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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Novartis ( Novartis Vaccines )
ClinicalTrials.gov Identifier:
NCT01339923
First received: April 13, 2011
Last updated: March 30, 2016
Last verified: March 2016
  Purpose

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.


Condition Intervention Phase
Meningococcal Disease
Meningococcal Meningitis
Biological: rMenB + OMV NZ vaccine
Biological: Meningococcal C oligosaccharide conjugated vaccine
Biological: Pneumococcal polysaccharide conjugate vaccine, 10 valent adsorbed.
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Prevention
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

Resource links provided by NLM:


Further study details as provided by Novartis:

Primary Outcome Measures:
  • 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 ] [ Designated as safety issue: No ]
    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.


Secondary Outcome Measures:
  • 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 ] [ Designated as safety issue: No ]
    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.

  • 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 ] [ Designated as safety issue: No ]
    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.

  • 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 ] [ Designated as safety issue: No ]

    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.


  • 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 ] [ Designated as safety issue: No ]

    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.


  • Geometric Mean hSBA Titers (GMTs) After First Infant Vaccination With rMenB+OMV. [ Time Frame: 1, 1.5 or 2 months after first infant vaccination ] [ Designated as safety issue: No ]
    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.

  • 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) ] [ Designated as safety issue: No ]
    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.

  • 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 ] [ Designated as safety issue: No ]
    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.

  • 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) ] [ Designated as safety issue: No ]
    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.

  • 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) ] [ Designated as safety issue: No ]
    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.

  • 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 ] [ Designated as safety issue: No ]
    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.

  • 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 ] [ Designated as safety issue: No ]
    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.

  • 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 ] [ Designated as safety issue: No ]
    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.

  • 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 ] [ Designated as safety issue: No ]
    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.

  • 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) ] [ Designated as safety issue: No ]
    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.

  • 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 ] [ Designated as safety issue: No ]
    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.

  • 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 ] [ Designated as safety issue: No ]
    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.

  • 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 ] [ Designated as safety issue: No ]
    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.

  • 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) ] [ Designated as safety issue: No ]
    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.

  • 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 ] [ Designated as safety issue: No ]
    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.

  • 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 ] [ Designated as safety issue: No ]
    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.

  • 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 ] [ Designated as safety issue: No ]
    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.

  • 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 ] [ Designated as safety issue: No ]
    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.

  • 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 ] [ Designated as safety issue: No ]
    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.

  • 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 ] [ Designated as safety issue: No ]
    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.

  • 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) ] [ Designated as safety issue: No ]
    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.

  • 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) ] [ Designated as safety issue: No ]
    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.

  • 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) ] [ Designated as safety issue: No ]
    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.


Enrollment: 1409
Study Start Date: April 2011
Study Completion Date: December 2014
Primary Completion Date: January 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: B_2h3h5_11
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.
Biological: rMenB + OMV NZ vaccine
3 doses (2.5, 3.5, 5 months if age) plus booster (11 months of age)
Other Name: rMenB for Group I
Experimental: B_3h5_11
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.
Biological: rMenB + OMV NZ vaccine
2 doses (3.5, 5 months of age) plus booster (11 months of age)
Other Name: rMenB for Group II
Experimental: B_68_11
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.
Biological: rMenB + OMV NZ vaccine
2 doses (6, 8 months of age) plus booster (11 months of age)
Other Name: rMenB for Group III
Experimental: B_02_2_5
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.
Biological: rMenB + OMV NZ vaccine
2 doses 2 months apart
Other Name: rMenB for Group IV
Experimental: B_02_6_10
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.
Biological: rMenB + OMV NZ vaccine
2 doses 2 months apart
Other Name: rMenB for Group IV
Experimental: BC_35_12
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.
Biological: Meningococcal C oligosaccharide conjugated vaccine
Schedule 3, 5, 7, 12, Meningococcal C oligosaccharide conjugated vaccine
Biological: Pneumococcal polysaccharide conjugate vaccine, 10 valent adsorbed.
Schedule 3, 5, 7, 12 Pneumococcal polysaccharide conjugate vaccine, 10 valent adsorbed.
Biological: rMenB + OMV NZ vaccine
Schedule 3, 5, 12 rMenB + OMV vaccine
Other Name: rMenB for Group V
Experimental: C_35_12
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.
Biological: Meningococcal C oligosaccharide conjugated vaccine
Schedule 3, 5, 7, 12, Meningococcal C oligosaccharide conjugated vaccine
Biological: Pneumococcal polysaccharide conjugate vaccine, 10 valent adsorbed.
Schedule 3, 5, 7, 12 Pneumococcal polysaccharide conjugate vaccine, 10 valent adsorbed.
Biological: rMenB + OMV NZ vaccine
Schedule 13,15 rMenB + OMV vaccine
Other Name: rMenB for Group VI

  Eligibility

Ages Eligible for Study:   71 Days to 10 Years   (Child)
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  1. 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).
    • Healthy infants 3 months of age (83-104 days, inclusive), (only applicable to Group V and VI).
  2. 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;
  3. Available for all the visits scheduled in the study;
  4. Individuals in good health as determined by the outcome of medical history, physical examination and clinical judgment of the investigator.

