A Phase 3, Observer-blind, Randomized, Placebo-controlled Study to Evaluate the Non-inferiority of the Immune Response and Safety of the RSVPreF3 OA Investigational Vaccine in Adults 50-59 Years of Age, Including Adults at Increased Risk of Respiratory Syncytial Virus Lower Respiratory Tract Disease, Compared to Older Adults ≥60 Years of Age

ClinicalTrials.gov processed this data on April 25, 2024. Link to the current ClinicalTrials.gov record.

Recruitment Status

COMPLETED - HAS RESULTS
 (See Contacts and Locations)
Verified April 2024 by GlaxoSmithKline

Sponsor

GlaxoSmithKline

Information Provided by (Responsible Party)

GlaxoSmithKline

Clinicaltrials.gov Identifier

NCT05590403
Other Study ID Numbers: 219238
First Submitted: October 18, 2022
First Posted: October 21, 2022
Results First Posted: May 21, 2024
Last Update Posted: May 21, 2024
Last Verified: April 2024
History of Changes

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Study Description

Not Provided
Condition or Disease Intervention/Treatment
  • Respiratory Syncytial Virus Infections
  • Biological: RSVPreF3 OA investigational vaccine
  • Drug: Placebo

Study Design

Study TypeInterventional
Actual Enrollment1544 participants
Design AllocationRandomized
Interventional ModelParallel Assignment
MaskingQuadruple
Primary PurposePrevention
Official TitleA Phase 3, Observer-blind, Randomized, Placebo-controlled Study to Evaluate the Non-inferiority of the Immune Response and Safety of the RSVPreF3 OA Investigational Vaccine in Adults 50-59 Years of Age, Including Adults at Increased Risk of Respiratory Syncytial Virus Lower Respiratory Tract Disease, Compared to Older Adults ≥60 Years of Age
Study Start DateOctober 28, 2022
Actual Primary Completion DateMarch 13, 2023
Actual Study Completion DateApril 3, 2024

Groups and Cohorts

Group/ CohortIntervention/ Treatment
  • Adults HA-RSV Group
    • Healthy adults or adults with chronic stable conditions with or without treatment that do not lead to an increased risk of RSV-Lower respiratory tract disease (RSV-LRTD), aged 50-59 years old received 1 dose of RSVPreF3 OA vaccine at Day 1 and were followed until study end.
  • Biological: RSVPreF3 OA investigational vaccine
    • One dose administered intramuscularly at Day 1.
  • Adults HA-Placebo Group
    • Healthy adults or adults with chronic stable conditions with or without treatment that do not lead to an increased risk of RSV-LRTD, aged 50-59 years old received 1 dose of placebo at Day 1 and were followed until study end.
  • Drug: Placebo
    • Adults AIR-RSV Group
      • Adults at increased risk of RSV-Lower respiratory tract disease (RSV-LRTD) aged 50-59 years old received 1 dose of RSVPreF3 OA vaccine at Day 1 and were followed until study end.
    • Biological: RSVPreF3 OA investigational vaccine
      • One dose administered intramuscularly at Day 1.
    • Adults AIR-Placebo Group
      • Adults at increased risk of RSV-LRTD aged 50-59 years old received 1 dose of placebo at Day 1 and were followed until study end.
    • Drug: Placebo
      • OA-RSV Group
        • Older adults aged 60 years old and above received 1 dose of RSVPreF3 OA vaccine at Day 1 and were followed until study end.
      • Biological: RSVPreF3 OA investigational vaccine
        • One dose administered intramuscularly at Day 1.

