The proposed study was aimed to assess the immunogenicity, safety, tolerability and lot to lot consistency of 3 lots of Novartis Meningococcal B vaccine when given concomitantly with routine infant vaccines.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
NONE
Enrollment
3,630
One dose of rMenB Lot concomitantly with the routinely administered infant vaccines
One dose of rMenB concomitantly with the routinely administered infant vaccines
One dose of rMenB concomitantly with the routinely administered infant vaccines
The Geometric Mean Human Serum Bactericidal Activity (hSBA) Titers After Three Doses of rMenB+OMV NZ Vaccination
The hSBA antibody titer responses, one month after receiving the third vaccination of rMenB+OMV NZ vaccination, are reported as geometric mean titers (GMTs).
Time frame: one month after the third vaccination
The Percentages of Subjects With hSBA Titer ≥1:5 After Receiving Three Doses of rMenB+OMV Vaccination (3 Lots Combined)
The immunogenicity was assessed in terms of the percentages of subjects who had received the three doses of rMenB+OMV NZ (3 lots combined) given concomitantly with routine infant vaccinations and percentages of subjects who received only the routine infant vaccinations as measured by hSBA titer ≥1:5 following rMenB+OMV NZ vaccinations one month after the third vaccination is reported.
Time frame: one month after the third vaccination
The Percentages of Subjects With hSBA Titer ≥1:5 After Receiving Three Doses of rMenB+OMV Vaccination (From 3 Lots)
The immunogenicity was evaluated to assess the consistency of the immune response from three lots of rMenB+OMV NZ in terms of percentage of subjects as measured by hSBA titer ≥1:5 when given to healthy infants at 2, 4, and 6 months of age, at 1 month after the third vaccination.
Time frame: 1 month after the third vaccination
Geometric Mean Human Serum Bactericidal Activity Titers After the Routine Vaccination Without rMenB OMV NZ
The immunogenicity was assessed in terms of prevalence of meningococcal B antibodies as measured by the hSBA, at baseline and at one month after the third vaccination, in the subjects that received routine infant vaccines without rMenB+OMV NZ.
Time frame: 1 Month after the third vaccination
Geometric Mean Concentrations After Three Doses of rMenB+OMV NZ Vaccination (Against the 287-953 Antigen)
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Routine vaccination
One dose of the routinely administered infant vaccines + MenC vaccine
Routine vaccination
Grässl
Hall in Tirol, Austria
Häckel
Kirchdorf, Austria
Prieler
Neufeld A.d. Leitha, Austria
Maurer
Salzburg, Austria
Sommer
Vienna, Austria
Angermayr
Wels, Austria
Site 27
Boskovice, Czechia
Site 19
Brno, Czechia
Site 22
Chomutov, Czechia
Site11
Červený Kostelec, Czechia
...and 56 more locations
The immunogenicity was evaluated to characterize the immune response against vaccine antigen 287-953, as measured by ELISA at one month after third vaccination.
Time frame: 1 month after third vaccination
Geometric Mean Concentrations for Antigens (Pertussis Components) for the Routine Vaccinations
Immunogenicity of the pertussis components (PT, FHA, pertactin) of DTPa-HBV-IPV when given concomitantly with rMenB and PCV7 would be considered non-inferior to that of the routine vaccines given alone if the lower limit of the two-sided CI for the ratio of GMCs one month after third vaccination.
Time frame: 1 month after third vaccination
Percentages of Subjects With Antibody Response Against the Routine Antigens
The immunogenicity of routine infant vaccines when given concomitantly with rMenB+OMV NZ at 2, 4, and 6 months of age and of the routine infant vaccines given without rMenB+OMV NZ at 1 month after third vaccination with B pertussis, diptheria and tetanus toxoid, H influenza type b, Hepatitis B antigens was measured by ELISA (Enzyme-linked immunosorbent assay) and for polio type 1, type 2 and type 3 by neutralization test (NT)(\>=1:8). Diptheria and Tetanus: primary endpoint ELISA \>=0.1 (international unit -IU) IU/mL and the secondary endpoint is ELISA\>=1.0 IU/mL. HepB (HBV):primary endpoint ELISA \>=10 mU/mL. PRP-T: primary endpoint ≥ 0.15 mcg/mL and ≥ 1.00 mcg/mL.PNC \>=0.35 mcg/ml
Time frame: 1 Month after third vaccination
Percentages of Subjects With Fourfold Increase in Antibody Concentrations Against the Routine Antigens
Immunogenicity was assessed in terms of the percentages of subjects with fourfold increase in antibody concentrations against the routine pertussis antigens FHA (Filamentous Hemagglutinin), Pertactin and PT (Pertussis Toxoid).
Time frame: 5 months
Percentages of Subjects With Fourfold Rise in hSBA Titers After Three Doses of rMenB+OMV NZ Vaccination
Immunogenicity was assessed in terms of the percentages of subjects with fourfold rise in hSBA titers after the three doses of rMenB+OMV NZ (lot 1 or lot 2 or lot 3) vaccination at 2, 4 and 6 months of age.
Time frame: 1 Month after third vaccination
Percentage of Subjects With hSBA Titers ≥1:8
Immunogenicity was assessed in terms of the percentages of subjects achieving hSBA titers ≥1:8 at one month after third vaccination with rMenB (lot 1 or lot 2 or lot 3) against the three vaccine strains.
Time frame: 1 month after third vaccination
Number of Subjects Reporting Solicited Adverse Events After Receiving Three Doses of rMenB+OMV NZ Vaccine
The safety and tolerability of three doses of rMenB+OMV NZ when given concomitantly with routine infant vaccines at 2, 4 and 6 months of age was assessed by the number of subjects reporting solicited local and systemic adverse events.
Time frame: upto 7 days after any vaccination