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Study Evaluating Safety & Immunogenicity of rLP2086 Vaccine in Healthy Toddlers

Last updated on December 15, 2017

FOR MORE INFORMATION
Study Location
Perth, Western Australia, 6840 Australia
Contact
1-800-718-1021
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

NCT00387569
Pfizer
Completed
Study Evaluating Safety & Immunogenicity of rLP2086 Vaccine in Healthy Toddlers

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Study Evaluating Safety & Immunogenicity of rLP2086 Vaccine in Healthy Toddlers
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
A study to assess the safety of an investigational meningitis vaccine in toddlers and their immune response to it.
Not Provided
Interventional
Phase 1
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Primary Purpose: Prevention
Healthy
  • 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)
  • 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
Not Provided


*   Includes publications given by the data provider as well as publications
identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
99
March 2008
March 2008   (Final data collection date for primary outcome measure)

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
Sexes Eligible for Study: All
18 Months to 36 Months   (Child)
Yes
Contact information is only displayed when the study is recruiting subjects
Australia
 
 
NCT00387569
6108A1-502
Yes
Not Provided
Not Provided
Wyeth (Registry Contact: Clinical Trial Registry Specialist), Wyeth
Wyeth is now a wholly owned subsidiary of Pfizer
Not Provided
Study Director: Medical Monitor Wyeth is now a wholly owned subsidiary of Pfizer
Principal Investigator: Trial Manager For Australia, [email protected]
Wyeth is now a wholly owned subsidiary of Pfizer
May 2008

ICMJE     Data element required by the

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

FOR MORE INFORMATION

Contact a representative by phone, email, or visiting thte study website. To get updates and notications about this trail, sign up using the form below.

BY PHONE

Pfizer Clinical Trials Contact Center

1-800-718-1021

BY EMAIL

Contact

[email protected]



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