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Trial details imported from ClinicalTrials.gov
For full trial details, please see the original record at
https://clinicaltrials.gov/study/NCT02360475
Registration number
NCT02360475
Ethics application status
Date submitted
29/01/2015
Date registered
10/02/2015
Titles & IDs
Public title
Safety, Reactogenicity and Immunogenicity Study of Different Formulations of GlaxoSmithKline (GSK) Biologicals' Investigational RSV Vaccine (GSK3003891A), in Healthy Women
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Scientific 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
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Secondary ID [1]
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2014-002688-14
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Secondary ID [2]
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201510
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Universal Trial Number (UTN)
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Trial acronym
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Linked study record
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Health condition
Health condition(s) or problem(s) studied:
Respiratory Syncytial Virus Infections
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Condition category
Condition code
Respiratory
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Other respiratory disorders / diseases
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Infection
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Other infectious diseases
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Infection
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Studies of infection and infectious agents
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Intervention/exposure
Study type
Interventional
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Description of intervention(s) / exposure
Treatment: Other - RSV vaccine GSK3003895A (formulation 1)
Treatment: Other - RSV vaccine GSK3003898A (formulation 2)
Treatment: Other - RSV vaccine GSK3003899A (formulation 3)
Treatment: Other - Boostrix
Experimental: RSV vaccine formulation 1 Group - Subjects in this group will receive a single dose of formulation 1 of the RSV vaccine
Experimental: RSV vaccine formulation 2 Group - Subjects in this group will receive a single dose of formulation 2 of RSV vaccine
Experimental: RSV vaccine formulation 3 Group - Subjects in this group will receive a single dose of formulation 3 of RSV vaccine
Active comparator: Boostrix Group - Subjects in this group will receive a single dose of Boostrix
Treatment: Other: RSV vaccine GSK3003895A (formulation 1)
Single dose administered intramuscularly at Day 0 in the deltoid region of the non-dominant arm
Treatment: Other: RSV vaccine GSK3003898A (formulation 2)
Single dose administered intramuscularly at Day 0 in the deltoid region of the non-dominant arm
Treatment: Other: RSV vaccine GSK3003899A (formulation 3)
Single dose administered intramuscularly at Day 0 in the deltoid region of the non-dominant arm
Treatment: Other: Boostrix
Single dose administered intramuscularly at Day 0 in the deltoid region of the non-dominant arm
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Intervention code [1]
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Treatment: Other
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Comparator / control treatment
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Control group
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Outcomes
Primary outcome [1]
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Number of Subjects With Solicited Local Symptoms
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Assessment method [1]
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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 = Significant pain at rest, pain that prevented normal activity. Grade 3 redness/swelling = redness/swelling with a maximum diameter greater than 100 millimeters (mm).
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Timepoint [1]
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During the 7-day (Days 0-6) post-vaccination period
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Primary outcome [2]
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Number of Subjects With Solicited General Symptoms
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Assessment method [2]
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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.
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Timepoint [2]
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During the 7-day (Days 0-6) post-vaccination period
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Primary outcome [3]
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Number of Subjects With Unsolicited Adverse Events (AEs)
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Assessment method [3]
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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 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.
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Timepoint [3]
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During the 30-Day (Days 0-29) post-vaccination period
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Primary outcome [4]
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Number of Subjects With Serious Adverse Events (SAEs)
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Assessment method [4]
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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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Timepoint [4]
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From vaccination at Day 0, up to Day 30 post-vaccination
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Primary outcome [5]
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Titres of RSV-A Neutralizing Antibodies
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Assessment method [5]
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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).
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Timepoint [5]
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At Day 0 pre-vaccination
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Primary outcome [6]
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Titres of RSV-A Neutralizing Antibodies
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Assessment method [6]
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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).
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Timepoint [6]
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At Day 30 post-vaccination
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Secondary outcome [1]
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Titres of RSV-A Neutralizing Antibodies
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Assessment method [1]
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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).
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Timepoint [1]
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At Day 60 post-vaccination
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Secondary outcome [2]
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Titres of RSV-A Neutralizing Antibodies
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Assessment method [2]
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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).
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Timepoint [2]
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At Day 90 post-vaccination
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Secondary outcome [3]
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Concentrations of Palivizumab Competing Antibodies (PCA)
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Assessment method [3]
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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).
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Timepoint [3]
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At Day 0 pre-vaccination
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Secondary outcome [4]
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Concentrations of PCA
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Assessment method [4]
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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).
