Phase 2 Study Testing Safety and Effectiveness of wSp Vaccine to Prevent Pneumococcal Bacteria in the Nose of Young Children

What this Trial Is About

Researchers are evaluating the safety and effectiveness of the whole-cell pneumococcal vaccine wSp in healthy young children aged approximately 6 months who have already received routine PCV15 or PCV20 vaccinations. The study aims to find out if the wSp vaccine can reduce the presence of pneumococcal bacteria in the nose and safely trigger the immune system to produce protective responses. This Phase 2 clinical trial is sponsored by Serum Life Science Europe GmbH and focuses on preventing infections such as acute otitis media in children. Participants will be randomly assigned to receive two injections given by intramuscular injection either the wSp vaccine containing 1 mg total protein or a saline placebo. The first dose is preferably given in the left thigh around 7 months of age, and the second dose in the right thigh around 9 months of age. The vaccine is supplied in single-dose glass vials with aluminum hydroxide as an adjuvant. The study uses a quadruple masking design to compare immune responses and bacterial colonization between the two groups. During the study, children will have blood samples collected at 6 andor 12 months to measure immune responses and nasal swabs taken at various times between 6 and 24 months to detect pneumococcal colonization and infections. Researchers will monitor for ear infections, respiratory illnesses, and other related infections. The primary outcome is the presence of Streptococcus pneumoniae in the nasopharynx at multiple time points after the second vaccine dose. The total participation period extends up to 24 months of age for observation of infections and immune response.

Safety and Efficacy of wSp Vaccine in Young Children