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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Vaccine Formulation 1 (Low dose) | Experimental | Participants will receive 2 injections of Pneumococcal Vaccine Formulation 1 (Low dose). |
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| Vaccine Formulation 2 (Middle dose) | Experimental | Participants will receive 2 injections of Pneumococcal Vaccine Formulation 2, (Middle dose). |
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| Vaccine Formulation 3 (High dose) | Experimental | Participants will receive 2 injections of Pneumococcal Vaccine Formulation 3, (High dose). |
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| Placebo Pooled | Placebo Comparator | Participants who receive 2 injections of tris buffered saline |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Pneumococcal vaccine Formulation 1 | Biological | 0.5 mL, Intramuscular (Low dose) |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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. | Days 0 through 30 post-vaccination |
| Measure | Description | Time Frame |
|---|---|---|
| Immunogenicity of Pneumococcal Vaccine After two Vaccinations | Evaluation of immune responses to antigen component of the investigational vaccine by enzyme-linked immunosorbent assay (ELISA). | Days 0 and 30 days post-vaccination |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Medical Director | Sanofi Pasteur Ltd. | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Allschwil | Switzerland |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 23153437 | Derived | Kamtchoua T, Bologa M, Hopfer R, Neveu D, Hu B, Sheng X, Corde N, Pouzet C, Zimmermann G, Gurunathan S. Safety and immunogenicity of the pneumococcal pneumolysin derivative PlyD1 in a single-antigen protein vaccine candidate in adults. Vaccine. 2013 Jan 2;31(2):327-33. doi: 10.1016/j.vaccine.2012.11.005. Epub 2012 Nov 12. |
| Label | URL |
|---|---|
| Related Info | View source |
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| Pneumococcal vaccine Formulation 2 | Biological | 0.5 mL, Intramuscular (Middle dose) |
|
| Pneumococcal vaccine Formulation 3 | Biological | 0.5 mL, Intramuscular (High dose) |
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| Placebo | Biological | 0.5 mL, Intramuscular |
|
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| ID | Term |
|---|---|
| D011008 | Pneumococcal Infections |
| D011018 | Pneumonia, Pneumococcal |
| ID | Term |
|---|---|
| D013290 | Streptococcal Infections |
| D016908 | Gram-Positive Bacterial Infections |
| D001424 | Bacterial Infections |
| D001423 | Bacterial Infections and Mycoses |
| D007239 | Infections |
| D018410 | Pneumonia, Bacterial |
| D011014 | Pneumonia |
| D012141 | Respiratory Tract Infections |
| D008171 | Lung Diseases |
| D012140 | Respiratory Tract Diseases |
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