Back to results

Safety and Immunogenicity in Dose-Ranging and Formulation-Finding Meningococcal B (MenB) Vaccine Study in 2-month-old Infants

Primary Purpose

Meningococcal Meningitis, Meningococcal Infections

Status

Completed

Phase

Phase 2

Locations

International

Study Type

Interventional

Intervention

Meningococcal B vaccine

Control

Meningococcal B vaccine with antipyretic

About this trial

This is an interventional prevention trial for Meningococcal Meningitis focused on measuring Immunogenicity, Meningitis, Antibody, Infants

Eligibility Criteria

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

Inclusion Criteria:

Healthy 2-month old infants (55-89 days, inclusive), born after full term pregnancy, gestational age ≥ 37 weeks and a birth weight ≥ 2.5 kg
Available for all the visits scheduled in the study and for whom a parent/legal guardian is willing/able to comply with all protocol requirements

Exclusion Criteria:

Any meningococcal B or C vaccine administration
Prior vaccination with any Diphtheria, Tetanus, Pertussis (acellular or whole cell), Polio (either Inactivated or Oral), Haemophilus influenzae type b (Hib), and Pneumococcal antigens;
Any ascertained or suspected disease caused by N. meningitidis
Household contact with and/or intimate exposure to an individual with laboratory confirmed N. meningitidis
History of severe allergic reaction after previous vaccinations
Recent significant acute or chronic infection
Oral or parenteral antibiotic treatment in the 7 days prior to the scheduled blood draw;
Any serious chronic or progressive disease according to the judgment of the investigator (e.g., neoplasm, diabetes mellitus Type I, cardiac disease, hepatic disease, progressive neurological disease or seizure, either associated with fever or as part of an underlying neurological disorder or syndrome, autoimmune disease, HIV infection or AIDS, or blood dyscrasias or diathesis, signs of cardiac or renal failure or severe malnutrition)
Any impairment/alteration of the immune system resulting from (for example):
- Receipt of any immunosuppressive therapy at any time since birth
- Receipt of immunostimulants at any time since birth
- Use of systemic corticosteroids or chronic use of inhaled high-potency corticosteroids at any time since birth
Receipt of blood, blood products and/or plasma derivatives or any parenteral immunoglobulin preparation
Participation in another clinical trial
Family members and household members of research staff
History of seizure
Any contraindication to paracetamol

Sites / Locations

Hospital Privado de Córdoba CMC SA
Universidad de Chile, Av Independencia 1027
Consultorio Manuel Bustos
Samostatna ordinace praktickeho lekare pro deti a dorost
Samostatna ordinace praktickeho lekare pro deti a dorost
Samostatna ordinace praktickeho lekare pro deti a dorost
Zdravotní středisko
Nemocnice Decin, Detske oddělení
Fakulta vojenskeho zdravotnictvi UO
Samostatna ordinace praktickeho lekare pro deti a dorost
Samostatna ordinace praktickeho lekare pro deti a dorost
Samostatna ordinace praktickeho lekare pro deti a dorost
Oblastni nemocnice Nachod, Destske oddělení
Samostatna ordinace praktickeho lekare pro deti a dorost
Prakticky lekar pro deti a dorost
KHS Ostrava, Protiepidemické oddělení
Nemocnice Pardubice, Destske odděleni
Fakultni nemocnice Bory
Samostatna ordinace praktickeho lekare pro deti a dorost
Samostatna ordinace praktickeho lekare pro deti a dorost
Samostatna ordinace praktickeho lekare pro deti a dorost
Házi Gyermekorvosi szolgálat
Medszolg 2000 Bt, 6723, Szeged, Dandár u.4
Erzsébet Kórház Gyermekosztály
Baby Box Bt,, 6724, Szeged, Kossuth Lajos sgt.109
Dr. Bán Mariann és Társa Bt.
Futurnest Kft
Ped-Med Kft. , 3434 Mályi, Fő u.12.
S.K. Sipka és Kovács Eü. Bt.
Oszila Kft. 6723, Szeged, Debreceni u.10-14.
Győriné dr. Bari Eszter egyéni vállalkozó
Vas Megyei Markusovszky Kórház, Gyermekosztály
Dipartimento di Neonatologia e Terapia Intensiva Neonatale, "Ospedale dei Bambini", Presidio Ospedaliero dell'Azienda Ospedaliera Spedali Civili di Brescia
Dipartimento di Pediatria dell'Università degli Studi di Firenze
Università degli Studi di Messina, Pad. NI - A.O.U. Policlinico G.Martino
Fondazione IRCCS dell'Ospedale Maggiore Policlinico, Mangiagalli e Regina Elena di Milano
Pediatria dell'Ospedale Sacco di Milano
Dipartimento di Pediatria Azienda Ospedaliera di Padova

