A Study to Assess the Safety, Reactogenicity and Immune Response of GlaxoSmithKline (GSK) Biologicals' Investigational Respiratory Syncytial Virus (RSV) Vaccine (GSK3844766A) in Older Adults

• ClinicalTrials.gov Identifier: NCT03814590
• Recruitment Status: Completed
• First Posted: January 24, 2019
• Results First Posted: March 23, 2022
• Last Update Posted: August 5, 2022
• Sponsor: GlaxoSmithKline
• Information provided by (Responsible Party): GlaxoSmithKline

Study Description

Brief Summary:

The purpose of this study is to assess the safety, reactogenicity and immune responses of two doses of the investigational RSV vaccines (with different formulations), when administered intramuscularly (IM) according to a 0, 2 month schedule, in older adults aged 60 to 80 years.

As the investigational vaccines have not yet been tested in humans before, the study will first assess the safety, reactogenicity and immune responses in young adults aged 18 to 40 years. The study will thus be conducted in 2 parts (Part A and Part B).

Condition or disease	Intervention/treatment	Phase
Respiratory Syncytial Virus Infections	Biological: RSV Vaccine (GSK3844766A) unadjuvanted low dose; Biological: RSV Vaccine (GSK3844766A) low dose adjuvanted with AS01E; Biological: RSV Vaccine (GSK3844766A) low dose adjuvanted with AS01B; Biological: RSV Vaccine (GSK3844766A) unadjuvanted medium dose; Biological: RSV Vaccine (GSK3844766A) medium dose adjuvanted with AS01E; Biological: RSV Vaccine (GSK3844766A) medium dose adjuvanted with AS01B; Biological: RSV Vaccine (GSK3844766A) unadjuvanted high dose; Biological: RSV Vaccine (GSK3844766A) high dose adjuvanted with AS01E; Biological: RSV Vaccine (GSK3844766A) high dose adjuvanted with AS01B; Drug: Placebo (Saline solution)	Phase 1; Phase 2

Study Design

• Study Type: Interventional (Clinical Trial)
• Actual Enrollment: 1053 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: Triple (Participant, Investigator, Outcomes Assessor)
• Primary Purpose: Prevention
• Official Title: Phase I/II, Observer-blind, Safety, Reactogenicity and Immunogenicity Study of GSK Biologicals' Respiratory Syncytial Virus (RSV) Vaccine GSK3844766A in Subjects Aged 18-40 or 60-80 Years
• Actual Study Start Date: January 21, 2019
• Actual Primary Completion Date: December 12, 2019
• Actual Study Completion Date: November 30, 2020

