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

Pfizer

Status and phase: Completed; Phase 3

Conditions: Meningitis, Meningococcal

Treatments: Biological: rLP2086 vaccine; Biological: control

Study type: Interventional

Funder types: Industry

Identifiers

NCT01352793

6108A1-3003 (Other Identifier)

2009-015198-11 (EudraCT Number)

B1971014

Details and patient eligibility

About

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.

Enrollment: 5,715 patients

Sex: All

Ages: 10 to 25 years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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5,715 participants in 2 patient groups

rLP2086 vaccine

Experimental group

Description:

rLP2086 vaccine

Treatment:

Biological: rLP2086 vaccine

control

Other group

Description:

The control treatment will be HAVRIX vaccine at month 0 and 6 and a normal saline injection at month 2.

Treatment:

Biological: control