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Study Evaluating Safety & Immunogenicity of rLP2086 Vaccine in Healthy Toddlers

NCT ID: NCT00387569

Last Updated: 2008-05-08

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE1

Total Enrollment

99 participants

Study Classification

INTERVENTIONAL

Study Start Date

2006-10-31

Study Completion Date

2008-03-31

Brief Summary

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

Detailed Description

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Conditions

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Healthy

Keywords

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Toddlers Vaccine Safety

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

PREVENTION

Blinding Strategy

TRIPLE

Participants Investigators Outcome Assessors

Study Groups

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Cohort 1

Experimental (20ug); Active Comparator/Placebo

Group Type EXPERIMENTAL

MnB vaccine rLP8026

Intervention Type 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)

Cohort 2

Experimental (60ug); Active Comparator/Placebo

Group Type EXPERIMENTAL

MnB vaccine rLP8026

Intervention Type 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)

Cohort 3

Experimental (200ug); Active Comparator/Placebo

Group Type EXPERIMENTAL

MnB vaccine rLP8026

Intervention Type 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)

Interventions

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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)

Intervention Type 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)

Intervention Type 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)

Intervention Type BIOLOGICAL

Eligibility Criteria

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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
Minimum Eligible Age

18 Months

Maximum Eligible Age

36 Months

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Wyeth is now a wholly owned subsidiary of Pfizer

INDUSTRY

Sponsor Role lead

Responsible Party

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Wyeth

Principal Investigators

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Medical Monitor

Role: STUDY_DIRECTOR

Wyeth is now a wholly owned subsidiary of Pfizer

Trial Manager

Role: PRINCIPAL_INVESTIGATOR

For Australia, [email protected]

Locations

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Perth, Western Australia, Australia

Site Status

Countries

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Australia

Other Identifiers

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6108A1-502

Identifier Type: -

Identifier Source: org_study_id