Arms and Interventions

Arm	Intervention/treatment
Experimental: Group Low Dose_PLAIN_A; Subjects in Part A, aged 18-40 years, receiving 2 doses of RSV Vaccine (GSK3844766A) unadjuvanted low dose on a 0, 2 Months schedule, by IM injection into the deltoid region of the arm.	Biological: RSV Vaccine (GSK3844766A) unadjuvanted low dose; Two doses administered intramuscularly at Days 1 and 61 in the deltoid region of the arm
Experimental: Group Medium Dose_PLAIN_A; Subjects in Part A aged 18-40 years, receiving 2 doses of RSV Vaccine (GSK3844766A) unadjuvanted medium dose, on a 0, 2 Months schedule, by IM injection into the deltoid region of the arm.	Biological: RSV Vaccine (GSK3844766A) unadjuvanted medium dose; Two doses administered intramuscularly at Days 1 and 61 in the deltoid region of the arm.
Experimental: Group High Dose_PLAIN_A; Subjects in Part A aged 18-40 years, receiving 2 doses of RSV Vaccine (GSK3844766A) unadjuvanted high dose, on a 0, 2 Months schedule, by IM injection into the deltoid region of the arm.	Biological: RSV Vaccine (GSK3844766A) unadjuvanted high dose; Two doses administered intramuscularly at Days 1 and 61 in the deltoid region of the arm.
Placebo Comparator: Group Placebo_A; Subjects in Part A aged 18-40 years, receiving 2 doses of placebo (saline solution) control, on a 0, 2 Months schedule, by IM injection into the deltoid region of the arm.	Drug: Placebo (Saline solution); Two doses administered intramuscularly at Days 1 and 61 in the deltoid region of the arm.
Experimental: Group Low Dose_PLAIN_B; Subjects in Part B aged 60-80 years, receiving 2 doses of RSV Vaccine (GSK3844766A) unadjuvanted low dose, on a 0, 2 Months schedule, by IM injection into the deltoid region of the arm.	Biological: RSV Vaccine (GSK3844766A) unadjuvanted low dose; Two doses administered intramuscularly at Days 1 and 61 in the deltoid region of the arm
Experimental: Group Low Dose_AS01E_B; Subjects in Part B aged 60-80 years, receiving 2 doses of the RSV Vaccine (GSK3844766A) low dose adjuvanted with AS01E, on a 0, 2 Months schedule, by IM injection into the deltoid region of the arm.	Biological: RSV Vaccine (GSK3844766A) low dose adjuvanted with AS01E; Two doses administered intramuscularly at Days 1 and 61 in the deltoid region of the arm.
Experimental: Group Low Dose_AS01B_B; Subjects in Part B aged 60-80 years, receiving 2 doses of the RSV Vaccine (GSK3844766A) low dose adjuvanted with AS01B, on a 0, 2 Months schedule, by IM injection into the deltoid region of the arm.	Biological: RSV Vaccine (GSK3844766A) low dose adjuvanted with AS01B; Two doses administered intramuscularly at Days 1 and 61 in the deltoid region of the arm
Experimental: Group Medium Dose_PLAIN_B; Subjects in Part B aged 60-80 years, receiving 2 doses of RSV Vaccine (GSK3844766A) unadjuvanted medium dose, on a 0, 2 Months schedule, by IM injection into the deltoid region of the arm.	Biological: RSV Vaccine (GSK3844766A) unadjuvanted medium dose; Two doses administered intramuscularly at Days 1 and 61 in the deltoid region of the arm.
Experimental: Group Medium Dose_AS01E_B; Subjects in Part B aged 60-80 years, receiving 2 doses of the RSV Vaccine (GSK3844766A) medium dose adjuvanted with AS01E, on a 0, 2 Months schedule, by IM injection into the deltoid region of the arm.	Biological: RSV Vaccine (GSK3844766A) medium dose adjuvanted with AS01E; Two doses administered intramuscularly at Days 1 and 61 in the deltoid region of the arm.
Experimental: Group Medium Dose_AS01B_B; Subjects in Part B aged 60-80 years, receiving 2 doses of the RSV Vaccine (GSK3844766A) medium dose adjuvanted with AS01B, on a 0, 2 Months schedule, by IM injection into the deltoid region of the arm.	Biological: RSV Vaccine (GSK3844766A) medium dose adjuvanted with AS01B; Two doses administered intramuscularly at Days 1 and 61 in the deltoid region of the arm.
Experimental: Group High Dose_PLAIN_B; Subjects in Part B aged 60-80 years, receiving 2 doses of RSV Vaccine (GSK3844766A) unadjuvanted high dose, on a 0, 2 Months schedule, by IM injection into the deltoid region of the arm.	Biological: RSV Vaccine (GSK3844766A) unadjuvanted high dose; Two doses administered intramuscularly at Days 1 and 61 in the deltoid region of the arm.
Experimental: Group High Dose_AS01E_B; Subjects in Part B aged 60-80 years, receiving 2 doses of the RSV Vaccine (GSK3844766A) high dose adjuvanted with AS01E, on a 0, 2 Months schedule, by IM injection into the deltoid region of the arm.	Biological: RSV Vaccine (GSK3844766A) high dose adjuvanted with AS01E; Two doses administered intramuscularly at Days 1 and 61 in the deltoid region of the arm
Experimental: Group High Dose_AS01B_B; Subjects in Part B aged 60-80 years, receiving 2 doses of the RSV Vaccine (GSK3844766A) high dose adjuvanted with AS01B, on a 0, 2 Months schedule, by IM injection into the deltoid region of the arm.	Biological: RSV Vaccine (GSK3844766A) high dose adjuvanted with AS01B; Two doses administered intramuscularly at Days 1 and 61 in the deltoid region of the arm.
Placebo Comparator: Group Placebo_B; Subjects in Part B aged 60-80 years, receiving 2 doses of placebo (saline solution) control, on a 0, 2 Months schedule, by IM injection into the deltoid region of the arm.	Drug: Placebo (Saline solution); Two doses administered intramuscularly at Days 1 and 61 in the deltoid region of the arm.

