Meningococcal DiseasePhase 3NCT01339923
A Phase 3B, Open Label, Multi-Center Study to Evaluate the Safety, Tolerability and Immunogenicity of Novartis Meningococcal B Recombinant Vaccine When Administered Alone to Healthy Infants According to Different Immunization Schedules and to Healthy Children Aged 2 to 10 Years
A Phase 3 study testing rMenB + OMV NZ vaccine, Meningococcal C oligosaccharide conjugated vaccine and Pneumococcal polysaccharide conjugate vaccine, 10 valent adsorbed. in people with Meningococcal Disease and Meningococcal Meningitis, run by Novartis Vaccines at 26 sites in 4 countries.
Trial summary
The proposed study is aimed at assessing the safety and immunogenicity of rMenB+OMV NZ when administered alone without routine infant vaccines to healthy infants in their first year of life according to different two and three dose immunization schedules, which are suitable to be adopted by various national programs. Read more about this study
- Who is it for?
- Ages 71 days to 10 yearsHealthy volunteers can take part
- Conditions the study is for
- Meningococcal Disease, Meningococcal Meningitis
- What is being tested?
- rMenB + OMV NZ vaccine, Meningococcal C oligosaccharide conjugated vaccine and Pneumococcal polysaccharide conjugate vaccine, 10 valent adsorbed.
- Type of treatment
- Vaccines, Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 1,409 participants
- Where
- 26 sitesin 4 countries
- Study dates
- Apr 2011to Dec 2014
- Phase
- Phase 3
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 71 days to 10 years
- All sexes
- Healthy volunteers accepted
- Child
Who may be able to join
- Healthy infants and children according to the following age groups:
- Healthy infants 2½ months of age (71 -79 days, inclusive), (only applicable to group I)
- Healthy infants 3½ months of age (101 -109 days, inclusive), (only applicable to group II)
- Healthy infants 6 months of age (only applicable to group III) (The age window is defined as the first day the subject turns 6 months of age up to the day before the subject turns 7 months of age).
- Healthy children 2 to 5 years of age (only applicable to group IVa) (The age window is defined as the first day the subject turns 2 years of age up to the day before the subject turns 6 years of age).
- Healthy children 6 to 10 years of age (only applicable to group IVb) (The age window is defined as the first day the subject turns 6 years of age up to the day before the subject turns 11 years of age).
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- Healthy infants 3 months of age (83-104 days, inclusive), (only applicable to Group V and VI).
- For whom parent(s)/legal guardian(s) have given written informed consent according to local regulations after the nature of the study has been explained;
- Available for all the visits scheduled in the study;
- Individuals in good health as determined by the outcome of medical history, physical examination and clinical judgment of the investigator.
Who cannot join
- Individuals whose parent(s)/legal guardian(s) are unwilling or unable to give written informed consent to participate in the study;
- Children's parents or legal guardian who are not able to comprehend and to follow all required study procedures for the whole period of the study.
- History of any meningococcal B vaccine administration;
- Previous 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 or hypersensitivity to any vaccine component
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- Significant acute or chronic infection within the previous 7 days or temperature 38° C within the previous day of receiving the study vaccine;
- Antibiotics treatment within 6 days prior to enrollment;
- Individuals with history of allergy to vaccine components.
- Any serious chronic or progressive disease according to the judgment of the investigator (e.g., neoplasm, diabetes mellitus Type I, cardiac disease, hepatic disease, 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);
- Known or suspected impairment/alteration of the immune system, immunosuppressive therapy, use of high dose systemic corticosteroids or chronic use of inhaled high-potency corticosteroids within 14 days prior to enrollment (use of low or moderate doses of inhaled steroids is not an exclusion);
- Receipt of blood, blood products and/or plasma derivatives or any parenteral immunoglobulin preparation within 90 days prior to enrollment.
- Receipt of, or intent to immunize with, any other vaccine(s) within 7 days prior to enrollment.
- Individuals participating in any clinical trial with another investigational product 30 days prior to first study visit or intent to participate in another clinical study at any time during the conduct of this study.
- Family members and household members of research staff
- Individuals with history or any illness that, in the opinion of the investigator, might interfere with the results of the study or pose additional risk to the subjects due to participation in the study.
- History of any meningococcal C vaccine administration (Only applicable to group V and VI).
- History of any Pneumococcal vaccine administration (Only applicable to group V and VI).
Trial locations and contacts
26 sites in 4 countries.
