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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
TRIPLE
Enrollment
507
Single dose administered intramuscularly at Day 0 in the deltoid region of the non-dominant arm
Single dose administered intramuscularly at Day 0 in the deltoid region of the non-dominant arm
Single dose administered intramuscularly at Day 0 in the deltoid region of the non-dominant arm
GSK Investigational Site
Mesa, Arizona, United States
GSK Investigational Site
San Diego, California, United States
GSK Investigational Site
Lenexa, Kansas, United States
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 = Significant pain at rest, pain that prevented normal activity. Grade 3 redness/swelling = redness/swelling with a maximum diameter greater than 100 millimeters (mm).
Time frame: During the 7-day (Days 0-6) post-vaccination period
Number of Subjects With Solicited General Symptoms
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.
Time frame: During the 7-day (Days 0-6) post-vaccination period
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 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.
Time frame: During the 30-Day (Days 0-29) post-vaccination period
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.
Time frame: From vaccination at Day 0, up to Day 30 post-vaccination
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Single dose administered intramuscularly at Day 0 in the deltoid region of the non-dominant arm
GSK Investigational Site
Lexington, Kentucky, United States
GSK Investigational Site
Milford, Massachusetts, United States
GSK Investigational Site
Syracuse, New York, United States
GSK Investigational Site
Austin, Texas, United States
GSK Investigational Site
Melbourne, Victoria, Australia
GSK Investigational Site
Hradec Králové, Czechia
GSK Investigational Site
Würzburg, Bavaria, Germany
...and 2 more locations
Titres of RSV-A Neutralizing Antibodies
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).
Time frame: At Day 0 pre-vaccination
Titres of RSV-A Neutralizing Antibodies
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).
Time frame: At Day 30 post-vaccination
Titres of RSV-A Neutralizing Antibodies
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).
Time frame: At Day 60 post-vaccination
Titres of RSV-A Neutralizing Antibodies
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).
Time frame: At Day 90 post-vaccination
Concentrations of Palivizumab Competing Antibodies (PCA)
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).
Time frame: At Day 0 pre-vaccination
Concentrations of PCA
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).
Time frame: At Day 30 post-vaccination
Concentrations of PCA
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).
Time frame: At Day 60 post-vaccination
Concentrations of PCA
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).
Time frame: At Day 90 post-vaccination
Number of Subjects With SAEs
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: Up to study end at Day 360