Outcome Measures

Primary Outcome Measures :

1. Number of Subjects With Any Solicited Local Symptoms After First Vaccination Dose [ Time Frame: During a 7-day follow-up period after first vaccination dose (i.e., on the day of vaccination [at Day 1] and 6 subsequent days) ]
   Assessed solicited local AEs at injection site are pain, erythema and swelling. Any erythema/swelling was scored as injection site erythema/swelling with a diameter larger than (>) 20 millimeters (mm)
2. Number of Subjects With Any Solicited Local Symptoms After Second Vaccination Dose [ Time Frame: During a 7-day follow-up period after second vaccination dose (i.e., on the day of vaccination [at Day 61] and 6 subsequent days) ]
   Assessed solicited local AEs at injection site are pain, erythema and swelling. Any erythema/swelling was scored as injection site erythema/swelling with a diameter larger than (>) 20 millimeters (mm)
3. Number of Subjects With Any Solicited General Symptom After First Vaccination Dose [ Time Frame: During a 7-day follow-up period after the first vaccination dose (i.e., on the day of vaccination [at Day 1] and 6 subsequent days) ]
   Assessed solicited general symptoms include arthralgia, fatigue, fever [defined as temperature equal to or above 38.0 degrees Celsius (°C)], gastrointestinal symptoms [nausea, vomiting, diarrhea and/or abdominal pain], headache, myalgia and shivering.
4. Number of Subjects With Any Solicited General Symptom After Second Vaccination Dose [ Time Frame: During a 7-day follow-up period after the second vaccination dose (i.e., on the day of vaccination [at Day 61] and 6 subsequent days) ]
   Assessed solicited general symptoms include arthralgia, fatigue, fever [defined as temperature equal to or above 38.0 degrees Celsius (°C)], gastrointestinal symptoms [nausea, vomiting, diarrhea and/or abdominal pain], headache, myalgia and shivering.
5. Number of Subjects With Any Unsolicited Adverse Events (AEs) After Any Vaccination Dose [ Time Frame: During a 30-day follow-up period (i.e., on the day of vaccination and 29 subsequent days) after any vaccination dose (across doses) ]
   An unsolicited AE covers any untoward medical occurrence in a clinical investigation subject temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product and reported in addition to those solicited during the clinical study and/or any solicited symptom with onset outside the specified period of follow-up for solicited symptoms. Any is defined as the occurrence of any unsolicited AE regardless of intensity grade or relation to vaccination.
6. Number of Subjects Presenting Change From Baseline in Hematology and Biochemistry With Respect of Normal Laboratory Ranges, After First Vaccine Dose (Part A Groups) [ Time Frame: At baseline and at 7 days after the first vaccine dose (Day 8) ]
   Assessed hematological laboratory parameters include basophils, eosinophils, erythrocytes, hemoglobin, lymphocytes, monocytes, neutrophils, platelets, white blood cells. Biochemical laboratory parameters include alanine aminotransferase [ALT], aspartate aminotransferase [AST], creatinine, urea nitrogen and uric acid. Categories reported when comparing Day 1 (pre-vaccination dose 1=baseline) and Day 8 hematological and biochemical laboratory results are defined as follows: <parameter>-<range at baseline>-<range at timing> (e.g. ALT-Within-Within). Ranges level being classified as unknown, below, within or above the normal ranges.
7. Number of Subjects Presenting Change From Baseline in Hematology and Biochemistry With Respect of Normal Laboratory Ranges, After First Vaccine Dose (Part B Groups) [ Time Frame: At baseline and at 7 days after the first vaccine dose (Day 8) ]
