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 is ongoing, but not recruiting participants.
Sponsor:
Information provided by (Responsible Party):
Novartis ( Novartis Vaccines )
ClinicalTrials.gov Identifier:
NCT01339923
First received: April 13, 2011
Last updated: March 6, 2014
Last verified: March 2014
  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.

to evaluate the safety and immunogenicity of the concomitant


Condition Intervention Phase
Meningococcal Disease
Meningococcal Meningitis
Biological: rMenB + OMV vaccine
Biological: rMenB + OMV NZ vaccine; Meningococcal C oligosaccharide conjugated vaccine; Pneumococcal polysaccharide conjugate vaccine, 10 valent adsorbed
Biological: Meningococcal C oligosaccharide conjugated vaccine; 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:
  • Immune response of rMenB+OMV NZ (defined as ≥70% for the lower limit of the two-sided 97.5% CI for the percentage of subjects achieving hSBA titers of at least 4 for all 3 indicator strains) [ Time Frame: 1 month after second dose ] [ Designated as safety issue: No ]
    To demonstrate a sufficient immune response following rMenB+OMV NZ vaccination, when given as a two dose primary series to healthy infants at 3-1/2 and 5 months of age or at 6 and 8 months of age, as measured by the percentage of subjects with serum bactericidal activity (SBA), using human serum as source of exogenous complement (hSBA) titers of at least 4, at 1 month after the second rMenB+OMV NZ dose, directed against MenB indicator strains H44/76, 5/99 and NZ98/254.


Secondary Outcome Measures:
  • % of subjects with SBA titer ≥ 1:5 against MenB strains H44/76,5/99 and NZ98/254 [ Time Frame: 1 month after: 3rd dose (group I), 2nd dose (group IV), booster dose (group I,II and III) ] [ Designated as safety issue: No ]
  • SBA GMTs against MenB strains H44/76,5/99 and NZ98/254 [ Time Frame: 1 month after: 3rd dose (group I), 2nd dose (group II, III), 1st dose (sub-group Ib, IIb, IIIb), last dose (Groups I-IV) ] [ Designated as safety issue: No ]
  • Bactericidal antibody persistence [ Time Frame: At 11 months of age (groups I to III) ] [ Designated as safety issue: No ]
  • Immune responses to antigen 287-953 by ELISA [ Time Frame: Following two and three dose primary immunization schedules with rMenB+OMV NZ in infants followed by a booster dose at 11 months of age; and after a two dose catch-up immunization series in children 2-10 years of age ] [ Designated as safety issue: No ]
  • MenC noninferiority in MenBC [ Time Frame: 1 month after the 2 vaccinations (3, 5 months) ] [ Designated as safety issue: No ]

Estimated Enrollment: 1400
Study Start Date: April 2011
Estimated Study Completion Date: December 2014
Primary Completion Date: January 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Ia
Healthy Subjects 2-1/2 months of age. rMenB + OMV vaccine
Biological: rMenB + OMV vaccine
3 doses (2-1/2, 3-1/2, 6 months if age) plus booster (11 months of age)
Experimental: Ib
Healthy Subjects 2-1/2 months of age. rMenB + OMV vaccine
Biological: rMenB + OMV vaccine
3 doses (2-1/2, 3-1/2, 6 months of age) plus booster (11 months of age)
Experimental: IIa
Healthy Subjects 3-1/2 months of age. rMenB + OMV vaccine
Biological: rMenB + OMV vaccine
2 doses (3-1/2, 6 months of age) plus booster (11 months of age)
Experimental: IIb
Healthy Subjects 3-1/2 months of age. rMenB + OMV vaccine
Biological: rMenB + OMV vaccine
2 doses (3-1/2, 6 months of age) plus booster (11 months of age)
Experimental: IIIa
Healthy Subjects 6 months of age. rMenB + OMV vaccine
Biological: rMenB + OMV vaccine
2 doses (6, 8 months of age) plus booster (11 months of age)
Experimental: IIIb
Healthy Subjects 6 months of age. rMenB + OMV vaccine
Biological: rMenB + OMV vaccine
2 doses (6, 8 months of age) plus booster (11 months of age)
Experimental: IVa
Healthy Subjects 2-5 years old. rMenB + OMV vaccine
Biological: rMenB + OMV vaccine
2 doses 2 months apart
Experimental: IVb
Healthy Subjects 6-10 years old. rMenB + OMV vaccine
Biological: rMenB + OMV vaccine
2 doses 2 months apart
Experimental: V
Healthy Subjects 3 months of age. "rMenB + OMV NZ vaccine; Meningococcal C oligosaccharide conjugated vaccine; Pneumococcal polysaccharide conjugate vaccine, 10 valent adsorbed."
Biological: rMenB + OMV NZ vaccine; Meningococcal C oligosaccharide conjugated vaccine; Pneumococcal polysaccharide conjugate vaccine, 10 valent adsorbed
Schedule 3, 5, 12 (rMenB + OMV NZ vaccine; Meningococcal C oligosaccharide conjugated vaccine)3, 5, 7 12 (Pneumococcal polysaccharide conjugate vaccine, 10 valent adsorbed)
Experimental: VI
Healthy Subjects 3 months of age. "Meningococcal C oligosaccharide conjugated vaccine; Pneumococcal polysaccharide conjugate vaccine, 10 valent adsorbed."
Biological: Meningococcal C oligosaccharide conjugated vaccine; Pneumococcal polysaccharide conjugate vaccine, 10 valent adsorbed
Schedule 3, 5, 12 (Meningococcal C oligosaccharide conjugated vaccine); 3, 5, 7, 12 (Pneumococcal polysaccharide conjugate vaccine, 10 valent adsorbed); 13, 15 (rMenB + OMV NZ vaccine)

  Eligibility

Ages Eligible for Study:   71 Days to 10 Years
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).
  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. Subjects 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 38C 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 16
Almeria, Spain, 04120
Site 15
Almeria, Spain, 04007
Site 20
Barcelona, Spain, 08195
Site 18
Madrid, Spain, 28935
Site 17
Madrid, Spain, 28041
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

No publications provided

Responsible Party: Novartis ( Novartis Vaccines )
ClinicalTrials.gov Identifier: NCT01339923     History of Changes
Other Study ID Numbers: V72_28
Study First Received: April 13, 2011
Last Updated: March 6, 2014
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 Infections
Central Nervous System Diseases
Nervous System Diseases
Neisseriaceae Infections
Gram-Negative Bacterial Infections
Bacterial Infections
Meningitis, Bacterial
Central Nervous System Bacterial Infections

ClinicalTrials.gov processed this record on September 18, 2014