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

NCT00721396 | Completed Phase 2 Results DMC

• 1 other identifier: V72P12
• Study Type: interventional
• Target: 1,885
• Locations: 6 countries
• Sites: 60

Brief Summary

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.

Conditions

Meningococcal Infections

Keywords

Meningococcal disease,; Neisseria meningitidis serogroup B,; Prevention,; Vaccination,; Infants

Outcome Measures

Primary Outcomes (2)

• Percentage of Subjects With Serum Bactericidal Activity ≥1:5 After Receiving Three Doses of rMenB+OMV NZ Vaccine

  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.

  One month after third Men B vaccination

• 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

  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).

  10 months (groups 1 and 2); 8 months (groups 3 and 4)

Secondary Outcomes (7)

• Non-inferiority of Immune Response to rMenB+OMV NZ Vaccination When Administered Concomitantly With Routine Infant Vaccines at 2,4,6 Months of Age

  One month after 3rd Men B vaccination

• Non-inferiority of Immune Response to Diphtheria and Tetanus Antigens When Routine Vaccines Are Administered Concomitantly With rMen+OMV NZ Vaccine

  One month after 3rd vaccination

• Geometric Mean Titers Against Neisseria Meningitidis Serogroup B, When rMenB+OMV NZ Vaccine is Administered Concomitantly With Routine Infant Vaccines.

  One month after third Men B vaccination

• Geometric Mean Ratio of hSBA Titers, When rMenB+OMV NZ Vaccine is Administered Concomitantly With Routine Infant Vaccines.

  one month after third Men B vaccination

• Percentage of Subjects With hSBA ≥1:8 After Receiving Three Doses of rMenB+OMV NZ Vaccine.

  One month after third Men B vaccination

Study Arms (4)

B+R246

EXPERIMENTAL

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; Biological: Pneumococcal vaccine

B246_R357

EXPERIMENTAL

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; Biological: Pneumococcal vaccine

B+R234

EXPERIMENTAL

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; Biological: Pneumococcal vaccine

R234

ACTIVE COMPARATOR

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; Biological: Pneumococcal vaccine

Interventions

rMenB+OMV NZ BIOLOGICAL

B+R234; B+R246; B246_R357

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

Also known as: Infanrix Hexa

B+R234; B+R246; B246_R357; R234

Pneumococcal vaccine BIOLOGICAL

Also known as: Prevenar

B+R234; B+R246; B246_R357; R234

Eligibility Criteria

• Age: 55 Days - 89 Days
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Novartis Vaccines: lead

Study Sites (60)

Novartis Investigational Site Nr. 59

Edegem, Antwerpen, 2650, Belgium

Location

Novartis Investigational Site Nr. 55

Antwerp, Antwerp, 2018, Belgium

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Study Investigational Site Nr. 60

Brussels, Brussels Capital, 1090, Belgium

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Novartis Investigational Site Nr. 57

Brussels, Brussels Capital, 1200, Belgium

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Novartis Investigational Site Nr. 56

Hasselt, Limburg, 3500, Belgium

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Novartis Investigational Site Nr. 58

Namur, Namur, 5000, Belgium

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Novartis Investigational Site Nr. 95

Červený Kostelec, Hradec Králové, 549 41, Czechia

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Novartis Investigational Site Nr. 93

Hradec Králové, Hradec Králové, 500 00, Czechia

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Novartis Investigational Site Nr. 94

Pardubice, Pardubice, 530 01, Czechia

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Novartis Investigational Site Nr. 96

Jindřichův Hradec, South Bohemian, 377 01, Czechia

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Novartis Investigational Site Nr. 68

Bad Saulgau, Baden-Wurttemberg, 88348, Germany

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Novartis Investigational Site Nr. 65

Bretten, Baden-Wurttemberg, 75015, Germany

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Novartis Investigational Site Nr. 62

Kehl, Baden-Wurttemberg, 77694, Germany

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Novartis Investigational Site Nr. 64

Oberstenfeld, Baden-Wurttemberg, 71720, Germany

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Novartis Investigational Site Nr. 66

Welzheim, Baden-Wurttemberg, 73642, Germany

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Novartis Investigational Site Nr. 69

Aschaffenburg, Bavaria, 63739, Germany

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Novartis Investigational Site Nr. 71

Bremerhaven, City state Bremen, 27568, Germany

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Novartis Investigational Site Nr. 72

Hamburg, Hamburg, 22415, Germany

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Novartis Investigational Site Nr. 73

Baunatal, Hesse, 34225, Germany

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Novartis Investigational Site Nr. 75

Bramsche, Lower Saxony, 49565, Germany

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Novartis Investigational Site Nr. 85

Bielefeld, North Rhine-Westphalia, 33617, Germany

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Novartis Investigational Site Nr. 81

Bochum, North Rhine-Westphalia, 44866, Germany

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Novartis Investigational Site Nr. 79

Heiligenhaus, North Rhine-Westphalia, 42579, Germany

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Novartis Investigational Site Nr. 80

