Safety, Tolerability and Immunogenicity of Meningococcal B Recombinant Vaccine Administered With or Without Routine Infant Vaccinations to Healthy Infants According to Different Immunization Schedules

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Novartis ( Novartis Vaccines )
ClinicalTrials.gov Identifier:
NCT00721396
First received: July 22, 2008
Last updated: March 17, 2015
Last verified: March 2015
  Purpose

Primary :1.To demonstrate a sufficient immune response of rMenB+OMV NZ, when given concomitantly with routine infant vaccines to healthy infants at 2, 4 and 6 and 2, 3 and 4 months of age, as measured by percentage of subjects with serum bactericidal activity (SBA) titer ≥1:5, at 1 month after the third vaccination Secondary :To demonstrate that immunogenicity of routine infant vaccines, when given concomitantly with rMenB+OMV NZ to healthy infants at 2, 3 and 4 months of age, was non-inferior to that of routine infant vaccines given without rMenB+OMV NZ. 2. To demonstrate that the immunogenicity of rMenB+OMV NZ when given concomitantly with routine infant vaccines was non-inferior to that of rMenB+OMV NZ given without routine infant vaccines at 2, 4 and 6 months of age. 3. To assess prevalence of meningococcal B antibodies over the study period by evaluation of SBA, at baseline and at 1 month after third vaccination, in subjects- received routine infant vaccine without rMenB+OMV NZ.


Condition Intervention Phase
Meningococcal Infections
Biological: rMenB+OMV NZ
Biological: combined diphtheria,tetanus,pertussis+polio+Hepatitis B+Haemophilus influenzae B vaccine
Biological: Pneumococcal vaccine
Phase 2

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 2b, Open Label, Randomized, Parallel-Group, Multi-Center Study to Evaluate the Safety, Tolerability and Immunogenicity of Novartis Meningococcal B Recombinant Vaccine When Administered With or Without Routine Infant Vaccinations to Healthy Infants According to Different Immunization Schedules.

Resource links provided by NLM:


Further study details as provided by Novartis:

Primary Outcome Measures:
  • Percentage of Subjects With Serum Bactericidal Activity ≥1:5 After Receiving Three Doses of rMenB+OMV NZ Vaccine [ Time Frame: One month after third Men B vaccination ] [ Designated as safety issue: No ]

    The percentage of subjects with serum bactericidal activity(hSBA)titer ≥1:5 after receiving three doses of rMenB+OMV NZ vaccine were evaluated to demonstrate sufficient immune response following rMenB+OMV NZ vaccination, when given concomitantly with routine infant vaccines to healthy infants.

    The serum bactericidal antibodies directed against serogroup B meningococci, are measured by human complement Serum Bactericidal Assay (hSBA).

    The immune response was considered sufficient for groups B+R246 and B+R234 if the lower limit of the 2-sided 95% confidence interval was ≥ 70% for all three strains.


  • Safety and Tolerability of 3 Doses of rMenB - Concomitantly With Routine Infant Vaccines at 2, 4 and 6 Months of Age - Concomitantly With Routine Vaccines at 2, 3 and 4 Months of Age - Alone at 2, 4 and 6 Months of Age [ Time Frame: 10 months (groups 1 and 2); 8 months (groups 3 and 4) ] [ Designated as safety issue: No ]
    Safety and Tolerability of 3 Doses of rMenB was assessed in terms of the number of subjects who reported solicited local and systemic adverse events when administered concomitantly with routine infant vaccines at 2,4,6 months of age (B+R246) to when rMenB+OMV NZ and routine vaccines were administered separately (group B246_R357).


Secondary Outcome Measures:
  • Non-inferiority of Immune Response to rMenB+OMV NZ Vaccination When Administered Concomitantly With Routine Infant Vaccines at 2,4,6 Months of Age [ Time Frame: One month after 3rd Men B vaccination ] [ Designated as safety issue: No ]
    The non-inferiority of immune response to rMenB+OMV NZ vaccination when administered concomitantly with routine infant vaccines at 2,4,6 months of age(B+R246) to when rMenB+OMV NZ and routine vaccines were administered separately (group B246_R357)was assessed in terms of percentage of subjects With hSBA≥ 1:5.

