Immunogenicity, Safety and Lot to Lot Consistency of Novartis Meningococcal B Recombinant Vaccine When Administered With Routine Infant Vaccinations to Healthy Infants
- Conditions
- Serogroup B Meningococcal Meningitis
- Interventions
- Biological: Infanrix HexaBiological: Serogroup B meningococcal Vaccine lot 3 (rMenB Lot 3)Biological: Serogroup B meningococcal Vaccine lot 1 (rMenB Lot 1)Biological: Serogroup B meningococcal Vaccine lot 2 (rMenB Lot 2)Biological: MenjugateBiological: Prevenar
- Registration Number
- NCT00657709
- Lead Sponsor
- Novartis Vaccines
- Brief Summary
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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 3630
- Healthy 2-month old infants (55-89 days, inclusive)
- 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;
- Any serious chronic or progressive disease
- Known or suspected impairment or alteration of the immune system
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Routine Infanrix Hexa Subjects received the routinely administered infant vaccines at 2, 4, 6 months of age. rMenB Lot3 Serogroup B meningococcal Vaccine lot 3 (rMenB Lot 3) Subjects received one injection of rMenB+OMV NZ (Lot 3) at 2, 4, 6 months of age concomitantly with the routinely administered infant vaccines. MenC + Routine Infanrix Hexa Subjects received the routinely administered infant vaccines and Men C vaccine at 2, 4 and 6 months of age. rMenB Lot1 Serogroup B meningococcal Vaccine lot 1 (rMenB Lot 1) Subjects received one injection of rMenB+OMV NZ (Lot 1) at 2, 4, 6 months of age concomitantly with the routinely administered infant vaccines. rMenB Lot2 Serogroup B meningococcal Vaccine lot 2 (rMenB Lot 2) Subjects received one injection of rMenB+OMV NZ (Lot 2) at 2, 4, 6 months of age concomitantly with the routinely administered infant vaccines. MenC + Routine Prevenar Subjects received the routinely administered infant vaccines and Men C vaccine at 2, 4 and 6 months of age. Routine Prevenar Subjects received the routinely administered infant vaccines at 2, 4, 6 months of age. MenC + Routine Menjugate Subjects received the routinely administered infant vaccines and Men C vaccine at 2, 4 and 6 months of age.
- Primary Outcome Measures
Name Time Method The Geometric Mean Human Serum Bactericidal Activity (hSBA) Titers After Three Doses of rMenB+OMV NZ Vaccination one month after the third 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).
The Percentages of Subjects With hSBA Titer ≥1:5 After Receiving Three Doses of rMenB+OMV Vaccination (3 Lots Combined) one month after the third vaccination 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.
- Secondary Outcome Measures
Name Time Method The Percentages of Subjects With hSBA Titer ≥1:5 After Receiving Three Doses of rMenB+OMV Vaccination (From 3 Lots) 1 month after the third vaccination 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.
Geometric Mean Human Serum Bactericidal Activity Titers After the Routine Vaccination Without rMenB OMV NZ 1 Month after the third vaccination 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.
Geometric Mean Concentrations After Three Doses of rMenB+OMV NZ Vaccination (Against the 287-953 Antigen) 1 month after third vaccination The immunogenicity was evaluated to characterize the immune response against vaccine antigen 287-953, as measured by ELISA at one month after third vaccination.
Geometric Mean Concentrations for Antigens (Pertussis Components) for the Routine Vaccinations 1 month after third vaccination 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.
Percentages of Subjects With Antibody Response Against the Routine Antigens 1 Month after third vaccination 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/mlPercentages of Subjects With Fourfold Increase in Antibody Concentrations Against the Routine Antigens 5 months 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).
Percentages of Subjects With Fourfold Rise in hSBA Titers After Three Doses of rMenB+OMV NZ Vaccination 1 Month after third 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.
Percentage of Subjects With hSBA Titers ≥1:8 1 month after third vaccination 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.
Number of Subjects Reporting Solicited Adverse Events After Receiving Three Doses of rMenB+OMV NZ Vaccine upto 7 days after any vaccination 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.
