- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT00937521
Safety and Immunogenicity in Dose-Ranging and Formulation-Finding Meningococcal B (MenB) Vaccine Study in 2-month-old Infants
March 17, 2015 updated by: Novartis Vaccines
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
This study is aimed at assessing the safety and immunogenicity of different doses and formulations of a new Novartis Meningococcal B Recombinant Vaccine.
Study Overview
Status
Completed
Conditions
Intervention / Treatment
Study Type
Interventional
Enrollment (Actual)
1507
Phase
- Phase 2
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
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Cordoba
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Naciones Unidas 346, Cordoba, Argentina, X5016KHE
- Hospital Privado de Córdoba CMC SA
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Santiago
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Comuna de Independencia, Santiago, Chile
- Universidad de Chile, Av Independencia 1027
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Lo Cruzat 486, Quilicura, Santiago, Chile
- Consultorio Manuel Bustos
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Boskovice
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O. Kubina 17, Boskovice, Czech Republic, 680 01
- Samostatna ordinace praktickeho lekare pro deti a dorost
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Brno
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Neklez 3, Brno, Czech Republic, 628 00
- Samostatna ordinace praktickeho lekare pro deti a dorost
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Chlumec nad Cidlinou
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Pernštýnská 127/l, Chlumec nad Cidlinou, Czech Republic, 503 51
- Samostatna ordinace praktickeho lekare pro deti a dorost
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Chomutov
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Vaclavska 4186, Chomutov, Czech Republic, 430 03
- Zdravotní středisko
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Děčín
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U nemocnice 1, Děčín, Czech Republic, 405 01
- Nemocnice Decin, Detske oddělení
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Hradec Králové
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Trebešská 1575, Hradec Králové, Czech Republic, 50001
- Fakulta vojenskeho zdravotnictvi UO
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Humpolec
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Masarykova 389, Humpolec, Czech Republic, 396 01
- Samostatna ordinace praktickeho lekare pro deti a dorost
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Jindřichův Hradec
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Ruských legii 352, Jindřichův Hradec, Czech Republic, 377 01
- Samostatna ordinace praktickeho lekare pro deti a dorost
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Lipník nad Bečvou
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Hrnčířská 1401, Lipník nad Bečvou, Czech Republic, 751 31
- Samostatna ordinace praktickeho lekare pro deti a dorost
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Náchod
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Purkyňova 446, Náchod, Czech Republic, 547 01
- Oblastni nemocnice Nachod, Destske oddělení
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Odolena Voda
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U lékárny 306, Odolena Voda, Czech Republic, 250 70
- Samostatna ordinace praktickeho lekare pro deti a dorost
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Ostrava
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Dvouletky 54, Ostrava, Czech Republic, 700 30
- Prakticky lekar pro deti a dorost
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Na Bělidle 7, Ostrava, Czech Republic, 702 00
- KHS Ostrava, Protiepidemické oddělení
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Pardubice
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Kyjevská 44, Pardubice, Czech Republic, 532 03
- Nemocnice Pardubice, Destske odděleni
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Plzeň
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E. Beneše 13, Plzeň, Czech Republic, 305 99
- Fakultni nemocnice Bory
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Praha 3
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Chrudimska 2a, Praha 3, Czech Republic, 130 00
- Samostatna ordinace praktickeho lekare pro deti a dorost
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Praha 6
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Kladenská 53, Praha 6, Czech Republic, 160 00
- Samostatna ordinace praktickeho lekare pro deti a dorost
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Znojmo
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Velka Michalska 22, Znojmo, Czech Republic, 669 00
- Samostatna ordinace praktickeho lekare pro deti a dorost
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Bordány
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Honvéd u.2., Bordány, Hungary, 6795
- Házi Gyermekorvosi szolgálat
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Budapest
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Ányos u.4., Budapest, Hungary, 1031
- Medszolg 2000 Bt, 6723, Szeged, Dandár u.4
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Kossuth Lajos sgt.109
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Szeged, Kossuth Lajos sgt.109, Hungary
- Baby Box Bt,, 6724, Szeged, Kossuth Lajos sgt.109
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Miskolc
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Kando Kalman u.1, Miskolc, Hungary, 3534
- Dr. Bán Mariann és Társa Bt.
