Safety and Immunogenicity in Dose-Ranging and Formulation-Finding Meningococcal B (MenB) Vaccine Study in 2-month-old Infants
Status and phase
Conditions
Treatments
Details and patient eligibility
About
This study is aimed at assessing the safety and immunogenicity of different doses and formulations of a new Novartis Meningococcal B Recombinant Vaccine.
Enrollment
Sex
Ages
Volunteers
Inclusion criteria
- Healthy 2-month old infants (55-89 days, inclusive), born after full term pregnancy, gestational age ≥ 37 weeks and a birth weight ≥ 2.5 kg
- 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
Exclusion criteria
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Any meningococcal B or C vaccine administration
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Prior vaccination with any Diphtheria, Tetanus, Pertussis (acellular or whole cell), Polio (either Inactivated or Oral), Haemophilus influenzae type b (Hib), and Pneumococcal antigens;
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Any ascertained or suspected disease caused by N. meningitidis
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Household contact with and/or intimate exposure to an individual with laboratory confirmed N. meningitidis
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History of severe allergic reaction after previous vaccinations
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Recent significant acute or chronic infection
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Oral or parenteral antibiotic treatment in the 7 days prior to the scheduled blood draw;
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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)
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Any impairment/alteration of the immune system resulting from (for example):
- Receipt of any immunosuppressive therapy at any time since birth
- Receipt of immunostimulants at any time since birth
- Use of systemic corticosteroids or chronic use of inhaled high-potency corticosteroids at any time since birth
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Receipt of blood, blood products and/or plasma derivatives or any parenteral immunoglobulin preparation
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Participation in another clinical trial
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Family members and household members of research staff
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History of seizure
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Any contraindication to paracetamol
Trial design
Primary purpose
Allocation
Interventional model
Masking
1,507 participants in 8 patient groups
Trial contacts and locations
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Data sourced from clinicaltrials.gov
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