A Study Evaluating Safety And Immunogenicity Of Meningococcal B Rlp2086 Vaccine In Adolescents

This study is currently recruiting participants.

Verified May 2013 by Pfizer

Sponsor:

Information provided by (Responsible Party):

Pfizer

ClinicalTrials.gov Identifier:

NCT00808028

First received: December 12, 2008

Last updated: May 14, 2013

Last verified: May 2013

History of Changes

Tracking Information

First Received Date ^ICMJE

December 12, 2008

Last Updated Date

May 14, 2013

Start Date ^ICMJE

February 2009

Primary Completion Date

October 2010 (final data collection date for primary outcome measure)

Current Primary Outcome Measures ^ICMJE

Adverse events will be monitored throughout the study to evaluate the safety and tolerability of rLP2086. [ Time Frame: until Oct 2010 ] [ Designated as safety issue: Yes ]
The Serum Bactericidal Assay (SBA) will be used to measure the primary immunogenicity objective. [ Time Frame: until Mar 2014 ] [ Designated as safety issue: No ]

Original Primary Outcome Measures ^ICMJE

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 ]

Change History

Complete list of historical versions of study NCT00808028 on ClinicalTrials.gov Archive Site

Current Secondary Outcome Measures ^ICMJE

The Enzyme-linked immunosorbent assay (ELISA), will be used to measure the secondary immunogenicity objective. [ Time Frame: ELISA assay results are expected throughout the study period ] [ Designated as safety issue: No ]

Original Secondary Outcome Measures ^ICMJE

Not Provided

Current Other Outcome Measures ^ICMJE

Not Provided

Original Other Outcome Measures ^ICMJE

Not Provided

Descriptive Information

Brief Title ^ICMJE

A Study Evaluating Safety And Immunogenicity Of Meningococcal B Rlp2086 Vaccine In Adolescents

Official Title ^ICMJE

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

Brief Summary

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.

Detailed Description

Not Provided

Study Type ^ICMJE

Interventional

Study Phase

Phase 2

Study Design ^ICMJE

Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Prevention

Condition ^ICMJE

Meningitis, Meningococcal

Intervention ^ICMJE

Biological: meningococcal B rLP2086 vaccine.
vaccine, 0.5 mL, 0 - 2 - 6 to 9 months
Other: normal saline (placebo)
vaccine, 0.5 mL, 0 - 2 - 6 to 9 months

Study Arm (s)

Experimental: 1
dose level 1 rLP2086 vaccine

Intervention: Biological: meningococcal B rLP2086 vaccine.
Experimental: 2
dose level 2 rLP2086 vaccine

Intervention: Biological: meningococcal B rLP2086 vaccine.
Experimental: 3
dose level 3 rLP2086 vaccine

Intervention: Biological: meningococcal B rLP2086 vaccine.
Placebo Comparator: 4
normal saline (placebo)

Intervention: Other: normal saline (placebo)

Publications *

Richmond PC, Marshall HS, Nissen MD, Jiang Q, Jansen KU, Garcés-Sánchez M, Martinón-Torres F, Beeslaar J, Szenborn L, Wysocki J, Eiden J, Harris SL, Jones TR, Perez JL; 2001 Study Investigators. Safety, immunogenicity, and tolerability of meningococcal serogroup B bivalent recombinant lipoprotein 2086 vaccine in healthy adolescents: a randomised, single-blind, placebo-controlled, phase 2 trial. Lancet Infect Dis. 2012 Aug;12(8):597-607. Epub 2012 May 7.

* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.

Recruitment Information

Recruitment Status ^ICMJE

Recruiting

Estimated Enrollment ^ICMJE

539

Estimated Completion Date

March 2014

Primary Completion Date

October 2010 (final data collection date for primary outcome measure)

Eligibility Criteria ^ICMJE

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.

Gender

Both

Ages

11 Years to 18 Years

Accepts Healthy Volunteers

Yes

Contacts ^ICMJE

Contact: Pfizer CT.gov Call Center

1-800-718-1021

Location Countries ^ICMJE

Australia, Poland, Spain

Administrative Information

NCT Number ^ICMJE

NCT00808028

Other Study ID Numbers ^ICMJE

6108A1-2001, B1971005

Has Data Monitoring Committee

Responsible Party

Pfizer

Study Sponsor ^ICMJE

Pfizer

Collaborators ^ICMJE

Not Provided

Investigators ^ICMJE

Study Director:

Pfizer CT.gov Call Center

Pfizer

Information Provided By

Pfizer

Verification Date

May 2013

^ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP

To Top