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Safety, Reactogenicity and Immunogenicity Study of Different Formulations of GlaxoSmithKline (GSK) Biologicals' Investigational RSV Vaccine (GSK3003891A), in Healthy Women

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ClinicalTrials.gov Identifier: NCT02360475
Recruitment Status : Completed
First Posted : February 10, 2015
Results First Posted : August 16, 2017
Last Update Posted : July 3, 2018
Sponsor:
Information provided by (Responsible Party):
GlaxoSmithKline

Brief Summary:
The purpose of this study is to evaluate the safety, reactogenicity and immunogenicity of different formulations of a single intramuscular dose of GSK Biologicals' investigational RSV vaccine, in healthy, non-pregnant women aged 18 to 45 years.

Condition or disease Intervention/treatment Phase
Respiratory Syncytial Virus Infections Biological: RSV vaccine GSK3003895A (formulation 1) Biological: RSV vaccine GSK3003898A (formulation 2) Biological: RSV vaccine GSK3003899A (formulation 3) Biological: Boostrix Phase 2

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 507 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Outcomes Assessor)
Primary Purpose: Prevention
Official Title: An Observer-blind Study to Assess the Safety, Reactogenicity and Immunogenicity of Different Formulations of GSK Biologicals' Investigational RSV Vaccine (GSK3003891A), in Healthy Women
Actual Study Start Date : March 20, 2015
Actual Primary Completion Date : July 2, 2015
Actual Study Completion Date : June 21, 2016

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: RSV vaccine formulation 1 Group
Subjects in this group will receive a single dose of formulation 1 of the RSV vaccine
Biological: RSV vaccine GSK3003895A (formulation 1)
Single dose administered intramuscularly at Day 0 in the deltoid region of the non-dominant arm

Experimental: RSV vaccine formulation 2 Group
Subjects in this group will receive a single dose of formulation 2 of RSV vaccine
Biological: RSV vaccine GSK3003898A (formulation 2)
Single dose administered intramuscularly at Day 0 in the deltoid region of the non-dominant arm

Experimental: RSV vaccine formulation 3 Group
Subjects in this group will receive a single dose of formulation 3 of RSV vaccine
Biological: RSV vaccine GSK3003899A (formulation 3)
Single dose administered intramuscularly at Day 0 in the deltoid region of the non-dominant arm

Active Comparator: Boostrix Group
Subjects in this group will receive a single dose of Boostrix
Biological: Boostrix
Single dose administered intramuscularly at Day 0 in the deltoid region of the non-dominant arm




Primary Outcome Measures :
  1. Number of Subjects With Solicited Local Symptoms [ Time Frame: During the 7-day (Days 0-6) post-vaccination period ]
    Assessed solicited local symptoms were pain, redness and swelling. Any = occurrence of the symptom regardless of intensity grade. Grade 3 pain = Significant pain at rest, pain that prevented normal activity. Grade 3 redness/swelling = redness/swelling with a maximum diameter greater than 100 millimeters (mm).

  2. Number of Subjects With Solicited General Symptoms [ Time Frame: During the 7-day (Days 0-6) post-vaccination period ]
    Assessed solicited general symptoms (symp.) were headache, fever [defined as oral temperature (temp.) equal to or above 37.5 degrees Celsius (°C)], fatigue, gastrointestinal (Gastro.) symptoms [nausea, vomiting, diarrhoea and/or abdominal pain]. Any = occurrence of the symptom regardless of intensity grade and relationship. Grade 3 (G3) symptom = symptom that prevented normal activity. Grade 3 fever = fever > 39.5 °C. Related = symptom assessed by the investigator as related to the vaccination.

  3. Number of Subjects With Unsolicited Adverse Events (AEs) [ Time Frame: During the 30-Day (Days 0-29) post-vaccination period ]
    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 any solicited symptom with onset outside the specified period of follow-up for solicited symptoms. "Any" was defined as the occurrence of any unsolicited AE regardless of intensity grade or relation to vaccination.

