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Safety and Reactogenicity Study of GlaxoSmithKline (GSK) Biologicals' Investigational Respiratory Syncytial Virus (RSV) Vaccine (GSK3003891A) in Healthy Women

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: NCT02753413
Recruitment Status : Completed
First Posted : April 27, 2016
Results First Posted : July 11, 2017
Last Update Posted : June 26, 2018
Sponsor:
Information provided by (Responsible Party):
GlaxoSmithKline

Brief Summary:
The purpose of this study is to assess the safety and reactogenicity 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 GSK3003891A Biological: Boostrix Phase 2

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 102 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Outcomes Assessor)
Primary Purpose: Prevention
Official Title: An Observer-blind Safety and Reactogenicity Study to Assess GlaxoSmithKline (GSK) Biologicals' Investigational Respiratory Syncytial Virus (RSV) Vaccine (GSK3003891A) in Healthy Women
Study Start Date : April 1, 2016
Actual Primary Completion Date : June 28, 2016
Actual Study Completion Date : June 28, 2016

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: RSV group
Subjects in this group will receive a single dose of the RSV vaccine.
Biological: RSV vaccine GSK3003891A
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 Abnormal Biochemical Laboratory Values. [ Time Frame: At Day 7 ]
    Among analysed biochemical parameters were alanine aminotransferase [ALT], aspartate aminotransferase [AST] and creatinine [CRE]. Biochemical value ranges assessed were below, within or above, as compared to baseline at Day 0.

  2. Number of Subjects With Abnormal Biochemical Laboratory Values. [ Time Frame: At Day 30 ]
    Among analysed biochemical parameters were alanine aminotransferase [ALT], aspartate aminotransferase [AST] and creatinine [CRE]. Biochemical value ranges assessed were below, within or above, as compared to baseline at Day 0.

  3. Number of Subjects With Abnormal Haematological Laboratory Values. [ Time Frame: At Day 7 ]
    Among analysed haematological parameters were eosinophils [EOS], haemoglobin [Hgb], leukocytes (white blood cells) [WBC], lymphocytes [LYM], neutrophils [NEU] and platelets [PLT]. Haematological value ranges assessed were below, within or above, as compared to baseline at Day 0. This outcome presents values for EOS, Hgb and WBC.

  4. Number of Subjects With Abnormal Haematological Laboratory Values. [ Time Frame: At Day 30 ]
    Among analysed haematological parameters were eosinophils [EOS], haemoglobin [Hgb], leukocytes (white blood cells) [WBC], lymphocytes [LYM], neutrophils [NEU] and platelets [PLT]. Haematological value ranges assessed were below, within or above, as compared to baseline at Day 0. This outcome presents values for EOS, Hgb and WBC.

  5. Number of Subjects With Abnormal Haematological Laboratory Values. [ Time Frame: At Day 7 ]
    Among analysed haematological parameters were eosinophils [EOS], haemoglobin [Hgb], leukocytes (white blood cells) [WBC], lymphocytes [LYM], neutrophils [NEU] and platelets [PLT]. Haematological value ranges assessed were below, within or above, as compared to baseline at Day 0. This outcome presents values for LYM, NEU and PLT

  6. Number of Subjects With Abnormal Haematological Laboratory Values. [ Time Frame: At Day 30 ]
    Among analysed haematological parameters were eosinophils [EOS], haemoglobin [Hgb], leukocytes (white blood cells) [WBC], lymphocytes [LYM], neutrophils [NEU] and platelets [PLT]. Haematological value ranges assessed were below, within or above, as compared to baseline at Day 0. This outcome presents values for LYM, NEU and PLT.

  7. Number of Subjects With Abnormal Biochemical Laboratory Parameter Values by Maximum Grading [ Time Frame: From Day 7 up to Day 30 ]
    Among biochemical parameters tested were ALT, AST and CRE, graded by FDA toxicity grading for biochemistry parameters. Assessed grades were unknown, grade 0 [G0], grade 1 [G1] (mild), grade 2 [G2] (moderate), grade 3 [G3] (severe) and grade 4 [G4] (potentially life threatening), as compared to baseline at Day 0.

  8. Number of Subjects With Abnormal Haematological Laboratory Parameter Values by Maximum Grading [ Time Frame: From Day 7 up to Day 30 ]
    Among haematological parameters tested were EOS, decreased Hgb and LYM graded by FDA toxicity grading for haematology parameters. Assessed grades were unknown, grade 0 [G0], grade 1 [G1] (mild), grade 2 [G2] (moderate), grade 3 [G3] (severe) and grade 4 [G4] (potentially life threatening), as compared to baseline at Day 0.

