Clinical trial NCT00847145: Extension Study of V72P13 to Evaluate the Safety, Tolerability and Immunogenicity of Novartis Meningococcal B Recombinant Vaccine When Administered as a Booster or as a Two-dose Catch-up to Healthy Toddlers
Official title: A Phase 3, Open Label, Multi-Center, Extension Study to Evaluate the Safety, Tolerability and Immunogenicity of Novartis Meningococcal B Recombinant Vaccine When Administered as a Booster at 12 Months of Age or as a Two-dose Catch-up to Healthy Toddlers Who Participated in Study V72P13
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Meningococcal Disease
Keywords: toddler
Meningococcal disease
prevention
vaccination
Lead sponsor: Novartis
Sponsor class: INDUSTRY
First posted: 2009-02-19
Enrollment: 2249
Sex: ALL
Minimum age (years): 365
Maximum age (years): 394
Standard ages: CHILD
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief summary: The proposed study is an Extension Study of V72P13 to Evaluate the Safety, Tolerability and Immunogenicity of Novartis Meningococcal B Recombinant Vaccine When Administered as a Booster at 12 Months of Age or as a Two-dose Catch-up to Healthy Toddlers


Eligibility criteria: Inclusion Criteria:

* Healthy 12-month-old toddlers (0/ +29 days) who completed Study V72P13

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/ alteration of the immune system,
* Receipt of, or intent to immunize with another vaccine, within 30 days prior to enrollment.

Primary outcomes:
measure: Percentages of Subjects With Serum Bactericidal Antibody Titers ≥1:5 After Receiving the Booster Dose of rMenB+OMV NZ Vaccination
timeFrame: one month after the booster (fourth) dose
Secondary outcomes:
measure: Percentages of Subjects With Antibody Response After Receiving the MMRV Vaccination
timeFrame: one month after booster (fourth) dose
measure: The Geometric Mean Titers After Receiving the Booster Dose of rMenB+OMV NZ Vaccination
timeFrame: one month after booster (fourth) vaccination.
measure: Geometric Mean Titers at 12 Months of Age (Predose 4) After Previously Receiving the Three Doses of rMenB+OMV NZ (Persistence)
timeFrame: one month after third vaccination and pre dose fourth (booster) vaccination
measure: Percentages of Subjects With Serum Bactericidal Antibody Titers ≥1:5 After Previously Receiving the Three Doses of rMenB+OMV NZ Vaccination (Persistence)
timeFrame: One month post vaccination and pe-booster (fourth) dose vaccination
measure: Geometric Mean Titers After Receiving the Booster Dose and Single Dose of rMen+OMV NZ Vaccination (Induction of Immunological Memory)
timeFrame: one month after booster (fourth) dose vaccination and pre-fourth dose vaccination
measure: SBA GMTs After a Two-dose Catch-up Schedule or Two-dose Schedule
timeFrame: One month after the second dose.
measure: Percentages of Subjects With SBA Titers ≥1:5 After a Two-dose Catch-up Schedule or Two-dose Schedule
timeFrame: One month after the second dose.
measure: ELISA Geometric Mean Concentration Against Vaccine Antigen 287-953 One Month After the Fourth (Booster) Dose Given at 12 Months
timeFrame: One month after the fourth (booster) dose.
measure: ELISA Geometric Mean Concentration Against Vaccine Antigen 287-953 After Two-dose Catch-up in Toddlers
timeFrame: One month after the first dose and one month after the second dose.
measure: Percentages of Subjects With Bactericidal Titers ≥ 1:5 (95% CI) Against Strain M10713 One Month After the Fourth (Booster) Dose Given at 12 Months
timeFrame: One month after the fourth (booster) dose.
measure: Number of Subjects Reporting Solicited Local and Systemic Reactions During the 7 Days Following rMenB+OMV NZ Vaccination at 12 Months of Age
timeFrame: From day 1 to day 7 after each rMenB+OMV NZ vaccination.
measure: Number of Subjects Reporting Solicited Local and Systemic Reactions During the 7 Days Following Two-dose Catch-up Schedules of rMenB+OMV NZ Vaccination
timeFrame: From day 1 to day 7 after each rMenB+MV NZ vaccination.
measure: Number of Subjects Reporting Solicited Local Reactions During the 7 Days Following MMRV Vaccination at 12 Months of Age
timeFrame: From day 1 to day 7 after MMRV vaccination.
measure: Number of Subjects Reporting Solicited Systemic Reactions During 8-28 Days Following MMRV Vaccination at 12 Months of Age
timeFrame: From day 8 to day 28 after MMRV vaccination.
Other outcomes:
Locations:
city: Eisenstadt
country: Austria
facility: Altenburger
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: Czech Republic
facility: Site 27
city: Brno
country: Czech Republic
facility: Site 19
city: Chomutov
country: Czech Republic
facility: Site 22
city: Havlíčkův Brod
country: Czech Republic
facility: Site 12
city: Hradec Králové
country: Czech Republic
facility: Fakulta vojenskeho zdravotnictví
city: Hranice I-mesto
country: Czech Republic
facility: Site 28
city: Humpolec
country: Czech Republic
facility: Site 13
city: Kladno 2
country: Czech Republic
facility: Site 25
city: Kolín
country: Czech Republic
facility: Site 21
city: Liberec
country: Czech Republic
facility: Site 10
city: Litomerice
country: Czech Republic
facility: Site 24
city: Ostrava-Poruba
country: Czech Republic
facility: Site 18
city: Ostrava
country: Czech Republic
facility: Site 17
city: Plzeň
country: Czech Republic
facility: Site 16
city: Rumburk
country: Czech Republic
facility: Site 26
city: Usti nad Labem
country: Czech Republic
facility: Site 23
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 80
city: München
country: Germany
facility: Site 83
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: Universita degli Studi di Messina, 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 di Novara
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.