Optic

ID

Name

C3511004

Description

This study is designed to describe the short-term immunogenicity and safety of 2 doses of Neisseria meningitidis group A, B, C, W, and Y vaccine (MenABCWY) separated by either 12 or 36 months during adolescence, and immunopersistence up to 24 months after completing 2 doses separated by a 12-month interval.

Trial arms

Trial start

2020-06-17

Estimated PCD

2024-01-05

Trial end

2024-01-05

Status

Completed

Phase

Early phase I

Treatment

MenABCWY

Neisseria meningitidis group A, B, C, W, and Y vaccine

Arms:

Group 1 (MenABCWY 0-, 12-months), Group 2 (MenABCWY 0-, 36-months)

Other names:

pentavalent meningococcal vaccine

Saline

Placebo

Arms:

Group 2 (MenABCWY 0-, 36-months)

Size

309

Primary endpoint

Percentage of participants achieving a serum bactericidal assay using human complement (hSBA) titer >= lower limit of quantitation (LLOQ) for 4 primary MenB test strains

1 month after second dose of MenABCWY in Group 1

Percentage of participants achieving an hSBA titer >= LLOQ for 4 primary MenB test strains

1 month after second dose of MenABCWY in Group 2

Percentage of participants reporting at least 1 adverse event (AE), at least 1 serious AE (SAE), at least 1 medically attended AE (MAE), and at least 1 newly diagnosed medical condition (NDCMC) within 30 days after the first MenABCWY vaccination

within 30 days after first MenABCWY vaccination

Percentage of participants reporting at least 1 adverse event (AE), at least 1 serious AE (SAE), at least 1 medically attended AE (MAE), and at least 1 newly diagnosed medical condition (NDCMC) within 30 days after the second MenABCWY vaccination

within 30 days after second MenABCWY vaccination

Percentage of participants reporting at least 1 adverse event (AE), at least 1 serious AE (SAE), at least 1 medically attended AE (MAE), and at least 1 newly diagnosed medical condition (NDCMC) within 30 days after the placebo vaccination in Group 2

within 30 days after placebo vaccination in Group 2

Percentage of participants reporting at least 1 adverse event (AE), at least 1 serious AE (SAE), at least 1 medically attended AE (MAE), and at least 1 newly diagnosed medical condition (NDCMC) within 30 days after any MenABCWY vaccination

within 30 days after any MenABCWY vaccination

Percentage of participants reporting at least 1 adverse event (AE), at least 1 serious AE (SAE), at least 1 medically attended AE (MAE), and at least 1 newly diagnosed medical condition (NDCMC) during the Vaccination 1 vaccination phase

from Vaccination 1 through 1 month after Vaccination 1

Percentage of participants reporting at least 1 adverse event (AE), at least 1 serious AE (SAE), at least 1 medically attended AE (MAE), and at least 1 newly diagnosed medical condition (NDCMC) during the Vaccination 2 vaccination phase

from Vaccination 2 through 1 month after Vaccination 2

Percentage of participants reporting at least 1 adverse event (AE), at least 1 serious AE (SAE), at least 1 medically attended AE (MAE), and at least 1 newly diagnosed medical condition (NDCMC) during the Vaccination 3 vaccination phase in Group 2

from Vaccination 3 through 1 month after Vaccination 3 in Group 2

Percentage of participants reporting at least 1 serious adverse event (SAE), at least 1 medically attended adverse event (MAE), and at least 1 newly diagnosed medical condition (NDCMC) during the Vaccination 1 follow-up phase

from 1 month after Vaccination 1 through 6 months after Vaccination 1

Percentage of participants reporting at least 1 serious adverse event (SAE), at least 1 medically attended adverse event (MAE), and at least 1 newly diagnosed medical condition (NDCMC) during the Vaccination 2 follow-up phase

from 1 month after Vaccination 2 through 6 months after Vaccination 2

Percentage of participants reporting at least 1 serious adverse event (SAE), at least 1 medically attended adverse event (MAE), and at least 1 newly diagnosed medical condition (NDCMC) within 6 months after Vaccination 1

from Vaccination 1 through 6 months after Vaccination 1

Percentage of participants reporting at least 1 serious adverse event (SAE), at least 1 medically attended adverse event (MAE), and at least 1 newly diagnosed medical condition (NDCMC) within 6 months after Vaccination 2

from Vaccination 2 through 6 months after Vaccination 2

Percentage of participants reporting at least 1 immediate adverse event (AE) after Vaccination 1

within 30 minutes after Vaccination 1

Percentage of participants reporting at least 1 immediate adverse event (AE) after Vaccination 2

within 30 minutes after Vaccination 2

Percentage of participants reporting at least 1 immediate adverse event (AE) after Vaccination 3 in Group 2

within 30 minutes after Vaccination 3 in Group 2

Percentage of participants reporting missed days of school or work due to adverse events within 6 months after Vaccination 1

within 6 months after Vaccination 1

Percentage of participants reporting missed days of school or work due to adverse events within 6 months after Vaccination 2

within 6 months after Vaccination 2

Percentage of participants reporting missed days of school or work due to adverse events within 1 month after Vaccination 3 in Group 2

within 1 month after Vaccination 3 in Group 2

Eligibility criteria

Inclusion Criteria: * Male or female participants 11 through \<15 years of age at the time of randomization. * Participants who have never received a prior dose of any meningococcal vaccine. Written confirmation of vaccination history must be obtained prior to randomization. * Available for the entire study period and can be reached by telephone. * Healthy participant as determined by medical history, physical examination, and judgement of the investigator. * Negative urine pregnancy test for all female participants; pregnancy test is not applicable to male participants. Exclusion Criteria: * A previous anaphylactic reaction to any vaccine or vaccine-related component. * Bleeding diathesis or condition associated with prolonged bleeding time that would contraindicate intramuscular injection. * 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. * History of microbiologically proven disease caused by Neisseria meningitidis or Neisseria gonorrhoeae. * Significant neurological disorder or history of seizure (excluding simple febrile seizure). * Any neuroinflammatory or autoimmune condition, including, but no limited to, transverse myelitis, uveitis, optic neuritis, and multiple sclerosis. * Participants receiving any allergen immunotherapy with a nonlicensed product or receiving allergen immunotherapy with a licensed product and are not on stable maintenance doses. * Receipt of any blood products, including immunoglobulin, within 6 months before the first study vaccination. * Current use of systemic antibiotics with no foreseeable date of discontinuation prior to anticipated date of enrollment (first vaccination).

Protocol

{'studyType': 'INTERVENTIONAL', 'phases': ['PHASE2'], 'designInfo': {'allocation': 'RANDOMIZED', 'interventionModel': 'PARALLEL', 'primaryPurpose': 'PREVENTION', 'maskingInfo': {'masking': 'QUADRUPLE', 'whoMasked': ['PARTICIPANT', 'CARE_PROVIDER', 'INVESTIGATOR', 'OUTCOMES_ASSESSOR']}}, 'enrollmentInfo': {'count': 309, 'type': 'ACTUAL'}}

Updated at

2024-02-21

Organization

Pfizer

Product

Saline

Indication

Meningococcal Vaccine

Product

MenABCWY

A PHASE 2b, RANDOMIZED, OBSERVER-BLINDED TRIAL TO DESCRIBE THE SAFETY, TOLERABILITY, AND IMMUNOGENICITY OF MenABCWY ADMINISTERED ON 2 DIFFERENT DOSING SCHEDULES IN HEALTHY PARTICIPANTS ≥11 TO <15 YEARS OF AGE