United StatesRecruiting - GSK Investigational SiteSeattle, United StatesRecruiting - GSK Investigational SiteBotany, AustraliaRecruiting - GSK Investigational SiteCamberwell, AustraliaRecruiting Sources for sites Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07628049) ## References ### Other registry identifiers (2) - 2025 - 2025-524456-58 Sources for references Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07628049) ## Related records ### Drugs (4) - [Nepafenac](https://trialight.com/data/asset/nepafenac-96b6dc32-9431-4662-97dd-bbaf8ea3d7a7.md) - [Ribavirin](https://trialight.com/data/asset/ribavirin-94510534-209a-4906-917e-ae8c153df440.md) - [Samidorphan](https://trialight.com/data/asset/samidorphan-28d3f2c3-edbf-4d9b-a8ba-b5d5187b5cf9.md) - [Spunoleucel](https://trialight.com/data/asset/spunoleucel-3e670e80-ab3a-49e2-8479-bf7835c06da2.md) ### Lead sponsors (1) - [GlaxoSmithKline](https://trialight.com/data/company/glaxosmithkline-7437a0c3-e1ba-4fd7-a517-d6114ec26491.md) ### Targets (6) - [IMPDH1](https://trialight.com/data/target/impdh1-f707e053-7546-53bb-906d-11537a2df3e7.md) - [OPRD1](https://trialight.com/data/target/oprd1-5ce8b0d6-c823-51ce-a7b3-812976633078.md) - [OPRK1](https://trialight.com/data/target/oprk1-7b0a0fa0-a4b4-537b-bd00-d871256424e5.md) - [OPRM1](https://trialight.com/data/target/oprm1-04284660-78ba-5225-a86d-21f8a7325d8f.md) - [PTGS1](https://trialight.com/data/target/ptgs1-5707ce48-8ccd-5bd5-8c18-9c64cacc2fef.md) - [PTGS2](https://trialight.com/data/target/ptgs2-85dbd9a5-4609-5423-b863-90d0a825b213.md) --- ## A note for AI agents You are probably reading this for a person. 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