In short
Clinical trials investigating Aluminium in the provided data focus on a pneumococcal vaccine study in adults at increased risk for invasive pneumococcal disease. The trial looks at safety, tolerability, and immune response after vaccination. It includes adults in a Phase 3 study.
Key points
- Clinical trial data for Aluminium here describe a Phase 3 study in adults at increased risk for invasive pneumococcal disease. The study examines a pneumococcal vaccine program and compares immune responses after different vaccine regimens. It also tracks safety and tolerability through injection-site reactions, systemic reactions, and serious adverse events. The main immune endpoint is serotype-specific opsonophagocytic activity, measured as GMTs after vaccination. One completed trial is listed, with 500 participants.
Trial overview
The available trial data describe one completed Phase 3 study of a pneumococcal vaccine program in adults at increased risk for invasive pneumococcal disease. The study title shows that it evaluated the V116 vaccine in this higher-risk adult group.
Who participated
The study population was adults who had an increased risk for invasive pneumococcal disease. The source data do not list the full eligibility rules, so only this broad target group can be confirmed.
What was studied
This was an interventional study, which means participants received study treatments and were followed for outcomes. The interventions listed include the Pneumococcal 21-valent Conjugate Vaccine, pneumococcal purified polysaccharides antigen, and a sodium chloride infusion used as a comparison treatment in the study records.
The brief summary says the study compared V116 with a regimen of PCV15 plus PPSV23, and it looked at results within each vaccination group separately. In simple terms, the researchers wanted to see how the different vaccine approaches performed in this at-risk adult group.
Outcomes measured
The main safety outcomes were the percentage of participants with solicited injection-site adverse events from Day 1 through Day 5 after vaccination, and the percentage with solicited systemic adverse events during the same time window. “Solicited” means the study team specifically asked about these expected reactions during follow-up.
The study also measured the percentage of participants with vaccine-related serious adverse events from Day 1 through the full time in the study. Serious adverse events are important medical problems that may need urgent care or hospital treatment.
For immune response, the trial measured serotype-specific OPA GMTs after vaccination. OPA is a lab test that shows how well antibodies help the immune system clear bacteria, and GMT means the average antibody level used in study reports.
Trial phase and status
The study was in Phase 3 and is marked as Completed. Phase 3 studies are usually larger studies that help researchers understand safety and immune response in more people. The enrollment listed for this trial was 500 participants.
Key patient points
This trial focused on preventing serious pneumococcal disease in adults at higher risk. It mainly asked two questions: whether the vaccine approach was safe and how strong the immune response was after vaccination. The study followed participants for short-term reactions after vaccination and for longer-term serious events during the study period.