A Large Global Study to Investigate the Safety of an experimental vaccine against meningococcal type B disease in Adolescents and Young Adults

• Conditions: Prevention of Bacterial Meningitis; MedDRA version: 17.0Level: LLTClassification code 10051594Term: Infectious disease prophylaxis NOSSystem Organ Class: 100000004865; Therapeutic area: Diseases [C] - Bacterial Infections and Mycoses [C01]

• Registration Number: EUCTR2009-015198-11-LT
• Lead Sponsor: Pfizer Inc.

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2011-06-02
• Last Update Posted: 27 October 2014

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: All
• Target Recruitment: 5700

Inclusion Criteria

Subjects must meet all of the following inclusion criteria to be eligible for enrollment into the study:
1. Evidence of a personally signed and dated informed consent document indicating that the subject (and/or a parent/legally authorized representative) has been informed of all pertinent aspects of the study.
2. Parent/legally authorized representative and/or subject who are willing and able to comply with scheduled visits, treatment plan, laboratory tests, and other study procedures.
3. Male or female subjects aged =10 and <26 years at time of enrollment.
4. Available for the entire study period and can be reached by telephone.
5. Healthy subject as determined by medical history, physical examination, and judgment of the investigator.
6.Male and female subjects of childbearing potential must agree to use a highly effective
method of contraception throughout the study (through the follow-up telephone contact at month 12). A subject is of childbearing potential if, in the opinion of the investigator,
he/she is biologically capable of having children and is sexually active. Refer to Section 4.4 for further information.
7. Negative urine pregnancy test for all female subjects.
Are the trial subjects under 18? yes
Number of subjects for this age range: 3118
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range 2582
F.1.3 Elderly (>=65 years) no
F.1.3.1 Number of subjects for this age range

Exclusion Criteria

Subjects presenting with any of the following will not be included in the study:
1. Previous vaccination with any meningococcal serogroup B vaccine.
2. Subjects who have received prior HAV vaccination.
3. Contraindication to vaccination with any HAV vaccin.
Subjects receiving any allergen immunotherapy with a non-licensed product or receiving
allergen immunotherapy with a licensed product and not on stable maintenance doses.
5. Subjects who are scheduled to receive one or more doses of a human papillomavirus
(HPV) vaccination as part of a 3-dose series during the period between Visit 1 and 28
days after the second study vaccination (Visit 3).
6. A previous anaphylactic reaction to any vaccine or vaccine-related component.
7. Bleeding diathesis or condition associated with prolonged bleeding time that would
contraindicate intramuscular injection.
8. A known or suspected defect of the immune system that would prevent an immune
response to the vaccine, such as subjects with congenital or acquired defects in B cell
function, those receiving chronic systemic (oral, intravenous or intramuscular)
corticosteroid therapy, or those receiving immunosuppressive therapy. Subjects in the
United States with terminal complement deficiency are excluded from participation in
this study. Please refer to the study reference manual (SRM) for additional details.
9. History of microbiologically proven disease caused by Neisseria meningitidis or
Neisseria gonorrhoea.
10. Significant neurological disorder or history of seizure (excluding simple febrile seizure).
11. Receipt of any blood products, including immunoglobulin within 6 months before the
first study vaccination.
12. Current participation in another investigational study. Participation in purely
observational studies is acceptable.
13. Received any investigational vaccines, drugs or devices within 28 days before
administration of the first study vaccination.
14. Any neuroinflammatory and autoimmune condition, including but not limited to
transverse myelitis, uveitis, optic neuritis, and multiple sclerosis.
15. Other severe acute or chronic medical or psychiatric condition or laboratory abnormality
that may increase the risk associated with study participation or investigational product
administration or may interfere with the interpretation of study results and, in the
judgment of the investigator, would make the subject inappropriate for entry into this
study.
16. Subject is pregnant or breastfeeding.
17. Subjects who are investigational site staff members or relatives of those site staff members, or subjects who are Pfizer employees directly involved in the conduct of the trial or relatives of those Pfizer employees.

Study & Design

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

Primary Outcome Measures

Name	Time	Method
Main Objective: To evaluate the safety of bivalent rLP2086 vaccine compared to a control (hepatitis A virus [HAV] vaccine/saline), as assessed by serious adverse events (SAEs) and medically attended adverse events.;Secondary Objective: To evaluate the safety profile of bivalent rLP2086 vaccine compared to a control<br>(HAV/saline), as measured by adverse events (AEs), SAEs, newly diagnosed chronic<br>medical conditions, medically attended adverse events and immediate AEs.;Primary end point(s): - Percentage of subjects with at least one SAE occurring during the time period from the<br>first study vaccination (Visit 1) through 6 months after last study vaccination (Visit 9).<br> - Percentage of subjects with at least one medically attended adverse event occurring<br>during the time period within 30 days after each vaccination.;Timepoint(s) of evaluation of this end point: 14 months after last subject last visit.