Clinical trial NCT00937521: 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
Overall status: COMPLETED
Phase: PHASE2
Conditions: Meningococcal Meningitis
Meningococcal Infections
Keywords: Immunogenicity
Meningitis
Antibody
Infants
Lead sponsor: Novartis
Sponsor class: INDUSTRY
First posted: 2009-07-13
Enrollment: 1507
Sex: ALL
Minimum age (years): 55
Maximum age (years): 89
Standard ages: CHILD
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

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.


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

Primary outcomes:
measure: Percentages of Subjects With Serum Bactericidal Activity (hSBA) ≥ 1:5 at 1 Month After Third Vaccination
timeFrame: At baseline (pre-vaccination) and 30 days after the third vaccination.
measure: Number of Subjects With Fever ≥ 38.5 °C (Rectal Temperature) Within 3 Days (Day 1-3) After First Vaccination
timeFrame: Day 1 to day 3 after first vaccination.
Secondary outcomes:
measure: Geometric Mean Bactericidal Titers (GMTs), One Month After Third and Booster Vaccination (Men B at 12 Months of Age)
timeFrame: At baseline (pre-vaccination), 30 days after the third vaccination, at booster Baseline and at booster vaccination (12 months of age)
measure: Geometric Mean Bactericidal Titers,One Month After Primary and Booster Vaccination (Men B at 12 Months of Age)
timeFrame: At Baseline (pre-vaccination), at 30 days after the third vaccination, at booster Baseline, at 30 days
measure: Geometric Mean Ratios, One Month After Primary and Booster Vaccination (Men B at 12 Months of Age)
timeFrame: After the third and the booster vaccination.
measure: Percentage of Subjects With hSBA≥1:5, Persistence of Bactericidal Antibodies at 12 Months of Age (Pre-fourth Dose)
timeFrame: 12 months (pre-fourth vaccination)
measure: Percentage of Subjects With hSBA≥1:5, Persistence of Bactericidal Antibodies at 12 Months of Age (One Month-post Fourth Dose)
timeFrame: 1 month after fourth vaccination
measure: Geometric Mean Bactericidal Titers, After Primary and Booster Vaccinations (Men B at 12 Months of Age)
timeFrame: At 13 months
measure: Percentage of Subjects With hSBA ≥1:5, First Dose of Meningococcal B Vaccine (One Month After Booster)
timeFrame: 1 month after booster
measure: Safety and Reactogenicity of Study Vaccines Within 7 Days After Second and Third Vaccination
timeFrame: Day 1 through day 7 after second and third vaccination.
measure: Number of Subjects With Solicited Local Reactions Within 7 Days (Day 1-7) After Each Vaccination
timeFrame: Day 1 through day 7 after each vaccination.
measure: Number of Subjects With Solicited Systemic Reactions Within 7 Days (Day 1-7) After Each Vaccination
timeFrame: Day 1 through day 7 after each vaccination.
measure: Number of Subjects With Unsolicited Adverse Events Within 7 Days (Day 1-7) After Each Vaccination
timeFrame: Day 1 through day 7 after each vaccination.
measure: 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.
timeFrame: Overall study period.
measure: Number of Subjects With Local and Systemic Reactions Within 7 Days (Day 1-7) After Second rMenB+OMV NZ Vaccination in MenC Group
timeFrame: Day 1 through day 7 at 13 months age.
Other outcomes:
Locations:
city: Naciones Unidas 346
country: Argentina
facility: Hospital Privado de Córdoba CMC SA
state: Cordoba
city: Comuna de Independencia
country: Chile
facility: Universidad de Chile, Av Independencia 1027
state: Santiago
city: Lo Cruzat 486, Quilicura
country: Chile
facility: Consultorio Manuel Bustos
state: Santiago
city: O. Kubina 17
country: Czech Republic
facility: Samostatna ordinace praktickeho lekare pro deti a dorost
state: Boskovice
city: Neklez 3
country: Czech Republic
facility: Samostatna ordinace praktickeho lekare pro deti a dorost
state: Brno
city: Pernštýnská 127/l
country: Czech Republic
facility: Samostatna ordinace praktickeho lekare pro deti a dorost