26 sites in 4 countries
Hungary10 sites
Site 34 - General Pediatric Practice Somorjai
Bajcsi Ut 32, Debrecen, 4025
Site 35 - Praxis Dr Eva Kovacs
Csongradi Sgt 63, Szeged, 6723
Site 36 - General Practice Dr Edit Oszlacs
Debreceni Utca 10-14, Szeged, 6723
Site 32 - Praxis Dr Eleonora Konya
Fo Utca 12, Malyi, 3434
Site 37 - Praxis Dr Julianna Kovacs
Honved Utca 2, Bordany, 6795
Site 31 - General Practice Dr Olga Fekete
Kando Kalman Utca 1, Miskolc, 3534
Site 40 - General Pediatric Practice Hacsek
Poth Iren U 80, Budapest
Site 30 - General Practice Dr Simko
Selyemret U. 1., Miskolc, 3527
Site 33 - General Pediatric Practice Ujhelyi
Szent Istvan U 10, Nyiregyhaza, 4400
Site 42 - Praxis Dr Eszter Bari
Szentharomsag Ter 10, Csongrád megye, 6640
Spain9 sites
Site 15
Almería, 04007
Site 16
Almería, 04120
Site 20
Barcelona, 08195
Site 17
Madrid, 28041
Site 18
Madrid, 28935
Site 11
Ourense, 32005
Site 13
Pontevedra, 36002
Site 10
Santiago de Compostela, 15706
Site 14
Seville, 41014
Brazil4 sites
Site 54- Associação Obras Sociais Irmã Dulce, Avenida Bonfim, nº 161
Largo de Roma, Salvador/BA-CEP, 40420-000
Site 53 - CRIE UNIFESP
Rua Borges Lagoa 770, São Paulo, 04038002
Site 55 - Instituto de Medicina Integral Prof. Fernando Figueira (IMIP)
Rua Dos Coelhos, 300 - Boa Vista, Recife/PE, 50070-550
Site 50 - Associacao Fundo de Incentivo a Psicofarmacologia
Rua Marselhesa 500 Vila Clementino, São Paulo, 04020-060
Peru3 sites
Site 80 - Hospital Nacional docente Madre Nino San Bartolome
Av Alfonso Ugarte, Lima
Site 82 - Investigaciones Medicas en Salud INMENSA
Jr Jose de La Torre Ugarte Lince, Lima
Site 81 - Via Libre
Jr Paraguay Cercado de Lima, Lima
About this study
The proposed study is aimed at assessing the safety and immunogenicity of rMenB+OMV NZ when administered alone without routine infant vaccines to healthy infants in their first year of life according to different two and three dose immunization schedules, which are suitable to be adopted by various national programs. This study will also investigate antibody persistence post primary series and administration of a subsequent booster dose of rMenB+OMV NZ at 11 months of age. In addition, this study will assess the safety and immunogenicity of two catch-up doses of rMenB+OMV NZ when administered to healthy children 2 to 10 years of age.
This study will also evaluate the safety and immunogenicity of the concomitant administration of rMenB+OMV NZ with meningococcal C conjugate vaccine (MenC-CRM) according to a 3, 5 and 12-month schedule.
- Conditions
- Meningococcal Disease, Meningococcal Meningitis
- Being tested
- rMenB + OMV NZ vaccine, Meningococcal C oligosaccharide conjugated vaccine, Pneumococcal polysaccharide conjugate vaccine, 10 valent adsorbed.
- Keywords
- Meningococcal disease, Vaccines, intercalated administration
- Medical subject headings
- Meningococcal Infections, Meningitis, Meningococcal
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
rMenB + OMV NZ vaccineBiological
Also called rMenB for Group I
3 doses (2.5, 3.5, 5 months if age) plus booster (11 months of age)
rMenB + OMV NZ vaccineBiological
Also called rMenB for Group II
2 doses (3.5, 5 months of age) plus booster (11 months of age)
rMenB + OMV NZ vaccineBiological
Also called rMenB for Group III
2 doses (6, 8 months of age) plus booster (11 months of age)
rMenB + OMV NZ vaccineBiological
Also called rMenB for Group IV
2 doses 2 months apart
Meningococcal C oligosaccharide conjugated vaccineBiological
Schedule 3, 5, 7, 12, Meningococcal C oligosaccharide conjugated vaccine
Pneumococcal polysaccharide conjugate vaccine, 10 valent adsorbed.Biological
Schedule 3, 5, 7, 12 Pneumococcal polysaccharide conjugate vaccine, 10 valent adsorbed.
rMenB + OMV NZ vaccineBiological
Also called rMenB for Group V
Schedule 3, 5, 12 rMenB + OMV vaccine
rMenB + OMV NZ vaccineBiological
Also called rMenB for Group VI
Schedule 13,15 rMenB + OMV vaccine
| Study group | Role | What they receive |
|---|---|---|
| B_2h3h5_11 | Experimental | Subjects, approximately 2.5 months of age, received 3 dose primary vaccination of rMenB+OMV NZ at 2.5, 3.5, 5 months of age, followed by a booster dose at 11 months of age. Receives: Biological: rMenB + OMV NZ vaccine |
| B_3h5_11 | Experimental | Subjects, approximately 3.5 months of age, received 2 dose primary vaccination of rMenB+OMV NZ at 3.5 and 5 months of age, followed by a booster dose at 11 months of age. Receives: Biological: rMenB + OMV NZ vaccine |
| B_68_11 | Experimental | Subjects, approximately 6 months of age, received 2 dose primary vaccination of rMenB+OMV NZ at 6 and 8 months of age, followed by a booster dose at 11 months of age. Receives: Biological: rMenB + OMV NZ vaccine |
| B_02_2_5 | Experimental | Subjects, 2-5 years of age received 2 catch-up doses of rMenB+OMV NZ, each at 0 and 2 months. Blood draw at 0 and 3 months since study start. Receives: Biological: rMenB + OMV NZ vaccine |
| B_02_6_10 | Experimental | Subjects, 6-10 years of age received 2 catch-up doses of rMenB+OMV NZ, each at 0 and 2 months. Blood draw at 0 and 3 months since study start. Receives: Biological: rMenB + OMV NZ vaccine |
| BC_35_12 | Experimental | Subjects, 3 months of age received rMenB+OMV NZ + MenC-CRM and Synflorix concomitantly at 3, 5 and 12 months of age and an additional dose of Synflorix alone dose at 7 months of age. Receives: Biological: Meningococcal C oligosaccharide conjugated vaccine; Biological: Pneumococcal polysaccharide conjugate vaccine, 10 valent adsorbed.; Biological: rMenB + OMV NZ vaccine |
| C_35_12 | Experimental | Subjects, 3 months of age received MenC-CRM and Synflorix concomitantly at 3, 5 and 12 months of age and an additional dose of Synflorix alone at 7 months of age and rMenB+OMV NZ alone at 13 and 15 months of age. Receives: Biological: Meningococcal C oligosaccharide conjugated vaccine; Biological: Pneumococcal polysaccharide conjugate vaccine, 10 valent adsorbed.; Biological: rMenB + OMV NZ vaccine |
What is being measured
The primary outcome is the main question the study is designed to answer.