      Outcome Measures

      Primary Outcome Measures

      1. RSV-A Neutralization Titers Expressed as Group Geometric Mean Titer (GMT) in Healthy Participants Compared to OA-RSV Group [At 1 month after the RSVPreF3 OA vaccine administration (Day 31)]
        Serological assays for the determination of antibodies against RSV-A were performed by neutralization assay. The corresponding antibody titers were expressed in Estimated Dilution 60 (ED60) and were measured on blood samples collected from vaccinated subjects. The ANCOVA model used to calculate the adjusted GMTs for RSV-A neutralizing antibodies included the baseline value as covariate (i.e. GMTs are adjusted for the PRE timepoint values) and only included Adult HA_RSV and OA_RSV groups in the model as fixed effect, as specified in Statistical Analysis Plan.
      2. RSV-A Neutralization Titers Expressed as Group Seroresponse Rate (SRR) Difference in Healthy Participants Compared to OA-RSV Group [At 1 month after the RSVPreF3 OA investigational vaccine administration (Day 31) compared to baseline (Day 1)]
        The SRR is defined as the proportion of participants having a fold increase in neutralization titers (1 month post-study intervention administration over pre-study intervention administration) greater than or equal to 4 (>=4).
      3. RSV-B Neutralization Titers Expressed as Group GMT in Healthy Participants Compared to OA-RSV Group [At 1 month after the RSVPreF3 OA vaccine administration (Day 31)]
        Serological assays for the determination of antibodies against RSV-B were performed by neutralization assay. The corresponding antibody titers were expressed in ED60. The ANCOVA model used to calculate the adjusted GMTs for RSV-B neutralizing antibodies included the baseline value as covariate (i.e. GMTs are adjusted for the PRE timepoint values) and only included Adult HA_RSV and OA_RSV groups in the model as fixed effect, as specified in Statistical Analysis Plan.
      4. RSV-B Neutralization Titers Expressed as Group SRR in Healthy Participants Compared to OA-RSV Group [At 1 month after the RSVPreF3 OA vaccine administration (Day 31) compared to baseline (Day 1)]
        The SRR is defined as the proportion of participants having a fold increase in neutralization titers (1 month post-study intervention administration over pre-study intervention administration) >=4.
      5. RSV-A Neutralization Titers Expressed as Group GMT Titer in Participants at Increased Risk of RSV-LRTD (Adults-AIR-RSV Group) Compared to OA-RSV Group [At 1 month after the RSVPreF3 OA investigational vaccine administration (Day 31)]
        Serological assays for the determination of antibodies against RSV-A are performed by neutralization assay. The corresponding antibody titers were expressed in ED60. The ANCOVA model used to calculate the adjusted GMTs for RSV-A neutralizing antibodies included the baseline value as covariate (i.e. GMTs are adjusted for the PRE timepoint values) and only included Adult AIR_RSV and OA_RSV groups in the model as fixed effect, as specified in Statistical Analysis Plan.
      6. RSV-A Neutralization Titers Expressed as Group SRR in Participants at Increased Risk of RSV-LRTD (Adults-AIR-RSV Group) Compared to OA-RSV Group [At 1 month after the RSVPreF3 OA vaccine administration (Day 31) compared to baseline (Day 1)]
        The SRR is defined as the proportion of participants having a fold increase in neutralization titers (1 month post-study intervention administration over pre-study intervention administration) >=4.
      7. RSV-B Neutralization Titers Expressed as Group GMT in Participants at Increased Risk of RSV-LRTD (Adults-AIR-RSV Group) Compared to OA-RSV Group [At 1 month after the RSVPreF3 OA vaccine administration (Day 31)]
        Serological assays for the determination of antibodies against RSV-B are performed by neutralization assay. The corresponding antibody titers were expressed in ED60. The ANCOVA model used to calculate the adjusted GMTs for RSV-B neutralizing antibodies included the baseline value as covariate (i.e. GMTs are adjusted for the PRE timepoint values) and only included Adult AIR_RSV and OA_RSV groups in the model as fixed effect, as specified in Statistical Analysis Plan.
      8. RSV-B Neutralization Titers Expressed as Group SRR in Participants at Increased Risk of RSV-LRTD (Adults-AIR-RSV Group) Compared to OA-RSV Group [At 1 month after the RSVPreF3 OA investigational vaccine administration (Day 31) compared to baseline (Day 1)]
        The SRR is defined as the proportion of participants having a fold increase in neutralization titers (1 month post-study intervention administration over pre-study intervention administration) >=4.

