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

May 26, 2026 updated by: GlaxoSmithKline

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.

Study Overview

Status

Not yet recruiting

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Estimated)

1808

Phase

  • Phase 2
  • Phase 1

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Study Locations

  • Australia
    • New South Wales
      • Botany, New South Wales, Australia, 2019
        • GSK Investigational Site
        • Contact:
        • Contact:
        • Principal Investigator:
          • Ronald Mark
    • Victoria
      • Camberwell, Victoria, Australia, 3124
        • GSK Investigational Site
        • Contact:
        • Contact:
        • Principal Investigator:
          • Rishi Shah

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

Yes

Description

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).
  • 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.

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, physical examination (and normal screening laboratory tests including Grade 1 laboratory abnormalities that are not-clinically significant in Phase 1 only).

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): Any laboratory abnormality. Grade 1 laboratory abnormalities that are not-clinically significant* may be included in the study.

    • The investigators should use their clinical judgment to decide which abnormalities are clinically significant.

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: Any hematologic and/or biochemical laboratory abnormality.
  • 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).

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Prevention
  • Allocation: Randomized
  • Interventional Model: Sequential Assignment
  • Masking: Quadruple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
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.
Biological: RSV/hMPV_X low dose vaccine
RSV/hMPV_X low dose vaccine administered intramuscularly.
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.
Biological: RSV/hMPV_X medium dose vaccine
RSV/hMPV_X medium dose vaccine administered intramuscularly.
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.
Biological: RSV/hMPV_X high dose vaccine
RSV/hMPV_X high dose vaccine administered intramuscularly.
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.
Biological: hMPV_Y high dose vaccine
hMPV_Y high dose vaccine administered intramuscularly.
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.
Biological: hMPV_Z low dose vaccine
hMPV_Z low dose vaccine administered intramuscularly.
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.
Biological: hMPV_Z medium dose vaccine
hMPV_Z medium dose vaccine administered intramuscularly.
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.
Biological: hMPV_Z high dose vaccine
hMPV_Z high dose vaccine administered intramuscularly.
Active Comparator: Control Vaccine_Ph1_YA Group
YA participants receive a single dose of control vaccine in Phase 1, at Day 1.
Biological: Control vaccine
Control vaccine administered intramuscularly.
Placebo Comparator: Placebo_Ph1_YA Group
YA participants receive a single dose of placebo in Phase 1, at Day 1.
Combination product: Placebo
Placebo administered intramuscularly.
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.
Biological: RSV/hMPV_V low dose vaccine
RSV/hMPV_V low dose vaccine administered intramuscularly.
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.
Biological: RSV/hMPV_V medium dose vaccine
RSV/hMPV_V medium dose vaccine administered intramuscularly.
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.
Biological: RSV/hMPV_V high dose vaccine
RSV/hMPV_V high dose vaccine administered intramuscularly.
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.
Biological: RSV/hMPV_W low dose vaccine
RSV/hMPV_W low dose vaccine administered intramuscularly.
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.
Biological: RSV/hMPV_W medium dose vaccine
RSV/hMPV_W medium dose vaccine administered intramuscularly.
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.
Biological: RSV/hMPV_W high dose vaccine
RSV/hMPV_W high dose vaccine administered intramuscularly.
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.
Biological: RSV/hMPV_X low dose vaccine
RSV/hMPV_X low dose vaccine administered intramuscularly.
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.
Biological: RSV/hMPV_X medium dose vaccine
RSV/hMPV_X medium dose vaccine administered intramuscularly.
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.
Biological: RSV/hMPV_X high dose vaccine
