Study Evaluating Safety & Immunogenicity of rLP2086 Vaccine in Healthy Toddlers

NCT00387569

Last updated date
Study Location
Perth, Western Australia, 6840, Australia
Contact
1-800-718-1021

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Eligibility Criteria
condition
The disease, disorder, syndrome, illness, or injury that is being studied.
Healthy
Sex
Females and Males
Age
Pediatric Trials: 0-17 Years
Adult Trials: 18+ Years
18-36 months
Inclusion Criteria
The factors, or reasons, that allow a person to participate in a clinical study.
Show details

- Aged 18- to 36-months

- Healthy male or female subjects

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


- Prior vaccination with a serogroup B meningococcal vaccine


- Prior history of any invasive meningococcal disease

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Advanced Information
Descriptive Information
Brief Title  ICMJE Study Evaluating Safety & Immunogenicity of rLP2086 Vaccine in Healthy Toddlers
Official Title  ICMJE A Randomized, Observer-Blinded, Parallel-Group, Active-Control, Phase 1/2 Trial of the Safety, Immunogenicity, and Tolerability of 20 µg, 60 µg, and 200 µg of Meningococcal Group B rLP2086 Vaccine in Healthy Adolescents Aged 10 to 12 Years
Brief Summary A study to assess the safety of an investigational meningitis vaccine in toddlers and their immune response to it.
Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 1
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Primary Purpose: Prevention
Condition  ICMJE Healthy
Intervention  ICMJE
  • Biological: MnB vaccine rLP8026
    MnB vaccine at 20ug dose (0,1,6 months) or control (Hepatitis A vaccine, placebo, Hepatitis A vaccine at 0,1,6 months, respectively)
  • Biological: MnB vaccine rLP8026
    MnB vaccine at 60ug dose (0,1,6 months) or control (Hepatitis A vaccine, placebo, Hepatitis A vaccine at 0,1,6 months, respectively)
  • Biological: MnB vaccine rLP8026
    MnB vaccine at 200ug dose (0,1,6 months) or control (Hepatitis A vaccine, placebo, Hepatitis A vaccine at 0,1,6 months, respectively)
Study Arms  ICMJE
  • Experimental: Cohort 1
    Experimental (20ug); Active Comparator/Placebo
    Intervention: Biological: MnB vaccine rLP8026
  • Experimental: Cohort 2
    Experimental (60ug); Active Comparator/Placebo
    Intervention: Biological: MnB vaccine rLP8026
  • Experimental: Cohort 3
    Experimental (200ug); Active Comparator/Placebo
    Intervention: Biological: MnB vaccine rLP8026
Publications * Not Provided

*   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
Estimated Enrollment  ICMJE
 (submitted: December 20, 2007)
99
Original Enrollment  ICMJE Not Provided
Actual Study Completion Date  ICMJE March 2008
Actual Primary Completion Date March 2008   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria

  • Aged 18- to 36-months
  • Healthy male or female subjects

Exclusion Criteria

  • Prior vaccination with a serogroup B meningococcal vaccine
  • Prior history of any invasive meningococcal disease
Sex/Gender  ICMJE
Sexes Eligible for Study:All
Ages  ICMJE 18 Months to 36 Months   (Child)
Accepts Healthy Volunteers  ICMJE Yes
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Australia
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT00387569
Other Study ID Numbers  ICMJE 6108A1-502
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Wyeth (Registry Contact: Clinical Trial Registry Specialist), Wyeth
Study Sponsor  ICMJE Wyeth is now a wholly owned subsidiary of Pfizer
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Study Director:Medical MonitorWyeth is now a wholly owned subsidiary of Pfizer
Principal Investigator:Trial ManagerFor Australia, [email protected]
PRS Account Wyeth is now a wholly owned subsidiary of Pfizer
Verification Date May 2008

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