Phase 3, Adolescent Large Scale Safety Study

• Conditions: Bacterial Meningitis; MedDRA version: 14.1Level: LLTClassification code 10004049Term: Bacterial meningitisSystem Organ Class: 100000004862; Therapeutic area: Diseases [C] - Bacterial Infections and Mycoses [C01]

• Registration Number: EUCTR2009-015198-11-FI
• Lead Sponsor: Pfizer Inc, 235 East 42nd Street, New York, NY 10017

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2011-06-27
• Last Update Posted: 17 November 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 Protocol 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 vaccine.
4. 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