Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
This study is designed to evaluate the safety, tolerability, and immunogenicity of two investigational pneumococcal vaccines at three dose levels in healthy adults.
Primary Objective:
- To evaluate the safety and tolerability of two investigational pneumococcal vaccines.
Observational Objective:
- To evaluate the immunogenicity of the investigational pneumococcal vaccines.
An initial cohort of 6 participants will receive a single dose of one of two investigational pneumococcal vaccines. After safety evaluation of that cohort, additional cohorts will receive 2 injections 30 days apart of same investigational pneumococcal vaccine at same or increased dose level. All participants will be monitored for safety for 30 days after each vaccination.
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Pneumococcal Vaccine Formulation 1 | Experimental | Participants will receive an injection of pneumococcal vaccine (Formulation 1, 1 middle dose) on Day 0 and Day 30, respectively. |
|
| Pneumococcal Vaccine Formulation 2 | Experimental | Participants will receive an injection of Pneumococcal vaccine (Formulation 2, 2 low doses) on Day 0 and Day 30, respectively. |
|
| Pneumococcal Vaccine Formulation 3 | Experimental | Participants will receive an injection of pneumococcal vaccine (Formulation 3, 2 middle doses) on Day 0 and Day 30, respectively. |
|
| Pneumococcal Vaccine Formulation 4 | Experimental | Participants will receive an injection of pneumococcal vaccine (Formulation 4, 2 middle doses) on Day 0 and Day 30, respectively. |
|
| Pneumococcal Vaccine Formulation 5 | Experimental | Participants will receive an injection of pneumococcal vaccine (Formulation 5, 2 high doses) on Day 0 and Day 30, respectively. |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Pneumococcal Vaccine Formulation 1 | Biological | 0.5 mL, intramuscular (1 middle 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 | 30 days post-vaccination |
| Measure | Description | Time Frame |
|---|---|---|
| Immunogenicity of Investigational Pneumococcal vaccines after 2 vaccinations | Evaluation of immune responses to antigen component of the investigational vaccine by enzyme linked immunosorbent assay (ELISA). | Days 0 and 30 post-vaccination |
Not provided
Inclusion Criteria:
Exclusion Criteria:
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Affiliation | Role |
|---|---|---|
| Medical Director | Sanofi Pasteur Ltd. | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Allschwil | Switzerland |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 23123106 | Derived | Bologa M, Kamtchoua T, Hopfer R, Sheng X, Hicks B, Bixler G, Hou V, Pehlic V, Yuan T, Gurunathan S. Safety and immunogenicity of pneumococcal protein vaccine candidates: monovalent choline-binding protein A (PcpA) vaccine and bivalent PcpA-pneumococcal histidine triad protein D vaccine. Vaccine. 2012 Dec 14;30(52):7461-8. doi: 10.1016/j.vaccine.2012.10.076. Epub 2012 Nov 2. |
| Label | URL |
|---|---|
| Related Info | View source |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
|
| Pooled placebo Group | Placebo Comparator | Participants will receive an injection of a placebo on Day 0 and Day 30, respectively. |
|
| Pneumococcal Vaccine Formulation 2 | Biological | 0.5 mL, intramuscular (2 low doses) |
|
| Pneumococcal Vaccine Formulation 3 | Biological | 0.5 mL, intramuscular (2 middle doses) |
|
| Pneumococcal Vaccine Formulation 4 | Biological | 0.5 mL, intramuscular (2 middle doses) |
|
| Pneumococcal Vaccine Formulation 5 | Biological | 0.5 mL, intramuscular (2 high doses) |
|
| Placebo | Biological | 0.5 mL, intramuscular |
|
|
| 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 |
Not provided
Not provided