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

NCT07059182 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 30

Last updated 2025-10-24

No results posted yet for this study

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.

Conditions

  • PREVENTION OF INVASIVE PNEUMOCOCCAL DISEASE
  • Prevention of Pneumococcal-induced Acute Otitis Media

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

Sponsors & Collaborators

  • Serum Life Science Europe GmbH

    lead INDUSTRY

Study Design

Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
49 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2025-06-11
Primary Completion
2025-08-29
Completion
2025-08-29
FDA Drug
Yes

Countries

  • United States

Study Locations

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Entities

Drugs

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT07059182 on ClinicalTrials.gov