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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Novartis ( Novartis Vaccines )
ClinicalTrials.gov Identifier:
NCT00847145
First received: February 18, 2009
Last updated: October 21, 2011
Last verified: October 2011
  Purpose

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


Condition Intervention Phase
Meningococcal Disease
Biological: 1a - rMenB+OMV NZ and routine infant vaccinations
Biological: 1b - rMenB+OMV NZ and routine infant vaccinations
Biological: 2a - Routine infant vaccinations and rMenB+OMV NZ
Biological: 2b - rMenB+OMV NZ and routine infant vaccinations
Biological: 3a - rMenB+OMV NZ and routine infant vaccinations
Biological: 3b - 1 dose of rMenB+OMV NZ plus routine infant vaccinations
Biological: 4a- rMenB+OMV NZ and routine infant vaccinations
Biological: 4b - rMenB+OMV NZ and routine infant vaccinations
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Prevention
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

Resource links provided by NLM:


Further study details as provided by Novartis:

Primary Outcome Measures:
  • Immunogenicity assessed by serum bactericidal assay (SBA) following a booster dose of Meningococcal B vaccine with or without concomitant MMRV vaccination, in toddlers who were previously primed with 3 doses of Meningococcal B vaccine as infants. [ Time Frame: 6 months ] [ Designated as safety issue: Yes ]
  • Safety and tolerability of a booster dose of MenB vaccine with and without MMRV, safety and tolerability of a two-dose catch-up regimen of MenB vaccine, and safety and tolerability of a single dose of MenB vaccine in toddlers. [ Time Frame: 6 months ] [ Designated as safety issue: Yes ]
  • Immunogenicity of a two-dose catch-up schedule of Meningococcal B vaccine given at 13 and 15 months or 12 and 14 months to naïve toddlers. [ Time Frame: 1-4 months ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Non-inferiority of immune responses to MMRV vaccination, when administered concomitantly with the booster dose of Meningococcal B vaccine to the immune responses of MMRV when given alone. [ Time Frame: 1-4 months ] [ Designated as safety issue: No ]
  • Immune response following a booster dose of Meningococcal B vaccine with or without concomitant MMRV vaccination, as measured by SBA GMTs and percentage of subjects with SBA titers ≥ 1:5. [ Time Frame: 1-4 months ] [ Designated as safety issue: No ]
  • Persistence of bactericidal antibodies in infants who previously received 3 doses ofMeningococcal B vaccine, as measured by SBA GMTs and the percentage of subjects with SBA titers ≥ 1:5. [ Time Frame: 1-4 months ] [ Designated as safety issue: No ]
  • Immunological memory in infants who previously received 3 doses of Meningococcal B vaccine. [ Time Frame: 1-4 months ] [ Designated as safety issue: No ]

Enrollment: 2249
Study Start Date: February 2009
Study Completion Date: August 2010
Primary Completion Date: August 2010 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: 1 Biological: 1a - rMenB+OMV NZ and routine infant vaccinations
1 dose of rMenB+OMV NZ plus routine infant vaccinations
Experimental: 2 Biological: 1b - rMenB+OMV NZ and routine infant vaccinations
1 dose of rMenB+OMV NZ plus routine infant vaccinations
Experimental: 3 Biological: 2a - Routine infant vaccinations and rMenB+OMV NZ
1 dose of routine infant vaccinations plus 2 doses of rMenB+OMV NZ
Experimental: 4 Biological: 2b - rMenB+OMV NZ and routine infant vaccinations
1 dose of rMenB+OMV NZ plus routine infant vaccinations plus 1 dose of rMenB+OMV NZ
Experimental: 5 Biological: 3a - rMenB+OMV NZ and routine infant vaccinations
1 dose of rMenB+OMV NZ plus routine infant vaccinations
Experimental: 6 Biological: 3b - 1 dose of rMenB+OMV NZ plus routine infant vaccinations
1 dose of rMenB+OMV NZ plus routine infant vaccinations
Experimental: 7 Biological: 4a- rMenB+OMV NZ and routine infant vaccinations
1 dose of rMenB+OMV NZ plus routine infant vaccinations
Experimental: 8 Biological: 4b - rMenB+OMV NZ and routine infant vaccinations
1 dose of rMenB+OMV NZ plus routine infant vaccinations

  Eligibility

Ages Eligible for Study:   365 Days to 394 Days
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00847145

