Skip to main content
OpenTrials
Completed

NCT Number: NCT02305446

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

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.

Completed

Looking for future studies?

Notify Me

Key information

Conditions

Meningitis, Meningococcal, Serogroup B Bacterial Infections Bacterial Infections and Mycoses Central Nervous System Bacterial Infections Central Nervous System Diseases Central Nervous System Infections Gram-Negative Bacterial Infections Infections Meningitis Meningitis, Bacterial Meningitis, Meningococcal Meningococcal Infections Neisseriaceae Infections Nervous System Diseases Neuroinflammatory Diseases

Age range

18 year–50 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 3

Primary location

01, Novartis Investigational Site

Krakow, Poland

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Individuals of 18 through 50 years of age on the day of informed consent;
  • Individuals who had voluntarily given written informed consent after the nature of the study had been explained according to local regulatory requirements, prior to study entry;
  • Individuals who could comply with study procedures including follow-up;
  • Males, females of non-childbearing potential or females of childbearing potential who are using an effective birth control method.

Exclusion criteria

  • Progressive, unstable or uncontrolled clinical conditions;
  • Hypersensitivity, including allergy, to any component of vaccines or medical equipment whose use is foreseen in this study;
  • Abnormal function of the immune system;
  • Chronic clinical significant conditions;
  • Been administered any group B meningococcal vaccine at any time prior to informed consent; 5. Current or previous, confirmed or suspected disease caused by N.meningitidis.

Treatment and study plan

Meningococcal (group B) multicomponent recombinant adsorbed vaccine

Biological

One dose (0.5 mL) vaccine administered by intramuscular (IM) injection in the deltoid area of the non-dominant arm.

Other names: rMenB+OMV NZ

Primary outcomes

  1. 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.

Other outcomes

  1. Number of Adult Volunteers Whose Blood Can be Used as a Reference in Serum Bactericidal Activity (SBA) Test.

    Time frame: Study day 1 blood sample was drawn between day -5 and day 1. Postvaccination 2 blood sample was drawn between day 23 and day 37 postvaccination 2.

    The number of identified healthy adult volunteers with pre and postvaccination blood donations were summarized to establish a control sera panel to be used as a reference in SBA test.

Sponsors and collaborators

Lead sponsor

Novartis

Industry

Registry information

Official study 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 Years of Age and to Collect Blood Donations to Develop Vaccines Against Neisseria Meningitidis

Important dates

Study start
2014
Primary completion
2015
Study completion
2015
First posted
Dec 2, 2014
Registry last updated
Jan 5, 2016

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Related clinical trials

Published trials that share one or more normalized conditions with this study.