Percentages of Subjects With Serum Bactericidal Activity Using Human Serum (hSBA) Titers ≥ 4 or hSBA Titers ≥ 5 (Strain M10713) Following a 2-dose Primary Series of rMenB+OMV Vaccination.
Immunogenicity was assessed in terms of percentages of subjects with hSBA titers ≥ 4 against N meningitidis serogroup B strains H44/76, 5/99, NZ98/254 and hSBA titers ≥ 5 against strain M10713 following 2-dose primary series of vaccination with rMenB+OMV NZ at 3.5 and 5 months of age or at 6 and 8 months of age. Analysis was done on Full analysis set (FAS)-Primary series.
Measured: 1 month after second vaccination
Secondary outcomes (27)
Percentages of Subjects With hSBA Titers ≥ 4, hSBA Titers ≥ 5 (Strain M10713) and hSBA ≥ 8 Following a 3-dose Primary Series of rMenB+OMV Vaccination
Immunogenicity was assessed in terms of percentages of subjects with hSBA titers ≥ 4 against N meningitidis serogroup B strains H44/76, 5/99, NZ98/254; hSBA titers ≥ 5 against strain M10713 and hSBA titers ≥ 8 against strains H44/76, 5/99, NZ98/254, M10713, following 3-dose primary series of vaccination with rMenB+OMV NZ at 2.5, 3.5 and 5 months of age. Analysis was done on FAS-primary series.
Measured: 1 month after third vaccination
Percentages of Subjects With hSBA Titers ≥ 4 or hSBA Titers ≥ 5 (Strain M10713) and hSBA ≥ 8 Following a 2-dose Catch-up Series of rMenB+OMV Vaccination
Immunogenicity was assessed in terms of percentages of subjects with hSBA titers ≥ 4 against N meningitidis serogroup B strains H44/76, 5/99, NZ98/254; hSBA titers ≥ 5 against strain M10713 and hSBA titers ≥ 8 against strains H44/76, 5/99, NZ98/254, M10713; following 2-dose catch-up series of vaccination with rMenB+OMV NZ in healthy children aged 2-10 years (0, 2 month schedule). Analysis was done on FAS-primary series.
Measured: 1 month after second vaccination
Percentages of Subjects Achieving Four-fold Rise Over Baseline hSBA Titers Following a 2-dose Catch-up Series of rMenB+OMV Vaccination
Immunogenicity was assessed in terms of percentages of subjects achieving 4-fold increase in hSBA titers as compared to baseline against N meningitidis serogroup B strains H44/76, 5/99, NZ98/254, M10713; following 2-dose catch-up series of vaccination with rMenB+OMV NZ in healthy children aged 2-10 years (0, 2 month schedule).
Analysis was done on FAS- primary series.
Measured: 1 month after second vaccination
Geometric Mean hSBA Titers (GMTs) Following 2 or 3 Dose Primary Series of Vaccination With rMenB+OMV
Immunogenicity was assessed in terms of Geometric mean hSBA titers (GMTs) against N meningitidis serogroup B indicator strains following 2 or 3 dose primary series of vaccination rMenB+OMV NZ (1 month after 3rd infant vaccination in B_2h3h5_11 and 1 month after 2nd infant vaccination in B_3h5_11, B_68_11 and B_02).
Analysis was done on FAS-primary series.
Measured: 1 month after primary series vaccination
Geometric Mean hSBA Titers (GMTs) After First Infant Vaccination With rMenB+OMV.
Immunogenicity was assessed in terms of Geometric mean hSBA titers (GMTs) against N meningitidis serogroup B indicator strains after the first infant vaccination in groups B_2h3h5_11b, B_3h5_11b and B_68_11b (after 1 month for group B_2h3h5_11b, 1.5 months for group B_2h3h5_11b and 2 months for group B_68_11b). Analysis was done on FAS-post first dose.
Measured: 1, 1.5 or 2 months after first infant vaccination
Percentages of Subjects With hSBA Titers ≥ 4 or hSBA Titers ≥ 5 and hSBA ≥ 8 After First Infant Vaccination With rMenB+OMV
Immunogenicity was assessed in terms of percentages of subjects with hSBA titers ≥ 4 against N meningitidis serogroup B strains H44/76, 5/99, NZ98/254, hSBA titers ≥ 5 against strain M10713 and hSBA titers ≥ 8 against strains H44/76, 5/99, NZ98/254, M10713 after the first infant vaccination in groups B_2h3h5_11b, B_3h5_11b and B_68_11b (at 3.5, 5, and 8 months of age respectively). Analysis was done on FAS-post first dose.
Measured: Post- first dose (1 month for B_2h3h5_11b, 1.5 month for B_3h5_11b and 2 months for B_68_11b after 1st vaccination)
Percentages of Subjects With hSBA Titers ≥ 4 or hSBA Titers ≥ 5 and hSBA ≥ 8 Following a Booster Dose of rMenB+OMV Vaccination
Immunogenicity was assessed in terms of percentages of subjects with hSBA titers ≥ 4 against N meningitidis serogroup B strains H44/76, 5/99, NZ98/254; hSBA titers ≥ 5 against strain M10713; hSBA titers ≥ 8 against strains H44/76, 5/99, NZ98/254, M10713; following a booster dose of rMenB+OMV NZ given at 11 months of age (4th dose for B_2h3h5_11 and 3rd dose for B_3h5_11 and B_68_11). Analysis was done on FAS-booster.
