Clinical trial NCT00657709: Immunogenicity, Safety and Lot to Lot Consistency of Novartis Meningococcal B Recombinant Vaccine When Administered With Routine Infant Vaccinations to Healthy Infants
Official title: A Phase 3, Partially Blinded, Randomized, Multi-Center, Controlled Study to Evaluate Immunogenicity, Safety and Lot to Lot Consistency of Novartis Meningococcal B Recombinant Vaccine When Administered With Routine Infant Vaccinations to Healthy Infants
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Serogroup B Meningococcal Meningitis
Keywords: infant
Meningococcal disease
prevention
vaccination
Lead sponsor: Novartis
Sponsor class: INDUSTRY
Collaborators: name: GlaxoSmithKline
First posted: 2008-04-14
Enrollment: 3630
Sex: ALL
Minimum age (years): 55
Maximum age (years): 89
Standard ages: CHILD
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

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.


Eligibility criteria: Inclusion Criteria:

* Healthy 2-month old infants (55-89 days, inclusive)

Exclusion Criteria:

* 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

Primary outcomes:
measure: The Geometric Mean Human Serum Bactericidal Activity (hSBA) Titers After Three Doses of rMenB+OMV NZ Vaccination
timeFrame: one month after the third vaccination
measure: The Percentages of Subjects With hSBA Titer ≥1:5 After Receiving Three Doses of rMenB+OMV Vaccination (3 Lots Combined)
timeFrame: one month after the third vaccination
Secondary outcomes:
measure: The Percentages of Subjects With hSBA Titer ≥1:5 After Receiving Three Doses of rMenB+OMV Vaccination (From 3 Lots)
timeFrame: 1 month after the third vaccination
measure: Geometric Mean Human Serum Bactericidal Activity Titers After the Routine Vaccination Without rMenB OMV NZ
timeFrame: 1 Month after the third vaccination
measure: Geometric Mean Concentrations After Three Doses of rMenB+OMV NZ Vaccination (Against the 287-953 Antigen)
timeFrame: 1 month after third vaccination
measure: Geometric Mean Concentrations for Antigens (Pertussis Components) for the Routine Vaccinations
timeFrame: 1 month after third vaccination
measure: Percentages of Subjects With Antibody Response Against the Routine Antigens
timeFrame: 1 Month after third vaccination
measure: Percentages of Subjects With Fourfold Increase in Antibody Concentrations Against the Routine Antigens
timeFrame: 5 months
measure: Percentages of Subjects With Fourfold Rise in hSBA Titers After Three Doses of rMenB+OMV NZ Vaccination
timeFrame: 1 Month after third vaccination
measure: Percentage of Subjects With hSBA Titers ≥1:8
timeFrame: 1 month after third vaccination
measure: Number of Subjects Reporting Solicited Adverse Events After Receiving Three Doses of rMenB+OMV NZ Vaccine
timeFrame: upto 7 days after any vaccination
Other outcomes:
Locations:
city: Hall in Tirol
country: Austria
facility: Grässl
city: Kirchdorf
country: Austria
facility: Häckel
city: Neufeld a.d. Leitha
country: Austria
facility: Prieler
city: Salzburg
country: Austria
facility: Maurer
city: Wels
country: Austria
facility: Angermayr
city: Wien
country: Austria
facility: Sommer
city: Boskovice
country: Czechia
facility: Site 27
city: Brno
country: Czechia
facility: Site 19
city: Chomutov
country: Czechia
facility: Site 22
city: Děčín
country: Czechia
facility: Site 14
city: Havlíčkův Brod
country: Czechia
facility: Site 12
city: Hradec Králové
country: Czechia
facility: Site 8
city: Hradec Králové
country: Czechia
facility: Site 9
city: Hranice I-mesto
country: Czechia
facility: Site 28
city: Humpolec
country: Czechia
facility: Site 13
city: Jindřichův Hradec
country: Czechia
facility: Site 15
city: Kladno 2
country: Czechia
facility: Site 25
city: Kolín
country: Czechia
facility: Site 21
city: Liberec
country: Czechia
facility: Site 10
city: Litomerice
country: Czechia
facility: Site 24
city: Ostrava-Poruba
country: Czechia
facility: Site 18
city: Ostrava
country: Czechia
facility: Site 17
city: Pardubice
country: Czechia
facility: Site 7
city: Plzeň
country: Czechia
facility: Site 16
city: Prague
country: Czechia
facility: Site 2
city: Prague
country: Czechia
facility: Site 3
city: Prague
country: Czechia
facility: Site 5
city: Prague
country: Czechia
facility: Site 6
city: Rumburk
country: Czechia
facility: Site 26
city: Usti nad Labem
country: Czechia
facility: Site 23
city: Znojmo
country: Czechia
facility: Site 20
city: Červený Kostelec
country: Czechia
facility: Site11
city: Espoo
country: Finland
facility: Site 30
city: Helsinki
country: Finland
facility: Site 31
city: Helsinki
country: Finland
facility: Site 32
city: Järvenpää
country: Finland
facility: Site 34
city: Kokkola
country: Finland
facility: Site 35
city: Kotka
country: Finland
facility: Site 45
city: Kuopio
country: Finland
facility: Site 46
city: Lahti
country: Finland
facility: Site 47
city: Oulu
country: Finland
facility: Site 49
city: Pori
country: Finland
facility: Site 50
city: Seinäjoki
country: Finland
facility: Site 51
city: Tampere
country: Finland
facility: Site 52
city: Turku
country: Finland
facility: Site 53
city: Vantaa
country: Finland
facility: Site 33
city: Vantaa
country: Finland
facility: Site 48
city: Detmold
country: Germany
facility: Site 99
city: Espelkamp
country: Germany
facility: Site 92
city: Freising
country: Germany
facility: Site 95
city: Fulda
country: Germany
facility: Site 64
city: Lauffen
country: Germany
facility: Site 58
city: Marbach a. N.
country: Germany
facility: Site 57
city: München
country: Germany
facility: Site 97
city: München
country: Germany
facility: Site 96
city: Műnchen
country: Germany
facility: Site 91
city: Porta Westfalica
country: Germany
facility: Site 81
city: Schwieberdingen
country: Germany
facility: Site 65
city: Weilheim
country: Germany
facility: Site 94
city: Genova
country: Italy
facility: Dipartimento di Scienze della Salute
city: Messina
country: Italy
facility: Università degli Studi di Messina - Pad. NI - A.O.U. Policlinico G. Martino
city: Milano
country: Italy
facility: Fondazione IRCCS Ospedale Maggiore Policlinico, Mangiagalli e Regina Elena Italia
city: Milano
country: Italy
facility: Pediatria dell' Ospedale Sacco
city: Novara
country: Italy
facility: Ospedale Maggiore della Carita'-Clinica Pediatrica
city: Sassari
country: Italy
facility: Istituto di Igiene e Medicina Preventiva - Università degli Studi di Sassari
city: Taranto
country: Italy
facility: ASL/TA
Study officials:
affiliation: Novartis Vaccines
name: Novartis Vaccines
role: STUDY_CHAIR
References:
citation: 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.
citation: 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.