RSV/hMPV_X high dose vaccine administered intramuscularly.
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.
Biological: hMPV_Y low dose vaccine
hMPV_Y low dose vaccine administered intramuscularly.
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.
Biological: hMPV_Y medium dose vaccine
hMPV_Y medium dose vaccine administered intramuscularly.
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.
Biological: hMPV_Y high dose vaccine
hMPV_Y high dose vaccine administered intramuscularly.
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.
Biological: hMPV_Z low dose vaccine
hMPV_Z low dose vaccine administered intramuscularly.
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.
Biological: hMPV_Z medium dose vaccine
hMPV_Z medium dose vaccine administered intramuscularly.
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.
Biological: hMPV_Z high dose vaccine
hMPV_Z high dose vaccine administered intramuscularly.
Active Comparator: Control Vaccine_Ph1_OA Group
OA participants receive a single dose of control vaccine in Phase 1, at Day 1.
Biological: Control vaccine
Control vaccine administered intramuscularly.
Placebo Comparator: Placebo_Ph1_OA Group
OA participants receive a single dose of placebo in Phase 1, at Day 1.
Combination product: Placebo
Placebo administered intramuscularly.
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.
Biological: RSV/hMPV_V low dose vaccine
RSV/hMPV_V low dose vaccine administered intramuscularly.
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.
Biological: RSV/hMPV_V medium dose vaccine
RSV/hMPV_V medium dose vaccine administered intramuscularly.
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.
Biological: RSV/hMPV_V high dose vaccine
RSV/hMPV_V high dose vaccine administered intramuscularly.
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.
Biological: RSV/hMPV_W low dose vaccine
RSV/hMPV_W low dose vaccine administered intramuscularly.
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.
Biological: RSV/hMPV_W medium dose vaccine
RSV/hMPV_W medium dose vaccine administered intramuscularly.
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.
Biological: RSV/hMPV_W high dose vaccine
RSV/hMPV_W high dose vaccine administered intramuscularly.
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.
Biological: RSV/hMPV_X low dose vaccine
RSV/hMPV_X low dose vaccine administered intramuscularly.
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.
Biological: RSV/hMPV_X medium dose vaccine
RSV/hMPV_X medium dose vaccine administered intramuscularly.
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.
Biological: RSV/hMPV_X high dose vaccine
RSV/hMPV_X high dose vaccine administered intramuscularly.
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.
Biological: hMPV_Y low dose vaccine
hMPV_Y low dose vaccine administered intramuscularly.
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.
Biological: hMPV_Y medium dose vaccine
hMPV_Y medium dose vaccine administered intramuscularly.
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.
Biological: hMPV_Y high dose vaccine
hMPV_Y high dose vaccine administered intramuscularly.
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.
Biological: hMPV_Z low dose vaccine
hMPV_Z low dose vaccine administered intramuscularly.
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.
Biological: hMPV_Z medium dose vaccine
hMPV_Z medium dose vaccine administered intramuscularly.
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.
Biological: hMPV_Z high dose vaccine
hMPV_Z high dose vaccine administered intramuscularly.
Active Comparator: Control vaccine_Ph2_OA Group
OA participants receive a single dose of control vaccine in Phase 2, at Day 1.
Biological: Control vaccine
Control vaccine administered intramuscularly.
Placebo Comparator: Placebo_Ph2_OA Group
OA participants receive a single dose of placebo in Phase 2, at Day 1.
Combination product: Placebo
Placebo administered intramuscularly.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
Day 1 to Day 7
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).
Day 1 to Day 7
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.
Day 1 to Day 30
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.
Day 1 to Month 12
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.
Day 1 to Month 12
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), 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.
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
Time Frame: At Day 1 (pre-vaccination) in Phase 1 groups
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
At Day 8 (post-vaccination) in Phase 1 groups

