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

NCT ID: NCT00721396

Last Updated: 2015-03-23

Study Results

Results available

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE2

Total Enrollment

1885 participants

Study Classification

INTERVENTIONAL

Study Start Date

2008-08-31

Study Completion Date

2010-07-31

Brief Summary

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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.

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Detailed Description

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Conditions

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Meningococcal Infections

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

PREVENTION

Blinding Strategy

NONE

Study Groups

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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.

Group Type EXPERIMENTAL

rMenB+OMV NZ

Intervention Type BIOLOGICAL

combined diphtheria,tetanus,pertussis+polio+Hepatitis B+Haemophilus influenzae B vaccine

Intervention Type BIOLOGICAL

Pneumococcal vaccine

Intervention Type BIOLOGICAL

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.

Group Type EXPERIMENTAL

rMenB+OMV NZ

Intervention Type BIOLOGICAL

combined diphtheria,tetanus,pertussis+polio+Hepatitis B+Haemophilus influenzae B vaccine

Intervention Type BIOLOGICAL

Pneumococcal vaccine

Intervention Type BIOLOGICAL

B+R234

Subjects in this group received rMenB+OMV NZ vaccine at 2, 3, 4 months of age, administered concomitantly with routine infant vaccinations.

Group Type EXPERIMENTAL

rMenB+OMV NZ

Intervention Type BIOLOGICAL

combined diphtheria,tetanus,pertussis+polio+Hepatitis B+Haemophilus influenzae B vaccine

Intervention Type BIOLOGICAL

Pneumococcal vaccine

Intervention Type BIOLOGICAL

R234

Subjects in this group received routine infant vaccines administered at 2, 3 and 4 months of age.

Group Type ACTIVE_COMPARATOR

combined diphtheria,tetanus,pertussis+polio+Hepatitis B+Haemophilus influenzae B vaccine

Intervention Type BIOLOGICAL

Pneumococcal vaccine

Intervention Type BIOLOGICAL

Interventions

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rMenB+OMV NZ

Intervention Type BIOLOGICAL

combined diphtheria,tetanus,pertussis+polio+Hepatitis B+Haemophilus influenzae B vaccine

Intervention Type BIOLOGICAL

Pneumococcal vaccine

Intervention Type BIOLOGICAL

Other Intervention Names

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Infanrix Hexa Prevenar

Eligibility Criteria

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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.
Minimum Eligible Age

55 Days

Maximum Eligible Age

89 Days

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Novartis Vaccines

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Novartis Vaccines

Role: STUDY_CHAIR

Novartis Vaccines

Locations

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Novartis Investigational Site Nr. 59