Trial Locations
- Locations (66)
Site 35
🇫🇮Kokkola, Finland
Site 47
🇫🇮Lahti, Finland
Site 33
🇫🇮Vantaa, Finland
Site 25
🇨🇿Kladno 2, Czechia
Site 24
🇨🇿Litomerice, Czechia
Site 18
🇨🇿Ostrava-Poruba, Czechia
Site 13
🇨🇿Humpolec, Czechia
Site 10
🇨🇿Liberec, Czechia
Site 16
🇨🇿Plzeň, Czechia
Site 23
🇨🇿Usti nad Labem, Czechia
Site 7
🇨🇿Pardubice, Czechia
Site 2
🇨🇿Prague, Czechia
Site 3
🇨🇿Prague, Czechia
Site11
🇨🇿Červený Kostelec, Czechia
Site 30
🇫🇮Espoo, Finland
Site 45
🇫🇮Kotka, Finland
Site 20
🇨🇿Znojmo, Czechia
Site 34
🇫🇮Järvenpää, Finland
Site 46
🇫🇮Kuopio, Finland
Site 51
🇫🇮Seinäjoki, Finland
Site 48
🇫🇮Vantaa, Finland
Site 52
🇫🇮Tampere, Finland
Fondazione IRCCS Ospedale Maggiore Policlinico, Mangiagalli e Regina Elena Italia
🇮🇹Milano, Italy
Site 95
🇩🇪Freising, Germany
Site 65
🇩🇪Schwieberdingen, Germany
Site 99
🇩🇪Detmold, Germany
Università degli Studi di Messina - Pad. NI - A.O.U. Policlinico G. Martino
🇮🇹Messina, Italy
Pediatria dell' Ospedale Sacco
🇮🇹Milano, Italy
Site 81
🇩🇪Porta Westfalica, Germany
Site 92
🇩🇪Espelkamp, Germany
Site 96
🇩🇪München, Germany
Site 58
🇩🇪Lauffen, Germany
Site 94
🇩🇪Weilheim, Germany
Site 64
🇩🇪Fulda, Germany
Dipartimento di Scienze della Salute
🇮🇹Genova, Italy
Ospedale Maggiore della Carita'-Clinica Pediatrica
🇮🇹Novara, Italy
ASL/TA
🇮🇹Taranto, Italy
Site 57
🇩🇪Marbach a. N., Germany
Site 97
🇩🇪München, Germany
Site 91
🇩🇪Műnchen, Germany
Istituto di Igiene e Medicina Preventiva - Università degli Studi di Sassari
🇮🇹Sassari, Italy
Grässl
🇦🇹Hall in Tirol, Austria
Site 19
🇨🇿Brno, Czechia
Angermayr
🇦🇹Wels, Austria
Site 14
🇨🇿Děčín, Czechia
Site 8
🇨🇿Hradec Králové, Czechia
Häckel
🇦🇹Kirchdorf, Austria
Prieler
🇦🇹Neufeld a.d. Leitha, Austria
Site 9
🇨🇿Hradec Králové, Czechia
Maurer
🇦🇹Salzburg, Austria
Sommer
🇦🇹Wien, Austria
Site 32
🇫🇮Helsinki, Finland
Site 49
🇫🇮Oulu, Finland
Site 50
🇫🇮Pori, Finland
Site 53
🇫🇮Turku, Finland
Site 26
🇨🇿Rumburk, Czechia
Site 22
🇨🇿Chomutov, Czechia
Site 27
🇨🇿Boskovice, Czechia
Site 28
🇨🇿Hranice I-mesto, Czechia
Site 15
🇨🇿Jindřichův Hradec, Czechia
Site 5
🇨🇿Prague, Czechia
Site 31
🇫🇮Helsinki, Finland
Site 12
🇨🇿Havlíčkův Brod, Czechia
Site 17
🇨🇿Ostrava, Czechia
Site 6
🇨🇿Prague, Czechia
Site 21
🇨🇿Kolín, Czechia