Study Evaluating Safety & Immunogenicity of rLP2086 Vaccine in Healthy Toddlers

Wyeth

Status and phase: Completed; Phase 1

Conditions: Healthy

Treatments: Biological: MnB vaccine rLP8026

Study type: Interventional

Funder types: Industry

Identifiers

NCT00387569

6108A1-502

Details and patient eligibility

About

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

Enrollment: 99 estimated patients

Sex: All

Ages: 18 to 36 months old

Volunteers: Accepts Healthy Volunteers

Inclusion and exclusion criteria

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

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Triple Blind

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99 participants in 3 patient groups

Cohort 1

Experimental group

Description:

Experimental (20ug); Active Comparator/Placebo

Treatment:

Biological: MnB vaccine rLP8026

Biological: MnB vaccine rLP8026

Biological: MnB vaccine rLP8026

Cohort 2

Experimental group

Description:

Experimental (60ug); Active Comparator/Placebo

Treatment:

Biological: MnB vaccine rLP8026

Biological: MnB vaccine rLP8026

Biological: MnB vaccine rLP8026

Cohort 3

Experimental group

Description:

Experimental (200ug); Active Comparator/Placebo

Treatment:

Biological: MnB vaccine rLP8026

Biological: MnB vaccine rLP8026

Biological: MnB vaccine rLP8026