Group B Streptococcus Vaccine in Healthy Females (NCT03807245) | Clinical Trial Compass
CompletedPhase 1
Group B Streptococcus Vaccine in Healthy Females
United Kingdom60 participantsStarted 2019-01-09
Plain-language summary
A Phase I, randomised, single centre, double-blind, placebo-controlled, parallel group study to evaluate the safety, tolerability and immunogenicity of two doses of Group B Streptococcus vaccine.
Who can participate
Age range
18 Years – 40 Years
Sex
FEMALE
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion criteria
. Healthy female subjects aged 18 - 40 years.
. Body mass index (BMI) ≥18 and ≤30 kg/m2.
. Subjects weight ≥50kg and ≤100kg at screening.
. Able to voluntarily provide written informed consent to participate in the study.
. Subjects are pre-menopausal.
. Females of childbearing potential must have a negative pregnancy test at screening (β HCG) and prior to each dose. To prevent pregnancy female subjects of childbearing potential must take adequate contraceptive precautions for the entire duration of study participation (up to Day 85). Adequate and highly effective contraceptive precautions include:
. Non-smokers for at least 3 months prior to first study vaccine administration.
Exclusion criteria
. Subjects who have received GBS-NN vaccine previously.
. Subjects with history or presence of significant cardiovascular disease, pulmonary, hepatic, gallbladder or biliary tract, renal, haematological, gastrointestinal, endocrine, immunologic, dermatological, neurological, psychiatric, autoimmune disease or current infection.
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Number of Participants With Treatment Emergent Adverse Events
. Laboratory values at screening which are deemed by the investigator to be clinically significantly abnormal.
. Positive drug screen for drugs of abuse or a positive alcohol urine test prior to first dosing unless there is a documented medical explanation for the positive result other than drugs of abuse (e.g., the subject has been prescribed opioids for pain).
. Positive for human immunodeficiency virus (HIV), hepatitis B or hepatitis C.
. Participation in a clinical drug study during the 90 days preceding the initial dose in this study.
. Any significant illness during the 4 weeks preceding check-in for this study (Day 1).