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Safety, Tolerability and Immunogenicity of Meningococcal B Recombinant Vaccine Administered as Booster Dose at 12, 18 or 24 Months of Age in Toddlers (12-24 Months) Primed With a Three-Dose Immunization Series as Infants in Study V72P12

Primary Purpose

Meningococcal Disease, Meningococcal Meningitis

Status

Completed

Phase

Phase 2

Locations

International

Study Type

Interventional

Intervention

rMenB+OMV NZ with routine vaccinations

rMenB+OMV NZ

rMenB+OMV NZ with routine vaccinations

two doses of rMenB+OMV NZ

rMenB+OMV NZ with routine vaccinations

two doses of rMenB+OMV NZ

rMenB+OMV NZ

two doses of rMenB+OMV NZ

rMenB+OMV NZ with routine vaccinations

About this trial

This is an interventional prevention trial for Meningococcal Disease focused on measuring Meningococcal meningitis, prevention, vaccination, toddler

Eligibility Criteria

12 Months - 24 Months (Child)All SexesAccepts Healthy Volunteers

Inclusion Criteria:

Follow-on participants of V72P12:

Healthy toddlers who completed Study V72P12, aged:

12 months or older - Groups 1a, 2a, 3a, 4
18 months (0/ +29 days window) - Groups 1b, 2b, 3b
24 months (0/ +29 days window) - Groups 1c, 2c, 3c

Naive subjects newly enrolled:

Group 5: healthy 18-month-old toddlers (0/ +29 days window)
Group 6: healthy 24-month-old toddlers (0/ +29 days window)

Exclusion Criteria:

History of any meningococcal B vaccine administration (only for groups 5 and 6);
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 to 38 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.

Sites / Locations

University Hospitals Bristol, NHS Foundation Trust, Trust Headquarters
South West Medicines for Children Research Network, Child Health Building, Royal Devon and Exeter NHS Foundation Trust
St. George's University of London
Oxford Vaccines Group, Centre for Clinical Vaccinology and Tropical Medicine, Churchill Hospital, Old Road
Centre for Clinical Vaccinology

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm 4

Arm 5

Arm 6

Arm 7

Arm 8

Arm 9

Arm 10

Arm 11

Arm 12

Arm Type

Experimental

Arm Label

B+R246_12

B+R246_18

B+R246_24

B246_12

B246_18

B246_24

B+R234_12

B+R234_18

B+R234_24

B12 14

B18 20

B24 26

Arm Description

Previously received rMenB+OMV NZ vaccine + routine vaccines at 2, 4 and 6 months of age followed by a booster dose of rMenB+OMV NZ vaccine at 12 months of age.

Previously received rMenB+OMV NZ vaccine + routine vaccines at 2, 4 and 6 months of age followed by a booster dose of rMenB+OMV NZ vaccine at 18 months of age.

Previously received rMenB+OMV NZ vaccine + routine vaccines at 2, 4 and 6 months of age followed by a booster dose of rMenB+OMV NZ vaccine at 24 months of age.

Previously received 3 doses of rMenB+OMV NZ vaccine at 2, 4 and 6 months of age and routine vaccines at 3, 5 and 7 months of age, followed by a booster dose of rMenB+OMV NZ vaccine at 12 months of age.

Previously received 3 doses of rMenB+OMV NZ vaccine at 2, 4 and 6 months of age and routine vaccines at 3,5 and 7 months of age, followed by a booster dose of rMenB+OMV NZ at 18 months of age.

Previously received 3 doses of rMenB+OMV NZ vaccine at 2, 4 and 6 months of age and routine vaccines at 3, 5 and 7 months of age, followed by a booster dose of rMenB+OMV NZ at 24 months of age.

Previously received rMenB+OMV NZ vaccine + routine vaccines at 2, 3 and 4 months of age followed by a booster dose of rMenB+OMV NZ at 12 months of age.

Previously received rMenB+OMV NZ vaccine + routine vaccines at 2, 3 and 4 months of age followed by a booster dose of rMenB+OMV NZ vaccine at 18 months of age.

Previously received rMenB+OMV NZ vaccine + routine vaccines at 2, 3 and 4 months of age followed by a booster dose of rMenB+OMV NZ vaccine at 24 months of age.

