A Global Phase 3 Safety Study of 120 mcg rLP2086 Vaccine in Adolescents and Young Adults Aged 10 to 25 Years

Status:	Completed
Conditions:	Infectious Disease
Therapuetic Areas:	Immunology / Infectious Diseases
Healthy:	No
Age Range:	10 - 25
Updated:	5/5/2014
Start Date:	November 2012
End Date:	November 2014
Contact:	Pfizer CT.gov Call Center
Phone:	1-800-718-1021

A Phase 3, Randomized, Active Controlled, Observer Blinded Trial to Assess the Safety and Tolerability of a Meningococcal Serogroup B Bivalent Recombinant Lipoprotein (rLP2086) Vaccine Given in Healthy Subjects Aged ≥10 to <26 Years

A multicenter phase 3 safety trial in which 5,700 subjects will be assigned in a 2:1 ratio
to receive 120 μg rLP2086 vaccine in a 0, 2, 6 month schedule or control. The control group
will receive HAVRIX vaccine at month 0 and 6 and saline at month 2.

All subjects will be followed for 6 months after the last vaccination to assess safety and
tolerability.

Inclusion Criteria:

- Healthy subjects aged 10 to 25 years.

Exclusion Criteria:

- Previous vaccination with Hepatitis A virus vaccine

- Previous vaccination with investigational meningococcal B vaccine

- History of culture-proven N. meningitidis serogroup B disease

- Any neuroinflammatory or autoimmune condition

- Any immune defect that would prevent an effective response to the study vaccine

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A Global Phase 3 Safety Study of 120 mcg rLP2086 Vaccine in Adolescents and Young Adults Aged 10 to 25 Years

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A Phase 3, Randomized, Active Controlled, Observer Blinded Trial to Assess the Safety and Tolerability of a Meningococcal Serogroup B Bivalent Recombinant Lipoprotein (rLP2086) Vaccine Given in Healthy Subjects Aged ≥10 to <26 Years

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