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm 4

Arm 5

Arm 6

Arm 7

Arm 8

Arm Type

Other

Arm Label

Arm Description

Vaccine candidate formulation I

Vaccine candidate formulation II

Vaccine candidate formulation III

Vaccine candidate formulation IV

Vaccine candidate formulation V

Vaccine candidate formulation VI

Control

Vaccine candidate formulation I with antipyretic

Outcomes

Primary Outcome Measures

Percentages of Subjects With Serum Bactericidal Activity (hSBA) ≥ 1:5 at 1 Month After Third Vaccination

To assess the immunogenicity of seven different formulations of 4CMenB (groups I-VI and VIII) given to healthy infants at 2,3 and 4 months of age as measured by percentages of subjects with serum bactericidal activity (SBA) titer≥1:5 against 44/76-SL, 5/99 and NZ98/254 reference strains, at 1 month after the third vaccination.. The analysis was done on the Per Protocol Primary Population at one month after third injection.

Number of Subjects With Fever ≥ 38.5 °C (Rectal Temperature) Within 3 Days (Day 1-3) After First Vaccination

To assess if any of six different formulations of vaccine groups (Group II to Group VI, Group VIII) reduced the incidence of fever >=38.5C (rectal) occurring within three days (day 1-day3) following first vaccination. The analysis was done on the Safety Population.

Secondary Outcome Measures

Geometric Mean Bactericidal Titers (GMTs), One Month After Third and Booster Vaccination (Men B at 12 Months of Age)

ToTo assess the immune response of seven different formulations of meningococcal multi-component recombinant, adsorbed vaccine (rMenB+OMV NZ or rMenB (no OMV)) in healthy toddlers as measured by SBA geometric mean titers (GMTs) at: One month after third vaccination. One month after booster vaccination (Men B at 12 months of age).

Geometric Mean Bactericidal Titers,One Month After Primary and Booster Vaccination (Men B at 12 Months of Age)

To compare the antibody response of meningococcal multi-component recombinant, adsorbed vaccine (formulation I vs. formulation VIII) and of routine infant vaccine given with or without prophylactic administration of paracetamol medication in healthy toddlers.

Geometric Mean Ratios, One Month After Primary and Booster Vaccination (Men B at 12 Months of Age)

To compare the antibody response between meningococcal multi-component recombinant adsorbed vaccine (formulation I) and routine infant vaccine group along with meningococcal multi-component recombinant adsorbed vaccine with prophylactic administration of paracetamol medication as measured by Geometric Mean Ratios (GMRs).

Percentage of Subjects With hSBA≥1:5, Persistence of Bactericidal Antibodies at 12 Months of Age (Pre-fourth Dose)

To assess the persistence of bactericidal antibodies at 12 months of age after primary vaccination - three doses of one of the seven different formulations of rMenB+OMV NZ or rMenB (no OMV) (Group I-VI and VIII) and rMenB+OMV NZ with paracetamol medication.

Percentage of Subjects With hSBA≥1:5, Persistence of Bactericidal Antibodies at 12 Months of Age (One Month-post Fourth Dose)

To assess if any of seven different formulations of rMenB+OMV NZ or rMenB (no OMV) vaccine (groups I-VI and VIII) induced sufficient immune response when given to healthy toddlers at 12 months of age, as measured by percentage of subjects with SBA titer ≥ 1:5, at 1 month after the fourth vaccination.

