ClinicalTrials.gov
ClinicalTrials.gov Menu
Trial record 1 of 26 for:    influenza and universal
Previous Study | Return to List | Next Study

A Study to Evaluate the Reactogenicity, Safety and Immunogenicity of GlaxoSmithKline (GSK) Biologicals' Investigational Supra-seasonal Universal Influenza Vaccines - Inactivated (SUIVs) (GSK3816302A) in Healthy Adults Aged 18 to 39 Years

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. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT03275389
Recruitment Status : Active, not recruiting
First Posted : September 7, 2017
Last Update Posted : March 23, 2018
Sponsor:
Information provided by (Responsible Party):
GlaxoSmithKline

Brief Summary:
The purpose of this study is to assess the reactogenicity, safety and immunogenicity of different formulations of GlaxoSmithKline (GSK) Biologicals' investigational supra-seasonal universal influenza vaccines (SUIVs) (unadjuvanted or adjuvanted) in 18 to 39 year-old healthy subjects. Subjects will be enrolled and vaccinated with one or 2 primary dose(s) followed by a booster dose one year later.

Condition or disease Intervention/treatment Phase
Influenza, Human Biological: D-SUIV Formulation 1 Biological: D-SUIV Formulation 2 Biological: D-SUIV Formulation 3 Biological: D-SUIV Formulation 4 Biological: D-SUIV Formulation 5 Biological: D-SUIV Formulation 6 Biological: D-SUIV Formulation 7 Biological: D-SUIV Formulation 8 Biological: D-SUIV Formulation 9 Biological: Placebo Biological: FLU-D-QIV Phase 1

Detailed Description:

Current seasonal influenza vaccines show good efficacy when they are well-matched with the circulating virus strains.

However, influenza viruses constantly change their surface glycoproteins that are the targets of most immune responses, allowing them to escape pre-existing immunity, a process called antigenic drift. Therefore, seasonal influenza vaccines have to be reformulated and re-administered on an annual basis. In addition, novel viruses can appear at irregular intervals and cause influenza virus pandemics that can claim millions of lives.

GSK Biologicals is now developing a new influenza vaccine that contains modified inactivated influenza viruses. The purpose of this approach is to elicit an immune response that would protect against all current and future circulating influenza strains without having to administer the vaccine each year.


Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 470 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Masking Description:

The site staff will work in an observer-blind manner during the entire study. As the vaccines appearance and preparation are different, two teams of study personnel will be set up:

  • A team of unblinded personnel (responsible for the reception, preparation and administration of the vaccines).
  • A team of blinded personnel (responsible for the clinical safety evaluation of the subjects).
Primary Purpose: Prevention
Official Title: Reactogenicity, Safety and Immunogenicity Study of GlaxoSmithKline (GSK) Biologicals' Investigational Supra-seasonal Universal Influenza Vaccines - Inactivated (SUIVs) (GSK3816302A) in Healthy Adults
Actual Study Start Date : September 8, 2017
Estimated Primary Completion Date : May 7, 2020
Estimated Study Completion Date : May 7, 2020

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Flu Flu Shot

Arm Intervention/treatment
Experimental: D-SUIV Adjuvanted Group 1
Subjects will receive one dose of D-SUIV Formulation 1 at Day 1, one dose of Placebo at Day 57 and one booster dose of D-SUIV Formulation 2 at Month 14
Biological: D-SUIV Formulation 1
1 Primary dose or 1 Booster dose will be administered intramuscularly (IM) in the deltoid region of non-dominant arm.

Biological: D-SUIV Formulation 2
1 Primary dose or 1 Booster dose will be administered IM in the deltoid region of non-dominant arm.

Biological: Placebo
1 dose will be administered IM in the deltoid region of non-dominant arm

Experimental: D-SUIV Adjuvanted Group 2
Subjects will receive one dose of D-SUIV Formulation 2 at Day 1, one dose of Placebo at Day 57 and one booster dose of D-SUIV Formulation 1 at Month 14
Biological: D-SUIV Formulation 1
1 Primary dose or 1 Booster dose will be administered intramuscularly (IM) in the deltoid region of non-dominant arm.