Previously received two catch-up doses of rMenB+OMV NZ vaccine at 12 and14 months of age.

Previously received two catch-up doses of rMenB+OMV NZ vaccine at 18 and 20 months of age.

Previously received two catch-up doses of rMenB+OMV NZ vaccine at 24 and 26 months of age.

Outcomes

Primary Outcome Measures

Percentages of Subjects With Serum Bactericidal Antibody Titers ≥1:5 After Receiving a Fourth (Booster) Dose of rMenB+OMV NZ Vaccination in Subjects Who Previously Received 3 Doses of rMenB+OMV NZ and Routine Vaccines at 2, 4 and 6 Months of Age.

Immunogenicity was assessed in terms of percentage of subjects with serum bactericidal antibody (SBA) titers ≥1:5 (98.3% CI) against N.meningitidis serogroup reference strains H44/76, NZ98/254 and 5/99, one month after the fourth (booster) dose of meningococcal B vaccine at 12 or 18 or24 months of age who were previously vaccinated with 3 doses of rMenB+OMV NZ and routine vaccines at 2, 4 and 6 months of age.

Secondary Outcome Measures

Percentages of Subjects With SBA Titers ≥1:5 After Receiving a Fourth (Booster) Dose of rMenB+OMV NZ Vaccination in Subjects Who Previously Received 3 Doses of rMenB+OMV NZ at 2, 4 and 6 Months of Age and Routine Vaccines at 3, 5 and 7 Months of Age.

Immunogenicity was assessed in terms of Percentages of Subjects With SBA Titers ≥1:5 (98.3% CI), After Receiving a Fourth (Booster) Dose of rMenB+OMV NZ Vaccination in subjects who previously received 3 doses of rMenB+OMV NZ at 2, 4 and 6 months of age and routine vaccines at 3, 5 and 7 months of age.

Geometric Mean Titers (GMTs) in Subjects One Month After Receiving a Fourth (Booster) Dose of rMenB+OMV NZ Vaccination in Subjects at 12 18 or 24 Months of Age Who Previously Received 3 Doses of rMenB+OMV NZ at 2, 3 and 4 or 2, 4 and 6 Months of Age.

The serum antibody titers one month after the fourth (booster) dose of meningococcal B vaccine at 12 or 18 or24 months of age who were previously vaccinated with 3 doses of rMenB+OMV NZ at 2, 3 and 4 or 2, 4 and 6 months of age, are reported as geometric mean titers (GMTs) against N.meningitidis serogroup reference strains H44/76, NZ98/254 and 5/99.

GMTs in Subjects One Month After the Fourth (Booster) Dose of Meningococcal B Vaccine at 12 Months of Age Previously Vaccinated With 3 Doses of rMenB+OMV NZ at 2, 3 and 4 or 2, 4 and 6 Months of Age and Single Dose of rMenB+OMV NZ Given at Same Age

Characterization of immunological memory by serum antibody titers (98.3% CI) one month after the fourth (booster) dose of meningococcal B vaccine at 12 months of age who were previously vaccinated with 3 doses of rMenB+OMV NZ at 2, 3 and 4 or 2, 4 and 6 months of age and single dose of rMenB+OMV NZ given at same ages, are reported as geometric mean titers (GMTs) against N.meningitidis serogroup reference strains H44/76, NZ98/254 and 5/99.

GMTs in Subjects One Month After the Fourth (Booster) Dose of Meningococcal B Vaccine at 18 and 24months of Age, Previously Vaccinated With 3 Doses of rMenB+OMV NZ at 2, 3 and 4 or 2, 4 and 6 Months of Age and Single Dose of rMenB+OMV NZ Given at Same Age

Characterization of immunological memory by serum antibody titers one month after the fourth (booster) dose of meningococcal B vaccine at 18 and 24months of age who were previously vaccinated with 3 doses of rMenB+OMV NZ at 2, 3 and 4 or 2, 4 and 6 months of age and single dose of rMenB+OMV NZ given at same ages, are reported as geometric mean titers (GMTs) against N.meningitidis serogroup reference strains H44/76, NZ98/254 and 5/99.