   Assessed hematological laboratory parameters include basophils, eosinophils, erythrocytes, hemoglobin, lymphocytes, monocytes, neutrophils, platelets, white blood cells. Biochemical laboratory parameters include alanine aminotransferase [ALT], aspartate aminotransferase [AST], creatinine, urea nitrogen and uric acid. Categories reported when comparing Day 1 (pre-vaccination dose 1=baseline) and Day 8 hematological and biochemical laboratory results are defined as follows: <parameter>-<range at baseline>-<range at timing> (e.g. ALT-Within-Within). Ranges level being classified as unknown, below, within or above the normal ranges.
8. Number of Subjects Presenting Change From Baseline in Hematology and Biochemistry With Respect of Normal Laboratory Ranges, After Second Vaccine Dose (Part A Groups) [ Time Frame: At baseline and at 7 days after the second vaccine dose (Day 68) ]
   Assessed hematological laboratory parameters include basophils, eosinophils, erythrocytes, hemoglobin, lymphocytes, monocytes, neutrophils, platelets, white blood cells. Biochemical laboratory parameters include alanine aminotransferase [ALT], aspartate aminotransferase [AST], creatinine, urea nitrogen and uric acid. Categories reported when comparing Day 61 (pre-vaccination dose 2=baseline) and Day 68 hematological and biochemical laboratory results are defined as follows: <parameter>-<range at baseline>-<range at timing> (e.g. ALT-Within-Within). Ranges level being classified as unknown, below, within or above the normal ranges.
9. Number of Subjects Presenting Change From Baseline in Hematology and Biochemistry With Respect of Normal Laboratory Ranges, After Second Vaccine Dose (Part B Groups) [ Time Frame: At baseline and at 7 days after the second vaccine dose (Day 68) ]
   Assessed hematological laboratory parameters include basophils, eosinophils, erythrocytes, hemoglobin, lymphocytes, monocytes, neutrophils, platelets, white blood cells. Biochemical laboratory parameters include alanine aminotransferase [ALT], aspartate aminotransferase [AST], creatinine, urea nitrogen and uric acid. Categories reported when comparing Day 61 (pre-vaccination dose 2=baseline) and Day 68 hematological and biochemical laboratory results are defined as follows: <parameter>-<range at baseline>-<range at timing> (e.g. ALT-Within-Within). Ranges level being classified as unknown, below, within or above the normal ranges.
10. Number of Subjects With Any Grade 3 Non-serious AEs (Solicited and Unsolicited) After First Dose of Vaccination [ Time Frame: During a 30-day follow-up period (i.e., on the day of vaccination at Day 1, and 29 subsequent days) after first dose of vaccination ]
    A Grade 3 AE is any AE assessed as severe, i.e. which prevents normal, everyday activities. In adults, such an AE would, for example, prevent attendance at work and would necessitate the administration of corrective therapy.
11. Number of Subjects With Any Grade 3 Non-serious AEs (Solicited and Unsolicited) After Second Dose of Vaccination [ Time Frame: During a 30-day follow-up period (i.e., on the day of vaccination at Day 61, and 29 subsequent days) after second dose of vaccination ]
    A Grade 3 AE is any AE assessed as severe, i.e. which prevents normal, everyday activities. In adults, such an AE would, for example, prevent attendance at work and would necessitate the administration of corrective therapy.
12. Number of Subjects With Any Serious Adverse Events (SAEs) up to 30 Days After the Second Vaccination [ Time Frame: From first vaccination (Day 1) up to 30 days post second vaccination (Day 91) ]
    A SAE is any untoward medical occurrence that results in death, is life-threatening, requires hospitalization or prolongation of existing hospitalization or results in disability/incapacity.
13. Number of Subjects With Any Potential Immune-mediated Diseases (pIMDs) up to 30 Days After the Second Vaccination (Part B Groups) [ Time Frame: From first vaccination (Day 1) up to 30 days post second vaccination (Day 91) ]
    pIMDs are a subset of AEs that include autoimmune diseases and other inflammatory and/or neurologic disorders of interest which may or may not have an autoimmune etiology.