Biological: D-SUIV Formulation 2
1 Primary dose or 1 Booster dose will be administered IM in the deltoid region of non-dominant arm.

Biological: Placebo
1 dose will be administered IM in the deltoid region of non-dominant arm

Experimental: D-SUIV Adjuvanted Group 3
Subjects will receive one dose of D-SUIV Formulation 1 at Day 1, one dose of D-SUIV Formulation 2 at Day 57 and one booster dose of D-SUIV Formulation 3 at Month 14
Biological: D-SUIV Formulation 1
1 Primary dose or 1 Booster dose will be administered intramuscularly (IM) in the deltoid region of non-dominant arm.

Biological: D-SUIV Formulation 2
1 Primary dose or 1 Booster dose will be administered IM in the deltoid region of non-dominant arm.

Biological: D-SUIV Formulation 3
1 Booster dose will be administered IM in the deltoid region of non-dominant arm.

Experimental: D-SUIV Adjuvanted Group 4
Subjects will receive one dose of D-SUIV Formulation 4 at Day 1, one dose of Placebo at Day 57 and one booster dose of D-SUIV Formulation 5 at Month 14
Biological: D-SUIV Formulation 4
1 Primary dose or 1 Booster dose will be administered IM in the deltoid region of non-dominant arm.

Biological: D-SUIV Formulation 5
1 Primary dose or 1 Booster dose will be administered IM in the deltoid region of non-dominant arm

Biological: Placebo
1 dose will be administered IM in the deltoid region of non-dominant arm

Experimental: D-SUIV Adjuvanted Group 5
Subjects will receive one dose of D-SUIV Formulation 5 at Day 1, one dose of Placebo at Day 57 and one booster dose of D-SUIV Formulation 4 at Month 14
Biological: D-SUIV Formulation 4
1 Primary dose or 1 Booster dose will be administered IM in the deltoid region of non-dominant arm.

Biological: D-SUIV Formulation 5
1 Primary dose or 1 Booster dose will be administered IM in the deltoid region of non-dominant arm

Biological: Placebo
1 dose will be administered IM in the deltoid region of non-dominant arm

Experimental: D-SUIV Adjuvanted Group 6
Subjects will receive one dose of D-SUIV Formulation 4 at Day 1, one dose D-SUIV Formulation 5 at Day 57 and one booster dose of D-SUIV Formulation 6 at Month 14
Biological: D-SUIV Formulation 4
1 Primary dose or 1 Booster dose will be administered IM in the deltoid region of non-dominant arm.

Biological: D-SUIV Formulation 5
1 Primary dose or 1 Booster dose will be administered IM in the deltoid region of non-dominant arm

Biological: D-SUIV Formulation 6
1 Booster dose will be administered IM in the deltoid region of non-dominant arm

Experimental: D-SUIV Unadjuvanted Group 1
Subjects will receive one dose of D-SUIV Formulation 7 at Day 1, one dose of Placebo at Day 57 and one booster dose of D-SUIV Formulation 8 at Month 14
Biological: D-SUIV Formulation 7
1 Primary dose or 1 Booster dose will be administered IM in the deltoid region of non-dominant arm

Biological: D-SUIV Formulation 8
1 Primary dose or 1 Booster dose will be administered IM in the deltoid region of non-dominant arm

Biological: Placebo
1 dose will be administered IM in the deltoid region of non-dominant arm

Experimental: D-SUIV Unadjuvanted Group 2
Subjects will receive one dose of D-SUIV Formulation 8 at Day 1, one dose of Placebo at Day 57 and one booster dose of D-SUIV Formulation 7 at Month 14
Biological: D-SUIV Formulation 7
1 Primary dose or 1 Booster dose will be administered IM in the deltoid region of non-dominant arm

Biological: D-SUIV Formulation 8
1 Primary dose or 1 Booster dose will be administered IM in the deltoid region of non-dominant arm

Biological: Placebo
1 dose will be administered IM in the deltoid region of non-dominant arm

