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

A PHASE 3, RANDOMIZED, ACTIVE-CONTROLLED, OBSERVER-BLINDED STUDY TO ASSESS THE IMMUNOGENICITY, SAFETY, AND TOLERABILITY OF BIVALENT rLP2086 WHEN ADMINISTERED AS A 2-DOSE REGIMEN AND A FIRST-IN-HUMAN STUDY TO DESCRIBE THE IMMUNOGENICITY, SAFETY, AND TOLERABILITY OF A BIVALENT rLP2086–CONTAINING PENTAVALENT VACCINE (MenABCWY) IN HEALTHY SUBJECTS = 10 TO < 26 YEARS OF AGE

Status

Active, not recruiting

Phases

Phase 1Phase 2Phase 3

Study type

Interventional

Source

EU CTR

Registry ID

EUCTR2016-004421-17-CZ

Enrollment

1590

Registered

2017-03-22

Start date

2020-02-17

Completion date

Unknown

Last updated

2022-03-02

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

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: 20.0 Level: PT Classification code 10027249 Term: Meningitis meningococcal System Organ Class: 10021881 - Infections and infestations

Interventions

Trade Name: Menveo Product Name: MenACWY-CRM Pharmaceutical Form: Solution for injection/infusion in pre-filled syringe INN or Proposed INN: MENINGOCOCCAL GROUP A OLIGOSACCHARIDES CONJUGATED TO CORYNE

Eligibility

Sex/Gender

All

Inclusion criteria

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 (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 =65 years) no F.1.3.1 Number of subjects for this age range

Exclusion criteria

Exclusion criteria: 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.

Design outcomes

Primary

Measure	Time frame
Main Objective: Primary Immunogenicity objective: To assess the immune response induced by bivalent rLP2086 as measured by serum bactericidal assay using human complement (hSBA) performed with 4 primary MnB test strains, 2 expressing a lipoproten 2086 (LP2086) subfamily A protein and 2 expressing an LP2086 subfamily B protein, measured 1 month after the second vaccination, in the bivalent rLP2086 arms (Group 2 and 4 subjects) combined. Primary Safety Objectives: - To describe the safety profile of bivalent rLP2086, as measured by local reactions, systemic events, adverse events (AEs), serious adverse events (SAEs), newly diagnosed chronic medical conditions, medically attended AEs, and immediate AEs, following Vaccinations 1 and 2 in the bivalent rLP2086 arms (Group 2 and 4 subjects) combined. - To describe the safety profile of MenABCWY after the booster vaccination. - To describe the safety profile of bivalent rLP2086 after the booster vaccination. ;Secondary Objective: Secondary immunogenicity objectives: - To describe the immune response induced by bivalent rLP2086 as measured by hSBA performed with 4 primary MnB test strains, 2 expressing an LP2086 subfamily A protein and 2 expressing an LP2086 subfamily B protein, measured 1 month after the second vaccination, in the bivalent rLP2086 arms (Group 2 and 4 subjects) combined. - To describe the MenB immune response as measured by hSBA performed with secondary MenB test strains measured 1 month after the second vaccination in Groups 2 and 4 combined. - To describe the immune response induced by 1 dose of MenABCWY compared to the immune response induced by 1 dose of MenACWY-CRM, as measured by hSBA performed with ACWY test strains, in ACWY-naive and ACWY-experienced subjects separately. Additional secondary immunogenicity objectives and all secondary safety objectives are listed in the study Protocol.;Timepoint(s) of evaluation of this end point: Timepoints are detailed above. Please refer to the protocol for	—

Measure

Time frame

Main Objective: Primary Immunogenicity objective: To assess the immune response induced by bivalent rLP2086 as measured by serum bactericidal assay using human complement (hSBA) performed with 4 primary MnB test strains, 2 expressing a lipoproten 2086 (LP2086) subfamily A protein and 2 expressing an LP2086 subfamily B protein, measured 1 month after the second vaccination, in the bivalent rLP2086 arms (Group 2 and 4 subjects) combined. Primary Safety Objectives: - To describe the safety profile of bivalent rLP2086, as measured by local reactions, systemic events, adverse events (AEs), serious adverse events (SAEs), newly diagnosed chronic medical conditions, medically attended AEs, and immediate AEs, following Vaccinations 1 and 2 in the bivalent rLP2086 arms (Group 2 and 4 subjects) combined. - To describe the safety profile of MenABCWY after the booster vaccination. - To describe the safety profile of bivalent rLP2086 after the booster vaccination. ;Secondary Objective: Secondary immunogenicity objectives: - To describe the immune response induced by bivalent rLP2086 as measured by hSBA performed with 4 primary MnB test strains, 2 expressing an LP2086 subfamily A protein and 2 expressing an LP2086 subfamily B protein, measured 1 month after the second vaccination, in the bivalent rLP2086 arms (Group 2 and 4 subjects) combined. - To describe the MenB immune response as measured by hSBA performed with secondary MenB test strains measured 1 month after the second vaccination in Groups 2 and 4 combined. - To describe the immune response induced by 1 dose of MenABCWY compared to the immune response induced by 1 dose of MenACWY-CRM, as measured by hSBA performed with ACWY test strains, in ACWY-naive and ACWY-experienced subjects separately. Additional secondary immunogenicity objectives and all secondary safety objectives are listed in the study Protocol.;Timepoint(s) of evaluation of this end point: Timepoints are detailed above. Please refer to the protocol for

