October 18, 2022
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October 21, 2022
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March 7, 2024
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October 28, 2022
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March 13, 2023 (Final data collection date for primary outcome measure)
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- RSV-A neutralization titers expressed as group geometric mean titer (GMT) ratio in healthy participants compared to OA [ Time Frame: 1 month after the RSVPreF3 OA investigational vaccine administration (Day 31) ]
- RSV-A neutralization titers expressed as group seroresponse rate (SRR) difference in healthy participants compared to OA [ Time Frame: 1 month after the RSVPreF3 OA investigational vaccine administration (Day 31) compared to baseline (Day 1) ]
- RSV-B neutralization titers expressed as group GMT ratio in healthy participants compared to OA [ Time Frame: 1 month after the RSVPreF3 OA investigational vaccine administration (Day 31) ]
- RSV-B neutralization titers expressed as group SRR difference in healthy participants compared to OA [ Time Frame: 1 month after the RSVPreF3 OA investigational vaccine administration (Day 31) compared to baseline (Day 1) ]
- RSV-A neutralization titers expressed as group GMT ratio in participants at increased risk of RSV-LRTD compared to OA [ Time Frame: 1 month after the RSVPreF3 OA investigational vaccine administration (Day 31) ]
- RSV-A neutralization titers expressed as group SRR difference in participants at increased risk of RSV-LRTD compared to OA [ Time Frame: 1 month after the RSVPreF3 OA investigational vaccine administration (Day 31) compared to baseline (Day 1) ]
- RSV-B neutralization titers expressed as group GMT ratio in participants at increased risk of RSV-LRTD compared to OA [ Time Frame: 1 month after the RSVPreF3 OA investigational vaccine administration (Day 31) ]
- RSV-B neutralization titers expressed as group SRR difference in participants at increased risk of RSV-LRTD compared to OA [ Time Frame: 1 month after the RSVPreF3 OA investigational vaccine administration (Day 31) compared to baseline (Day 1) ]
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- RSV-A neutralization antibody titers expressed as group geometric mean titer (GMT) ratio in healthy participants compared to OA [ Time Frame: 1 month after the RSVPreF3 OA investigational vaccine administration (Day 31) ]
- RSV-A neutralization antibody titers expressed as group seroresponse rate (SRR) difference in healthy participants compared to OA [ Time Frame: 1 month after the RSVPreF3 OA investigational vaccine administration (Day 31) compared to baseline (Day 1) ]
- RSV-B neutralization antibody titers expressed as group GMT ratio in healthy participants compared to OA [ Time Frame: 1 month after the RSVPreF3 OA investigational vaccine administration (Day 31) ]
- RSV-B neutralization antibody titers expressed as group SRR difference in healthy participants compared to OA [ Time Frame: 1 month after the RSVPreF3 OA investigational vaccine administration (Day 31) compared to baseline (Day 1) ]
- RSV-A neutralization antibody titers expressed as group GMT ratio in participants at increased risk of RSV-LRTD compared to OA [ Time Frame: 1 month after the RSVPreF3 OA investigational vaccine administration (Day 31) ]
- RSV-A neutralization antibody titers expressed as group SRR difference in participants at increased risk of RSV-LRTD compared to OA [ Time Frame: 1 month after the RSVPreF3 OA investigational vaccine administration (Day 31) compared to baseline (Day 1) ]
- RSV-B neutralization antibody titers expressed as group GMT ratio in participants at increased risk of RSV-LRTD compared to OA [ Time Frame: 1 month after the RSVPreF3 OA investigational vaccine administration (Day 31) ]
- RSV-B neutralization antibody titers expressed as group SRR difference in participants at increased risk of RSV-LRTD compared to OA [ Time Frame: 1 month after the RSVPreF3 OA investigational vaccine administration (Day 31) compared to baseline (Day 1) ]
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- Percentage of participants reporting each solicited administration site event (pain, redness and swelling) [ Time Frame: Within 4 days after study intervention administered on Day 1 ]
- Percentage of participants reporting each solicited systemic event (fever, headache, muscle pain, joint pain, tiredness) [ Time Frame: Within 4 days after study intervention administered at Day 1 ]
- Percentage of participants reporting unsolicited adverse events (AEs) [ Time Frame: Within 30 days after study intervention administered at 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.
- Percentage of participants reporting any serious adverse events (SAEs) [ Time Frame: After study intervention administration (Day 1) up to 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.
- Percentage of participants reporting any potential immune mediated diseases (pIMDs) [ Time Frame: After study intervention administration (Day 1) up to 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.
- Percentage of participants reporting SAEs related to study intervention administration [ Time Frame: After study intervention administration (Day 1) up to study end (Month 12) ]
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.
- Percentage of participants reporting pIMDs related to study intervention administration [ Time Frame: After study intervention administration (Day 1) up to study end (Month 12) ]
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.
- Percentage of participants reporting any fatal SAEs [ Time Frame: After study intervention administration (Day 1) up to study end (Month 12) ]
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.
- RSV-A neutralization titers expressed as GMT [ Time Frame: At pre-study intervention administration, 1 month, 6 months and at 12 months after study intervention administration ]
- RSV-B neutralization titers expressed as GMT [ Time Frame: At pre-study intervention administration, 1 month, 6 months and at 12 months after study intervention administration ]
- Frequency of RSVPreF3-specific cluster of differentiation (CD)4+ T cells expressing at least 2 activation markers [ Time Frame: At pre-study intervention administration, 1 month, 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.
- Frequency of RSVPreF3-specific CD8+ T cells expressing at least 2 activation markers [ Time Frame: At pre-study intervention administration, 1 month, 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.