Experimental: D-SUIV Unadjuvanted Group 3
Subjects will receive one dose of D-SUIV Formulation 7 at Day 1, one dose D-SUIV Formulation 8 at Day 57 and one booster dose of D-SUIV Formulation 9 at Month 14
Biological: D-SUIV Formulation 7
1 Primary dose or 1 Booster dose will be administered IM in the deltoid region of non-dominant arm

Biological: D-SUIV Formulation 8
1 Primary dose or 1 Booster dose will be administered IM in the deltoid region of non-dominant arm

Biological: D-SUIV Formulation 9
1 Booster dose will be administered IM in the deltoid region of non-dominant arm

Active Comparator: IIV4 Group
Subjects will receive one dose of Fluarix Quadrivalent at Day 1, one dose of Placebo at Day 57 and one dose of Fluarix Quadrivalent at Month 14
Biological: Placebo
1 dose will be administered IM in the deltoid region of non-dominant arm

Biological: FLU-D-QIV
1 Primary dose and 1 Booster dose will be administered IM in the deltoid region of non-dominant arm
Other Name: Fluarix Quadrivalent




Primary Outcome Measures :
  1. Occurrence of solicited local and general adverse events (AEs) [ Time Frame: During the 7-day follow-up period (i.e. on the day of vaccination and 6 subsequent days) after each vaccine dose ]

    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.

    An adverse event (AE) can therefore be any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease (new or exacerbated) temporally associated with the use of a medicinal product to be recorded as endpoints in the clinical study.

    The presence/occurrence/intensity of well defined AEs is actively solicited from the study participant during a specified post-vaccination follow-up period.


  2. Occurrence of unsolicited AEs [ Time Frame: During the 28-day follow-up period (i.e. on the day of vaccination and 27 subsequent days) after each vaccine dose. ]
    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 and reported in addition to those solicited during the clinical study and any 'solicited' symptom with onset outside the specified period of follow-up for solicited symptoms.

  3. Number of Subjects with Normal and Abnormal Biochemical and Haematological Parameters. [ Time Frame: At Day 8 ]
    Per parameter, it was assessed whether subjects had laboratory values unknown, below, within or above the normal ranges.

  4. Number of Subjects with Normal and Abnormal Biochemical and Haematological Parameters. [ Time Frame: At Day 29 ]
    Per parameter, it was assessed whether subjects had laboratory values unknown, below, within or above the normal ranges.

  5. Number of Subjects with Normal and Abnormal Biochemical and Haematological Parameters. [ Time Frame: At Day 57 ]
    Per parameter, it was assessed whether subjects had laboratory values unknown, below, within or above the normal ranges.

  6. Number of Subjects with Normal and Abnormal Biochemical and Haematological Parameters. [ Time Frame: At Day 64 ]
    Per parameter, it was assessed whether subjects had laboratory values unknown, below, within or above the normal ranges.

  7. Number of Subjects with Normal and Abnormal Biochemical and Haematological Parameters. [ Time Frame: At Day 85 ]
    Per parameter, it was assessed whether subjects had laboratory values unknown, below, within or above the normal ranges.

  8. Number of Subjects with Normal and Abnormal Biochemical and Haematological Parameters. [ Time Frame: At Month 8 ]
    Per parameter, it was assessed whether subjects had laboratory values unknown, below, within or above the normal ranges.

  9. Number of Subjects with Normal and Abnormal Biochemical and Haematological Parameters. [ Time Frame: At Month 14 ]
    Per parameter, it was assessed whether subjects had laboratory values unknown, below, within or above the normal ranges.

  10. Number of Subjects with Normal and Abnormal Biochemical and Haematological Parameters. [ Time Frame: At Month 14 + 7 days ]
    Per parameter, it was assessed whether subjects had laboratory values unknown, below, within or above the normal ranges.

  11. Number of Subjects with Normal and Abnormal Biochemical and Haematological Parameters. [ Time Frame: At Month 14 + 28 days ]
    Per parameter, it was assessed whether subjects had laboratory values unknown, below, within or above the normal ranges.

  12. Number of Subjects with Normal and Abnormal Biochemical and Haematological Parameters. [ Time Frame: At Month 20 ]
    Per parameter, it was assessed whether subjects had laboratory values unknown, below, within or above the normal ranges.

