An Open-Label Safety And Blood Collection Study In Mnb Rlp2086 Vaccinated Healthy Adult Volunteers For Immunological Assay Development

NCT00780806 Phase 1/Phase 2 COMPLETED

The purpose of this study is to evaluate the safety of an investigational meningococcal B rLP2086 vaccine in adults and to obtain blood samples from immunized subjects for use in assay development.

Details

Lead sponsor	Wyeth is now a wholly owned subsidiary of Pfizer
Phase	Phase 1/Phase 2
Status	COMPLETED
Enrolment	60
Start date	2008-10
Completion	2010-05

Conditions

• Meningitis, Meningococcal

Interventions

• meningococcal B rLP2086 vaccine candidate
• Blood draw

Primary outcomes

• Safety of 3 doses of MnB rLP2086 vaccine candidate assessed by frequency of solicited local and systemic reactions collected for 7 days after each study vaccination; evaluation of occurrence of AE and SAE during the duration of study — Up to 2 years

Countries

Australia