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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 Phase 1 and Phase 2 OA groups
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
Time Frame: At Day 1 (pre-vaccination), Day 8 and Day 31 in Phase 1 and Phase 2 OA groups
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
Time Frame: At Day 8 and Day 31 compared to Day 1 (pre-vaccination) in Phase 1 and Phase 2 OA groups
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
Time Frame: At Day 8 and Day 31 compared to Day 1 (pre-vaccination) in Phase 1 and Phase 2 OA groups
SRR is defined as the number of participants having >=4-fold increase post-vaccination in neutralization titers 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
Time Frame: At Day 1 (pre-vaccination), Day 8 and Day 31 in Phase 1 and Phase 2 OA groups
At Day 1 (pre-vaccination), Day 8 and Day 31 in Phase 1 and Phase 2 OA groups
GMTs of RSV-A neutralization titers
Time Frame: At Day 1 (pre-vaccination), Day 8 and Day 31 in Phase 1 and Phase 2 OA groups
At Day 1 (pre-vaccination), Day 8 and Day 31 in Phase 1 and Phase 2 OA groups
MGI of RSV-A neutralization titers
Time Frame: At Day 8 and Day 31 compared to Day 1 (pre-vaccination) in Phase 1 and Phase 2 OA groups
At Day 8 and Day 31 compared to Day 1 (pre-vaccination) in Phase 1 and Phase 2 OA groups
SRR against RSV-A
Time Frame: At Day 8 and Day 31 compared to Day 1 (pre-vaccination) in Phase 1 and Phase 2 OA groups
SRR is defined as number of participants having >=4-fold-increase post-vaccination in neutralization titers against RSV-A.
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-B neutralization titers >= assay cut-off value
Time Frame: At Day 1 (pre-vaccination), Day 8 and Day 31 in Phase 1 and Phase 2 OA groups
At Day 1 (pre-vaccination), Day 8 and Day 31 in Phase 1 and Phase 2 OA groups
GMTs of RSV-B neutralization titers
Time Frame: At Day 1 (pre-vaccination), Day 8 and Day 31 in Phase 1 and Phase 2 OA groups
At Day 1 (pre-vaccination), Day 8 and Day 31 in Phase 1 and Phase 2 OA groups
MGI of RSV-B neutralization titers
Time Frame: At Day 8 and Day 31 compared to Day 1 (pre-vaccination) in Phase 1 and Phase 2 OA groups
At Day 8 and Day 31 compared to Day 1 (pre-vaccination) in Phase 1 and Phase 2 OA groups
SRR against RSV-B
Time Frame: At Day 8 and Day 31 compared to Day 1 (pre-vaccination) in Phase 1 and Phase 2 OA groups
SRR is defined as number of participants having >=4-fold-increase post-vaccination in neutralization titers against RSV-B.
At Day 8 and Day 31 compared to Day 1 (pre-vaccination) in Phase 1 and Phase 2 OA groups
Cell-mediated immunity (CMI) response expressed as frequency of hMPV-specific CD4+ T-cells
Time Frame: At Day 1 (pre-vaccination) and Day 31 in Phase 2 OA groups
At Day 1 (pre-vaccination) and Day 31 in Phase 2 OA groups
CMI response expressed as frequency of hMPV-specific CD8+ T-cells
Time Frame: At Day 1 (pre-vaccination) and Day 31 in Phase 2 OA groups
At Day 1 (pre-vaccination) and Day 31 in Phase 2 OA groups
Geometric mean fold-increase of the hMPV-specific CD4+ T-cells frequency
Time Frame: At Day 31 compared to Day 1 (pre-vaccination) in Phase 2 OA groups
At Day 31 compared to Day 1 (pre-vaccination) in Phase 2 OA groups
Geometric mean fold-increase of the hMPV-specific CD8+ T-cells frequency
Time Frame: At Day 31 compared to Day 1 (pre-vaccination) in Phase 2 OA groups
At Day 31 compared to Day 1 (pre-vaccination) in Phase 2 OA groups

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

GlaxoSmithKline

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Estimated)

June 3, 2026

Primary Completion (Estimated)

April 5, 2029

Study Completion (Estimated)

April 5, 2029

Study Registration Dates

First Submitted

May 26, 2026

First Submitted That Met QC Criteria

May 26, 2026

First Posted (Actual)

June 4, 2026

Study Record Updates

Last Update Posted (Actual)

June 4, 2026

Last Update Submitted That Met QC Criteria

May 26, 2026

Last Verified

May 1, 2026

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 223960
  • 2025-524456-58 (Other Identifier: EU CT Number)

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

YES

IPD Plan Description

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

IPD Sharing 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.

IPD Sharing 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.

IPD Sharing Supporting Information Type

  • STUDY_PROTOCOL
  • SAP
  • ICF
  • CSR

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

Yes

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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