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Selyemrét u.1., Miskolc, Hungary, 3527
- Futurnest Kft
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Mályi
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Fő u.12., Mályi, Hungary, 3434
- Ped-Med Kft. , 3434 Mályi, Fő u.12.
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Szeged
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Csongrádi sgt. 63., Szeged, Hungary, 6723
- S.K. Sipka és Kovács Eü. Bt.
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Debreceni u.10-14., Szeged, Hungary, 6723
- Oszila Kft. 6723, Szeged, Debreceni u.10-14.
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Szentháromság tér 10
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Csongrad, Szentháromság tér 10, Hungary
- Győriné dr. Bari Eszter egyéni vállalkozó
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Szombathely
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Markusovszky u. 1-3, Szombathely, Hungary, 9700
- Vas Megyei Markusovszky Kórház, Gyermekosztály
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dr. Imre József u.2.
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Hodmezovasarhely, dr. Imre József u.2., Hungary
- Erzsébet Kórház Gyermekosztály
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Brescia
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P.le Spedali di Brescia,1, Brescia, Italy, 25125
- Dipartimento di Neonatologia e Terapia Intensiva Neonatale, "Ospedale dei Bambini", Presidio Ospedaliero dell'Azienda Ospedaliera Spedali Civili di Brescia
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Firenze
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Viale Pieraccini n. 24, Firenze, Italy, 50139
- Dipartimento di Pediatria dell'Università degli Studi di Firenze
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Messina
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Via Consolare Valeria, 1, Messina, Italy, 98125
- Università degli Studi di Messina, Pad. NI - A.O.U. Policlinico G.Martino
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Milano
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Via Commenda, 9, Milano, Italy, 20122
- Fondazione IRCCS dell'Ospedale Maggiore Policlinico, Mangiagalli e Regina Elena di Milano
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Via G.B.Grossi 74, Milano, Italy, 20157
- Pediatria dell'Ospedale Sacco di Milano
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Padova
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Via Giustiniani, 3, Padova, Italy, 35128
- Dipartimento di Pediatria Azienda Ospedaliera di Padova
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Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
1 month to 2 months (Child)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
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
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Prevention
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Single
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
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Other: 1
Vaccine candidate formulation I
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Vaccine candidate formulation I
Vaccine candidate formulation II
Vaccine candidate formulation III
Vaccine candidate formulation IV
Vaccine candidate formulation V
Vaccine candidate formulation VI
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Other: 2
Vaccine candidate formulation II
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Vaccine candidate formulation I
Vaccine candidate formulation II
Vaccine candidate formulation III
Vaccine candidate formulation IV
Vaccine candidate formulation V
Vaccine candidate formulation VI
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Other: 3
Vaccine candidate formulation III
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Vaccine candidate formulation I
Vaccine candidate formulation II
Vaccine candidate formulation III
Vaccine candidate formulation IV
Vaccine candidate formulation V
Vaccine candidate formulation VI
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Other: 4
Vaccine candidate formulation IV
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Vaccine candidate formulation I
Vaccine candidate formulation II
Vaccine candidate formulation III
Vaccine candidate formulation IV
Vaccine candidate formulation V
Vaccine candidate formulation VI
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Other: 5
Vaccine candidate formulation V
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Vaccine candidate formulation I
Vaccine candidate formulation II
Vaccine candidate formulation III
Vaccine candidate formulation IV
Vaccine candidate formulation V
Vaccine candidate formulation VI
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Other: 6
Vaccine candidate formulation VI
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Vaccine candidate formulation I
Vaccine candidate formulation II
Vaccine candidate formulation III
Vaccine candidate formulation IV
Vaccine candidate formulation V
Vaccine candidate formulation VI
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Other: 7
Control
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Control
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Other: 8
Vaccine candidate formulation I with antipyretic
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Vaccine candidate formulation I with antipyretic
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
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Percentages of Subjects With Serum Bactericidal Activity (hSBA) ≥ 1:5 at 1 Month After Third Vaccination
Time Frame: At baseline (pre-vaccination) and 30 days after the third vaccination.
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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.
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At baseline (pre-vaccination) and 30 days after the third vaccination.
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Number of Subjects With Fever ≥ 38.5 °C (Rectal Temperature) Within 3 Days (Day 1-3) After First Vaccination
Time Frame: Day 1 to day 3 after first vaccination.
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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.
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Day 1 to day 3 after first vaccination.
