Back to resultsSafety and Reactogenicity Study of GlaxoSmithKline (GSK) Biologicals' Investigational Respiratory Syncytial Virus (RSV) Vaccine (GSK3003891A) in Healthy Women
Primary Purpose
Respiratory Syncytial Virus Infections
Status
Completed
Phase
Phase 2
Locations
Belgium
Study Type
Interventional
Intervention
RSV vaccine GSK3003891A
Boostrix
Sponsored by
About this trial
This is an interventional prevention trial for Respiratory Syncytial Virus Infections focused on measuring Vaccine, Safety, Reactogenicity, Respiratory syncytial virus (RSV)
Eligibility 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.
Sites / Locations
- GSK Investigational Site
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Active Comparator
Arm Label
RSV group
Boostrix group
Arm Description
Subjects in this group will receive a single dose of the RSV vaccine.
Subjects in this group will receive a single dose of Boostrix.
Outcomes
Primary Outcome Measures
Number of Subjects With Abnormal Biochemical Laboratory Values.
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.
Number of Subjects With Abnormal Biochemical Laboratory Values.
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.
Number of Subjects With Abnormal Haematological Laboratory Values.
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.
Number of Subjects With Abnormal Haematological Laboratory Values.
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.
Number of Subjects With Abnormal Haematological Laboratory Values.
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
Number of Subjects With Abnormal Haematological Laboratory Values.
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.
Number of Subjects With Abnormal Biochemical Laboratory Parameter Values by Maximum Grading
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.
Number of Subjects With Abnormal Haematological Laboratory Parameter Values by Maximum Grading
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.
Number of Subjects With Abnormal Haematological Laboratory Parameter Values by Maximum Grading
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.
Number of Subjects With Haematology Change From Baseline by Maximum Grade
Assessed laboratory parameter changed from baseline was haemoglobin (Hgb). FDA grading for Hgb (change from baseline) was not applicable a baseline.
Number of Subjects With Solicited Local Symptoms
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.
Number of Subjects With Solicited General Symptoms
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.
Number of Subjects With Unsolicited Adverse Events (AEs)
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.
Number of Subjects With Serious Adverse Events (SAEs)
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.
Secondary Outcome Measures
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT02753413
Brief Title
Safety and Reactogenicity Study of GlaxoSmithKline (GSK) Biologicals' Investigational Respiratory Syncytial Virus (RSV) Vaccine (GSK3003891A) in Healthy Women
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 Type
Interventional
2. Study Status
Record Verification Date
May 2018
Overall Recruitment Status
Completed
Study Start Date
April 1, 2016 (undefined)
Primary Completion Date
June 28, 2016 (Actual)
Study Completion Date
June 28, 2016 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
GlaxoSmithKline
4. Oversight
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Respiratory Syncytial Virus Infections
Keywords
Vaccine, Safety, Reactogenicity, Respiratory syncytial virus (RSV)
7. Study Design
Primary Purpose
Prevention
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderOutcomes Assessor
Allocation
Randomized
Enrollment
102 (Actual)
8. Arms, Groups, and Interventions
Arm Title
RSV group
Arm Type
Experimental
Arm Description
Subjects in this group will receive a single dose of the RSV vaccine.
Arm Title
Boostrix group
Arm Type
Active Comparator
Arm Description
Subjects in this group will receive a single dose of Boostrix.
Intervention Type
Biological
Intervention Name(s)
RSV vaccine GSK3003891A
Intervention Description
Single dose administered intramuscularly at Day 0 in the deltoid region of the non-dominant arm.
Intervention Type
Biological
Intervention Name(s)
Boostrix
Intervention Description
Single dose administered intramuscularly at Day 0 in the deltoid region of the non-dominant arm.
Primary Outcome Measure Information:
Title
Number of Subjects With Abnormal Biochemical Laboratory Values.
Description
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.
Time Frame
At Day 7
Title
Number of Subjects With Abnormal Biochemical Laboratory Values.
Description
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.
Time Frame
At Day 30
Title
Number of Subjects With Abnormal Haematological Laboratory Values.
Description
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.
Time Frame
At Day 7
Title
Number of Subjects With Abnormal Haematological Laboratory Values.
Description
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.
Time Frame
At Day 30
Title
Number of Subjects With Abnormal Haematological Laboratory Values.
Description
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
Time Frame
At Day 7
Title
Number of Subjects With Abnormal Haematological Laboratory Values.
Description
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.
Time Frame
At Day 30
Title
Number of Subjects With Abnormal Biochemical Laboratory Parameter Values by Maximum Grading
Description
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.
Time Frame
From Day 7 up to Day 30
Title
Number of Subjects With Abnormal Haematological Laboratory Parameter Values by Maximum Grading
Description
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.
Time Frame
From Day 7 up to Day 30
Title
Number of Subjects With Abnormal Haematological Laboratory Parameter Values by Maximum Grading
Description
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.
Time Frame
From Day 7 up to Day 30
Title
Number of Subjects With Haematology Change From Baseline by Maximum Grade
Description
Assessed laboratory parameter changed from baseline was haemoglobin (Hgb). FDA grading for Hgb (change from baseline) was not applicable a baseline.
Time Frame
From Day 7 up to Day 30
Title
Number of Subjects With Solicited Local Symptoms
Description
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.
Time Frame
During a 7-day follow-up period (from Day 0 to Day 6) after vaccination
Title
Number of Subjects With Solicited General Symptoms
Description
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.
Time Frame
During a 7-day follow-up period (from Day 0 to Day 6) after vaccination
Title
Number of Subjects With Unsolicited Adverse Events (AEs)
Description
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.
Time Frame
During a 30-day follow-up period (from Day 0 to Day 29) after vaccination
Title
Number of Subjects With Serious Adverse Events (SAEs)
Description
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.
Time Frame
From vaccination (Day 0) up to study end (Day 30)
10. Eligibility
Sex
Female
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
45 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility 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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
GSK Clinical Trials
Organizational Affiliation
GlaxoSmithKline
Official's Role
Study Director
Facility Information:
Facility Name
GSK Investigational Site
City
Wilrijk
ZIP/Postal Code
2610
Country
Belgium
12. IPD Sharing Statement
Plan to Share IPD
Yes
IPD Sharing Plan Description
IPD for this study will be made available via the Clinical Study Data Request site.
IPD Sharing Time Frame
IPD is available via the Clinical Study Data Request site (click on the link provided below)
IPD Sharing 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.
IPD Sharing URL
https://clinicalstudydatarequest.com
Citations:
PubMed Identifier
29401325
Citation
Beran J, Lickliter JD, Schwarz TF, Johnson C, Chu L, Domachowske JB, Van Damme P, Withanage K, Fissette LA, David MP, Maleux K, Schmidt AC, Picciolato M, Dieussaert I. Safety and Immunogenicity of 3 Formulations of an Investigational Respiratory Syncytial Virus Vaccine in Nonpregnant Women: Results From 2 Phase 2 Trials. J Infect Dis. 2018 Apr 23;217(10):1616-1625. doi: 10.1093/infdis/jiy065.
Results Reference
derived
Links:
URL
https://clinicalstudydatarequest.com
Description
IPD for this study will be made available via the Clinical Study Data Request site.
Learn more about this trial
Safety and Reactogenicity Study of GlaxoSmithKline (GSK) Biologicals' Investigational Respiratory Syncytial Virus (RSV) Vaccine (GSK3003891A) in Healthy Women
We'll reach out to this number within 24 hrs