A Single-arm, Open-label Study To Describe The Safety, Tolerability, And Immunogenicity Of Bivalent Rlp2086 Vaccine In Laboratory Workers >=18 To < =65 Years Of Age (B1971042)

NCT01768117 Phase 2 COMPLETED Results posted

This study will assess the safety, tolerability and immunogenicity of bivalent rLP2086 vaccine in laboratory workers ≥18 to ≤65 years of age administered on a Month 0, 2, and 6 schedule. The study will recruit laboratory personnel (inclusive of Pfizer staff) who work directly with pathogenic Neisseria meningitidis in the context of the bivalent rLP2086 vaccine development program. The study will provide descriptive safety and immunogenicity data following vaccination of these individuals with bivalent rLP2086 vaccine.

Details

Lead sponsor	Pfizer
Phase	Phase 2
Status	COMPLETED
Enrolment	13
Start date	2013-02
Completion	2014-02

Conditions

• Meningitis, Meningococcal, Serogroup B

Interventions

• rLP2086

Primary outcomes

• Number of Participants With Serum Bactericidal Assay Using Human Complement (hSBA) Titer Greater Than or Equal to (>=) Lower Limit of Quantitation (LLOQ) — 1 month after vaccination 3
• Percentage of Participants With at Least One Adverse Event (AE) — Vaccination 1 up to 1 month after Vaccination 3

Countries

United States