search
Back to results

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

Primary Purpose

Serogroup B Meningococcal Meningitis

Status
Completed
Phase
Phase 3
Locations
International
Study Type
Interventional
Intervention
Serogroup B meningococcal Vaccine lot 1 (rMenB Lot 1)
Serogroup B meningococcal Vaccine lot 2 (rMenB Lot 2)
Serogroup B meningococcal Vaccine lot 3 (rMenB Lot 3)
Infanrix Hexa
Menjugate
Prevenar
Sponsored by
Novartis Vaccines
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Serogroup B Meningococcal Meningitis focused on measuring infant, Meningococcal disease, prevention, vaccination

Eligibility Criteria

55 Days - 89 Days (Child)All SexesAccepts Healthy Volunteers

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

Sites / Locations

  • Grässl
  • Häckel
  • Prieler
  • Maurer
  • Angermayr
  • Sommer
  • Site 27
  • Site 19
  • Site 22
  • Site 14
  • Site 12
  • Site 8
  • Site 9
  • Site 28
  • Site 13
  • Site 15
  • Site 25
  • Site 21
  • Site 10
  • Site 24
  • Site 18
  • Site 17
  • Site 7
  • Site 16
  • Site 2
  • Site 3
  • Site 5
  • Site 6
  • Site 26
  • Site 23
  • Site 20
  • Site11
  • Site 30
  • Site 31
  • Site 32
  • Site 34
  • Site 35
  • Site 45
  • Site 46
  • Site 47
  • Site 49
  • Site 50
  • Site 51
  • Site 52
  • Site 53
  • Site 33
  • Site 48
  • Site 99
  • Site 92
  • Site 95
  • Site 64
  • Site 58
  • Site 57
  • Site 97
  • Site 96
  • Site 91
  • Site 81
  • Site 65
  • Site 94
  • Dipartimento di Scienze della Salute
  • Università degli Studi di Messina - Pad. NI - A.O.U. Policlinico G. Martino
  • Fondazione IRCCS Ospedale Maggiore Policlinico, Mangiagalli e Regina Elena Italia
  • Pediatria dell' Ospedale Sacco
  • Ospedale Maggiore della Carita'-Clinica Pediatrica
  • Istituto di Igiene e Medicina Preventiva - Università degli Studi di Sassari
  • ASL/TA

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm 4

Arm 5

Arm Type

Experimental

Experimental

Experimental

Active Comparator

Active Comparator

Arm Label

rMenB Lot1

rMenB Lot2

rMenB Lot3

Routine

MenC + Routine

Arm Description

Subjects received one injection of rMenB+OMV NZ (Lot 1) at 2, 4, 6 months of age concomitantly with the routinely administered infant vaccines.

Subjects received one injection of rMenB+OMV NZ (Lot 2) at 2, 4, 6 months of age concomitantly with the routinely administered infant vaccines.

Subjects received one injection of rMenB+OMV NZ (Lot 3) at 2, 4, 6 months of age concomitantly with the routinely administered infant vaccines.

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

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

Outcomes

Primary Outcome Measures

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).
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.

Secondary Outcome Measures

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

Full Information

First Posted
April 2, 2008
Last Updated
September 11, 2017
Sponsor
Novartis Vaccines
Collaborators
GlaxoSmithKline
search

1. Study Identification

Unique Protocol Identification Number
NCT00657709
Brief Title
Immunogenicity, Safety and Lot to Lot Consistency of Novartis Meningococcal B Recombinant Vaccine When Administered With Routine Infant Vaccinations to Healthy Infants
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
Study Type
Interventional

2. Study Status

Record Verification Date
September 2017
Overall Recruitment Status
Completed
Study Start Date
March 2008 (undefined)
Primary Completion Date
January 2010 (Actual)
Study Completion Date
January 2010 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Novartis Vaccines
Collaborators
GlaxoSmithKline

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Serogroup B Meningococcal Meningitis
Keywords
infant, Meningococcal disease, prevention, vaccination

7. Study Design

Primary Purpose
Prevention
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
3630 (Actual)