Geometric Mean Bactericidal Titers, After Primary and Booster Vaccinations (Men B at 12 Months of Age)

To assess the induction of immunological memory of three doses of meningococcal multi-component recombinant, adsorbed vaccine by comparing the serum bactericidal antibodies Geometric Mean Bactericidal Titers (GMTs) response in healthy toddlers administered the fourth dose at 12 months of age to the response in meningococcal B vaccine naive toddlers (Group VII) receiving the first dose of meningococcal multi-component recombinant, adsorbed vaccine at 12 months of age.

Percentage of Subjects With hSBA ≥1:5, First Dose of Meningococcal B Vaccine (One Month After Booster)

To assess the immune response of first dose of meningococcal multi-component recombinant, adsorbed vaccine given at 12 months of age to toddlers who previously received three doses of MenC-CRM197 vaccine as infants (group VII).

Safety and Reactogenicity of Study Vaccines Within 7 Days After Second and Third Vaccination

To assess if any of six different formulations of rMenB+OMV NZ or rMenB (no OMV) vaccine (Group II to VI, Group VIII) reduced the incidence of fever ≥ 38.5ºC (rectal) occurring within 3 days (day 1-3) following second and third vaccination and 7 days (day 1-7) following each vaccination as compared to rMenB+OMV NZ (Group I).

Number of Subjects With Solicited Local Reactions Within 7 Days (Day 1-7) After Each Vaccination

Number of Subjects With Solicited Systemic Reactions Within 7 Days (Day 1-7) After Each Vaccination

Number of Subjects With Unsolicited Adverse Events Within 7 Days (Day 1-7) After Each Vaccination

To assess the safety and tolerability of each of seven different formulations of rMenB+OMV NZ or rMenB (no OMV) vaccine (group I to VI, group VIII) in terms of number of subjects reporting unsolicited Adverse Events (AEs), serious adverse events (SAEs), medically attended AEs, AEs leading to premature withdrawal (throughout the study period) within 7 days (day 1-7) after each vaccination.

Number of Subjects With Severe Adverse Events and Adverse Events Necessitating a Medical Office or Emergency Room (ER) Visit and/or Resulting in Premature Withdrawal of the Subject From the Study, Throughout the Study Period.

To assess the safety and tolerability of each of seven different formulations of rMenB+OMV NZ or rMenB (no OMV) vaccine (group I to VI, group VIII) in terms of number of subjects reporting Severe Adverse Events (SAEs) and Adverse Events (AEs) necessitating a medical office or Emergency Room (ER) visit and/or resulting in premature withdrawal of the subject from the study, throughout the study period.

Number of Subjects With Local and Systemic Reactions Within 7 Days (Day 1-7) After Second rMenB+OMV NZ Vaccination in MenC Group

To assess the safety and tolerability of two doses of rMenB+OMV NZ vaccine (Group VII) given at 12 and 13 months of age to toddlers who previously received three doses of Menjugate as infants.

Full Information

NCT ID

NCT00937521

First Posted

June 29, 2009

Last Updated

March 17, 2015

Sponsor

Novartis Vaccines

1. Study Identification

Unique Protocol Identification Number

NCT00937521

Brief Title

Safety and Immunogenicity in Dose-Ranging and Formulation-Finding Meningococcal B (MenB) Vaccine Study in 2-month-old Infants

Official Title

A Phase 2 Partially Observer-Blind Randomized Controlled Multicenter Dose-Ranging and Formulation-Finding Study of a New Novartis Meningococcal B Recombinant Vaccine Evaluating the Safety and Immunogenicity When Given Concomitantly With Routine Vaccines in 2-month-old Infants

Study Type

Interventional

2. Study Status

Record Verification Date

March 2015

Overall Recruitment Status

Completed

Study Start Date

July 2009 (undefined)

Primary Completion Date

November 2010 (Actual)

Study Completion Date

February 2012 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

Novartis Vaccines

4. Oversight

5. Study Description

Brief Summary

This study is aimed at assessing the safety and immunogenicity of different doses and formulations of a new Novartis Meningococcal B Recombinant Vaccine.

