Clinical trial NCT00433914: Safety, Tolerability and Immunogenicity of Two Different Formulations of Meningococcal B Recombinant Vaccine, When Administered to Healthy Infants
Official title: A Phase 2, Single Blind, Single Center, Randomized Study of the Safety, Tolerability and Immunogenicity of Novartis Meningococcal B Recombinant Vaccine +/- OMV, When Administered to Healthy Infants 6-8 Months Old
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Meningococcal Disease
Keywords: Meningococcal disease, prevention, vaccination
Lead sponsor: Novartis
Sponsor class: INDUSTRY
First posted: 2007-02-12
Enrollment: 60
Sex: ALL
Minimum age (years): 6
Maximum age (years): 8
Standard ages: CHILD
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief 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

Primary outcomes:
measure: 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
timeFrame: Baseline and one month after second and third vaccination
measure: 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
timeFrame: Baseline and one month after second and third vaccination
Secondary outcomes:
measure: 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
timeFrame: One month after second and third vaccination
measure: Geometric Mean Bactericidal Titers Against Meningococcal Strains One Month After Second and Third Vaccination of rMenB Vaccine With and Without OMV-NZ
timeFrame: Baseline and one month after second and third vaccination
measure: Geometric Mean ELISA Concentration Against Meningococcal 287-953 Antigen One Month After Second and Third Vaccination of rMenB Vaccine With and Without OMV-NZ
timeFrame: Baseline and one month after second and third vaccination
measure: 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
timeFrame: One month after second and third vaccination
measure: Number of Subjects Who Reported Solicited Local and Systemic Reactions After Each Vaccination of rMenB Vaccine With and Without OMV-NZ
timeFrame: Day 1 through day 7 after each vaccination
Other outcomes:
Locations:
city: Oxford
country: United Kingdom
Study officials:
affiliation: Novartis Vaccines
name: Novartis Vaccines (formerly Chiron Vaccines) Novartis
role: STUDY_CHAIR
References:
citation: Viviani V, Biolchi A, Pizza M. Synergistic activity of antibodies in the multicomponent 4CMenB vaccine. Expert Rev Vaccines. 2022 May;21(5):645-658. doi: 10.1080/14760584.2022.2050697. Epub 2022 Mar 14.
citation: Snape MD, Dawson T, Oster P, Evans A, John TM, Ohene-Kena B, Findlow J, Yu LM, Borrow R, Ypma E, Toneatto D, Pollard AJ. Immunogenicity of two investigational serogroup B meningococcal vaccines in the first year of life: a randomized comparative trial. Pediatr Infect Dis J. 2010 Nov;29(11):e71-9. doi: 10.1097/INF.0b013e3181f59f6d.