  Hide Study Locations
Locations
Austria
Altenburger
Eisenstadt, Austria, 7000
Grässl
Hall in Tirol, Austria, 6060
Häckel
Kirchdorf, Austria, 4560
Prieler
Neufeld a.d. Leitha, Austria, 2491
Maurer
Salzburg, Austria, 5020
Angermayr
Wels, Austria, 4600
Sommer
Wien, Austria, 1230
Czech Republic
Site 27
Boskovice, Czech Republic, 680 01
Site 19
Brno, Czech Republic, 628 00
Site 22
Chomutov, Czech Republic, 430 03
Site 12
Havlíčkův Brod, Czech Republic, 580 22
Fakulta vojenskeho zdravotnictví
Hradec Králové, Czech Republic, 500 01
Site 28
Hranice I-mesto, Czech Republic, 753 01
Site 13
Humpolec, Czech Republic, 396 01
Site 25
Kladno 2, Czech Republic, 272 00
Site 21
Kolín, Czech Republic, 280 02
Site 10
Liberec, Czech Republic, 460 15
Site 24
Litomerice, Czech Republic, 412 01
Site 17
Ostrava, Czech Republic, 702 00
Site 18
Ostrava-Poruba, Czech Republic, 708 68
Site 16
Plzeň, Czech Republic, 305 99
Site 26
Rumburk, Czech Republic, 408 01
Site 23
Usti nad Labem, Czech Republic, 400 01
Finland
Site 30
Espoo, Finland, 02100
Site 31
Helsinki, Finland, 00100
Site 32
Helsinki, Finland, 00930
Site 34
Järvenpää, Finland, 04400
Site 35
Kokkola, Finland, 67100
Site 45
Kotka, Finland, 48600
Site 46
Kuopio, Finland, 70100
Site 47
Lahti, Finland, 15140
Site 49
Oulu, Finland, 90220
Site 50
Pori, Finland, 28100
Site 51
Seinäjoki, Finland, 60100
Site 52
Tampere, Finland, 33100
Site 53
Turku, Finland, 20520
Site 33
Vantaa, Finland, 01300
Site 48
Vantaa, Finland, 01600
Germany
Site 99
Detmold, Germany, 32756
Site 92
Espelkamp, Germany, 32339
Site 95
Freising, Germany, 85354
Site 64
Fulda, Germany, 36037
Site 58
Lauffen, Germany, 74348
Site 57
Marbach a. N., Germany, 71672
Site 80
München, Germany, 80337
Site 83
München, Germany, 81241
Site 96
München, Germany, 81475
Site 97
München, Germany, 81377
Site 91
Műnchen, Germany, 81737
Site 81
Porta Westfalica, Germany, 32457
Site 65
Schwieberdingen, Germany, 71701
Site 94
Weilheim, Germany, 82362
Italy
Dipartimento di Scienze della Salute
Genova, Italy, 16132
Universita degli Studi di Messina, Policlinico G. Martino
Messina, Italy
Fondazione IRCCS Ospedale Maggiore Policlinico, Mangiagalli e Regina Elena Italia
Milano, Italy, 20122
Pediatria dell' Ospedale Sacco
Milano, Italy, 20157
Ospedale Maggiore di Novara
Novara, Italy, 28100
Istituto di Igiene e Medicina Preventiva - Università degli Studi di Sassari
Sassari, Italy, 07100
ASL/TA
Taranto, Italy, 74100
Sponsors and Collaborators
Novartis Vaccines
Investigators
Study Chair: Novartis Vaccines Novartis Vaccines
  More Information

No publications provided by Novartis

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Novartis ( Novartis Vaccines )
ClinicalTrials.gov Identifier: NCT00847145     History of Changes
Other Study ID Numbers: V72P13E1, 2008-006301-17
Study First Received: February 18, 2009
Last Updated: October 21, 2011
Health Authority: United States: Food and Drug Administration
Italy: AIFA
Finland: NAM
Germany: PEI
Czech Republic: SUKL
Austria: Austrian Federal Agency for Safety in Health Care (BSAG)

Keywords provided by Novartis:
toddler
Meningococcal disease
prevention
vaccination

Additional relevant MeSH terms:
Meningococcal Infections
Neisseriaceae Infections
Gram-Negative Bacterial Infections
Bacterial Infections

ClinicalTrials.gov processed this record on August 25, 2014