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COMPLETED
NCT07059182
PHASE1

Safety Study of a Single Dose of Pneumococcal Whole-Cell Vaccine in Healthy Adults

Sponsor: Serum Life Science Europe GmbH

View on ClinicalTrials.gov

Summary

The goal of this clinical trial is to learn if whole-cell Streptococcus pneumoniae (wSp) vaccination is safe and tolerated in healthy adults. The main aim is to evaluate the safety and tolerability of wSp vaccine. Researchers will compare wSp vaccinated participants with placebo-treated participants. Participants will be administered once with 1mg wSp vaccine or placebo. After dosing, they will be followed up for 30 days. In addition to the screening and enrollment visits, each participant will come to the study site for scheduled study visits on Days 14 and 30 to undergo study evaluations and measurements and to monitor safety. Each participant also will receive scheduled phone calls on Days 3 and 7 to monitor safety.

Official title: Phase 1 Trial to Assess Safety and Tolerability of a Single Dose of Streptococcus Pneumoniae Whole-Cell (wSp) Vaccine in Healthy Adults

Key Details

Gender

All

Age Range

18 Years - 49 Years

Study Type

INTERVENTIONAL

Enrollment

30

Start Date

2025-06-11

Completion Date

2025-08-29

Last Updated

2026-11-03

Healthy Volunteers

Yes

Interventions

BIOLOGICAL

Inactivated whole-cell Streptococcus pneumoniae vaccine

Single intramuscular injection of 1 mg protein/0.5 mL wSp vaccine

DRUG

Placebo

Single intramuscular injection of 0.5 mL placebo

Locations (1)

Rochester Clinical Research

Rochester, New York, United States