Edegem, Antwerpen, Belgium

Site Status

Novartis Investigational Site Nr. 55

Antwerp, Antwerp, Belgium

Site Status

Study Investigational Site Nr. 60

Brussels, Brussels Capital, Belgium

Site Status

Novartis Investigational Site Nr. 57

Brussels, Brussels Capital, Belgium

Site Status

Novartis Investigational Site Nr. 56

Hasselt, Limburg, Belgium

Site Status

Novartis Investigational Site Nr. 58

Namur, Namur, Belgium

Site Status

Novartis Investigational Site Nr. 95

Červený Kostelec, Hradec Králové, Czechia

Site Status

Novartis Investigational Site Nr. 93

Hradec Králové, Hradec Králové, Czechia

Site Status

Novartis Investigational Site Nr. 94

Pardubice, Pardubice, Czechia

Site Status

Novartis Investigational Site Nr. 96

Jindřichův Hradec, South Bohemian, Czechia

Site Status

Novartis Investigational Site Nr. 68

Bad Saulgau, Baden-Wurttemberg, Germany

Site Status

Novartis Investigational Site Nr. 65

Bretten, Baden-Wurttemberg, Germany

Site Status

Novartis Investigational Site Nr. 62

Kehl, Baden-Wurttemberg, Germany

Site Status

Novartis Investigational Site Nr. 64

Oberstenfeld, Baden-Wurttemberg, Germany

Site Status

Novartis Investigational Site Nr. 66

Welzheim, Baden-Wurttemberg, Germany

Site Status

Novartis Investigational Site Nr. 69

Aschaffenburg, Bavaria, Germany

Site Status

Novartis Investigational Site Nr. 71

Bremerhaven, City state Bremen, Germany

Site Status

Novartis Investigational Site Nr. 72

Hamburg, City state of Hamburg, Germany

Site Status

Novartis Investigational Site Nr. 73

Baunatal, Hesse, Germany

Site Status

Novartis Investigational Site Nr. 75

Bramsche, Lower Saxony, Germany

Site Status

Novartis Investigational Site Nr. 85

Bielefeld, North Rhine-Westphalia, Germany

Site Status

Novartis Investigational Site Nr. 81

Bochum, North Rhine-Westphalia, Germany

Site Status

Novartis Investigational Site Nr. 79

Heiligenhaus, North Rhine-Westphalia, Germany

Site Status

Novartis Investigational Site Nr. 80

Kleve Materborn, North Rhine-Westphalia, Germany

Site Status

Novartis Investigational Site Nr. 78

Mönchengladbach, North Rhine-Westphalia, Germany

Site Status

Novartis Investigational Site Nr. 82

Münster, North Rhine-Westphalia, Germany

Site Status

Novartis Investigational Site Nr. 83

Warburg, North Rhine-Westphalia, Germany

Site Status

Novartis Investigational Site Nr. 61

Mainz, Rhineland-Palatinate, Germany

Site Status

Novartis Investigational Site Nr. 67

Schweigen, Rhineland-Palatinate, Germany

Site Status

Novartis Investigational Site Nr. 86

Wanzleben, Saxony-Anhalt, Germany

Site Status

Novartis Investigational Site Nr. 88

Itzenhoe, Schleswig-Holstein, Germany

Site Status

Novartis Investigational Site Nr. 89

Itzenhoe, Schleswig-Holstein, Germany

Site Status

Novartis Investigational Site Nr. 87

Stockelsdorf, Schleswig-Holstein, Germany

Site Status

Novartis Investigational Site Nr. 70

Berlin, State of Berlin, Germany

Site Status

Novartis Investigational Site Nr. 90

Erfurt, Thuringia, Germany

Site Status

Novartis Investigational Site Nr. 5

Milan, Lombardy, Italy

Site Status

Novartis Investigational Site Nr. 52

Milan, Lombardy, Italy

Site Status

Novartis Investigational Site Nr. 6

Novara, Piedmont, Italy

Site Status

Novartis Investigational Site Nr. 7

Florence, Tuscany, Italy

Site Status

Novartis Investigational Site Nr. 9

Padua, Veneto, Italy

Site Status

Novartis Investigational Site Nr. 46

Santiago de Compostela, A Coruña, Spain

Site Status

Novartis Investigational Site Nr. 11

Almassora, Castellón, Spain

Site Status

Novartis Investigational Site Nr. 10

Castellon, Castellón, Spain

Site Status

Novartis Investigational Site Nr. 12

Vall D'Uixo, Castelló, Spain

Site Status

Novartis Investigational Site Nr. 48

Vigo Pontevedra, Pontevedra, Spain

Site Status

Novartis Investigational Site Nr. 49

Oviedo, Principality of Asturias, Spain

Site Status

Novartis Investigational Site Nr. 25

Catarroja, Valencia, Spain

Site Status

Novartis Investigational Site Nr. 21

L'Eliana, Valencia, Spain

Site Status

Novartis Investigational Site 14

Sagunto, Valencia, Spain

Site Status

Novartis Investigational Site Nr. 17

Valencia, Valencia, Spain

Site Status

Novartis Investigational Site Nr. 24

Valencia, Valencia, Spain

Site Status

Novartis Investigational Site Nr. 15

Valencia, Valencia, Spain

Site Status

Novartis Investigational Site Nr. 18

Valencia, Valencia, Spain

Site Status

Novartis Investigational Site Nr. 19

Valencia, Valencia, Spain

Site Status

Novartis Investigational Site Nr. 16

Valencia, Valencia, Spain

Site Status

Novartis Investigational Site Nr. 23

Valencia, Valencia, Spain

Site Status

Novartis Investigational Site Nr. 2

London, London, United Kingdom

Site Status

Novartis Investigational Site Nr. 1

Oxford, South East England, United Kingdom

Site Status

Novartis Investigational Site 3

Bristol, South West England, United Kingdom

Site Status

Novartis Investigational Site Nr. 4

Exeter, South West England, United Kingdom

Site Status

Countries

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Belgium Czechia Germany Italy Spain United Kingdom

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.

Reference Type DERIVED
PMID: 31110098 (View on PubMed)

Gossger N, Snape MD, Yu LM, Finn A, Bona G, Esposito S, Principi N, Diez-Domingo J, Sokal E, Becker B, Kieninger D, Prymula R, Dull P, Ypma E, Toneatto D, Kimura A, Pollard AJ; European MenB Vaccine Study Group. Immunogenicity and tolerability of recombinant serogroup B meningococcal vaccine administered with or without routine infant vaccinations according to different immunization schedules: a randomized controlled trial. JAMA. 2012 Feb 8;307(6):573-82. doi: 10.1001/jama.2012.85.

Reference Type DERIVED
PMID: 22318278 (View on PubMed)

Other Identifiers

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V72P12

Identifier Type: -

Identifier Source: org_study_id

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