E.1 Medical condition or disease under investigation |
E.1.1 | Medical condition(s) being investigated |
Test the safety and immunogenicity of Bexsero used as a vaccine for Neisseria meningitidis |
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E.1.1.1 | Medical condition in easily understood language |
Safety and immunogenicity of Neisseria meningitidis |
|
E.1.1.2 | Therapeutic area | Diseases [C] - Bacterial Infections and Mycoses [C01] |
MedDRA Classification |
E.1.2 Medical condition or disease under investigation |
E.1.2 | Version | 18.0 |
E.1.2 | Level | PT |
E.1.2 | Classification code | 10027249 |
E.1.2 | Term | Meningitis meningococcal |
E.1.2 | System Organ Class | 10021881 - Infections and infestations |
|
E.1.3 | Condition being studied is a rare disease | No |
E.2 Objective of the trial |
E.2.1 | Main objective of the trial |
Primary Immunogenicity Objective
• To describe the immune response, relative to baseline status, following receipt of Bexsero as measured by hSBA performed with a panel of MnB
test strains assessed 1 month after the second vaccination with Bexsero vaccine.
Primary Safety Objective
• To describe local reactions and systemic events following receipt of Bexsero vaccine. |
|
E.2.2 | Secondary objectives of the trial |
|
E.2.3 | Trial contains a sub-study | No |
E.3 | Principal inclusion criteria |
Subject eligibility should be reviewed and documented by an appropriate member of the investigator's study team before subjects are included in the study.
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/assent
document indicating that the subject (and a legally acceptable
representative/parent(s)/legal guardian, if applicable) has been
informed of all pertinent aspects of the study.
2. Subjects (and legally acceptable representative/parent(s)/legal
guardian, if applicable) who are willing and able to comply with
scheduled visits, treatment plan, laboratory tests, and other study
procedures.
3. Male or female subjects aged 12 years to <19 years at the 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 and at risk for pregnancy must agree to use a highly effective method of contraception throughout the study (through the persistence blood draw visit at Month 7).
7.Negative urine pregnancy test for all female subjects who are
biologically capable of having children. |
|
E.4 | Principal 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 any non-live vaccine (or intramuscular/sublingual allergen immunotherapy) within the previous 14 days or live vaccine within the previous 28 days of study vaccination.
3. Subjects receiving any allergen immunotherapy with a non-licensed product or receiving allergen immunotherapy with a licensed product and are not on stable maintenance doses.
4. A previous anaphylactic reaction to any vaccine or vaccine-related component, including kanamycin and latex.
5. Bleeding diathesis or condition associated with prolonged bleeding time that would contraindicate intramuscular injection.
6. 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. Additional details will be
provided in the study reference manual (SRM).
7. History of microbiologically proven disease caused by N meningitidis or Neisseria gonorrhoeae.
8. Significant neurological disorder or history of seizure (excluding
simple febrile seizure).
9. Receipt of any blood products, including immunoglobulin, within 6
months before the first study vaccination.
10. Current chronic use of systemic antibiotics.
11. Participation in other studies involving investigational vaccines,
drugs, or devices within 28 days before the current study begins and during study participation. Participation in purely observational studies is acceptable.
12. 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.
13. Pregnant female subjects, breastfeeding female subjects, male subjects with partners currently pregnant, or male and female subjects of childbearing potential who are unwilling or unable to use a highly effective method of contraception as outlined in this protocol for the
duration of the study (through the persistence blood draw visit at Month 7).
14. Subjects who are investigational site staff members directly involved in the conduct of the study and their family members, site staff members otherwise supervised by the investigator, or subjects who are Pfizer employees directly involved in the conduct of the study. |
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E.5 End points |
E.5.1 | Primary end point(s) |
Primary Immunogenicity Endpoint
• Proportion of subjects achieving at least a 4-fold increase in hSBA titer from baseline to 1 month after the second vaccination with Bexsero vaccine for each strain included in the panel of MnB test strains.
Primary Safety Endpoints
• Percentage of subjects reporting local reactions (pain, redness, and
swelling).
• Percentage of subjects reporting systemic events (fever, vomiting,
diarrhea, headache, fatigue, chills, muscle pain other than muscle pain at any injection site, and joint pain).
• Percentage of subjects reporting the use of antipyretic medication
after each vaccination visit. |
|
E.5.1.1 | Timepoint(s) of evaluation of this end point |
1 month after the second vaccination with Bexsero vaccine. |
|
E.5.2 | Secondary end point(s) |
|
E.5.2.1 | Timepoint(s) of evaluation of this end point |
1 month after the second vaccination with Bexsero vaccine. |
|
E.6 and E.7 Scope of the trial |
E.6 | Scope of the trial |
E.6.1 | Diagnosis | No |
E.6.2 | Prophylaxis | No |
E.6.3 | Therapy | No |
E.6.4 | Safety | Yes |
E.6.5 | Efficacy | No |
E.6.6 | Pharmacokinetic | No |
E.6.7 | Pharmacodynamic | No |
E.6.8 | Bioequivalence | No |
E.6.9 | Dose response | No |
E.6.10 | Pharmacogenetic | No |
E.6.11 | Pharmacogenomic | No |
E.6.12 | Pharmacoeconomic | No |
E.6.13 | Others | Yes |
E.6.13.1 | Other scope of the trial description |
|
E.7 | Trial type and phase |
E.7.1 | Human pharmacology (Phase I) | No |
E.7.1.1 | First administration to humans | No |
E.7.1.2 | Bioequivalence study | No |
E.7.1.3 | Other | No |
E.7.1.3.1 | Other trial type description | |
E.7.2 | Therapeutic exploratory (Phase II) | No |
E.7.3 | Therapeutic confirmatory (Phase III) | No |
E.7.4 | Therapeutic use (Phase IV) | Yes |
E.8 Design of the trial |
E.8.1 | Controlled | No |
E.8.1.1 | Randomised | No |
E.8.1.2 | Open | Yes |
E.8.1.3 | Single blind | No |
E.8.1.4 | Double blind | No |
E.8.1.5 | Parallel group | No |
E.8.1.6 | Cross over | No |
E.8.1.7 | Other | No |
E.8.2 | Comparator of controlled trial |
E.8.2.1 | Other medicinal product(s) | No |
E.8.2.2 | Placebo | No |
E.8.2.3 | Other | No |
E.8.2.4 | Number of treatment arms in the trial | 1 |
E.8.3 |
The trial involves single site in the Member State concerned
| Yes |
E.8.4 | The trial involves multiple sites in the Member State concerned | No |
E.8.5 | The trial involves multiple Member States | No |
E.8.6 Trial involving sites outside the EEA |
E.8.6.1 | Trial being conducted both within and outside the EEA | No |
E.8.6.2 | Trial being conducted completely outside of the EEA | No |
E.8.7 | Trial has a data monitoring committee | No |
E.8.8 |
Definition of the end of the trial and justification where it is not the last
visit of the last subject undergoing the trial
|
The end of the study will be the last visit of the last subject (LSLV) for
purposes of closing out sites, informing the institutional review
board/ethics committee (IRB/EC), and ceasing to send Council for
International Organizations of Medical Sciences (CIOMS) reports;
however, for other purposes, the end of the study will be when the last
serology sample is assayed. |
|
E.8.9 Initial estimate of the duration of the trial |
E.8.9.1 | In the Member State concerned years | 0 |
E.8.9.1 | In the Member State concerned months | 8 |
E.8.9.1 | In the Member State concerned days | |