Two-dose Catch-up Regimen of rMenB+OMV NZ in Unprimed Toddlers Aged 12, 18 or 24 Months

Immunogenicity evaluation of a two-dose catch-up regimen of rMenB+OMV NZ in unprimed toddlers aged 12, 18 or 24 months as measured by serum antibody titers one month after the second vaccination f meningococcal B vaccine at 18 and 24months of age who were previously vaccinated with 3 doses of rMenB+OMV NZ reported as geometric mean titers (GMTs) against N.meningitidis serogroup reference strains H44/76, NZ98/254 and 5/99.

Geometric Mean Concentrations Against Vaccine Antigen 287- 953 One Month After Fourth Booster Dose to Previously Primed Toddlers at 12, 18 or 24 Months of Age.

Immunogenicity evaluation against vaccine antigen 287-953 one month after fourth booster dose to previously primed toddlers at 12, 18 or 24 months measured by ELISA.

Geometric Mean Concentrations Against Vaccine Antigen 287- 953 One Month After Booster Given After a Two-dose Catch-up Regimen in Toddlers Starting at 12, 18 or 24 Months of Age.

Immunogenicity evaluation against vaccine antigen 287-953 one month after booster given after a two-dose catch-up regimen in toddlers starting at 12, 18 or 24 months of age.one month after fourth booster dose to previously primed toddlers at 12, 18 or 24 months of age measured by ELISA

Number of Children Reporting Solicited Local and Systemic Adverse Events After Receiving a Fourth Booster Dose of rMenB+OMV NZ Vaccine at 12, 18 or 24 Months of Age.

The safety and tolerability of the 4th booster dose rMenB+OMV NZ vaccine in children (12, 18 or 24 months age) is reported as number of subjects with solicited local and systemic adverse events.

Number of Children Reporting Solicited Local and Systemic Adverse Events After Receiving a Two-dose Catch-up Regimen of rMenB+OMV NZ Vaccine at 12, 18 or 24 Months of Age.

The safety and tolerability of the two-dose catch-up regimen of rMenB+OMV NZ vaccine in children (12, 18 or 24 months age) is reported as number of subjects with solicited local and systemic adverse events.

Full Information

NCT ID

NCT00944034

First Posted

July 21, 2009

Last Updated

July 12, 2017

Sponsor

Novartis Vaccines

Collaborators

GlaxoSmithKline

1. Study Identification

Unique Protocol Identification Number

NCT00944034

Brief Title

Safety, Tolerability and Immunogenicity of Meningococcal B Recombinant Vaccine Administered as Booster Dose at 12, 18 or 24 Months of Age in Toddlers (12-24 Months) Primed With a Three-Dose Immunization Series as Infants in Study V72P12

Official Title

A Phase 2b, Open Label, Multi-Center, Extension Study to Evaluate the Safety, Tolerability and Immunogenicity of a Booster Dose of Novartis Meningococcal B Recombinant Vaccine Administered at 12, 18 or 24 Months of Age in Subjects Who Previously Received a Three-Dose Primary Series of the Novartis Meningococcal B Recombinant Vaccine as Infants in Study V72P12

Study Type

Interventional

2. Study Status

Record Verification Date

July 2017

Overall Recruitment Status

Completed

Study Start Date

July 2009 (undefined)

Primary Completion Date

August 2011 (Actual)

Study Completion Date

January 2012 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

Novartis Vaccines

Collaborators

GlaxoSmithKline

4. Oversight

5. Study Description

Brief Summary

This extension study V72P12E1 will investigate the safety, tolerability and immunogenicity of a fourth (booster) dose of rMenB+OMV NZ at 12, 18 and 24 months of age in subjects previously primed with rMenB+OMV NZ according to two different three-dose immunization schedules in infancy (2, 4 and 6 or 2, 3 and 4 months of age in the parent study V72P12). The study will also explore the bactericidal antibody persistence at 12, 18 and 24 months of age, following the two different immunization schedules, in order to identify the optimal timing for boosting. Two catch-up rMenB+OMV NZ doses will be given to unprimed, naïve toddlers at 12 (subjects enrolled in the control group of V72P12), 18 and 24 months of age (two new cohort of subjects enrolled). These subjects will generate data for assessing the safety and immunogenicity of a two-dose catch-up regimen at these ages, but will also serve as controls for a descriptive comparison of antibody persistence and booster responses for the other groups.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Meningococcal Disease, Meningococcal Meningitis

Keywords

Meningococcal meningitis, prevention, vaccination, toddler

7. Study Design

Primary Purpose

Prevention

Study Phase

Phase 2, Phase 3

Interventional Study Model

Parallel Assignment

Masking

None (Open Label)

Allocation

Randomized

Enrollment

1588 (Actual)

8. Arms, Groups, and Interventions

Arm Title

B+R246_12

Arm Type

Experimental

Arm Description

Previously received rMenB+OMV NZ vaccine + routine vaccines at 2, 4 and 6 months of age followed by a booster dose of rMenB+OMV NZ vaccine at 12 months of age.

