Study to Evaluate the Safety, Tolerability and Immunogenicity of Three Doses of GBS Vaccine in El… (NCT05782179) | Clinical Trial Compass
CompletedPhase 1
Study to Evaluate the Safety, Tolerability and Immunogenicity of Three Doses of GBS Vaccine in Elderly Participants
Belgium90 participantsStarted 2023-03-01
Plain-language summary
The study is a randomised, double-blind, placebo-controlled, parallel group study to evaluate the safety, tolerability and immunogenicity of three doses of GBS NN/NN2 with Alhydrogel® (Recombinant protein vaccine against Group B Streptococcus) in elderly participants aged 55 to 75.Participants will be followed up to 6 months after last vaccination.
Who can participate
Age range55 Years – 75 Years
SexALL
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Inclusion criteria
✓. Participants aged 55 to 75 years.
✓. Body mass index (BMI) ≥18 and ≤30 kg/m2 for healthy participants, ≥ 30 to ≤45 kg/m2 for obese participants and ≥18 to ≤45 kg/m2 for type 2 diabetic participants.
✓. Able to voluntarily provide written informed consent to participate in the study.
✓. Female participants must be post-menopausal.
✓. Participants capable and willing to follow trial schedule and procedures.
Exclusion criteria
✕. Participants who have received a GBS vaccine previously.
✕. Participants with history or presence of significant (as evaluated by the investigator) cardiovascular disease, pulmonary, hepatic, gallbladder or biliary tract, renal, haematological, gastrointestinal, endocrine, immunologic, dermatological, neurological, psychiatric, autoimmune disease or current infection.
✕. Laboratory values at screening which are deemed by the investigator to be clinically significantly abnormal.
✕. Current or history of drug or alcohol abuse per investigator judgement.
✕. Positive for human immunodeficiency virus (HIV), hepatitis B, or hepatitis C.
✕. Participants currently participating in a clinical trial.
✕. Participants receiving an investigational drug, vaccine or device during the 90 days preceding the initial dose in this study.
What they're measuring
1
Safety and Tolerability of the GBS-NN/NN2 Vaccine for 4 Weeks After Each Dose of Vaccine