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Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Geometric Mean Bactericidal Titers (GMTs), One Month After Third and Booster Vaccination (Men B at 12 Months of Age)
Time Frame: At baseline (pre-vaccination), 30 days after the third vaccination, at booster Baseline and at booster vaccination (12 months of age)
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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:
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At baseline (pre-vaccination), 30 days after the third vaccination, at booster Baseline and at booster vaccination (12 months of age)
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Geometric Mean Bactericidal Titers,One Month After Primary and Booster Vaccination (Men B at 12 Months of Age)
Time Frame: At Baseline (pre-vaccination), at 30 days after the third vaccination, at booster Baseline, at 30 days
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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.
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At Baseline (pre-vaccination), at 30 days after the third vaccination, at booster Baseline, at 30 days
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Geometric Mean Ratios, One Month After Primary and Booster Vaccination (Men B at 12 Months of Age)
Time Frame: After the third and the booster vaccination.
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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).
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After the third and the booster vaccination.
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Percentage of Subjects With hSBA≥1:5, Persistence of Bactericidal Antibodies at 12 Months of Age (Pre-fourth Dose)
Time Frame: 12 months (pre-fourth vaccination)
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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.
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12 months (pre-fourth vaccination)
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Percentage of Subjects With hSBA≥1:5, Persistence of Bactericidal Antibodies at 12 Months of Age (One Month-post Fourth Dose)
Time Frame: 1 month after fourth vaccination
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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.
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1 month after fourth vaccination
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Geometric Mean Bactericidal Titers, After Primary and Booster Vaccinations (Men B at 12 Months of Age)
Time Frame: At 13 months
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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.
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At 13 months
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Percentage of Subjects With hSBA ≥1:5, First Dose of Meningococcal B Vaccine (One Month After Booster)
Time Frame: 1 month after booster
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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).
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1 month after booster
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Safety and Reactogenicity of Study Vaccines Within 7 Days After Second and Third Vaccination
Time Frame: Day 1 through day 7 after second and third vaccination.
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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).
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Day 1 through day 7 after second and third vaccination.
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Number of Subjects With Solicited Local Reactions Within 7 Days (Day 1-7) After Each Vaccination
Time Frame: Day 1 through day 7 after each vaccination.
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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 solicited local reactions within 7 days (day 1-7) after each vaccination.
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Day 1 through day 7 after each vaccination.
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Number of Subjects With Solicited Systemic Reactions Within 7 Days (Day 1-7) After Each Vaccination
Time Frame: Day 1 through day 7 after each vaccination.
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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 solicited systemic reactions within 7 days (day 1-7) after each vaccination.
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Day 1 through day 7 after each vaccination.
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Number of Subjects With Unsolicited Adverse Events Within 7 Days (Day 1-7) After Each Vaccination
Time Frame: Day 1 through day 7 after each vaccination.
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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.
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Day 1 through day 7 after each vaccination.
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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.
Time Frame: Overall study period.
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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.
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Overall study period.
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Number of Subjects With Local and Systemic Reactions Within 7 Days (Day 1-7) After Second rMenB+OMV NZ Vaccination in MenC Group
Time Frame: Day 1 through day 7 at 13 months age.
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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.
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Day 1 through day 7 at 13 months age.
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Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
General Publications
- 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.
- 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.
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
July 1, 2009
Primary Completion (Actual)
November 1, 2010
Study Completion (Actual)
February 1, 2012
Study Registration Dates
First Submitted
June 29, 2009
First Submitted That Met QC Criteria
July 10, 2009
First Posted (Estimate)
July 13, 2009
Study Record Updates
Last Update Posted (Estimate)
April 7, 2015
Last Update Submitted That Met QC Criteria
March 17, 2015
Last Verified
March 1, 2015
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
- Central Nervous System Diseases
- Nervous System Diseases
- Infections
- Central Nervous System Infections
- Gram-Negative Bacterial Infections
- Bacterial Infections
- Bacterial Infections and Mycoses
- Meningitis, Bacterial
- Central Nervous System Bacterial Infections
- Neisseriaceae Infections
- Meningitis, Meningococcal
- Meningitis
- Meningococcal Infections
- Physiological Effects of Drugs
- Immunologic Factors
- Vaccines
- Antipyretics
Other Study ID Numbers
- V72P16
- 2009-010106-11
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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