A Phase 1 interventional study of Pneumococcal vaccine Formulation 1 and Pneumococcal vaccine Formulation 2 in Pneumococcal Infections, Streptococcus Pneumoniae Infections and Pneumococcal Pneumonia, sponsored by Sanofi Pasteur, a Sanofi Company. Completed at 1 site in Switzerland. Open to participants aged 18 Years to 50 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2015-03-18.
Sponsored by Sanofi Pasteur, a Sanofi Company · Phase 1, Interventional, and Prevention
This study is designed to evaluate the safety, tolerability, and immunogenicity of an investigational pneumococcal vaccine in healthy adult volunteers.
Primary Objective:
Observational Objective:
An initial cohort of 10 participants will receive a single dose of investigational pneumococcal vaccine. After safety assessment of this cohort during a 24-hour in-unit observation period, additional cohorts will receive two injections of the study vaccine 30 days apart, at three dose levels, in ascending doses by cohort, pending safety review at each dose level. All participants will be monitored for safety for 30 days after each vaccination.
6,687 studies on the registry are indexed under Infections; 807 are open to participants now.
This study's enrollment of 100 is below the median of 120 across 4,200 interventional studies indexed under Infections.
Browse Infections studies →Sanofi Pasteur, a Sanofi Company is the lead sponsor of 366 studies on the registry; 4 are open to participants now.
Of its 94 completed or terminated interventional studies of FDA-regulated products, 73 (78%) have results posted.
Counted across the registry records on this site, refreshed daily.
Exclusion Criteria:
Participants will receive 2 injections of Pneumococcal Vaccine Formulation 1 (Low dose).
Biological: Pneumococcal vaccine Formulation 1
Participants will receive 2 injections of Pneumococcal Vaccine Formulation 2, (Middle dose).
Biological: Pneumococcal vaccine Formulation 2
Participants will receive 2 injections of Pneumococcal Vaccine Formulation 3, (High dose).
Biological: Pneumococcal vaccine Formulation 3
Participants who receive 2 injections of tris buffered saline
Biological: Placebo
0.5 mL, Intramuscular (Low dose)
0.5 mL, Intramuscular (Middle dose)
0.5 mL, Intramuscular (High dose)
0.5 mL, Intramuscular
Also known as: Tris Buffered Saline
Number and percentage of participants reporting solicited injection site reactions, solicited systemic reactions, unsolicited systemic reactions, and serious adverse events occurring throughout the trial
Solicited injection site reactions: Pain, Erythema, and Swelling. Solicited systemic reactions: Fever (Temperature), Headache, Malaise, and Myalgia.
Time frame: Days 0 through 30 post-vaccination
Immunogenicity of Pneumococcal Vaccine After two Vaccinations
Evaluation of immune responses to antigen component of the investigational vaccine by enzyme-linked immunosorbent assay (ELISA).
Time frame: Days 0 and 30 days post-vaccination
This study is completed, as verified in Mar 2015. You cannot join it, but the record below documents what was studied.
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Sanofi Pasteur, a Sanofi Company