A study to find out if vaccines designed to protect against a disease (meningococcal meningitis) is safe and protects people aged 10 to < 26 years
- Conditions
- Active immunization to prevent invasive disease caused by Neisseria meningitidis serogroups A, B, C, W and Y in individuals 10 through 25 years of age.MedDRA version: 20.0Level: PTClassification code 10027249Term: Meningitis meningococcalSystem Organ Class: 10021881 - Infections and infestationsTherapeutic area: Diseases [C] - Bacterial Infections and Mycoses [C01]
- Registration Number
- EUCTR2016-004421-17-FI
- Lead Sponsor
- Pfizer Inc. 235 East 42nd Street, New York, NY 10017
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Authorised-recruitment may be ongoing or finished
- Sex
- All
- Target Recruitment
- 1590
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 (ICD) indicating that the subject (or parent(s)/legal guardian) has been informed of all pertinent aspects of the study.
2. Willing and able to comply with scheduled visits, treatment plan, laboratory tests, and other study procedures.
3. Male and femle subject aged =10 and <26 years, at the time of randomization.
4. Subjects who have never received a prior dose, or who have received not more than 1 prior dose no sooner than 4 years prior to the date of randomization, of a vaccine containing 1 or more ACWY groups. Written confirmation of ACWY vaccination history should be obtained prior to randomization; however, if written ACWY vaccination history is not available, history obtained verbally from the subject (or parent(s)/legal guardian) is acceptable, if deemed reliable by the investigator.
5. Available for the entire study period and can be reached by telephone.
6. Healthy subject as determined by medical history, physical examination, and judgment of the investigator.
7. Male and female subjects of childbearing potential must agree to use a highly effective method of contraception throughout Stage 1 (through the follow-up telephone contact at Month 12), and from Visit 10 (booster vaccination) to Visit 11. 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.
8. Negative urine pregnancy test for all female subjects.
Are the trial subjects under 18? yes
Number of subjects for this age range: 1190
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range 795
F.1.3 Elderly (>=65 years) no
F.1.3.1 Number of subjects for this age range
Subjects with any of the following characteristics/conditions will not be included in the study:
1. Previous vaccination with any meningococcal group B vaccine or any purely polysaccharide (nonconjugate) meningococcal vaccine. Written vaccination history should be obtained prior to randomization; however, if written vaccination history is not available, history obtained verbally from the subject (or parent(s)/legal guardian) is acceptable, if deemed reliable by the investigator.
2. Previous vaccination with >1 dose of a vaccine containing 1 or more ACWY group.
3. Subjects having received 1 prior dose of a vaccine containing 1 or more ACWY group <4 years prior to the date of randomization.
4. A previous anaphylactic reaction to any vaccine or vaccine-related component.
5. Subjects receiving any allergen immunotherapy with a nonlicensed product or receiving allergen immunotherapy with a licensed product and are not on stable maintenance doses.
6. Bleeding diathesis or condition associated with prolonged bleeding time that would contraindicate intramuscular injection.
7. 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.
8. History of microbiologically proven disease caused by Neisseria meningitidis or Neisseria gonorrhoeae.
9. Significant neurological disorder or history of seizure (excluding simple febrile seizure).
10. Receipt of any blood products, including immunoglobulin, within 6 months before the first study vaccination.
11. Current chronic use of systemic antibiotics.
12. Participation in other studies involving investigational drug(s) within 28 days prior to study entry and/or during study participation.
13. Any neuroinflammatory or autoimmune condition, including, but not limited to, transverse myelitis, uveitis, optic neuritis, and multiple sclerosis.
14. Other acute or chronic medical or psychiatric condition including recent (within the past year) or active suicidal ideation or behavior 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.
15. Investigator site staff members directly involved in the conduct of the study and their embers, site staff members otherwise supervised by the investigator, or subjects who are Pfizer employees, including their family members, directly involved in the conduct of the study.
16. Pregnant female subjects; breastfeeding female subjects; fertile male subjects and female subjects of childbearing potential who are unwilling or unable to use a highly effective method of contraception as outlined in the Protocol Section 4.5.
Study & Design
- Study Type
- Interventional clinical trial of medicinal product
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method
- Secondary Outcome Measures
Name Time Method