E.1 Medical condition or disease under investigation |
E.1.1 | Medical condition(s) being investigated |
Healthy volunteers (prevention of bacterial meningitis). |
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E.1.1.1 | Medical condition in easily understood language |
Prevention of Meningitis caused by N.meningitidis B bacteria. |
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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 | 15.1 |
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 demonstrate that the immune response induced by Repevax given with bivalent rLP2086 vaccine (group 1) is non-inferior to the immune response induced by Repevax alone (group 2) when measured 1 month after vaccination 1. The immune responses to all components of Repevax will be assessed. |
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E.2.2 | Secondary objectives of the trial |
To describe the immune response as measured by hSBA performed with 4 primary MnB test strains, two expressing a LP2086 subfamily A protein and two expressing a LP2086 subfamily B protein, measured 1 month after the third vaccination with bivalent rLP2086 vaccine. Serum samples from approximately 50% of the subjects will have hSBA performed with test strains of LP2086 variants A22 and B24 and the other 50% will be tested with strains of variants A56 and B44. |
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E.2.3 | Trial contains a sub-study | No |
E.3 | Principal inclusion criteria |
Subject eligibility should be reviewed and documented by an appropriately qualified member of the investigator’s study team before subjects are included in the study.
1.Evidence of a personally signed and dated informed consent document (ICD) indicating that the parent/legally acceptable representative and/or subject has been informed of all pertinent aspects of the study.
2.Parent/legally acceptable representative and/or subjects who are willing and able to comply with scheduled visits, laboratory tests, and other study procedures.
3.Male or female subject aged ≥11 and <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.Has received full series of diphtheria, tetanus, and pertussis (DTP)/DTaP vaccines and oral poliomyelitis virus/inactivated polio virus (OPV)/IPV vaccines per countryspecific recommendations applicable at the time of receipt.
7.All male and female subjects must agree to practice a form of effective contraception, such as barrier contraception (ie, condom plus spermicide, a female condom, diaphragm, cervical cap or intrauterine device), implants, injectables, combined oral contraceptives or sexual abstinence prior to entering into the study, for the duration of the vaccination period and for 28 days after the last study vaccination. For Germany: The phrase sexual abstinence is not applicable, with the understanding that all male and all female subjects of childbearing potential must practice an effective form of contraception during the study.
8.Negative urine pregnancy test for female subjects. |
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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.Vaccination with any diphtheria, tetanus, pertussis, or poliomyelitis virus vaccine within 5 years of the first study vaccination.
3.A previous anaphylactic reaction to any vaccine or vaccine-related component.
4.Contraindication to vaccination with diphtheria, tetanus, pertussis, or poliomyelitis virus vaccine.
5.Bleeding diathesis or condition associated with prolonged bleeding time that would contraindicate intramuscular injection.
6.A known or suspected disease of the immune system or those receiving immunosuppressive therapy.
7.History of culture-proven disease caused by Neisseria 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 during study participation. Participation in purely observational studies is acceptable.
12.Received any investigational drugs, vaccines or devices within 28 days before administration of the first study vaccination.
13.Any neuroinflammatory or autoimmune condition, including, but not limited to, transverse myelitis, uveitis, optic neuritis, and multiple sclerosis.
14.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.
15.Subjects who are investigational site staff members or subjects who are Pfizer employees directly involved in the conduct of the trial.
16.Subject is a direct descendant (e.g. child, grandchild or other family member) of study site or Pfizer personnel.
17.Subject is pregnant or breastfeeding. |
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E.5 End points |
E.5.1 | Primary end point(s) |
The primary endpoints for this study are the proportions of subjects achieving the prespecified criteria for the concomitant antigens 1 month after vaccination 1. |
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E.5.1.1 | Timepoint(s) of evaluation of this end point |
One month after vaccination 1 in both groups. |
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E.5.2 | Secondary end point(s) |
An additional descriptive endpoint for the primary objective is
The concomitant antigens measured as geometric mean titer (GMT) or geometric mean concentrations (GMCs) at 1-month after vaccination 1 (visit 2).
Serum samples from approximately 50% of the subjects will have hSBA performed with test strains of LP2086 variants A22 and B24 and the other 50% will be tested with strains of variants A56 and B44. The hSBA endpoints for the secondary objectives will be considered as secondary endpoints:
Proportion of subjects with hSBA titer ≥ lower limit of quantitation (LLOQ) at visit 6 (1-month postvaccination 3) for each of the 4 primary MnB test strains. |
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E.5.2.1 | Timepoint(s) of evaluation of this end point |
One month after vaccination 1 in both groups. |
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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 | Yes |
E.6.3 | Therapy | No |
E.6.4 | Safety | Yes |
E.6.5 | Efficacy | Yes |
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 | No |
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 | Yes |
E.8.1.1 | Randomised | Yes |
E.8.1.2 | Open | No |
E.8.1.3 | Single blind | Yes |
E.8.1.4 | Double blind | No |
E.8.1.5 | Parallel group | Yes |
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 | Yes |
E.8.2.3 | Other | No |
E.8.2.4 | Number of treatment arms in the trial | 2 |
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 | 10 |
E.8.5 | The trial involves multiple Member States | Yes |
E.8.5.1 | Number of sites anticipated in the EEA | 35 |
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 | Yes |
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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As per Protocol.
The end of the clinical phase of the study will be the telephone contact (visit 7) to the last subject. At this time, sites will be closed out, IRB/IEC will be informed, and no further CIOMS reports will be sent. For other purposes, the end of the study will be last serology sample assayed. |
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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 | 2 |
E.8.9.1 | In the Member State concerned months | 0 |
E.8.9.1 | In the Member State concerned days | 0 |
E.8.9.2 | In all countries concerned by the trial years | 2 |
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 |