  • Non-inferiority of Immune Response to Diphtheria and Tetanus Antigens When Routine Vaccines Are Administered Concomitantly With rMen+OMV NZ Vaccine [ Time Frame: One month after 3rd vaccination ] [ Designated as safety issue: No ]
    Non-inferiority of immune response to routine vaccine antigens when routine vaccines were administered concomitantly with rMenB+OMV NZ vaccine [group B+R234] to when only routine vaccines were given [Group R234] were assessed in terms of percentage of subjects with antibody concentrations ≥0.1 IU/mL against Diphtheria and Tetanus antigens as measured by enzyme-linked immunosorbent assay.

  • Geometric Mean Titers Against Neisseria Meningitidis Serogroup B, When rMenB+OMV NZ Vaccine is Administered Concomitantly With Routine Infant Vaccines. [ Time Frame: One month after third Men B vaccination ] [ Designated as safety issue: No ]
    The hSBA antibody titers when rMenB+OMV NZ vaccine is administered concomitantly with routine infant vaccines to when rMenB+OMV NZ vaccine and routine vaccines were given separately are reported in terms of vaccine-group-specific geometric mean titers.

  • Geometric Mean Ratio of hSBA Titers, When rMenB+OMV NZ Vaccine is Administered Concomitantly With Routine Infant Vaccines. [ Time Frame: one month after third Men B vaccination ] [ Designated as safety issue: No ]
    The geometric mean ratio(GMR) of GMTs at 1 month after 3rd rMenB+OMV NZ vaccination to prevaccination GMTs, when rMenB+OMV NZ was administered concomitantly with routine infant vaccines to when rMenB+OMV NZ vaccine and routine vaccines were given separately.

  • Percentage of Subjects With hSBA ≥1:8 After Receiving Three Doses of rMenB+OMV NZ Vaccine. [ Time Frame: One month after third Men B vaccination ] [ Designated as safety issue: No ]
    The percentage of subjects with hSBA titers ≥1:8, following rMenB+OMV NZ vaccination when given concomitantly with routine infant vaccines to when rMenB+OMV NZ and routine vaccines were given separately.

  • Percentage of Subjects With 4-fold Rise in hSBA Titers, When rMenB+OMV NZ Vaccine is Administered Concomitantly With Routine Infant Vaccines. [ Time Frame: One month after third Men B vaccination ] [ Designated as safety issue: No ]
    The percentage of subjects with 4-fold rise in hSBA titers at 1 month after 3rd rMenB+OMV NZ vaccination from baseline, when rMenB+OMV NZ was administered concomitantly with routine infant vaccines to when rMenB+OMV NZ vaccine and routine vaccines were given separately.

  • Non-inferiority of Immune Response to Acellular Pertussis Antigens When Routine Vaccines Are Administered Concomitantly With rMen+OMV NZ Vaccine. [ Time Frame: 1 month after 3rd vaccination ] [ Designated as safety issue: No ]

    Non-inferiority of immune response to routine vaccine antigens when routine vaccines were administered concomitantly with rMenB+OMV NZ vaccine [group B+R234] to when only routine vaccines were given [Group R234] were assessed in terms of percentage of subjects achieving seroconversion for pertussis antigens - Filamentous Hemagglutinin (FHA), Pertactin and Pertussis Toxoid (PT) at 1 month after 3rd vaccination versus baseline.

    Seroconversion was defined as a 4-fold increase for each pertussis antigen or in those initially seropositive, persistence of the pre-vaccination antibody concentration at least at the same antibody concentration as before vaccination, taking into account the decay of maternal antibodies.



