Study Evaluating Safety & Immunogenicity of rLP2086 Vaccine in Healthy Toddlers
NCT00387569 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 99
Last updated 2008-05-08
Summary
A study to assess the safety of an investigational meningitis vaccine in toddlers and their immune response to it.
Conditions
- Healthy
Interventions
- BIOLOGICAL
-
MnB vaccine rLP8026
MnB vaccine at 20ug dose (0,1,6 months) or control (Hepatitis A vaccine, placebo, Hepatitis A vaccine at 0,1,6 months, respectively)
- BIOLOGICAL
-
MnB vaccine rLP8026
MnB vaccine at 60ug dose (0,1,6 months) or control (Hepatitis A vaccine, placebo, Hepatitis A vaccine at 0,1,6 months, respectively)
- BIOLOGICAL
-
MnB vaccine rLP8026
MnB vaccine at 200ug dose (0,1,6 months) or control (Hepatitis A vaccine, placebo, Hepatitis A vaccine at 0,1,6 months, respectively)
Sponsors & Collaborators
-
Wyeth is now a wholly owned subsidiary of Pfizer
lead INDUSTRY
Principal Investigators
-
Medical Monitor · Wyeth is now a wholly owned subsidiary of Pfizer
-
Trial Manager · For Australia, [email protected]
Study Design
- Allocation
- RANDOMIZED
- Purpose
- PREVENTION
- Masking
- TRIPLE
- Model
- PARALLEL
Eligibility
- Min Age
- 18 Months
- Max Age
- 36 Months
- Sex
- ALL
- Healthy Volunteers
- Yes
Timeline & Regulatory
- Start
- 2006-10-31
- Primary Completion
- 2008-03-31
- Completion
- 2008-03-31
Countries
- Australia
Study Locations
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