  13. Number of Subjects with Normal and Abnormal Biochemical and Haematological Parameters. [ Time Frame: At Month 26 ]
    Per parameter, it was assessed whether subjects had laboratory values unknown, below, within or above the normal ranges.

  14. Occurrence of Medically Attended Events (MAEs) [ Time Frame: Throughout the entire study period (Day 1 to Month 26) ]
    MAEs are adverse events with medically-attended visits that are not routine visits for physical examination or vaccination, such as visits for hospitalization, an emergency room visit, or an otherwise unscheduled visit to or from medical personnel (medical doctor) for any reason.

  15. Occurrence of Potential Immune-Mediated Diseases (pIMDs) [ Time Frame: Throughout the entire study period (Day 1 to Month 26) ]
    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.

  16. Occurrence of Serious Adverse Events (SAEs) [ Time Frame: Throughout the entire study period (Day 1 to Month 26) ]
    A SAE is any untoward medical occurrence that: results in death, is life threatening, requires hospitalization or prolongation of existing hospitalization, results in disability/incapacity or is a congenital anomaly/birth defect in the offspring of a study subject.

  17. Titers for anti-H1 stalk. [ Time Frame: At pre-vaccination (Day 1). ]
    Titers will be expressed as geometric mean titers (GMTs) for the seropositivity cut-off by ELISA and MN assays.

  18. Titers for anti-H1 stalk. [ Time Frame: At Dose 2 (i.e. at Day 29 and Day 85). ]
    Titers will be expressed as geometric mean titers (GMTs) for the seropositivity cut-off by ELISA and MN assays.

  19. Number of seropositive subjects for anti-H1. [ Time Frame: At pre-vaccination (Day 1) ]
    A seropositive subject is a subject whose titre is greater than or equal to the cut-off value by ELISA and MN assays.

  20. Number of seropositive subjects for anti-H1. [ Time Frame: At Dose 2 (i.e. at Day 29 and Day 85). ]
    A seropositive subject is a subject whose titre is greater than or equal to the cut-off value by ELISA and MN assays.

  21. Number of subjects with a fold increase of anti-H1 stalk antibody titers. [ Time Frame: From Day 1 to Days 29 and 85. ]
    The number of subjects with a ≥ 4-fold increase in GMTs will be tabulated by ELISA and MN assays.

  22. Number of subjects with a fold increase of anti-H1 stalk antibody titers. [ Time Frame: From Day 1 to Days 29 and 85. ]
    The number of subjects with a ≥ 10-fold increase in GMTs will be tabulated by ELISA and MN assays.

  23. Mean geometric increase (MGI) for anti-H1 stalk antibody titers. [ Time Frame: From Day 1 to Days 29 and 85. ]
    Mean geometric increase (MGI) will be calculated for the above parameters with 95% CI by ELISA and MN assays.


Secondary Outcome Measures :
  1. GMT ratio for anti-stalk ELISA titer SUIV+AS03 or AS01/SUIV non-adjuvanted. [ Time Frame: At 28 days post vaccination (i.e. at Day 29 to evaluate the adjuvant effect post-dose 1 and at Day 85 to evaluate the adjuvant effect post-dose 2). ]
    The GMT ratio will be tabulated to evaluate the adjuvant effect post-dose 1 and post-dose 2.

  2. Titers for anti-H1 stalk. [ Time Frame: At the protocol defined blood sampling timepoints for antibody determination (i.e. At Days 1, 29, 85, Month 8, Month 14, Month 14 + 28 days, Month 20 and Month 26). ]
    Titers will be expressed as geometric mean titers (GMTs) for the seropositivity cut-off by ELISA and MN assays.

  3. Number of seropositive subjects for anti-H1. [ Time Frame: At Days 1, 29, 85, Month 8, Month 14, Month 14 + 28 days, Month 20 and Month 26. ]
    A seropositive subject is a subject whose titre is greater than or equal to the cut-off value by ELISA and MN assays.