6. Conditions and Keywords

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

Meningococcal Meningitis, Meningococcal Infections

Keywords

Immunogenicity, Meningitis, Antibody, Infants

7. Study Design

Primary Purpose

Prevention

Study Phase

Phase 2

Interventional Study Model

Parallel Assignment

Masking

Participant

Allocation

Randomized

Enrollment

1507 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Arm Type

Other

Arm Description

Vaccine candidate formulation I

Arm Title

Arm Type

Other

Arm Description

Vaccine candidate formulation II

Arm Title

Arm Type

Other

Arm Description

Vaccine candidate formulation III

Arm Title

Arm Type

Other

Arm Description

Vaccine candidate formulation IV

Arm Title

Arm Type

Other

Arm Description

Vaccine candidate formulation V

Arm Title

Arm Type

Other

Arm Description

Vaccine candidate formulation VI

Arm Title

Arm Type

Other

Arm Description

Control

Arm Title

Arm Type

Other

Arm Description

Vaccine candidate formulation I with antipyretic

Intervention Type

Biological

Intervention Name(s)

Meningococcal B vaccine

Intervention Description

Vaccine candidate formulation I

Intervention Type

Biological

Intervention Name(s)

Meningococcal B vaccine

Intervention Description

Vaccine candidate formulation II

Intervention Type

Biological

Intervention Name(s)

Meningococcal B vaccine

Intervention Description

Vaccine candidate formulation III

Intervention Type

Biological

Intervention Name(s)

Meningococcal B vaccine

Intervention Description

Vaccine candidate formulation IV

Intervention Type

Biological

Intervention Name(s)

Meningococcal B vaccine

Intervention Description

Vaccine candidate formulation V

Intervention Type

Biological

Intervention Name(s)

Meningococcal B vaccine

Intervention Description

Vaccine candidate formulation VI

Intervention Type

Biological

Intervention Name(s)

Control

Intervention Description

Control

Intervention Type

Biological

Intervention Name(s)

Meningococcal B vaccine with antipyretic

Intervention Description

Vaccine candidate formulation I with antipyretic

Primary Outcome Measure Information:

Title

Percentages of Subjects With Serum Bactericidal Activity (hSBA) ≥ 1:5 at 1 Month After Third Vaccination

Description

Time Frame

At baseline (pre-vaccination) and 30 days after the third vaccination.

Title

Number of Subjects With Fever ≥ 38.5 °C (Rectal Temperature) Within 3 Days (Day 1-3) After First Vaccination

Description

Time Frame

Day 1 to day 3 after first vaccination.

Secondary Outcome Measure Information:

Title

Geometric Mean Bactericidal Titers (GMTs), One Month After Third and Booster Vaccination (Men B at 12 Months of Age)

Description

Time Frame

At baseline (pre-vaccination), 30 days after the third vaccination, at booster Baseline and at booster vaccination (12 months of age)

Title

Geometric Mean Bactericidal Titers,One Month After Primary and Booster Vaccination (Men B at 12 Months of Age)

Description

Time Frame

At Baseline (pre-vaccination), at 30 days after the third vaccination, at booster Baseline, at 30 days

Title

Geometric Mean Ratios, One Month After Primary and Booster Vaccination (Men B at 12 Months of Age)

Description

Time Frame

After the third and the booster vaccination.

