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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT00937521
Other study ID # V72P16
Secondary ID 2009-010106-11
Status Completed
Phase Phase 2
First received June 29, 2009
Last updated March 17, 2015
Start date July 2009
Est. completion date February 2012

Study information

Verified date March 2015
Source Novartis
Contact n/a
Is FDA regulated No
Health authority Italy: AIFA
Study type Interventional

Clinical Trial Summary

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


Recruitment information / eligibility

Status Completed
Enrollment 1507
Est. completion date February 2012
Est. primary completion date November 2010
Accepts healthy volunteers Accepts Healthy Volunteers
Gender Both
Age group 55 Days to 89 Days
Eligibility 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 Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Single Blind (Subject), Primary Purpose: Prevention


Intervention

Biological:
Meningococcal B vaccine
Vaccine candidate formulation I
Meningococcal B vaccine
Vaccine candidate formulation II
Meningococcal B vaccine
Vaccine candidate formulation III
Meningococcal B vaccine
Vaccine candidate formulation IV
Meningococcal B vaccine
Vaccine candidate formulation V
Meningococcal B vaccine
Vaccine candidate formulation VI
Control
Control
Meningococcal B vaccine with antipyretic
Vaccine candidate formulation I with antipyretic

Locations

Country Name City State
Argentina Hospital Privado de Córdoba CMC SA Naciones Unidas 346 Cordoba
Chile Universidad de Chile, Av Independencia 1027 Comuna de Independencia Santiago
Chile Consultorio Manuel Bustos Lo Cruzat 486, Quilicura Santiago
Czech Republic Samostatna ordinace praktickeho lekare pro deti a dorost Chrudimska 2a Praha 3
Czech Republic Prakticky lekar pro deti a dorost Dvouletky 54 Ostrava
Czech Republic Fakultni nemocnice Bory E. Beneše 13 Plzen
Czech Republic Samostatna ordinace praktickeho lekare pro deti a dorost Hrncírská 1401 Lipník nad Becvou
Czech Republic Samostatna ordinace praktickeho lekare pro deti a dorost Kladenská 53 Praha 6
Czech Republic Nemocnice Pardubice, Destske oddeleni Kyjevská 44 Pardubice
Czech Republic Samostatna ordinace praktickeho lekare pro deti a dorost Masarykova 389 Humpolec
Czech Republic KHS Ostrava, Protiepidemické oddelení Na Belidle 7 Ostrava
Czech Republic Samostatna ordinace praktickeho lekare pro deti a dorost Neklez 3 Brno
Czech Republic Samostatna ordinace praktickeho lekare pro deti a dorost O. Kubina 17 Boskovice
Czech Republic Samostatna ordinace praktickeho lekare pro deti a dorost Pernštýnská 127/l Chlumec nad Cidlinou
Czech Republic Oblastni nemocnice Nachod, Destske oddelení Purkynova 446 Náchod
Czech Republic Samostatna ordinace praktickeho lekare pro deti a dorost Ruských legii 352 Jindrichuv Hradec
Czech Republic Fakulta vojenskeho zdravotnictvi UO Trebešská 1575 Hradec Králové
Czech Republic Samostatna ordinace praktickeho lekare pro deti a dorost U lékárny 306 Odolena Voda
Czech Republic Nemocnice Decin, Detske oddelení U nemocnice 1 Decín
Czech Republic Zdravotní stredisko Vaclavska 4186 Chomutov
Czech Republic Samostatna ordinace praktickeho lekare pro deti a dorost Velka Michalska 22 Znojmo
Hungary Medszolg 2000 Bt, 6723, Szeged, Dandár u.4 Ányos u.4. Budapest
Hungary Gyoriné dr. Bari Eszter egyéni vállalkozó Csongrad Szentháromság tér 10
Hungary S.K. Sipka és Kovács Eü. Bt. Csongrádi sgt. 63. Szeged
Hungary Oszila Kft. 6723, Szeged, Debreceni u.10-14. Debreceni u.10-14. Szeged
Hungary Ped-Med Kft. , 3434 Mályi, Fo u.12. Fo u.12. Mályi
Hungary Erzsébet Kórház Gyermekosztály Hodmezovasarhely dr. Imre József u.2.
Hungary Házi Gyermekorvosi szolgálat Honvéd u.2. Bordány
Hungary Dr. Bán Mariann és Társa Bt. Kando Kalman u.1 Miskolc
Hungary Vas Megyei Markusovszky Kórház, Gyermekosztály Markusovszky u. 1-3 Szombathely
Hungary Futurnest Kft Selyemrét u.1. Miskolc
Hungary Baby Box Bt,, 6724, Szeged, Kossuth Lajos sgt.109 Szeged Kossuth Lajos sgt.109
Italy 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
Italy Fondazione IRCCS dell'Ospedale Maggiore Policlinico, Mangiagalli e Regina Elena di Milano Via Commenda, 9 Milano
Italy Università degli Studi di Messina, Pad. NI - A.O.U. Policlinico G.Martino Via Consolare Valeria, 1 Messina
Italy Pediatria dell'Ospedale Sacco di Milano Via G.B.Grossi 74 Milano
Italy Dipartimento di Pediatria Azienda Ospedaliera di Padova Via Giustiniani, 3 Padova
Italy Dipartimento di Pediatria dell'Università degli Studi di Firenze Viale Pieraccini n. 24 Firenze

Sponsors (1)

Lead Sponsor Collaborator
Novartis Vaccines

Countries where clinical trial is conducted

Argentina,  Chile,  Czech Republic,  Hungary,  Italy, 

Outcome

Type Measure Description Time frame Safety issue
Primary 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. No
Primary 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. Yes
Secondary 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).
At baseline (pre-vaccination), 30 days after the third vaccination, at booster Baseline and at booster vaccination (12 months of age) No
Secondary 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. At Baseline (pre-vaccination), at 30 days after the third vaccination, at booster Baseline, at 30 days No
Secondary 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). After the third and the booster vaccination. No
Secondary 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. 12 months (pre-fourth vaccination) No
Secondary 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. 1 month after fourth vaccination No
Secondary 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. At 13 months No
Secondary 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). 1 month after booster No
Secondary 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). Day 1 through day 7 after second and third vaccination. No
Secondary Number of Subjects With Solicited Local Reactions 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 solicited local reactions within 7 days (day 1-7) after each vaccination. Day 1 through day 7 after each vaccination. Yes
Secondary Number of Subjects With Solicited Systemic Reactions 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 solicited systemic reactions within 7 days (day 1-7) after each vaccination. Day 1 through day 7 after each vaccination. Yes
Secondary 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. Day 1 through day 7 after each vaccination. Yes
Secondary 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. Overall study period. No
Secondary 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. Day 1 through day 7 at 13 months age. Yes
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