8. Arms, Groups, and Interventions

Arm Title
rMenB Lot1
Arm Type
Experimental
Arm Description
Subjects received one injection of rMenB+OMV NZ (Lot 1) at 2, 4, 6 months of age concomitantly with the routinely administered infant vaccines.
Arm Title
rMenB Lot2
Arm Type
Experimental
Arm Description
Subjects received one injection of rMenB+OMV NZ (Lot 2) at 2, 4, 6 months of age concomitantly with the routinely administered infant vaccines.
Arm Title
rMenB Lot3
Arm Type
Experimental
Arm Description
Subjects received one injection of rMenB+OMV NZ (Lot 3) at 2, 4, 6 months of age concomitantly with the routinely administered infant vaccines.
Arm Title
Routine
Arm Type
Active Comparator
Arm Description
Subjects received the routinely administered infant vaccines at 2, 4, 6 months of age.
Arm Title
MenC + Routine
Arm Type
Active Comparator
Arm Description
Subjects received the routinely administered infant vaccines and Men C vaccine at 2, 4 and 6 months of age.
Intervention Type
Biological
Intervention Name(s)
Serogroup B meningococcal Vaccine lot 1 (rMenB Lot 1)
Intervention Description
One dose of rMenB Lot concomitantly with the routinely administered infant vaccines
Intervention Type
Biological
Intervention Name(s)
Serogroup B meningococcal Vaccine lot 2 (rMenB Lot 2)
Intervention Description
One dose of rMenB concomitantly with the routinely administered infant vaccines
Intervention Type
Biological
Intervention Name(s)
Serogroup B meningococcal Vaccine lot 3 (rMenB Lot 3)
Intervention Description
One dose of rMenB concomitantly with the routinely administered infant vaccines
Intervention Type
Biological
Intervention Name(s)
Infanrix Hexa
Intervention Description
Routine vaccination
Intervention Type
Biological
Intervention Name(s)
Menjugate
Intervention Description
One dose of the routinely administered infant vaccines + MenC vaccine
Intervention Type
Biological
Intervention Name(s)
Prevenar
Intervention Description
Routine vaccination
Primary Outcome Measure Information:
Title
The Geometric Mean Human Serum Bactericidal Activity (hSBA) Titers After Three Doses of rMenB+OMV NZ Vaccination
Description
The hSBA antibody titer responses, one month after receiving the third vaccination of rMenB+OMV NZ vaccination, are reported as geometric mean titers (GMTs).
Time Frame
one month after the third vaccination
Title
The Percentages of Subjects With hSBA Titer ≥1:5 After Receiving Three Doses of rMenB+OMV Vaccination (3 Lots Combined)
Description
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.
Time Frame
one month after the third vaccination
Secondary Outcome Measure Information:
Title
The Percentages of Subjects With hSBA Titer ≥1:5 After Receiving Three Doses of rMenB+OMV Vaccination (From 3 Lots)
Description
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.
Time Frame
1 month after the third vaccination
Title
Geometric Mean Human Serum Bactericidal Activity Titers After the Routine Vaccination Without rMenB OMV NZ
Description
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.
Time Frame
1 Month after the third vaccination
Title
Geometric Mean Concentrations After Three Doses of rMenB+OMV NZ Vaccination (Against the 287-953 Antigen)
Description
The immunogenicity was evaluated to characterize the immune response against vaccine antigen 287-953, as measured by ELISA at one month after third vaccination.
Time Frame
1 month after third vaccination
Title
Geometric Mean Concentrations for Antigens (Pertussis Components) for the Routine Vaccinations
Description
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.
Time Frame
1 month after third vaccination
Title
Percentages of Subjects With Antibody Response Against the Routine Antigens
Description
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
Time Frame
1 Month after third vaccination
Title
Percentages of Subjects With Fourfold Increase in Antibody Concentrations Against the Routine Antigens
Description
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).
Time Frame
5 months
Title
Percentages of Subjects With Fourfold Rise in hSBA Titers After Three Doses of rMenB+OMV NZ Vaccination
Description
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.
Time Frame
1 Month after third vaccination
Title
Percentage of Subjects With hSBA Titers ≥1:8
Description
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.
Time Frame
1 month after third vaccination
Title
Number of Subjects Reporting Solicited Adverse Events After Receiving Three Doses of rMenB+OMV NZ Vaccine
Description
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.
Time Frame
upto 7 days after any vaccination

