NCT03303976

Phase I to Test a New Pneumococcal Vaccine

Safety and Immunogenicity of a Candidate Bioconjugate Vaccine Against Streptococcus Pneumoniae When Administered to Adult and Elderly Healthy Subjects. A Phase I Randomized Study.

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 72 (actual)
• Sponsor: LimmaTech Biologics AG · Industry
• Sex: All
• Age: 60 Years – 70 Years
• Healthy volunteers: Accepted

Summary

To obtain first-in-human data on a new candidate vaccine against Streptococcus pneumoniae in healthy adult and elderly volunteers. The study aims to assess the safety and immunogenicity of a bioconjugate investigational vaccine compared to the control group (Pneumovax23).

Detailed description

The study aims to assess the safety and immunogenicity of a new bioconjugate investigational vaccine compared to the control group (Pneumovax23) in a randomised, staggered, 2-steps controlled trial.

Conditions

• Pneumococcal Pneumonia
• Pneumonia, Bacterial

Interventions

Type	Name	Description
BIOLOGICAL	Bioconjugate pneumococcal vaccine	Bioconjuagte vaccine against bacterial pneumococcal infection
BIOLOGICAL	Multivalent plain polysaccharide vaccine	Multivalent plain polysaccharide vaccine against bacterial pneumococcal infection

Timeline

• Start date: 2017-09-07
• Primary completion: 2018-09-12
• Completion: 2018-09-12
• First posted: 2017-10-06
• Last updated: 2018-12-04

Locations

1 site across 1 country: Germany