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Study Evaluating Safety & Immunogenicity of rLP2086 Vaccine in Healthy Toddlers

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ClinicalTrials.gov Identifier: NCT00387569
Recruitment Status : Completed
First Posted : October 13, 2006
Last Update Posted : May 8, 2008
Sponsor:
Information provided by:
Wyeth is now a wholly owned subsidiary of Pfizer

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

Condition or disease Intervention/treatment Phase
Healthy Biological: MnB vaccine rLP8026 Phase 1

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 99 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple (Participant, 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
Study Start Date : October 2006
Actual Primary Completion Date : March 2008
Actual Study Completion Date : March 2008

Arm Intervention/treatment
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)




Primary Outcome Measures :
  1. Local and systemic reactions through 14 days post-injection; Vaccinations at 0,1,6 months [ Time Frame: Vaccinations at 0,1,6 months ]


Information from the National Library of Medicine

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Ages Eligible for Study:   18 Months to 36 Months   (Child)
Sexes Eligible for Study:   All
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): 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

Responsible Party: Wyeth (Registry Contact: Clinical Trial Registry Specialist), Wyeth
ClinicalTrials.gov Identifier: NCT00387569     History of Changes
Other Study ID Numbers: 6108A1-502
First Posted: October 13, 2006    Key Record Dates
Last Update Posted: May 8, 2008
Last Verified: May 2008

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

Additional relevant MeSH terms:
Vaccines
Immunologic Factors
Physiological Effects of Drugs