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NCT00387569 Clinical Trial

Study Evaluating Safety & Immunogenicity of rLP2086 Vaccine in Healthy Toddlers

Healthy Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT00387569
Other study ID # 6108A1-502
Secondary ID
Status Completed
Phase Phase 1
First received October 11, 2006
Last updated May 6, 2008
Start date October 2006
Est. completion date March 2008

Study information
Verified date May 2008
Source Wyeth is now a wholly owned subsidiary of Pfizer
Contact n/a
Is FDA regulated No
Health authority Australia: Human Research Ethics Committee
Study type Interventional

Clinical Trial Summary

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

Recruitment information / eligibility
Status Completed
Enrollment 99
Est. completion date March 2008
Est. primary completion date March 2008
Accepts healthy volunteers Accepts Healthy Volunteers
Gender Both
Age group 18 Months to 36 Months
Eligibility 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

Study Design

Allocation: Randomized, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator, Outcomes Assessor), Primary Purpose: Prevention

Related Conditions & MeSH terms

Intervention

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)
• 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)
• 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)

Locations
Country Name City State
n/a

Sponsors (1)
Lead Sponsor Collaborator
Wyeth is now a wholly owned subsidiary of Pfizer

Country where clinical trial is conducted

Australia, 

Outcome
Type Measure Description Time frame Safety issue
Primary Local and systemic reactions through 14 days post-injection; Vaccinations at 0,1,6 months Vaccinations at 0,1,6 months Yes
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