| E.1 Medical condition or disease under investigation |
| E.1.1 | Medical condition(s) being investigated |
| Invasive Meningococcal Disease (IMD) |
|
| E.1.1.1 | Medical condition in easily understood language |
| Prevention of disease caused by a type of bacteria called 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 | 20.0 |
| E.1.2 | Level | PT |
| E.1.2 | Classification code | 10076061 |
| E.1.2 | Term | Meningococcal immunisation |
| E.1.2 | System Organ Class | 10042613 - Surgical and medical procedures |
|
| 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:
- To demonstrate that the immune response for N meningitidis group A (MenA), N meningitidis group C (MenC), N meningitidis group W (MenW), and N meningitidis group Y (MenY) induced by 2 doses of MenABCWY is noninferior to the immune response induced by 1 dose of MenACWY-CRM in both ACWY-naïve and ACWY-experienced participants, separately.
- To demonstrate that the immune response induced by 2 doses of MenABCWY is noninferior to the immune response induced by 2 doses of Trumenba.
Primary Safety:
To describe the safety profile of MenABCWY, as measured by local reactions, systemic events, adverse events (AEs), serious adverse events (SAEs), newly diagnosed chronic medical conditions (NDCMCs), medically attended AEs (MAEs), and immediate AEs. |
|
| E.2.2 | Secondary objectives of the trial |
Secondary Immunogenicity:
- To demonstrate that the immune response for MenA, MenC, MenW, and MenY induced by 1 dose of MenABCWY is noninferior to the immune response induced by 1 dose of MenACWY-CRM, in both ACWY-naïve and ACWY-experienced participants, separately.
- To describe the immune response for MenB, as measured by hSBA performed with secondary MenB test strains, induced by 2 doses of MenABCWY.
|
|
| E.2.3 | Trial contains a sub-study | No |
| E.3 | Principal inclusion criteria |
Age and Sex:
1.Male and female participants greater than or equal to 10 and <26 years of age at the time of randomization.
Refer to Appendix 4 for reproductive criteria for male (Section 10.4.1) and female (Section 10.4.2) participants.
Type of Participant and Disease Characteristics:
2.Willing and able to comply with scheduled visits, treatment plan, laboratory tests, and other study procedures.
3.ACWY-naïve participants: Participants who have never received a prior dose of a meningococcal vaccine containing ACWY serogroups. Written confirmation of vaccination history must be obtained prior to randomization.
ACWY-experienced participants: Participants who have received not more than 1 prior dose, no sooner than 4 years prior to the date of randomization of Menactra or Menveo. Written confirmation of vaccination history must be obtained prior to randomization.
4.Available for the entire study period and can be reached by telephone.
5.Healthy participant as determined by medical history, physical examination, and judgment of the investigator.
6.Male and female participants of childbearing potential must agree to use a highly effective method of contraception for at least 28 days after last study vaccination. A participant is of childbearing potential if, in the opinion of the investigator, he/she is biologically capable of having children and is sexually active (Appendix 4).
7.Negative urine pregnancy test for all female participants; pregnancy test is not applicable to male participants.
Weight: Not applicable.
Informed Consent:
8.Capable of giving signed informed consent as described in Appendix 1, which includes compliance with the requirements and restrictions listed in the informed consent document (ICD) and in this protocol.
Please refer to Protocol section 5.1 Inclusion Criteria. |
|
| E.4 | Principal exclusion criteria |
Medical Conditions:
1.A previous anaphylactic reaction to any vaccine or vaccine-related component.
2.Bleeding diathesis or condition associated with prolonged bleeding time that would contraindicate intramuscular injection.
3.A known or suspected defect of the immune system that would prevent an immune response to the vaccine, such as participants with congenital or acquired defects in B-cell function, those receiving chronic systemic (oral, intravenous, or intramuscular) corticosteroid therapy, or those receiving immunosuppressive therapy. Participants 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.
4.History of microbiologically proven disease caused by N meningitidis or Neisseria gonorrhoeae.
5.Significant neurological disorder or history of seizure (excluding simple febrile seizure).
6.Any neuroinflammatory or autoimmune condition, including, but not limited to, transverse myelitis, uveitis, optic neuritis, and multiple sclerosis.
