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

NCT00657709 | Completed Phase 3 Results DMC

• 2 other identifiers: V72P13EUDRACT 2007-007781-38
• Study Type: interventional
• Target: 3,630
• Locations: 5 countries
• Sites: 66

Brief Summary

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.

Conditions

Serogroup B Meningococcal Meningitis

Keywords

infant; Meningococcal disease; prevention; vaccination

Outcome Measures

Primary Outcomes (2)

• The Geometric Mean Human Serum Bactericidal Activity (hSBA) Titers After Three Doses of rMenB+OMV NZ Vaccination

  The hSBA antibody titer responses, one month after receiving the third vaccination of rMenB+OMV NZ vaccination, are reported as geometric mean titers (GMTs).

  one month after the third vaccination

• The Percentages of Subjects With hSBA Titer ≥1:5 After Receiving Three Doses of rMenB+OMV Vaccination (3 Lots Combined)

  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.

  one month after the third vaccination

Secondary Outcomes (9)

• The Percentages of Subjects With hSBA Titer ≥1:5 After Receiving Three Doses of rMenB+OMV Vaccination (From 3 Lots)

  1 month after the third vaccination

• Geometric Mean Human Serum Bactericidal Activity Titers After the Routine Vaccination Without rMenB OMV NZ

  1 Month after the third vaccination

• Geometric Mean Concentrations After Three Doses of rMenB+OMV NZ Vaccination (Against the 287-953 Antigen)

  1 month after third vaccination

• Geometric Mean Concentrations for Antigens (Pertussis Components) for the Routine Vaccinations

  1 month after third vaccination

• Percentages of Subjects With Antibody Response Against the Routine Antigens

  1 Month after third vaccination

Study Arms (5)

rMenB Lot1

EXPERIMENTAL

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)

rMenB Lot2

EXPERIMENTAL

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)

rMenB Lot3

EXPERIMENTAL

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)

Routine

ACTIVE COMPARATOR

Subjects received the routinely administered infant vaccines at 2, 4, 6 months of age.

Biological: Infanrix Hexa; Biological: Prevenar

MenC + Routine

ACTIVE COMPARATOR

Subjects received the routinely administered infant vaccines and Men C vaccine at 2, 4 and 6 months of age.

Biological: Infanrix Hexa; Biological: Menjugate; Biological: Prevenar

Interventions

Serogroup B meningococcal Vaccine lot 1 (rMenB Lot 1) BIOLOGICAL

One dose of rMenB Lot concomitantly with the routinely administered infant vaccines

rMenB Lot1

Serogroup B meningococcal Vaccine lot 2 (rMenB Lot 2) BIOLOGICAL

One dose of rMenB concomitantly with the routinely administered infant vaccines

rMenB Lot2

Serogroup B meningococcal Vaccine lot 3 (rMenB Lot 3) BIOLOGICAL

One dose of rMenB concomitantly with the routinely administered infant vaccines

rMenB Lot3

Infanrix Hexa BIOLOGICAL

Routine vaccination

MenC + Routine; Routine

Menjugate BIOLOGICAL

One dose of the routinely administered infant vaccines + MenC vaccine

MenC + Routine

Prevenar BIOLOGICAL

Routine vaccination

MenC + Routine; Routine

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)

You may not qualify if:

• 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

Sponsors & Collaborators

• Novartis Vaccines: lead
• GlaxoSmithKline: collaborator

Study Sites (66)