      Secondary Outcome Measures

      1. Percentage of Participants Reporting Each Solicited Administration Site Event (Pain, Redness and Swelling) [During the 4-day follow up period after vaccination (vaccine or placebo administered on Day 1)]
        Assessed solicited administration site events were pain, erythema and swelling. Any = occurrence of the symptom regardless of intensity grade. Any erythema and swelling symptom = symptom reported with a surface diameter greater than 0 millimeters.
      2. Percentage of Participants Reporting Each Solicited Systemic Event (Fever, Headache, Muscle Pain, Joint Pain, Tiredness) [During the 4-day follow up period after vaccination (vaccine or placebo administered on Day 1)]
        Assessed solicited systemic events were arthralgia, fatigue, headache, myalgia and fever [temperature equal to or above (>=) 38 degrees Celsius (°C)]. Any = occurrence of the symptom regardless of intensity grade or relation to study intervention.
      3. Percentage of Participants Reporting Any Unsolicited Adverse Events (AEs) [During the 30-day follow up period after vaccination (vaccine or placebo administered on Day 1)]
        Unsolicited AEs are defined as any AE reported in addition to those solicited during the clinical study. Also, any 'solicited' symptom with onset outside the specified period of follow-up for solicited symptoms will be reported as an unsolicited adverse event.
      4. Percentage of Participants Reporting Any Serious Adverse Events (SAEs) [From the day of the vaccination (Day 1) up to 6 months post dose (Month 6)]
        An SAE is any untoward medical occurrence that results in death, is life-threatening, requires hospitalization or prolongation of existing hospitalization, results in disability/incapacity, is a congenital anomaly/birth defect in the offspring of a study participant, or results in an abnormal pregnancy outcome.
      5. Percentage of Participants Reporting Any Potential Immune Mediated Diseases (pIMDs) [From the day of the vaccination (Day 1) up to 6 months post dose (Month 6)]
        pIMDs are a subset of AEs of special interest that include autoimmune diseases and other inflammatory and/or neurologic disorders of interest which may or may not have an autoimmune etiology.
      6. Percentage of Participants Reporting SAEs Related to Study Intervention Administration [From the day of the vaccination up to 12 months after vaccination (vaccine or placebo administered on Day 1)]
        An SAE is any untoward medical occurrence that results in death, is life-threatening, requires hospitalization or prolongation of existing hospitalization, results in disability/incapacity, is a congenital anomaly/birth defect in the offspring of a study participant, or results in an abnormal pregnancy outcome.
      7. Percentage of Participants Reporting pIMDs Related to Study Intervention Administration [From the day of the vaccination up to 12 months after vaccination (vaccine or placebo administered on Day 1)]
        pIMDs are a subset of AEs of special interest that include autoimmune diseases and other inflammatory and/or neurologic disorders of interest which may or may not have an autoimmune etiology.
      8. Percentage of Participants Reporting Any Fatal SAEs [From the day of the vaccination up to 12 months after vaccination (vaccine or placebo administered on Day 1)]
