Phase 2 N=60 Randomized Single-blind Prevention

Safety, Tolerability and Immunogenicity of Two Different Formulations of Meningococcal B Recombinant Vaccine, When Administered to Healthy Infants

Meningococcal Disease

Bottom Line

View on ClinicalTrials.gov: NCT00433914 ↗

Enrolled (actual)

Serious AEs

10.0%

Results posted

Mar 2015

Primary outcome: Primary: Percentage of Subjects With Bactericidal Titers ≥1:4 Against Meningococcal Strains One Month After Second and Third Vaccination of rMenB Vaccine With and Without OMV-NZ — 8; 29; 100; 100 Percentage of subjects

Study Design & Population

Study type: Interventional
Phase: Phase 2
Interventions: rMenB (Biological); rMenB+OMV (Biological)
Age: Pediatric · 0+ yrs
Sex: All
Sponsor: Novartis Vaccines
Primary completion: Dec 2007

Outcome Measures

Outcome	Result	p-value
PRIMARY Percentage of Subjects With Bactericidal Titers ≥1:4 Against Meningococcal Strains One Month After Second and Third Vaccination of rMenB Vaccine With and Without OMV-NZ	8; 29; 100; 100; 100; 100	—
PRIMARY Percentage of Subjects With Bactericidal Titers ≥1:8 Against Meningococcal Strains One Month After Second and Third Vaccination of rMenB Vaccine With and Without OMV-NZ	0; 4; 96; 100; 100; 100	—
SECONDARY Percentage of Subjects With Four-fold Rise in Bactericidal Titers Against Meningococcal Strains One Month After Second and Third Vaccination of rMenB Vaccine With and Without OMV-NZ	96; 100; 100; 100; 100; 100	—
SECONDARY Geometric Mean Bactericidal Titers Against Meningococcal Strains One Month After Second and Third Vaccination of rMenB Vaccine With and Without OMV-NZ	1.16; 1.70; 94; 250; 109; 189	—
SECONDARY Geometric Mean ELISA Concentration Against Meningococcal 287-953 Antigen One Month After Second and Third Vaccination of rMenB Vaccine With and Without OMV-NZ	24; 21; 1759; 2912; 2298; 3521	—
SECONDARY Percentage of Subjects With Four-fold Rise in ELISA Concentration Against Meningococcal 287-953 Antigen One Month After Second and Third Vaccination of rMenB Vaccine With and Without OMV-NZ	100; 100; 100; 100	—
SECONDARY Number of Subjects Who Reported Solicited Local and Systemic Reactions After Each Vaccination of rMenB Vaccine With and Without OMV-NZ	29; 29; 4; 9; 5; 11	—

Summary

To explore safety, Tolerability and immunogenicity of two formulations of a Meningococcal B Recombinant Vaccine when administered to healthy infants.

Eligibility Criteria

Inclusion Criteria

healthy 6-8 months old infants

Exclusion Criteria

previous receipt of any meningococcal B vaccine;
previous ascertained or suspected disease caused by N meningitidis;
history of any anaphylactic shock, asthma, urticaria or other allergic reaction after previous vaccinations or known hypersensitivity to any vaccine component;
any present or suspected serious acute or chronic disease
known or suspected autoimmune disease or impairment /alteration of immune function

View full record on ClinicalTrials.gov →

Data sourced from ClinicalTrials.gov (NCT00433914). 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.