Safety and Immunogenicity of the Liquid Formulation of Group B Streptococcus Trivalent Vaccine an… (NCT02270944) | Clinical Trial Compass
CompletedPhase 2
Safety and Immunogenicity of the Liquid Formulation of Group B Streptococcus Trivalent Vaccine and of the Lyophilized Formulation of Group B Streptococcus Trivalent Vaccine
United States1,053 participantsStarted 2014-11-20
Plain-language summary
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.
Who can participate
Age range18 Years – 40 Years
SexFEMALE
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Inclusion criteria
✓. Healthy females 18-40 years of age, inclusive.
✓. Individuals who have given written consent after the nature of the study has been explained according to local regulatory requirements.
✓. Individuals in good health as determined by the outcome of medical history, physical examination and clinical judgment of the investigator.
✓. Individuals who can comply with all study procedures and are available for follow-up.
Exclusion criteria
✕. Individuals who are pregnant (urine pregnancy test at Study Day 1) or who anticipate becoming pregnant prior to the end of the study, Day 181 Visit.
✕. Individuals "of childbearing potential", heterosexually active, and has not used any of the "acceptable contraceptive methods" for at least 2 months prior to study entry and who will not continue to use acceptable contraceptive methods through to the end of the study, Day 181 Visit.
✕. Individuals who are nursing (breastfeeding).
✕. Individuals who have participated in any clinical trial with another investigational product 30 days prior to first study visit or who intend to participate in another trial prior to the end of the study, Day 181 Visit.
✕. Individuals who have had a previous immunization with a vaccine containing Group B Streptococcus antigens.
✕. Individuals who receive:
✕
What they're measuring
1
Concentration of Serotype Ia GBS IgG Levels in Healthy Non-pregnant Women
Timeframe: At Day 31 after a single vaccination
2
Concentration of Serotype III GBS IgG Levels in Healthy Non-pregnant Women
Timeframe: At Day 31 after a single vaccination
3
Concentration of Serotype Ib GBS IgG Levels in Healthy Non-pregnant Women
. Individuals with a fever (oral temperature ≥ 38°C) within 3 days prior to Study Day 1.
✕. Individuals with acute or chronic infection(s) (e.g. requiring systemic antibiotic treatment or antiviral therapy) within 7 days prior to Study Day 1.