  4. Number of Subjects With Serious Adverse Events (SAEs) [ Time Frame: From vaccination at Day 0, up to Day 30 post-vaccination ]
    Serious adverse events (SAEs) assessed include medical occurrences that result in death, are life-threatening, require hospitalization or prolongation of hospitalization or result in disability/incapacity.

  5. Titres of RSV-A Neutralizing Antibodies [ Time Frame: At Day 0 pre-vaccination ]
    RSV-A neutralizing antibody titres, expressed as Geometric Mean Titres (GMTs). Seropositive subjects were defined as subjects whose antibody titre was greater than or equal to (≥) the cut-off 8 serum dilution that induced 60 % inhibition in plaque forming units (ED60).

  6. Titres of RSV-A Neutralizing Antibodies [ Time Frame: At Day 30 post-vaccination ]
    RSV-A neutralizing antibody titres, expressed as Geometric Mean Titres (GMTs). Seropositive subjects were defined as subjects whose antibody titre was greater than or equal to (≥) the cut-off 8 serum dilution that induced 60 % inhibition in plaque forming units (ED60).


Secondary Outcome Measures :
  1. Titres of RSV-A Neutralizing Antibodies [ Time Frame: At Day 60 post-vaccination ]
    RSV-A neutralizing antibody titres, expressed as Geometric Mean Titres (GMTs), were defined as any titre greater than or equal to (≥) the cut-off 8 serum dilution inducing 60 % inhibition in plaque forming units (ED60).

  2. Titres of RSV-A Neutralizing Antibodies [ Time Frame: At Day 90 post-vaccination ]
    RSV-A neutralizing antibody titres, expressed as Geometric Mean Titres (GMTs), were defined as any titre greater than or equal to (≥) the cut-off 8 serum dilution inducing 60 % inhibition in plaque forming units (ED60).

  3. Concentrations of Palivizumab Competing Antibodies (PCA) [ Time Frame: At Day 0 pre-vaccination ]
    Palivizumab competing antibody concentrations, expressed as Geometric Mean Concentrations (GMCs). The assay cut-off was greater than or equal to 3.34 micrograms per millilitre (µg/mL).

  4. Concentrations of PCA [ Time Frame: At Day 30 post-vaccination ]
    PCA concentrations, expressed as Geometric Mean Concentrations (GMCs). The assay cut-off was greater than or equal to 3.34 micrograms per millilitre (µg/mL).

  5. Concentrations of PCA [ Time Frame: At Day 60 post-vaccination ]
    PCA concentrations, expressed as Geometric Mean Concentrations (GMCs).The assay cut-off was greater than or equal to 3.34 micrograms per millilitre (µg/mL).

  6. Concentrations of PCA [ Time Frame: At Day 90 post-vaccination ]
    PCA concentrations, expressed as Geometric Mean Concentrations (GMCs). The assay cut-off was greater than or equal to 3.34 micrograms per millilitre (µg/mL).

  7. Number of Subjects With SAEs [ Time Frame: Up to study end at Day 360 ]
    SAEs assessed include medical occurrences that result in death, are life-threatening, require hospitalization or prolongation of hospitalization or result in disability/incapacity.



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 45 Years   (Adult)
Sexes Eligible for Study:   Female
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 performing any study specific procedure.
  • Non-pregnant female between, and including, 18 and 45 years of age at the time of study vaccination.
  • Healthy subjects as established by medical history and clinical examination before entering into the study.
  • Female subjects of non-childbearing potential may be enrolled in the study.
  • Female subjects of childbearing potential may be enrolled in the study, if the subject:

    • Has practiced adequate contraception for 30 days prior to study vaccination, and
    • Has a negative pregnancy test on the day of study vaccination, and
    • Has agreed to continue adequate contraception during the study period.