Enrollment: 1885
Study Start Date: August 2008
Study Completion Date: July 2010
Primary Completion Date: July 2010 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: B+R246
Subjects in this group received rMenB+OMV NZ vaccine at 2, 4, and 6 months of age, administered concomitantly with routine infant vaccinations.
Biological: rMenB+OMV NZ Biological: combined diphtheria,tetanus,pertussis+polio+Hepatitis B+Haemophilus influenzae B vaccine
Other Name: Infanrix Hexa
Biological: Pneumococcal vaccine
Other Name: Prevenar
Experimental: B246_R357
Subjects in this group received rMenB+OMV NZ vaccine at at 2, 4, and 6 months of age; routine infant vaccinations were administered at 3, 5 and 7 months of age.
Biological: rMenB+OMV NZ Biological: combined diphtheria,tetanus,pertussis+polio+Hepatitis B+Haemophilus influenzae B vaccine
Other Name: Infanrix Hexa
Biological: Pneumococcal vaccine
Other Name: Prevenar
Experimental: B+R234
Subjects in this group received rMenB+OMV NZ vaccine at 2, 3, 4 months of age, administered concomitantly with routine infant vaccinations.
Biological: rMenB+OMV NZ Biological: combined diphtheria,tetanus,pertussis+polio+Hepatitis B+Haemophilus influenzae B vaccine
Other Name: Infanrix Hexa
Biological: Pneumococcal vaccine
Other Name: Prevenar
Active Comparator: R234
Subjects in this group received routine infant vaccines administered at 2, 3 and 4 months of age.
Biological: combined diphtheria,tetanus,pertussis+polio+Hepatitis B+Haemophilus influenzae B vaccine
Other Name: Infanrix Hexa
Biological: Pneumococcal vaccine
Other Name: Prevenar

  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), who were born after full term pregnancy with an estimated gestational age ≥ 37 weeks and a birth weight ≥ 2.5 kg;
  • For whom a parent/legal guardian has given written informed consent after the nature of the study has been explained.

Exclusion Criteria:

  • History of any meningococcal B or C vaccine administration;
  • 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;
  • Significant acute or chronic infection within the previous 7 days or axillary temperature major or equal to38 degrees within the previous day;
  • Antibiotics within 6 days prior to enrollment;
  • Any serious chronic or progressive disease;
  • Known or suspected impairment or alteration of the immune system;
  • Receipt of blood, blood products and/or plasma derivatives or any parenteral immunoglobulin preparation.
  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: NCT00721396