  9. Number of Subjects With Abnormal Haematological Laboratory Parameter Values by Maximum Grading [ Time Frame: From Day 7 up to Day 30 ]
    Among haematological parameters tested were NEU, PLT, decreased WBC and increased WBC/I, graded by FDA toxicity grading for haematology parameters. Assessed grades were unknown, grade 0 [G0], grade 1 [G1] (mild), grade 2 [G2] (moderate), grade 3 [G3] (severe) and grade 4 [G4] (potentially life threatening), as compared to baseline at Day 0.

  10. Number of Subjects With Haematology Change From Baseline by Maximum Grade [ Time Frame: From Day 7 up to Day 30 ]
    Assessed laboratory parameter changed from baseline was haemoglobin (Hgb). FDA grading for Hgb (change from baseline) was not applicable a baseline.

  11. Number of Subjects With Solicited Local Symptoms [ Time Frame: During a 7-day follow-up period (from Day 0 to Day 6) after vaccination ]
    Assessed solicited local symptoms were pain, redness and swelling. Any = occurrence of the symptom regardless of intensity grade. Grade 3 pain = pain that prevented normal activity. Grade 3 redness/swelling = redness/swelling spreading beyond 100 millimetres (mm) of injection site. All solicited local symptoms are considered as related to the vaccination.

  12. Number of Subjects With Solicited General Symptoms [ Time Frame: During a 7-day follow-up period (from Day 0 to Day 6) after vaccination ]
    Assessed solicited general symptoms were fatigue, temperature (defined as oral temperature equal to or above [≥] 37.5 degrees Celsius [°C] for oral, axillary or tympanic route), gastrointestinal symptoms (gastro) including nausea, vomiting, diarrhoea and/or abdominal pain; and headache. Any = occurrence of the symptom regardless of intensity grade and relationship to the vaccination. Grade 3 symptom = symptom that prevented normal activity. Grade 3 fever = fever ≥ 39.5 °C. Related = symptom assessed by the investigator as related to the vaccination.

  13. Number of Subjects With Unsolicited Adverse Events (AEs) [ Time Frame: During a 30-day follow-up period (from Day 0 to Day 29) after vaccination ]
    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 out-side 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.

  14. Number of Subjects With Serious Adverse Events (SAEs) [ Time Frame: From vaccination (Day 0) up to study end (Day 30) ]
    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.



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 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 vaccination, and
    • has a negative pregnancy test on the day of vaccination and
    • has agreed to continue adequate contraception during the entire 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.
  • Chronic administration of immunosuppressants or other immune-modifying drugs, as well as administration of long-acting immune-modifying drugs during the period starting 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 during the period starting 3 months before study vaccination or planned administration during the study period.
  • Planned administration/administration of a vaccine not foreseen by the study protocol in the period starting 30 days before and ending 30 days after the 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.
  • Family history of congenital or hereditary immunodeficiency.
  • Any confirmed or suspected immunosuppressive or immunodeficient condition, based on medical history and physical examination.
  • History of or current auto-immune disease.
  • Acute or chronic, clinically significant pulmonary, cardiovascular, hepatic or renal functional abnormality as determined by physical examination and/or Medical History.
  • Lymphoproliferative disorder or malignancy within previous 5 years.
  • History of hypersensitivity after a previous dose of any tetanus, diphtheria, or pertussis 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.
  • History of any reaction or hypersensitivity likely to be exacerbated by any component of the study vaccines.
  • Hypersensitivity to latex.
  • Any medical condition that in the judgment of the investigator would make intramuscular injection unsafe.
  • Current chronic alcohol consumption and/or drug abuse.
  • Acute disease and/or fever at the time of enrolment.
  • Body mass index (BMI) > 40 kg/m2.
  • 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.

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): NCT02753413


Locations
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Belgium
GSK Investigational Site
Wilrijk, Belgium, 2610
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: NCT02753413    
Other Study ID Numbers: 204813
2015-005742-58 ( EudraCT Number )
First Posted: April 27, 2016    Key Record Dates
Results First Posted: July 11, 2017
Last Update Posted: June 26, 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
Safety
Reactogenicity
Respiratory syncytial virus (RSV)
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