Study Evaluating Safety & Immunogenicity of rLP2086 Vaccine in Adolescents

Phase 2

Completed

• Conditions: Healthy
• Interventions: Biological: rLP2086

• Registration Number: NCT00387725
• Lead Sponsor: Pfizer

Brief Summary

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

Detailed Description

Not available

Basic Information
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Recruitment & Eligibility
|
Study & Design
|
Trial Locations

Study Timeline

• Study First Submitted: 2006-10-11
• Study First Submitted QC: 2006-10-12
• Study First Posted: 2006-10-13
• Study Start: 2006-11
• Primary Completion: 2008-01
• Study Completion: 2008-02
• Status Verified: 2014-11
• Results First Submitted: 2014-11-14
• Results First Submitted QC: 2014-11-14
• Last Update Submitted: 2014-11-14
• Results First Posted: 2014-11-21
• Last Update Posted: 2014-11-21

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 127

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

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Exclusion Criteria

Exclusion Criteria

• Prior vaccination with a meningococcal B vaccine
• Prior meningococcal disease

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Group 4	rLP2086	Active comparator
Group 2	rLP2086	60ug Experimental
Group 3	rLP2086	200ug Experimental
Group A	rLP2086	20ug Experimental

Primary Outcome Measures

Name	Time	Method
Percentage of Participants With Seroconversion in rLP2086 Specific SBA Titer 1 Month After Dose 3	1 month after Dose 3
Percentage of Participants With at Least One Adverse Event (AE)	Dose 1 up to 1 month after Dose 3
Percentage of Participants With Seroconversion in rLP2086 Specific Serum Bactericidal Assay (SBA) Titer 1 Month After Dose 2	1 month after Dose 2

Trial Locations

Locations (9)

Royal Children's Hospital; 🇦🇺 Herston, Queensland, Australia

Department of Paediatrics and Child Health; 🇦🇺 Woden, Australia

National Centre for Immunisation; 🇦🇺 Westmead, Australia

The Telethon Institute for Child Health Research; 🇦🇺 Subiaco, Australia

Sir Albert Sakzewski Virus Research Centre (SASVRC); 🇦🇺 Herston, Australia

Women's & Children's Hospital; 🇦🇺 North Adelaide, Australia

Princess Margaret Hospital for Children; 🇦🇺 Subiaco, Western Australia, Australia

Sydney Children's Hospital; 🇦🇺 Randwick, New South Wales, Australia

The Children's Hospital at Westmead; 🇦🇺 Westmead, New South Wales, Australia