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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03814590
Recruitment Status : Recruiting
First Posted : January 24, 2019
Last Update Posted : September 18, 2019
Sponsor:
Information provided by (Responsible Party):
GlaxoSmithKline

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

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 1048 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
Estimated Primary Completion Date : November 14, 2019
Estimated Study Completion Date : November 6, 2020

Resource links provided by the National Library of Medicine


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.




Primary Outcome Measures :
  1. Number of subjects with any solicited local symptoms [ Time Frame: During a 7-day follow-up period (i.e., on the day of vaccination and 6 subsequent days) after any vaccination (across doses). ]
    Assessed solicited local symptoms include pain, redness and swelling, at the injection site. Any pain = pain neither interfering with nor preventing normal every day activities. Any redness/swelling = redness/swelling higher than (>) 20 millimeters (mm), but lower than and equal to (≤) 50 mm surface diameter.

  2. Number of subjects with any general symptom. [ Time Frame: During a 7-day follow-up period (i.e., on the day of vaccination and 6 subsequent days) after any vaccination (across doses). ]
    Assessed solicited general symptoms include fatigue, fever [defined as temperature equal to or above 38.0 degrees Celsius (°C)], headache, gastrointestinal symptoms [nausea, vomiting, diarrhoea and/or abdominal pain], arthralgia, myalgia and shivering. Any fatigue/headache/gastrointestinal symptoms/arthralgia/myalgia/shivering = general symptoms easily tolerated.

  3. Number of subjects with any unsolicited adverse events (AEs). [ Time Frame: During a 30-day follow-up period (i.e., on the day of vaccination and 29 subsequent days) after any vaccination (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.

  4. Number of subjects presenting haematological and biochemical laboratory abnormalities. [ Time Frame: At 7 days after the first vaccine dose (Day 8). ]
    Assessed haematological laboratory parameters include erythrocytes, white blood cells (WBC) and differential count, platelets count and hemoglobin level. Biochemical laboratory parameters include alanine aminotransferase (ALT), aspartate aminotransferase (AST), creatinine, blood urea nitrogen (BUN) and uric acid. Abnormalities reported when comparing Day 1 and Day 8 haematological and biochemical laboratory results are tabulated.

  5. Number of subjects presenting haematological and biochemical laboratory abnormalities. [ Time Frame: At 7 days after the second vaccine dose (Day 68). ]
    Assessed haematological laboratory parameters include erythrocytes, white blood cells (WBC) and differential count, platelets count and hemoglobin level. Biochemical laboratory parameters include alanine aminotransferase (ALT), aspartate aminotransferase (AST), creatinine, blood urea nitrogen (BUN) and uric acid. Abnormalities reported when comparing Day 61 and Day 68 haematological and biochemical laboratory results are tabulated.

  6. Number of subjects with Grade 3 non-serious AEs (solicited and unsolicited). [ Time Frame: During a 30-day follow-up period (i.e., on the day of vaccination and 29 subsequent days) after any vaccination (across doses). ]
    An adverse event is defined as any untoward medical occurrence in a patient or clinical investigation subject, temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product. Grade 3 AE = an AE which prevents normal, everyday activities.

  7. Number of subjects with serious adverse events (SAEs). [ Time Frame: From first vaccination (Day 1) up to 30 days post second vaccination (Day 91). ]
    SAEs assessed include medical occurrences that result in death, are life threatening, require hospitalization or prolongation of hospitalization or result in disability/incapacity.

  8. Number of subjects reporting any potential immune-mediated disease (pIMD). [ 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 aetiology.


Secondary Outcome Measures :
  1. 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 - pre-Dose 2) and 30 days post-Dose 2 (Day 91). ]
    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).

  2. Anti-RSVPreF3-specific antibody concentrations. [ Time Frame: At pre-vaccination (Day 1), 30 days post-Dose 1 (Day 31), on the day of second vaccination (Day 61 - pre-Dose 2) and 30 days post-Dose 2 (Day 91). ]
    Concentrations are presented as geometric mean concentrations (GMCs), expressed in ELISA units per millilitre (EL.U/mL), calculated on subjects seropositive (subjects with anti-RSVPreF3 antibody concentrations equal to or above the assay cut-off).

  3. Frequency of RSVPreF3-specific cluster of differentiation 4+ (CD4+) T-cells expressing at least two markers. [ Time Frame: At pre-vaccination (Day 1), 30 days post-Dose 1 (Day 31), on the day of second vaccination (Day 61 - pre-Dose 2) and 30 days post-Dose 2 (Day 91). ]
    Among markers expressed are interleukin-2 (IL2), cluster of 40 ligand (CD40L), tumour necrosis factor alpha (TNF α) and interferon gamma (IFN γ), in vitro upon stimulation with RSVPreF3 peptide preparations.

