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

This study is ongoing, but not recruiting participants.
Sponsor:
Information provided by (Responsible Party):
Pfizer
ClinicalTrials.gov Identifier:
NCT00808028
First received: December 12, 2008
Last updated: April 11, 2014
Last verified: April 2014

December 12, 2008
April 11, 2014
February 2009
October 2010   (final data collection date for primary outcome measure)
  • 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 ]
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 ]
Complete list of historical versions of study NCT00808028 on ClinicalTrials.gov Archive Site
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 ]
Not Provided
Not Provided
Not Provided
 
A Study Evaluating Safety And Immunogenicity Of Meningococcal B Rlp2086 Vaccine In Adolescents
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

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.

Not Provided
Interventional
Phase 2
Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Prevention
Meningitis, Meningococcal
  • 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
  • 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)
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.
 
Active, not recruiting
539
April 2014
October 2010   (final data collection date for primary outcome measure)

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.
Both
11 Years to 18 Years
Yes
Contact information is only displayed when the study is recruiting subjects
Australia,   Poland,   Spain
 
NCT00808028
6108A1-2001, B1971005
No
Pfizer
Pfizer
Not Provided
Study Director: Pfizer CT.gov Call Center Pfizer
Pfizer
April 2014

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