CompletedPhase 3

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

Poland55 participantsStarted 2014-12

Plain-language 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.

Who can participate

Age range18 Years – 50 Years

SexALL

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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;

What they're measuring

Number of Subjects Reporting Unsolicited Adverse Events (AEs).

Timeframe: From day 1 to day 7 after each vaccination (Vaccination 1: Day 1 to Day 7; Vaccination 2: Day 61 to Day 67)

Trial details

NCT IDNCT02305446

SponsorNovartis

Sponsor typeINDUSTRY

Study typeINTERVENTIONAL

Primary completion2015-04

Results submitted2015-10-01

View on ClinicalTrials.gov More Meningitis, Meningococcal, Serogroup B trials