Study Evaluating Safety & Immunogenicity of rLP2086 Vaccine in Healthy Toddlers

Phase 1

Completed

• Conditions: Healthy
• Interventions: Biological: MnB vaccine rLP8026

• Registration Number: NCT00387569
• Lead Sponsor: Wyeth is now a wholly owned subsidiary of Pfizer

Brief Summary

A study to assess the safety of an investigational meningitis vaccine in toddlers and their immune response to it.

Detailed Description

Not available

Study Timeline

• Study Start: 2006-10
• Study First Submitted: 2006-10-11
• Study First Submitted QC: 2006-10-12
• Study First Posted: 2006-10-13
• Primary Completion: 2008-03
• Study Completion: 2008-03
• Status Verified: 2008-05
• Last Update Submitted: 2008-05-06
• Last Update Posted: 2008-05-08

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 99

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Cohort 1	MnB vaccine rLP8026	Experimental (20ug); Active Comparator/Placebo
Cohort 2	MnB vaccine rLP8026	Experimental (60ug); Active Comparator/Placebo
Cohort 3	MnB vaccine rLP8026	Experimental (200ug); Active Comparator/Placebo

Primary Outcome Measures

Name	Time	Method
Local and systemic reactions through 14 days post-injection; Vaccinations at 0,1,6 months	Vaccinations at 0,1,6 months