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Secondary

Measure	Time frame
Secondary end point(s): Secondary Immunogenicity endpoints - - Proportions of subjects with hSBA titers =LLOQ, =1:4,=1:8, =1:16, =1:32, =1:64, and =1:128 for each of the 4 primary MenB test strains at Visit 4. - hSBA geometric mean titers (GMTs) for each of the 4 primary MnB test strains at Visit 4. The secondary immunogenicity endpoints for the subsets tested with the additional hSBA test strains are as follows: -Proportions of subjects with hSBA titers =LLOQ (1:16 for A06, A12, and A19 and 1:8 for A07, A15, A29, B03,B09, B15, and B16) for each of the secondary test strains 1 month after the second vaccination. -Proportions of subjects with hSBA titers =1:4, =1:8, =1:16, =1:32, =1:64, and =1:128 for each of the secondary test strains 1 month after the second vaccination. -hSBA GMTs for each of the secondary test strains 1 month after the second vaccination. -Proportions of subjects with hSBA-MenA, hSBA-MenC, hSBA-MenW, and hSBA-MenY titers =1:8 (or LLOQ, whichever is higher) at Visit 2. -Proportions of subjects with hSBA-MenA, hSBA-MenC, hSBA-MenW, and hSBA-MenY titers =1:4, =1:8, =1:16, =1:32, =1:64, and =1:128 at Visit 2. -hSBA GMTs for each of the ACWY test strains at Visit 2. - Proportions of subjects with hSBA-MenA, hSBA-MenC, hSBA-MenW, and hSBA-MenY titers =1:8 (or LLOQ, whichever is higher) at Visit 4 in Groups 1 and 3 and at Visit 2 in Groups 2 and 4. -Proportions of subjects with hSBA-MenA, hSBA-MenC, hSBA-MenW, and hSBA-MenY titers =1:4, =1:8, =1:16, =1:32, =1:64, and =1:128 at Visit 4 in Groups 1 and 3 and Visit 2 in Groups 2 and 4. -hSBA GMTs for each of the ACWY test strains at Visit 4 in Groups 1 and 3 and Visit 2 in Groups 2 and 4. - Proportions of subjects who achieve the 5 MnB endpoints 1 month after the second vaccination, which are defined for hSBA performed with each of the 4 primary test strains: PMB80 (A22), PMB2001 (A56), PMB2948 (B24), and PMB2707 (B44), as detailed below: -One (1) of the 5 endpoints is the composite endpoint	—

Measure

Time frame

Secondary end point(s): Secondary Immunogenicity endpoints - - Proportions of subjects with hSBA titers =LLOQ, =1:4,=1:8, =1:16, =1:32, =1:64, and =1:128 for each of the 4 primary MenB test strains at Visit 4. - hSBA geometric mean titers (GMTs) for each of the 4 primary MnB test strains at Visit 4. The secondary immunogenicity endpoints for the subsets tested with the additional hSBA test strains are as follows: -Proportions of subjects with hSBA titers =LLOQ (1:16 for A06, A12, and A19 and 1:8 for A07, A15, A29, B03,B09, B15, and B16) for each of the secondary test strains 1 month after the second vaccination. -Proportions of subjects with hSBA titers =1:4, =1:8, =1:16, =1:32, =1:64, and =1:128 for each of the secondary test strains 1 month after the second vaccination. -hSBA GMTs for each of the secondary test strains 1 month after the second vaccination. -Proportions of subjects with hSBA-MenA, hSBA-MenC, hSBA-MenW, and hSBA-MenY titers =1:8 (or LLOQ, whichever is higher) at Visit 2. -Proportions of subjects with hSBA-MenA, hSBA-MenC, hSBA-MenW, and hSBA-MenY titers =1:4, =1:8, =1:16, =1:32, =1:64, and =1:128 at Visit 2. -hSBA GMTs for each of the ACWY test strains at Visit 2. - Proportions of subjects with hSBA-MenA, hSBA-MenC, hSBA-MenW, and hSBA-MenY titers =1:8 (or LLOQ, whichever is higher) at Visit 4 in Groups 1 and 3 and at Visit 2 in Groups 2 and 4. -Proportions of subjects with hSBA-MenA, hSBA-MenC, hSBA-MenW, and hSBA-MenY titers =1:4, =1:8, =1:16, =1:32, =1:64, and =1:128 at Visit 4 in Groups 1 and 3 and Visit 2 in Groups 2 and 4. -hSBA GMTs for each of the ACWY test strains at Visit 4 in Groups 1 and 3 and Visit 2 in Groups 2 and 4. - Proportions of subjects who achieve the 5 MnB endpoints 1 month after the second vaccination, which are defined for hSBA performed with each of the 4 primary test strains: PMB80 (A22), PMB2001 (A56), PMB2948 (B24), and PMB2707 (B44), as detailed below: -One (1) of the 5 endpoints is the composite endpoint

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Countries

Czechia, Czech Republic, Finland, Poland, United States

Contacts

Public ContactClinical Trials.gov Call Center

Pfizer Inc

clinicaltrials.gov_inquiries@pfizer.com001800718 1021

Outcome results

None listed

Source: EU CTR (via WHO ICTRP) · Data processed: Feb 4, 2026