Kleve Materborn, North Rhine-Westphalia, 47533, Germany

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Novartis Investigational Site Nr. 78

Mönchengladbach, North Rhine-Westphalia, 41236, Germany

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Novartis Investigational Site Nr. 82

Münster, North Rhine-Westphalia, 48163, Germany

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Novartis Investigational Site Nr. 83

Warburg, North Rhine-Westphalia, 34414, Germany

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Novartis Investigational Site Nr. 61

Mainz, Rhineland-Palatinate, 55131, Germany

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Novartis Investigational Site Nr. 67

Schweigen, Rhineland-Palatinate, 76889, Germany

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Novartis Investigational Site Nr. 86

Wanzleben, Saxony-Anhalt, 39164, Germany

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Novartis Investigational Site Nr. 88

Itzenhoe, Schleswig-Holstein, 25524, Germany

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Novartis Investigational Site Nr. 89

Itzenhoe, Schleswig-Holstein, 25524, Germany

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Novartis Investigational Site Nr. 87

Stockelsdorf, Schleswig-Holstein, 23617, Germany

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Novartis Investigational Site Nr. 70

Berlin, State of Berlin, 13125, Germany

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Novartis Investigational Site Nr. 90

Erfurt, Thuringia, 99086, Germany

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Novartis Investigational Site Nr. 5

Milan, Lombardy, 20122, Italy

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Novartis Investigational Site Nr. 52

Milan, Lombardy, 20157, Italy

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Novartis Investigational Site Nr. 6

Novara, Piedmont, 28100, Italy

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Novartis Investigational Site Nr. 7

Florence, Tuscany, 50139, Italy

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Novartis Investigational Site Nr. 9

Padua, Veneto, 35100, Italy

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Novartis Investigational Site Nr. 46

Santiago de Compostela, A Coruña, 15706, Spain

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Novartis Investigational Site Nr. 11

Almassora, Castellón, 12550, Spain

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Novartis Investigational Site Nr. 10

Castellon, Castellón, 12006, Spain

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Novartis Investigational Site Nr. 12

Vall D'Uixo, Castelló, 12600, Spain

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Novartis Investigational Site Nr. 48

Vigo Pontevedra, Pontevedra, 36204, Spain

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Novartis Investigational Site Nr. 49

Oviedo, Principality of Asturias, 33006, Spain

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Novartis Investigational Site Nr. 25

Catarroja, Valencia, 46470, Spain

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Novartis Investigational Site Nr. 21

L'Eliana, Valencia, 46183, Spain

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Novartis Investigational Site 14

Sagunto, Valencia, 46500, Spain

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Novartis Investigational Site Nr. 17

Valencia, Valencia, 46011, Spain

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Novartis Investigational Site Nr. 24

Valencia, Valencia, 46017, Spain

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Novartis Investigational Site Nr. 15

Valencia, Valencia, 46021, Spain

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Novartis Investigational Site Nr. 18

Valencia, Valencia, 46022, Spain

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Novartis Investigational Site Nr. 19

Valencia, Valencia, 46022, Spain

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Novartis Investigational Site Nr. 16

Valencia, Valencia, 46024, Spain

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Novartis Investigational Site Nr. 23

Valencia, Valencia, 46200, Spain

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Novartis Investigational Site Nr. 2

London, London, SW17 0RE, United Kingdom

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Novartis Investigational Site Nr. 1

Oxford, South East England, OX3 7LE, United Kingdom

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Novartis Investigational Site 3

Bristol, South West England, BS8 1TH, United Kingdom

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Novartis Investigational Site Nr. 4

Exeter, South West England, EX2 5DW, United Kingdom

Location

Related Publications (2)

• 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.

  PMID: 31110098 DERIVED

• 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.

  PMID: 22318278 DERIVED

MeSH Terms

Conditions

Meningococcal Infections

Interventions

diphtheria-tetanus-acellular pertussis-inactivated poliovirus-Haemophilus influenzae b conjugate-hepatitis B vaccine; Pneumococcal Vaccines; Heptavalent Pneumococcal Conjugate Vaccine

Condition Hierarchy (Ancestors)

Neisseriaceae Infections; Gram-Negative Bacterial Infections; Bacterial Infections; Bacterial Infections and Mycoses; Infections

Intervention Hierarchy (Ancestors)

Streptococcal Vaccines; Bacterial Vaccines; Vaccines; Biological Products; Complex Mixtures; Vaccines, Combined

Results Point of Contact

• Title: Posting Director
• Organization: Novartis Vaccines and Diagnostics

RegistryContactVaccinesUS@novartis.com

Study Officials

• Novartis Vaccines

  Novartis Vaccines

  STUDY CHAIR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: GT60
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 22, 2008
• First Posted: July 24, 2008
• Study Start: August 1, 2008
• Primary Completion: July 1, 2010
• Study Completion: July 1, 2010
• Last Updated: March 23, 2015
• Results First Posted: March 23, 2015

Record last verified: 2015-03

Locations

IT (5); GB (4); DE (25); ES (16); BE (6); CZ (4)