Clinical trial
A Phase I, Single-center, Randomized, Observer-blind, Placebo-controlled Study to Evaluate Safety, Reactogenicity and Immunogenicity of GSK's Clostridium Difficile Investigational Vaccine Based on the F2 Antigen With or Without AS01B Adjuvant, When Administered Intramuscularly According to a 0, 1-month Schedule to Healthy Adults Aged Between 18-45 Years and Between 50-70 Years, Followed by an Additional Dose Administered in a Partial Blind Manner Within an Interval of Approximately 15 Months After Dose 2, in a Subcohort of Subjects Aged 50-70 Years
NCT04026009 is registered in ClinicalTrials.gov with GlaxoSmithKline as lead sponsor.
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Registry record
As filed in ClinicalTrials.gov.
- Title
- A Phase I, Single-center, Randomized, Observer-blind, Placebo-controlled Study to Evaluate Safety, Reactogenicity and Immunogenicity of GSK's Clostridium Difficile Investigational Vaccine Based on the F2 Antigen With or Without AS01B Adjuvant, When Administered Intramuscularly According to a 0, 1-month Schedule to Healthy Adults Aged Between 18-45 Years and Between 50-70 Years, Followed by an Additional Dose Administered in a Partial Blind Manner Within an Interval of Approximately 15 Months After Dose 2, in a Subcohort of Subjects Aged 50-70 Years
- Lead sponsor
- GlaxoSmithKline
- Phase
- Phase 1
- Overall status
- Completed
- Start date
- August 5, 2019
- Completion date
- May 10, 2022
- Enrollment
- 140 (actual)
- Sites
- 1
Conditions
As the registry lists them; a condition with its own page is linked.