Immunogenicity, Safety and Lot to Lot Consistency of Novartis Meningococcal B Recombinant Vaccine When Administered With Routine Infant Vaccinations to Healthy Infants

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Novartis ( Novartis Vaccines )
ClinicalTrials.gov Identifier:
NCT00657709
First received: April 2, 2008
Last updated: April 13, 2015
Last verified: April 2015
  Purpose

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.


Condition Intervention Phase
Serogroup B Meningococcal Meningitis
Biological: Serogroup B meningococcal Vaccine lot 1 (rMenB Lot 1)
Biological: Serogroup B meningococcal Vaccine lot 2 (rMenB Lot 2)
Biological: Serogroup B meningococcal Vaccine lot 3 (rMenB Lot 3)
Biological: Infanrix Hexa
Biological: Menjugate
Biological: Prevenar
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, 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

Resource links provided by NLM:


Further study details as provided by Novartis:

Primary Outcome Measures:
  • The Geometric Mean Human Serum Bactericidal Activity (hSBA) Titers After Three Doses of rMenB+OMV NZ Vaccination [ Time Frame: one month after the third vaccination ] [ Designated as safety issue: No ]
    The hSBA antibody titer responses, one month after receiving the third vaccination of rMenB+OMV NZ vaccination, are reported as geometric mean titers (GMTs).

  • The Percentages of Subjects With hSBA Titer ≥1:5 After Receiving Three Doses of rMenB+OMV Vaccination (3 Lots Combined) [ Time Frame: one month after the third vaccination ] [ Designated as safety issue: No ]
    The immunogenicity was assessed in terms of the percentages of subjects who had received the three doses of rMenB+OMV NZ (3 lots combined) given concomitantly with routine infant vaccinations and percentages of subjects who received only the routine infant vaccinations as measured by hSBA titer ≥1:5 following rMenB+OMV NZ vaccinations one month after the third vaccination is reported.


Secondary Outcome Measures:
  • The Percentages of Subjects With hSBA Titer ≥1:5 After Receiving Three Doses of rMenB+OMV Vaccination (From 3 Lots) [ Time Frame: 1 month after the third vaccination ] [ Designated as safety issue: No ]
    The immunogenicity was evaluated to assess the consistency of the immune response from three lots of rMenB+OMV NZ in terms of percentage of subjects as measured by hSBA titer ≥1:5 when given to healthy infants at 2, 4, and 6 months of age, at 1 month after the third vaccination.

  • Geometric Mean Human Serum Bactericidal Activity Titers After the Routine Vaccination Without rMenB OMV NZ [ Time Frame: 1 Month after the third vaccination ] [ Designated as safety issue: No ]
    The immunogenicity was assessed in terms of prevalence of meningococcal B antibodies as measured by the hSBA, at baseline and at one month after the third vaccination, in the subjects that received routine infant vaccines without rMenB+OMV NZ.

  • Geometric Mean Concentrations After Three Doses of rMenB+OMV NZ Vaccination (Against the 287-953 Antigen) [ Time Frame: 1 month after third vaccination ] [ Designated as safety issue: No ]
    The immunogenicity was evaluated to characterize the immune response against vaccine antigen 287-953, as measured by ELISA at one month after third vaccination.

  • Geometric Mean Concentrations for Antigens (Pertussis Components) for the Routine Vaccinations [ Time Frame: 1 month after third vaccination ] [ Designated as safety issue: No ]
    Immunogenicity of the pertussis components (PT, FHA, pertactin) of DTPa-HBV-IPV when given concomitantly with rMenB and PCV7 would be considered non-inferior to that of the routine vaccines given alone if the lower limit of the two-sided CI for the ratio of GMCs one month after third vaccination.

  • Percentages of Subjects With Antibody Response Against the Routine Antigens [ Time Frame: 1 Month after third vaccination ] [ Designated as safety issue: No ]

    The immunogenicity of routine infant vaccines when given concomitantly with rMenB+OMV NZ at 2, 4, and 6 months of age and of the routine infant vaccines given without rMenB+OMV NZ at 1 month after third vaccination with B pertussis, diptheria and tetanus toxoid, H influenza type b, Hepatitis B antigens was measured by ELISA (Enzyme-linked immunosorbent assay) and for polio type 1, type 2 and type 3 by neutralization test (NT)(>=1:8). Diptheria and Tetanus: primary endpoint ELISA >=0.1 (international unit -IU) IU/mL and the secondary endpoint is ELISA>=1.0 IU/mL.

    HepB (HBV):primary endpoint ELISA >=10 mU/mL. PRP-T: primary endpoint ≥ 0.15 mcg/mL and ≥ 1.00 mcg/mL.PNC >=0.35 mcg/ml


  • Percentages of Subjects With Fourfold Increase in Antibody Concentrations Against the Routine Antigens [ Time Frame: 5 months ] [ Designated as safety issue: No ]
    Immunogenicity was assessed in terms of the percentages of subjects with fourfold increase in antibody concentrations against the routine pertussis antigens FHA (Filamentous Hemagglutinin), Pertactin and PT (Pertussis Toxoid).