Measured: 1 month post-booster dose
Antibody Persistence in Terms of Percentages of Subjects With hSBA Titers ≥ 4 or hSBA Titers ≥ 5 (M10713) and hSBA ≥ 8 Following 2 or 3-dose Primary Series of Vaccination With rMenB+OMV NZ
Persistence of bactericidal antibodies at 11 months of age was assessed in terms of percentages of subjects with hSBA titers ≥ 4 against N meningitidis serogroup B strains H44/76, 5/99, NZ98/254; hSBA titers ≥ 5 against strain M10713; hSBA titers ≥ 8 against strains H44/76, 5/99, NZ98/254, M10713 in subjects who previously received a primary series of 2 or 3-doses of rMenB+OMV NZ vaccine. Analysis was done on FAS-persistence.
Measured: 11 months of age (persistence)
Antibody Persistence in Terms of Geometric Mean Titers Following 2 or 3-dose Primary Series of Vaccination With rMenB+OMV NZ
Persistence of bactericidal antibodies at 11 months of age was assessed in terms of GMTs against N meningitidis serogroup B indicator strains in subjects who previously received a primary series of 2 or 3-doses of rMenB+OMV NZ. Analysis was done on FAS-persistence.
Measured: 11 months of age (persistence)
Geometric Mean ELISA Concentrations Against Vaccine Antigen 287-953 Following 2 or 3-dose Primary Series and Booster Dose of Vaccination With rMenB+OMV NZ
Immunogenicity was assessed in terms of Geometric mean ELISA concentrations (GMCs) against N meningitidis serogroup B vaccine antigen 287-953, following 2 or 3 dose primary series and booster dose of rMenB+OMV NZ. Analysis was done on FAS-persistence and FAS-booster.
Measured: 1 month after primary vaccination, pre-booster vaccination (persistence) and 1 month after booster vaccination
Geometric Mean ELISA Concentrations Against Vaccine Antigen 287-953 After a Two Dose Catch-up rMenB+OMV NZ Immunization Series in Children 2-10 Years of Age
Immunogenicity was assessed in terms of Geometric mean ELISA concentrations (GMCs) against N meningitidis serogroup B vaccine antigen 287-953, after a two dose catch-up immunization series with rMenB+OMV NZ in children 2-10 years of age. Analysis was done on FAS-primary series.
Measured: 1 month after second vaccination
Percentages of Subjects With hSBA Titers ≥ 8 Against Serogroup C Following Concomitant Administration of rMenB+OMV NZ With MenC-CRM or MenC-CRM Alone
Non-inferiority of MenC-CRM was determined following co-administration of MenC-CRM and rMenB+OMV NZ or MenC-CRM alone at 3 and 5 months and booster dose at 12 months, as measured by the percentages of subjects achieving hSBA titers ≥ 8 against serogroup C. Analysis was done on PPS-primary series and PPS-booster.
Measured: Baseline, 1 month after second vaccination and 1 month after booster vaccination
GMTs Following Concomitant Administration of rMenB+OMV NZ With MenC-CRM or MenC-CRM Alone
Immunogenicity was assessed in terms of GMTs against N meningitidis serogroup C strain following co-administration of MenC-CRM and rMenB+OMV NZ or MenC-CRM alone at 3 and 5 months and booster dose at 12 months. Analysis was done on FAS-primary series and FAS-booster.
Measured: 1 month after second vaccination, 1 month after booster vaccination
GMTs Following Concomitant Administration of rMenB+OMV NZ With MenC-CRM or MenC-CRM Alone - Persistence
Immunogenicity was assessed in terms of GMTs against N meningitidis serogroup C strain following co-administration of MenC-CRM and rMenB+OMV NZ or MenC-CRM alone at 3 and 5 months and booster dose at 12 months. Analysis was done on FAS-persistence.
Measured: Pre-booster vaccination (persistence; 12 months of age)
Percentages of Subjects With hSBA Titers ≥ 4 or hSBA Titers ≥ 5 (M10713) and hSBA ≥ 8 Following Concomitant Administration of rMenB+OMV NZ With MenC-CRM
Immunogenicity was assessed in terms of percentages of subjects with hSBA titers ≥ 4 against N meningitidis serogroup B strains H44/76, 5/99, NZ98/254; hSBA titers ≥ 5 against strain M10713; hSBA titers ≥ 8 against strains H44/76, 5/99, NZ98/254, M10713; following co-administration of MenC-CRM and rMenB+OMV NZ at 3 and 5 months and a booster at 12 months. Analysis was done on FAS-primary series and FAS-booster.
Measured: 1 month after second vaccination and 1 month after booster vaccination
GMTs Against N. Meningitidis Serogroup B Strains Following Concomitant Administration of rMenB+OMV NZ With MenC-CRM
Immunogenicity was assessed in terms of GMTs against N meningitidis serogroup C strain following co-administration of MenC-CRM and rMenB+OMV NZ at 3 and 5 months and booster dose at 12 months. Analysis was done on FAS-persistence and FAS-booster.
Measured: 1 month after second vaccination, pre-booster vaccination and 1 month after booster vaccination
Geometric Mean ELISA Concentrations Against Vaccine Antigen 287-953 Following Concomitant Administration of rMenB+OMV NZ With MenC-CRM
Immunogenicity was assessed in terms of Geometric mean ELISA concentrations against N meningitidis serogroup B vaccine antigen 287-953, following co-administration of MenC-CRM and rMenB+OMV NZ at 3 and 5 months and booster dose at 12 months. Analysis was done on FAS-primary and FAS-booster.
Measured: 1 month after second vaccination, pre-booster vaccination and 1 month after booster vaccination
Geometric Mean ELISA Concentrations Against Vaccine Antigen 287-953 Following Concomitant Administration of rMenB+OMV NZ With MenC-CRM - Persistence
Immunogenicity was assessed in terms of GMTs against Geometric mean ELISA concentrations against N meningitidis serogroup B vaccine antigen 287-953, following co-administration of MenC-CRM and rMenB+OMV NZ at 3 and 5 months and booster dose at 12 months. Analysis was done on FAS-persistence.
