A Study Evaluating Safety And Immunogenicity Of Meningococcal B Rlp2086 Vaccine In Adolescents

Pfizer

Status and phase: Completed; Phase 2

Conditions: Meningitis, Meningococcal

Treatments: Other: normal saline (placebo); Biological: meningococcal B rLP2086 vaccine.

Study type: Interventional

Funder types: Industry

Identifiers

NCT00808028

2008-007789-51 (EudraCT Number)

B1971005 (Other Identifier)

6108A1-2001

Details and patient eligibility

About

The purpose of this study is to evaluate the safety and immunogenicity of an investigational meningococcal B rLP2086 vaccine in adolescents aged 11 to 18 years old.

Enrollment: 538 patients

Sex: All

Ages: 11 to 18 years old

Volunteers: Accepts Healthy Volunteers

Inclusion criteria

• Healthy male or female subjects between the ages of >=11 and <=18 years at the time of enrollment.
• Negative urine pregnancy test for all female subjects.
• Parent/legal guardian or subject under supervision of the parent/legal guardian must be able to complete all relevant study procedures during study participation.

Exclusion criteria

• History of any invasive meningococcal disease.
• A previous anaphylactic or severe vaccine-associated adverse reaction.
• Any clinically significant chronic disease.
• A known or suspected disease of the immune system or those receiving immunosuppressive therapy, including systemic corticosteroids. Topical, inhaled or intra-articular corticosteroids are allowed.
• Participation in another investigational study in the 1-month (30-day) period before study visit 1 and during the conduct of the study.

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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538 participants in 4 patient groups, including a placebo group

1

Experimental group

Description:

dose level 1 rLP2086 vaccine

Treatment:

Biological: meningococcal B rLP2086 vaccine.

Biological: meningococcal B rLP2086 vaccine.

Biological: meningococcal B rLP2086 vaccine.

2

Experimental group

Description:

dose level 2 rLP2086 vaccine

Treatment:

Biological: meningococcal B rLP2086 vaccine.

Biological: meningococcal B rLP2086 vaccine.

Biological: meningococcal B rLP2086 vaccine.

3

Experimental group

Description:

dose level 3 rLP2086 vaccine

Treatment:

Biological: meningococcal B rLP2086 vaccine.

Biological: meningococcal B rLP2086 vaccine.

Biological: meningococcal B rLP2086 vaccine.

4

Placebo Comparator group

Description:

normal saline (placebo)

Treatment:

Other: normal saline (placebo)