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Timepoint [4]
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At Day 30 post-vaccination
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Secondary outcome [5]
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Concentrations of PCA
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Assessment method [5]
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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).
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Timepoint [5]
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At Day 60 post-vaccination
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Secondary outcome [6]
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Concentrations of PCA
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Assessment method [6]
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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).
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Timepoint [6]
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At Day 90 post-vaccination
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Secondary outcome [7]
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Number of Subjects With SAEs
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Assessment method [7]
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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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Timepoint [7]
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Up to study end at Day 360
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Eligibility
Key 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.
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Minimum age
18
Years
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Maximum age
45
Years
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Sex
Females
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Can healthy volunteers participate?
Yes
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Key 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.
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Study design
Purpose of the study
Prevention
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Allocation to intervention
Randomised controlled trial
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Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
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Methods used to generate the sequence in which subjects will be randomised (sequence generation)
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Masking / blinding
Blinded (masking used)
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Who is / are masked / blinded?
The people receiving the treatment/s
The people administering the treatment/s
The people assessing the outcomes
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Intervention assignment
Parallel
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Other design features
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Phase
Phase 2
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Type of endpoint/s
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Statistical methods / analysis
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Recruitment
Recruitment status
Completed
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Data analysis
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Reason for early stopping/withdrawal
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Other reasons
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Date of first participant enrolment
Anticipated
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Actual
20/03/2015
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Date of last participant enrolment
Anticipated
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Actual
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Date of last data collection
Anticipated
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Actual
21/06/2016
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Sample size
Target
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Accrual to date
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Final
507
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Recruitment in Australia
Recruitment state(s)
VIC
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Recruitment hospital [1]
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GSK Investigational Site - Melbourne
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Recruitment postcode(s) [1]
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3004 - Melbourne
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Recruitment outside Australia
Country [1]
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United States of America
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State/province [1]
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Arizona
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Country [2]
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United States of America
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State/province [2]
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California
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Country [3]
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United States of America
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State/province [3]
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Kansas
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Country [4]
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United States of America
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State/province [4]
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Kentucky
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Country [5]
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United States of America
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State/province [5]
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Massachusetts
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Country [6]
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United States of America
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State/province [6]
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New York
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Country [7]
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United States of America
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State/province [7]
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Texas
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Country [8]
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Czechia
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State/province [8]
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Hradec Kralove
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Country [9]
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Germany
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State/province [9]
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Bayern
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Country [10]
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Germany
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State/province [10]
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Sachsen
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Country [11]
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Germany
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State/province [11]
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Schleswig-Holstein
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Funding & Sponsors
Primary sponsor type
Commercial sector/industry
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Name
GlaxoSmithKline
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Address
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Country
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Ethics approval
Ethics application status
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Summary
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.
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Trial website
https://clinicaltrials.gov/study/NCT02360475
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Trial related presentations / publications
Steff AM, Cadieux-Dion C, de Lannoy G, Prato MK, Czeszak X, Andre B, Ingels DC, Louckx M, Dewe W, Picciolato M, Maleux K, Fissette L, Dieussaert I. Hamster neogenin, a host-cell protein contained in a respiratory syncytial virus candidate vaccine, induces antibody responses in rabbits but not in clinical trial participants. Hum Vaccin Immunother. 2020 Jun 2;16(6):1327-1337. doi: 10.1080/21645515.2019.1693749. Epub 2020 Jan 17. 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.
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Public notes
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Contacts
Principal investigator
Name
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GSK Clinical Trials
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Address
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GlaxoSmithKline
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Country
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Phone
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Fax
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Email
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Contact person for public queries
Name
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Address
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Country
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Phone
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Fax
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Email
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Contact person for scientific queries
Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
Yes
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What data in particular will be shared?
IPD for this study will be made available via the Clinical Study Data Request site.
Supporting document/s available: Study protocol, Statistical analysis plan (SAP), Informed consent form (ICF), Clinical study report (CSR)
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When will data be available (start and end dates)?
IPD is available via the Clinical Study Data Request site (click on the link provided below)
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Available to whom?
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.
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Available for what types of analyses?
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How or where can data be obtained?
IPD available at link: https://clinicalstudydatarequest.com
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What supporting documents are/will be available?
No Supporting Document Provided
Results publications and other study-related documents
No documents have been uploaded by study researchers.
Results are available at
https://clinicaltrials.gov/study/NCT02360475