Secondary Outcome Measures :

1. Number of Subjects With Any SAEs, up the End of Follow-up Period (Month 14) - Part B Groups [ Time Frame: From Day 1 up to the end of follow-up period (Month 14) ]
   A SAE is any untoward medical occurrence that results in death, is life-threatening, requires hospitalization or prolongation of existing hospitalization or results in disability/incapacity or is a congenital anomaly/birth defect in the offspring of a study subject.
2. Number of Subjects Reporting pIMDs up to the End of Follow-up Period (Month 14) - Part B Groups [ Time Frame: From Day 1 up to the end of follow-up period (Month 14) ]
   pIMDs are a subset of AEs that include autoimmune diseases and other inflammatory and/or neurologic disorders of interest which may or may not have an autoimmune etiology.
3. Number of Subjects With at Least One RSV-confirmed Respiratory Tract Infection (RTI) Episode Post-vaccination Reported During RTI Surveillance - Part B Groups [ Time Frame: During the RSV season (from October 2019 to March 2020) ]
   The number of subjects with at least one RTI case was provided by group. Reported categories are RSV+ (= RTI episode tested as RSV positive by quantitative reverse transcription polymerase chain reaction (qRT-PCR) on nasal/throat swab) and RSV- (= RTI episode tested as RSV negative by qRT-PCR on nasal/throat swab).
4. Humoral Immune Response With Respect to Components of the Investigational Vaccine in Terms of Neutralizing Antibody Titers Against RSV-serotype A [ Time Frame: At pre-vaccination (Day 1), 30 days post-Dose 1 (Day 31), on the day of second vaccination (Day 61) and 30 days post-Dose 2 (Day 91) ]
   Serological assays for the determination of functional antibodies against RSV-A were performed by neutralization assay. Anti RSV-A neutralizing antibody titers are given as geometric mean titers (GMTs) and expressed as Estimated Dose: serum dilution giving a 60% reduction of the signal compared to a control without serum (ED60).
5. Humoral Immune Response With Respect to Components of the Investigational Vaccine in Terms of RSVPreF3-specific Immunoglobulin G (IgG) Antibody Concentrations [ Time Frame: At pre-vaccination (Day 1), 30 days post-Dose 1 (Day 31), on the day of second vaccination (Day 61) and 30 days post-Dose 2 (Day 91) ]
   The detection and the quantification of total IgG antibodies directed against RSVPreF3 in human serum samples were based on an indirect enzyme-linked immunosorbent assay (ELISA). Anti RSVPreF3 antibody concentration is given in geometric mean concentration (GMC) and is expressed in ELISA Laboratory Units per milliliter (ELU/mL).
6. Descriptive Statistics of the Frequency of RSVPreF3 Specific Cluster of Differentiation 4+ (CD4+) T Cells Expressing at Least 2 Markers [ Time Frame: At pre-vaccination (Day 1), 30 days post-Dose 1 (Day 31), on the day of second vaccination (Day 61) and 30 days post-Dose 2 (Day 91) ]
   Among markers expressed were interleukin-2 (IL2), cluster of 40 ligand (CD40L), tumor necrosis factor alpha (TNF α) and interferon gamma (IFN γ), in vitro upon stimulation with RSVPreF3 peptide preparations. Reported statistics at each time point during which blood sample were collected for cell-mediated immunity, are geometric mean and inter-quartile range.

Eligibility Criteria

• Ages Eligible for Study: 18 Years to 80 Years (Adult, Older Adult)
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: Yes

Criteria

Inclusion Criteria:

For all subjects:

• Subjects who, in the opinion of the investigator, can and will comply with the requirements of the protocol.
• Written informed consent obtained from the subject prior to performing any study specific procedure.

For Part A:

• A male or female between, and including, 18 and 40 years of age at the time of the first vaccination.