  4. Number of subjects with any respiratory tract infection associated with RSV infection (RSV-RTI). [ Time Frame: From Dose 1 administration (Day 1) up to study conclusion (Month 14), during the RSV season only. ]
    Any RTI episode for which a visit for the assessment of potential RSV-RTI has been performed (with nasal/throat swab sampling) is considered for the analysis. The assessment of RSV infection is performed using Quantitative Reverse Transcription Polymerase Chain Reaction (qRT-PCR) on nasal/throat swabs separately for samples collected by the subject and those collected by an appropriately qualified person (i.e., medical or nursing) at the assessment visit.

  5. Number of subjects with serious adverse events (SAEs) [ Time Frame: From first vaccination (Day 1) up to study conclusion (Month 14). ]
    SAEs assessed include medical occurrences that result in death, are life threatening, require hospitalization or prolongation of hospitalization or result in disability/incapacity.

  6. Number of subjects reporting any potential immune-mediated disease (pIMD). [ Time Frame: From first vaccination (Day 1) up to study conclusion (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 aetiology.



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03814590


Contacts
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Contact: US GSK Clinical Trials Call Center 877-379-3718 GSKClinicalSupportHD@gsk.com
Contact: EU GSK Clinical Trials Call Center +44 (0) 20 89904466 GSKClinicalSupportHD@gsk.com