Measured: Pre-booster vaccination (persistence; 12 months of age)
Number of Subjects Who Reported Immediate Reactions Within 30 Minutes After Any Vaccination With rMenB+OMV NZ
Safety was assessed in terms of number of subjects who reported immediate reactions within 30 minutes following a 4-dose regimen (2.5, 3.5, 5 and 11 months) or a 3-dose regimen (3.5, 5 and 11 months or 6, 8 and 11 months) of rMenB+OMV NZ. Analysis was done on solicited safety set.
Measured: Within 30 minutes after any vaccination
Number of Subjects With Solicited Local and Systemic Adverse Events (AEs) Following a 3 or 4-dose Regimen of rMenB+OMV NZ
Safety was assessed in terms of number of subjects with solicited local and systemic AEs after any vaccination following a 4-dose regimen (2.5, 3.5, 5 and 11 months) or as a 3-dose regimen (3.5, 5 and 11 months or 6, 8 and 11 months) of rMenB+OMV NZ. Analysis was done on solicited safety set.
Measured: Day 1 to day 7 after any vaccination
Number of Subjects Who Reported Immediate Reactions Within 30 Minutes After Any Vaccination - Groups B_02_2_5 and B_02_6_10
Safety was assessed in terms of number of subjects with solicited local and systemic AEs after any vaccination in subjects aged 2 - 10 years who received 2 catch-up doses of rMenB+OMV NZ, each at 0 and 2 months. Analysis was done on solicited safety set.
Measured: Within 30 minutes after any vaccination
Number of Subjects With Solicited Local and Systemic AEs in Groups B_02_2_5 and B_02_6_10
Safety was assessed in terms of number of subjects with solicited local and systemic AEs after any vaccination in subjects aged 2- 10 years who received 2 catch-up doses of rMenB+OMV NZ, each at 0 and 2 months. Analysis was done on solicited safety set.
Measured: Day 1 to day 7 after any vaccination
Number of Subjects Who Reported Immediate Reactions Within 30 Minutes After Any rMenB+OMV NZ or MenC-CRM Vaccination
Safety was assessed in terms of number of subjects with solicited local and systemic AEs after any vaccination with rMenB+OMV NZ or MenC-CRM. Analysis was done on solicited safety set.
Measured: Within 30 minutes after any vaccination
Number of Subjects With Solicited Local and Systemic AEs in Groups BC_35_12 and C_35_12 After Any rMenB+OMV NZ or MenC-CRM Vaccination
Safety was assessed in terms of number of subjects with solicited local and systemic AEs after any vaccination with rMenB+OMV NZ or MenC-CRM. Analysis was done on solicited safety set.
Measured: Day 1 to day 7 after any vaccination
Number of Subjects Reporting Unsolicited AEs Following Any Vaccination With rMenB+OMV NZ in Groups B_2h3h5_11, B_3h5_11 and B_68_11
Safety was assessed in terms of number of subjects reporting any unsolicited AEs (day 1-7 after any vaccination), serious adverse events (SAEs), medically attended AEs, AEs leading to premature withdrawal from the study (collected throughout the study period) following any vaccination with rMenB+OMV. Analysis was done on unsolicited safety set.
Measured: Until 12 months of age; Day 1 to day 7 (All AEs)
Number of Subjects Reporting Unsolicited AEs Following Any Vaccination With rMenB+OMV NZ in Groups B_02_2_5 and B_02_6_10
Safety was assessed in terms of number of subjects reporting any unsolicited AEs (day 1-7 after any vaccination), serious adverse events (SAEs), medically attended AEs, AEs leading to premature withdrawal from the study (collected throughout the study period) following any vaccination with rMenB+OMV NZ. Analysis was done on unsolicited safety set.
Measured: Day 1 to day 7 (All AEs). Throughout the study period (SAEs, medically attended or leading to premature withdrawal AEs)
Number of Subjects Reporting Unsolicited AEs Following Any Vaccination With rMenB+OMV NZ in Group BC_35_12 and C_35_12
Safety was assessed in terms of number of subjects reporting any unsolicited AEs (day 1-7 after any vaccination), serious adverse events (SAEs), medically attended AEs, AEs leading to premature withdrawal from the study (collected throughout the study period) following any vaccination with rMenB+OMV NZ or MenC-CRM. Analysis was done on unsolicited safety set.
Measured: Day 1 to Day 301 for BC_35_12 and C_35_12, Day 302 to Day 391 for C_35_12; Day 1 to day 7 (All AEs)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Apr 2011 (estimated)
- Study startApr 2011
- Primary completionJan 2014
- Study completionDec 2014
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for Meningococcal DiseaseStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 3
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 1,409 participants (actual)
Sponsor and investigators
- Lead sponsor
- Novartis Vaccines
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Novartis Vaccines, Study chair, Novartis Vaccines
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01339923
- Sponsor's protocol ID
- V72_28
- Status last verified
- Mar 2016
- First submitted
- 13 Apr 2011
- Last updated
- 9 May 2016
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
Publications
Safadi MAP, Martinon-Torres F, Weckx LY, Moreira ED Junior, da Fonseca Lima EJ, Willemsen A, Toneatto D, Habib MA, Borys D. Immunogenicity of the pneumococcal non-typeable Haemophilus influenzae protein D conjugate vaccine (PHiD-CV) administered concomitantly with the meningococcal serogroup B (4CMenB) vaccine in infants: A post-hoc analysis in a phase 3b, randomised, controlled trial. Vaccine. 2019 Aug 14;37(35):4858-4863. doi: 10.1016/j.vaccine.2019.07.021. Epub 2019 Jul 18.
