Safety, Tolerability and Immunogenicity of Meningococcal B Recombinant Vaccine Administered With or Without Routine Infant Vaccinations to Healthy Infants According to Different Immunization Schedules
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About
Primary :1.To demonstrate a sufficient immune response of rMenB+OMV NZ, when given concomitantly with routine infant vaccines to healthy infants at 2, 4 and 6 and 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 Secondary :To demonstrate that immunogenicity of routine infant vaccines, when given concomitantly with rMenB+OMV NZ to healthy infants at 2, 3 and 4 months of age, was non-inferior to that of routine infant vaccines given without rMenB+OMV NZ. 2. To demonstrate that the immunogenicity of rMenB+OMV NZ when given concomitantly with routine infant vaccines was non-inferior to that of rMenB+OMV NZ given without routine infant vaccines at 2, 4 and 6 months of age. 3. To assess prevalence of meningococcal B antibodies over the study period by evaluation of SBA, at baseline and at 1 month after third vaccination, in subjects- received routine infant vaccine without rMenB+OMV NZ.
Enrollment
Sex
Ages
Volunteers
Inclusion criteria
- 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;
- For whom a parent/legal guardian has given written informed consent after the nature of the study has been explained.
Exclusion criteria
- History of any meningococcal B or C vaccine administration;
- prior vaccination with routine infant vaccines (Diphtheria, Tetanus, Pertussis, Polio, Haemophilus influenzae type b (Hib), and Pneumococcal antigens);
- Previous ascertained or suspected disease caused by N. meningitidis;
- History of severe allergic reaction after previous vaccinations or hypersensitivity to any vaccine component;
- Significant acute or chronic infection within the previous 7 days or axillary temperature major or equal to38 degrees within the previous day;
- Antibiotics within 6 days prior to enrollment;
- Any serious chronic or progressive disease;
- Known or suspected impairment or alteration of the immune system;
- Receipt of blood, blood products and/or plasma derivatives or any parenteral immunoglobulin preparation.
Trial design
Primary purpose
Allocation
Interventional model
Masking
1,885 participants in 4 patient groups
Trial contacts and locations
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Data sourced from clinicaltrials.gov
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