For Part B:

• A male or female between, and including, 60 and 80 years of age at the time of the first vaccination.
• Subjects with residence status allowing free mixing with general community or in an assisted-living facility that provides minimal assistance, such that the subject is primarily responsible for self-care and activities of daily living.

Exclusion Criteria:

For all subjects:

• Use of any investigational or non-registered product other than the study vaccine during the period starting 30 days before the first dose of study vaccine, or planned use during the study period.
• Any medical condition that in the judgment of the investigator would make IM injection unsafe.
• Chronic administration of immunosuppressants or other immune-modifying drugs during the period starting 6 months prior to the first vaccine dose. For corticosteroids, this will mean prednisone (≥ 20 mg/day, or equivalent). Inhaled and topical steroids are allowed.
• Administration of long-acting immune-modifying drugs or planned administration at any time during the study period.
• Planned administration/administration of a vaccine not foreseen by the study protocol in the period starting 30 days before the first dose and ending 30 days after the last dose of study vaccine administration, with the exception of inactivated and subunit influenza vaccines which can be administered up to 14 days before or from 30 days after each study vaccination.
• Concurrently participating in another clinical study, at any time during the study period, in which the subject has been or will be exposed to an investigational or a non-investigational vaccine/product.
• Any confirmed or suspected immunosuppressive or immunodeficient condition, based on medical history and physical examination.
• History of any reaction or hypersensitivity likely to be exacerbated by any component of the vaccine.
• Hypersensitivity to latex.
• Serious or unstable chronic illness. Patients with chronic stable conditions with or without specific treatment, such as diabetes, hypertension or cardiac disease, are allowed to participate in this study.
• Any other condition (e.g. chronic obstructive pulmonary disease or severe respiratory condition) that, in the opinion of the investigator, might interfere with the evaluations required by the study.
• History of any neurological disorders or seizures.
• Acute disease and/or fever at the time of enrolment.
• Acute or chronic, clinically significant pulmonary, cardiovascular, hepatic or renal functional abnormality, as determined by the investigator based on medical history, physical examination or laboratory screening tests.
• Hepatomegaly, right upper quadrant abdominal pain or tenderness.
• Administration of immunoglobulins and/or any blood products during the period starting 3 months before the first dose of study vaccine or planned administration during the study period.
• History of chronic alcohol consumption and/or drug abuse as deemed by the investigator to render the potential subject unable/unlikely to provide accurate safety reports.
• Significant underlying illness that in the opinion of the investigator would be expected to prevent completion of the study.
• Previous vaccination with an RSV vaccine.
• Lymphoproliferative disorder and malignancy within 5 years.
• Body mass index > 40 kg/m².
• Planned move to a location that will prohibit participating in the trial until study end.
• At screening: Hematology parameters (complete blood cell count [red blood cells, white blood cells], white blood cells differential count [lymphocytes, neutrophils and eosinophils], platelets count or hemoglobin level) and/or biochemistry parameters (creatinine, blood urea nitrogen or liver enzymes [alanine aminotransferase or aspartate aminotransferase]) outside the normal laboratory ranges, unless the laboratory abnormalities are considered not clinically significant by the investigator.

For Part A:

• Pregnant or lactating female.

• Female subjects of childbearing potential, except if the subject:

  • has practiced adequate contraception for 30 days prior to vaccination, and
  • has a negative pregnancy test on the day of vaccination, and
  • has agreed to continue adequate contraception during the entire treatment period and for 2 months after completion of the vaccination series.

For Part B:

• Known previous administration of a vaccine containing MPL, QS-21 and/or MF59 (e.g. GSK Biologicals' vaccine against human papillomavirus infection marketed as Cervarix, GSK Biologicals' Herpes Zoster vaccine marketed as Shingrix, an adjuvanted recombinant varicella zoster virus envelope gE subunit vaccine [HZ/su], or MF59 adjuvanted influenza vaccines [e.g. Fluad]).
• Planned administration of GSK Biologicals' Herpes Zoster vaccine marketed as Shingrix or an adjuvanted recombinant varicella zoster virus envelope gE subunit vaccine [HZ/su] within 180 days after the second dose of the study vaccine.
• Bedridden subjects.

