A clinical study to test the safety and immune response of a vaccine against a bacteria causing meningitis B at doses of 60 µg, 120 µg, and 200 µg in healthy adolescents aged 11 to 18 Years

• Conditions: Prevention of invasive meningococcal disease caused by Neisseria meningitidis serogroup B (MnB) in adolescents and young adults, aged 10 through 25 years.; MedDRA version: 17.1Level: LLTClassification code 10004049Term: Bacterial meningitisSystem Organ Class: 100000004862; Therapeutic area: Body processes [G] - Immune system processes [G12]

• Registration Number: EUCTR2008-007789-51-Outside-EU/EEA
• Lead Sponsor: Wyeth Research Division of Wyeth Pharmaceuticals Inc.

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2015-02-11
• Last Update Posted: 16 February 2015

Recruitment & Eligibility

• Status: A
• Sex: All
• Target Recruitment: 539

Inclusion Criteria

Stage 1:
1. Male or female subjects between the ages of =11 and =18 years at the time of enrollment.
2. Healthy male or female subjects as determined by medical history and physical examination.
3. Negative urine pregnancy test for all female subjects.
4. All female and male subjects who are biologically capable of having children must agree to abstinence or commit to the use of a reliable method of hormonal and/or nonhormonal contraception during the 6-month vaccination period and for 30 days after the final vaccination or early discontinuation of the study. A subject is biologically capable of having children if he or she is using contraceptives or if his or her sexual partner is sterile or using contraceptives.
5. arent/legal guardian or subject under supervision of the parent/legal guardian must be able to complete all relevant study procedures during study participation.

Stage 2:
1. Healthy male or female subjects as determined by medical history and physical examination.
2. Parent/legal guardian or subject under supervision of the parent/legal guardian must be able to complete all relevant study procedures during study participation.

Are the trial subjects under 18? yes
Number of subjects for this age range: 503
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range 36
F.1.3 Elderly (>=65 years) no
F.1.3.1 Number of subjects for this age range

Exclusion Criteria

Stage 1:
1. Pregnant or breastfeeding women.
2. Receipt of any vaccination with a serogroup B meningococcal vaccine at any time prior to the administration of the first dose of test article.
3. History of any invasive meningococcal disease.
4. A previous anaphylactic or severe vaccine-associated adverse reaction.
5. A known hypersensitivity to any study vaccine components.
6. Any clinically significant chronic disease.
7. 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.
8. Bleeding diathesis or condition associated with prolonged bleeding time that would contraindicate intramuscular (IM) injection.
9. Receipt of any blood products, including gamma globulin, in the period from 6 months before study vaccination through the study conclusion.
10. Participation in another investigational study in the 1-month (30-day) period before study visit 1 and during the conduct of the study.
11. Any major illness/condition that, in the investigator’s judgment, will substantially increase the risk associated with the subject’s participation in and completion of, the study, or could preclude the evaluation of the subject’s response.
12. Subject is a direct descendant (child or grandchild) of the study site personnel.

Stage 2:
1. Receipt of any vaccination with a serogroup B meningococcal vaccine at any time prior to the administration of the first dose of test article.
2. History of any invasive meningococcal disease.
3. Any clinically significant chronic disease.
4. 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.
5. Bleeding diathesis or condition associated with prolonged bleeding time that would contraindicate intramuscular (IM) injection.
6. Receipt of any blood products, including gamma globulin, in the period from 6 months before study vaccination through the study conclusion.
7. Participation in another investigational study in the 1-month (30-day) period before study visit 1 and during the conduct of the study.
8. Any major illness/condition that, in the investigator’s judgment, will substantially increase the risk associated with the subject’s participation in and completion of, the study, or could preclude the evaluation of the subject’s response.
9. Subject is a direct descendant (child or grandchild) of the study site personnel.

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Main Objective: To assess the immunogenicity of 60 mcg, 120 mcg, and 200 mcg rLP2086 vaccine as measured by SBA performed with MnB strains expressing LP2086 subfamily A and B proteins in healthy adolescents aged 11 to 18 years.;Secondary Objective: To assess the immunogenicity of 60 mcg, 120 mcg, and 200 mcg rLP2086 vaccine as determined by quantitation of immunoglobulin (Ig) binding to rLP2086 vaccine subfamily A and B proteins in healthy adolescents aged 11 to 18 years.;Primary end point(s): The primary immunological endpoint is the seroconversion rate of rLP2086 specific SBA titers to 1 subfamily A strain and 1 subfamily B strain after postdose 2 and postdose 3 in subjects receiving the dose levels selected for the full enrollment phase. Seroconversion is defined as a 4 fold rise in rLP2086 specific SBA titers from predose 1. ;Timepoint(s) of evaluation of this end point: 29-43 days postdose.

Secondary Outcome Measures

Name	Time	Method
Secondary end point(s): None;Timepoint(s) of evaluation of this end point: N/A