PubMed 31327652Martinon-Torres F, Carmona Martinez A, Simko R, Infante Marquez P, Arimany JL, Gimenez-Sanchez F, Couceiro Gianzo JA, Kovacs E, Rojo P, Wang H, Bhusal C, Toneatto D. Antibody persistence and booster responses 24-36 months after different 4CMenB vaccination schedules in infants and children: A randomised trial. J Infect. 2018 Mar;76(3):258-269. doi: 10.1016/j.jinf.2017.12.005. Epub 2017 Dec 15.
PubMed 29253560P Safadi MA, Martinon-Torres F, Weckx LY, Moreira ED Junior, da Fonseca Lima EJ, Mensi I, Calabresi M, Toneatto D. Immunogenicity and safety of concomitant administration of meningococcal serogroup B (4CMenB) and serogroup C (MenC-CRM) vaccines in infants: A phase 3b, randomized controlled trial. Vaccine. 2017 Apr 11;35(16):2052-2059. doi: 10.1016/j.vaccine.2017.03.002. Epub 2017 Mar 18.
PubMed 28318767
Study at a glance
From the registry record, last updated by the sponsor on 9 May 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase 3B, Open Label, Multi-Center Study to Evaluate the Safety, Tolerability and Immunogenicity of Novartis Meningococcal B Recombinant Vaccine When Administered Alone to Healthy Infants According to Different Immunization Schedules and to Healthy Children Aged 2 to 10 Years
- ClinicalTrials.gov ID
- NCT01339923
- Acronym / sponsor ID
- V72_28
- Conditions
- Meningococcal Disease, Meningococcal Meningitis
- Keywords
- Meningococcal disease, Vaccines, intercalated administration
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 1,409 participants (actual)
- Lead sponsor
- Novartis VaccinesIndustry (pharma, biotech, devices)
- Study start
- Apr 2011
- Primary completion
- Jan 2014 (actual)
- Study completion
- Dec 2014 (actual)
- First posted
- 21 Apr 2011 (estimated)
- Results
- Posted 20 Jan 2016
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The proposed study is aimed at assessing the safety and immunogenicity of rMenB+OMV NZ when administered alone without routine infant vaccines to healthy infants in their first year of life according to different two and three dose immunization schedules, which are suitable to be adopted by various national programs. This study will also investigate antibody persistence post primary series and administration of a subsequent booster dose of rMenB+OMV NZ at 11 months of age. In addition, this study will assess the safety and immunogenicity of two catch-up doses of rMenB+OMV NZ when administered to healthy children 2 to 10 years of age.
This study will also evaluate the safety and immunogenicity of the concomitant administration of rMenB+OMV NZ with meningococcal C conjugate vaccine (MenC-CRM) according to a 3, 5 and 12-month schedule.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 7
| Arm | Type | Receives |
|---|---|---|
| B_2h3h5_11 | Experimental | Biological: rMenB + OMV NZ vaccineSubjects, approximately 2.5 months of age, received 3 dose primary vaccination of rMenB+OMV NZ at 2.5, 3.5, 5 months of age, followed by a booster dose at 11 months of age. |
| B_3h5_11 | Experimental | Biological: rMenB + OMV NZ vaccineSubjects, approximately 3.5 months of age, received 2 dose primary vaccination of rMenB+OMV NZ at 3.5 and 5 months of age, followed by a booster dose at 11 months of age. |
| B_68_11 | Experimental | Biological: rMenB + OMV NZ vaccineSubjects, approximately 6 months of age, received 2 dose primary vaccination of rMenB+OMV NZ at 6 and 8 months of age, followed by a booster dose at 11 months of age. |
| B_02_2_5 | Experimental | Biological: rMenB + OMV NZ vaccineSubjects, 2-5 years of age received 2 catch-up doses of rMenB+OMV NZ, each at 0 and 2 months. Blood draw at 0 and 3 months since study start. |
| B_02_6_10 | Experimental | Biological: rMenB + OMV NZ vaccineSubjects, 6-10 years of age received 2 catch-up doses of rMenB+OMV NZ, each at 0 and 2 months. Blood draw at 0 and 3 months since study start. |
| BC_35_12 | Experimental | Biological: Meningococcal C oligosaccharide conjugated vaccine, Biological: Pneumococcal polysaccharide conjugate vaccine, 10 valent adsorbed., Biological: rMenB + OMV NZ vaccineSubjects, 3 months of age received rMenB+OMV NZ + MenC-CRM and Synflorix concomitantly at 3, 5 and 12 months of age and an additional dose of Synflorix alone dose at 7 months of age. |
| C_35_12 | Experimental | Biological: Meningococcal C oligosaccharide conjugated vaccine, Biological: Pneumococcal polysaccharide conjugate vaccine, 10 valent adsorbed., Biological: rMenB + OMV NZ vaccineSubjects, 3 months of age received MenC-CRM and Synflorix concomitantly at 3, 5 and 12 months of age and an additional dose of Synflorix alone at 7 months of age and rMenB+OMV NZ alone at 13 and 15 months of age. |
Who may qualify
- Ages
- 71 days to 10 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
Key inclusion criteria (10 listed)
- Healthy infants and children according to the following age groups:
- For whom parent(s)/legal guardian(s) have given written informed consent according to local regulations after the nature of the study has been explained;
- Available for all the visits scheduled in the study;
- Individuals in good health as determined by the outcome of medical history, physical examination and clinical judgment of the investigator.
Key exclusion criteria (18 listed)
- Individuals whose parent(s)/legal guardian(s) are unwilling or unable to give written informed consent to participate in the study;
- Children's parents or legal guardian who are not able to comprehend and to follow all required study procedures for the whole period of the study.