Title

Percentage of Subjects With hSBA≥1:5, Persistence of Bactericidal Antibodies at 12 Months of Age (Pre-fourth Dose)

Description

Time Frame

12 months (pre-fourth vaccination)

Title

Percentage of Subjects With hSBA≥1:5, Persistence of Bactericidal Antibodies at 12 Months of Age (One Month-post Fourth Dose)

Description

Time Frame

1 month after fourth vaccination

Title

Geometric Mean Bactericidal Titers, After Primary and Booster Vaccinations (Men B at 12 Months of Age)

Description

Time Frame

At 13 months

Title

Percentage of Subjects With hSBA ≥1:5, First Dose of Meningococcal B Vaccine (One Month After Booster)

Description

Time Frame

1 month after booster

Title

Safety and Reactogenicity of Study Vaccines Within 7 Days After Second and Third Vaccination

Description

Time Frame

Day 1 through day 7 after second and third vaccination.

Title

Number of Subjects With Solicited Local Reactions Within 7 Days (Day 1-7) After Each Vaccination

Description

Time Frame

Day 1 through day 7 after each vaccination.

Title

Number of Subjects With Solicited Systemic Reactions Within 7 Days (Day 1-7) After Each Vaccination

Description

Time Frame

Day 1 through day 7 after each vaccination.

Title

Number of Subjects With Unsolicited Adverse Events Within 7 Days (Day 1-7) After Each Vaccination

Description

Time Frame

Day 1 through day 7 after each vaccination.

Title

Description

To assess the safety and tolerability of each of seven different formulations of rMenB+OMV NZ or rMenB (no OMV) vaccine (group I to VI, group VIII) in terms of number of subjects reporting Severe Adverse Events (SAEs) and Adverse Events (AEs) necessitating a medical office or Emergency Room (ER) visit and/or resulting in premature withdrawal of the subject from the study, throughout the study period.

Time Frame

Overall study period.

Title

Number of Subjects With Local and Systemic Reactions Within 7 Days (Day 1-7) After Second rMenB+OMV NZ Vaccination in MenC Group

Description

To assess the safety and tolerability of two doses of rMenB+OMV NZ vaccine (Group VII) given at 12 and 13 months of age to toddlers who previously received three doses of Menjugate as infants.

Time Frame

Day 1 through day 7 at 13 months age.

10. Eligibility

Sex

All

Minimum Age & Unit of Time

55 Days

Maximum Age & Unit of Time

89 Days

Accepts Healthy Volunteers

Eligibility Criteria

Inclusion Criteria: Healthy 2-month old infants (55-89 days, inclusive), born after full term pregnancy, gestational age ≥ 37 weeks and a birth weight ≥ 2.5 kg Available for all the visits scheduled in the study and for whom a parent/legal guardian is willing/able to comply with all protocol requirements Exclusion Criteria: Any meningococcal B or C vaccine administration Prior vaccination with any Diphtheria, Tetanus, Pertussis (acellular or whole cell), Polio (either Inactivated or Oral), Haemophilus influenzae type b (Hib), and Pneumococcal antigens; Any ascertained or suspected disease caused by N. meningitidis Household contact with and/or intimate exposure to an individual with laboratory confirmed N. meningitidis History of severe allergic reaction after previous vaccinations Recent significant acute or chronic infection Oral or parenteral antibiotic treatment in the 7 days prior to the scheduled blood draw; Any serious chronic or progressive disease according to the judgment of the investigator (e.g., neoplasm, diabetes mellitus Type I, cardiac disease, hepatic disease, progressive neurological disease or seizure, either associated with fever or as part of an underlying neurological disorder or syndrome, autoimmune disease, HIV infection or AIDS, or blood dyscrasias or diathesis, signs of cardiac or renal failure or severe malnutrition) Any impairment/alteration of the immune system resulting from (for example): Receipt of any immunosuppressive therapy at any time since birth Receipt of immunostimulants at any time since birth Use of systemic corticosteroids or chronic use of inhaled high-potency corticosteroids at any time since birth Receipt of blood, blood products and/or plasma derivatives or any parenteral immunoglobulin preparation Participation in another clinical trial Family members and household members of research staff History of seizure Any contraindication to paracetamol

Facility Information:

Facility Name

Hospital Privado de Córdoba CMC SA

City

Naciones Unidas 346

State/Province

Cordoba

ZIP/Postal Code

X5016KHE

Country

Argentina

Facility Name

Universidad de Chile, Av Independencia 1027

City

Comuna de Independencia

State/Province

Santiago

Country

Chile

Facility Name

Consultorio Manuel Bustos

City

Lo Cruzat 486, Quilicura

State/Province

Santiago

Country

Chile

Facility Name

Samostatna ordinace praktickeho lekare pro deti a dorost

City

O. Kubina 17

State/Province

Boskovice

ZIP/Postal Code

680 01

Country

Czech Republic

Facility Name

Samostatna ordinace praktickeho lekare pro deti a dorost

City

Neklez 3

State/Province

Brno

ZIP/Postal Code

628 00

Country

Czech Republic

Facility Name

Samostatna ordinace praktickeho lekare pro deti a dorost

City

Pernštýnská 127/l

State/Province

Chlumec nad Cidlinou

ZIP/Postal Code

503 51

Country

Czech Republic

Facility Name

Zdravotní středisko

City

Vaclavska 4186

State/Province

Chomutov

ZIP/Postal Code

430 03

Country

Czech Republic

Facility Name

Nemocnice Decin, Detske oddělení

City

U nemocnice 1

State/Province

Děčín

ZIP/Postal Code

405 01

Country

Czech Republic

Facility Name

Fakulta vojenskeho zdravotnictvi UO

City

Trebešská 1575

State/Province

Hradec Králové

ZIP/Postal Code

50001

Country

Czech Republic

Facility Name

Samostatna ordinace praktickeho lekare pro deti a dorost

City

Masarykova 389

State/Province

Humpolec

ZIP/Postal Code

396 01

Country

Czech Republic

Facility Name

Samostatna ordinace praktickeho lekare pro deti a dorost

City

Ruských legii 352

State/Province

Jindřichův Hradec

ZIP/Postal Code

377 01

Country

Czech Republic

Facility Name

Samostatna ordinace praktickeho lekare pro deti a dorost

City

Hrnčířská 1401

State/Province

Lipník nad Bečvou

ZIP/Postal Code

751 31

Country

Czech Republic

Facility Name

Oblastni nemocnice Nachod, Destske oddělení

City

Purkyňova 446

State/Province

Náchod

ZIP/Postal Code

547 01

Country

Czech Republic

Facility Name

Samostatna ordinace praktickeho lekare pro deti a dorost

City

U lékárny 306

State/Province

Odolena Voda

ZIP/Postal Code

250 70

Country

Czech Republic

Facility Name

Prakticky lekar pro deti a dorost

City

Dvouletky 54

State/Province

Ostrava

ZIP/Postal Code

700 30

Country

Czech Republic

Facility Name

KHS Ostrava, Protiepidemické oddělení

City

Na Bělidle 7

State/Province

Ostrava

ZIP/Postal Code

702 00

Country

Czech Republic

Facility Name

Nemocnice Pardubice, Destske odděleni

City

Kyjevská 44

State/Province

Pardubice

ZIP/Postal Code

532 03

Country

Czech Republic

Facility Name

Fakultni nemocnice Bory

City

E. Beneše 13

State/Province

Plzeň

ZIP/Postal Code

305 99

Country

Czech Republic

Facility Name

Samostatna ordinace praktickeho lekare pro deti a dorost

City

Chrudimska 2a

State/Province

Praha 3

ZIP/Postal Code

130 00

Country

Czech Republic

Facility Name

Samostatna ordinace praktickeho lekare pro deti a dorost

City

Kladenská 53

State/Province

Praha 6

ZIP/Postal Code

160 00

Country

Czech Republic

Facility Name

Samostatna ordinace praktickeho lekare pro deti a dorost

City

Velka Michalska 22

State/Province

Znojmo

ZIP/Postal Code

669 00

Country

Czech Republic

Facility Name

Házi Gyermekorvosi szolgálat

City

Honvéd u.2.

State/Province

Bordány

ZIP/Postal Code

6795

Country

Hungary

Facility Name

Medszolg 2000 Bt, 6723, Szeged, Dandár u.4

City

Ányos u.4.