Grässl

Hall in Tirol, 6060, Austria

Location

Häckel

Kirchdorf, 4560, Austria

Location

Prieler

Neufeld A.d. Leitha, 2491, Austria

Location

Maurer

Salzburg, 5020, Austria

Location

Sommer

Vienna, 1230, Austria

Location

Angermayr

Wels, 4600, Austria

Location

Site 27

Boskovice, 680 01, Czechia

Location

Site 19

Brno, 628 00, Czechia

Location

Site 22

Chomutov, 430 03, Czechia

Location

Site11

Červený Kostelec, 54941, Czechia

Location

Site 14

Děčín, 405 01, Czechia

Location

Site 12

Havlíčkův Brod, 580 22, Czechia

Location

Site 8

Hradec Králové, 500 01, Czechia

Location

Site 9

Hradec Králové, 500 05, Czechia

Location

Site 28

Hranice I-mesto, 753 01, Czechia

Location

Site 13

Humpolec, 396 01, Czechia

Location

Site 15

Jindřichův Hradec, 377 01, Czechia

Location

Site 25

Kladno, 272 00, Czechia

Location

Site 21

Kolín, 280 02, Czechia

Location

Site 10

Liberec, 460 15, Czechia

Location

Site 24

Litoměřice, 412 01, Czechia

Location

Site 17

Ostrava, 702 00, Czechia

Location

Site 18

Ostrava-Poruba, 708 68, Czechia

Location

Site 7

Pardubice, 532 03, Czechia

Location

Site 16

Pilsen, 305 99, Czechia

Location

Site 2

Prague, 130 00, Czechia

Location

Site 3

Prague, 140 00, Czechia

Location

Site 5

Prague, 16000, Czechia

Location

Site 6

Prague, 19000, Czechia

Location

Site 26

Rumburk, 408 01, Czechia

Location

Site 23

Ústí nad Labem, 400 01, Czechia

Location

Site 20

Znojmo, 669 00, Czechia

Location

Site 30

Espoo, 02230, Finland

Location

Site 31

Helsinki, 00100, Finland

Location

Site 32

Helsinki, 00930, Finland

Location

Site 34

Jarvenpaa, 04400, Finland

Location

Site 35

Kokkola, 67100, Finland

Location

Site 45

Kotka, 48600, Finland

Location

Site 46

Kuopio, 70211, Finland

Location

Site 47

Lahti, 15140, Finland

Location

Site 49

Oulu, 90220, Finland

Location

Site 50

Pori, 28100, Finland

Location

Site 51

Seinäjoki, 60100, Finland

Location

Site 52

Tampere, 33100, Finland

Location

Site 53

Turku, 20520, Finland

Location

Site 33

Vantaa, 01300, Finland

Location

Site 48

Vantaa, 01600, Finland

Location

Site 99

Detmold, 32756, Germany

Location

Site 92

Espelkamp, 32339, Germany

Location

Site 95

Freising, 85354, Germany

Location

Site 64

Fulda, 36037, Germany

Location

Site 58

Lauffen am Neckar, 74348, Germany

Location

Site 57

Marbach A. N., 74348, Germany

Location

Site 97

München, 81377, Germany

Location

Site 96

München, 81475, Germany

Location

Site 91

Műnchen, 81737, Germany

Location

Site 81

Porta Westfalica, 32457, Germany

Location

Site 65

Schwieberdingen, 71701, Germany

Location

Site 94

Weilheim, 82362, Germany

Location

Dipartimento di Scienze della Salute

Genova, 16132, Italy

Location

Università degli Studi di Messina - Pad. NI - A.O.U. Policlinico G. Martino

Messina, 98122, Italy

Location

Fondazione IRCCS Ospedale Maggiore Policlinico, Mangiagalli e Regina Elena Italia

Milan, 20122, Italy

Location

Pediatria dell' Ospedale Sacco

Milan, 20157, Italy

Location

Ospedale Maggiore della Carita'-Clinica Pediatrica

Novara, 28100, Italy

Location

Istituto di Igiene e Medicina Preventiva - Università degli Studi di Sassari

Sassari, 07100, Italy

Location

ASL/TA

Taranto, 74100, Italy

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

• Vesikari T, Esposito S, Prymula R, Ypma E, Kohl I, Toneatto D, Dull P, Kimura A; EU Meningococcal B Infant Vaccine Study group. Immunogenicity and safety of an investigational multicomponent, recombinant, meningococcal serogroup B vaccine (4CMenB) administered concomitantly with routine infant and child vaccinations: results of two randomised trials. Lancet. 2013 Mar 9;381(9869):825-35. doi: 10.1016/S0140-6736(12)61961-8.

  PMID: 23324563 DERIVED

MeSH Terms

Conditions

Meningitis, Meningococcal; Meningococcal Infections

Interventions

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

Condition Hierarchy (Ancestors)

Meningitis, Bacterial; Central Nervous System Bacterial Infections; Bacterial Infections; Bacterial Infections and Mycoses; Infections; Neisseriaceae Infections; Gram-Negative Bacterial Infections; Central Nervous System Infections; Central Nervous System Diseases; Nervous System Diseases; Meningitis; Neuroinflammatory Diseases

Intervention Hierarchy (Ancestors)

Pneumococcal Vaccines; 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 3
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 2, 2008
• First Posted: April 14, 2008
• Study Start: March 1, 2008
• Primary Completion: January 1, 2010
• Study Completion: January 1, 2010
• Last Updated: October 10, 2017
• Results First Posted: April 10, 2015

Record last verified: 2017-09

Locations

CZ (26); FI (15); DE (12); AU (6); IT (7)