  4. Number of subjects with a fold increase of anti-H1 stalk antibody titers. [ Time Frame: From Day 1 to Day 29, at Day 85, Month 8, Month 14, Month 14 + 28 days, Month 20 and Month 26. ]
    The number of subjects with a ≥ 4-fold increase in GMTs will be tabulated by ELISA and MN assays.

  5. Number of subjects with a fold increase of anti-H1 stalk antibody titers. [ Time Frame: From Day 1 to Day 29, at Day 85, Month 8, Month 14, Month 14 + 28 days, Month 20 and Month 26. ]
    The number of subjects with a ≥ 10-fold increase in GMTs will be tabulated by ELISA and MN assays.

  6. Mean geometric increase (MGI) for anti-H1 stalk antibody titers. [ Time Frame: From Day 1 to Day 29, at Day 85, Month 8, Month 14, Month 14 + 28 days, Month 20 and Month 26. ]
    Mean geometric increase (MGI) will be calculated for the above parameters with 95% CI by ELISA and MN assays.

  7. Titers for anti-H2 and anti-H18. [ Time Frame: At Days 1, 29, 85, Month 8, Month 14, Month 14 + 28 days, Month 20 and Month 26. ]
    Titers will be expressed as geometric mean titers (GMTs) for the seropositivity cut-off by ELISA and MN assays.

  8. Number of seropositive subjects for anti-H2 and anti-H18. [ Time Frame: At Days 1, 29, 85, Month 8, Month 14, Month 14 + 28 days, Month 20 and Month 26. ]
    A seropositive subject is a subject whose titer is greater than or equal to the cut-off value by ELISA and MN assays.

  9. Number of subjects with a fold increase of anti-H2 and anti-H18 stalk antibody titers. [ Time Frame: From Day 1 to Day 29, at Day 85, Month 8, Month 14, Month 14 + 28 days, Month 20 and Month 26. ]
    The number of subjects with a ≥ 4-fold increase in GMTs will be tabulated by ELISA and MN assays.

  10. Number of subjects with a fold increase of anti-H2 and anti-H18 stalk antibody titers. [ Time Frame: From Day 1 to Day 29, at Day 85, Month 8, Month 14, Month 14 + 28 days, Month 20 and Month 26. ]
    The number of subjects with a ≥ 10-fold increase in GMTs will be tabulated by ELISA and MN assays.

  11. Mean geometric increase (MGI) for anti-H2 and anti-H18 stalk antibody titers. [ Time Frame: From Day 1 to Day 29, at Day 85, Month 8, Month 14, Month 14 + 28 days, Month 20 and Month 26. ]
    Mean geometric increase (MGI) will be calculated for the above parameters with 95% CI by ELISA and MN assays.



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.


Ages Eligible for Study:   18 Years to 39 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • 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 performance of any study specific procedure.
  • A male or female between, and including, 18 and 39 years of age at the time of the first vaccination.
  • Healthy subjects without acute or chronic, clinically significant pulmonary, cardiovascular, hepatic or renal functional abnormality, as established by medical history and clinical examination before first vaccination and laboratory screening tests (the latter being only applicable for subjects enrolled in Phase I).
  • Subjects with no history of influenza vaccination within 6 months prior to first study vaccination and who are willing to forego any influenza vaccination during the entire study period.
  • Female subjects of childbearing potential may be enrolled in the study, if the subject:

    • Has practiced adequate contraception for 30 days prior to first 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 (last vaccination at Month 14).

Exclusion Criteria:

  • Use of any investigational or non-registered product other than the study vaccines during the period starting 30 days before the first dose of study vaccines, or planned use during the study period.
  • Any medical condition that in the judgment of the investigator would make intramuscular 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. Topical steroids are allowed.
  • Administration of long-acting immune-modifying drugs within 6 months before first vaccination, or planned administration 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 up to the blood sampling at Day 85 and in the period starting 30 days before booster vaccination at Month 14 up to the blood sample at Month 14 + 28 days.
  • 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.
  • Previous vaccination against influenza within the 6 months preceding the first vaccination at Visit 1 or planned use of such vaccines during the study period.
  • History of vaccination with a (pre)pandemic influenza vaccine other than an H1N1pdm09 vaccine or history of laboratory-confirmed influenza infection other than seasonal or H1N1pdm09 influenza.
  • Any confirmed or suspected immunosuppressive or immunodeficient condition, based on medical history and physical examination.
  • History of or current autoimmune disease.
  • Subjects diagnosed with excessive daytime sleepiness or narcolepsy; or history of narcolepsy in a subject's parent or sibling.
  • History of Guillain-Barré syndrome.
  • History of any reaction or hypersensitivity likely to be exacerbated by any component of the vaccines; a history of anaphylactic-type reaction to consumption of eggs; or a history of severe adverse reaction to a previous influenza vaccine.
  • Hypersensitivity to latex.
  • Acute disease and/or fever at the time of enrolment.

