A Trial to Describe the Safety and Immunogenicity of MenABCWY When Administered on 2 Schedules

Pfizer

Status and phase: Completed; Phase 2

Conditions: Meningococcal Vaccine

Treatments: Biological: Saline; Biological: MenABCWY

Study type: Interventional

Funder types: Industry

Identifiers

NCT04440176

2019-004923-19 (EudraCT Number)

C3511004

Details and patient eligibility

About

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.

Enrollment: 309 patients

Sex: All

Ages: 11 to 14 years old

Volunteers: Accepts Healthy Volunteers

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).

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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309 participants in 2 patient groups

Group 1 (MenABCWY 0-, 12-months)

Experimental group

Description:

MenABCWY administered at Month 0 and Month 12

Treatment:

Biological: MenABCWY

Group 2 (MenABCWY 0-, 36-months)

Experimental group

Description:

MenABCWY administered at Month 0 and Month 36

Treatment:

Biological: MenABCWY

Biological: Saline