Study Evaluating Safety & Immunogenicity of rLP2086 Vaccine in Adolescents

Pfizer

Status and phase: Completed; Phase 2

Conditions: Healthy

Treatments: Biological: rLP2086

Study type: Interventional

Funder types: Industry

Identifiers

NCT00387725

B1971006 (Other Identifier)

6108A1-501

Details and patient eligibility

About

Study to evaluate the safety of an investigational meningitis vaccine and the immune response to it in adolescents

Enrollment: 127 patients

Sex: All

Ages: 8 to 14 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

Inclusion Criteria

• Aged 8 to 14 years at the time of enrollment.
• Healthy male or female subjects
• Negative urine pregnancy test for female subjects

Exclusion criteria

Exclusion Criteria

• Prior vaccination with a meningococcal B vaccine
• Prior meningococcal disease

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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127 participants in 4 patient groups

Group A

Experimental group

Description:

20ug Experimental

Treatment:

Biological: rLP2086

Biological: rLP2086

Biological: rLP2086

Biological: rLP2086

Group 2

Experimental group

Description:

60ug Experimental

Treatment:

Biological: rLP2086

Biological: rLP2086

Biological: rLP2086

Biological: rLP2086

Group 3

Experimental group

Description:

200ug Experimental

Treatment:

Biological: rLP2086

Biological: rLP2086

Biological: rLP2086

Biological: rLP2086

Group 4

Active Comparator group

Description:

Active comparator

Treatment:

Biological: rLP2086

Biological: rLP2086

Biological: rLP2086

Biological: rLP2086