Exclusion Criteria:

  1. Individuals whose parent(s)/legal guardian(s) are unwilling or unable to give written informed consent to participate in the study;
  2. 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.
  3. History of any meningococcal B vaccine administration;
  4. Previous ascertained or suspected disease caused by N. meningitidis;
  5. Household contact with and/or intimate exposure to an individual with laboratory confirmed N. meningitidis;
  6. History of severe allergic reaction after previous vaccinations or hypersensitivity to any vaccine component
  7. Significant acute or chronic infection within the previous 7 days or temperature 38° C within the previous day of receiving the study vaccine;
  8. Antibiotics treatment within 6 days prior to enrollment;
  9. Individuals with history of allergy to vaccine components.
  10. 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);
  11. 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);
  12. Receipt of blood, blood products and/or plasma derivatives or any parenteral immunoglobulin preparation within 90 days prior to enrollment.
  13. Receipt of, or intent to immunize with, any other vaccine(s) within 7 days prior to enrollment.
  14. 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.
  15. Family members and household members of research staff
  16. 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.
  17. History of any meningococcal C vaccine administration (Only applicable to group V and VI).
  18. History of any Pneumococcal vaccine administration (Only applicable to group V and VI).
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01339923

Locations
Brazil
Site 55 - Instituto de Medicina Integral Prof. Fernando Figueira (IMIP)
Rua dos Coelhos, 300 - Boa Vista, Recife/PE, Brazil, 50070-550
Site 54- Associação Obras Sociais Irmã Dulce, Avenida Bonfim, nº 161
Largo de Roma, Salvador/BA-CEP, Brazil, 40420-000
Site 53 - CRIE UNIFESP
Rua Borges Lagoa 770, Sao Paulo, Brazil, 04038002
Site 50 - Associacao Fundo de Incentivo a Psicofarmacologia
Rua Marselhesa 500 Vila Clementino, Sao Paulo, Brazil, 04020-060
Hungary
Site 37 - Praxis Dr Julianna Kovacs
Honved utca 2, Bordany, Hungary, 6795
Site 40 - General Pediatric Practice Hacsek
Poth Iren u 80, Budapest, Hungary
Site 42 - Praxis Dr Eszter Bari
Szentharomsag ter 10, Csongrad, Hungary, 6640
Site 34 - General Pediatric Practice Somorjai
Bajcsi ut 32, Debrecen, Hungary, 4025
Site 32 - Praxis Dr Eleonora Konya
Fo utca 12, Malyi, Hungary, 3434
Site 31 - General Practice Dr Olga Fekete
Kando Kalman utca 1, Miskolc, Hungary, 3534
Site 30 - General Practice Dr Simko
Selyemret u. 1., Miskolc, Hungary, 3527
Site 33 - General Pediatric Practice Ujhelyi
Szent Istvan u 10, Nyiregyhaza, Hungary, 4400
Site 35 - Praxis Dr Eva Kovacs
Csongradi sgt 63, Szeged, Hungary, 6723
Site 36 - General Practice Dr Edit Oszlacs
Debreceni utca 10-14, Szeged, Hungary, 6723
Peru
Site 80 - Hospital Nacional docente Madre Nino San Bartolome
Av Alfonso Ugarte, Lima, Peru
Site 82 - Investigaciones Medicas en Salud INMENSA
Jr Jose de la Torre Ugarte Lince, Lima, Peru
Site 81 - Via Libre
Jr Paraguay Cercado de Lima, Lima, Peru
Spain
Site 15
Almeria, Spain, 04007
Site 16
Almeria, Spain, 04120
Site 20
Barcelona, Spain, 08195
Site 17
Madrid, Spain, 28041
Site 18
Madrid, Spain, 28935
Site 11
Ourense, Spain, 32005
Site 13
Pontevedra, Spain, 36002
Site 10
Santiago de Compostela, Spain, 15706
Site 14
Sevilla, Spain, 41014
Sponsors and Collaborators
Novartis Vaccines
Investigators
Study Chair: Novartis Vaccines Novartis Vaccines
  More Information

Responsible Party: Novartis Vaccines
ClinicalTrials.gov Identifier: NCT01339923     History of Changes
Other Study ID Numbers: V72_28 
Study First Received: April 13, 2011
Results First Received: December 14, 2015
Last Updated: March 30, 2016
Health Authority: Europe: European Medicines Agency

Keywords provided by Novartis:
Meningococcal disease
Vaccines
intercalated administration

Additional relevant MeSH terms:
Meningitis
Meningococcal Infections
Meningitis, Meningococcal
Central Nervous System Diseases
Nervous System Diseases
Neisseriaceae Infections
Gram-Negative Bacterial Infections
Bacterial Infections
Meningitis, Bacterial
Central Nervous System Bacterial Infections
Central Nervous System Infections
Vaccines
Immunologic Factors
Physiological Effects of Drugs

ClinicalTrials.gov processed this record on August 28, 2016