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Trial record 1 of 1 for:    NCT00808028
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A Study Evaluating Safety And Immunogenicity Of Meningococcal B Rlp2086 Vaccine In Adolescents

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ClinicalTrials.gov Identifier: NCT00808028
Recruitment Status : Completed
First Posted : December 15, 2008
Results First Posted : April 14, 2015
Last Update Posted : April 14, 2015
Sponsor:
Information provided by (Responsible Party):
Pfizer

Tracking Information
First Submitted Date  ICMJE December 12, 2008
First Posted Date  ICMJE December 15, 2008
Results First Submitted Date  ICMJE March 27, 2015
Results First Posted Date  ICMJE April 14, 2015
Last Update Posted Date April 14, 2015
Study Start Date  ICMJE February 2009
Actual Primary Completion Date March 2014   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: March 27, 2015)
  • Percentage of Participants With at Least 4-fold Rise in Recombinant Lipoprotein 2086 (rLP2086) Specific Serum Bactericidal Assay Using Human Complement (hSBA) Titer: Before Vaccination 1 up to 1 Month After Vaccination 2 [ Time Frame: Before vaccination 1 up to 1 month after vaccination 2 ]
  • Percentage of Participants With at Least 4-fold Rise in Recombinant Lipoprotein 2086 (rLP2086) Specific Serum Bactericidal Assay Using Human Complement (hSBA) Titer: Before Vaccination 1 up to 1 Month After Vaccination 3 [ Time Frame: Before vaccination 1 up to 1 month after vaccination 3 ]
  • Percentage of Participants With Atleast One Adverse Event (AE): Stage 1 [ Time Frame: Vaccination 1 upto 1 Month after vaccination 3 ]
  • Percentage of Participants With Atleast One Adverse Event (AE): Stage 2 [ Time Frame: 6 month after vaccination 3 up to 48 months ]
Original Primary Outcome Measures  ICMJE
 (submitted: December 12, 2008)
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. ]
Change History Complete list of historical versions of study NCT00808028 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures  ICMJE
 (submitted: March 27, 2015)
Percentage of Participants Achieving Serum Bactericidal Assay Using Human Complement (hSBA) Titer Level Greater Than or Equal To (>=) Prespecified Titer Level [ Time Frame: 1 month before vaccination 1, 1 month after vaccination 2, 3 ]
Original Secondary Outcome Measures  ICMJE Not Provided
Current Other Pre-specified Outcome Measures
 (submitted: March 27, 2015)
Immunogloblulin G (IgG) Measured by Geometric Mean Titer (GMT) for Sub Family A and Sub Family B [ Time Frame: Before Vaccination 1, 1 month after vaccination 2, 1 month after vaccination 3 ]
Original Other Pre-specified Outcome Measures 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 (Mnb) Rlp2086 Vaccine At Doses Of 60 Mug, 120 Mug, And 200 Mug 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  ICMJE Phase 2
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single
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 Arms  ICMJE
  • 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 *

*   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 Completed
Actual Enrollment  ICMJE
 (submitted: July 15, 2014)
538
Original Estimated Enrollment  ICMJE
 (submitted: December 12, 2008)
715
Actual Study Completion Date  ICMJE March 2014
Actual Primary Completion Date March 2014   (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.
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 11 Years to 18 Years   (Child, Adult)
Accepts Healthy Volunteers  ICMJE Yes
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Australia,   Poland,   Spain
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT00808028
Other Study ID Numbers  ICMJE 6108A1-2001
B1971005 ( Other Identifier: Alias Study Number )
2008-007789-51 ( EudraCT Number )
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Pfizer
Study Sponsor  ICMJE Pfizer
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Study Director: Pfizer CT.gov Call Center Pfizer
PRS Account Pfizer
Verification Date March 2015

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