Arm Title

B+R246_18

Arm Type

Experimental

Arm Description

Previously received rMenB+OMV NZ vaccine + routine vaccines at 2, 4 and 6 months of age followed by a booster dose of rMenB+OMV NZ vaccine at 18 months of age.

Arm Title

B+R246_24

Arm Type

Experimental

Arm Description

Previously received rMenB+OMV NZ vaccine + routine vaccines at 2, 4 and 6 months of age followed by a booster dose of rMenB+OMV NZ vaccine at 24 months of age.

Arm Title

B246_12

Arm Type

Experimental

Arm Description

Arm Title

B246_18

Arm Type

Experimental

Arm Description

Previously received 3 doses of rMenB+OMV NZ vaccine at 2, 4 and 6 months of age and routine vaccines at 3,5 and 7 months of age, followed by a booster dose of rMenB+OMV NZ at 18 months of age.

Arm Title

B246_24

Arm Type

Experimental

Arm Description

Previously received 3 doses of rMenB+OMV NZ vaccine at 2, 4 and 6 months of age and routine vaccines at 3, 5 and 7 months of age, followed by a booster dose of rMenB+OMV NZ at 24 months of age.

Arm Title

B+R234_12

Arm Type

Experimental

Arm Description

Previously received rMenB+OMV NZ vaccine + routine vaccines at 2, 3 and 4 months of age followed by a booster dose of rMenB+OMV NZ at 12 months of age.

Arm Title

B+R234_18

Arm Type

Experimental

Arm Description

Previously received rMenB+OMV NZ vaccine + routine vaccines at 2, 3 and 4 months of age followed by a booster dose of rMenB+OMV NZ vaccine at 18 months of age.

Arm Title

B+R234_24

Arm Type

Experimental

Arm Description

Previously received rMenB+OMV NZ vaccine + routine vaccines at 2, 3 and 4 months of age followed by a booster dose of rMenB+OMV NZ vaccine at 24 months of age.

Arm Title

B12 14

Arm Type

Experimental

Arm Description

Previously received two catch-up doses of rMenB+OMV NZ vaccine at 12 and14 months of age.

Arm Title

B18 20

Arm Type

Experimental

Arm Description

Previously received two catch-up doses of rMenB+OMV NZ vaccine at 18 and 20 months of age.

Arm Title

B24 26

Arm Type

Experimental

Arm Description

Previously received two catch-up doses of rMenB+OMV NZ vaccine at 24 and 26 months of age.

Intervention Type

Biological

Intervention Name(s)

rMenB+OMV NZ with routine vaccinations

Intervention Description

rMenB+OMV NZ with routine vaccinations at 2, 4, and 6 months of age; random allocation in a 1:1:1 ratio to receive a booster dose of rMenB+OMV NZ at 12 months of age

Intervention Type

Biological

Intervention Name(s)

rMenB+OMV NZ with routine vaccinations

Intervention Description

rMenB+OMV NZ with routine vaccinations at 2, 4, and 6 months of age; random allocation in a 1:1:1 ratio to receive a booster dose of rMenB+OMV NZ at 18 months of age

Intervention Type

Biological

Intervention Name(s)

rMenB+OMV NZ

Intervention Description

rMenB+OMV NZ at 2, 4, and 6 months of age and routine vaccinations at 3, 5 and 7 months of age; random allocation in a 1:1:1 ratio to receive a booster dose of rMenB+OMV NZ at 12 months of age

Intervention Type

Biological

Intervention Name(s)

rMenB+OMV NZ

Intervention Description

rMenB+OMV NZ at 2, 4, and 6 months of age and routine vaccinations at 3, 5 and 7 months of age; random allocation in a 1:1:1 ratio to receive a booster dose of rMenB+OMV NZ at 18 months of age