7.Other acute or chronic medical or psychiatric condition including recent (within the past year) or active suicidal ideation, recent (within the past year) hospitalization for psychiatric illness, 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 participant inappropriate for entry into this study.
Prior/Concomitant Therapy:
8.Previous vaccination with any meningococcal group B vaccine, any purely polysaccharide (nonconjugate) meningococcal vaccine, or monovalent/bivalent meningococcal vaccine. Written vaccination history must be obtained prior to randomization.
9.Participants receiving any allergen immunotherapy with a nonlicensed product or receiving allergen immunotherapy with a licensed product and are not on stable maintenance doses.
10.Receipt of any blood products, including immunoglobulin, within 6 months before the first study vaccination.
11.Current use of systemic antibiotics with no foreseeable date of discontinuation prior to anticipated date of enrollment (first vaccination).
Prior/Concurrent Clinical Study Experience:
12.Participation in other studies involving investigational drug(s) or investigational vaccine(s) within 28 days prior to study entry and/or during study participation.
Diagnostic Assessments:Not applicable.
Other Exclusions:
13.Investigator site staff members directly involved in the conduct of the study and their family members (including grandchildren), site staff members otherwise supervised by the investigator, or Pfizer employees, including their family members, directly involved in the conduct of the study.
14.Pregnant female participants; breastfeeding female participants; fertile male participants and female participants of childbearing potential who are unwilling or unable to use a highly effective method of contraception.
Please refer to Protocol section 5.2 Exclusion Criteria. |
|
| E.5 End points |
| E.5.1 | Primary end point(s) |
Primary Immunogenicity:
- hSBA titer for each of the ACWY test strains.
- hSBA titer for each of the primary MenB test strains (A22, A56, B24, and B44).
Primary Safety:
- Local reactions (pain, redness, and swelling).
- Systemic events (fever, vomiting, diarrhea, headache, fatigue, chills, muscle pain other than muscle pain at any injection site, and joint pain).
- Use of antipyretic medication.
- AEs, SAEs, MAEs, NDCMCs, and immediate AEs.
- Days missing from school or work because of AEs.
|
|
| E.5.1.1 | Timepoint(s) of evaluation of this end point |
Immunogenicity evaluation at Day 1, 28 to 42 Days After Visit 1, and 28 to 42 Days After Visit 3.
Safety evaluation at each visit during the study duration. |
|
| E.5.2 | Secondary end point(s) |
Secondary Immunogenicity:
- hSBA titer for each of the ACWY test strains.
- hSBA titer for each secondary MenB test strain. |
|
| E.5.2.1 | Timepoint(s) of evaluation of this end point |
Immunogenicity evaluation at Day 1, 28 to 42 Days After Visit 1, and 28 to 42 Days After Visit 3.
Safety evaluation at each visit during the study duration. |
|
| 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 | 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 |
Immunogenicity
Tolerability
Non-inferiority |
|
| 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) | Yes |
| 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 | 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 | Yes |
| E.8.1.7.1 | Other trial design description |
|
| E.8.2 | Comparator of controlled trial |
| E.8.2.1 | Other medicinal product(s) | Yes |
| E.8.2.2 | Placebo | Yes |
| E.8.2.3 | Other | No |
| E.8.2.4 | Number of treatment arms in the trial | 8 |
| 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 | 6 |
| E.8.5 | The trial involves multiple Member States | Yes |
| E.8.5.1 | Number of sites anticipated in the EEA | 24 |
| E.8.6 Trial involving sites outside the EEA |
| E.8.6.1 | Trial being conducted both within and outside the EEA | Yes |
| E.8.6.2 | Trial being conducted completely outside of the EEA | No |
| E.8.6.3 | If E.8.6.1 or E.8.6.2 are Yes, specify the regions in which trial sites are planned |
| Bulgaria |
| Czechia |
| Denmark |
| Hungary |
| Poland |
| United States |
|
| 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
|
|
| E.8.9 Initial estimate of the duration of the trial |
| E.8.9.1 | In the Member State concerned years | 1 |
| E.8.9.1 | In the Member State concerned months | 6 |
| E.8.9.1 | In the Member State concerned days | 9 |
| E.8.9.2 | In all countries concerned by the trial years | 1 |
| E.8.9.2 | In all countries concerned by the trial months | 9 |
| E.8.9.2 | In all countries concerned by the trial days | 15 |
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