10. Eligibility

Sex
All
Minimum Age & Unit of Time
55 Days
Maximum Age & Unit of Time
89 Days
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Novartis Vaccines
Organizational Affiliation
Novartis Vaccines
Official's Role
Study Chair
Facility Information:
Facility Name
Grässl
City
Hall in Tirol
ZIP/Postal Code
6060
Country
Austria
Facility Name
Häckel
City
Kirchdorf
ZIP/Postal Code
4560
Country
Austria
Facility Name
Prieler
City
Neufeld a.d. Leitha
ZIP/Postal Code
2491
Country
Austria
Facility Name
Maurer
City
Salzburg
ZIP/Postal Code
5020
Country
Austria
Facility Name
Angermayr
City
Wels
ZIP/Postal Code
4600
Country
Austria
Facility Name
Sommer
City
Wien
ZIP/Postal Code
1230
Country
Austria
Facility Name
Site 27
City
Boskovice
ZIP/Postal Code
680 01
Country
Czechia
Facility Name
Site 19
City
Brno
ZIP/Postal Code
628 00
Country
Czechia
Facility Name
Site 22
City
Chomutov
ZIP/Postal Code
430 03
Country
Czechia
Facility Name
Site 14
City
Děčín
ZIP/Postal Code
405 01
Country
Czechia
Facility Name
Site 12
City
Havlíčkův Brod
ZIP/Postal Code
580 22
Country
Czechia
Facility Name
Site 8
City
Hradec Králové
ZIP/Postal Code
500 01
Country
Czechia
Facility Name
Site 9
City
Hradec Králové
ZIP/Postal Code
500 05
Country
Czechia
Facility Name
Site 28
City
Hranice I-mesto
ZIP/Postal Code
753 01
Country
Czechia
Facility Name
Site 13
City
Humpolec
ZIP/Postal Code
396 01
Country
Czechia
Facility Name
Site 15
City
Jindřichův Hradec
ZIP/Postal Code
377 01
Country
Czechia
Facility Name
Site 25
City
Kladno 2
ZIP/Postal Code
272 00
Country
Czechia
Facility Name
Site 21
City
Kolín
ZIP/Postal Code
280 02
Country
Czechia
Facility Name
Site 10
City
Liberec
ZIP/Postal Code
460 15
Country
Czechia
Facility Name
Site 24
City
Litomerice
ZIP/Postal Code
412 01
Country
Czechia
Facility Name
Site 18
City
Ostrava-Poruba
ZIP/Postal Code
708 68
Country
Czechia
Facility Name
Site 17
City
Ostrava
ZIP/Postal Code
702 00
Country
Czechia
Facility Name
Site 7
City
Pardubice
ZIP/Postal Code
532 03
Country
Czechia
Facility Name
Site 16
City
Plzeň
ZIP/Postal Code
305 99
Country
Czechia
Facility Name
Site 2
City
Prague
ZIP/Postal Code
130 00
Country
Czechia
Facility Name
Site 3
City
Prague
ZIP/Postal Code
140 00
Country
Czechia
Facility Name
Site 5
City
Prague
ZIP/Postal Code
16000
Country
Czechia
Facility Name
Site 6
City
Prague
ZIP/Postal Code
19000
Country
Czechia
Facility Name
Site 26
City
Rumburk
ZIP/Postal Code
408 01
Country
Czechia
Facility Name
Site 23
City
Usti nad Labem
ZIP/Postal Code
400 01
Country
Czechia
Facility Name
Site 20
City
Znojmo
ZIP/Postal Code
669 00
Country
Czechia
Facility Name
Site11
City
Červený Kostelec
ZIP/Postal Code
54941
Country
Czechia
Facility Name
Site 30
City
Espoo
ZIP/Postal Code
02230
Country
Finland
Facility Name
Site 31
City
Helsinki
ZIP/Postal Code
00100
Country
Finland
Facility Name
Site 32
City
Helsinki
ZIP/Postal Code
00930
Country
Finland
Facility Name
Site 34
City
Järvenpää
ZIP/Postal Code
04400