Intervention Type

Biological

Intervention Name(s)

rMenB+OMV NZ with routine vaccinations

Intervention Description

rMenB+OMV NZ with routine vaccinations at 2, 3 and 4 months of age; random allocation in a 1:1:1 ratio to receive 1 booster dose of rMenB+OMV NZ at 12 months of age

Intervention Type

Biological

Intervention Name(s)

rMenB+OMV NZ with routine vaccinations

Intervention Description

rMenB+OMV NZ with routine vaccinations at 2, 3 and 4 months of age; random allocation in a 1:1:1 ratio to receive 1 booster dose of rMenB+OMV NZ at 18 months of age

Intervention Type

Biological

Intervention Name(s)

two doses of rMenB+OMV NZ

Intervention Description

two catch-up doses of rMenB+OMV NZ at 12 and 14 months of age.

Intervention Type

Biological

Intervention Name(s)

rMenB+OMV NZ with routine vaccinations

Intervention Description

rMenB+OMV NZ with routine vaccinations at 2, 4, and 6 months of age; random allocation in a 1:1:1 ratio to receive a booster dose of rMenB+OMV NZ at 24 months of age

Intervention Type

Biological

Intervention Name(s)

two doses of rMenB+OMV NZ

Intervention Description

two catch-up doses of rMenB+OMV NZ at 18 and 20 months of age

Intervention Type

Biological

Intervention Name(s)

rMenB+OMV NZ

Intervention Description

rMenB+OMV NZ at 2, 4, and 6 months of age and routine vaccinations at 3, 5 and 7 months of age; random allocation in a 1:1:1 ratio to receive a booster dose of rMenB+OMV NZ at 24 months of age

Intervention Type

Biological

Intervention Name(s)

two doses of rMenB+OMV NZ

Intervention Description

two catch-up doses of rMenB+OMV NZ at 24 and 26 months of age

Intervention Type

Biological

Intervention Name(s)

rMenB+OMV NZ with routine vaccinations

Intervention Description

rMenB+OMV NZ with routine vaccinations at 2, 3 and 4 months of age; random allocation in a 1:1:1 ratio to receive 1 booster dose of rMenB+OMV NZ at 12 (Group 3a), 18 (Group 3b) or 24 (Group 3c) months of age

Primary Outcome Measure Information:

Title

Description

Time Frame

1 month after booster

Secondary Outcome Measure Information:

Title

Description

Time Frame

1 month after booster

Title

Description

Time Frame

1 month after booster

Title

Description

Time Frame

1 month after booster

Title

Description

Time Frame

1 month after booster

Title

Description

Time Frame

1 month after booster

Title

Two-dose Catch-up Regimen of rMenB+OMV NZ in Unprimed Toddlers Aged 12, 18 or 24 Months

Description

Time Frame

1 month after second vaccination

Title

Geometric Mean Concentrations Against Vaccine Antigen 287- 953 One Month After Fourth Booster Dose to Previously Primed Toddlers at 12, 18 or 24 Months of Age.

Description

Immunogenicity evaluation against vaccine antigen 287-953 one month after fourth booster dose to previously primed toddlers at 12, 18 or 24 months measured by ELISA.

Time Frame

1 month after booster vaccination

Title

Geometric Mean Concentrations Against Vaccine Antigen 287- 953 One Month After Booster Given After a Two-dose Catch-up Regimen in Toddlers Starting at 12, 18 or 24 Months of Age.

Description

Time Frame

1 month after booster vaccination

Title

Number of Children Reporting Solicited Local and Systemic Adverse Events After Receiving a Fourth Booster Dose of rMenB+OMV NZ Vaccine at 12, 18 or 24 Months of Age.

Description

The safety and tolerability of the 4th booster dose rMenB+OMV NZ vaccine in children (12, 18 or 24 months age) is reported as number of subjects with solicited local and systemic adverse events.

Time Frame

From day 1 to day 7 after vaccination

Title

Number of Children Reporting Solicited Local and Systemic Adverse Events After Receiving a Two-dose Catch-up Regimen of rMenB+OMV NZ Vaccine at 12, 18 or 24 Months of Age.