State/Province

Budapest

ZIP/Postal Code

1031

Country

Hungary

Facility Name

Erzsébet Kórház Gyermekosztály

City

Hodmezovasarhely

State/Province

dr. Imre József u.2.

Country

Hungary

Facility Name

Baby Box Bt,, 6724, Szeged, Kossuth Lajos sgt.109

City

Szeged

State/Province

Kossuth Lajos sgt.109

Country

Hungary

Facility Name

Dr. Bán Mariann és Társa Bt.

City

Kando Kalman u.1

State/Province

Miskolc

ZIP/Postal Code

3534

Country

Hungary

Facility Name

Futurnest Kft

City

Selyemrét u.1.

State/Province

Miskolc

ZIP/Postal Code

3527

Country

Hungary

Facility Name

Ped-Med Kft. , 3434 Mályi, Fő u.12.

City

Fő u.12.

State/Province

Mályi

ZIP/Postal Code

3434

Country

Hungary

Facility Name

S.K. Sipka és Kovács Eü. Bt.

City

Csongrádi sgt. 63.

State/Province

Szeged

ZIP/Postal Code

6723

Country

Hungary

Facility Name

Oszila Kft. 6723, Szeged, Debreceni u.10-14.

City

Debreceni u.10-14.

State/Province

Szeged

ZIP/Postal Code

6723

Country

Hungary

Facility Name

Győriné dr. Bari Eszter egyéni vállalkozó

City

Csongrad

State/Province

Szentháromság tér 10

Country

Hungary

Facility Name

Vas Megyei Markusovszky Kórház, Gyermekosztály

City

Markusovszky u. 1-3

State/Province

Szombathely

ZIP/Postal Code

9700

Country

Hungary

Facility Name

Dipartimento di Neonatologia e Terapia Intensiva Neonatale, "Ospedale dei Bambini", Presidio Ospedaliero dell'Azienda Ospedaliera Spedali Civili di Brescia

City

P.le Spedali di Brescia,1

State/Province

Brescia

ZIP/Postal Code

25125

Country

Italy

Facility Name

Dipartimento di Pediatria dell'Università degli Studi di Firenze

City

Viale Pieraccini n. 24

State/Province

Firenze

ZIP/Postal Code

50139

Country

Italy

Facility Name

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

City

Via Consolare Valeria, 1

State/Province

Messina

ZIP/Postal Code

98125

Country

Italy

Facility Name

Fondazione IRCCS dell'Ospedale Maggiore Policlinico, Mangiagalli e Regina Elena di Milano

City

Via Commenda, 9

State/Province

Milano

ZIP/Postal Code

20122

Country

Italy

Facility Name

Pediatria dell'Ospedale Sacco di Milano

City

Via G.B.Grossi 74

State/Province

Milano

ZIP/Postal Code

20157

Country

Italy

Facility Name

Dipartimento di Pediatria Azienda Ospedaliera di Padova

City

Via Giustiniani, 3

State/Province

Padova

ZIP/Postal Code

35128

Country

Italy

12. IPD Sharing Statement

Citations:

PubMed Identifier

35257644

Citation

Viviani V, Biolchi A, Pizza M. Synergistic activity of antibodies in the multicomponent 4CMenB vaccine. Expert Rev Vaccines. 2022 May;21(5):645-658. doi: 10.1080/14760584.2022.2050697. Epub 2022 Mar 14.

Results Reference

derived

PubMed Identifier

25424810

Citation

Esposito S, Prymula R, Zuccotti GV, Xie F, Barone M, Dull PM, Toneatto D. A phase 2 randomized controlled trial of a multicomponent meningococcal serogroup B vaccine, 4CMenB, in infants (II). Hum Vaccin Immunother. 2014;10(7):2005-14. doi: 10.4161/hv.29218.

Results Reference

derived

Learn more about this trial

Safety and Immunogenicity in Dose-Ranging and Formulation-Finding Meningococcal B (MenB) Vaccine Study in 2-month-old Infants

We'll reach out to this number within 24 hrs