NCT04959344View on ClinicalTrials.gov

Safety and Immunogenicity of a Klebsiella Pneumoniae Tetravalent Bioconjugate Vaccine (Kleb4V)

PHASE1/PHASE2CompletedINTERVENTIONAL
Enrollment

166

Participants

Timeline

Start Date

July 5, 2021

Primary Completion Date

September 26, 2022

Study Completion Date

September 26, 2022

Conditions
Klebsiella Pneumoniae Infection
Interventions
BIOLOGICAL

Kleb4V target dose

Two doses of the non-adjuvanted Kleb4V target dose will be administered intramuscularly 2 months apart

BIOLOGICAL

Kleb4V target dose + AS03

Two doses of the adjuvanted Kleb4V target dose will be administered intramuscularly 2 months apart

BIOLOGICAL

Kleb4V low dose

Two doses of the non-adjuvanted Kleb4V low dose will be administered intramuscularly 2 months apart

BIOLOGICAL

Kleb4V low dose + AS03

Two doses of the adjuvanted Kleb4V low dose will be administered intramuscularly 2 months apart

BIOLOGICAL

Placebo

Two doses of the Placebo will be administered intramuscularly 2 months apart

Trial Locations (2)

82131

Nuvisan GmbH, Standort Gauting, Robert-Koch-Allee 29, Gauting

89231

Nuvisan GmbH, Standort Neu-Ulm, Wegenerstrasse 13, Neu-Ulm

Sponsors

Collaborators (1)

GlaxoSmithKline
All Listed Sponsors
collaborator

GlaxoSmithKline

INDUSTRY

lead

LimmaTech Biologics AG

INDUSTRY

NCT04959344 - Safety and Immunogenicity of a Klebsiella Pneumoniae Tetravalent Bioconjugate Vaccine (Kleb4V) | Biotech Hunter | Biotech Hunter