Exclusion Criteria:

  • Use of any investigational or non-registered product other than the study vaccine within 30 days prior to study vaccination, or planned use during the study period.
  • 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 medical condition that in the judgment of the investigator would make intramuscular injection unsafe.
  • Planned administration/ administration of a vaccine not foreseen by the study protocol within the period starting 30 days before and ending 30 days after study vaccination, with the exception of any licensed influenza vaccine which may be administered ≥ 15 days before or after study vaccination.
  • Previous experimental vaccination against RSV.
  • History of any reaction or hypersensitivity likely to be exacerbated by any component of the study vaccines.
  • History of severe allergic reaction after a previous dose of any tetanus toxoid, diphtheria toxoid, or pertussis antigen-containing vaccine or to any component of Boostrix.
  • History of encephalopathy of unknown aetiology occurring within 7 days following a previous vaccination with pertussis-containing vaccine.
  • History of any neurological disorders or seizures
  • History of transient thrombocytopenia or neurological complications following a previous vaccination against diphtheria and/ or tetanus.
  • Chronic administration of immunosuppressants or other immune-modifying drugs within 6 months prior to study vaccination, or planned administration during the study period. Inhaled and topical steroids are allowed.
  • Administration of immunoglobulins and/ or any blood products within the 3 months prior to study vaccination, or planned administration during the study period.
  • Any confirmed or suspected immunosuppressive or immunodeficient condition, based on medical history and physical examination.
  • Family history of congenital or hereditary immunodeficiency.
  • History of or current autoimmune disease.
  • Acute or chronic, clinically significant pulmonary, cardiovascular, hepatic or renal functional abnormality.
  • Malignancy within previous 5 years or lymphoproliferative disorder.
  • Current alcohol and/or drug abuse.
  • Acute disease and/ or fever at the time of enrolment.
  • Hypersensitivity to latex.
  • Pregnant or lactating female.
  • Planned move to a location that will prohibit participating in the trial until study end.
  • Any other condition that the investigator judges may interfere with study procedures or findings.

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): NCT02360475


Locations
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United States, Arizona
GSK Investigational Site
Mesa, Arizona, United States, 85213
United States, California
GSK Investigational Site
San Diego, California, United States, 92108
United States, Kansas
GSK Investigational Site
Lenexa, Kansas, United States, 66219
United States, Kentucky
GSK Investigational Site
Lexington, Kentucky, United States, 40509
United States, Massachusetts
GSK Investigational Site
Milford, Massachusetts, United States, 01757
United States, New York
GSK Investigational Site
Syracuse, New York, United States, 13210
United States, Texas
GSK Investigational Site
Austin, Texas, United States, 78705
Australia, Victoria
GSK Investigational Site
Melbourne, Victoria, Australia, 3004
Czechia
GSK Investigational Site
Hradec Kralove, Czechia
Germany
GSK Investigational Site
Wuerzburg, Bayern, Germany, 97070
GSK Investigational Site
Dippoldiswalde, Sachsen, Germany, 01744
GSK Investigational Site
Luebeck, Schleswig-Holstein, Germany, 23554
Sponsors and Collaborators
GlaxoSmithKline
Investigators
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Study Director: GSK Clinical Trials GlaxoSmithKline

Additional Information:
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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Responsible Party: GlaxoSmithKline
ClinicalTrials.gov Identifier: NCT02360475    
Other Study ID Numbers: 201510
2014-002688-14 ( EudraCT Number )
First Posted: February 10, 2015    Key Record Dates
Results First Posted: August 16, 2017
Last Update Posted: July 3, 2018
Last Verified: May 2018
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 is available via the Clinical Study Data Request site (click on the link provided below)
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
Keywords provided by GlaxoSmithKline:
Vaccine
Immunogenicity
Safety
Respiratory syncytial virus (RSV)
Reactogenicity
Additional relevant MeSH terms:
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Respiratory Syncytial Virus Infections
Virus Diseases
Pneumovirus Infections
Paramyxoviridae Infections
Mononegavirales Infections
RNA Virus Infections
Vaccines
Immunologic Factors
Physiological Effects of Drugs