NCT00387569

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

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 99 (estimated)
• Sponsor: Wyeth is now a wholly owned subsidiary of Pfizer · Industry
• Sex: All
• Age: 18 Months – 36 Months
• Healthy volunteers: Accepted

Summary

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

Conditions

• Healthy

Interventions

Type	Name	Description
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)

Timeline

• Start date: 2006-10-01
• Primary completion: 2008-03-01
• Completion: 2008-03-01
• First posted: 2006-10-13
• Last updated: 2008-05-08

Locations

1 site across 1 country: Australia