The purpose of the present study is to assess and compare in healthy non-pregnant women 18 to 40 years of age the safety and immunogenicity of a liquid formulation of Group B Streptococcus (GBS) Trivalent Vaccine (not requiring reconstitution prior to administration), and of the lyophilized formulation of GBS Trivalent Vaccine, administered in non-pregnant and pregnant women in the clinical development program to date.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
TRIPLE
Enrollment
1,053
Liquid formulation of a vaccine containing polysaccharide capsules from serotypes Ia, Ib, and III of the Group B Streptococcus
Lyophilized formulation of a vaccine containing polysaccharide capsules from serotypes Ia, Ib, and III of the Group B Streptococcus
GSK Investigational Site
Redding, California, United States
GSK Investigational Site
Lenexa, Kansas, United States
GSK Investigational Site
Baltimore, Maryland, United States
GSK Investigational Site
Stevensville, Michigan, United States
GSK Investigational Site
Salt Lake City, Utah, United States
GSK Investigational Site
Antwerp, Belgium
GSK Investigational Site
Ghent, Belgium
GSK Investigational Site
Leuven, Belgium
GSK Investigational Site
Hradec Králové, Czechia
Concentration of Serotype Ia GBS IgG Levels in Healthy Non-pregnant Women
To evaluate serotype-specific Ia GBS serum IgG antibody levels (anti-Ia) in healthy non-pregnant women when administered with the liquid GBS trivalent vaccine formulation or the lyophilized GBS trivalent vaccine formulation. Antibody concentrations were measured by Enzyme-linked immunosorbent assay (ELISA), expressed as geometric mean concentrations (GMCs), in micrograms per milliliter (µg/mL).
Time frame: At Day 31 after a single vaccination
Concentration of Serotype III GBS IgG Levels in Healthy Non-pregnant Women
To evaluate serotype-specific III GBS serum IgG antibody levels (anti-III) in healthy non-pregnant women when administered with the liquid GBS trivalent vaccine formulation or the lyophilized GBS trivalent vaccine formulation. Antibody concentrations were measured by Enzyme-linked immunosorbent assay (ELISA), expressed as geometric mean concentrations (GMCs), in micrograms per milliliter (µg/mL).
Time frame: At Day 31 after a single vaccination
Concentration of Serotype Ib GBS IgG Levels in Healthy Non-pregnant Women
To evaluate serotype-specific Ib GBS serum IgG antibody levels (anti-Ib) in healthy non-pregnant women when administered with the liquid GBS trivalent vaccine formulation or the lyophilized GBS trivalent vaccine formulation. Geometric mean concentrations (GMCs) were measured and expressed in micrograms per milliliter (μg/mL). As the singleton ELISA was no longer in use at the time of serotype Ib testing, results were obtained using multiplex immunoassay.
Time frame: At Day 31 after a single vaccination
Number of Subjects Reporting Solicited Local and Systemic Adverse Events (AEs)
Safety was assessed as the number of subjects who reported solicited local and solicited systemic AEs following a single injection with either liquid or lyophilized GBS trivalent vaccine formulations.
Time frame: From 6 hours through Day 7 post-vaccination
Number of Subjects Reporting Any Unsolicited AEs
Safety was assessed as the number of subjects who reported unsolicited AEs following a single injection with either liquid or lyophilized GBS trivalent vaccine formulations.
Time frame: From Day 1 to Day 181 (end of the study)
Number of Subjects Reporting Any Serious Adverse Events (SAEs)
Safety was assessed as the number of subjects who reported SAEs following a single injection with either liquid or lyophilized GBS trivalent vaccine formulations.
Time frame: From Day 1 to Day 181 (end of the study)
This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.