Contacts and Locations

Locations

United States, Florida

GSK Investigational Site

Jacksonville, Florida, United States, 32216

GSK Investigational Site

Miami, Florida, United States, 33143

United States, Georgia

GSK Investigational Site

Stockbridge, Georgia, United States, 30281

United States, Kansas

GSK Investigational Site

Lenexa, Kansas, United States, 66219

GSK Investigational Site

Wichita, Kansas, United States, 67207

United States, Maryland

GSK Investigational Site

Elkridge, Maryland, United States, 21075

United States, Missouri

GSK Investigational Site

Kansas City, Missouri, United States, 64114

United States, Nebraska

GSK Investigational Site

Omaha, Nebraska, United States, 68134

United States, New York

GSK Investigational Site

Rochester, New York, United States, 14609

United States, North Carolina

GSK Investigational Site

Hickory, North Carolina, United States, 28602

GSK Investigational Site

Wilmington, North Carolina, United States, 28401

United States, Ohio

GSK Investigational Site

Cleveland, Ohio, United States, 44122

United States, Oregon

GSK Investigational Site

Medford, Oregon, United States, 97504

United States, South Carolina

GSK Investigational Site

Mount Pleasant, South Carolina, United States, 29464

GSK Investigational Site

Spartanburg, South Carolina, United States, 29303

United States, Texas

GSK Investigational Site

Fort Worth, Texas, United States, 76135

GSK Investigational Site

Houston, Texas, United States, 77081

GSK Investigational Site

San Antonio, Texas, United States, 78229

Belgium

GSK Investigational Site

Gent, Belgium, 9000

GSK Investigational Site

Leuven, Belgium, 3000

GSK Investigational Site

Wilrijk, Belgium, 2610

Sponsors and Collaborators

GlaxoSmithKline

Investigators

• Study Director: GSK Clinical Trials; GlaxoSmithKline

  Study Documents (Full-Text)

Documents provided by GlaxoSmithKline:

Study Protocol  [PDF] May 13, 2020

Statistical Analysis Plan  [PDF] March 17, 2020

More Information

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

Leroux-Roels I, Davis MG, Steenackers K, Essink B, Vandermeulen C, Fogarty C, Andrews CP, Kerwin E, David MP, Fissette L, Abeele CV, Collete D, de Heusch M, Salaun B, De Schrevel N, Koch J, Verheust C, Dezutter N, Struyf F, Mesaros N, Tica J, Hulstrom V. Safety and immunogenicity of a respiratory syncytial virus prefusion F (RSVPreF3) candidate vaccine in older adults: phase I/II randomized clinical trial. J Infect Dis. 2022 Jul 29:jiac327. doi: 10.1093/infdis/jiac327. Online ahead of print.

• Responsible Party: GlaxoSmithKline
• ClinicalTrials.gov Identifier: NCT03814590
• Other Study ID Numbers: 208851; 2018-000849-38 ( EudraCT Number )
• First Posted: January 24, 2019
• Results First Posted: March 23, 2022
• Last Update Posted: August 5, 2022
• Last Verified: July 2022

Individual Participant Data (IPD) Sharing Statement:

• 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; Statistical Analysis Plan (SAP); Informed Consent Form (ICF); Clinical Study Report (CSR)
• Time Frame: IPD will be made available within 6 months of publishing the results of the primary endpoints, 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.
• URL: https://clinicalstudydatarequest.com

• Studies a U.S. FDA-regulated Drug Product: Yes
• Studies a U.S. FDA-regulated Device Product: No

Keywords provided by GlaxoSmithKline:

Respiratory syncytial virus (RSV); Vaccine; Safety; Reactogenicity; Immunogenicity

Additional relevant MeSH terms:

Respiratory Syncytial Virus Infections; Virus Diseases; Infections; Pneumovirus Infections; Paramyxoviridae Infections; Mononegavirales Infections; RNA Virus Infections; Vaccines; Immunologic Factors; Physiological Effects of Drugs