  Hide Study Locations
Locations
Belgium
Novartis Investigational Site Nr. 59
Edegem, Antwerpen, Belgium, 2650
Novartis Investigational Site Nr. 57
Brussels, Brussels-Capital Region, Belgium, 1200
Study Investigational Site Nr. 60
Brussels, Brussels-Capital Region, Belgium, 1090
Novartis Investigational Site Nr. 56
Hasselt, Limburg, Belgium, 3500
Novartis Investigational Site Nr. 55
Antwerp, Belgium, 2018
Novartis Investigational Site Nr. 58
Namur, Belgium, 5000
Czech Republic
Novartis Investigational Site Nr. 95
Červený Kostelec, Hradec Králové, Czech Republic, 549 41
Novartis Investigational Site Nr. 96
Jindřichův Hradec, South Bohemian, Czech Republic, 377 01
Novartis Investigational Site Nr. 93
Hradec Králové, Czech Republic, 500 00
Novartis Investigational Site Nr. 94
Pardubice, Czech Republic, 530 01
Germany
Novartis Investigational Site Nr. 68
Bad Saulgau, Baden-Württemberg, Germany, 88348
Novartis Investigational Site Nr. 65
Bretten, Baden-Württemberg, Germany, 75015
Novartis Investigational Site Nr. 62
Kehl, Baden-Württemberg, Germany, 77694
Novartis Investigational Site Nr. 64
Oberstenfeld, Baden-Württemberg, Germany, 71720
Novartis Investigational Site Nr. 66
Welzheim, Baden-Württemberg, Germany, 73642
Novartis Investigational Site Nr. 69
Aschaffenburg, Bavaria, Germany, 63739
Novartis Investigational Site Nr. 71
Bremerhaven, Bremen, Germany, 27568
Novartis Investigational Site Nr. 73
Baunatal, Hesse, Germany, 34225
Novartis Investigational Site Nr. 75
Bramsche, Lower Saxony, Germany, 49565
Novartis Investigational Site Nr. 81
Bochum, North Rhine-Westphalia, Germany, 44866
Novartis Investigational Site Nr. 79
Heiligenhaus, North Rhine-Westphalia, Germany, 42579
Novartis Investigational Site Nr. 80
Kleve Materborn, North Rhine-Westphalia, Germany, 47533
Novartis Investigational Site Nr. 78
Monchengladbach, North Rhine-Westphalia, Germany, 41236
Novartis Investigational Site Nr. 82
Munster, North Rhine-Westphalia, Germany, 48163
Novartis Investigational Site Nr. 83
Warburg, North Rhine-Westphalia, Germany, 34414
Novartis Investigational Site Nr. 85
Bielefeld, North-Rhine Westphalia, Germany, 33617
Novartis Investigational Site Nr. 61
Mainz, Rhineland-Palatinate, Germany, 55131
Novartis Investigational Site Nr. 67
Schweigen, Rhineland-Palatinate, Germany, 76889
Novartis Investigational Site Nr. 86
Wanzleben, Saxony-Anhalt, Germany, 39164
Novartis Investigational Site Nr. 88
Itzenhoe, Schleswig-Holstein, Germany, 25524
Novartis Investigational Site Nr. 89
Itzenhoe, Schleswig-Holstein, Germany, 25524
Novartis Investigational Site Nr. 87
Stockelsdorf, Schleswig-Holstein, Germany, 23617
Novartis Investigational Site Nr. 90
Erfurt, Thuringia, Germany, 99086
Novartis Investigational Site Nr. 70
Berlin, Germany, 13125
Novartis Investigational Site Nr. 72
Hamburg, Germany, 22415
Italy
Novartis Investigational Site Nr. 5
Milano, Lombardy, Italy, 20122
Novartis Investigational Site Nr. 52
Milano, Lombardy, Italy, 20157
Novartis Investigational Site Nr. 6
Novara, Piedmont, Italy, 28100
Novartis Investigational Site Nr. 7
Firenze, Tuscany, Italy, 50139
Novartis Investigational Site Nr. 9
Padova, Veneto, Italy, 35100
Spain
Novartis Investigational Site Nr. 46
Santiago de Compostela, A Coruña, Spain, 15706
Novartis Investigational Site Nr. 49
Oviedo, Asturias, Spain, 33006
Novartis Investigational Site Nr. 11
Almassora, Castellón, Spain, 12550
Novartis Investigational Site Nr. 10
Castellon de la Plana, Castellón, Spain, 12006
Novartis Investigational Site Nr. 12
Vall D'Uixo, Castelló, Spain, 12600
Novartis Investigational Site Nr. 48
Vigo Pontevedra, Pontevedra, Spain, 36204
Novartis Investigational Site Nr. 25
Catarroja, Valencia, Spain, 46470
Novartis Investigational Site Nr. 21
La Eliana, Valencia, Spain, 46183
Novartis Investigational Site 14
Sagunto, Valencia, Spain, 46500
Novartis Investigational Site Nr. 16
Valencia, Spain, 46024
Novartis Investigational Site Nr. 24
Valencia, Spain, 46017
Novartis Investigational Site Nr. 17
Valencia, Spain, 46011
Novartis Investigational Site Nr. 15
Valencia, Spain, 46021
Novartis Investigational Site Nr. 19
Valencia, Spain, 46022
Novartis Investigational Site Nr. 23
Valencia, Spain, 46200
Novartis Investigational Site Nr. 18
Valencia, Spain, 46022
United Kingdom
Novartis Investigational Site Nr. 1
Oxford, South East England, United Kingdom, OX3 7LE
Novartis Investigational Site 3
Bristol, South West England, United Kingdom, BS8 1TH
Novartis Investigational Site Nr. 4
Exeter, South West England, United Kingdom, EX2 5DW
Novartis Investigational Site Nr. 2
London, United Kingdom, SW17 0RE
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: NCT00721396     History of Changes
Other Study ID Numbers: V72P12
Study First Received: July 22, 2008
Results First Received: February 18, 2015
Last Updated: March 17, 2015
Health Authority: United States: Food and Drug Administration
United Kingdom: Medicines and Healthcare Products Regulatory Agency
Germany: Federal Institute for Drugs and Medical Devices
Belgium: Federal Agency for Medicinal Products and Health Products
Spain: Agencia Española de Medicamentos y Productos Sanitarios
Italy: National Monitoring Centre for Clinical Trials - Ministry of Health
Czech Republic: State Institute for Drug Control

Keywords provided by Novartis:
Meningococcal disease,
Neisseria meningitidis serogroup B,
Prevention,
Vaccination,
Infants

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

ClinicalTrials.gov processed this record on April 26, 2015