state: Chlumec nad Cidlinou
city: Vaclavska 4186
country: Czech Republic
facility: Zdravotní středisko
state: Chomutov
city: U nemocnice 1
country: Czech Republic
facility: Nemocnice Decin, Detske oddělení
state: Děčín
city: Trebešská 1575
country: Czech Republic
facility: Fakulta vojenskeho zdravotnictvi UO
state: Hradec Králové
city: Masarykova 389
country: Czech Republic
facility: Samostatna ordinace praktickeho lekare pro deti a dorost
state: Humpolec
city: Ruských legii 352
country: Czech Republic
facility: Samostatna ordinace praktickeho lekare pro deti a dorost
state: Jindřichův Hradec
city: Hrnčířská 1401
country: Czech Republic
facility: Samostatna ordinace praktickeho lekare pro deti a dorost
state: Lipník nad Bečvou
city: Purkyňova 446
country: Czech Republic
facility: Oblastni nemocnice Nachod, Destske oddělení
state: Náchod
city: U lékárny 306
country: Czech Republic
facility: Samostatna ordinace praktickeho lekare pro deti a dorost
state: Odolena Voda
city: Dvouletky 54
country: Czech Republic
facility: Prakticky lekar pro deti a dorost
state: Ostrava
city: Na Bělidle 7
country: Czech Republic
facility: KHS Ostrava, Protiepidemické oddělení
state: Ostrava
city: Kyjevská 44
country: Czech Republic
facility: Nemocnice Pardubice, Destske odděleni
state: Pardubice
city: E. Beneše 13
country: Czech Republic
facility: Fakultni nemocnice Bory
state: Plzeň
city: Chrudimska 2a
country: Czech Republic
facility: Samostatna ordinace praktickeho lekare pro deti a dorost
state: Praha 3
city: Kladenská 53
country: Czech Republic
facility: Samostatna ordinace praktickeho lekare pro deti a dorost
state: Praha 6
city: Velka Michalska 22
country: Czech Republic
facility: Samostatna ordinace praktickeho lekare pro deti a dorost
state: Znojmo
city: Honvéd u.2.
country: Hungary
facility: Házi Gyermekorvosi szolgálat
state: Bordány
city: Ányos u.4.
country: Hungary
facility: Medszolg 2000 Bt, 6723, Szeged, Dandár u.4
state: Budapest
city: Hodmezovasarhely
country: Hungary
facility: Erzsébet Kórház Gyermekosztály
state: dr. Imre József u.2.
city: Szeged
country: Hungary
facility: Baby Box Bt,, 6724, Szeged, Kossuth Lajos sgt.109
state: Kossuth Lajos sgt.109
city: Kando Kalman u.1
country: Hungary
facility: Dr. Bán Mariann és Társa Bt.
state: Miskolc
city: Selyemrét u.1.
country: Hungary
facility: Futurnest Kft
state: Miskolc
city: Fő u.12.
country: Hungary
facility: Ped-Med Kft. , 3434 Mályi, Fő u.12.
state: Mályi
city: Csongrádi sgt. 63.
country: Hungary
facility: S.K. Sipka és Kovács Eü. Bt.
state: Szeged
city: Debreceni u.10-14.
country: Hungary
facility: Oszila Kft. 6723, Szeged, Debreceni u.10-14.
state: Szeged
city: Csongrad
country: Hungary
facility: Győriné dr. Bari Eszter egyéni vállalkozó
state: Szentháromság tér 10
city: Markusovszky u. 1-3
country: Hungary
facility: Vas Megyei Markusovszky Kórház, Gyermekosztály
state: Szombathely
city: P.le Spedali di Brescia,1
country: Italy
facility: Dipartimento di Neonatologia e Terapia Intensiva Neonatale, "Ospedale dei Bambini", Presidio Ospedaliero dell'Azienda Ospedaliera Spedali Civili di Brescia
state: Brescia
city: Viale Pieraccini n. 24
country: Italy
facility: Dipartimento di Pediatria dell'Università degli Studi di Firenze
state: Firenze
city: Via Consolare Valeria, 1
country: Italy
facility: Università degli Studi di Messina, Pad. NI - A.O.U. Policlinico G.Martino
state: Messina
city: Via Commenda, 9
country: Italy
facility: Fondazione IRCCS dell'Ospedale Maggiore Policlinico, Mangiagalli e Regina Elena di Milano
state: Milano
city: Via G.B.Grossi 74
country: Italy
facility: Pediatria dell'Ospedale Sacco di Milano
state: Milano
city: Via Giustiniani, 3
country: Italy
facility: Dipartimento di Pediatria Azienda Ospedaliera di Padova
state: Padova
Study officials:
References:
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.
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.