Phase 3 N=55 Prevention

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

Meningitis, Meningococcal, Serogroup B

Bottom Line

View on ClinicalTrials.gov: NCT02305446 ↗

Enrolled (actual)

Serious AEs

1.8%

Results posted

Nov 2015

Primary outcome: Primary: Number of Subjects Reporting Unsolicited Adverse Events (AEs). — 0; 0; 0; 0 Subjects

Study Design & Population

Study type: Interventional
Phase: Phase 3
Interventions: Meningococcal (group B) multicomponent recombinant adsorbed vaccine (Biological)
Age: Adult · 18+ yrs
Sex: All
Sponsor: Novartis
Primary completion: Apr 2015

Outcome Measures

Outcome	Result	p-value
PRIMARY Number of Subjects Reporting Unsolicited Adverse Events (AEs).	0; 0; 0; 0; 0; 0	—

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.

Eligibility Criteria

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.

View full record on ClinicalTrials.gov →

Data sourced from ClinicalTrials.gov (NCT02305446). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.