    • Fever is defined as temperature ≥ 38.0°C / 100.4°F. The preferred location for measuring temperature in this study will be the oral cavity.
    • Subjects with a minor illness without fever may be enrolled at the discretion of the investigator.
    • For subjects with acute disease and/or fever at the time of enrolment, Visit 1 may be re-scheduled within the allowed time-window.
  • Administration of immunoglobulins and/or any blood products during the period starting 3 months before the first dose of study vaccines or planned administration during the study period.
  • Blood donation within 30 days before the first study blood sampling or planned blood donation within 30 days before and up to 30 days after any study blood sampling.
  • Pregnant or lactating female.
  • 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.
  • Female planning to become pregnant or planning to discontinue contraceptive precautions.
  • Any condition that puts the subject at risk for serious influenza-related complications, as identified by the Advisory Committee on Immunization Practices [Grohskopf, 2017] (note that only criteria applicable for the study population are listed below):
  • Chronic pulmonary (including asthma), cardiovascular (except isolated hypertension), renal, hepatic, neurologic, hematologic or metabolic disorders (including diabetes mellitus);
  • Persons who are immunocompromised due to any cause (including immunosuppression caused by medications or by HIV infection);
  • Adolescents (through 18 years) who are receiving aspirin- or salicylate-containing medications and who might be at risk for experiencing Reye syndrome after influenza virus infection;
  • Residents of nursing homes and other long-term care facilities;
  • American Indians/Alaska Natives; and
  • Persons who are extremely obese (Body Mass Index ≥ 40).

Additional criterion applicable for Phase I subjects:

  • Hematological and/or biochemical parameters outside the laboratory normal ranges, unless the laboratory abnormalities are considered not clinically significant by the investigator.
  • Liver enzymes (alanine aminotransferase [ALT] or aspartate aminotransferase [AST]) outside of the normal laboratory ranges.

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): NCT03275389


Locations
United States, Florida
GSK Investigational Site
South Miami, Florida, United States, 33143
United States, Kansas
GSK Investigational Site
Wichita, Kansas, United States, 67207
United States, New York
GSK Investigational Site
Rochester, New York, United States, 14609
United States, Texas
GSK Investigational Site
Austin, Texas, United States, 78705
United States, Virginia
GSK Investigational Site
Norfolk, Virginia, United States, 23507
Belgium
GSK Investigational Site
Wilrijk, Belgium, 2610
Sponsors and Collaborators
GlaxoSmithKline
Investigators
Study Director: GSK Clinical Trials GlaxoSmithKline

Responsible Party: GlaxoSmithKline
ClinicalTrials.gov Identifier: NCT03275389     History of Changes
Other Study ID Numbers: 207543
2017-001584-20 ( EudraCT Number )
First Posted: September 7, 2017    Key Record Dates
Last Update Posted: March 23, 2018
Last Verified: March 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Yes
Plan Description: Patient-level data for this study will be made available through www.clinicalstudydatarequest.com following the timelines and process described on this site.
URL: http://

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

Keywords provided by GlaxoSmithKline:
Safety
Healthy adults
Immunogenicity
Supra-seasonal universal influenza vaccines - inactivated (SUIVs)

Additional relevant MeSH terms:
Influenza, Human
Orthomyxoviridae Infections
RNA Virus Infections
Virus Diseases
Respiratory Tract Infections
Respiratory Tract Diseases
Vaccines
Immunologic Factors
Physiological Effects of Drugs