- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT02753413
Safety and Reactogenicity Study of GlaxoSmithKline (GSK) Biologicals' Investigational Respiratory Syncytial Virus (RSV) Vaccine (GSK3003891A) in Healthy Women
May 29, 2018 updated by: GlaxoSmithKline
An Observer-blind Safety and Reactogenicity Study to Assess GlaxoSmithKline (GSK) Biologicals' Investigational Respiratory Syncytial Virus (RSV) Vaccine (GSK3003891A) in Healthy Women
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.
Study Overview
Status
Completed
Conditions
Intervention / Treatment
Study Type
Interventional
Enrollment (Actual)
102
Phase
- Phase 2
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
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Wilrijk, Belgium, 2610
- GSK Investigational Site
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Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years to 45 years (ADULT)
Accepts Healthy Volunteers
Yes
Genders Eligible for Study
Female
Description
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.
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: PREVENTION
- Allocation: RANDOMIZED
- Interventional Model: PARALLEL
- Masking: TRIPLE
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
EXPERIMENTAL: RSV group
Subjects in this group will receive a single dose of the RSV vaccine.
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Single dose administered intramuscularly at Day 0 in the deltoid region of the non-dominant arm.
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ACTIVE_COMPARATOR: Boostrix group
Subjects in this group will receive a single dose of Boostrix.
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Single dose administered intramuscularly at Day 0 in the deltoid region of the non-dominant arm.
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Number of Subjects With Abnormal Biochemical Laboratory Values.
Time Frame: At Day 7
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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.
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At Day 7
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Number of Subjects With Abnormal Biochemical Laboratory Values.
Time Frame: At Day 30
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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.
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At Day 30
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Number of Subjects With Abnormal Haematological Laboratory Values.
Time Frame: At Day 7
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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.
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At Day 7
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Number of Subjects With Abnormal Haematological Laboratory Values.
Time Frame: At Day 30
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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.
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At Day 30
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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
|
At Day 7
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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.
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At Day 30
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Number of Subjects With Abnormal Biochemical Laboratory Parameter Values by Maximum Grading
Time Frame: From Day 7 up to Day 30
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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.
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From Day 7 up to Day 30
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Number of Subjects With Abnormal Haematological Laboratory Parameter Values by Maximum Grading
Time Frame: From Day 7 up to Day 30
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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.
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From Day 7 up to Day 30
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Number of Subjects With Abnormal Haematological Laboratory Parameter Values by Maximum Grading
Time Frame: From Day 7 up to Day 30
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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.
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From Day 7 up to Day 30
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Number of Subjects With Haematology Change From Baseline by Maximum Grade
Time Frame: From Day 7 up to Day 30
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Assessed laboratory parameter changed from baseline was haemoglobin (Hgb).
FDA grading for Hgb (change from baseline) was not applicable a baseline.
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From Day 7 up to Day 30
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Number of Subjects With Solicited Local Symptoms
Time Frame: During a 7-day follow-up period (from Day 0 to Day 6) after vaccination
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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.
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During a 7-day follow-up period (from Day 0 to Day 6) after vaccination
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Number of Subjects With Solicited General Symptoms
Time Frame: During a 7-day follow-up period (from Day 0 to Day 6) after vaccination
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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.
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During a 7-day follow-up period (from Day 0 to Day 6) after vaccination
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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
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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.
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During a 30-day follow-up period (from Day 0 to Day 29) after vaccination
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Number of Subjects With Serious Adverse Events (SAEs)
Time Frame: From vaccination (Day 0) up to study end (Day 30)
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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.
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From vaccination (Day 0) up to study end (Day 30)
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Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
April 1, 2016
Primary Completion (ACTUAL)
June 28, 2016
Study Completion (ACTUAL)
June 28, 2016
Study Registration Dates
First Submitted
April 21, 2016
First Submitted That Met QC Criteria
April 25, 2016
First Posted (ESTIMATE)
April 27, 2016
Study Record Updates
Last Update Posted (ACTUAL)
June 26, 2018
Last Update Submitted That Met QC Criteria
May 29, 2018
Last Verified
May 1, 2018
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- 204813
- 2015-005742-58 (EUDRACT_NUMBER)
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
YES
IPD 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 Supporting Information Type
- STUDY_PROTOCOL
- SAP
- ICF
- CSR
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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