E.1 Medical condition or disease under investigation |
E.1.1 | Medical condition(s) being investigated |
Meningococcal type B Bacterial Meningitis |
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E.1.1.1 | Medical condition in easily understood language |
Meningococcal type B Bacterial Meningitis |
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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 | 15.0 |
E.1.2 | Level | PT |
E.1.2 | Classification code | 10027202 |
E.1.2 | Term | Meningitis bacterial |
E.1.2 | System Organ Class | 10021881 - Infections and infestations |
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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 |
To describe the immunogenicity of rLP2086 vaccine as determined by hSBA-titers to primary test strains at approximately 6, 12, 18, 24, 36, and 48 months after the last dose (second or the third dose) of vaccine in the ‘primary’ study (a previously conducted Pfizer study using the final formulation and dose of rLP2086 vaccine).
Exploratory Objective:
To describe the immunogenicity of rLP2086 vaccine as determined by hSBA-titers to secondary test strains at approximately 6, 12 , 18, 24, 36, and 48 months after the last dose (2- or 3-dose regimen) of vaccine in the ‘primary’ study. |
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E.2.2 | Secondary objectives of the trial |
There are no Secondary Objectives for this Study. |
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E.2.3 | Trial contains a sub-study | No |
E.3 | Principal 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 (or a legal representative) has been informed of all pertinent aspects of the study.
2. Subjects who are willing and able to comply with scheduled visits, laboratory tests, and other study procedures.
3. Completed primary Pfizer Sponsored MnB study meaning subjects who completed their originally intended number of scheduled vaccinations of rLP2086 vaccine,
subjects who completed the blood draw following the last vaccination and subjects who completed the 6 months follow-up telephone call in the ‘primary’ study. |
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E.4 | Principal exclusion criteria |
Subjects presenting with any of the following will not be included in the study:
1. Subjects who are investigational site staff members or or subjects who are Pfizer employees directly involved in the conduct of the trial.
2. With the exception of the primary rLP2086 vaccine study, participation in other studies within the 1-month (30-day) period before study Visit 1 and/or during study participation. Participation in purely observational studies is permitted.
3. Other severe acute or chronic medical or psychiatric condition or laboratory abnormality that may increase the risk associated with study participation 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.
4. History of culture-proven disease caused by Neisseria meningitidis or Neisseria gonorrhoeae.
5. Bleeding diathesis or condition associated with prolonged bleeding time that would
contraindicate blood draw.
6. Receipt of any blood products, including gamma globulin, in the period from 6 months before any study visit.
7. Vaccination with any licensed or experimental meningococcal serogroup B vaccine
since being enrolled in the primary Pfizer sponsored MnB study (other than study vaccines permitted in the primary study). |
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E.5 End points |
E.5.1 | Primary end point(s) |
hSBA will be performed for the 4 primary test strains. hSBAs on additional secondary test strains may be performed.
• Proportion of subjects with hSBA titers ≥ lower limit of quantitation (LLOQ), at each blood draw visit
• Proportion of subjects with hSBA titers ≥1:4, ≥1:8, ≥1:16 , ≥1:32, ≥1:64,and ≥1:128
at each blood draw visit
• hSBA geometric mean titers (GMTs) at each blood draw visit |
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E.5.1.1 | Timepoint(s) of evaluation of this end point |
Blood draws for serology assessment at 6, 12, 18, 24, 36, and 48 months after the last dose (second or the third dose) of vaccine in the ‘primary’ study (defined as phase 2 and 3 B197 studies). |
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E.5.2 | Secondary end point(s) |
Not Applicable in this case. |
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E.5.2.1 | Timepoint(s) of evaluation of this end point |
Not Applicable in this case. |
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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 | No |
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 |
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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) | Yes |
E.7.3 | Therapeutic confirmatory (Phase III) | No |
E.7.4 | Therapeutic use (Phase IV) | No |
E.8 Design of the trial |
E.8.1 | Controlled | No |
E.8.1.1 | Randomised | No |
E.8.1.2 | Open | No |
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.8.3 |
The trial involves single site in the Member State concerned
| No |
E.8.4 | The trial involves multiple sites in the Member State concerned | Yes |
E.8.4.1 | Number of sites anticipated in Member State concerned | 4 |
E.8.5 | The trial involves multiple Member States | Yes |
E.8.5.1 | Number of sites anticipated in the EEA | 25 |
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
|
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E.8.9 Initial estimate of the duration of the trial |
E.8.9.1 | In the Member State concerned years | 3 |
E.8.9.1 | In the Member State concerned months | 2 |
E.8.9.1 | In the Member State concerned days | 0 |
E.8.9.2 | In all countries concerned by the trial years | 5 |
E.8.9.2 | In all countries concerned by the trial months | 0 |
E.8.9.2 | In all countries concerned by the trial days | 0 |