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Aluminium

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.

Table of contents

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.[1] The study title shows that it evaluated the V116 vaccine in this higher-risk adult group.[1]

Who participated

The study population was adults who had an increased risk for invasive pneumococcal disease.[1] The source data do not list the full eligibility rules, so only this broad target group can be confirmed.[1]

What was studied

This was an interventional study, which means participants received study treatments and were followed for outcomes.[1] 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.[1]

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.[1] In simple terms, the researchers wanted to see how the different vaccine approaches performed in this at-risk adult group.[1]

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.[1] “Solicited” means the study team specifically asked about these expected reactions during follow-up.[1]

The study also measured the percentage of participants with vaccine-related serious adverse events from Day 1 through the full time in the study.[1] Serious adverse events are important medical problems that may need urgent care or hospital treatment.[1]

For immune response, the trial measured serotype-specific OPA GMTs after vaccination.[1] 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.[1]

Trial phase and status

The study was in Phase 3 and is marked as Completed.[1] Phase 3 studies are usually larger studies that help researchers understand safety and immune response in more people.[1] The enrollment listed for this trial was 500 participants.[1]

Key patient points

This trial focused on preventing serious pneumococcal disease in adults at higher risk.[1] It mainly asked two questions: whether the vaccine approach was safe and how strong the immune response was after vaccination.[1] The study followed participants for short-term reactions after vaccination and for longer-term serious events during the study period.[1]

Trial ID Phase Condition studied Status Enrollment
2022-502791-22-01 Phase 3 Pneumococcal infection Completed 500

FAQ

  • What is being studied in the Aluminium trial data? The trial data describe a study of a pneumococcal vaccine program in adults at increased risk for invasive pneumococcal disease. It compares vaccine regimens and measures safety and immune response.
  • Who can take part in the trial? The study is for adults who have an increased risk for invasive pneumococcal disease. The source does not give more detailed eligibility rules.
  • What phase is the trial? The study is in Phase 3. This means it is a later-stage clinical trial that usually helps confirm safety and how well the vaccine response works in a larger group.
  • What outcomes are measured? The trial measures injection-site reactions, systemic reactions, serious adverse events, and serotype-specific opsonophagocytic activity, or OPA. OPA is a lab measure of how well antibodies help the immune system clear bacteria.
  • What condition is the trial studying? The condition studied is pneumococcal infection. The study focuses on prevention in adults at higher risk for invasive disease.

Ongoing Clinical Trials on Aluminium

  • Study on the V116 Vaccine for Adults Aged 18-64 at Increased Risk of Pneumococcal Infection

    Not recruiting

    1 1 1
    Investigated drugs:
    Poland

Glossary

  • Phase 3: A later stage of clinical research that tests a treatment or vaccine in a larger group of people.
  • Pneumococcal infection: An infection caused by pneumococcal bacteria, which can lead to serious illness.
  • Invasive pneumococcal disease: A severe form of pneumococcal infection that spreads into parts of the body where bacteria are not usually found.
  • Vaccine: A product given to help the body build protection against a disease.
  • Safety: How often unwanted medical problems happen during a study.
  • Tolerability: How well participants can handle the study treatment without major problems.
  • Adverse event: A medical problem that happens during a study, whether or not it is caused by the study treatment.
  • Serious adverse event: A severe medical problem that may need hospital care, cause lasting harm, or be life-threatening.
  • Injection-site adverse event: A reaction where the shot was given, such as pain, redness, or swelling.
  • Systemic adverse event: A reaction that affects the whole body, not just the injection area.
  • Opsonophagocytic activity (OPA): A lab test that shows how well antibodies help immune cells find and remove bacteria.
  • Geometric mean titer (GMT): An average level used in studies to describe antibody results.

References

  1. https://clinicaltrials.gov/study/2022-502791-22-01