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This study was designed to evaluate the safety, tolerability, and immunogenicity of three doses of an investigational pneumococcal vaccine in healthy adult volunteers.
Primary Objective:
Each volunteer participant will receive two injections with one of three vaccine doses, administered on Day 0 and Day 30, in a dose-ascending manner, pending safety review at each dose level. All participants will be monitored for safety for 30 days after each injection.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Pneumococcal Vaccine Dose 1 (Low dose) | Experimental | Participants will receive 2 injections of Dose 1 investigational Pneumococcal vaccine (Low dose) on Day 0 and Day 30, respectively. |
|
| Pneumococcal Vaccine Dose 2 (Middle dose) | Experimental | Participants will receive 2 injections of the investigational Pneumococcal vaccine (Middle dose) on Day 0 and Day 30, respectively. |
|
| Pneumococcal Vaccine Dose 3 (High dose) | Experimental | Participants will receive 2 injections of the investigational Pneumococcal vaccine (High dose) on Day 0 and Day 30, respectively. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Pneumococcal Vaccine | Biological | 0.5 mL, intramuscular |
| |
| Measure | Description | Time Frame |
|---|---|---|
| The occurrence of 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 | Day 0 up to Day 60 post vaccination |
| Measure | Description | Time Frame |
|---|---|---|
| Immunogenicity of pneumococcal vaccine after 2 vaccinations | Evaluation of immune responses to antigen component of the investigational vaccine by enzyme linked immunosorbent assay (ELISA). | Day 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 |
|---|---|---|---|
| 23131206 | Derived | Seiberling M, Bologa M, Brookes R, Ochs M, Go K, Neveu D, Kamtchoua T, Lashley P, Yuan T, Gurunathan S. Safety and immunogenicity of a pneumococcal histidine triad protein D vaccine candidate in adults. Vaccine. 2012 Dec 14;30(52):7455-60. doi: 10.1016/j.vaccine.2012.10.080. Epub 2012 Nov 3. |
| Label | URL |
|---|---|
| Related Info | View source |
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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 |
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| ID | Term |
|---|---|
| D022242 | Pneumococcal Vaccines |
| ID | Term |
|---|---|
| D022541 | Streptococcal Vaccines |
| D001428 | Bacterial Vaccines |
| D014612 | Vaccines |
| D001688 | Biological Products |
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| Pneumococcal Vaccine |
| Biological |
0.5 mL, intramuscular |
|
| Pneumococcal Vaccine | Biological | 0.5 mL, intramuscular |
|
| D007239 | Infections |
| D018410 | Pneumonia, Bacterial |
| D011014 | Pneumonia |
| D012141 | Respiratory Tract Infections |
| D008171 | Lung Diseases |
| D012140 | Respiratory Tract Diseases |
| D045424 |
| Complex Mixtures |