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

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NCT00808028

Last updated on November 9, 2018
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FOR MORE INFORMATION
Study Location
Queensland Paediatric Infectious Diseases (QPID) Laboratory
Herston, Queensland, 4029 Australia
See other locations
Contact
1-800-718-1021
[email protected]
Related Links
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 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.

NCT00808028
Pfizer
Completed
A Study Evaluating Safety And Immunogenicity Of Meningococcal B Rlp2086 Vaccine In Adolescents

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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 (Mnb) Rlp2086 Vaccine At Doses Of 60 Mug, 120 Mug, And 200 Mug 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
Intervention Model: Parallel Assignment
Masking: Single
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)


*   Includes publications given by the data provider as well as publications
identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
538
March 2014
March 2014   (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.
Sexes Eligible for Study: All
11 Years to 18 Years   (Child, Adult)
Yes
Contact information is only displayed when the study is recruiting subjects
Australia,   Poland,   Spain
 
 
NCT00808028
6108A1-2001
B1971005 ( Other Identifier: Alias Study Number )
2008-007789-51 ( EudraCT Number )
No
Not Provided
Not Provided
Pfizer
Pfizer
Not Provided
Study Director: Pfizer CT.gov Call Center Pfizer
Pfizer
March 2015

ICMJE     Data element required by the

International Committee of Medical Journal Editors and the
World Health Organization ICTRP

FOR MORE INFORMATION

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1-800-718-1021

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