Locations
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United States, Florida
GSK Investigational Site Recruiting
Jacksonville, Florida, United States, 32216
Contact: US GSK Clinical Trials Call Center    877-379-3718    GSKClinicalSupportHD@gsk.com   
Contact: EU GSK Clinical Trials Call Centre    +44 (0) 20 8990 4466    GSKClinicalSupportHD@gsk.com   
Principal Investigator: Jeff A. Jacqmein         
GSK Investigational Site Recruiting
South Miami, Florida, United States, 33143
Contact: US GSK Clinical Trials Call Center    877-379-3718    GSKClinicalSupportHD@gsk.com   
Contact: EU GSK Clinical Trials Call Centre    +44 (0) 20 8990 4466    GSKClinicalSupportHD@gsk.com   
Principal Investigator: Thomas M. Wade         
United States, Georgia
GSK Investigational Site Recruiting
Stockbridge, Georgia, United States, 30281
Contact: US GSK Clinical Trials Call Center    877-379-3718    GSKClinicalSupportHD@gsk.com   
Contact: EU GSK Clinical Trials Call Centre    +44 (0) 20 8990 4466    GSKClinicalSupportHD@gsk.com   
Principal Investigator: Nathan Segall         
United States, Kansas
GSK Investigational Site Recruiting
Lenexa, Kansas, United States, 66219
Contact: US GSK Clinical Trials Call Center    877-379-3718    GSKClinicalSupportHD@gsk.com   
Contact: EU GSK Clinical Trials Call Centre    +44 (0) 20 8990 4466    GSKClinicalSupportHD@gsk.com   
Principal Investigator: Carlos A Fierro         
GSK Investigational Site Recruiting
Wichita, Kansas, United States, 67207
Contact: US GSK Clinical Trials Call Center    877-379-3718    GSKClinicalSupportHD@gsk.com   
Contact: EU GSK Clinical Trials Call Centre    +44 (0) 20 8990 4466    GSKClinicalSupportHD@gsk.com   
Principal Investigator: Terry Lee Poling         
United States, Maryland
GSK Investigational Site Recruiting
Elkridge, Maryland, United States, 21075
Contact: US GSK Clinical Trials Call Center    877-379-3718    GSKClinicalSupportHD@gsk.com   
Contact: EU GSK Clinical Trials Call Centre    +44 (0) 20 8990 4466    GSKClinicalSupportHD@gsk.com   
Principal Investigator: Steven A Geller         
United States, Missouri
GSK Investigational Site Recruiting
Kansas City, Missouri, United States, 64114
Contact: US GSK Clinical Trials Call Center    877-379-3718    GSKClinicalSupportHD@gsk.com   
Contact: EU GSK Clinical Trials Call Centre    +44 (0) 20 8990 4466    GSKClinicalSupportHD@gsk.com   
Principal Investigator: Victor Vidals         
United States, Nebraska
GSK Investigational Site Recruiting
Omaha, Nebraska, United States, 68134
Contact: US GSK Clinical Trials Call Center    877-379-3718    GSKClinicalSupportHD@gsk.com   
Contact: EU GSK Clinical Trials Call Centre    +44 (0) 20 8990 4466    GSKClinicalSupportHD@gsk.com   
Principal Investigator: Brandon James Essink         
United States, New York
GSK Investigational Site Recruiting
Rochester, New York, United States, 14609
Contact: US GSK Clinical Trials Call Center    877-379-3718    GSKClinicalSupportHD@gsk.com   
Contact: EU GSK Clinical Trials Call Centre    +44 (0) 20 8990 4466    GSKClinicalSupportHD@gsk.com   
Principal Investigator: Matthew G Davis         
United States, North Carolina
GSK Investigational Site Recruiting
Hickory, North Carolina, United States, 28602
Contact: US GSK Clinical Trials Call Center    877-379-3718    GSKClinicalSupportHD@gsk.com   
Contact: EU GSK Clinical Trials Call Centre    +44 (0) 20 8990 4466    GSKClinicalSupportHD@gsk.com   
Principal Investigator: John K Earl         
GSK Investigational Site Recruiting
Wilmington, North Carolina, United States, 28401
Contact: US GSK Clinical Trials Call Center    877-379-3718    GSKClinicalSupportHD@gsk.com   
Contact: EU GSK Clinical Trials Call Centre    +44 (0) 20 8990 4466    GSKClinicalSupportHD@gsk.com   
Principal Investigator: Kevin Cannon         
United States, Ohio
GSK Investigational Site Recruiting
Cleveland, Ohio, United States, 44122
Contact: US GSK Clinical Trials Call Center    877-379-3718    GSKClinicalSupportHD@gsk.com   
Contact: EU GSK Clinical Trials Call Centre    +44 (0) 20 8990 4466    GSKClinicalSupportHD@gsk.com   
Principal Investigator: Mary Beth Manning         
United States, Oregon
GSK Investigational Site Recruiting
Medford, Oregon, United States, 97504
Contact: US GSK Clinical Trials Call Center    877-379-3718    GSKClinicalSupportHD@gsk.com   
Contact: EU GSK Clinical Trials Call Centre    +44 (0) 20 8990 4466    GSKClinicalSupportHD@gsk.com   
Principal Investigator: Edward M. Kerwin         
United States, South Carolina
GSK Investigational Site Recruiting
Mount Pleasant, South Carolina, United States, 29464
Contact: US GSK Clinical Trials Call Center    877-379-3718    GSKClinicalSupportHD@gsk.com   
Contact: EU GSK Clinical Trials Call Centre    +44 (0) 20 8990 4466    GSKClinicalSupportHD@gsk.com   
Principal Investigator: Richard Ernest Mills         
GSK Investigational Site Recruiting
Spartanburg, South Carolina, United States, 29303
Contact: US GSK Clinical Trials Call Center    877-379-3718    GSKClinicalSupportHD@gsk.com   
Contact: EU GSK Clinical Trials Call Centre    +44 (0) 20 8990 4466    GSKClinicalSupportHD@gsk.com   
Principal Investigator: Charles M. Fogarty         
United States, Texas
GSK Investigational Site Recruiting
Fort Worth, Texas, United States, 76135
Contact: US GSK Clinical Trials Call Center    877-379-3718    GSKClinicalSupportHD@gsk.com   
Contact: EU GSK Clinical Trials Call Centre    +44 (0) 20 8990 4466    GSKClinicalSupportHD@gsk.com   
Principal Investigator: William M Seger         
GSK Investigational Site Recruiting
Houston, Texas, United States, 77081
Contact: US GSK Clinical Trials Call Center    877-379-3718    GSKClinicalSupportHD@gsk.com   
Contact: EU GSK Clinical Trials Call Centre    +44 (0) 20 8990 4466    GSKClinicalSupportHD@gsk.com   
Principal Investigator: Vicki Miller         
GSK Investigational Site Recruiting
San Antonio, Texas, United States, 78229
Contact: US GSK Clinical Trials Call Center    877-379-3718    GSKClinicalSupportHD@gsk.com   
Contact: EU GSK Clinical Trials Call Centre    +44 (0) 20 8990 4466    GSKClinicalSupportHD@gsk.com   
Principal Investigator: Charles P Andrews         
Belgium
GSK Investigational Site Recruiting
Gent, Belgium, 9000
Contact: US GSK Clinical Trials Call Center    877-379-3718    GSKClinicalSupportHD@gsk.com   
Contact: EU GSK Clinical Trials Call Centre    +44 (0) 20 8990 4466    GSKClinicalSupportHD@gsk.com   
Principal Investigator: Isabel Leroux-Roels         
GSK Investigational Site Recruiting
Leuven, Belgium, 3000
Contact: US GSK Clinical Trials Call Center    877-379-3718    GSKClinicalSupportHD@gsk.com   
Contact: EU GSK Clinical Trials Call Centre    +44 (0) 20 8990 4466    GSKClinicalSupportHD@gsk.com   
Principal Investigator: Corinne Vandermeulen         
GSK Investigational Site Recruiting
Wilrijk, Belgium, 2610
Contact: US GSK Clinical Trials Call Center    877-379-3718    GSKClinicalSupportHD@gsk.com   
Contact: EU GSK Clinical Trials Call Centre    +44 (0) 20 8990 4466    GSKClinicalSupportHD@gsk.com   
Principal Investigator: Pierre A Van Damme         
Sponsors and Collaborators
GlaxoSmithKline
Investigators
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Study Director: GSK Clinical Trials GlaxoSmithKline

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Responsible Party: GlaxoSmithKline
ClinicalTrials.gov Identifier: NCT03814590     History of Changes
Other Study ID Numbers: 208851
2018-000849-38 ( EudraCT Number )
First Posted: January 24, 2019    Key Record Dates
Last Update Posted: September 18, 2019
Last Verified: September 2019
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 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: http://clinicalstudydatarequest.com

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