- History of any meningococcal B vaccine administration;
- Previous ascertained or suspected disease caused by N. meningitidis;
- Household contact with and/or intimate exposure to an individual with laboratory confirmed N. meningitidis;
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| rMenB + OMV NZ vaccineAlso: rMenB for Group I3 doses (2.5, 3.5, 5 months if age) plus booster (11 months of age) | Biological | B_2h3h5_11 |
| rMenB + OMV NZ vaccineAlso: rMenB for Group II2 doses (3.5, 5 months of age) plus booster (11 months of age) | Biological | B_3h5_11 |
| rMenB + OMV NZ vaccineAlso: rMenB for Group III2 doses (6, 8 months of age) plus booster (11 months of age) | Biological | B_68_11 |
| rMenB + OMV NZ vaccineAlso: rMenB for Group IV2 doses 2 months apart | Biological | B_02_2_5, B_02_6_10 |
| Meningococcal C oligosaccharide conjugated vaccineSchedule 3, 5, 7, 12, Meningococcal C oligosaccharide conjugated vaccine | Biological | BC_35_12, C_35_12 |
| Pneumococcal polysaccharide conjugate vaccine, 10 valent adsorbed.Schedule 3, 5, 7, 12 Pneumococcal polysaccharide conjugate vaccine, 10 valent adsorbed. | Biological | BC_35_12, C_35_12 |
| rMenB + OMV NZ vaccineAlso: rMenB for Group VSchedule 3, 5, 12 rMenB + OMV vaccine | Biological | BC_35_12 |
| rMenB + OMV NZ vaccineAlso: rMenB for Group VISchedule 13,15 rMenB + OMV vaccine | Biological | C_35_12 |
Primary outcome
Percentages of Subjects With Serum Bactericidal Activity Using Human Serum (hSBA) Titers ≥ 4 or hSBA Titers ≥ 5 (Strain M10713) Following a 2-dose Primary Series of rMenB+OMV Vaccination.
Time frame: 1 month after second vaccination
Immunogenicity was assessed in terms of percentages of subjects with hSBA titers ≥ 4 against N meningitidis serogroup B strains H44/76, 5/99, NZ98/254 and hSBA titers ≥ 5 against strain M10713 following 2-dose primary series of vaccination with rMenB+OMV NZ at 3.5 and 5 months of age or at 6 and 8 months of age. Analysis was done on Full analysis set (FAS)-Primary series.
27 secondary outcomes
Percentages of Subjects With hSBA Titers ≥ 4, hSBA Titers ≥ 5 (Strain M10713) and hSBA ≥ 8 Following a 3-dose Primary Series of rMenB+OMV Vaccination
Time frame: 1 month after third vaccination
Percentages of Subjects With hSBA Titers ≥ 4 or hSBA Titers ≥ 5 (Strain M10713) and hSBA ≥ 8 Following a 2-dose Catch-up Series of rMenB+OMV Vaccination
Time frame: 1 month after second vaccination
Percentages of Subjects Achieving Four-fold Rise Over Baseline hSBA Titers Following a 2-dose Catch-up Series of rMenB+OMV Vaccination
Time frame: 1 month after second vaccination
Geometric Mean hSBA Titers (GMTs) Following 2 or 3 Dose Primary Series of Vaccination With rMenB+OMV
Time frame: 1 month after primary series vaccination
Geometric Mean hSBA Titers (GMTs) After First Infant Vaccination With rMenB+OMV.
Time frame: 1, 1.5 or 2 months after first infant vaccination
Percentages of Subjects With hSBA Titers ≥ 4 or hSBA Titers ≥ 5 and hSBA ≥ 8 After First Infant Vaccination With rMenB+OMV
Time frame: Post- first dose (1 month for B_2h3h5_11b, 1.5 month for B_3h5_11b and 2 months for B_68_11b after 1st vaccination)
Percentages of Subjects With hSBA Titers ≥ 4 or hSBA Titers ≥ 5 and hSBA ≥ 8 Following a Booster Dose of rMenB+OMV Vaccination
Time frame: 1 month post-booster dose
Antibody Persistence in Terms of Percentages of Subjects With hSBA Titers ≥ 4 or hSBA Titers ≥ 5 (M10713) and hSBA ≥ 8 Following 2 or 3-dose Primary Series of Vaccination With rMenB+OMV NZ
Time frame: 11 months of age (persistence)
Antibody Persistence in Terms of Geometric Mean Titers Following 2 or 3-dose Primary Series of Vaccination With rMenB+OMV NZ
Time frame: 11 months of age (persistence)
Geometric Mean ELISA Concentrations Against Vaccine Antigen 287-953 Following 2 or 3-dose Primary Series and Booster Dose of Vaccination With rMenB+OMV NZ
Time frame: 1 month after primary vaccination, pre-booster vaccination (persistence) and 1 month after booster vaccination
Geometric Mean ELISA Concentrations Against Vaccine Antigen 287-953 After a Two Dose Catch-up rMenB+OMV NZ Immunization Series in Children 2-10 Years of Age
Time frame: 1 month after second vaccination
Percentages of Subjects With hSBA Titers ≥ 8 Against Serogroup C Following Concomitant Administration of rMenB+OMV NZ With MenC-CRM or MenC-CRM Alone
Time frame: Baseline, 1 month after second vaccination and 1 month after booster vaccination
GMTs Following Concomitant Administration of rMenB+OMV NZ With MenC-CRM or MenC-CRM Alone
Time frame: 1 month after second vaccination, 1 month after booster vaccination
GMTs Following Concomitant Administration of rMenB+OMV NZ With MenC-CRM or MenC-CRM Alone - Persistence
Time frame: Pre-booster vaccination (persistence; 12 months of age)
Percentages of Subjects With hSBA Titers ≥ 4 or hSBA Titers ≥ 5 (M10713) and hSBA ≥ 8 Following Concomitant Administration of rMenB+OMV NZ With MenC-CRM
Time frame: 1 month after second vaccination and 1 month after booster vaccination