Country
Finland
Facility Name
Site 35
City
Kokkola
ZIP/Postal Code
67100
Country
Finland
Facility Name
Site 45
City
Kotka
ZIP/Postal Code
48600
Country
Finland
Facility Name
Site 46
City
Kuopio
ZIP/Postal Code
70211
Country
Finland
Facility Name
Site 47
City
Lahti
ZIP/Postal Code
15140
Country
Finland
Facility Name
Site 49
City
Oulu
ZIP/Postal Code
90220
Country
Finland
Facility Name
Site 50
City
Pori
ZIP/Postal Code
28100
Country
Finland
Facility Name
Site 51
City
Seinäjoki
ZIP/Postal Code
60100
Country
Finland
Facility Name
Site 52
City
Tampere
ZIP/Postal Code
33100
Country
Finland
Facility Name
Site 53
City
Turku
ZIP/Postal Code
20520
Country
Finland
Facility Name
Site 33
City
Vantaa
ZIP/Postal Code
01300
Country
Finland
Facility Name
Site 48
City
Vantaa
ZIP/Postal Code
01600
Country
Finland
Facility Name
Site 99
City
Detmold
ZIP/Postal Code
32756
Country
Germany
Facility Name
Site 92
City
Espelkamp
ZIP/Postal Code
32339
Country
Germany
Facility Name
Site 95
City
Freising
ZIP/Postal Code
85354
Country
Germany
Facility Name
Site 64
City
Fulda
ZIP/Postal Code
36037
Country
Germany
Facility Name
Site 58
City
Lauffen
ZIP/Postal Code
74348
Country
Germany
Facility Name
Site 57
City
Marbach a. N.
ZIP/Postal Code
74348
Country
Germany
Facility Name
Site 97
City
München
ZIP/Postal Code
81377
Country
Germany
Facility Name
Site 96
City
München
ZIP/Postal Code
81475
Country
Germany
Facility Name
Site 91
City
Műnchen
ZIP/Postal Code
81737
Country
Germany
Facility Name
Site 81
City
Porta Westfalica
ZIP/Postal Code
32457
Country
Germany
Facility Name
Site 65
City
Schwieberdingen
ZIP/Postal Code
71701
Country
Germany
Facility Name
Site 94
City
Weilheim
ZIP/Postal Code
82362
Country
Germany
Facility Name
Dipartimento di Scienze della Salute
City
Genova
ZIP/Postal Code
16132
Country
Italy
Facility Name
Università degli Studi di Messina - Pad. NI - A.O.U. Policlinico G. Martino
City
Messina
ZIP/Postal Code
98122
Country
Italy
Facility Name
Fondazione IRCCS Ospedale Maggiore Policlinico, Mangiagalli e Regina Elena Italia
City
Milano
ZIP/Postal Code
20122
Country
Italy
Facility Name
Pediatria dell' Ospedale Sacco
City
Milano
ZIP/Postal Code
20157
Country
Italy
Facility Name
Ospedale Maggiore della Carita'-Clinica Pediatrica
City
Novara
ZIP/Postal Code
28100
Country
Italy
Facility Name
Istituto di Igiene e Medicina Preventiva - Università degli Studi di Sassari
City
Sassari
ZIP/Postal Code
07100
Country
Italy
Facility Name
ASL/TA
City
Taranto
ZIP/Postal Code
74100
Country
Italy

12. IPD Sharing Statement

Citations:
PubMed Identifier
31110098
Citation
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.
Results Reference
derived
PubMed Identifier
23324563
Citation
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. Erratum In: Lancet. 2013 Mar 9;381(9869):804.
Results Reference
derived

Learn more about this trial

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

We'll reach out to this number within 24 hrs