        An SAE is any untoward medical occurrence that results in death, is life-threatening, requires hospitalization or prolongation of existing hospitalization, results in disability/incapacity, is a congenital anomaly/birth defect in the offspring of a study participant, or results in an abnormal pregnancy outcome.
      9. RSV-A Neutralization Titers Expressed as GMT, up to One Month Post-intervention [At pre-study intervention administration (Day 1) and 1 month after study intervention administration (Day 31)]
        Serological assays for the determination of antibodies against RSV-A are performed by neutralization assay. The corresponding antibody titers were expressed in ED60. Unadjusted GMTs were provided for Adult HA_RSV, Adults HA-Placebo, Adult AIR_RSV, Adult AIR_Placebo and OA_RSV groups.
      10. RSV-A Neutralization Titers Expressed as GMT at Month 6 and Month 12 Post-intervention [At 6 months and at 12 months after study intervention administration]
        Serological assays for the determination of antibodies against RSV-A are performed by neutralization assay. The corresponding antibody titers were expressed in ED60.
      11. RSV-B Neutralization Titers Expressed as GMT, up to One Month Post-intervention [At pre-study intervention administration (Day 1) and 1 month after study intervention administration (Day 31)]
        Serological assays for the determination of antibodies against RSV-B are performed by neutralization assay. The corresponding antibody titers were expressed in ED60. Unadjusted GMTs were provided for Adult HA_RSV, Adults HA-Placebo, Adult AIR_RSV, Adult AIR_Placebo and OA_RSV groups.
      12. RSV-B Neutralization Titers Expressed as GMT, at Month 6 and Month 12 Post-intervention [At 6 months and at 12 months after study intervention administration]
        Serological assays for the determination of antibodies against RSV-B are performed by neutralization assay. The corresponding antibody titers were expressed in ED60.
      13. Frequency of RSVPreF3-specific Cluster of Differentiation (CD)4+ T Cells Expressing at Least 2 Activation Markers up to One Month Post-intervention [At pre-study intervention administration (Day 1) and 1 months after study intervention administration (Day 31)]
        Among markers expressed are interleukin-2/13/17 (IL-2, IL-13, IL-17), cluster of 40 ligand (CD40L), 41BB, tumour necrosis factor alpha (TNF-α) and interferon gamma (IFN-γ), in vitro upon stimulation with RSVPreF3 peptide preparations.
      14. Frequency of RSVPreF3-specific CD4+ T Cells Expressing at Least 2 Activation Markers, at Month 6 and Month 12 Post-intervention [At 6 months and at 12 months after study intervention administration]
        Among markers expressed are interleukin-2/13/17 (IL-2, IL-13, IL-17), cluster of 40 ligand (CD40L), 41BB, tumour necrosis factor alpha (TNF-α) and interferon gamma (IFN-γ), in vitro upon stimulation with RSVPreF3 peptide preparations.
      15. Frequency of RSVPreF3-specific CD8+ T Cells Expressing at Least 2 Activation Markers, up to One Month Post-intervention [At pre-study intervention administration (Day 1) and 1 month after study intervention administration (Day 31)]
        Among markers expressed are IL-2, IL-13, IL-17, CD40L, 41BB, TNF-α and IFN-γ, in vitro upon stimulation with RSVPreF3 peptide preparations.
      16. Frequency of RSVPreF3-specific CD8+ T Cells Expressing at Least 2 Activation Markers, at Month 6 and Month 12 [At 6 months and at 12 months after study intervention administration]
        Among markers expressed are IL-2, IL-13, IL-17, CD40L, 41BB, TNF-α and IFN-γ, in vitro upon stimulation with RSVPreF3 peptide preparations.

