Immunogenicity, Safety and Lot to Lot Consistency of Novartis Meningococcal B Recombinant Vaccine When Administered With Routine Infant Vaccinations to Healthy Infants
NCT ID: NCT00657709
Last Updated: 2017-10-10
Study Results
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View full resultsBasic Information
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COMPLETED
PHASE3
3630 participants
INTERVENTIONAL
2008-03-31
2010-01-31
Brief Summary
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Detailed Description
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Conditions
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Keywords
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Study Design
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RANDOMIZED
PARALLEL
PREVENTION
NONE
Study Groups
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rMenB Lot1
Subjects received one injection of rMenB+OMV NZ (Lot 1) at 2, 4, 6 months of age concomitantly with the routinely administered infant vaccines.
Serogroup B meningococcal Vaccine lot 1 (rMenB Lot 1)
One dose of rMenB Lot concomitantly with the routinely administered infant vaccines
rMenB Lot2
Subjects received one injection of rMenB+OMV NZ (Lot 2) at 2, 4, 6 months of age concomitantly with the routinely administered infant vaccines.
Serogroup B meningococcal Vaccine lot 2 (rMenB Lot 2)
One dose of rMenB concomitantly with the routinely administered infant vaccines
rMenB Lot3
Subjects received one injection of rMenB+OMV NZ (Lot 3) at 2, 4, 6 months of age concomitantly with the routinely administered infant vaccines.
Serogroup B meningococcal Vaccine lot 3 (rMenB Lot 3)
One dose of rMenB concomitantly with the routinely administered infant vaccines
Routine
Subjects received the routinely administered infant vaccines at 2, 4, 6 months of age.
Infanrix Hexa
Routine vaccination
Prevenar
Routine vaccination
MenC + Routine
Subjects received the routinely administered infant vaccines and Men C vaccine at 2, 4 and 6 months of age.
Infanrix Hexa
Routine vaccination
Menjugate
One dose of the routinely administered infant vaccines + MenC vaccine
Prevenar
Routine vaccination
Interventions
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Serogroup B meningococcal Vaccine lot 1 (rMenB Lot 1)
One dose of rMenB Lot concomitantly with the routinely administered infant vaccines
Serogroup B meningococcal Vaccine lot 2 (rMenB Lot 2)
One dose of rMenB concomitantly with the routinely administered infant vaccines
Serogroup B meningococcal Vaccine lot 3 (rMenB Lot 3)
One dose of rMenB concomitantly with the routinely administered infant vaccines
Infanrix Hexa
Routine vaccination
Menjugate
One dose of the routinely administered infant vaccines + MenC vaccine
Prevenar
Routine vaccination
Eligibility Criteria
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Inclusion Criteria
Exclusion Criteria
* 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
55 Days
89 Days
ALL
Yes
Sponsors
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GlaxoSmithKline
INDUSTRY
Novartis Vaccines
INDUSTRY
Responsible Party
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Principal Investigators
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Novartis Vaccines
Role: STUDY_CHAIR
Novartis Vaccines
Locations
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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
Site 14
Děčín, , Czechia
Site 12
Havlíčkův Brod, , Czechia
Site 8
Hradec Králové, , Czechia
Site 9
Hradec Králové, , Czechia
Site 28
Hranice I-mesto, , Czechia
Site 13
Humpolec, , Czechia
Site 15
Jindřichův Hradec, , Czechia
Site 25
Kladno, , Czechia
Site 21
Kolín, , Czechia
Site 10
Liberec, , Czechia
Site 24
Litoměřice, , Czechia
Site 17
Ostrava, , Czechia
Site 18
Ostrava-Poruba, , Czechia
Site 7
Pardubice, , Czechia
Site 16
Pilsen, , Czechia
Site 2
Prague, , Czechia
Site 3
Prague, , Czechia
Site 5
Prague, , Czechia
Site 6
Prague, , Czechia
Site 26
Rumburk, , Czechia
Site 23
Ústí nad Labem, , Czechia
Site 20
Znojmo, , Czechia
Site 30
Espoo, , Finland
Site 31
Helsinki, , Finland
Site 32
Helsinki, , Finland
Site 34
Järvenpää, , Finland
Site 35
Kokkola, , Finland
Site 45
Kotka, , Finland
Site 46
Kuopio, , Finland
Site 47
Lahti, , Finland
Site 49
Oulu, , Finland
Site 50
Pori, , Finland
Site 51
Seinäjoki, , Finland
Site 52
Tampere, , Finland
Site 53
Turku, , Finland
Site 33
Vantaa, , Finland
Site 48
Vantaa, , Finland
Site 99
Detmold, , Germany
Site 92
Espelkamp, , Germany
Site 95
Freising, , Germany
Site 64
Fulda, , Germany
Site 58
Lauffen am Neckar, , Germany
Site 57
Marbach A. N., , Germany
Site 97
München, , Germany
Site 96
München, , Germany
Site 91
Műnchen, , Germany
Site 81
Porta Westfalica, , Germany
Site 65
Schwieberdingen, , Germany
Site 94
Weilheim, , Germany
Dipartimento di Scienze della Salute
Genova, , Italy
Università degli Studi di Messina - Pad. NI - A.O.U. Policlinico G. Martino
Messina, , Italy
Fondazione IRCCS Ospedale Maggiore Policlinico, Mangiagalli e Regina Elena Italia
Milan, , Italy
Pediatria dell' Ospedale Sacco
Milan, , Italy
Ospedale Maggiore della Carita'-Clinica Pediatrica
Novara, , Italy
Istituto di Igiene e Medicina Preventiva - Università degli Studi di Sassari
Sassari, , Italy
ASL/TA
Taranto, , Italy
Countries
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References
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Zafack JG, Bureau A, Skowronski DM, De Serres G. Adverse events following immunisation with four-component meningococcal serogroup B vaccine (4CMenB): interaction with co-administration of routine infant vaccines and risk of recurrence in European randomised controlled trials. BMJ Open. 2019 May 19;9(5):e026953. doi: 10.1136/bmjopen-2018-026953.
Vesikari T, Esposito S, Prymula R, Ypma E, Kohl I, Toneatto D, Dull P, Kimura A; EU Meningococcal B Infant Vaccine Study group. Immunogenicity and safety of an investigational multicomponent, recombinant, meningococcal serogroup B vaccine (4CMenB) administered concomitantly with routine infant and child vaccinations: results of two randomised trials. Lancet. 2013 Mar 9;381(9869):825-35. doi: 10.1016/S0140-6736(12)61961-8.
Other Identifiers
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EUDRACT 2007-007781-38
Identifier Type: -
Identifier Source: secondary_id
V72P13
Identifier Type: -
Identifier Source: org_study_id