Study Evaluating Safety & Immunogenicity of rLP2086 Vaccine in Healthy Toddlers

This study has been completed.
Sponsor:
Information provided by:
Wyeth is now a wholly owned subsidiary of Pfizer
ClinicalTrials.gov Identifier:
NCT00387569
First received: October 11, 2006
Last updated: May 6, 2008
Last verified: May 2008
  Purpose

A study to assess the safety of an investigational meningitis vaccine in toddlers and their immune response to it.


Condition Intervention Phase
Healthy
Biological: MnB vaccine rLP8026
Phase 1

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Investigator, Outcomes Assessor)
Primary Purpose: Prevention
Official Title: 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

Further study details as provided by Wyeth is now a wholly owned subsidiary of Pfizer:

Primary Outcome Measures:
  • Local and systemic reactions through 14 days post-injection; Vaccinations at 0,1,6 months [ Time Frame: Vaccinations at 0,1,6 months ] [ Designated as safety issue: Yes ]

Estimated Enrollment: 99
Study Start Date: October 2006
Study Completion Date: March 2008
Primary Completion Date: March 2008 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Cohort 1
Experimental (20ug); Active Comparator/Placebo
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)
Experimental: Cohort 2
Experimental (60ug); Active Comparator/Placebo
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)
Experimental: Cohort 3
Experimental (200ug); Active Comparator/Placebo
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)

  Eligibility

Ages Eligible for Study:   18 Months to 36 Months
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Criteria

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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00387569

Locations
Australia, Western Australia
Perth, Western Australia, Australia, 6840
Sponsors and Collaborators
Wyeth is now a wholly owned subsidiary of Pfizer
Investigators
Study Director: Medical Monitor Wyeth is now a wholly owned subsidiary of Pfizer
Principal Investigator: Trial Manager For Australia, medinfo@wyeth.com
  More Information

No publications provided

Responsible Party: Wyeth (Registry Contact: Clinical Trial Registry Specialist), Wyeth
ClinicalTrials.gov Identifier: NCT00387569     History of Changes
Other Study ID Numbers: 6108A1-502
Study First Received: October 11, 2006
Last Updated: May 6, 2008
Health Authority: Australia: Human Research Ethics Committee

Keywords provided by Wyeth is now a wholly owned subsidiary of Pfizer:
Toddlers
Vaccine
Safety

ClinicalTrials.gov processed this record on April 15, 2014