GMTs Against N. Meningitidis Serogroup B Strains Following Concomitant Administration of rMenB+OMV NZ With MenC-CRM
Time frame: 1 month after second vaccination, pre-booster vaccination and 1 month after booster vaccination
Geometric Mean ELISA Concentrations Against Vaccine Antigen 287-953 Following Concomitant Administration of rMenB+OMV NZ With MenC-CRM
Time frame: 1 month after second vaccination, pre-booster vaccination and 1 month after booster vaccination
Geometric Mean ELISA Concentrations Against Vaccine Antigen 287-953 Following Concomitant Administration of rMenB+OMV NZ With MenC-CRM - Persistence
Time frame: Pre-booster vaccination (persistence; 12 months of age)
Number of Subjects Who Reported Immediate Reactions Within 30 Minutes After Any Vaccination With rMenB+OMV NZ
Time frame: Within 30 minutes after any vaccination
Number of Subjects With Solicited Local and Systemic Adverse Events (AEs) Following a 3 or 4-dose Regimen of rMenB+OMV NZ
Time frame: Day 1 to day 7 after any vaccination
Number of Subjects Who Reported Immediate Reactions Within 30 Minutes After Any Vaccination - Groups B_02_2_5 and B_02_6_10
Time frame: Within 30 minutes after any vaccination
Number of Subjects With Solicited Local and Systemic AEs in Groups B_02_2_5 and B_02_6_10
Time frame: Day 1 to day 7 after any vaccination
Number of Subjects Who Reported Immediate Reactions Within 30 Minutes After Any rMenB+OMV NZ or MenC-CRM Vaccination
Time frame: Within 30 minutes after any vaccination
Number of Subjects With Solicited Local and Systemic AEs in Groups BC_35_12 and C_35_12 After Any rMenB+OMV NZ or MenC-CRM Vaccination
Time frame: Day 1 to day 7 after any vaccination
Number of Subjects Reporting Unsolicited AEs Following Any Vaccination With rMenB+OMV NZ in Groups B_2h3h5_11, B_3h5_11 and B_68_11
Time frame: Until 12 months of age; Day 1 to day 7 (All AEs)
Number of Subjects Reporting Unsolicited AEs Following Any Vaccination With rMenB+OMV NZ in Groups B_02_2_5 and B_02_6_10
Time frame: Day 1 to day 7 (All AEs). Throughout the study period (SAEs, medically attended or leading to premature withdrawal AEs)
Number of Subjects Reporting Unsolicited AEs Following Any Vaccination With rMenB+OMV NZ in Group BC_35_12 and C_35_12
Time frame: Day 1 to Day 301 for BC_35_12 and C_35_12, Day 302 to Day 391 for C_35_12; Day 1 to day 7 (All AEs)
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 May 2016.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Derived from this study: PubMed 31327652Safadi MAP, Martinon-Torres F, Weckx LY, Moreira ED Junior, da Fonseca Lima EJ, Willemsen A, Toneatto D, Habib MA, Borys D. Immunogenicity of the pneumococcal non-typeable Haemophilus influenzae protein D conjugate vaccine (PHiD-CV) administered concomitantly with the meningococcal serogroup B (4CMenB) vaccine in infants: A post-hoc analysis in a phase 3b, randomised, controlled trial. Vaccine. 2019 Aug 14;37(35):4858-4863. doi: 10.1016/j.vaccine.2019.07.021. Epub 2019 Jul 18.
- Derived from this study: PubMed 29253560Martinon-Torres F, Carmona Martinez A, Simko R, Infante Marquez P, Arimany JL, Gimenez-Sanchez F, Couceiro Gianzo JA, Kovacs E, Rojo P, Wang H, Bhusal C, Toneatto D. Antibody persistence and booster responses 24-36 months after different 4CMenB vaccination schedules in infants and children: A randomised trial. J Infect. 2018 Mar;76(3):258-269. doi: 10.1016/j.jinf.2017.12.005. Epub 2017 Dec 15.
- Derived from this study: PubMed 28318767P Safadi MA, Martinon-Torres F, Weckx LY, Moreira ED Junior, da Fonseca Lima EJ, Mensi I, Calabresi M, Toneatto D. Immunogenicity and safety of concomitant administration of meningococcal serogroup B (4CMenB) and serogroup C (MenC-CRM) vaccines in infants: A phase 3b, randomized controlled trial. Vaccine. 2017 Apr 11;35(16):2052-2059. doi: 10.1016/j.vaccine.2017.03.002. Epub 2017 Mar 18.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Novartis Vaccines study chair
Novartis Vaccines
26 sites in 4 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing rMenB + OMV NZ vaccine, Meningococcal C oligosaccharide conjugated vaccine and Pneumococcal polysaccharide conjugate vaccine, 10 valent adsorbed. in people with Meningococcal Disease and Meningococcal Meningitis, run by Novartis Vaccines at 26 sites in 4 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 10 inclusion and 18 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 9 May 2016. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 26 sites in Hungary, Spain, Brazil, Peru. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Yes. Results are posted in the registry (first posted 20 Jan 2016). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Percentages of Subjects With Serum Bactericidal Activity Using Human Serum (hSBA) Titers ≥ 4 or hSBA Titers ≥ 5 (Strain M10713) Following a 2-dose Primary Series of rMenB+OMV Vaccination. (time frame: 1 month after second vaccination). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01339923, which also lists 3 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 9 May 2016.