  • Percentages of Subjects With Fourfold Rise in hSBA Titers After Three Doses of rMenB+OMV NZ Vaccination [ Time Frame: 1 Month after third vaccination ] [ Designated as safety issue: No ]
    Immunogenicity was assessed in terms of the percentages of subjects with fourfold rise in hSBA titers after the three doses of rMenB+OMV NZ (lot 1 or lot 2 or lot 3) vaccination at 2, 4 and 6 months of age.

  • Percentage of Subjects With hSBA Titers ≥1:8 [ Time Frame: 1 month after third vaccination ] [ Designated as safety issue: Yes ]
    Immunogenicity was assessed in terms of the percentages of subjects achieving hSBA titers ≥1:8 at one month after third vaccination with rMenB (lot 1 or lot 2 or lot 3) against the three vaccine strains.

  • Number of Subjects Reporting Solicited Adverse Events After Receiving Three Doses of rMenB+OMV NZ Vaccine [ Time Frame: upto 7 days after any vaccination ] [ Designated as safety issue: Yes ]
    The safety and tolerability of three doses of rMenB+OMV NZ when given concomitantly with routine infant vaccines at 2, 4 and 6 months of age was assessed by the number of subjects reporting solicited local and systemic adverse events.


Enrollment: 3630
Study Start Date: March 2008
Study Completion Date: January 2010
Primary Completion Date: January 2010 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: 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.
Biological: Serogroup B meningococcal Vaccine lot 1 (rMenB Lot 1)
One dose of rMenB Lot concomitantly with the routinely administered infant vaccines
Experimental: 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.
Biological: Serogroup B meningococcal Vaccine lot 2 (rMenB Lot 2)
One dose of rMenB concomitantly with the routinely administered infant vaccines
Experimental: 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.
Biological: Serogroup B meningococcal Vaccine lot 3 (rMenB Lot 3)
One dose of rMenB concomitantly with the routinely administered infant vaccines
Active Comparator: Routine
Subjects received the routinely administered infant vaccines at 2, 4, 6 months of age.
Biological: Infanrix Hexa
Routine vaccination
Biological: Prevenar
Routine vaccination
Active Comparator: MenC + Routine
Subjects received the routinely administered infant vaccines and Men C vaccine at 2, 4 and 6 months of age.
Biological: Infanrix Hexa
Routine vaccination
Biological: Menjugate
One dose of the routinely administered infant vaccines + MenC vaccine
Biological: Prevenar
Routine vaccination

  Eligibility

Ages Eligible for Study:   55 Days to 89 Days
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
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
  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: NCT00657709

  Hide Study Locations
Locations
Austria
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 14
Děčín, Czech Republic, 405 01
Site 12
Havlíčkův Brod, Czech Republic, 580 22
Site 8
Hradec Králové, Czech Republic, 500 01
Site 9
Hradec Králové, Czech Republic, 500 05
Site 28
Hranice I-mesto, Czech Republic, 753 01
Site 13
Humpolec, Czech Republic, 396 01
Site 15
Jindřichův Hradec, Czech Republic, 377 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 7
Pardubice, Czech Republic, 532 03
Site 16
Plzeň, Czech Republic, 305 99
Site 6
Prague, Czech Republic, 19000
Site 2
Prague, Czech Republic, 130 00
Site 5
Prague, Czech Republic, 16000
Site 3
Prague, Czech Republic, 140 00
Site 26
Rumburk, Czech Republic, 408 01
Site 23
Usti nad Labem, Czech Republic, 400 01
Site 20
Znojmo, Czech Republic, 669 00
Site11
Červený Kostelec, Czech Republic, 54941
Finland
Site 30
Espoo, Finland, 02230
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, 70211
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, 74348
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
Università degli Studi di Messina - Pad. NI - A.O.U. Policlinico G. Martino
Messina, Italy, 98122
Fondazione IRCCS Ospedale Maggiore Policlinico, Mangiagalli e Regina Elena Italia
Milano, Italy, 20122
Pediatria dell' Ospedale Sacco
Milano, Italy, 20157
Ospedale Maggiore della Carita'-Clinica Pediatrica
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: NCT00657709     History of Changes
Other Study ID Numbers: V72P13, EUDRACT 2007-007781-38
Study First Received: April 2, 2008
Results First Received: February 13, 2015
Last Updated: April 13, 2015
Health Authority: United States: Food and Drug Administration
Finland: Finnish Medicines Agency
Germany: Paul-Ehrlich-Institut
Czech Republic: State Institute for Drug Control
Austria: Federal Office for Safety in Health Care

Keywords provided by Novartis:
infant
Meningococcal disease
prevention
vaccination

Additional relevant MeSH terms:
Meningitis, Meningococcal
Bacterial Infections
Central Nervous System Bacterial Infections
Central Nervous System Diseases
Central Nervous System Infections
Gram-Negative Bacterial Infections
Meningitis
Meningitis, Bacterial
Meningococcal Infections
Neisseriaceae Infections
Nervous System Diseases

ClinicalTrials.gov processed this record on September 03, 2015