Study Evaluating Safety & Immunogenicity of rLP2086 Vaccine in Healthy Toddlers

Phase 1CompletedNCT00387569

Wyeth is now a wholly owned subsidiary of Pfizer99 enrolled

Overview

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

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

PREVENTION

Masking

TRIPLE

Enrollment

Conditions

Healthy

Interventions

MnB vaccine rLP8026BIOLOGICAL

MnB vaccine at 20ug dose (0,1,6 months) or control (Hepatitis A vaccine, placebo, Hepatitis A vaccine at 0,1,6 months, respectively)

MnB vaccine rLP8026BIOLOGICAL

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 rLP8026BIOLOGICAL

MnB vaccine at 200ug dose (0,1,6 months) or control (Hepatitis A vaccine, placebo, Hepatitis A vaccine at 0,1,6 months, respectively)

Eligibility

Sex: ALLMin age: 18 MonthsMax age: 36 MonthsHealthy volunteers:

Medical Language ↔ Plain English

Inclusion Criteria * Aged 18- to 36-months * Healthy male or female subjects Exclusion Criteria * Prior vaccination with a serogroup B meningococcal vaccine * Prior history of any invasive meningococcal disease

Locations (1)

Unnamed facility

Perth, Western Australia, Australia

Outcomes

Primary Outcomes

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

Time frame: Vaccinations at 0,1,6 months

Data from ClinicalTrials.gov

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