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A study to assess the safety of an investigational meningitis vaccine in toddlers and their immune response to it.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Cohort 1 | Experimental | Experimental (20ug); Active Comparator/Placebo |
|
| Cohort 2 | Experimental | Experimental (60ug); Active Comparator/Placebo |
|
| Cohort 3 | Experimental | Experimental (200ug); Active Comparator/Placebo |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| MnB vaccine rLP8026 | Biological | MnB vaccine at 20ug dose (0,1,6 months) or control (Hepatitis A vaccine, placebo, Hepatitis A vaccine at 0,1,6 months, respectively) |
|
| Measure | Description | Time Frame |
|---|---|---|
| Local and systemic reactions through 14 days post-injection; Vaccinations at 0,1,6 months | Vaccinations at 0,1,6 months |
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Inclusion Criteria
Exclusion Criteria
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| Name | Affiliation | Role |
|---|---|---|
| Medical Monitor | Wyeth is now a wholly owned subsidiary of Pfizer | Study Director |
| Trial Manager | For Australia, medinfo@wyeth.com | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Perth | Western Australia | 6840 | Australia |
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| MnB vaccine rLP8026 | Biological | MnB vaccine at 60ug dose (0,1,6 months) or control (Hepatitis A vaccine, placebo, Hepatitis A vaccine at 0,1,6 months, respectively) |
|
| MnB vaccine rLP8026 | Biological | MnB vaccine at 200ug dose (0,1,6 months) or control (Hepatitis A vaccine, placebo, Hepatitis A vaccine at 0,1,6 months, respectively) |
|