A Phase 2 Partially Observer-Blind Randomized Controlled Multicenter Dose- Ranging and Formulation-Finding Study of a new Novartis Meningococcal B Recombinant Vaccine evaluating the safety and immunogenicity when given concomitantly with routine vaccines in 2-month-old infants - ND
- Conditions
- This study is aimed at assessing the safety and immunogenicity of different doses and formulations of a new Novartis Meningococcal B Recombinant Vaccine (rMenB + OMV NZ) in order to optimize its safety profile while maintaining sufficient immunogenicity. In addition, this study will assess whether prophylactic administration of paracetamol can decrease the incidence of febrile reactions following vaccination without impacting the immunogenicity of rMenB
- Registration Number
- EUCTR2009-010106-11-IT
- Lead Sponsor
- OVARTIS VACCINES AND DIAGNOSTICS S.R.L.
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ot Recruiting
- Sex
- All
- Target Recruitment
- 1600
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) 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
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 ≥ 38C 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);
Study & Design
- Study Type
- Interventional clinical trial of medicinal product
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method
- Secondary Outcome Measures
Name Time Method