Description

Time Frame

day 1 to day 7 after vaccination

10. Eligibility

Sex

All

Minimum Age & Unit of Time

12 Months

Maximum Age & Unit of Time

24 Months

Accepts Healthy Volunteers

Eligibility Criteria

Inclusion Criteria: Follow-on participants of V72P12: Healthy toddlers who completed Study V72P12, aged: 12 months or older - Groups 1a, 2a, 3a, 4 18 months (0/ +29 days window) - Groups 1b, 2b, 3b 24 months (0/ +29 days window) - Groups 1c, 2c, 3c Naive subjects newly enrolled: Group 5: healthy 18-month-old toddlers (0/ +29 days window) Group 6: healthy 24-month-old toddlers (0/ +29 days window) Exclusion Criteria: History of any meningococcal B vaccine administration (only for groups 5 and 6); 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 to 38 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.

Facility Information:

City

Avenue Albert 1er 185, 5000 Namur

Country

Belgium

City

Avenue Hippocrate 10, 1200 Brussels

Country

Belgium

City

Laarbeeklaan 101, 1090 Brussels

Country

Belgium

City

Lindendreef 1, 2020 Antwerpen

Country

Belgium

City

Sint Vincentiusstraat 20, 2018 Antwerpen

Country

Belgium

City

Stadsomvaart 11, 3500 Hasselt

Country

Belgium

City

Wilrijkstraat 10, 2650 Edegem

Country

Belgium

City

Cerveny Kostelec

ZIP/Postal Code

549 41

Country

Czechia

City

Kyjevska 44, 532 03 Pardubice

Country

Czechia

City

Ruskych legii 352, 377 01 Jindrichuv Hradec

Country

Czechia

City

Trebesska 1575, 500 01 Hradec Kralove

Country

Czechia

City

Ahrensböker Str. 11, 23617 Stockelsdorf

Country

Germany

City

Am Alten Hafen 117, 27568 Bremerhaven

Country

Germany

City

Ammertalweg 7, 99086 Erfurt

Country

Germany

City

Anne Frank Str.27, 75015 Bretten

Country

Germany

City

Bucher Chaussee 1-3, 13125 Berlin

Country

Germany

City

Christian-Bauer-Str.5, 73642 Welzheim

Country

Germany

City

Deckertstr. 53, 33645 Bielefeld

Country

Germany

City

Dingbängerweg 69, 48163 Münster

Country

Germany

City

Elisenstr. 28, 63739 Aschaffenburg

Country

Germany

City

Gartenstr. 3,76889 Schweigen

Country

Germany

City

Großbottwarer Str. 47, 71720 Oberstenfeld

Country

Germany

City

Hanseatenplatz 1, 25524 Itzehoe

Country

Germany

City

Hauptstr. 165, 42579 Heiligenhaus

Country

Germany

City

Hauptstr. 240, 77694 Kehl

Country

Germany

City

Hauptstr. 46, 37083 Göttingen

Country

Germany

City

Josef-Sugg-Str. 5, 88348 Bad Saulgau

Country

Germany

City

Kapellenstraße 27, 47533 Kleve-Materborn

Country

Germany

City

Kleinenbroicher Str. 68, 41352 Korschenbroich

Country

Germany

City

Kuhtrift 8a, 34414 Warburg

Country

Germany

City

Langenbeckstraße 1, 55101 Mainz

Country

Germany

City

Lindenpromenade 34b, 39164 Wanzleben

Country

Germany

City

Lindenstr. 9, 25524 Itzehoe

Country

Germany

City

Marienstraße 2, 44866 Bochum

Country

Germany

City

Maschstr. 8a, 49565 Bramsche

Country

Germany

City

Mose-Stern-Str. 28, 41236 Mönchengladbach

Country

Germany

City

Ostlandstr. 10, 32339 Espelkamp

Country

Germany

City

Poststr. 10, 34225 Baunatal

Country

Germany

City

Tangstedter Landstr 77, 22415 Hamburg

Country

Germany

City

Wilhelmshöher Allee 109, 34121 Kassel

Country

Germany

City

Würzburger Str. 1, 97941 Tauberbischofsheim

Country

Germany

City

C.so Mazzini 18, 28100 Novar

Country

Italy

City

Current address: Via Luca Giordano n. 13, 50132 Firenze

Country

Italy

City

Piazza Ospedale 10, 20900 Lodi

Country

