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
NCT ID: NCT00847145
Last Updated: 2015-03-03
Study Results
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View full resultsBasic Information
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COMPLETED
PHASE3
2249 participants
INTERVENTIONAL
2009-02-28
2010-08-31
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
PREVENTION
NONE
Study Groups
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12B12M (1a)
Previously in the parent study subjects had received three doses of rMenB+OMV NZ and routine vaccine at 2, 4 and 6 months of age,respectively. These subjects received a booster (fourth) dose at 12 months of age concomitantly with one dose of MMRV vaccine in the present study.
1a - rMenB+OMV NZ and routine vaccines
One dose of rMenB vaccine and routine vaccine at study month 12.
12B13M (1b)
Previously in the parent study subjects had received three doses of rMenB+OMV NZ and routine vaccine at 2, 4 and 6 months of age, respectively. These subjects received a booster (fourth) dose at 12 months and one dose of MMRV vaccine at 13 months of age in the present study.
1b - rMenB+OMV NZ and routine vaccines
One dose of rMenB vaccine at study month 12 and routine vaccine at study month 13.
12M13B15B (2a)
Previously in the present study subjects had received routine vaccine at 2, 4 and 6 months of age respectively. These subjects received MMRV vaccine at 12 months of age and two catch-up doses of rMenB+OMV NZ vaccine at 13 and 15 months of age in the present study.
2a - Routine and rMenB+OMV NZ vaccines
One dose of routine vaccine at study month 12 and two doses of rMenB vaccine at study months 13 and 15.
12M12B14B (2b)
Previously in the parent study subjects ahd received three doses of routine vaccine at 2, 4 and 6 months of age, respectively. These subjects received two catch-up doses of rMenB+OMV NZ at 12 and 14 months of age and one dose of MMRV vaccine given concomitantly at 12 months of age in the present study.
2b - rMenB+OMV NZ and routine vaccines
Two doses of rMenB vaccine at study months 12 and 14 and one dose of routine vaccine at study month 12.
12B12M (3a)
Previously in the parent study subjects had received three doses of rMenB+OMV NZ at 2, 4 and 6 months of age respectively. These subjects had received one booster (fourth) dose of rMenB+OMV NZ at 12 months of age concomitantly with one dose of MMRV vaccine in the present study.
3a - rMenB+OMV NZ and routine vaccines
One dose of rMenB vaccine and one dose of routine vaccine at study month 12.
12B13M (3b)
Previously in the present study subjects had received three doses of rMenB+OMV NZ at 12 months of age respectively. These subjects one booster (fourth) dose of rMenB+OMV NZ at 12 months of age and one dose of MMRV vaccine at 13 months of age in the present study.
3b - 1 dose of rMenB+OMV NZ plus routine infant vaccinations
One dose of rMenB vaccine at study month 12 and one dose of routine vaccine study month 13.
12B12M_C (4a)
Previously in the parent study subjects had received three doses of Meningococcal C vaccine and routine vaccine at 2, 4 and 6 months of age respectively. These subjects had received one single dose of rMenB+OMV NZ at 12 months of age concomitantly with one dose of MMRV vaccine in the present study.
4a- rMenB+OMV NZ and routine vaccines
One dose of rMenB vaccine and one dose of routine vaccine at study month 12.
12B13M_C (4b)
Previously in the parent study subjects had received three doses of Meningococcal C vaccine and routine vaccine at 2, 4 and 6 months of age. These subjects received one single dose o rMenB+OMV NZ at 12 months of age and one dose of MMRV vaccine at 13 months of age in the present study.
4b - rMenB+OMV NZ and routine vaccines
One dose of rMenB vaccine and one dose of routine vaccine at study month 12.
Interventions
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1a - rMenB+OMV NZ and routine vaccines
One dose of rMenB vaccine and routine vaccine at study month 12.
1b - rMenB+OMV NZ and routine vaccines
One dose of rMenB vaccine at study month 12 and routine vaccine at study month 13.
2a - Routine and rMenB+OMV NZ vaccines
One dose of routine vaccine at study month 12 and two doses of rMenB vaccine at study months 13 and 15.
2b - rMenB+OMV NZ and routine vaccines
Two doses of rMenB vaccine at study months 12 and 14 and one dose of routine vaccine at study month 12.
3a - rMenB+OMV NZ and routine vaccines
One dose of rMenB vaccine and one dose of routine vaccine at study month 12.
3b - 1 dose of rMenB+OMV NZ plus routine infant vaccinations
One dose of rMenB vaccine at study month 12 and one dose of routine vaccine study month 13.
4a- rMenB+OMV NZ and routine vaccines
One dose of rMenB vaccine and one dose of routine vaccine at study month 12.
4b - rMenB+OMV NZ and routine vaccines
One dose of rMenB vaccine and one dose of routine vaccine at study month 12.
Eligibility Criteria
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Inclusion Criteria
Exclusion Criteria
* 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.
365 Days
394 Days
ALL
Yes
Sponsors
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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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Altenburger
Eisenstadt, , Austria
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
Site 12
Havlíčkův Brod, , Czechia
Fakulta vojenskeho zdravotnictví
Hradec Králové, , Czechia
Site 28
Hranice I-mesto, , Czechia
Site 13
Humpolec, , 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 16
Pilsen, , Czechia
Site 26
Rumburk, , Czechia
Site 23
Ústí nad Labem, , 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 80
München, , Germany
Site 83
München, , 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, Genova, Italy
Fondazione IRCCS Ospedale Maggiore Policlinico, Mangiagalli e Regina Elena Italia
Milan, Milano, Italy
Pediatria dell' Ospedale Sacco
Milan, Milano, Italy
Istituto di Igiene e Medicina Preventiva - Università degli Studi di Sassari
Sassari, Sassari, Italy
ASL/TA
Taranto, Taranto, Italy
Universita degli Studi di Messina, Policlinico G. Martino
Messina, , Italy
Ospedale Maggiore di Novara
Novara, , 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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2008-006301-17
Identifier Type: EUDRACT_NUMBER
Identifier Source: secondary_id
V72P13E1
Identifier Type: -
Identifier Source: org_study_id
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