A Study Evaluating Safety and Immunogenicity of Meningococcal B rLP2086 Vaccine in Adolescents - Full Text View

Sponsored by:	Wyeth
Information provided by:	Wyeth
ClinicalTrials.gov Identifier:	NCT00808028

Purpose

The purpose of this study is to evaluate the safety and immunogenicity of an investigational meningococcal B rLP2086 vaccine in adolescents aged 11 to 18 years old.

Condition	Intervention	Phase
Meningitis, Meningococcal	Biological: meningococcal B rLP2086 vaccine. Other: normal saline (placebo)	Phase II

MedlinePlus related topics: Meningitis

Drug Information available for: Sodium chloride

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Prevention, Randomized, Single Blind (Subject), Parallel Assignment, Safety/Efficacy Study
Official Title:	A Randomized, Single-Blind, Placebo-Controlled, Phase 2 Trial of the Safety, Immunogenicity, and Tolerability of Meningococcal Serogroup B rLP2086 Vaccine at Doses of 60 Mcg, 120 Mcg, and 200 Mcg in Healthy Adolescents Aged 11 to 18 Years

Further study details as provided by Wyeth:

Primary Outcome Measures:

Adverse events will be monitored throughout the study to evaluate the safety and tolerability of rLP2086. The Serum Bactericidal Assay (SBA) will be used to measure the primary immunogenicity objective. [ Time Frame: SBA assay results are expected throughout the study period. The first SBA results are expected for June 2009. ] [ Designated as safety issue: Yes ]

Estimated Enrollment:	715
Study Start Date:	September 2009
Estimated Study Completion Date:	March 2014
Estimated Primary Completion Date:	March 2014 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
1: Experimental dose level 1 rLP2086 vaccine	Biological: meningococcal B rLP2086 vaccine.
2: Experimental dose level 2 rLP2086 vaccine	Biological: meningococcal B rLP2086 vaccine.
3: Experimental dose level 3 rLP2086 vaccine	Biological: meningococcal B rLP2086 vaccine.
4: Placebo Comparator normal saline (placebo)	Other: normal saline (placebo)

Eligibility

Ages Eligible for Study:	11 Years to 18 Years
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	Yes

Criteria

Inclusion criteria:

Healthy male or female subjects between the ages of ≥11 and ≤18 years at the time of enrollment.
Negative urine pregnancy test for all female subjects.
Parent/legal guardian or subject under supervision of the parent/legal guardian must be able to complete all relevant study procedures during study participation.

Exclusion Criteria:

History of any invasive meningococcal disease.
A previous anaphylactic or severe vaccine-associated adverse reaction.
Any clinically significant chronic disease.
A known or suspected disease of the immune system or those receiving immunosuppressive therapy, including systemic corticosteroids. Topical, inhaled or intra-articular corticosteroids are allowed.
Participation in another investigational study in the 1-month (30-day) period before study visit 1 and during the conduct of the study.

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00808028

Contacts

Contact: Trial Manager

clintrialparticipation@wyeth.com

Sponsors and Collaborators

Wyeth

Investigators

Study Director:

Medical Monitor

Wyeth

More Information

Responsible Party:	Wyeth ( Wyeth (Registry Contact: Clinical Trial Registry Specialist) )
Study ID Numbers:	6108A1-2001
Study First Received:	December 12, 2008
Last Updated:	December 17, 2008
ClinicalTrials.gov Identifier:	NCT00808028
Health Authority:	Australia: Human Research Ethics Committee

Study placed in the following topic categories:

Bacterial Infections
Central Nervous System Infections
Meningococcal Infections
Meningitis, Bacterial
Meningitis, Meningococcal
Central Nervous System Diseases

Healthy
Meningococcal infection
Gram-Negative Bacterial Infections
Neisseriaceae Infections
Meningitis

Additional relevant MeSH terms:

Nervous System Diseases
Central Nervous System Bacterial Infections

ClinicalTrials.gov processed this record on January 14, 2009