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- Percentage of participants reporting each solicited administration site event (pain, redness and swelling) [ Time Frame: Within 4 days after study intervention administered on Day 1 ]
- Percentage of participants reporting each solicited systemic event (fever, headache, muscle pain, joint pain, tiredness) [ Time Frame: Within 4 days after study intervention administered at Day 1 ]
- Percentage of participants reporting unsolicited adverse events (AEs) [ Time Frame: Within 30 days after study intervention administered at 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.
- Percentage of participants reporting any serious adverse events (SAEs) [ Time Frame: After study intervention administration (Day 1) up to 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.
- Percentage of participants reporting any potential immune mediated diseases (pIMDs) [ Time Frame: After study intervention administration (Day 1) up to 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.
- Percentage of participants reporting SAEs related to study intervention administration [ Time Frame: After study intervention administration (Day 1) up to study end (Month 12) ]
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.
- Percentage of participants reporting pIMDs related to study intervention administration [ Time Frame: After study intervention administration (Day 1) up to study end (Month 12) ]
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.
- Percentage of participants reporting any fatal SAEs [ Time Frame: After study intervention administration (Day 1) up to study end (Month 12) ]
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.
- RSV-A neutralization antibody titers expressed as GMT [ Time Frame: At pre-study intervention administration, 1 month, 6 months and at 12 months after study intervention administration ]
- RSV-B neutralization antibody titers expressed as GMT [ Time Frame: At pre-study intervention administration, 1 month, 6 months and at 12 months after study intervention administration ]
- Frequency of RSVPreF3-specific cluster of differentiation (CD)4+ T cells expressing at least 2 activation markers [ Time Frame: At pre-study intervention administration, 1 month, 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.
- Frequency of RSVPreF3-specific CD8+ T cells expressing at least 2 activation markers [ Time Frame: At pre-study intervention administration, 1 month, 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.
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Not Provided
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Not Provided
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A Study on the Immune Response and Safety of a Vaccine Against Respiratory Syncytial Virus Given to 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 and Above
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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
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The aim of this study is to demonstrate the non-inferiority (NI) of the immune response and evaluate safety of RSVPreF3 older adults (OA) investigational vaccine in adults 50-59 years of age (YOA), including those who are at increased risk (AIR) of respiratory syncytial virus (RSV)-lower respiratory tract disease (LRTD), versus adults ≥60 YOA
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Not Provided
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Interventional
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Phase 3
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Allocation: Randomized Intervention Model: Parallel Assignment Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor) Masking Description: Observer-blind for Cohort 1 (Day1-Day 31) and single-blind afterwards and open-label for Cohort 2 Primary Purpose: Prevention
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Respiratory Syncytial Virus Infections
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- Experimental: Adults HA-RSV Group
Healthy adults (HA) 50-59 YOA, who receive 1 dose of RSVPreF3 OA investigational vaccine at Day 1.
Intervention: Biological: RSVPreF3 OA investigational vaccine
- Placebo Comparator: Adults HA-Placebo Group
HA 50-59 YOA, who receive 1 dose of placebo at Day 1.
Intervention: Drug: Placebo
- Experimental: Adults AIR-RSV Group
Adults at increased risk (AIR) 50-59 YOA, who receive 1 dose of RSVPreF3 OA investigational vaccine at Day 1.
Intervention: Biological: RSVPreF3 OA investigational vaccine
- Placebo Comparator: Adults AIR-Placebo Group
Adults AIR 50-59 YOA, who receive 1 dose of placebo at Day 1.
Intervention: Drug: Placebo
- Experimental: OA-RSV Group
Older adults (OA) ≥60 YOA, who receive 1 dose of RSVPreF3 OA investigational vaccine at Day 1.
Intervention: Biological: RSVPreF3 OA investigational vaccine
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Not Provided
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Active, not recruiting
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1576
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1520
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April 3, 2024
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March 13, 2023 (Final data collection date for primary outcome measure)
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Inclusion Criteria:
- Participants who, in the opinion of the investigator, can and will comply with the requirements of the protocol
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Written or witnessed informed consent obtained from the participant prior to performance of any study-specific procedure.
1. 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.
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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):
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.
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.
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Sexes Eligible for Study: |
All |
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50 Years and older (Adult, Older Adult)
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Yes
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Contact information is only displayed when the study is recruiting subjects
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Argentina, Canada, Germany, Japan, Netherlands, Poland, Spain, United States
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NCT05590403
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219238 2022-001981-36 ( EudraCT Number )
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No
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Studies a U.S. FDA-regulated Drug Product: |
Yes |
Studies a U.S. FDA-regulated Device Product: |
No |
Product Manufactured in and Exported from the U.S.: |
No |
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Plan to Share IPD: |
Yes |
Plan Description: |
IPD for this study will be made available via the Clinical Study Data Request site. |
Supporting Materials: |
Study Protocol |
Supporting Materials: |
Statistical Analysis Plan (SAP) |
Supporting Materials: |
Informed Consent Form (ICF) |
Supporting Materials: |
Clinical Study Report (CSR) |
Time Frame: |
IPD will be made available within 6 months of publishing the results of the primary endpoints, a key secondary endpoints and safety data of the study. |
Access Criteria: |
Access is provided after a research proposal is submitted and has received approval from the 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 can be granted, when justified, for up to another 12 months. |
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GlaxoSmithKline
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Same as current
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GlaxoSmithKline
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Same as current
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Not Provided
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Not Provided
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GlaxoSmithKline
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March 2024
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