The Novartis Meningococcal B Recombinant±OMV NZ vaccine is intended for prevention of meningitidis and/or septicemia caused by N.meningitidis serogroup B. This study is aimed at assessing the safety and immunogenicity of different doses and formulations (including decreasing OMV contents) of a Novartis Meningococcal B Recombinant Vaccine (rMenB + OMV NZ) in order to optimize its safety profile while maintaining sufficient immunogenicity.
Conditions
Interventions
Product Name: Novartis Meningococcal B Recombinant + OMV NZ vaccine
Pharmaceutical Form: Suspension for injection
Other descriptive name: N.meningitidis 287-953 purified antigen
Concentration unit: µg
Sponsors
Novartis Vaccines and Diagnostics S.r.l.
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: Subjects eligible to be enrolled in the study: 1. Healthy 2-month old infants (55-89 days, inclusive), who were born after full term pregnancy with an estimated gestational age = 37 weeks and a birth weight = 2.5 kg; 2. For whom a parent/legal guardian has given written informed consent after the nature of the study has been explained; 3. Available for all the visits scheduled in the study and for whom a parent/legal guardian is willing/able to comply with all protocol requirements; 4. In good health as determined by medical history, physical examination and clinical judgment of the investigator. Are the trial subjects under 18? yes Number of subjects for this age range: F.1.2 Adults (18-64 years) F.1.2.1 Number of subjects for this age range F.1.3 Elderly (>=65 years) F.1.3.1 Number of subjects for this age range
Exclusion criteria
Exclusion criteria: 1. History of any meningococcal B or C vaccine administration; 2. Prior vaccination with any Diphtheria, Tetanus, Pertussis (acellular or whole cell), Polio (either Inactivated or Oral), Haemophilus influenzae type b (Hib), and Pneumococcal antigens; 3. Previous or current ascertained or suspected disease caused by N. meningitidis; 4. Household contact with and/or intimate exposure to an individual with laboratory confirmed N. meningitidis; 5. History of severe allergic reaction after previous vaccinations or hypersensitivity to any vaccine component; 6. Significant acute or chronic infection within the previous 7 days or temperature =38°C within the previous day; 7. Oral or parenteral antibiotic treatment in the 7 days prior to the scheduled blood draw; 8. Any serious chronic or progressive disease according to the judgment of the investigator (e.g., neoplasm, diabetes mellitus Type I, cardiac disease, hepatic disease, progressive neurological disease or seizure, either associated with fever or as part of an underlying neurological disorder or syndrome, autoimmune disease, HIV infection or AIDS, or blood dyscrasias or diathesis, signs of cardiac or renal failure or severe malnutrition); 9. Known or suspected impairment/alteration of the immune system resulting from (for example): a. Receipt of any immunosuppressive therapy at any time since birth b. Receipt of immunostimulants at any time since birth c. Use of systemic corticosteroids or chronic use of inhaled high-potency corticosteroids at any time since birth; 10. Receipt of blood, blood products and/or plasma derivatives or any parenteral immunoglobulin preparation; 11. Receipt of, or intent to immunize with any other licensed vaccine(s) (with the exception of Rotavirus vaccines), from 28 days prior to enrollment to 28 days after the last study vaccination. 12. Receipt of any antipyretic medication in the previous 6 hours; 13. Participation in another clinical trial since birth or throughout study period; 14. Family members and household members of research staff; 15. Who have any history of seizure (one febrile seizure is not a reason for exclusion); 16. Any condition which, in the opinion of the investigator, might interfere with the evaluation of the study objectives; 17. Subject with any contraindication to treatment with paracetamol.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: Immunogenicity Objectives To assess if any of seven different formulations of rMenB+OMV NZ or rMenB (no OMV) vaccine induce sufficient immune response when given to healthy infants at 2, 3 and 4 months of age, as measured by percentage of subjects with serum bactericidal activity (SBA) titer = 1:5, at 1 month after the third vaccination. Safety Objectives To assess if any of six different formulations of rMenB+OMV NZ or rMenB (no OMV) vaccine will reduce the incidence of fever = 38.5 °C (rectal) occurring within 3 days (day 1–3) following first vaccination as compared to rMenB+OMV NZ. ;Secondary Objective: Immunogenicity Objectives -To assess the immune response of seven different formulations of rMenB+OMV NZ or rMenB (no OMV) vaccine, as measured by SBA geometric mean titers (GMTs) titer, at 1 month after the third vaccination. -To compare the immune response of rMenB+OMV NZ and of routine infant vaccines given with or without prophylactic antipyretic treatment. Safety Objectives -To assess if any of six different formulations of rMenB+OMV NZ or rMenB (no OMV) vaccine, will reduce the incidence of fever = 38.5 °C (rectal) occurring within 3 days (day 1–3) following second and third vaccination and 7 days (day 1–7) following each vaccination as compared to rMenB+OMV NZ. -To assess the incidence of fever = 38.5 °C (rectal) following co-administration of routine infant vaccinations with Menjugate® or with each of seven formulations of rMenB+OMV NZ. -To assess the safety and tolerability of each of seven different formulations of rMenB+OMV NZ or rMenB (no OMV) vaccine.;Primary end point(s): The immune response will be considered sufficient if the lower limit of the two-sided 95% confidence interval (CI) of the percentage of subjects with SBA =1:5 for N. meningitidis serogroup B is =65% for strains H44/76, NZ98/254 and 5/99. Immunogenicity Endpoints - percentage of subjects with SBA titer = 1:5 to N. meningitidis serogroup B reference strains H44/76, | — |
Countries
Czech Republic, Hungary, Italy
Outcome results
None listed