Extension Study to Evaluate the Immunogenicity and Safety of the Second Dose of GBS Trivalent Vac… (NCT02690181) | Clinical Trial Compass
CompletedPhase 2
Extension Study to Evaluate the Immunogenicity and Safety of the Second Dose of GBS Trivalent Vaccine in Healthy Non-Pregnant Subjects.
Belgium80 participantsStarted 2016-03-29
Plain-language summary
The objective of this extension study is the initial assessment of safety and immunogenicity of the second dose of GBS Trivalent Vaccine following the time interval that is close to the inter-pregnancy interval observed in the general population.
Who can participate
Age range22 Years – 46 Years
SexFEMALE
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Inclusion criteria
✓. Healthy, non-pregnant subjects who have received a single 5 µg dose of GBS Trivalent Vaccine or placebo in the V98\_06 study and healthy non-pregnant female subjects aged 22-46 years inclusive on the day of informed consent who have not received any GBS vaccine in the past
✓. Individuals in good health as determined by the outcome of medical history, physical examination and clinical judgment of the investigator
✓. Females of childbearing potential who are using an effective birth control method which they intend to use until the end of the study (day 181 visit) or females of non-childbearing potential
Exclusion criteria
✕. Progressive, unstable or uncontrolled clinical conditions, or clinical conditions representing a contraindication to intramuscular vaccination and blood draws
✕. Abnormal function of the immune system
✕. Received immunoglobulins or any blood products within 180 days prior to informed consent
✕. Received an investigational or non-registered medicinal product within 30 days prior to informed consent
✕. Any other clinical condition that, in the opinion of the investigator, might interfere with the results of the study or pose additional risk to the subject due to participation in the study
✕. Individuals who received any other vaccines within 14 days for inactivated vaccines or 28 days for live vaccines prior to enrolment in this study or who are planning to receive any vaccine within 28 days from the study vaccination. Exception - an inactivated influenza vaccine may be administered up to 7 days prior to study vaccination or 7 days after study vaccination
What they're measuring
1
Percentage of Subjects With ELISA Antibody Concentrations of GBS Serotype Ia Above Pre-specified Thresholds - Day 61
Timeframe: At Day 61
2
Percentage of Subjects With Antibody Concentrations of GBS Serotype Ib Above Pre-specified Thresholds - Day 61
Timeframe: At Day 61
3
Percentage of All Subjects With Antibody Concentrations of GBS Serotype III Above Pre-specified Thresholds - Day 61
Timeframe: At Day 61
4
Numbers of Subjects With Solicited Local and Systemic Adverse Events (AEs)
Timeframe: Day 1 to Day 7
5
Number of Subjects With Any Unsolicited Adverse Events (AEs)
Timeframe: Day 1 to Day 31
6
Number of Subjects With Serious Adverse Events (SAEs), Medically Attended AEs, and AEs Leading to Study Withdrawal