Men4age study

Phase 1

• Conditions: Invasive meningococcal disease, sepsis, meningitis; MedDRA version: 20.0Level: PTClassification code: 10076061Term: Meningococcal immunisation Class: 100000004865; Therapeutic area: Diseases [C] - Bacterial Infections and Mycoses [C01]

• Registration Number: CTIS2024-513640-29-00
• Lead Sponsor: Rijksinstituut voor Volksgezondheid en Milieu (RIVM)

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2024-04-26
• Last Update Posted: 22 July 2024

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: All
• Target Recruitment: 280

Inclusion Criteria

Participants eligible for this study are Dutch older persons 65-85 years of age, Moderate to good general health with regard to age, Did not receive a MenACWY-TT vaccine before

Exclusion Criteria

Antibiotic use within 14 days of enrolment, Serious surgery within the last 3 months, Previous vaccination with the MenC, MenC-TT or MenACWY-TT vaccine, Previous confirmed or suspected meningococcal disease, Any vaccination within a month before enrolment, Known or suspected allergy to any of the vaccine components (by medical history), Severe acute infectious illness or fever above 38.0 °C within 14 days before vaccination, Present evidence of serious diseases either demanding regular use of oral immunosuppressive medical treatment, like corticosteroids, that might interfere with the results of the study within the last 3 months or demanding acute use of high dose oral immunosuppressive that might interfere with the results of the study within the last 2 weeks, Occurrence of a serious adverse event after other vaccination by medical history, Known or suspected immune deficiency, Known or suspected coagulation disorder, Oral hormone use, such as postmenopausal hormones, within the last 3 months, History of one of the following neurological disorders: multiple sclerosis, Parkinson’s disease, or epilepsy, Previous administration of plasma-serum products including immunoglobulins within 6 months before vaccination and blood sampling

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified