Completed PHASE2 INTERVENTIONAL 2-arm NCT00560313

Safety, Tolerability and Immunogenicity of Three Doses of Novartis Meningococcal B Vaccine When Administered to Healthy At-risk Adults

A Phase 2, Multi-Center, Open-label Study of the Safety, Tolerability and Immunogenicity of Novartis Meningococcal B Recombinant Vaccine When Administered at a 0, 2, 6-Month Schedule and of a Single Dose of Novartis Meningococcal ACWY Conjugate Vaccine in Healthy At-risk Adults 18-50 Years of Age

Sponsor: Novartis Vaccines

Conditions Meningococcal Disease

Interventions 4CMenB Men ACWY CRM

Updated 5 times since 2017 Last updated: Mar 3, 2016 Started: Jul 31, 2007 Primary completion: Nov 30, 2009 Completion: Nov 30, 2009

This information is for research purposes only and is not medical advice. Consult a healthcare provider before making any medical decision.

This PHASE2 trial investigates Meningococcal Disease and is currently completed. Novartis Vaccines leads this study, which shows 5 recorded versions since 2007 — indicating limited longitudinal coverage. The change history captured here reflects the iterative nature of clinical trial conduct.

Status Flow

Change History

5 versions recorded

Sep 2024 — Present [monthly]

Completed PHASE2
Jul 2024 — Sep 2024 [monthly]

Completed PHASE2
Jan 2021 — Jul 2024 [monthly]

Completed PHASE2
Jun 2018 — Jan 2021 [monthly]

Completed PHASE2
Jan 2017 — Jun 2018 [monthly]

Completed PHASE2

First recorded

Jul 2007

Trial started

Per CT.gov start date — pre-dates our first snapshot

Eligibility Summary

No eligibility information available.

Contact Information

Sponsor contact:

Novartis Vaccines

Data source: Novartis

For direct contact, visit the study record on ClinicalTrials.gov .

Study Locations

• Siena, Italy