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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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 July 29, 2014