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

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NCT00808028

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Study Location
Queensland Paediatric Infectious Diseases (QPID) Laboratory
Herston, Queensland, 4029, Australia
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Contact
1-800-718-1021
[email protected]
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Eligibility Criteria
condition
The disease, disorder, syndrome, illness, or injury that is being studied.
Meningococcal Meningitis
Sex
Females and Males
Age
Pediatric Trials: 0-17 Years
Adult Trials: 18+ Years
11-18 years
Inclusion Criteria
The factors, or reasons, that allow a person to participate in a clinical study.
Show details

- 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
The factors, or reasons, that prevent a person from participating in a clinical study.
Show details


- 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.

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NCT00808028
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  2. North Adelaide, South Australia
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  4. Subiaco, Western Australia
  5. Debica,
  6. Krakow,
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  11. Lubartow,
  12. Lublin,
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Advanced Information
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 CenterPfizer
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