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Serum Life Science Europe GmbH

🇩🇪Germany
Ownership
-
Employees
-
Market Cap
-
Website

Clinical Trials

1

Active:0
Completed:0

Trial Phases

1 Phases

Not Applicable:1

Drug Approvals

1

EMA:1

Drug Approvals

Siiltibcy

Authorization Status
Authorised
Approval Date
Jan 13, 2025
EMA

Clinical Trials

Distribution across different clinical trial phases (1 trials with phase data)• Click on a phase to view related trials

Not Applicable
1 (100.0%)

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

Not Applicable
Recruiting
Conditions
PREVENTION OF INVASIVE PNEUMOCOCCAL DISEASE
Prevention of Pneumococcal-induced Acute Otitis Media
Interventions
Biological: Inactivated whole-cell Streptococcus pneumoniae vaccine
Drug: Placebo
First Posted Date
2025-07-10
Last Posted Date
2025-07-31
Lead Sponsor
Serum Life Science Europe GmbH
Target Recruit Count
30
Registration Number
NCT07059182
Locations
🇺🇸

Rochester Clinical Research, Rochester, New York, United States

News

SIILTIBCY Receives Positive CHMP Opinion for Tuberculosis Detection in Europe

• The European Medicines Agency's CHMP has recommended SIILTIBCY, a novel tuberculosis skin test, for approval in Europe. • SIILTIBCY is designed to accurately detect TB, irrespective of prior BCG vaccination status, addressing a key diagnostic challenge. • Phase 3 clinical trials involving over 2,500 participants demonstrated the accuracy and safety of SIILTIBCY in diagnosing TB. • Upon European Commission approval, SIILTIBCY will be available in EU Member States, with SLS Europe managing authorization and BBio handling distribution.

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