Italy

City

Via Commenda 9, 20122, Milano

Country

Italy

City

Via Consolare Valeria 1, 98125 Messina

Country

Italy

City

Via G.B.Grossi 74, 20157 Milano

Country

Italy

City

Via Giustiniani,3, 35128 Padova

Country

Italy

City

Via Pastore 1,16132 Genova

Country

Italy

City

Via Siracusa, 45, 90143 Palermo

Country

Italy

City

Viale Pieraccini n. 24 50139 Firenze

Country

Italy

City

Avda. Rambleta, s/n Catarroja Valencia

Country

Spain

City

C/ Tossal del Rei nº 7 Castellón de la Plana Castellón

Country

Spain

City

Catarroja Esquina Ministro Serrano. Paiporta Valencia

Country

Spain

City

Celestino Villamil, s/n Oviedo

Country

Spain

City

Ctra. Anfondeguilla, s/n Vall Duixo Castellón

Country

Spain

City

Isabel de Villena,2 Pabellón Valencia

Country

Spain

City

Molí s/n Puçol Valencia

Country

Spain

City

Médico Fernando Moray de la Horra, 2 acceso Y9 Valencia

Country

Spain

City

Pedro s/n Almazora Castellón

Country

Spain

City

Pizarro, 22 Vigo Pontevedra

Country

Spain

City

Plaza Blasco Ibañez, 4 Sagunto Valencia

Country

Spain

City

Plaza Segovia s/n Valencia

Country

Spain

City

República Argentina nº 8, Valencia

Country

Spain

City

Rosales, 23 La Eliana Valencia

Country

Spain

City

Serreria,73 Valencia

Country

Spain

City

Travesía da Choupana, s/n Santiago de Compostela A Coruña

Country

Spain

Facility Name

University Hospitals Bristol, NHS Foundation Trust, Trust Headquarters

City

Marlborough Street

State/Province

Bristol

ZIP/Postal Code

BS1 3NU

Country

United Kingdom

Facility Name

South West Medicines for Children Research Network, Child Health Building, Royal Devon and Exeter NHS Foundation Trust

City

Barrack Road

State/Province

Exeter

ZIP/Postal Code

EX2 5DW

Country

United Kingdom

Facility Name

St. George's University of London

City

Cranmer Terrace

State/Province

London

ZIP/Postal Code

SW17 0RE

Country

United Kingdom

Facility Name

Oxford Vaccines Group, Centre for Clinical Vaccinology and Tropical Medicine, Churchill Hospital, Old Road

City

Headington

State/Province

Oxford

ZIP/Postal Code

OX3 7LJ

Country

United Kingdom

Facility Name

Centre for Clinical Vaccinology

City

Oxford

ZIP/Postal Code

OX3 7LJ

Country

United Kingdom

12. IPD Sharing Statement

Citations:

PubMed Identifier

33020485

Citation

Bartolini E, Borgogni E, Bruttini M, Muzzi A, Giuliani M, Iozzi S, Petracca R, Martinelli M, Bonacci S, Marchi S, Brettoni C, Donati C, Torricelli G, Guidotti S, Domina M, Beninati C, Teti G, Felici F, Rappuoli R, Castellino F, Del Giudice G, Masignani V, Pizza M, Maione D. Immunological fingerprint of 4CMenB recombinant antigens via protein microarray reveals key immunosignatures correlating with bactericidal activity. Nat Commun. 2020 Oct 5;11(1):4994. doi: 10.1038/s41467-020-18791-0.

Results Reference

derived

PubMed Identifier

26756390

Citation

Snape MD, Voysey M, Finn A, Bona G, Esposito S, Principi N, Diez-Domingo J, Sokal E, Kieninger D, Prymula R, Dull PM, Kohl I, Barone M, Wang H, Toneatto D, Pollard AJ; European MenB Vaccine Study Group. Persistence of Bactericidal Antibodies After Infant Serogroup B Meningococcal Immunization and Booster Dose Response at 12, 18 or 24 Months of Age. Pediatr Infect Dis J. 2016 Apr;35(4):e113-23. doi: 10.1097/INF.0000000000001056. Erratum In: Pediatr Infect Dis J. 2020 Jul;39(7):e162.

Results Reference

derived

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