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

NCT00937521 | Completed Phase 2 Results

• 2 other identifiers: V72P162009-010106-11
• Study Type: interventional
• Target: 1,507
• Locations: 5 countries
• Sites: 38

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.

Conditions

Meningococcal Meningitis; Meningococcal Infections

Keywords

Immunogenicity; Meningitis; Antibody; Infants

Outcome Measures

Primary Outcomes (2)

• 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.

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

• 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.

  Day 1 to day 3 after first vaccination.

Secondary Outcomes (13)

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

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

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

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

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

  After the third and the booster vaccination.

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

  12 months (pre-fourth vaccination)

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

  1 month after fourth vaccination

Study Arms (8)

1

OTHER

Vaccine candidate formulation I

Biological: Meningococcal B vaccine

2

OTHER

Vaccine candidate formulation II

Biological: Meningococcal B vaccine

3

OTHER

Vaccine candidate formulation III

Biological: Meningococcal B vaccine

4

OTHER

Vaccine candidate formulation IV

Biological: Meningococcal B vaccine

5

OTHER

Vaccine candidate formulation V

Biological: Meningococcal B vaccine

6

OTHER

Vaccine candidate formulation VI

Biological: Meningococcal B vaccine

7

OTHER

Control

Biological: Control

8

OTHER

Vaccine candidate formulation I with antipyretic

Biological: Meningococcal B vaccine with antipyretic

Interventions

Meningococcal B vaccine BIOLOGICAL

Vaccine candidate formulation I

1

Control BIOLOGICAL

Control

7

Meningococcal B vaccine with antipyretic BIOLOGICAL

Vaccine candidate formulation I with antipyretic

8

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), 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Novartis Vaccines: lead

Study Sites (38)

Hospital Privado de Córdoba CMC SA

Naciones Unidas 346, Córdoba Province, X5016KHE, Argentina

Location

Universidad de Chile, Av Independencia 1027

Comuna de Independencia, Santiago Metropolitan, Chile

Location

Consultorio Manuel Bustos

Lo Cruzat 486, Quilicura, Santiago Metropolitan, Chile

Location

Samostatna ordinace praktickeho lekare pro deti a dorost

O. Kubina 17, Boskovice, 680 01, Czechia

Location

Samostatna ordinace praktickeho lekare pro deti a dorost

Neklez 3, Brno, 628 00, Czechia

Location

Samostatna ordinace praktickeho lekare pro deti a dorost

Pernštýnská 127/l, Chlumec Nad Cidlinou, 503 51, Czechia

Location

Zdravotní středisko

Vaclavska 4186, Chomutov, 430 03, Czechia

Location

Nemocnice Decin, Detske oddělení

U Nemocnice 1, Děčín, 405 01, Czechia

Location

Fakulta vojenskeho zdravotnictvi UO

Trebešská 1575, Hradec Králové, 50001, Czechia

Location

Samostatna ordinace praktickeho lekare pro deti a dorost

Masarykova 389, Humpolec, 396 01, Czechia

Location

Samostatna ordinace praktickeho lekare pro deti a dorost

Ruských Legii 352, Jindřichův Hradec, 377 01, Czechia

Location

Samostatna ordinace praktickeho lekare pro deti a dorost

Hrnčířská 1401, Lipník Nad Bečvou, 751 31, Czechia

Location

Oblastni nemocnice Nachod, Destske oddělení

Purkyňova 446, Náchod, 547 01, Czechia

Location

Samostatna ordinace praktickeho lekare pro deti a dorost

U Lékárny 306, Odolena Voda, 250 70, Czechia

Location

Prakticky lekar pro deti a dorost

Dvouletky 54, Ostrava, 700 30, Czechia

Location

KHS Ostrava, Protiepidemické oddělení

Na Bělidle 7, Ostrava, 702 00, Czechia

Location

Nemocnice Pardubice, Destske odděleni

Kyjevská 44, Pardubice, 532 03, Czechia

Location

Fakultni nemocnice Bory

E. Beneše 13, Plzeň, 305 99, Czechia

Location

Samostatna ordinace praktickeho lekare pro deti a dorost

Chrudimska 2a, Praha 3, 130 00, Czechia

Location

Samostatna ordinace praktickeho lekare pro deti a dorost

Kladenská 53, Praha 6, 160 00, Czechia

Location

Samostatna ordinace praktickeho lekare pro deti a dorost

Velka Michalska 22, Znojmo, 669 00, Czechia

Location

Házi Gyermekorvosi szolgálat

Honvéd U.2., Bordány, 6795, Hungary

Location

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

Ányos U.4., Budapest, 1031, Hungary

Location

Erzsébet Kórház Gyermekosztály

Hódmezővásárhely, Dr. Imre József U.2., Hungary

Location

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

Szeged, Kossuth Lajos Sgt.109, Hungary

Location

Dr. Bán Mariann és Társa Bt.

Kando Kalman U.1, Miskolc, 3534, Hungary

Location

Futurnest Kft

Selyemrét U.1., Miskolc, 3527, Hungary

Location

Ped-Med Kft. , 3434 Mályi, Fő u.12.

Fő U.12., Mályi, 3434, Hungary

Location

S.K. Sipka és Kovács Eü. Bt.

Csongrádi Sgt. 63., Szeged, 6723, Hungary

Location

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

Debreceni U.10-14., Szeged, 6723, Hungary

Location

Győriné dr. Bari Eszter egyéni vállalkozó

Csongrád, Szentháromság Tér 10, Hungary

Location

Vas Megyei Markusovszky Kórház, Gyermekosztály

Markusovszky U. 1-3, Szombathely, 9700, Hungary

Location

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

P.le Spedali Di Brescia,1, Brescia, 25125, Italy

Location

Dipartimento di Pediatria dell'Università degli Studi di Firenze

Viale Pieraccini N. 24, Firenze, 50139, Italy

Location

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

Via Consolare Valeria, 1, Messina, 98125, Italy

Location

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

Via Commenda, 9, Milano, 20122, Italy

Location

Pediatria dell'Ospedale Sacco di Milano

Via G.B.Grossi 74, Milano, 20157, Italy

Location

Dipartimento di Pediatria Azienda Ospedaliera di Padova

Via Giustiniani, 3, Padova, 35128, Italy

Location

Related Publications (2)

• 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.

  PMID: 35257644 DERIVED

• 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.

  PMID: 25424810 DERIVED

MeSH Terms

Conditions

Meningitis, Meningococcal; Meningococcal Infections; Meningitis

Interventions

4CMenB vaccine; Antipyretics

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; Neuroinflammatory Diseases

Intervention Hierarchy (Ancestors)

Physiological Effects of Drugs; Pharmacologic Actions; Chemical Actions and Uses

Results Point of Contact

• Title: Novartis Vaccines
• Organization: Novartis Vaccines

RegistryContactVaccinesUS@novartis.com

Publication Agreements

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

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 29, 2009
• First Posted: July 13, 2009
• Study Start: July 1, 2009
• Primary Completion: November 1, 2010
• Study Completion: February 1, 2012
• Last Updated: April 7, 2015
• Results First Posted: March 4, 2015

Record last verified: 2015-03

Locations

CL (2); CZ (18); HU (11); IT (6); AR (1)