The Novartis Meningococcal B Recombinant + OMV NZ Vaccine is intended for prevention of meningitidis and/or septicemia caused by N.meningitidis serogroup B. The objective of the Novartis Meningococcal B Recombinant + OMV vaccine is to identify a vaccine candidate that is safe and provide functional immune responses against heterologous meningococcal B strains. MedDRA version: 9.1 Level: LLT Classification code 10027276 Term: Meningococcal meningitis
Conditions
Sponsors
Novartis Vaccines and Diagnostics S.r.l.
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 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. 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) no F.1.2.1 Number of subjects for this age range F.1.3 Elderly (>=65 years) no 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 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 axillary temperature = 38°C within the previous day. 7. Antibiotics within 6 days prior to enrollment. 8. Any serious chronic or progressive disease according to the judgment of the investigator (e.g., neoplasm, insulin dependent 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, immunosuppressive therapy, use of systemic corticosteroids or chronic use of inhaled high-potency corticosteroids 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 vaccine(s) (with the exception of rotavirus), within 30 days prior and throughout the study period. 12. Participation in another clinical trial since birth or planned for during study. 13. Family members and household members of research staff. 14. Any condition which, in the opinion of the investigator, might interfere with the evaluation of the study objectives.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Primary end point(s): End points For Assessing Immunogenicity Objectives: Bactericidal activity (% =1:5, i.e., percentage of subjects with SBA titer =1:5) 30 days following the third vaccination. The immune response will be sufficient for groups 1 (rMenB+OMV NZ + concomitant vaccines at 2, 4, 6 months of age) and 3 (rMenB+OMV + concomitant vaccines at 2, 3, 4 months of age) if the lower limit of the two-sided 95% confidence interval (CI) for the % =1:5 is =70% for the Norwegian strain H44/76, the New Zealand strain NZ98/254 and for strain 5/99. End points For Assessing Safety Objectives: serious adverse events and all other AEs including local and systemic reactions, and safety information obtained at all visits will be collected. All subjects receiving at least one injection and providing post-baseline safety data will be included in the safety and tolerability analyses. Local and Systemic Reactions. Incidences of local (i.e., injection site tenderness, erythema, induration, swelling) and systemic (i.e., fever [defined as axillary temperature =38°C], medically attended fever, change in eating habits, sleepiness, vomiting, diarrhea, irritability, unusual crying, rash) reactions occurring during the 7 days following each injection will be summarized by maximal severity and study group. In the analysis of safety criteria rectal measured temperature will be converted to axillary by subtracting 0.5 °C (38.0 °C axillary temperature corresponds to 38.5 °C rectal temperature). Additionally, the number of subjects who used antipyretic medication will be summarized, distinguishing between prophylactic and therapeutic use. All local and systemic reactions but rash will be categorized as none, mild, moderate, and severe. If a reaction occurs more than once for a subject, the reaction will be classified according to the maximal severity. Other Adverse Events. The original verbatim terms used by investigators to identify AEs in the case CRFs will be mapped to preferred te | — |
Countries
Czech Republic, Germany, Italy, Spain, United Kingdom
Outcome results
None listed