Study Evaluating Safety & Immunogenicity of rLP2086 Vaccine in Adolescents

Phase 2CompletedNCT00387725

Pfizer127 enrolled

Overview

Study to evaluate the safety of an investigational meningitis vaccine and the immune response to it in adolescents

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

PREVENTION

Masking

DOUBLE

Enrollment

127

Conditions

Healthy

Interventions

rLP2086BIOLOGICAL

Vaccine administered at 0, 1, and 6 months

rLP2086BIOLOGICAL

Vaccine administered at 0, 1, and 6 months

rLP2086BIOLOGICAL

Vaccine administered at 0, 1, and 6 months

rLP2086

Eligibility

Sex: ALLMin age: 8 YearsMax age: 14 Years

Medical Language ↔ Plain English

Inclusion Criteria: Inclusion Criteria * Aged 8 to 14 years at the time of enrollment. * Healthy male or female subjects * Negative urine pregnancy test for female subjects Exclusion Criteria: Exclusion Criteria * Prior vaccination with a meningococcal B vaccine * Prior meningococcal disease

Locations (9)

Sydney Children's Hospital

Randwick, New South Wales, Australia

The Children's Hospital at Westmead

Westmead, New South Wales, Australia

Royal Children's Hospital

Herston, Queensland, Australia

Princess Margaret Hospital for Children

Outcomes

Primary Outcomes

Percentage of Participants With Seroconversion in rLP2086 Specific Serum Bactericidal Assay (SBA) Titer 1 Month After Dose 2

Time frame: 1 month after Dose 2

Percentage of Participants With Seroconversion in rLP2086 Specific SBA Titer 1 Month After Dose 3

Time frame: 1 month after Dose 3

Percentage of Participants With at Least One Adverse Event (AE)

Time frame: Dose 1 up to 1 month after Dose 3

Data from ClinicalTrials.gov

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