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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Pfizer
ClinicalTrials.gov Identifier:
NCT00808028
First received: December 12, 2008
Last updated: July 15, 2014
Last verified: July 2014
  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 2

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

Resource links provided by NLM:


Further study details as provided by Pfizer:

Primary Outcome Measures:
  • 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 ]

Secondary Outcome Measures:
  • 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 ]

Enrollment: 538
Study Start Date: February 2009
Study Completion Date: March 2014
Primary Completion Date: October 2010 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: 1
dose level 1 rLP2086 vaccine
Biological: meningococcal B rLP2086 vaccine.
vaccine, 0.5 mL, 0 - 2 - 6 to 9 months
Experimental: 2
dose level 2 rLP2086 vaccine
Biological: meningococcal B rLP2086 vaccine.
vaccine, 0.5 mL, 0 - 2 - 6 to 9 months
Experimental: 3
dose level 3 rLP2086 vaccine
Biological: meningococcal B rLP2086 vaccine.
vaccine, 0.5 mL, 0 - 2 - 6 to 9 months
Placebo Comparator: 4
normal saline (placebo)
Other: normal saline (placebo)
vaccine, 0.5 mL, 0 - 2 - 6 to 9 months

  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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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

Locations
Australia, Queensland
Pfizer Investigational Site
Herston, Queensland, Australia, 4029
Australia, South Australia
Pfizer Investigational Site
North Adelaide, South Australia, Australia, 5006
Australia, Victoria
Pfizer Investigational Site
Carlton, Victoria, Australia, 3053
Australia, Western Australia
Pfizer Investigational Site
Subiaco, Western Australia, Australia, 6008
Poland
Pfizer Investigational Site
Debica, Poland, 39-200
Pfizer Investigational Site
Krakow, Poland, 31-202
Pfizer Investigational Site
Krakow, Poland, 31-503
Pfizer Investigational Site
Leczna, Poland, 21-010
Pfizer Investigational Site
Lodz, Poland, 91-347
Pfizer Investigational Site
Lubartow, Poland, 21-100
Pfizer Investigational Site
Lublin, Poland, 20-044
Pfizer Investigational Site
Melno, Poland, 86-330
Pfizer Investigational Site
Oborniki Slaskie, Poland, 55-120
Pfizer Investigational Site
Poznan, Poland, 61-734
Pfizer Investigational Site
Siemianowice Slaskie, Poland, 41-03
Pfizer Investigational Site
Torun, Poland, 87-100
Pfizer Investigational Site
Trzebnica, Poland, 55-100
Pfizer Investigational Site
Wroclaw, Poland, 50-345
Spain
Pfizer Investigational Site
Santiago de Compostela, La Coruna, Spain, 15706
Pfizer Investigational Site
Getafe, Madrid, Spain, 28905
Pfizer Investigational Site
Vigo, Pontevedra, Spain, 36204
Pfizer Investigational Site
Almeria, Spain, 04120
Pfizer Investigational Site
Barcelona, Spain, 08195
Pfizer Investigational Site
Madrid, Spain, 28041
Pfizer Investigational Site
Valencia, Spain, 46024
Sponsors and Collaborators
Pfizer
Investigators
Study Director: Pfizer CT.gov Call Center Pfizer
  More Information

Additional Information:
No publications provided by Pfizer

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Pfizer
ClinicalTrials.gov Identifier: NCT00808028     History of Changes
Other Study ID Numbers: 6108A1-2001, B1971005
Study First Received: December 12, 2008
Last Updated: July 15, 2014
Health Authority: Australia: Human Research Ethics Committee

Additional relevant MeSH terms:
Meningitis
Meningitis, Meningococcal
Bacterial Infections
Central Nervous System Bacterial Infections
Central Nervous System Diseases
Central Nervous System Infections
Gram-Negative Bacterial Infections
Meningitis, Bacterial
Meningococcal Infections
Neisseriaceae Infections
Nervous System Diseases

ClinicalTrials.gov processed this record on October 20, 2014