Clinical Trial: Safety and Blood Donations in Adults Vaccinated With rMenB+OMV NZ.

Study Status: Completed
Recruit Status: Completed
Study Type: Interventional

Official Title: Phase 3b, Open Label, Uncontrolled, Single-arm, Single-centre Study to Evaluate the Safety of Two Doses of Novartis Meningococcal Group B Vaccine When Administered to Healthy Adults From 18 to 50 Year

Brief Summary: The purpose of this trial is to assess the safety of a Meningococcal Group B Vaccine and to collect blood donation. Sera panel obtained from blood donations will be used as a control to measure the immunoresponse to the Meningococcal Group B Vaccine in other studies.

Detailed Summary:
Sponsor: Novartis

Current Primary Outcome: Number of Subjects Reporting Unsolicited Adverse Events (AEs). [ Time Frame: From day 1 to day 7 after each vaccination (Vaccination 1: Day 1 to Day 7; Vaccination 2: Day 61 to Day 67) ]

Safety was assessed as the number of the subjects who reported unsolicited AEs following vaccination.


Original Primary Outcome:

  • The number and percentages of subjects experiencing any Serious adverse events (SAE), Adverse events (AE) leading to withdrawal, AE of special interest, and medically attended AEs for 7 days (including the day of vaccination) after each vaccination. [ Time Frame: Day 1 ]
  • The number and percentages of subjects experiencing any Serious adverse events (SAE), Adverse events (AE) leading to withdrawal, AE of special interest, and medically attended AEs for 7 days (including the day of vaccination) after each vaccination. [ Time Frame: Day 61 ]
  • The number and percentages of subjects experiencing any Serious adverse events (SAE), Adverse events (AE) leading to withdrawal, AE of special interest, and medically attended AEs for 7 days (including the day of vaccination) after each vaccination. [ Time Frame: Day 91 ]


Current Secondary Outcome:

Original Secondary Outcome:

Information By: Novartis

Dates:
Date Received: November 20, 2014
Date Started: December 2014
Date Completion:
Last Updated: December 3, 2015
Last Verified: December 2015