      Eligibility Criteria

      Ages Eligible for Study 50 Years and Older (Adult, Older Adult)
      Sexes Eligible for Study All
      Accepts Healthy Volunteers Yes
      Inclusion Criteria
      • Participants who, in the opinion of the investigator, can and will comply with the requirements of the protocol
      • Written or witnessed informed consent obtained from the participant prior to performance of any study-specific procedure.
      • Specific inclusion criteria for all participants in Cohort 1 (Adults HA-RSV Group, Adults HA-Placebo Group, Adults AIR-RSV Group & Adults AIR-Placebo Group)
      • A male or female participant 50-59 YOA at the time of the study intervention administration.
      • Female participants of non-childbearing potential may be enrolled in the study. Non-childbearing potential is defined as hysterectomy, bilateral oophorectomy, bilateral salpingectomy or post-menopause.
      • Female participants of childbearing potential may be enrolled in the study, if the participant:
      • has practiced adequate contraception from 1 month prior to study intervention administration until study end for this study, and
      • has a negative pregnancy test on the day of study intervention administration.
      • Specific inclusion criteria for participants in the Adults-HA Sub-cohort
      • Healthy participants as established by medical history and clinical examination before entering into the study.
      • Participants with chronic stable medical conditions with or without specific treatment, such as hypertension, hypercholesterolemia, or hypothyroidism, and who are not at increased risk for RSV-LRTD , are allowed to participate in this study if considered by the investigator as medically stable (no changes in the treatment or disease severity in the past 3 months).
      • Specific inclusion criteria for participants in the Adults-AIR Sub cohort
      • Participants should be diagnosed with at least 1 of the following medical conditions and have a stable condition (no changes in the treatment or disease severity in the past 3 months):
      • Chronic pulmonary disease resulting in activity restricting symptoms or use of long-term medication
      • Chronic cardiovascular disease
      • Diabetes mellitus: types 1 and 2
      • Other diseases at increased risk for RSV-LRTD disease
      • Chronic kidney disease
      • Chronic liver disease 2. Specific inclusion criteria for Cohort 2 (OA-RSV Group)
      • A male or female participant ≥60 YOA at the time of the study intervention administration.
      • Participants with chronic stable medical conditions with or without specific treatment, such as diabetes, hypertension or cardiac disease are allowed to participate in this study if considered by the investigator as medically stable (no changes in the treatment or disease severity in the past 3 months).
      • Participants living in the general community or in an assisted-living facility that provides minimal assistance, such that the participant is primarily responsible for self-care and activities of daily living.
      Exclusion Criteria
      • Medical conditions
      • Any confirmed or suspected immunosuppressive or immunodeficient condition resulting from disease or immunosuppressive/cytotoxic therapy, based on medical history and physical examination (no laboratory testing required).
      • History of any reaction or hypersensitivity likely to be exacerbated by any component of the study intervention.
      • Hypersensitivity to latex.
      • Unstable chronic illness.
      • Any history of dementia or any medical condition that moderately or severely impairs cognition.
      • Recurrent or uncontrolled neurological disorders or seizures. Participants with medically controlled active or chronic neurological diseases can be enrolled in the study as per investigator assessment, provided that their condition will allow them to comply with the requirements of the protocol. Study participants may decide to assign a caregiver to help them complete the study procedures.
      • Significant underlying illness that in the opinion of the investigator would be expected to prevent completion of the study.
      • Any medical condition that in the judgment of the investigator would make intramuscular injection unsafe.
      • Prior/Concomitant therapy
      • Use of any investigational or non-registered product (drug, vaccine, or medical device) other than the study intervention during the period beginning 30 days before the dose of study intervention (Day -29 to Day 1), or planned use during the study period (up to Visit 4, Month 12).
      • Planned or actual administration of a vaccine not foreseen by the study protocol in the period starting 30 days before and ending 30 days after the dose of study intervention administration, with the exception of inactivated and subunit influenza vaccines or COVID-19 vaccines (fully licensed or with EUA) which can be administered up to 14 days before or from 14 days after the study intervention administration.
      • Note: In case an emergency mass vaccination for an unforeseen public health threat is recommended and/or organized by the public health authorities, outside the routine immunization program, the time period described above can be reduced if necessary for that vaccine provided it is used according to the local governmental recommendations and that the Sponsor is notified accordingly.
      • Previous vaccination with an RSV vaccine, including investigational RSV vaccines.
      • Chronic administration of immune-modifying drugs (defined as more than 14 consecutive days in total) and/or administration of long-acting immune modifying treatments or planned administration 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 ≥20 mg/day, or equivalent. Inhaled and topical 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.
      • Prior/Concurrent clinical study experience
      • • 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 vaccine/product (drug or invasive medical device).
      • Other exclusions Other exclusions for all participants
      • 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.
      • Bedridden participants.
      • Planned move during the study period that will prohibit participating in the study until study end.
      • Participation of any study personnel or their immediate dependents, family, or household members.
      • Other exclusions for Cohort 1
      • Pregnant or lactating female.
      • Female planning to become pregnant or planning to discontinue contraceptive precautions.

      Contacts and Locations

      Sponsors and Collaborators GlaxoSmithKline
      Locations
      • GSK Investigational Site | Daphne, Alabama, United States, 36526
      • GSK Investigational Site | San Diego, California, United States, 92120
      • GSK Investigational Site | Waterbury, Connecticut, United States, 06708
      • GSK Investigational Site | Fort Myers, Florida, United States, 33912
      • GSK Investigational Site | Immokalee, Florida, United States, 34142
      • GSK Investigational Site | Mishawaka, Indiana, United States, 46544
      • GSK Investigational Site | Wichita, Kansas, United States, 67207
      • GSK Investigational Site | Lexington, Kentucky, United States, 40509
      • GSK Investigational Site | New Orleans, Louisiana, United States, 70119
      • GSK Investigational Site | Minneapolis, Minnesota, United States, 55402
      • GSK Investigational Site | Rochester, New York, United States, 14609
      • GSK Investigational Site | Raleigh, North Carolina, United States, 27612
      • GSK Investigational Site | Wilmington, North Carolina, United States, 28401
      • GSK Investigational Site | Columbia, South Carolina, United States, 21045
      • GSK Investigational Site | Knoxville, Tennessee, United States, 37909
      • GSK Investigational Site | Dallas, Texas, United States, 75224
      • GSK Investigational Site | Seattle, Washington, United States, 98105
      • GSK Investigational Site | Wenatchee, Washington, United States, 98801
      • GSK Investigational Site | Caba, Buenos Aires, Argentina, C1426BOF
      • GSK Investigational Site | Buenos Aires, Argentina, C1425AGC
      • GSK Investigational Site | Ciudad Autónoma de Buenos Aires, Argentina, C1426ABP
      • GSK Investigational Site | Ciudad de Buenos Aires, Argentina, C1425AZE
      • GSK Investigational Site | New Westminster, British Columbia, Canada, V3L 3W4
      • GSK Investigational Site | Victoria, British Columbia, Canada, V8R 6R3
      • GSK Investigational Site | Truro, Nova Scotia, Canada, B2N 1L2
      • GSK Investigational Site | London, Ontario, Canada, N5W 6A2
      • GSK Investigational Site | Sherbrooke, Quebec, Canada, J1J 2G2
      • GSK Investigational Site | St-Charles-Borromée, Quebec, Canada, J6E 2B4
      • GSK Investigational Site | Trois-Rivieres, Quebec, Canada, G9A 4P3
      • GSK Investigational Site | Weinheim, Baden-Wuerttemberg, Germany, 69469
      • GSK Investigational Site | Muenchen, Bayern, Germany, 80339
      • GSK Investigational Site | Wallerfing, Bayern, Germany, 94574
      • GSK Investigational Site | Wuerzburg, Bayern, Germany, 97070
      • GSK Investigational Site | Stuhr, Niedersachsen, Germany, 28816
      • GSK Investigational Site | Essen, Nordrhein-Westfalen, Germany, 45359
      • GSK Investigational Site | Mainz, Rheinland-Pfalz, Germany, 55116
      • GSK Investigational Site | Magdeburg, Sachsen-Anhalt, Germany, 39120
      • GSK Investigational Site | Berlin, Germany, 13347
      • GSK Investigational Site | Tokyo, Japan, 145-0063
      • GSK Investigational Site | Tokyo, Japan, 155-0031
      • GSK Investigational Site | Tokyo, Japan, 170-0003
      • GSK Investigational Site | Tokyo, Japan, 192-0918
      • GSK Investigational Site | Den Haag, Netherlands, 2572 GM
      • GSK Investigational Site | Groningen, Netherlands, 9713 AG
      • GSK Investigational Site | Zwijndrecht, Netherlands, 3334 SB
      • GSK Investigational Site | Elblag, Poland, 82-300
      • GSK Investigational Site | Katowice, Poland, 40-648
      • GSK Investigational Site | Krakow, Poland, 31-501
      • GSK Investigational Site | Krakow, Poland, 31-559
      • GSK Investigational Site | Piaseczno, Poland, 05-500
      • GSK Investigational Site | Wroclaw, Poland, 50-088
      • GSK Investigational Site | Pozuelo De Alarcón, Madrid, Spain, 28223
      • GSK Investigational Site | Barcelona, Spain, 08540
      • GSK Investigational Site | Barcelona, Spain, 8025
      • GSK Investigational Site | Burgos, Spain, 09006
      • GSK Investigational Site | Hospitalet de Llobregat, Spain, 08907
      • GSK Investigational Site | Madrid, Spain, 28006
      • GSK Investigational Site | Madrid, Spain, 28041
      • GSK Investigational Site | Pama de Mallorca, Spain, 07010
      • GSK Investigational Site | Vigo, Spain, 36312

      Study Documents (Full Text)

      More Information

      Additional Relevant MeSH Terms

      • Respiratory Syncytial Virus Infections
      • Respiratory Tract Diseases
      • Virus Diseases
      • Infections
      • Pneumovirus Infections
      • Paramyxoviridae Infections
      • Mononegavirales Infections
      • RNA Virus Infections